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BEFORE THE ASSISTANT CONTROLLER OF PATENTS:

Patent office, Chennai.

THE PATENTS ACT, 1970 &

THE PATENTS RULES, 2003

In the matter of the Application for Patent bearing number 4387/CHENP/2006 and titled

“A SYNERGISTIC IMMUNE RESPONSE STIMULATING COMPOSITION”

Filed by

INSTITUTO CIENTIFICO Y TECNOLOGICO DE NAVARRA.

And

In the matter of Section 15 of the Patents

Act, 1970

Hearing held on 05.09.2012

Attended by:-

1. Ms. Shakira N of De Penning & De Penning

2. Ms. R. Hemalatha , Examiner of Patents and Designs

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1. The instant patent application referred in the cover note was filed at Chennai patent office

on 29.11.2006. This application was a national phase application of the PCT international

application PCT/ES05/00225 filed on 28.04.2005.Request for examination was filed on

13.03.2008.First examination report (FER) was dispatched on 11.08.2011. Applicant filed

their response to FER on 16.07.2012 with claim amendments.

2. In view of the outstanding objections after response to FER was filed, notice was issued on

22.08.2012 for a hearing scheduled for 05.09.2012

Content of hearing notice:-

The instant amendment does not meet the requirement u/s 59 of The Patents Act 1970.The amended claims do not comply with the objections raised in the FER and the amended claims fall beyond the scope of original claims and the subject matter as filed. Even in-voluntary amendments have to meet section 59.

3. Applicant was represented during the hearing by Ms. Shakira of D/D. Applicant made the

following arguments during the hearing.

(1). Amended Claims fall within the scope of original claims

Applicant stated that according to Section 59 of the Act, any amendment to a claim should

not fall beyond the scope of a claim of the specification before the amendment. In other

words amendment should not fall beyond the scope of the original claims. The amendment

currently made to the claims of the present application satisfies Section 59 as the

amendment do not fall beyond the scope of the claims before the amendment i.e., the PCT

claims.

Applicant submitted that the PCT claims constitutes the originally filed claims for a National

Phase entry since the national phase application is merely an entry of the International

application into individual countries. Applicant quoted Section 138(4) of the Act which

states that "An international application filed under the Patent Cooperation Treaty

designating India shall have effect of filing an application for patent under section 7, section 54

and section 135, as the case may be, and the title. Description, claim and abstract and

drawings, if any, filed in the international application shall be taken as complete

specification for the purpose of this Act". Thus Section 59 read with Section 138(4) implicitly

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confirms that the claims of the international application will be and should be considered as

original claims for the national phase application.

Applicant further stated that the originally filed claims of the PCT application from which the

present application is derived relates to composition. More specifically, the original PCT

claims where directed to an immune response stimulating composition comprising

nanoparticles (claims 1 to 14 ), vaccine (claims 15 to 24), use of the response stimulating

composition (claims 25 & 26) and a process for producing nanoparticles (claims 26 to 33).

Claim 1 (as filed in the PCT application).

An immune response stimulating composition comprising nanoparticles based on a methyl

vinyl ether and maleic anhydride (PVMIMA) copolymer.

Claim 1 (as amended).

A synergistic immune response stimulating composition comprising an allergen or an antigen

and nanoparticles based on a methyl vinyl ether and maleic anhydride copolymer (PVMIMA) as

adjuvant.

Thus according to applicant, recent amendment made to the claims to overcome the

objection raised by the Controller in the FER is within the scope of the PCT claims which is

the claims before the amendment as stipulated under Section 59.

(2). Amended Claims fall within the scope of claims entered in India

Applicant further stated that without prejudice to the above made submission, even while

considering the claims as entered into India as the claim before amendment, the amended

claims still falls within the scope of these claims as required under Section 59.

The scope covered by the claims that were entered in India is depicted below:

Claim 1 (as entered into India).

Use of nanoparticles based on a methyl vinyl ether and maleic anhydride copolymer (PVMIMA)

as adjuvant for the manufacture of a vaccine comprising an antigen or for the manufacture of

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an immunotherapy composition comprising an allergen.

The scope covered by the amended claims is depicted below:

Claim 1 (as amended).

A synergistic immune response stimulating composition comprising an allergen or an antigen

and nanoparticles based on a methyl vinyl ether and maleic anhydride copolymer (PVMIMA) as

adjuvant.

