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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on 07 September 2023. Receipt is acknowledged of certified copies of paper require by 37 CFR 1.55.
Election/Restrictions
Applicant’s election with traverse of Group I, corresponding to claims 1-15 and UL11, UL16, and UL21 in claims 1-2, HSV glycoprotein E in claim 4, UL11, UL16, UL21 with gE, gD, and/or gB in claim 5, HSV gE in claim 9, a poly-A tail and 5’ and 3’ UTRs that enhance translation in claim 10, and HSV-2 in claim 13, in the reply filed 15 April 2026 is acknowledged.
The traversal on the ground(s) that the HSV vaccine of Stergiou (Prior Art of Record) differs from the instant claimed HSV vaccine due to the instant claimed vaccine comprising mRNA and the Stergiou vaccine comprising proteins. However, this is not found persuasive in the least because unity of invention will only be fulfilled when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The inventions are drawn to an HSV vaccine which is a special technical feature over Stergiou, which is also drawn to an HSV vaccine. The requirement is still deemed proper and is therefore made FINAL.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 15 April 2026.
Specification
The Specification is objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R. § 1.84 (u)(1) (see also MPEP §608.02 (V)).
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital
letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be
numbered and the abbreviation “FIG.” must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in
reply to the Office action to avoid abandonment of the application. Any amended
replacement drawing sheet should include all of the figures appearing on the immediate
prior version of the sheet, even if only one figure is being amended. The figure or figure
number of an amended drawing should not be labeled as “amended.” If a drawing figure
is to be canceled, the appropriate figure must be removed from the replacement sheet,
and where necessary, the remaining figures must be renumbered and appropriate
changes made to the brief description of the several views of the drawings for
consistency. Additional replacement sheets may be necessary to show the renumbering
of the remaining figures. Each drawing sheet submitted after the filing date of an
application must be labeled in the top margin as either “Replacement Sheet” or “New
Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner,
the applicant will be notified and informed of any required corrective action in the next
Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-8, and 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
The instant claims are broadly drawn to mRNAs that encode the UL11, UL16, UL21, and gE proteins and compositions comprising the same. As such, the instant claims are drawn to a composition of matter, which is a statutory category of invention (STEP 1: YES).
The instant Specification evidences that UL11, UL16, and UL21 are HSV tegument proteins (Pg. 13-14) and gE is an HSV glycoprotein (Pgs. 17-18). As such, HSV would naturally create mRNAs that encode these proteins in the process of protein production. Moreover, the broadest reasonable interpretation of a pharmaceutically acceptable carrier or adjuvant recited by instant claim 15 encompasses, e.g., water.
Expressing naturally occurring mRNAs and, in some embodiments, formulating with water would not, absent evidence to the contrary, result in any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed mRNAs from their naturally occurring counterparts.
Accordingly, the instant claims recite a natural phenomenon, i.e., naturally occurring bacteriophage, which is a judicial exception (JE) (STEP 2A, Prong One: Yes).
The instant claims are drawn solely to the JE, and not a method of using the JE for, e.g., a specific treatment or prophylaxis. As such the instant claims do no recite any additional elements that integrate the JE into a practical application (STEP 2A, Prong Two: NO).
Since the instant claims are limited to only the JE, the instant claims do not recite any additional elements that amount to significantly more than the JE (STEP 2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. §101.
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.
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.
Claims 6, 9-11, and 14 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.
The term “preferably” in claims 6, 9-11, and 14 is a relative term which renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
UL11, UL16, and UL21
Instant claims 1-2 are drawn to a vaccine comprising mRNAs that encode UL11 (SEQ ID NO:1), UL16 (SEQ ID NO: 2), and UL21 (SEQ ID NO: 3), which has written description support. However, the instant claims also broadly encompass a vaccine composition comprising mRNAs that encode an amino acid sequence that is 75% or more identical to SEQ ID NO: 1, 72% or more identical to SEQ ID NO: 2, and 80% or more identical to SEQ ID NO: 3 and immunogenic fragments of UL11, UL16, and UL21.
The Specification has failed to sufficiently describe the amino acids that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the proteins to elicit an immune response to UL11, UL16, and UL21.
Immunogenic fragments as well as 75%, 72%, or 80% or more identical amino acid sequences encompasses a vast genus of proteins and the Specification does not adequately describe the necessary amino acids that must remain for the amino acid sequences that are immunogenic fragment to be able to elicit an immune response.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successfully reduced to practice vaccines with the full UL11, UL16, and UL21 proteins. As such, the Specification reasonably demonstrates that Applicant was in possession of the full length UL11, UL16, and UL21 proteins. However, this is not representative of the extremely large genus of proteins since only the full-length protein is supported and not the innumerable sequences or proteins contained within a genus of 75%, 72%, or 80% identical to the amino acid sequences or immunogenic fragments of the proteins.
