Tribunals and CommissionsDivision Bench(2011) 08 IPAB CK 0010

M/s. Nutra Specialities Pvt. Ltd., No. 26, Vandalur-Kelambakkam Main Road,Keelakottaiyur,Chennai – 600048 vs Ganga Raju Gokaraju, No. 40-15-14, Brindavan Colony, Vijayawada - 520010, Andhra Pradesh And Others

Intellectual Property Appellate Board · Decided on 10 August 2011

HON’BLE JUDGES
Prabha Sridevan, J · D.P.S. Parmar, Technical Member
RESULT
Allowed
CASE NUMBER
ORA/2/2009/PT/CH

AI Structured Summary

Not yet generated for this judgment

Judgment

325 paragraphs · 7,010 words

D.P.S. Parmar, Technical Member

1.

This is an application under Section 64 for revocation of granted Indian Patent No. 205269(95/CHENP/2004) relating to the process for producing a

fraction enriched upto 100% of 3-O-acetyl-11-keto-""á-Boswellic Acid (""AKBA"") from an extract containing a mixture of boswellic Acids filed by

Gokaraju Ganga Raju for Respondent Nos. 1 to 5.

2.

The Learned Counsel for the applicant submitted that they have file an application for declaration of non infringement under Section 105 which is

pending before the Chennai High Court.

3.

The Learned Counsel for the applicant submitted that the alleged invention claims that the said extract containing a mixture of boswellic acids is

oxidized and acetylated in know manner and resultant mixture is separated chromatographically to collect the enriched fraction of ABKA. The claim 1

of the patents is reproduced below:

A process for producing upto 100% 3-O-acetyl-11keto-á-boswellic acid from an extract containing a mixture of boswellic acids obtained from

gum resin of Boswellia species comprising the steps of oxidizing in a known manner boswellic acids containing fraction from the said extract with

subsequent acetylation in a known manner of said oxidized fraction followed by chromatographic separation to obtain a fraction enriched in 3-O-

acetyl-11-keto-B-boswellic acid in the range of 10 to 100%.

4.

The Learned Counsel for the applicant submitted that the patent claims no novelty or inventive step over the first two steps, ie. of Oxidation and

Acetylation, as it is expressedly stated the first two steps pertain to a known manner which is by definition known to a person skilled in the Article

Additionally, there is no novelty or inventive step in the order in which Oxidation and Acetylation are done as the claims state that the effect would be

the same even if the first two steps are reversed, ie. Acetylation is followed by Oxidation. Chromatographic separation is a method of purification

known to a person skilled in the Article The alleged invention claims a combination of known steps that are known in the Article The alleged invention

only demonstrates the mere use of known process whereby the known process does not result in a new product or employs at least one new reactant.

5.

The patent in question is based on the PCT Application PCT/IN2002/00034 filed on 5 March 2002. This application entered international phase in

United State, EPO, Hong Kong and Australia on 5.03.2002 and entered the national phase in India. On 16. 01.2004, which was numbered as

95/CHENP/2004. The said application was examined by the Patent Office and Patent bearing No. 205269 was granted on 23. 12.2004.

6.

The Learned Counsel for the applicant submitted that US PTO has rejected the said application in view Pardhy et al ""á-Boswellic Acid,

Acetyl-""á-Boswellic Acid, Acetyl-11-keto-""á-Boswellic Acid & 11-keto-""á-Boswellic acid, Four Pentacyclic Triterpene Acids from the

Resin of Boswellia serrata Roxb"" published in Indian Journal of Chemistry, vol 16B, March 1978, pp176-178.

7.

The Learned Counsel relied on the following ground:

a) that the subject of any claim of the complete specification is not an invention with in the meaning of this Act; Section 64(1)(d)

b) that the invention so far as claimed in any claim of the complete specification is obvious or does not involve any inventive step, having regard to

what was publicity known or publicly used in India or what was published in India or elsewhere before the priority date of the claim; Section 64(1)(l)

c) that the scope of any claim of the complete specification is not sufficiently

and clearly defined or that any claim of the complete specification is not fairly based on the matter disclosed in the specification; Section 64(1)(i)

d) that the subject of any claim of the complete specification is not patentable under this Act; Section 64(1)(k)

(a) The subject of claims 1 to 13 is not an invention with the meaning of the Act - Section 64(1)(d)

Section 3 lists the categories that are not inventions under the Act. Any invention which falls within the categories mentioned in Section 3 can be

revoked under Section 3 can be revoked under Section 64(1)(d) of the Act. Section 3(d) which comprises of three parts states that the following are

not inventions within the meaning of the Patents Act:

