University Of Copenhagen vs Controller Of Patents

The present appeal has been preferred under Section 117A of the Indian Patents Act, 1970 against the order dated 06/05/2020, passed by

Respondent, being the Controller of Patents, under Section 15 of the Act, refusing the Appellant’s Indian patent application no. 531/DELNP/2013.

Facts of the case.

2.1 This application was filed as National phase application based on the PCT International application No. PCT/EP2011/004565 dated 06/07/2011.It

was assigned an application no. 531/DELNP/2013. The First Examination Report (FER) was issued on 02/07/2018. The main objections

communicated in FER are as follows:

A. In view of the plurality of distinct inventions (see Para under heading- Unity of invention), the search and examination u/s 12 and 13 of

the Patents Act, 1970 (as amended) has been deferred with respect to groups of inventions II to VII containing claims 22 to 28. Hence,

present examination report is restricted to Invention I having claims 1-21 only.

B. INVENTIVE STEP:

Claim(s) (1-21) lack(s) inventive step, being obvious in view of teaching (s) of cited document(s) above under reference D1-D3 for the

following reasons:

D1 provides evidence for the existence of glucosinolate transport proteins and teaches biochemical characterization of glucosinolate

transport activity and also teaches the directions of research on glucosinolate transport.

D2 teaches a functional genomics approach based on expression cloning in Xenopus oocytes and subsequent screening for uptake activity

to identify plant transporter function and also teaches glucosinolates transport in Arabidopsis, and provides a pool of 239 genes in an

Arabidopsis thaliana transporter library that includes Atlg69870.

D3 discloses a potential transporter molecule, which shows 100% sequence identity to present glucosinolate transporter GTR1

fromArabidopsis; this molecule only now turns out to be a glucosinolate transporter. Said molecule has 92% identity to instant SEQ ID NO:

26, and refers to this sequence as SEQ ID NO: 96267. D3 further teaches methods of modulating gene expression by regulation of

expression of one or more endogenous genes in a plant, or by suppression or expression of the polynucleotides encoding SEQ ID NO:

96267 in a plant. The methods of modulation include inserting antisense or ribozyme constructs of SEQ ID NO: 96267 into a host cell.

Dl teaches attempts to breed Brassica napus seeds with low levels of glucosinolates, this would also result in the identification of

glucosinolate transporters in Brassica spp. based on homology and in silico screening, complemented with glucosinolate uptake assays; and

optionally functional confirmation by expression of the homologous clones in Xenopus oocytes, complemented with glucosinolate uptake

assays, as taught by D2. Given the earlier attempts to breed Brassica napus seeds with low levels of glucosinolates, it would have been

obvious to modify the above Arabidopsis-based method to Brassica-based methodology by incorporating cDNAs from the closely related

Brassica spp., in the absence of evidence to the contrary. Obviously, a person skilled in the art would have been motivated to do so for the

purpose of identifying glucosinolate transporters and obtaining plants with reduced levels of glucosinolates, as taught by Dl. This would

also result in modification of the GSL content in Arabidopsis and/or Brassica plants, using standard molecular biology techniques known in

the art. Bioinformatic analysis, in silico and cDNA library screening, isolation and purification and identification of DNA clones, expression

in Xenopus oocytes, uptake assays, plant transformation, and up- and down-regulated expression of genes and proteins, are techniques

that were routine in the art at the time the invention was made, as taught by the cited documents.

It would have been obvious and within the scope of a person skilled in the art at the time the invention was made to express an Arabidopsis

and/or Brassica transporter cDNA library, such as the one taught by D2, in Xenopus oocytes, and to subsequently screen for glucosinolate

uptake activity, to identify glucosinolate transporters in Arabidopsis and/or Brassica. The identification would have been greatly facilitated

by the availability of the pool of only 239 Arabidopsis transporter genes and the known transporter sequences taught by D2 and D3 (SEQ

ID N0:36913 AND/OR SEQ ID NO: 96267).

Thus, the inventive step for the subject matter claimed in claims 1-21 cannot be acknowledged.