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In view of the above, applicant submitted that both claims are directed to the novel concept

of mixing nanoparticles based on a methyl vinyl ether and maleic anhydride copolymer as

adjuvant with an antigen or allergen to enhance the immunogenic response of the body to

the antigen or allergen. As acknowledged by the IPRP, the combination of the two

components, i.e., the composition comprising an allergen or an antigen and the adjuvant

renders a new joint effect in that the immune response to the antigen or allergen is

enhanced by the composition. This concept is the basis for both the claims as entered and as

amended in this application. Thus the scope of the amended claims does not fall beyond the

scope of the claims as entered in the national phase. Applicant believe that the use claim and

the composition claim provides them the same scope of protection that they require and

that they have amended the claims only since use claims are not allowed in India. The claims

as amended in response to the objection raised by the Controller is to convert the claims

into "purpose-limited" composition claims as acceptable in various other jurisdictions such

as Japan. Applicant feel that this amendment would have been unnecessary if use claims

would have been acceptable.

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(Ill). Claims entered in India were Art. 19 claims

Without prejudice to the above submission, even if both the scenario is not considered by

the Controller, we still believe that the applicant are under their reasonable rights to

amended the claims to revert back to the claims as originally filed in the PCT application. As

quoted above, under Section 138(4) of the Act the claim of the international application shall

be taken as the claims of the national phase application.

Moreover, it was brought to my notice that the claims as entered into India were the claims

as amended under Article 19 of the PCT. According to applicant, he can choose to prosecute

in the national phase application either the original filed claims of the PCT application or the

Article 19 amendment claims according to his desire. In view of the unique scenario at the

Indian Patent Office, applicant now wishes to revert back this amendment to the original

PCT claims. Under the principle of natural justice, applicant requested controller to allow

amendment to revert back to the originally filed claims. Applicant concluded that the

invention basically lies in the composition. It was not the malice intention of the applicant to

claim any new subject matter. The applicant merely wishes to retain the claims of the

original PCT claims in this application which we believe is well within their rights.

4. Applicant submitted a formal request on Form 13 to consider the earlier amended set of

claims filed on 16.07.2012.

Background of the claim amendments:-

5. In order to fathom the intricacies of this case, we need to see the history of claim

amendments in closer detail. The original set of claims with which the national phase

application was filed in India on 29.11.2006 is reproduced below.

1. Use of nanoparticles based on a methyl vinyl ether and maleic anhydride copolymer (PVM/MA) as

adjuvant for the manufacture of a vaccine comprising an antigen or for the manufacture of an

immunotherapy composition comprising an allergen.

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2. Use according to claim 1, wherein said PVM/MA-based nanoparticles comprise said allergen or said

antigen.

3. Use according to claim 2, wherein said allergen or antigen at least partially coats the surface of said

nanoparticles and/or is contained inside said nanoparticles.

4. Use according to claim 1 or 2, wherein said PVM/MA-based nanoparticles further comprise an

immunostimulating agent.

5. Use according to claim 4, wherein said immunostimulating agent at least partially coats the surface

of said nanoparticles and/or is contained inside said nanoparticles.

6. Use according to claim 4, wherein said allergen or antigen and immunostimulating agent at least

partially coat the surface of said nanoparticles and/or are contained inside said nanoparticles.

7. Use according to any of claims 1 to 6, wherein said nanoparticles further comprise a cross-linking

agent.

8. Use according to any of claims 1 to 7, wherein said nanoparticles have a mean size that is equal to

or less than 1.0 micrometer, preferably between 10 and 900 nm, more preferably equal to or less than

400 nm.

9. Use according to claim I, wherein said PVM/MA copolymer has a molecular weight comprised

between 100 and 2,400 kDa, preferably between 200 and 2,000 kDa, more preferably between 180

and 250 kDa.

10. Use according to any of claims 1 to 9, wherein said vaccme or immunotherapy composition is in a

lyophilized form.

11. Use according to any of claims 1 to 9, wherein said vaccme or immunotherapy composition is in

administration form suitable for its oral or parenteral administration.

I2. Use according to claim 7, wherein said vaccme or immunotherapy composition comprises:

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13. Use according to claim 1, wherein said allergen comprises an allergenic pollen extract, an

allergenic insect extract or an allergenic food product extract.