1) the more discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance; or

2) the mere discovery of any new property or new use for a known substance; or

3) the mere discovery of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at

least one new reactant

The third part of Section 3(d) prohibits the use of a known process unless such a known process results in a new product or employs at least one new

reactant. The alleged invention relates to a process for producing a fraction enriched in 3-O-acetyl- 11-keto-á-boswellic acid (""AKBA"") in the

range of 10 to 100%. The inventive merit does not lie in the end product but in the process of making AKBA. As discussed above, the main claim

comprises of three steps: oxidation in a known manner, acetylation in a known manner and chromatographic separation. The patentee cannot claim

inventiveness to the first two steps as it is admitted as known. The process of chromatographic separation is also known to a person skilled in the

Article In the Patent Applicant's response dated 18 September 2007 to the Fourth Office Action of the USPTA, Claims 1, 2, 28 and 29 were amended

whereby the Patent Applicant deleted the chromatography step in claims 1 and 2. Under Section 3(d), for the grant off patent for a known process, it

must be shown that the end product is new or that the process employs one new reactant. The main claims (Claims 1 and 2) do not specify any new

product which results from the known process or any new reactant to get over the prohibition under the third part of Section 3(d).

(b) The invention claimed in claims 1 to 13 is obvious or lacks inventive step - Section 64(1)(f).

For the reasons stated in the First Office Action of the USPTO which rejected the claims 1 to 14 under 35 USC 103(a) as being unpatentable over

Pardhy et al and Taneja et al (US 5,629,351), the claims 1 to 13 of the above patent ought to be rejected as obvious and lacking inventive step. The

USPTO observed that Pardhy et al teach triterpene acids, including acetyl-11-keto-á-Boswellic acid, isolated from the gum resin of Boswellia

serrata. Pardhy et al teaches the acetylation of the 3-hydroxy group with acetic anhydride and pyridine as well as oxidation of the 11-position with N-

bromosuccinimide (NBS) and CaCo3 in dioxane and water. It also teaches the use of silica gel chromatography in the isolation process. Taneja et al

teach boswellic acid compositions obtained from Boswellic serrata. The reference teaches (a) extraction using various polar solvent including ethyl

acetate, (b) acetylating a boswellic acid mixture with acetic acid and pyridine and (c) isolation using different methods such as chromatography over

silica gel and HPLC, the USPTO observed that production of acetyl-11-keto-á-Boswellic acid by acetylating and oxidizing an extract containing a

mixture of boswellic acids obtained from gum resin of Boswellic serrata would have been obvious to a skilled artisan in the chemical art at the time of

the present invention because (a) the prior art teaches acetylating a mixture containing boswellic acid derivatives (b) the prior art teaches oxidation of

different boswellic acid derivatives and (c) of the level of skill of the ordinary artisan in the art at the time of the present invention. The skilled person

at the time of the invention would have the reasonable expectation any boswellic acid derivative, either alone or in combination, would undergo

acetylation and/or oxidation as taught by the prior art with the production of the desired end product. The motivation is based on the teaching of each

step by the cited prior art and the knowledge in the art of the biological properties of boswellic acid derivatives including acetyl-11-keto-á-

Boswellic acid as well as the desire to obtain a compound having the various properties known in the art for boswellic acids without impurities that

would result in adverse reactions. The USPTO noted that the claimed process is a selective combination of prior art teachings, done in a manner

obvious to one of ordinary skill in the Article It further notes that Claim 6 (which corresponds to claim 6 of the above patent) differs from the cited

prior art by reciting the utilization of dicholorethane with acetyl chloride in the presence of pyridine for oxidation. Claim 7 (which corresponds to claim

7 of the above patent) differs from the cited prior art by reciting the crystallization utilizing crushed ice followed by separation and drying under

vacuum. Claim 9 (which corresponds to claim 9 of the above patent) differs from the cited prior art by reciting rechromatography in order a purer

compound. The USPTO's First Office Action notes that (a) acetyl chloride like acetic anhydride and acetic acid, is a well known acetylating agent

(see, US 4,725,588, col 5, lines 7-10 and US 5,212,323, col 4, lines 14-17); (b) dichloroethene and pyridine are known to be useful in acetylation

processes (see, US 5,212,323, col 4, lines 9-13; US 6,147,088, col 13, lines 55-66); (c) decreasing the temperature of a reaction mixture in order to

obtain precipitates/crystals is well known in the chemical art and (d) repeated isolated such as repeated chromatography in order to obtain a purer

compound would be obvious to a person skilled in the Article The USPTO held the claimed process to be prima facie obvious. The second office

action sustained the rejection of the amended and the newly introduced claims under 35 USC 103(a) over Pardhy et al (Indian Journal of Chemistry)

and Taneja et al (US 5,629,351) for reasons stated in the First Office Action. 14. The Third Office Action dated 13 November 2006 and the Fourth

Office Action dated 18 July 2007 sustained the rejection of claims 1, 2 and 16-29 under 35 USC 103(a) as being obvious and lacking inventive step.