C. NON PATENTABILITY

Claim(s) (19-20) are statutorily non-patentable under the provision of clause ( j ) of Section 3 for the following reasons: A plant or plant

part and seed from said plant claimed in claims 19 and 20 are non- patentable subject-matter as per provision of Section 3(j) of the Patents

Act. Besides, the plant claimed in claim 19 is a claim by way of product-by-process, which is not allowable, as being claimed based on the

method of production.

D. UNITY OF INVENTION:

Claim(s) 1-28 lack(s) unity of invention as the claims do not relate to a single invention or to a group of inventions linked so as to form a

single inventive concept:

Subject matter of claims 1-28 does not relate to a single invention, or to a group of inventions linked so as to form a single inventive

concept as per Section 10 (5) of the Act. It means that the present application does not comply with the requirement of unity of invention.

There are 7 separate groups of inventions and there is no technical interrelation between these inventions. The groups of inventions can be

seen as under:

Invention I:

Claims 1-21-

Methods for modifying the glucosinolate content of Brassicales plants, for reducing GTR activity in a cell of a plant as defined in the claims.

Invention II: Claims: 28(completely); 22-27(partially)-

Isolated DNA and protein molecules, chimeric genes for plant expression and plants derived therefrom, wherein the DNA and protein

molecules comprise a GTR1 sequence of any of SEQ ID NO: 1 ,2,13-24,37-42,49-54,142- 150.

Invention III: Claims: 22-27(partially)-

Isolated DNA and protein molecules, chimeric genes for plant expression and plants derived therefrom, wherein the DNA and protein

molecules comprise a GTR2 sequence of any of SEQ ID NO: 3,4,25-32,35,36,43-48,55- 60,119-136

Invention IV: Claims: 22, 25-27(all partially)-

Isolated DNA and protein molecules, chimeric genes for plant expression and plants derived therefrom, wherein the DNA and protein

molecules comprise a GTR3 sequence of SEQ ID NO: 5, 6.

Invention V: Claims: 22, 25-27(all partially)-

Isolated DNA and protein molecules, chimeric genes for plant expression and plants derived therefrom, wherein the DNA and protein

molecules comprise a GTR4 sequence of SEQ ID NO: 7, 8.

Invention VI: Claims: 22, 25-27(all partially)-

Isolated DNA and protein molecules, chimeric genes for plant expression and plants derived therefrom, wherein the DNA and protein

molecules comprise a GTR5 sequence of any of SEQ ID NO: 9, 10.

Invention VII: Claims: 22, 25-27(all partially)- Isolated DNA and protein molecules, chimeric genes for plant expression and plants derived

therefrom, wherein the DNA and protein molecules comprise a GTR6 sequence of SEQ ID NO: 11, 12.

The common feature among the subject matters of claims mentioned in above said groups of inventions is that they refer to DNA and

polypeptide molecules encode putative glucosinolate transporter molecules. Although the existence of this kind of genes was not known

from the prior art in a functional sense, the prior art discloses polypeptide and polynucleotide molecules from Arabidopsis which encode for

a putative transporter and share 100% identity with present SEQ ID NO: 2 (see D3: US 2007/214517 A1). Further, it is entirely obvious in

the light of the prior art and also anticipated in the documents to use said polynucleotide sequence to create plant expressible constructs

and corresponding transgenic plants. It means that there is no common special technical feature for the whole scope of the present

application that would define an appreciable contribution over the prior art. Hence, the present application lacks unity of invention.

E. CLARITY AND CONCISENESS:

Claim(s) 14-16 and 21 are not clearly worded in respect of: The subject-matter of present claims 14-16 and 21 is regarded to lack clarity.

The methods and uses relate to employment of a GTR gene. The term “GTRâ€, however, appears to be an arbitrary designation which

has no generally accepted meaning in the art. The claims lack those technical features which are needed to characterize the claimed genes,

i.e. the DNA sequences as disclosed in the application. Due to this lack of technical characterization, claimed subject-matter appears to be

defined merely by desirable features and a result to be achieved.

