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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election with traverse of Group I. Claim 1-12, drawn to a vaccine composition, classified in A61P31/14 in the reply (via telephone message) filed on October 15, 2025 is acknowledged. The traversal is on the ground(s) that “there is no burden examining all the claims in one application”.
The traversal on the grounds outlined above is not found persuasive because there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions have acquired a separate status in the art in view of their different classifications; the inventions require a different field of search (searching different subclasses or electronic resources, or employing different search strategies of search queries); the inventions have acquired a separate status in the art due to their recognized divergent subject matter. The requirement is still deemed proper and is therefore made FINAL.
Claims 13-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-12 are under consideration.
Priority
2. This application claims benefit of 63/394,132, 08/01/2022.
Information Disclosure Statement
3. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
It is noted that Applicants have not filed an information disclosure statement under § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicant’s duty to disclose all information known to be material to patentability.
Claim Objections
4. Claims 3 and 9 are objected to because of the following informalities. Appropriate correction is required.
a. In Claim 3 there is an “In some embodiments” typo.
b. In Claim 9, there is an additional “a” typo.
Claim Rejections - 35 USC § 112
5. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 8,11, and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
a. Claim 8 is rejected because the statement “a recombinant mixture of the S. pneumoniae pneumococcal proteins (rAAC) is vague on the specific S. pneumoniae pneumococcal proteins (rAAC) being used in the recombinant mixture. The specification at paragraph 0061 established “the mixture of protein rAAC including pneumococcal surface adhesin A (rPsaA), pneumococcal surface protein A (rPSpA), and pneumococcal surface protein C (rPspC) but lacks precision to the identity and amount of each.
b. Claim 11 is rejected because it is unclear what is meant by “inactived Zika virus”: “inactive” versus “inactivated” versus meaning something else. Claim 11 is dependent on Claim 10 which specifies “inactivated”.
c. Claim 12 is rejected because it is unclear what is meant by “inactive” influenza virus: “inactive” versus “inactivated” versus something else. Claim 12 is dependent on Claim 10 which specifies “inactivated”.
Claim Rejections - 35 USC § 103
7. 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 (i.e., changing from AIA to pre-AIA ) 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.
8. 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.
9. The factual inquiries 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.
10. 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.
11. Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (“Chen”)(WO2018128931 A1) in view of Chen et al. (2009) (“Chen 2009”)(See PTO-892: Notice of References Cited).
Claims 1-7 as submitted on 08/01/2023.
For Claims 1,2,5-7:
Chen teaches a pharmaceutical composition, which contains an antigen fusion protein including an antigen and an antagonist of an Fc gamma receptor (e.g., where the antagonist of an Fc gamma receptor is a formyl peptide receptor-like 1 inhibitory protein (FLIPr or a FLIPr-like protein)[0010, 0047, 0060] (as recited in claim 1, 2); enhancing an immune response to an antigen in a subject, including administering to the subject an effective amount of an antigen fusion protein, wherein the antigen fusion protein includes the antigen and an antagonist of an Fc gamma receptor [0009](as recited in claim 5); the antigen fusion protein of the present invention can induce higher antigen-specific immune responses in a subject than the antigen itself [0080] (as recited in claim 5); the immunogen is a subunit protein of a virus and the immunogen is a recombinant envelope protein domain III of Zika virus [0011, Example 9 & 10] (as recited in claims 6 and 7); a pharmaceutical composition which contains such antigen fusion protein may be employed in the development of potent vaccines, such as antitumor and antivirus vaccines [0080](as cited in claim 6).
Chen does not teach a recombinant lipidated FLIPr (rLF).
Chen 2009 teaches a novel platform technology that can express high levels of recombinant lipoproteins with intrinsic adjuvant properties and teaches “to enhance the potency of recombinant protein subunit vaccines, one can design and engineer immunogens as lipoproteins by covalently linking the antigen proteins with lipid moieties” (Abstract). Chen 2009 further teaches that the lipid moiety “should be recognized as danger signals by the immune system and confer intrinsic immunostimulatory properties” (p. 1409).
One of ordinary skill in the art would have been motivated to make this lipidation modification as taught by Chen 2009 for the benefit of making the recombinant FLIPr more immunogenic thus improving the vaccine composition (See MPEP 2143, A. and 2143.02: Combining prior art elements according to known methods to yield predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success modifying the recombinant FLIPr segment of Chen with the lipidation technology of Chen 2009.