(c) The scope of claims 1 to 13 is not sufficiently and clearly defined - Section 64(1)

(i)

The First Office Action rejected the claims 1 and 3-12 under 35 USC 112 as being indefinite for failing to particularly point out and distinctly claim the

subject matter which applicant regards as the invention. In the Patent Applicant's response dated 17 January 2006 to the First Office Action, claims 1

and 2 were amended, claims 3 to 14 were cancelled and claims 15 to 24 were newly introduced. Despite the amendment and introduction of new

claims, the Second Office Action dated 30 March 2006 rejected the claims in toto. Claims 1, 2 and 16-25 were rejected under 35 USC 112 as failing

to comply with the written description requirement. It is submitted that the claims 1 to 13 are not sufficiently and clearly defined. The claims 1 and 2

do not describe the preparation of extract of boswellic acids from gum resin of Boswellia species. Claim 3 refers to an 'organic solvent extract' but the

same in not specified. Claims 5 and 7 recite 'said reaction mixture', whereas the parent claim does not recite a mixture. Claim 8 recites the phrase

'such as' which renders the claim indefinite as it is unclear whether the limitations following the phrase are part of the claimed invention. Claim 9

recites 'wherein the fraction eluted from the said column'. There is no reference to eluting a fraction from a column in parent claim 7. Claim 10 recites

'wherein said solid supports' and 'solvents are selected from...' Parents claim 8 does not recite a solid support nor does it recite all of the solvents

recited by the instant claim. Claim 11 recites 'wherein said fraction eluted from the said column'. Parent claim 8 does not recite a fraction. Claim 12

recites 'said natural boswellic acids fraction'. There is no antecedent basis for the said limitation because the parent claim does not refer to a natural

boswellic acids fraction. Claim 13 is an omnibus claim. The Second Office Action noted that the Original Claim 15 was cancelled in the preliminary

amendment dated 16 May 2003 as it was an omnibus claim. Claim 13 of the above patent corresponds to claim 15 of the US Application.

8 . The Learned Counsel for the Appellant relied on two citations viz. Pardhy and Taneja et.

Pardhy et al. teach triterpene acids, including actety-11-keto-B-boswellic acid, isolated from the gum resign of Boswellia serrata (see the entire article,

especially page 176-col.1. paragraph 3 and 4, col. 2, formula V; page 177, Experimental Procedure, Acid-B(V)). Pardhy el at. Teaches the acetylation

of the 3-hydroxy group with acetic anhydride and pyridine as well as oxidation of the 11-position with N-bromosuccinimide (NBS) and CaCO3 in

dioxane and water (see for example, page 177, col. 1, paragraphs 4 and 6 and Company 2, paragraph 5). The reference also teaches the use of silica

gel chromatography in the isolation process (see for example page 177, col. 2, paragraphs 3 and 4).

Taneja et al. teach boswellic acid compositions obtained from Boswellic serrata (see the entire article, especially Company4, lines 3-30). The

reference teaches (a) extraction using various polar solvent including ethyl acetate, (b) acetylating a boswellic acid mixture with acetic acid and

pyridine and (c) isolation using different methods such as chromatography over silica gel and HPLC (see col. 5, line 49 - col. 6, line 47; col. 10,

Example 5).

The production of acetyl-11-keto-B-Boswellic acid by acetylating and oxidizing an extract containing a mixture of boswellic acids obtained from gum

resin of Boswellic serrata would have been obvious to the skilled artisan in the chemical art at the time of the present invention because (a) the prior

art teaches acetylating a mixture containing boswellic acid derivatives (see Taneja et al. as discussed above), (b) the prior art teaches the oxidation of

different boswellic acid derivatives (see Pardhy et al. as discussed above) and (c) of the level of skill of the ordinary artisan in the art at the time of

the present invention. The ordinary artisan in the art at the time of the present invention would have the reasonable expectation any boswellic acid

derivative, either alone or in combination, would undergo acetylation and/or oxidation as taught by the prior art with the production of the desired end

product. The motivation is based on the teaching of each step by the cited prior art and the knowledge in the art of the biological properties of

boswellic acid derivatives including acetyl-11-keto-á-boswellic acid as well as the desire to obtain a compound having the various properties

known in the art for boswellic acids without impurities that would result in adverse reactions. It is also noted that the claimed is a selective combination

of prior art teachings, done in a manner obvious to one of ordinary skill in the Article Each of the steps of the claimed process appears to be relatively

complete in itself (see Pardhy et al.)