F. DEFINITIVENESS:

Claim(s) 13 do not sufficiently define the invention for the reasons as follows: Regarding claim 13, the claim recites decreased GSL content

in plant seed. However, it is not clear, which plant exactly the recited plant seed is referring to, and how it is related to the claimed method.

For example, it is not clear how modifying the GSL content in an Arabidopsis thaliana plant growing in Virginia would decrease the GSL

content in the seed of a Brassica napus plant growing in Saskatchewan. Therefore, one of ordinary skill in the art would not be reasonably

apprised of the scope of the invention.

G. OTHERS REQUIREMENTS:

(a) Claim 21 is directed to use of GTR-encoding nucleic acid sequence and hence, this claim is nothing but an application claim, which are

not allowable u/s 2 (1) (j) of the Act.

(b) Claim 18 being dependent claims is incorrectly made dependent on claim 1-37. Further, Braisscica plant has already been mentioned in

claim 1 on which it is dependent; thus, it may be redundant in nature.

(c) Claims 1 and 7 characterize the modification of functional activity of GTR protein in plant, but the modification of said activity in terms

of essential technical features of the method for modification and components thereof not characterized in the claims. Claim 1 merely

defines 33% sequence identity of the GTR protein with SEQ ID NO: 2 or 142. Thus, said claims are not allowable u/s 10(5) of the Act being

unclear. Further, whether claims 14, 15 and 16 have any technical definitions of the said modification of GTR functional activity is not

clear, because claims 14 and 16 are in fact drafted as independent claims. Besides, the claims define plurality of sequences of proteins and

nucleic acids of said GTR proteins; thus the scope of protection claimed becomes unclear.

2.2 The appellant submitted the response to FER on 02/01/2019. The appellant sent a hearing notice dated 03/01/2020 containing the

following official requirements:

“Objections

A. Clarity and Conciseness

Claim 1 is unclear with respect to expression “sead mealâ€​ used in claim 1, necessary correction/clarification should be given.

The submissions in your letter dated 02/01/2019 have been considered carefully and following objections are outstanding;

Regarding objection 7 (c) applicant’s observation to objection regarding defining GTR protein by 33% sequence identity of the GTR

protein with SEQ ID NO: 2 or 142 is not persuasive. From the definition it is not clear 33% sequence identity will retain the functional

activity of GTR protein or not. It causes raise serious doubts on intended result. The said definition of GTR protein is still too broad and

thus, objection 7 (c) is still maintained.

B. Non-Patentability u/s 3

Subject matter of claim 19 falls within the scope of Section 3 (c) of the Patents Act, 1970 (as amended), as it attempt to claim Mutant GTR

allele encoding GTR protein. The allele recited in the claim is not markedly different from naturally occurring products. Thus, what is

claimed in the said claim is treated as a discovery of a non-living thing occurring in nature, which is not allowable as per Section 3 (c) of

the Act.

C. Formal Requirement(s)

SEQ listing in e-form is not submitted. Definitiveness 1. The amended claim 1 is not definitive with the method steps by which the

decreasing the GSL content is achieved. The claim is only defining the object and content but there is no steps are defined or claimed how

the method is performed. In the absence of the method steps the claim 1 and its dependent claims are not definitive.

D. Unity of Invention u/s 10 (5)

The different methods claimed amended method claims 1, 14 and 16 are not linked with a single invnetive concept by their technical

feature of the method. Though they define the same SEQ in them but these are not the special techncial feature for making them linked as

per the provisions of Sec 10(5) of the Act.â€​

2.3 The hearing was conducted on 04/03/2020 and the Appellant filed written arguments along with amended claims at the Patent Office on

17/04/2020.

2.4 The respondent issued the impunged order dated 06/03/2020.

2.5 Aggreived by the impunged order the appellant has preferred this appeal.

Let’s have a look on the operating part of the order of the respondent:

“It is well known that produced mutants are not natural but the mutant should have its definite structure. The referred Tables 1 to 3f

never define the exact artificial product claimed in the amended claim 17. Hence, the argument of the agent falls short to explain artificial

product per se claimed in the amended claim 17. Therefore, the amended claim 17 is not patentable as per the provisions of Section 3(c) of

the Patents Act, 1970 as there is no establishment of the non-natural or artificial claimed product. Since, the amended claim 17 is not

eligible for patent as per the Section 3(c) of the Patents Act, 1970 and hence the requirements of other technical objections communicated

in the hearing notice are not elucidated in the order.