14. Use according to claim 1, wherein said antigen comprises an immunogenic extract from an

organism.

15. Use according to claim I4, wherein said orgamsm IS Salmonella spp., preferably, S. enteritidis.

I6. Use according to claim I 4, wherein said antigen is the HE extract of S. enteritidis or ChE extract of

S. enteritidis.

I7. Use of nanoparticles based on a methyl vinyl ether and maleic anhydride copolymer (PVM/MA) for

the manufacture of a composition for enhancing the immune response of an antigen or allergen eo-

administered therewith.

I8. Use of nanoparticles based on a methyl vinyl ether and maleic anhydride copolymer (PVM/MA),

together with an antigen or allergen, in the manufacture of a pharmaceutical composition for the

selective stimulation of the Th I immune response, or in the manufacture of a pharmaceutical

composition for the selective stimulation of the Th2 immune response, or in the manufacture of a

pharmaceutical composition for the balanced stimulation of the Th I and Th2 immune responses.

19. Use according to claim 17 or 18, wherein said allergen composes allergenic pollen extract, an

allergenic insect extract or an allergenic food product extract.

20. Use according to claim I 7 or I 8, wherein said antigen composes an immunogenic extract from an

organism.

21. Use according to claim 20, wherein said orgamsm ts Salmonella spp., preferably, S. enteritidis.

22. Use according to claim 20, wherein said antigen is the HE extract of S. enteritidis or ChE extract of

S. enteritidis.

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23. A product comprising, separately, (i) a composition comprising an allergen or an antigen, and (ii)

a composition comprising nanoparticles based on a methyl vinyl ether and maleic anhydride

copolymer (PVM/MA), as immune response enhancing composition with regard to said allergen or

antigen, as combination for its simultaneous or sequential administration to an individual, for

enhancing the immune response with regard to said allergen or antigen within said individual.

6. Thus, the original set of claims with which the national phase application was filed in India

consisted of 22 use claims and 1 product claim. As use claims were not allowed under the

Act, these 22 use claims were objected to in the FER. Applicant converted these 22 use

claims into composition claims and re-filed them along with their response to FER on

16.07.2012.

7. The amended set of claims filed on 16.07.2012 is reproduced below.

1. A synergistic immune response stimulating composition comprising an allergen or an antigen and

nanoparticles based on a methyl vinyl ether and maleic anhydride copolymer (PVMIMA) as adjuvant.

2. The composition as claimed in claim 1, wherein said PVMIMA based nanoparticles comprise said

allergen or said antigen.

3. The composition as claimed in claim 2, wherein said allergen or antigen at least partially coats the

surface of said nanoparticles and/or is contained inside said nanoparticles.

4. The composition as claimed in claim 1 or 2, wherein said PVMIMA based nanoparticles further

comprise an immune-stimulating agent.

5. The composition as claimed in claim 4, wherein said immune-stimulating agent at least partially

coats the surface of said nanoparticles and/or is contained inside said nanoparticles.

6. The composition as claimed in claim 4, wherein said allergen or antigen and immune-stimulating

agent at least partially coat the surface of said nanoparticles and/or are contained inside said

nanoparticles.

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7. The composition as claimed in any of claims 1 to 6, wherein said nanoparticles further comprises a

cross-linking agent.

8. The composition as claimed in any of claims 1 to 7, wherein said nanoparticles have a mean size

that is equal to or less than 1.0 micrometer, preferably between 10 and 900 nm, more preferably equal

to or less than 400 nm.

9. The composition as claimed in claim 1, wherein said PVMIMA copolymer has a molecular weight

comprised between 100 and 2,400 kDa, preferably between 200 and 2,000 kDa, more preferably

between 180 and 250 kDa.

10. The composition as claimed in any of claims 1 to 9, wherein said composition is in a lyophilized

form.

11. The composition as claimed in any of claims 1 to 9, wherein said composition is in administration

form suitable for its oral or parenteral administration.

12. The composition as claimed in claim 7, wherein said composition comprises:

13. The composition as claimed in claim 1, wherein said allergen comprises an allergenic pollen

extract, an allergenic insect extract or an allergenic food product extract.

14. The composition as claimed in claim 1, wherein said antigen comprises an < immunogenic extract

from an organism.