Claim 6 differs from the cited prior art by reciting the utilization of dichloroe thane with acetyl chloride in the presence of pyridine for oxidation.

Claim 7 differs from the cited prior art by reciting the crystallization utilizing crushed ice followed by separation and drying under vacuum.

Claim 9 differs from the cited prior art by reciting rechromatography in order to obtain a purer compound.

However, (a) acetyl chloride like acetic anhydride and acetic acid, is a well known acetylating agent (see for example, US 4,725,323, col.4, lines 9-13;

US 6,147.088, col.13, lines 55-66); (c) decreasing the temperature of a reaction mixture in order to obtain precipitates/crystals is well known in the

chemical art and (d) repeated isolation such as repeated chromatography in order to obtain a purer compound would be obvious to the ordinary artisan

in the chemical Article Based on the teachings of the references as discussed above and the level of skill of the ordinary artisan in the art at the time

of the present invention, the claimed process is prima facie obvious.

9 . The Learned Counsel for the Appellant argued that the combined teaching of Pardhy and Taneja, clearly indicate that the invention claimed is

obvious, because

(a) each step on the claimed process is known in the art as shown by Pardhy and Taneja,

(b) the prior art also teaches AKBA is more active forms of all the boswellic acids. (page 616 table and page 617. Results and discussion 1st

paragraph).

(c) the inter concession of the boswellic acids via acetylation and/or oxidation (para Pardhy 177).

(d) Example 5(b) of Taneja.. Separation of Boswellic Acids of the Formulae I through VI by Chemical and Chromatographic Methods.

i) The fraction of the acid mixture (10 g) as obtained in example 1 is hydrolysed with potassium carbonate (12g) in methonal (100 ml) at 65o C for 2

hrs. The hydrolysed mixture is filtered and concentrated to one fourth of its original volume. The concentrated extract is refrigerated for 6 hrs and first

crop of pure boswellic acid (3 g) of formula 1 is separted by filtration. The mother liquor is further concentrated, kept overnight and filtered to obtain

the second crop of B-boswellic acid (1.0 g). From the

remaining mother liquor solvent is evaporated and mixture is subjected to column chromatography over silica gel (60 to 120 mesh) 120 g. The elution is

carried out with methanol/chlorogorm (5/95 to 20/80) with gradient elution and monitoring the progress of column by TLC. The following compounds

could be separated by repeated column chromatography. á-boswellic acid of formula I (1.3 g), 11-keto-B-boswellic acid of the formula III (1.00

g) and 2a, 3a-dihydroxy-urs-12-ene-24-oic acid of the formula VI (0.09 g) and other unidentified compounds.

ii) The fraction containing the boswellic acid mixture (10 g) as obtained in example 1 is acetylated in acetic anhydride (35 ml) and pyridine (2 ml) and

the mixture is kept overnight in a refrigerator. Acetyl B-boswellic acid of the formula II (3.7 g) which crystallized out is separated by filtration and

washing with dilhy drochloric acid and water. The mother liquor is concentrated to one third of its original volume and again refrigerated for 12 hrs to

give second crop of the compound of formula II (1.5 g). From the remaining mother liquor the solvent is evaporated under reduced pressure and the

mixture is subjected to column chromatography over silica gel (60 - 120 mesh) 120 g as described in part (a) of this example. The following

compounds were separated by repeated chromatography. Acetyl á-boswellic acid of the formula II (1.0 g), 3a-acetoxyurs-9, 12 diene-24-oic acid

which was hydrolysed with sodium carbonate in liquor is further concentrated, kept overnight and filtered to obtain the second crop of B-boswellic

acid (1.0 g). From the remaining mother liquor solvent is evaporated and mixture is subjected to column chromatography over silica gel (60 to 120

mesh) 120 g. The elution is carried out with methonal/chloroform (5/95 to 20/80) with gradient elution and monitoring the progress of column by TLC.

The following compounds could be separated by repeated column chromatography. á-boswellic acid of formula I (1.3 g), 11-keto-B-boswellic

acid of the formula III (1.00 g) and 2a, 3a-dihydroxy-urs- 12-ene-25-oic acid of the formula VI (0.09 g) and other unidentified compounds.

(e) Knowing that acetyl group at C3 position of AKBA also contributes the ant in fiantory patents of AKBA (its ability to use inhabit 5-LOX activity)

(para 2 of Counter Statement). The anti informatory potency of the mixture by increasing the amount of AKBA - boswellic acid having keto group at

C11 and cetyl group at C3. It would be obvious to a person shall in the act to optimize the amount of AKBA in the extracted mixture. Similarly, it

would be obvious to use extracted mixture and remove the impurities that may result in adverse reaction.