IV. In view of the above, the requirements of objection communicated in the hearing notice are not met as the amended claim 17 is not

patentable as per the provisions of clause (c) of section 3 of Patents Act, 1970 in the absence of any artificial/non-natural structural

characteristics. Therefore, it is hereby decided that the patent application 531/DELNP/2013 is refused for grant of a patent.â€​

The learned counsel of the appellant submits as under:

4.1 Tables l to 3f of the as filed specification depicts a number of mutations in Arabidopsis and Brassica GTR sequences.

4.2 Further, example 5 of the specification which is a representative example demonstrating the generation and characterization of mutant

GTRI and GTR2 alleles with altered phosphorylation/dephosphorylation status. Therefore, the as filed specification (especially example 5)

discloses the artificial product (mutant).

4.3 Therefore, it is clear from the specification that the mutant allele as claimed in claim 17 has been prepared by the Appellant and the

same does not occur in nature.

4.4 Accordingly, the claim 17 of the subject application does not fall under the prohibition of Section 3(c).

4.5 The learned counsel further submits that the impugned order is vitiated in as much the Respondent has erroneously held that ""The

claimed subject matter in the claim 17 is defined with the technical features of protein which is a resulting product along with the vaguely

defined nucleic acid sequences. The claimed mutant GTR allele is not defined with its exact technical feature which constitutes the artificial

molecule.

4.6 The aforementioned statement of the Respondent makes is apparently clear that the Respondent has failed to appreciate the invention.

4.7 The Appellant submits that the technical features of the mutant GTR allele are sufficiently defined in claim 17 in terms of amino acid and nucleic

acid sequences of the GTR protein. The Appellant further submits that such claim language is appropriate in the context of the invention.

4.8 In this regard, the Appellant submits that in plant breeding where the target of the breeding is a coding sequence, it is customary to refer to the

protein sequence, as the aim of the mutation is to alter the activity of the protein. The DNA sequence is only a means to an end. If the object of a

mutation is to generate a single amino acid substitution there are several ways of achieving this due to the degeneracy of the genetic code. It cannot

be expected of an applicant to list all possible substitutions in the specification. The same applies to generation of' premature stop codons. This can

also be done in a number of different ways at different positions to obtain the exact same goal of having a dysfunctional protein. Describing each and

every solution with respect to the DNA sequence would put an enormous burden on applicants and would result in very lengthy patent applications.

4.9 Therefore, the Appellant submits that wording of claims is appropriate in the context of the present invention.

4.10 In this regard, they have submitted the fact that such wording of claims has been allowed in plethora of Indian patent applications. Some

examples of such patent applications are given below:

• Indian Patent Application No. 1243/CHENP/2012: introducing disruptions in genes encoding an enzyme comprising a polypeptide sequence being

identical to or having at least 95% sequence identity to SEQ ID No.

• Indian Patent Application No. 344/DELNP/2011: partial knockout alleles in Brassica plants defined with respect to the amino acids in the

polypeptide sequence.

• Indian Patent Application No. 800/DELNP/2010: a mutant allele defined with respect to the encoding amino acid sequence.

4.11 Therefore, the Appellant submits that the claim 17 sufficiently defines the claimed artificial product.

4.12 The Appellant submits that the Respondent has miserably failed to understand that by specifying the specific mutations in the GTR protein

encoded by the mutant allele and by specifying the specific mutations in the nucleic acids, the claimed mutant allele has been sufficiently defined.

4.13 The learned counsel also submit that the impugned order has been passed without proper application of mind with a preconceived notion to refuse

the application as is clear from the illogical and irrational reasoning in the impugned order.

4.14 It is stated by the appellant that the Respondent has held that ""It is well known that produced mutants are not natural but the mutant should have

its definite structure. The referred Tables 1 to 3f never define the exact artificial product claimed in the amended claim I7,

4.15 The Appellant submits the above statement is self contradictory as the Respondent has acknowledged that claimed mutants are not naturally

occurring, and yet has refused the subject application as non-patentable under Section 3(c).