The data generated for the vaccine comprising the full-length proteins cannot be reasonably extrapolated and applied to support possession of the entire claimed genus of proteins because no one species, combination, or variant accounts for the variability among the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Stergiou, et al. (WO 2017157969, NPL-IDS, filed, 09/07/2023, hereinafter “Stergiou”) provides a review of using UL11, UL16, and UL21 in HSV vaccines, the full-length protein is used, not fragments. While Applicant may have possession of mRNAs that encode portions of these proteins, as the portions have not been shown to elicit an immune response, these fragments would not be considered vaccines.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
HSV glycoprotein E
Instant claim 4 is drawn to a vaccine comprising mRNA that encoded HSV gE and instant claim 9 is drawn to an mRNA that encodes amino acids 24-405 of HSV gE, which have written description support. However, the instant claims also broadly encompass a vaccine composition comprising an mRNA that encodes an amino acid sequence that is 70% or more identical to SEQ ID NO: 4, and 80% or more identical to SEQ ID NO: 5, and immunogenic fragments of HSV gE.
The Specification has failed to sufficiently describe the amino acids that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the proteins to elicit an immune response to HSV gE.
Immunogenic fragments as well as 70% or 80% or more identical amino acid sequences encompasses a vast genus of proteins and the Specification does not adequately describe the necessary amino acids that must remain for the amino acid sequences that are immunogenic fragment to be able to elicit an immune response.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successfully reduced to practice vaccines with the full-length HSV gE or amino acids 24-405 of HSV gE from HSV-2 strain 2.12. As such, the Specification reasonably demonstrates that Applicant was in possession of the full length HSV gE protein and the truncated 24-405 protein. However, this is not representative of the extremely large genus of proteins since only the full-length protein is supported and not the innumerable sequences or proteins contained within a genus of 70% identical to the amino acid sequences or immunogenic fragments of the proteins.
The data generated for the vaccine comprising the full-length proteins cannot be reasonably extrapolated and applied to support possession of the entire claimed genus of proteins because no one species, combination, or variant accounts for the variability among the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Stergiou provides a review of using HSV gE in HSV vaccines, the full-length protein is used, not fragments. Friedman, et al. (US 20200276300, hereinafter “Friedman”) provides a review of using the truncated 24-405 HSV gE in vaccines, no other HSV gE fragment is used. While Applicant may have possession of mRNAs that encode portions of these proteins, as the portions have not been shown to elicit an immune response, these fragments would not be considered vaccines.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
Scope of Enablement
Claims 12-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the Specification, while being enabling for treating HSV, does not reasonably provide enablement for preventing HSV. The Specification does not enable any person skilled in the area to which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 732, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of claims 12-14 broadly encompasses a vaccine configured for treatment or prevention of HSV infection. When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. See MPEP 2164.01(c). With regard to prevention of HSV infection, it is noted that the term “preventing” was interpreted in an absolute sense to mean always keep something from happening or arising i.e. preventing infection from occurring not just preventing cell to cell transfer.
The embodiment of preventing HSV infection is not enabled because not all infections by HSV are prevented by the vaccine composition being claimed. The level of skill in the art is high, e.g. PhD level scientists.
The Specification provides examples of the vaccine eliciting an immune (IFN-γ) response in PBMCs (Examples 6-7 and 9) but does not provide any working examples or reasonable direction in preventing all infections caused by HSV.
Nouri (https://www.aaas.org/membership/qualia/conflicting-results-herpes-vaccine, Published January 31, 2012) provides a review of the state of the art in HSV vaccine efficacy. HSV vaccines are not 100% effective in preventing infections (¶5). Nouri demonstrates that the ability of a vaccine to prevent some HSV infections is not reasonably predictive of the ability of the vaccine to prevent all HSV infections.
In view of the breadth of the claims, the limited teachings of the specification and the examples regarding preventing HSV infection, the state of the art, and the low predictability with regard to the ability of a vaccine to prevent HSV infection, it would require undue experimentation to practice the claimed methods. Amendment to the claims to only require treatment of an HSV infection would overcome the rejection.