Optimisation flows for the normal desire of scientists to improve upon what is ahead separately known.

10.

Learned Counsel for the Respondent first raised the issue of delay/laches as the Appellant has not filed any pre-grant/post grant opposition.

Learned Counsel relied on AIR 2010 SC 715 Rasiklal Dalpatram Thakkar v. State o Gujarat and Ors. ""It was held that ""It is settled law that fence-

sitters cannot be allowed to raise the dispute or challenge the validity of the order after its conclusion. No party can claim the relief as a matter of right

as one of the grounds for refusing relief is that the person approaching the Court is guilty of delay and the laches. The Court exercising public law

jurisdiction does not encourage agitation of stale claims where the right of third parties crystallizes int he interregnum. (Vide Aflatoon and Ors. v. Lt.

Governor Delhi and Ors. AIR 1974 SC 20771 State of Mysore v. V.K. Kangan and Ors. AIR 1975 SC 2190; Municipal Counci Ahmednagar and

Anr. v. Shah Hyder Beig and Ors. AIR 2000 SC 671 : 2000 AIR SCW 197; Inder Jit Gjpta v. Union of India and Ors (2001) 6 SCC 637 : (2001 AIR

SCW 3183); Shiv Dass v Union of India and Ors. AIR 2007 SC 1330 : (2007 AIR SC 1487); Regional Manager A.P. SRTC v. N. Satyanarayana and

Ors. (2008) SCC 210 : (AIR 2007 SCW 7137); and City and Industrial Development Corporation v. Dosu Aardeshir Bhiwandiwala and Ors. (2009) 1

SCC 168: AIR( 2008 SCW 7706).

Thus, in view of the above, the settled legal proposition that emerges is that once the seniority had been fixed and it remains in existence for a

reasonable period, any challenge to the same should not be entertained. In K.R. Mudgal, (Air 1986 SC 2086) (supra), this Court has laid down, in

crystal clear words that a seniority list which remains in existence for 3 to 4 years unchallenged, should not be disturbed. Thus, 3-4 years is a

reasonable period for challenging the seniority and in case someone agitates the issue of seniority beyond this period, he has to explain the delay and

laches in approaching the adjudicatory forum, by furnishing satisfactory explanation.

11.

We do not find his argument convincing in view of the position of law in this matter Section 64 of the Patents Act, 1970 does not impose any such

limitation. Section 64(1) ""subject to the provisions contained in this Act, a patent whether granted before or after the commencement of this Act may

be revoked on a petition of any person interested or of the Central Government by the Appellate Board or on a counter-claim in a suit for infringement

of the patent by the High Court."" Hence the applicant are within the time in filing the present revocation petition.

12 . According to the Learned Counsel for the Respondent, when calculation were made it was found that if Pardhy is followed for producing 1kg of

AKBA, 270 kg of raw material is required. If example of Taneja is used for 1 kg of AKBA 100 kg of raw material is required. But in the invention

claimed by Respondent for obtains 1 kg of AKBA only 13 kg of raw material is sufficient. In view of this, this invented process is mere economical.

13.

The Learned Counsel for the Respondent argued that the product produced by the invented process by multiple sequential steps using crude

extract containing inter alia the desired boswellic acid (AKBA) is unpredictable and has unexpected properties as shown in the Dr. Shivas affidavit.

14.

The Learned Counsel for the Respondent argued that neither Pardhy nor Taneja nor Sailes teach sequential acetylation and oxidation of extract

containing mixture of boswellic acids to obtain a modified extract having an AKBA extract 30% -40% wt. and additionally subjecting the modified

extract to chromatography to further increase AKBA concentration upto 80% wt. According to the Appellant, Pardhy only teaches oxidation of

purified boswellic acids, not the mixture of boswellic acids and the Appellant invention uses crude extract where it would be difficult to predict

reaction outcomes.

15.

We shall now examine the citations and compare it with the alleged invention. The alleged process of the invention combine well-known processes

such as oxidation and acetylation steps in an obvious manner to produce an obvious product followed by the purification step in this case

chromatography. The organic extract of gum risen from Boswellia plants yield a mixture of boswellic acids, such as 11-keto-á-boswellic acid, 3-

acetyl-11-keto-á-boswellic acid (AKBA), á-boswellic acids, and 3-acetyl-á-boswellic acid minor amounts of other boswellic acids and

some unidentified compounds. The mixture of acids is known to have anti-inflammatory activity due to the presence of AKBA. It would have been

prima facie obvious to improve the anti-inflammatory potency of the mixtures of boswellic acids extracted from Boswellia resin by increasing (alleged

enriching) the amount of AKBA as these structures determine 5-LOX inhibition ability taught by Sailer. With this knowledge a person skilled in the art