4.16 Moreover, the Respondent has failed to appreciate that Tables 1 to 3f clearly describe the position and type of mutations introduced in the

specific nucleotide sequences. Therefore, these table clearly described the artificial product.

4.17 Further, the Respondent has, without providing any reasonable explanation, ignored Example 5 of the specification of the subject application

wherein the generation and characterization of mutant GTR1 and GTR2 alleles has been described.

4.18 Without prejudice, the Appellant submits that subject matter of claim 17 does not fall under the prohibition of Section 3(c), and is also definitive.

4.19 Without prejudice, the Appellant is amenable to delete claim 17, if the Hon’ble Board deems the said amendment necessary. In this regard,

the Appellant submits an auxiliary request.

4.20 The Appellant submits that while the Respondent did not elucidate other technical objections in the impugned order, all the requirements raised by

the Respondent have already been complied by the Appellant.

4.21 The Appellant submits that the amino acid sequence having at least 80% sequence identity with SEQ ID: 2 or 142 shows activity.

In this regard, the Hon'ble Board's attention is respectfully invited to Table 4 (page 75) of the specification wherein it has been demonstrated that

AtGTR2 has 78% sequence identity with SEQ ID

Further, it has been demonstrated in the specification (page 77, para [4051) that AtGTR2 has 4-MTB uptake activity. Therefore, the amino acid

sequence having at least 80% sequence identity with SEQ ID 2 is bound to have activity.

4.22 Further, the Appellant submits that all the essential method steps and parameters have been defined in claim 1. The Appellant submits that in

plant breeding where the target of the breeding is a coding sequence, it is customary to refer to the protein sequence, as the aim of the mutation is to

alter the activity of the protein. If the object of a mutation is to generate a single amino acid substitution there are several ways of achieving this due to

the degeneracy of the genetic code. It cannot be expected of an applicant to list all possible substitutions in the specification. The same applies to

generation of premature stop codons. This can also be done in a number of different ways at different positions to obtain the exact same goal of

having a dysfunctional protein. Describing each and every solution with respect to claim 17 the DNA sequence would put an enormous burden on

applicants and would result in very lengthy patent applications.

4.23 Therefore, the Appellant submits that wording of' claims is appropriate in the context of the present invention.

Analysis

5.1 We have noted that the respondent raised objection in FER mainly on the grounds of Inventive Step, Non-Patentability u/s 3, Unity of Invention,

Clarity and Conciseness, Definitiveness and Others Requirements. In context of ‘unity of invention’, he held that there exist 7 separate

inventions namely Invention I: Claims 1-21, Invention II: Claims: 28(completely); 22-27(partially), Invention III:

Claims: 22-27(partially), Invention IV: Claims: 22, 25-27(all partially), Invention V: Claims: 22, 25-27(all partially, Invention VI: Claims: 22, 25-27 (all

partially) and Invention VII: Claims: 22, 25- 27(all partially), claimed in the instant application. He went on to examine only first set of claims as per his

findings i.e. claim 1-21. Indian Patents Act, 1970, do not give liberty to the examiner/Controller to chose a set of claims as per his choice and

examines only those chosen set of claims.

5.2 The provisions of section 12 of Patents Act, 1970, which mandates the examination of the patent application is under:

“Section 12 Available at http://ipindia.nic.in/writereaddata/Portal/ev/sections/ps12.html Examination of application

(1) When a request for examination has been made in respect of an application for a patent in the prescribed manner under sub-section (1)

or sub-section (3) of section 11B, the application and specification and other documents related thereto shall be referred at the earliest by

the Controller to an examiner for making a report to him in respect of the following matters, namely:â€

(a) whether the application and the specification and other documents relating thereto are in accordance with the requirements of this Act

and of any rules made thereunder;

(b) whether there is any lawful ground of objection to the grant of the patent under this Act in pursuance of the application;

(c) the result of investigations made under section 13; and (d)any other matter which may be prescribed.