Claim Rejections - 35 USC § 103
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 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 1-5, 7-8, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Stergiou and further in view of PHG (RNA vaccines: an introduction found at https://web.archive.org/web/20181206210317/https://www.phgfoundation.org/briefing/rna-vaccines, archived on Dec 06, 2018 and retrieved 05/19/2026).
Regarding claim 1, Stergiou teaches a vaccine composition comprising HSV polypeptides UL11, UL16, and UL21 (claim 1) and that these polypeptides are encoded by a nucleic acid. Stergiou does not teach that the vaccine comprises mRNAs that encode UL11, UL16, and UL21. However, PHG teaches that mRNA vaccines are faster and cheaper to produce than traditional vaccines and are safer for patients (Summary bullet point 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the teachings of Stergiou for an HSV vaccine comprising UL11, UL16, and UL21 and the teachings of PHG for mRNA vaccines. PHG provides motivation by teaching that mRNA vaccines are faster and cheaper to produce as well as safer for the patients (Summary bullet point 2). One of ordinary skill would have had a reasonable expectation of success in combining Stergiou and PHG because they both teach vaccines.
Regarding claim 2, Stergiou teaches that the UL11, UL16, and UL21 proteins have 100% sequence identity to instant SEQ ID NOs: 1-3, respectively (Claims 2-4 and SEQ ID NO: 1-3, see below for alignments).
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Regarding claim 3, Stergiou teaches that the vaccine is capable of eliciting an immune response (claims 2-4 and 17).
Regarding claim 4, Stergiou teaches that the vaccine further comprises HSV gE which has 100% sequence identity to instant SEQ ID NO: 4 (claims 9-10 and SEQ ID NO: 4, see below for alignment).
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Regarding claim 5, Stergiou teaches a vaccine comprising UL11, UL16, UL21, and gE (claim 9).
Regarding claim 7, Stergiou teaches that the vaccine contains at least one HSV-1 polypeptide (claim 13).
Regarding claim 8, Stergiou teaches that the vaccine contains at least one HSV-2 polypeptide (claim 14).
Regarding claim 12, Stergiou teaches that the vaccine treats HSV infection in a subject (claim 18).
Regarding claim 13, Stergiou teaches that the vaccine treats HSV-2 (claim 20).
Regarding claim 14, Stergiou teaches administering the vaccine by a variety of routes including topical, intramuscularly, and subcutaneously (¶22).
Regarding claim 15, Stergiou teaches that the vaccine further comprises a pharmaceutically acceptable carrier or adjuvant (claim 16).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention, especially in the absence of evidence to the contrary.
Claims 6 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Stergiou and PHG as applied to claims 1-5, 7-8, and 12-15 above, and further in view of Friedman.
As discussed above, claims 1-5, 7-8, and 12-15 were rendered prima facie obvious over Stergiou and PHG.
Regarding claim 6, Stergiou and PHG do not teach that the mRNA encoding the HSV glycoprotein is a nucleoside mRNA comprising one or more pseudouridine residues. However, Friedman teaches mRNA vaccines encoding HSV glycoproteins, including gE, where the mRNAs are nucleoside modified mRNAs and comprises at least one pseudouridine residue (¶0013-0014).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the infection to have combined the teachings of Stergiou and PGH for an mRNA vaccine encoding UL11, UL16, UL21, and gE which the teachings of Friedman for nucleoside modified mRNAs. Friedman provides motivation by teaching that increasing modified uridines increasing translation efficiency (¶0190). One of ordinary skill would have had a reasonable expectation of success in combining Stergiou, PGH, and Friedman because they all teach vaccines.
Regarding claim 9, Friedman teaches that the HSV gE comprises amino acids 24-405 from HSV-2 strain 2.12 (SEQ ID NO: 16, see alignment below).
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Regarding claim 10, Friedman teaches that the mRNAs further comprise a poly-A tail and a 5’ and 3’ untranslated region that enhances translation (Claim 16).
Regarding claim 11, Friedman teaches that the mRNAs are encapsulated in a nanoparticle (¶0308).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention, especially in the absence of evidence to the contrary.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7-8, and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9-10, 13-14, 16, 18, and 20 of U.S. Patent No. 11058765 (conflicting claims) in view of PHG.
Regarding instant claim 1, conflicting claims 1 and 9 recite a vaccine composition comprising UL11, UL16, and UL21. The conflicting claims do not recite that the vaccine comprises mRNAs that encode UL11, UL16, and UL21. However, PHG teaches that mRNA vaccines are faster and cheaper to produce than traditional vaccines and are safer for patients (Summary bullet point 2).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of PHG resulting in an mRNA vaccine comprising mRNAs that encode UL11, UL16, and UL21 because PHG teaches the benefits of mRNA vaccines over traditional vaccines (Summary bullet point 2). PHG provides motivation to modify the conflicting claims by teaching that mRNA vaccines are faster and cheaper to produce as well as safer for the patients (Summary bullet point 2).