would obviously convert one boswellic acid into another boswellic acid by using well known techniques of hydrolysis acetylation and oxidation which

the Respondent also admits. The Respondent's argument is essentially based on the premise that it is difficult to predict reaction outcomes when

dealing using a crude extracts as used in the invention. However, the Respondent failed to account for the processing that occurs between the initial

crude extract and the final dry boswellic acid mixture that is the extract containing 1% to 10% of AKBA recited in the claimed invention as starting

material. Taneja teaches the extraction of boswellia gum resin with methanol and extraction of concentrated methanol extract to precipitate out the

boswellic acid as referred in Example1. Taneja also teaches further to hydrolyzes or acetylates, the precipitate as obtained in Example 1 exemplified in

Example 5. This precipitated as a mixture contain 5% of AKBA is an extract containing 1% to 10% of AKBA as recited in the Respondent claim.

Further Pardhy teaches oxidation of purified boswellic acids which provides a reasonable expectation to the person skilled in the art in using the

mixture of boswellic acids produced by Taneja using acetylating and hydroxyurs of a mixture of boswellinc acids. Taneja also hydrolyzes the

acetylated products back to original acids. Therefore, we are not convinced with the Respondent arguments that neither Pardhy nor Taneja or Sailer

individually teaches or suggest sequential acetylation and oxidation or vice versa of an extracted mixture of bosewellic acid. Further, the Respondent

arguments that it would not be prima facie obvious to enrich the AKBA content for the extracted mixture of boswellic acids up to 100% as claimed in

subsequent claims is also not convincing as a person skill in the art would have obviously optimize the amount of AKBA in the extracted mixture by

extracting the mixture and removing the impurities by chromatography. The Respondent's contention that the claim product has unexpected properties

as compared to the existing product does not come to his rescue as the existence of synergism is taught by Taneja and hence the synergism in AKBA

containing mixture when compared to AKBA solution alone is not unexpected.

16.

The Respondent relied on the following citations that combination patents are allowed:

MANU/MH/0203/1934 - Lallubhai Chakubai Jarivala v. Shamaldas Sankalchand Shah -

It was stated that the law on the subject is stated in Haisbury, Vol.22, para 292, P.138, as follows:

A new combination may be the subject matter of a patent although every part of the combination per se is cold, for here the new article is not the

parts themselves, but the assembling and working them together, which ex hypothesis is new if the result produced by such a combination is either a

new article, or a better article, or a cheaper article than before, such combination is an invention or a manufacture within the statute and may well be

the subject matter of a patent.

I may also refer to a passage which the learned Judge himself has used from Fletcher Moulton on Patents (1913 Edn.) p. 46, which is in these terms:

In some cases and more particularly in the case of chemical patents, a variation of old methods has been held to form subject matter because it was

not possible to predict the new result from the results of the old method with any certainty or without experiments and research.

The above passages, in my opinion, support the view which I am now taking. A new manufacture does not mean only a new article of manufacture,

but also means a new process or method of manufacturing something new. It does not mean a new principle of manufacture; a principle cannot be an

invention but it means a new application of the principles so as to produce a new method or a new manufacture.

MANU/SC/0255/1978 - Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries

It was stated that the object of Patent Law is to encourage scientific research, new technology and industrial progress. Grant of exclusive privilege to

own, use or sell the method or the product patented for a limited period, stimulates new inventions of commercial utility. The price of the grant of the

monopoly is the disclosure of the invention at the Patent Office, which after the expiry of the fixed period of the monopoly, passes into the public

domain.

The fundamental principle of Patent Law is that a patent is granted only for an invention which must be new and useful. That is to say, it must have

novelty and utility. It is essential for the validity of a patent then it must be the inventor's own discovery as opposed to mere verification of what was

already known before the date of the patent.

'Invention' means any manner of new manufacture and includes an improvement and an allied invention"". [Section 2(8) of 1911 Act]. It is to be noted

that unlike the Patents Act 1970, the Act of 1911 does not specify the requirement of being useful in the definition of 'invention'. But courts have

always taken the view that a patentable invention, apart from being a new manufacture, must also be useful. The foundation for this judicial

interpretation is to be found in the fact that Section 26(1)(f) of the 1911 Act recognizes lack of utility as one of the grounds on which a patent can be

revoked.

'Manufacture' according to the definition of the term in Section 2(11) of the Act, includes not only 'any art, process or manner of providing, preparation

or making an article' but also 'any article prepared or produced by the manufacture'.

It is important to bear in mind that in order to patentable an improvement on something known before or a combination of different matters already

known, should be something more than a mere workshop improvement; and must independently satisfy the test of invention or an 'inventive step'. To

be patentable the improvement or the combination must produce a new result, or a new article or a better or cheaper article than before. The

combination of old known integers may be so combined that by their working inter relation they produce a new process or improved result. Mere

collection of more than one integers or things, not involving the exercise of any inventive faculty, does not qualify for the grant of a patent.