15. The composition as claimed in claim 14, wherein said organism is Salmonella spp., preferably, S.

enteritidis.

16. The composition as claimed in claim 14, wherein said antigen is the HE extract of S. enteritidis or

ChE extract of S. enteritidis.

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17. The composition as claimed in claim 1, wherein the nanoparticles based on PVM!MA and the

antigen or allergen are eo-administered therewith.

18. The composition as claimed in claim 1 for the selective stimulation of the Thl immune response, or

for the selective stimulation of the Th2 immune response, or for the balanced stimulation of the Th 1

and Th2 immune responses.

19. The composition as claimed in claim 1, 1 7 or 18, wherein said allergen comprises an allergenic

pollen extract, an allergenic insect extract or an allergenic food product extract.

20. The composition as claimed in claim 1, 17 or 18, wherein said antigen comprises an immunogenic

extract from an organism.

21. The composition as claimed in claim 20, wherein said organism is Salmonella spp., preferably, S.

enteritidis.

22. The composition as claimed in claim 20, wherein said antigen is the HE extract of S. enteritidis or

ChE extract of S. enteritidis.

23. A product comprising, separately, (i) a composition comprising an allergen or an antigen, and (ii)

a composition comprising nanoparticles based on a methyl vinyl ether and maleic anhydride

copolymer (PVM/MA), as immune response enhancing composition with regard to said allergen or

antigen.

9. The law: Section 59 of the Patents Act, 1970:

S. 59 Supplementary provisions as to amendment of application or specification

No amendment of an application for a patent or a complete specification

or any document related thereto shall be made except by way of disclaimer, correction or

explanation, and no amendment thereof shall be allowed, except for the purpose of

incorporation of actual fact, and no amendment of a complete specification shall be

allowed, the effect of which would be that the specification as amended would claim or

describe matter not in substance disclosed or shown in the specification before the

amendment, or that any claim of the specification as amended would not fall wholly

within the scope of a claim of the specification before the amendment

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Further in OA/4/2009/PT/CH and ORA/17/2009/PT/CH, IPAB has already clarified

that claim amendments, even to meet controller’s objections, has to meet both the

requirements of Section 59 of the act- i.e., (i) any amendment to claims has to be supported

by description/claims before amendment and (ii) that the scope of claims as amended

should fall within the scope of claim in the specification before amendment.

Now I shall consider applicant’s arguments:-

10. Amended claims fall within the scope of original claims:-

Applicant admitted during the hearing and in the subsequent written submission, that as

per section 59 of the Patents Act 1970 (hereinafter ‘the Act’), any amendment to claim

should not fall beyond the scope of a claim of the specification before amendment. Yet

applicant argued that the scope should be compared with the original PCT claims.

Applicant relied on section 138 (4) of the act to substantiate that the claims of

international filing has to be considered as the original claims. Applicant then compared

the present claims with claims purported to be the original claims of the international

application (the international publication was made in Spanish, no verified translation has

been provided) to show that the scope of the present set of claims is a subset of the scope

of original PCT claims.

11. However, S59 of the act do not refer to original claims, rather it refers to the claims of the

specification before amendment. In the instant case, the claims before amendment are

those claims with which applicant had filed the national phase application. Therefore

comparison of amended claims to the original PCT international claims is not appropriate. I

shall compare the scope of the amended claims and the scope of the claims before the

amendment subsequently.

12. In referring to the international application claims as the original claims, applicant

attempts to disown the claims which they themselves had filed while entering national

phase. This is cannot be allowed for multiple reasons:

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a. The corresponding international application for this application was filed and

published in Spanish. As per Rule 20.3.b of the Patent Rules, when an international

application has not been published in English, applicant has to file with patent office an

English translation of the publication duly verified by the applicant or any person

authorized by him that the contents thereof are correct and complete. Therefore

applicant themselves cannot now disown the specification and claims they had filed

with the national phase entry.

