DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 14-21 and 29-30, drawn to a pharmaceutical combination comprising a cyclic dinucleotide packaged into a virus-like particle and an anti-CTLA-4 antibody or a fragment thereof binding a CTLA-4 antigen.
Group II, claim(s) 22-28, drawn to a method for treating cancer in a subject wherein the method comprises administering a pharmaceutical combination comprising a cyclic dinucleotide packaged into a virus-like particle and an anti-CTLA-4 antibody or a fragment thereof binding a CTLA-4 antigen.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The two groups lack unity of invention because even though the inventions of these groups require the technical feature of a pharmaceutical combination comprising a cyclic dinucleotide packaged into a virus-like particle and an anti-CTLA-4 antibody or a fragment thereof binding a CTLA-4 antigen, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Manel et al. (US 2016/0074507; in IDS dated 10/20/23) and Lightcap et al. (WO 2021/005541; in IDS dated 10/20/23). Manel et al. teach a virus-like particle comprising a lipoprotein envelope including a viral fusogenic glycoprotein wherein said VLP contains cGAMP packaged into said VLP and further teach that such can be administers to a subject to prevent or treat an infectious disease or cancer (see claims). Lightcap et al. teach a method of treating cancer by combining a STING agonist (e.g., one known STING agonist is cGAMP) and a checkpoint inhibitor (e.g., ipilimumab; i.e., the claimed anti-CTLA-4 antibody). Therefore, one of ordinary skill in the art would have found it prima facie obvious to combine the two compositions known to be used for the same purpose.
During a telephone conversation with Frank Eisenschenk on 9/12/25 a provisional election was made with traverse to prosecute the invention of Group I, claims 14-21 and 29-30. Affirmation of this election must be made by applicant in replying to this Office action. Claims 22-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims 14-21 and 29-30 are under current examination.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 19 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 19 is unclear. Claim 19, which is dependent on claims 14, 16 and 18, recites: “…wherein the VLP comprises a capsid from a retroviridae”. Claim 18 requires the VLP to further comprise a capsid; therefore, it is unclear if “a capsid” in claim 19 is referring to the “capsid” recited in claim 18 or it is an additional capsid. The Examiner suggests amending claim 19 to read “wherein the VLP further comprises a second capsid, wherein the second capsid is from a retroviridae” or “wherein the capsid is from a retroviridae” in order to obviate this rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14-21 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Manel et al. (US 2016/0074507; in IDS dated 10/20/23) in view of Lightcap et al. (WO 2021/005541; in IDS dated 10/20/23).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Manel et al. is directed to a method of preparing viral particles with cyclic dinucleotide and use of said particles for unducing an immune response (Title).
With regards to instant claims 14-16 and 30, Manel et al. teach a pharmaceutical composition comprising virus-like particle comprising a lipoprotein envelope including a viral fusogenic glycoprotein wherein said VLP contains cGAMP packaged into said VLP and further teach that such can be administers to a subject to prevent or treat an infectious disease or cancer (see entire reference; e.g., claims 1, 7-8 and 11).
With regards to instant claim 17, Manel et al. teach wherein the viral fusogenic glycoprotein is a glycoprotein from retroviridae (including lentivirus and retrovirus), herpesviridae, poxviridae, hepadnaviridae, flaviviridae, togavoridae, coronaviridae, hepatitis D virus, orthomyxoviridae, paramyxoviridae, filoviridae, rhabdoviridae, bunyaviridae, or orthopoxivridae (e.g. variola), preferably from orthomyxovirus, retroviruses, rhabdovirus (claims 3-4).
With regards to instant claims 18-19, Manel et al. teach wherein the VLP further comprises a retroviral capsid which is from retroviridae (lentivirus, retrovirus) (claims 2 and 5).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Manel et al. teach that the virus-like particle can further comprise an antigen or any other protein or nucleic acid of interest (see claim 9), they do not teach wherein the composition further comprises specifically an anti-CTLA-4 antibody such as ipilimumab, as required by instant claims 14, 20-21 and 30. However, this deficiency is cured by Lightcap et al.
Lightcap et al. is directed to the combination of STING agonists and checkpoint inhibitors. Lightcap et al. teach a method of treating cancer by combining a STING agonist (e.g., one known STING agonist is cGAMP) and a checkpoint inhibitor (e.g., ipilimumab; i.e., the claimed anti-CTLA-4 antibody).
Although, Manel et al. teach that when the coding sequences for the cyclic dinucleotide synthase and for the proteins of the enveloped virus-like particle are not comprised in the same expression vector or construct, the present invention relates to a combination or kit of nucleic acid constructs or expression vectors comprising at least one nucleic acid construct or expression vector comprising the sequence encoding the cyclic dinucleotide synthase and one nucleic acid construct or expression vector comprising the sequence encoding at least one protein of the enveloped virus-like particle, in particular the envelope glycoprotein and/or the capsid ([0099]), they do not specifically teach wherein a kit comprising a first part comprising a cyclic dinucleotide packaged into a VLP and a second part comprising an anti-CTLA-4 antibody or a fragment thereof binding a CTLA-4 antigen, the first and second parts of the kit being in distinct compartments or containers.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional active agents used in cancer-treating composition/formulations. It would follow that the recited claims define prima facie obvious subject matter. (See MPEP 2144.06).
Based on the teachings of Manel et al. and Lightcap et al., which are both directed to STING agonist-containing pharmaceutical compositions useful in treating cancer, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the components taught above (i.e., a VLP containing cGAMP and ipilimumab) in separate compartments of a kit in order to achieve the predictable result of obtaining a pharmaceutical composition suitable for treating cancer. One of ordinary skill in the art would have been motivated to do so because both components of said kit have been taught to treat the same type of patient and therefore it would be advantageous to keep all therapeutics for one patient in one kit.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 14-21 and 29-30 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,010,607 in view of Lightcap et al. (WO 2021/005541; in IDS dated 10/20/23). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same pharmaceutical composition comprising a virus-like particle (VLP) comprising a cyclic dinucleotide (e.g., cGAMP), a lipoprotein envelope including a viral fusogenic glycoprotein (e.g., glycoprotein obtained from retroviridae) and capsid from a retroviridae and a kit thereof. The difference is that the instant application recites an additional component: an anti-CTLA-4 antibody or a fragment thereof binding a CTLA-4 antigen (e.g., ipilimumab. However, Lightcap et al. teach a method of treating cancer by combining a STING agonist (e.g., one known STING agonist is cGAMP) and a checkpoint inhibitor (e.g., ipilimumab; i.e., the claimed anti-CTLA-4 antibody). Therefore, it would have been obvious to one of ordinary skill in the art to further incorporate ipilimumab into the instantly claimed composition as it is also taught to treat cancer. Thus, the instant claims and the application claims are obvious variants.
Claims 14-21 and 29-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-28 and 32-33 of copending Application No. 18/287,664 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same pharmaceutical composition comprising a virus-like particle (VLP) comprising a cyclic dinucleotide (e.g., cGAMP), a lipoprotein envelope including a viral fusogenic glycoprotein (e.g., glycoprotein obtained from retroviridae) and capsid from a retroviridae and a kit thereof. It is noted that the ‘664 composition represents a species (with regards to mutation of the anti-CTLA-4 antibody) within the scope of the instantly claimed genus. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cor. 1993). Thus, the instant claims and the application claims are obvious variants.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617