Regarding instant claim 2, conflicting claims 2-4 recite conflicting SEQ ID NOS: 1-3, which are identical to instant SEQ ID NOs: 1-3 (see alignment above).
Regarding instant claim 3, conflicting claims 2-4 recite that the vaccine elicits an immune response.
Regarding instant claim 4, conflicting claims 1 and 9-10 recite that the vaccine further comprises HSV gE with conflicting SEQ ID NO: 4 which is identical to instant SEQ ID NO: 4 (see alignment above).
Regarding instant claim 5, conflicting claims 1 and 9 recite a vaccine composition comprising UL11, UL16, UL21, and HSV gE.
Regarding instant claim 7, conflicting claim 13 recites that the vaccine comprises HSV-1 polypeptides.
Regarding instant claim 8, conflicting claim 14 recites that the vaccine comprises HSV-2 polypeptides .
Regarding instant claim 12, conflicting claim 18 recites that the vaccine treats HSV.
Regarding instant claim 13, conflicting claim 20 recites that the vaccine treats HSV-2.
Regarding instant claim 15, conflicting claim 16 recites that the vaccine further comprises a pharmaceutically acceptable carrier or adjuvant.
Claims 6 and 9-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9-10 of U.S. Patent No. 11058765 (conflicting claims) in view of PHG and Friedman.
As discussed above, claims 1-5, 7-8, and 12-15 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9-10, 13-14, 16, 18, and 20 of U.S. Patent No. 11058765 (conflicting claims) in view of PHG.
Regarding claim 6, the conflicting claims and PHG do not recite that at least one of the mRNAs is a nucleoside modified mRNA. However, , Friedman teaches mRNA vaccines encoding HSV glycoproteins, including gE, where the mRNAs are nucleoside modified mRNAs and comprises at least one pseudouridine residue (¶0013-0014).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the conflicting claims with the teachings of PHG and Friedman resulting in a in an mRNA vaccine comprising mRNAs that encode UL11, UL16, and UL21 with at least one mRNA is a nucleoside modified mRNA because Friedman teaches the benefits of nucleoside modified mRNA. Friedman provides motivation to modifying the conflicting claims by teaching that increasing modified uridines increasing translation efficiency (¶0190).
Regarding, claim 9, the conflicting claims do not recite that the HSV gE protein comprises amino acids 24-4005 from HSV-2 strain 2.12. However, Friedman teaches that the HSV gE comprises amino acids 24-405 from HSV-2 strain 2.12 (SEQ ID NO: 16, see alignment above).
Regarding claim 10, the conflicting claims do not recite that the mRNAs further comprise a poly-A tail and a 5’ and 3’ untranslated region that enhances translation . However, Friedman teaches that the mRNAs further comprise a poly-A tail and a 5’ and 3’ untranslated region that enhances translation (Claim 16).
Regarding claim 11, the conflicting claims do not recite that the mRNAs are encapsulated in a nanoparticle. However, Friedman teaches that the mRNAs are encapsulated in a nanoparticle (¶0308).
Claims 1-3, 6, 8, 11, and 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 13, and 15-17 of copending Application No. 18/515,010.
Regarding instant claim 1, conflicting claims 1, 3, and 7 recite an mRNA vaccine that encodes UL11, UL16, and UL21.
Regarding instant claim 2, conflicting claim 1 recites conflicting SEQ ID NOS: 1-3, which are identical to instant SEQ ID NOs: 1-3 (see alignment above).
Regarding instant claim 3, conflicting claim 1 recites recite that the vaccine elicits an immune response.
Regarding instant claim 6, conflicting claim 12 recites that the mRNA is a nucleoside modified mRNA comprising a pseudouridine residue.
Regarding instant claim 8, conflicting claim 1 recites recite that the vaccine encodes HSV-2 polypeptides.
Regarding instant claim 11, conflicting claims 15-16 recite that the mRNA is encapsulated in a lipid nanoparticle.
Regarding instant claim 14, conflicting claim 17 recites that the vaccine is formulated for intramuscular administration.
Regarding instant claim 15, conflicting claim 13 recites that the vaccine further comprises a pharmaceutical carrier.
Conclusion
NO CLAIMS ARE ALLOWED
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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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