b. As per section 11A of the Act all patent applications are published at the expiry of 18

months, thereafter the specification and claims are open for public inspection. The

instant application has been published in India with the set of claims filed in IPO

during the national phase filing. As per section 25. 1 of the Act, after publication of an

application, any person can represent by way of opposition to controller against the

grant of patent on the grounds specified therein. Further, section 59 of the act

(reproduced above) curtails any amendment to claims which would in effect expand

the scope of protection claimed. Now, if a person X, manufacturing a composition

comprising an allergen or an antigen and nanoparticles based on methyl vinyl ether

and maleic anhydride copolymer (PVMIMA) as adjuvant had examined the claims as

published he would choose not to represent to the controller availing pre-grant

opposition provision, as the claims were innocuous to his interest. In this he is also

placing his trust on Patent office, that it would religiously apply restrictions of section

59 and would not allow any claims, which would have a different/expansive scope

than the already published claims. Now, if I were to grant the latest set of claims

presented by applicants, which would be infringing X’s product, then the purpose of

section 25.1 would fail. Therefore strict adherence of S59 is not only essential to the

provisions of amendments, but also for the overall deliverance of other provisions of

the Act as well.

c. IPO manual also reiterate this-“…For the National Phase Application, the title,

description, drawings, abstract and claims as filed with the International Application

under PCT shall be taken as the Complete Specification. However, if the applicant has

amended the Complete Specification under Chapter-I and/or Chapter-II of the PCT,

such amended specification shall be taken as the Complete Specification for the

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purpose of filing in India. ……The fee payable in respect of a National Phase Application

is calculated as per the number of pages and claims as they stand in the PCT

Application on the date of filing in India.” It is pertinent to note that applicant has only

paid fee according to the amended set of claims filed with national phase application-

again showing their desire, intention and conviction to prosecute that set of claims in

India.

d. The flow of events in the international phase also does not augur well for applicant.

Applicant initially filed an application with composition, use and process claims. The

composition claims faced resistance in the international search report as at least 3

documents were found individually relevant to novelty and/or inventiveness of the

composition claims.

Applicant subsequently made a demand for international preliminary examination.

Along with this demand, applicant furnished amended set of claims under article 34 of

PCT, which again contained product, composition, use and process claims. The

independent claims were:

1. A product comprising separately, (i) a composition comprising an allergen or an antigen,

and (ii) a composition comprising nanoparticles based on a methyl vinyl ether and maleic

anhydride copolymer (PVM/MA), as immune response stimulating composition with regard to

said allergen or antigen, as combination for its simultaneous or sequential administration to an

individual, for stimulating the immune response with regard to said allergen or antigen within

said individual.

2. An immune response stimulating composition comprising nanoparticles based on methyl vinyl

ether and maleic m1hydride copolymer (PVM/MA) and, additionally; an allergen or an antigen.

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15. A vaccine or immunotherapy composition comprising therapeutically effective amount of a

composition according to any of claims 2 to 14 together with a pharmaceutically acceptable

carrier or excipient.

16. A vaccine or immunotherapy composition according to claim 15, in lyophilized tom1 or in a

suitable administration from for its oral or parenteral administration.

17. A vaccine or immunotherapy composition comprising, separately) (i) a composition

comprising an allergen or an antigen, and (ii} a composition comprising nanoparticles based on a

methyl vinyl ether and maleic anhydride copolymer (PVM/MA), as immune response stimulating

composition with regard to said allergen or antigen, and a cross-linking agent .if so desired, as

combination tor its simultaneous or sequential administration to an individual.

25. Use of a composition comprising empty nanoparticles based on a methyl vinyl ether and

maleic anhydride copolymer (PVM/MA) or of a composition according to any of claims 2 to 14 in

preparing a vaccine or immunotherapy composition.

26.Use of a composition comprising empty nanoparticles based on a methyl vinyl ether and

maleic anhydride copolymer (PVM/MA) or of a composition according to any of claims 2 to 14 in

the manufacture or a pharmaceutical composition for the selective stimulation of the Th1

immune response, or in the manufacture of a pharmaceutical composition for the selective

stimulation of the Th2 immune response, or in the manufacture of a pharmaceutical composition

tor the balanced stimulation of the Th1 and Th2 immune responses.

27. A process for producing PVM/MA copolymer-based nanoparticles comprising an allergen or

an antigen) where said allergen or antigen at least partially covers the surface of said

nanoparticles and/or is contained inside said nanoparticles, said process comprising the steps of:

a) desolvating an organic solution of a PVM/MA copolymer dissolved in an organic solvent with a

hydroalcoholic solution;

b) removing the organic solvents to obtain nanoparticles; and

c) Adding said allergen or said antigen to said PVM/MA copolymer organic solution before

desolvating said PVM/MA copolymer organic solution, or alternatively incubating said allergen

or said antigen wilh said nanoparticles obtained in step b).