Narayanan Para 16-117

What constitutes combination patents. "" It is accepted as sound law that a mere placing side by side of old integers so that each performs its own

proper function independently of any of the others is not a patentable combination, but that where the old integere when placed together have some

working inter relation producing a new or improved result then there is patentable subject matter in the idea of the working inter relation brought about

by the collocation of the integers. Almost every patent is for a new combination.

In Biswanath Prasad Radhey Shyam v. Hindustan metal Industries (1979)2 SCC 511 at 518 it was observed: ""In order to be patentable an

improvement on something already known before or a combination of different matters already known, should be something more than a mere

workshop improvement, and must independently satisfy the test of invention or an inventive step. To be patentable the improvement or the combination

must produce a new result, or a new article or a better or cheaper article than before. The combination of old, known integers may be so combined

that by their working inter relation they produce a new process or improved result. Mere collection of more than one integer or things, not involving the

exercise of any inventive faculty does not qualify for the grant of a patent"". See also para 16-71, footnote 3.

RPC Vol. LX page 142 -The overriding difference (in addition to the change to operation by pushing up instead of pulling down) is that in the

Plaintiff's patent the liquid inlet is closed and the air inlet is opened by means which are carried by the moving member and disposed within the

measuring chamber.

In my opinion, even if it be assumed that the mere change from downward to upward movement involved no inventive step, when that change is

associated with the mechanical features indicated above, good subject matter for a valid patent has been disclosed.

Counsel for Stranger's Ld., invited us to approach the question of validity of the lines adopted by Lord Moulton in the Gillette Safety Razor Coy. v.

Anglo American Trading Coy. Ld. (30 R.P.C. 465), and he argued that if he established that Newland's device, if changed to operation by upward

pressure, was within Claim 1 of the Plaintiff's patent there could be no novelty in the Plaintiff's invention; in other words, he argued that the mere

change from push to pull was not patentable and that if the device shown in ""R"" was within Claim 1 of the Plaintiff's patent, then that patent must be

invalid because in the words of Lord Moulton, ""it would include something which differed by no patentable difference from that which was ""already in

possession of the public"". This, after all, is only approaching the problem from the other end, and I have already given my reasons for holding that ""R

is not within Claim 1 of the Plaintiff's patent.

Whether there has or has not been an inventive step in constructing a device for giving effect to an idea which when given effect to seems a simple

Idea which ought to or might have occurred to anyone, is often matter of dispute. More especially is this the case when many integers of the new

device are already known. Nothing is easier than to say, after the event, that the thing was obvious and involved no invention. The words of Moulton

L.J. (British Westinghouse Coy. v. Braulik 27 R.P.C.209 at page 230) may well be called to mind in this connection:""I confess"" (he said) ""that I view

with suspicion arguments to ""the effect that a new combination, bringing with it new and important consequences in the shape of practical machines, is

not an invention because when it has once been established. It is easy to show how it might be arrived at by starting from something known, and

taking a series of apparently easy steps. This ex post facto analysis of invention is unfair to the inventors and in my opinion it is not countenanced by

English Patent Law.

My Lords, it is always pertinent to ask, as to the article which is alleged to have been a mere workshop improvement, and to have involved no

inventive step, has it been a commercial success? Has it supplied a want?

919 F.2d 720, 16 U.S.P.Q.2d 1923 - The Gillette Company v. S.C. Johnson and Son Inc., -What we stressed in Kimberly-Clark, and have repeated

may times since, was that 35 UC 103 requires analysis of a claimed invention as a whole.

It is true that the claimed invention consists of a combination of old elements so arranged as to perform certain related functions. It is immaterial to the

issue, however, that all of the elements were old in other contests. What must be found obvious to defeat the patent is the claimed combination.

745 F.2d at 1448, 223 USPQ at 609-10 (emphasis added). Focusing on the obviousness of substitutions and differences, instead of on the invention as

a whole, is a legally improper way to simplify the often difficult determination of obviousness. Hybritech Inc. v. Monoclonal Antibodies Inc. 802 F.2d

1367, 1838, 231 USPQ k1, 93 (Fed.Cir.1986), cert. denied, 480 U.S. 947, 107 S. Ct. 1606, 94 L. Ed.2d 792 (1987).

Here, the ""claimed combination"" is a composition whose individual components were concededly well known at the time of the invention. As the

district court found, however, the prior art made no suggestion, clear or otherwise, of substituting the claimed water-soluble polymers for Bluard's oil-

soluble jellifying agent; nothing in the prior art suggested the idea of a post-foaming shaving gel, much less one in which water soluble polymers were

used.