There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated in the context of vaccinology and/or immunity, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
For Claims 3 & 4
It is noted that the courts have held that when a claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated (In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978)). The phrases “used to induce anti-FLIPr responses”(as recited in claim 3) and “used to prevent phagocytosis inhibition caused by S. aureus FLIPr protein”(as recited in claim 4) clearly defines a use of the composition as recited in claims 1 and 2, and thus does not further distinguish the composition over the prior art. (See MPEP 2112.02).
12. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Chen 2009 as applied to claims 1,5, and 6 above and further in view of Wiedinger et al. (“Wiedinger”) (See PTO-892: Notice of References Cited).
Claim 8 recites the vaccine composition according to claim 6, wherein the immunogen is a recombinant mixture of the S. pneumoniae pneumococcal proteins (rAAC).
Chen in view of Chen 2009 teaches claims 1, 5, and 6 as above.
Chen in view of Chen 2009 does not teach the immunogen is a recombinant mixture of the S. pneumoniae pneumococcal proteins (rAAC).
Wiedinger teaches that targeting activating [Fc gamma receptor] with fusion proteins consisting of PspA and IgG2a Fc enhance PspA-specific immune responses, and effectively protect against mucosal Spn [Streptococcus pneumoniae) challenge (Abstract). The current invention teaches in its specification bacterial, Streptococcus pneumoniae pneumococcal proteins (rAAC) with the mixture protein of rAAC including pneumococcal surface adhesin A (rPSaA), pneumococcal surface protein A (rPspA), and pneumococcal surface protein C (rPspC)[0061].
One of ordinary skill in the art would have been motivated to devise this Spn antigen – lipidated FLIPr construct because FLIPr is an effective carrier for targeting antigens to Fc gamma receptors just as IgG2a Fc is as taught by Wiedinger, a lipidated FLIPR might enhance immunity, and the immunization with the vaccine composition, perhaps via an intranasal route as noted in Wiedinger, may confer protective immunity against a Streptococcus infection (See MPEP 2143, A. and 2143.02: Combining prior art elements according to known methods to yield predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success replacing the IgG2A Fc as taught by Wiedinger with a lipidated FLIPr and for the antigen/immunogen, replace the aforementioned pneumococcal proteins (rAAC) in a vaccine composition construct. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated in the context of vaccinology and/or immunity, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
13. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Chen 2009 as applied to claims 1,5,6 above, and further in view of Kuo et al. (“Kuo”)(See PTO-892: Notice of References Cited).
Claim 9 recites the vaccine composition according to claim 6, wherein the immunogen is a recombinant trimeric spike protein of SARS CoV-2 (rTS).
Chen in view of Chen 2009 teaches claims 1, 5,and 6 above.
Chen in view of Chen 2009 does not teach the immunogen is a recombinant trimeric spike protein of SARS-CoV-2 (rTS).
Kuo teaches “similar to SARS-CoV, the spike (S) protein of SARS-CoV-2 is the receptor for attachment and cell entry via the cellular receptor hACE2. Researchers are also adapting antigen design strategies used for SARS-CoV-2”(p. 1-2). Kuo also teaches S-2P proteins produced in CHO cells and their structure displayed typical spike trimers under cryo-EM (Supplementary Figure S1), resembling that of 293-expressed SARS-CoV-2 S protein, suggesting that CHO cells are feasible in production of S-2P (p.2). Kuo further teaches subunit vaccines such as the spike protein are often poorly immunogenic by themselves and therefore typically require adjuvants to enhance their ability to produce an immune response (p.2). And finally, Kuo teaches that S-2P, when mixed with CpG1018 and aluminum hydroxide adjuvants, was most effective in inducing antibodies that neutralized pseudovirus and wild-type live virus while minimizing Th2-biased responses with no vaccine-related adverse effects (p.2).
One of ordinary skill in the art would have been motivated to use a recombinant trimeric spike protein of SARS-CoV-2 as taught by Kuo as the immunogen of a vaccine composition, comprising a recombinant lipidated FLIPr (rLF) in order to develop an even more immunogenic and protective vaccine against the SARS-CoV-2 virus (see MPEP 2143 A. and 2143.02 Combining prior art elements according to known methods to yield predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success of developing a vaccine composition with recombinant trimeric spike protein of SARS-CoV-2 as the immunogen as taught by Kuo. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated in the context of vaccinology and/or immunity, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
14. Claim 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view Chen 2009 as applied to claims 1,5 above, and further in view of Kim et al. (“Kim”) (See PTO-892: Notice of References Cited).