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Even this amended set of claims presented under article 34 of PCT received a negative

IPER, wherein all claims were objected as lacking novelty over document cited in ISR.

Applicant then chose to file yet another set of claims for IPER which consisted of only

use claims and 1 product claim. Only this set of claims secured a positive IPER. It was

this very same set of claims with which applicant had made the national phase entry in

India. Therefore, it is clear from the prosecution that the claim amendments in the

international phase were completely involuntary. Applicant made these amendments

only to overcome novelty and inventive step objections in ISR and IPER. Applicant is

now attempting to reinstate the very set of claims which they themselves had pruned

earlier for not being novel and/or inventive. I am not sure whether an estoppel would

be valid in Indian patent prosecution, but it can be concluded that had it not been for

the amendments at IPEA, the claims would have been anticipated and obvious.

e. As per Rule 20.5 of the Patent Rules, when an international application has not been

published in English, applicant has to furnish a duly verified translation of specification

and amended claims (under article 19 or 34) with the national phase application. If

applicant does not file translation of amended claims, eventually these amendments

would be discarded. Therefore, where applicants present a translation of amended

claims; it is an express manifestation of their desire to prosecute the amended set of

claims in the national phase. In the instant case applicant has filed amended claims and

paid fees according to number of amended claims. Having done all these, applicant

cannot now do a sudden swirl and fall back on the original PCT application claims.

13. Applicant’s second argument is that the Amended Claims fall within the scope of claims

entered in India. As reproduced above the national phase entry was done with 22 use

claims and 1 product claim. Applicant argues that the scope of use claims and composition

claims are same. However, this argument is not in tune with the provisions of section 48 of

the Act. As per section 48 of the Act, product claims entail applicant the right to use the

product along with certain other rights. Whereas mere use claim would entail patentee

only the right to use the compound with respect to the specific use recited in the claims. In

other patent regimes where use claims are allowed, use claims are interpreted as process

claims –not as product claims. The guidelines for examination in the European patent office

chapter 4.16 says, “Use claims: For the purposes of examination, a "use" claim in a form such

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as "the use of substance X as an insecticide" should be regarded as equivalent to a "process"

claim of the form "a process of killing insects using substance X". Thus a claim in the form

indicated should not be interpreted as directed to the substance X recognisable (e.g. by

further additives) as intended for use as an insecticide. Similarly, a claim for "the use of a

transistor in an amplifying circuit" would be equivalent to a process claim for the process of

amplifying using a circuit containing the transistor and should not be interpreted as being

directed to "an amplifying circuit in which the transistor is used", nor to "the process of

using the transistor in building such a circuit". However, a claim directed to the use of a

process for a particular purpose is equivalent to a claim directed to that very same process

(see T 684/02)”. Similarly PCT international search and preliminary examination guidelines

says in A5.21 says, “…In some International Searching and Preliminary Examining Authorities, for

purposes of international search and examination, a “use” claim of the form such as “the use of

substance X as an insecticide” or “substance X when/whenever used as an insecticide” should be

regarded as equivalent to a “process” claim of the form “a process of killing insects using substance

X.”

14. The international application was filed and published in Spanish. Machine translation of

some claims of the international publication:

Claim 2: A composition of stimulating an immune response comprising nanoparticles based on a copolymer of methyl vinyl ether and maleic anhydride (PVM / MA) wherein said nanoparticles based PVM / MA further comprise an allergen or an antigen.

Claim 15: A vaccine for immunotherapy or a composition of comprising a therapeutically effective amount of a composition of response stimulating as immune seglln any claims 1 to 14 together with a vehicle 'or pharmaceutically acceptable excipient

Claim 25: Use of a composition of immune response stimulating according any of claims 1 to 14 in the preparation of a vaccine or immunotherapy composition.