In re Eli Lilly & Company, 902 F.2d 943, 14 USPQ 2d 1741, (Fed. Cir. 1990). However, we have consistently held that ""obvious to try"" is not to be

equated with obviousness under 35 USC 103. See O'Farrell, 853 F.2d at 903, 7 USPQ2d at 1680; Hybritech, 802 F.2d at 1380, 231 USPQ at 91; Jones

v. Hardy 727 F.2d 1524 1530 220 USPQ 1021 1026 (Fed.Cir.1984)

We see no reason why the above reasoning from Interconnect, a case that dealt with a mechanical invention should not apply with equal weight to the

present chemical case. There is no question that each component of Monson's composition was separately known in the prior Article What was not

known or suggested, however, was the composition that resulted from the combination of those components and its unique properties. As Johnson

succinctly states.

Gillette, 12 USPQ2d at 1963. Indeed, Gillette's skepticism is relevant and persuasive evidence of the non obviousness of Monson's invention.

We reject Gillette;s remaining argument that other art-recognized advantages of cellulose based polymers, namely lubricity and consistency

enhancement provide the ""suggestion"" sufficient to motivate the art worker to substitute them for Bluard's aluminum octoate. This theory boils down to

no more than hindsight reconstruction of the type so aptly described by the poet Milton over three centuries ago. The invention all admired and each

how he to be the inventor missed so easy it seemed. Once found, which yet unfound most would have thought impossible.

17.

The Learned Counsel for the Respondents argued that in view of the above cases the present invention is beyond the purview of Section 3(d).

Learned Counsel further added that in the present case the new product is 30-40% enriched AKBA in an extract containing mixture of boswellic acid

which is not known in any of the prior prior art cited by the applicant. The product makes the process much more than a 'mere' use of a known

process as it has shown unexpected properties in anti-in flamatory actively.

18.

We do not find his argument of allow ability of combination patent convincing in view of the fact that the invention claimed is obvious in view of

the citations referred above. Even if his invention passes the 3(d) test it fails to over come the obviousness test in view of the cited documents. He,

therefore does not succeed on this count.

1 9 . Learned Counsel for the Respondent contented that the claim 3, 5,6,7,8 are clearly defined, however seeks to make the amendments of claims as

stated below, if the patent is likely to be revoked.

Amended Claims

1 . A process for producing upto 100% 30-40% enriched 3-O-acetu;1-11-keto-á-boswellic acid from in an extract, containing a fraction of a

mixture of boswellic acids, obtained from gum resin of Boswellia species, comprising the steps of Oxidizing oxidation in a known manner of the

boswellic acids containing fraction from in said extract and with subsequent acetylation in a known manner of said oxidized fraction followed by

chromatographic separation to obtain a fraction enriched in of said 3-O-acetyl-11-keto-á-boswellic acid in the range of 10-100% purity.

2.

A process for producing upto 100% 30-40% enriched 3-O-acetyl-11-keto-á-boswellic acid from in an extract containing a fraction of a mixture

of boswellic acids, obtained from gum resin of Boswellia species, comprising the steps of Acetylating acetylation in a known manner of the boswellic

acids containing fraction from in said extract and with subsequent oxidation in a known manner of said oxidized fraction followed by chromatographic

separation to obtain a fraction enriched in of said 3-O acetyl-11-keto-á-boswellic acid in the range of 10-100% purity.

5 . The process as claimed in claim 3 4, wherein said reaction mixture is diluted with water and extracted with ethyl acetate; said ethyl acetate extract

is washed, dried and evaporated to remove the organic solvent.

6.

The process as claimed in claims 1 to 5, wherein said acetylation step is carried out by treating said keto-boswellic acids from the oxidation step in

dichloroethane with acetyl chloride in the presence of pyridine.

7 . The process as claimed in claim 5 6, wherein said reaction mixture is poured into crushed ice and the white precipitate obtained is separated and

dried under vacuum.

9.

The process as claimed in claim 7 8, wherein the fraction eluted from said column is dried and re-chromatographed to obtain 98% to 100% pure of

3-O-acetyl-11-keto-á-boswellic acid.

13 . A process for producing upto 100% 30-40% enriched 3-O-acetyl-11-keto-B-boswellic acid from an extract containing a mixture of boswellic

acids obtained form gum rein of boswellia species substantially as herein described with reference to the accompanying drawings.

20.

In view of the above analysis and over the combined teaching of Pardhy, Taneja and Sailer we are inclined to conclude that the claimed invention

is obvious to the person skilled in art and hence the Indian patent No. 25269 is revoked. The revocation petition is allowed.