Claim 10 recites the vaccine composition according to claim 5, wherein the immunogen is an inactivated virus.
Claim 11 recites the vaccine composition according to claim 10, where in the immunogen is an inactived Zika virus (IZV).
Chen in view of Chen 2009 teaches claims 1 and 5 above.
Chen in view of Chen 2009 does not teach the immunogen is an inactivated virus (claim 10) or an inactived Zika virus (IZV)(claim 11).
Kim teaches the Zika purified inactivated virus (ZPIV) vaccine is a whole formalin-inactivated ZIKV derived from Puerto Rico (ZK-PR) strain, PRVABC59, developed by the Walter Reed Army Institute of Research (WRAIR). The vaccine is co-formulated with aluminum hydroxide adjuvant. Using the immunocompetent mouse and marmoset models, Kim tested the protective efficacy of ZPIV following ZIKV challenges during pregnancy and demonstrated that ZPIV significantly reduced ZIKV-induced fetal malformations. Protection of fetuses was positively correlated with virus-neutralizing antibody levels. In marmosets, the vaccine prevented vertical transmission of ZIKV and elicited neutralizing antibodies (Abstract, p. 1-2).
One of ordinary skill in the art would have been motivated to use an inactivated virus, such as Zika purified inactivated virus (ZPIV) vaccine as taught by Kim as the immunogen in a vaccine composition, comprising a recombinant lipidated FLIPr (rLF), in order to develop an even more immunogenic and protective vaccine against Zika virus. (see MPEP 2143 A. and 2143.02 Combining prior art elements according to known methods to yield predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success of developing a vaccine composition with the Zika purified inactivated virus (ZPIV) as the immunogen as taught by Kim. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated in the context of vaccinology and/or immunity, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
15. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Chen 2009 as applied to claims 1,5 above, in view of Kim as applied to claim 10 above, and further in view of Pulendran et al. (“Pulendran”)(See PTO-892: Notice of References Cited).
Claim 12 recites the vaccine composition according to claim 10, wherein the immunogen is an inactive influenza virus.
Chen in view of Chen 2009 teaches the claims 1 and 5, while Kim teaches claim 10.
Chen in view of Chen 2009, further in view of Kim does not teach the immunogen is an inactive influenza virus.
Pulendran teaches emerging concepts in the science of vaccine antigens. Pulendran discusses both oil-in-water adjuvant MF59 which is used in Fluad, a standard-dose, inactivated influenza (flu) vaccine, which is a trivalent inactivated vaccine against seasonal influenza licensed for adults older than 65 years of age, as well as ASO3 used for the pandemic influenza vaccines Pandemrix and Arepanrix (Introduction, p. 454). Pulendran also teaches “the past two decades have witnessed a revolution in our understanding of how the innate immune system senses microbes, which offers a huge opportunity for additional insights into adjuvant design and development”(p. 454). Pulendran notes “in the decade following the discovery of TLRs, other innate PRRs (such as retinoic acid-inducible gene I (RIG-I) and other RNA sensors), DNA sensors (such as stimulator of interferon genes (STING) protein), C-type lectins, nucleotide-binding oligomerization domain (NOD)-like receptors (NLRs) and cytosolic receptors – such as NLRP3, which activate the inflammasome – were also discovered and shown to impact adaptive immunity” (p. 454-455).
One of ordinary skill in the art would have been motivated to use an inactivated virus, such as the inactivated influenza (flu) vaccine taught by Pulendran, especially in light of Pulendran’s remarks about adjuvant design developments, as the immunogen in a vaccine composition, comprising a recombinant lipidated FLIPr (rLF), in order to develop an even more immunogenic and protective vaccine against the influenza virus. (see MPEP 2143 A. and 2143.02 Combining prior art elements according to known methods to yield predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success of developing a vaccine composition with an inactivated influenza virus as the immunogen as taught by Pulendran. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated in the context of vaccinology and/or immunity, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims allowed.
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/C.C./Examiner, Art Unit 1671
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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