16. If the applicant had themselves believed that the scope of protection of use claims is same

as the composition claims, there would not have been any need to have both set of claims

initially in their international application. In the instant case, if the original claims filed on

national phase entry (Use of nanoparticles based on a methyl vinyl ether and maleic

anhydride copolymer (PVM/MA) as adjuvant for the manufacture of a vaccine comprising an

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antigen or for the manufacture of an immunotherapy composition comprising an allergen.)

were to be granted in India, the Patentee’s right would have been restricted to mere use of

the said nanoparticles in the manufacture of vaccine or immunotherapy composition. It

would not have entailed patentee the right to extend his claim to a vaccine/composition as

presently claimed in the amended set. Hence, use claims and composition claims offer

different scopes of protection and I am afraid applicant’s attempt to equate them is not

correct. Therefore applicant’s argument that the scope of use claims and composition

claims are same do not carry any persuasive value.

16. As the present set of claims relate to compositions, they obviously goes beyond the scope

of use claims. During the hearing and in the written submission, applicant has only

attempted to compare the scope of the initial use claims and present composition claim.

Though there was a product claim (Kit claim), applicant did not attempt to compare the

scope of that claim with the amended set of claims. For the sake of completeness, it has to

be seen if the lone product claim of the earlier set of claims can encompass the scope of all

the present composition claims. The initial claim 23 of is now compared with the broadest

claim of the amended set- i.e., claim 1.

23. A product comprising, separately, (i) a

composition comprising an allergen or an antigen,

and (ii) a composition comprising nanoparticles

based on a methyl vinyl ether and maleic anhydride

copolymer (PVM/MA), as immune response

enhancing composition with regard to said allergen

or antigen, as combination for its simultaneous or

sequential administration to an individual, for

enhancing the immune response with regard to said

allergen or antigen within said individual

1. A synergistic immune response

stimulating composition comprising an

allergen or an antigen and nanoparticles

based on a methyl vinyl ether and maleic

anhydride copolymer (PVMIMA) as

adjuvant.

18. It can be seen from the above table that the initial claim 23 had a further limitation i.e., the

allergen or an antigen and nanoparticles based on methyl vinyl ether and maleic anhydride

copolymer (PVMIMA) is present separately. This limitation is not present in the amended

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set of claims. When limitations are dropped, the scope of claims would change. In the

instant case claims to a composition wherein two components are together and claims for a

kit wherein they are required to be separate, points to mutually exclusive domains.

Therefore the scope of the present set of claims extends beyond the scope of original set of

claims.

19. Applicant argued that the amendment of claims was carried out to meet unique

requirements of Indian patent act. It is true that the Patents act do not give room for use

claims. However, it is clear from the prosecution of this application in the international

phase, that the amendments were carried not because of any unique provisions; rather it

was due to common provisions of novelty and inventive step; which would apply similarly

in the Patents Act here as well as the Articles which govern PCT international phase.

20. Finally applicant argues that since the amendments carried out in international phase

were under article 19 of PCT, applicant retains the right to prosecute in national

phase either the amended claims or original PCT claims. I am not sure if the

amendment which applicant is referring is under article 19. On perusal of PCT records

these amendments appears to have been made under article 34. However as this do not

materially affect the issue at hand we need not dwell further on this issue. In my

considered view, even if applicant had the choice to opt a particular set of claims in

national, that choice was exhausted when the specification with amended set of claims was

filed at the national phase entry. I have detailed more than one reason for this under

paragraph 12 and do not intend to reproduce it here for the sake of brevity.

21. In view of the above, I do not see any persuasive value in any of applicant’s arguments. I am

convinced that the amended set of claims filed in response to FER do not meet the

requirements of section 59 of the act in that the scope of claims as amended extends

beyond the scope of claims before amendment. For this same reason, even the application

for amendment of claims filed on Form 13 cannot be considered.

22. The objection was clearly outlined in the Hearing notice. Applicant was also advised about

the same during hearing as well. It was conveyed to the applicant that the initial product

claim would be allowable. However applicant has chosen to adhere to the earlier set of

21 | P a g e

claims in its entirety and refused to make any amendments. I cannot extend further

windows to make amendments. As I am satisfied that the requirement of section 59 of the

act has not been complied, and as applicant has refused to make amendments to the

satisfaction of controller, in spite of having been given opportunity, I refuse the instant

application 4387/CHENP/2006 under section 15 of the Patents Act.

(ANOOP K JOY)

Assistant controller of Patents & Designs

20th November,2012.