(2) The examiner to whom the application and the specification and other documents relating thereto are referred under sub- section (1)

shall ordinarily make the report to the Controller within such period as may be prescribed.â€​

5.3 Further section 10(5) of Patents Act, 1970, which is applicable for ‘unity of invention’ is as under:

“Section 10 Available at http://ipindia.nic.in/writereaddata/Portal/ev/sections/ps10.html Contents of specifications

(5) The claim or claims of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single

inventive concept, shall be clear and succinct and shall be fairly based on the matter disclosed in the specification.

5.4 Therefore, while the objection with regard to ‘unity of invention’ can well be taken if the plurality of invention is found to have been claimed

but restricting the examination to any chosen set of claims by the Controller is not mandated by the Patents Act,1970, particluarly so when the fee in

respect of examination of all the claims are paid by the applicant.

5.5 A review of the International Search Report in respect of this application in International Phase, we notice that International Seraching Authority

(ISA) has found the lack of “unity of invention†and searched only the first set of claims i.e. claims 1-21. Further, ISA objections on ‘Unity of

Inventionâ€​ are verbatim matching with that raised by the learned Controller in the instant application.

5.6 The International Searching Authority (ISA) is under no obligation to conduct search for the multiple sets of claims once a single search fee is

paid. They intimate their contention to the applicant and on receipt of correponding fee, the search, is respect of other sets are conducted. Similar

analogy cannot be applied to the search conducted by the Indian Patent Office under section 13 of the Patents Act, 1970. Since the fee, in respect of

all the claims, is paid before search and examination under the Act and Rules made thereunder, the search and examination of all the claims is

supposed to be carried out by the examiner. The law do not provide any provision for chosing any particualr set, as per the convenience of the

Controller for conducting search and examination.

5.7 On noticing the verbatim copy of the objection on search and ‘unity of invention’ from International Search Report (ISR) , should we believe

that since ISA didn’t have the search report in respect of other claims (other than claim1-21), the corresponding substantive examination Report

of examiner/Controller in this instant application, also misses them. If this is true, it is very unfortunate scenario. The International Search of an

International application and substantive search and examination of the patent application in National Phase, under the provisions of the Indian Patents

Act,1970 and the rules made thereunder, are two different things. While the former may have certain persuasive value, it cannot be copied verbatim in

the national phase. By verbatim copying the report from ISR, the respondent has shown absence of his input in the examination and search of the

instant application.

5.8 We further note that in hearing notice that the Controller has held that “amended method claims 1, 14 and 16 are not linked with a single

inventive concept.â€​ And objected claims 17 under section 3

(c) holding that the ‘as there is no establishment of the non-natural or artificial claimed product.â€. It is also noted that the respondent has

contradicted his own statement on this issue when he hold that “It is well known that produced mutants are not natural but the mutant should have

its definite structure.†In respect of other objection, the respondent in his order has noted “Since, the amended claim 17 is not eligible for patent as

per the Section 3(c) of the Patents Act, 1970 and hence the requirements of other technical objections communicated in the hearing notice are not

elucidated in the order.†We have considered the submission of the appellant and are of the view that their submission addresses all the issues, even

if not elucidated, by the respondent.

We find that claims 1-16 relates to “A method for decreasing the glucosinolate (GSL) content in seed or seed meal…†while claim 17 relates

to “A mutant GTR allele encoding a GTR protein comprising an amino acid sequenceâ€. Further, claim 17 is an independent claim and if we incline

to agree with the auxiliary request of the appellant to delete this claim, the scope of claims 1-16 won’t be altered and the objection taken by

learned Controller on the specific claim 17 will also be obviated.

We, therefore, allow the auxiliary request of the respondent. The appellants are directed to delete claim 17. They are directed to file remaining

claims 1-16 at the earliest at the Indian Patent office.

Therefore, keeping in view the above facts, we set aside the impunged order dated 31/01/2020 of respondent and direct him to grant the patent in

respect of the invention, claimed in the instant application no. 513/DELNP/2013 as restricted in claims 1-16, strictly within 2 weeks of the issuance of

this order.

The appeal is allowed. No Cost.