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 .
Response to Amendment
The Amendment filed 10/30/2025 in which claims 1 and 8 were amended, claim 11 was canceled, has been entered. Claims 20-22, and 24-25 were previously withdrawn.
Claims 1-10, 12-15 are under examination on the merits.
Drawings
(Previous objection, withdrawn) Applicant’s amendments to the Drawings submitted on 10/30/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 06/30/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 10/30/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 06/30/2025.
Nucleotide and/or Amino Acid Sequence Disclosures
(Previous objection, withdrawn) Applicant’s amendments to the Drawings concerning nucleotide and/or amino acid sequence disclosures submitted on 10/30/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 06/30/2025.
Claim Objections
(Previous objections, withdrawn as to claims 1-15). Applicant’s amendments to the instant claims have overcome previous objections previously set forth in the Non-Final Office Action mailed 06/30/2025.
Claim Rejections - 35 USC § 112
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.
(Previous rejection, withdrawn as to claims 1, 3-10, maintained as to claims 2, 12-15) Claims 2, 12-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as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.
See claims 1-10, 12-15 as submitted on 10/30/2025.
Applicant’s amendment to claim 1 has overcome previous rejection to claims 1, 3-10.
The previous rejections of claim 11 is moot in view of Applicant’s cancelation of this claim.
Regarding claim 2 and its dependents claims 12-15, it is noted that claim 2 was not amended. Accordingly, the rejection under 35 U.S.C. 112 set forth in the previous Non-Final Office Action still applies to claim 2. As previously explained, claim 2 recites “essentially inactive”. It is unclear what this term means. The Specification (page 4) states that the term "essentially inactive" refers to transcript levels of the gene that is naturally controlled by the chosen third exogenous promoter as published in professional databases. However, such definition still renders the claim indefinite because the indicated term relies on access to online databases that are continually being updated and modified as technology improves. Further, databases present experimental values which can differ from one database to another. Therefore, the provided definition does not provide a standard for ascertaining the requisite degree of promoter activity or inactivity, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The dependent claims do not add additional clarity and, therefore, are also indefinite. (See also Response to Arguments below).
Further, as previously explained, claim 2 recites “a third exogenous promoter that is active in cells in a selected inoculation site of a mammalian subject to which site the replication-competent controlled herpesvirus is administered but is essentially inactive in cells of nerve ganglia of the mammalian subject”. This recitation is unclear because of the following reasons: First, it is known in the art that tissue-specific promoters do not really exist (See Voellmy cited below, column 1). Although a promoter may have a much stronger activity in a particular cell type than in others, it is likely to display at least some level of basal activity in some other cells, (see also above the explanation of the term “essentially inactive”). Second, gene expression under promoter control cannot be restricted to one cell type when the gene is delivered via infection of a replication competent virus because upon replication the viral progeny will infect other permissive cell types. Third, gene expression under promoter control cannot be locally restricted when a small molecule regulator is used to activate the promoter, as it is the case in instant claims, for the simple reason that a small molecule regulator readily diffuses through tissues. The same applies to gene expression under a heat shock promoter control because temperature readily diffuses through tissues. For at least those reasons claim 2 is indefinite. The dependent claims do not add additional clarity and, therefore, are also indefinite. For the purposes of compact prosecution and applying prior art, claim 2 was interpreted herein to refer to a third exogenous promoter functionally linked to a second replication-essential gene of the replication-competent controlled herpesvirus.
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.
(Previous rejection, withdrawn as to claim 11) Claim 11 was rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The previous rejections of claim 11 is moot in view of Applicant’s cancelation of this claim.
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.
(Previous rejection, withdrawn as to claim 11, maintained as to claims 1-8, 10, 12-15) Claims 1-8, and 10, 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Voellmy, in view of Wu et al. (prior art of record).
See claims 1-8, 10, 12-15 as submitted on 10/30/2025.
The previous rejections of claim 11 is moot in view of Applicant’s cancelation of this claim.
Regarding claim 1, it is noted that all of the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 06/30/2025. No new limitations were introduced in the amendment filed on 10/30/2025. Accordingly, the rejection under 35 U.S.C. 103 set forth in the previous Non-Final Office Action mailed on 06/30/2025 still applies to amended claim 1. As previously explained, Voellmy teaches a replication-competent controlled herpesvirus capable of delivering a viral antigen comprising genome of an alpha-herpesvirus such as a herpes simplex virus (columns 2, 12-14; claims 1-3) comprising the additional following elements:
(a) a first exogenous promoter that acts as a heat shock promoter functionally linked to a viral gene whose product is required for efficient viral replication (column 2)
(b) a second exogenous promoter functionally linked to an exogenous or passenger gene for an antigen (columns 2, 3, 8)
Voellmy does not teach an antigen gene of a SARS CoV-2 virus.
Wu et al. teach the full genomic sequence of SARS-CoV-2 including the antigenic RBD region of SARS-CoV-2 S protein (Abstract, pages 265-267). Wu et al. further teach that the RBD region is the site of ACE2 receptor binding and it is implicated in horizontal transmission and therefore immune activation (pages 267-268).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated a sequence of SARS-CoV-2 as taught by Wu et al. into the replication-competent controlled herpesvirus of Voellmy for the benefit of formulating a viral construct comprising a SARS-CoV-2 antigen under promoter control for therapeutic gene expression. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in formulating the replication-competent controlled herpesvirus comprising a SARS-CoV-2 antigen given that the methods of vector cloning and controlled expression are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 2, it is noted that no amendments were introduced to claim 2 in the amendment filed on 10/30/2025. As previously explained, Voellmy teaches the replication-competent controlled herpesvirus of claim 1 further comprising a third exogenous promoter functionally linked to a second viral gene whose product is required for efficient viral replication such as ICP4 and ICP27 (columns 2, 13).
Regarding claim 3, it is noted that no amendments were introduced to claim 3 in the amendment filed on 10/30/2025. As previously explained, Voellmy further teaches an exogenous gene for a transactivator that is the functionally linked to the first exogenous promoter and the first replication-essential gene is functionally linked to a transactivator-responsive promoter (columns 2, 3).
Regarding claim 4, it is noted that no amendments were introduced to claim 4 in the amendment filed on 10/30/2025. As previously explained, Voellmy further teaches wherein the first exogenous promoter is a nucleic acid sequence that acts as a heat shock promoter as well as a transactivator-responsive promoter (columns 2, 3; claim 6).
Regarding claim 5, it is noted that no amendments were introduced to claim 5 in the amendment filed on 10/30/2025. As previously explained, Voellmy further teaches wherein the transactivator is a small-molecule regulator-activated transactivator (columns 2, 3).
Regarding claim 6, it is noted that no amendments were introduced to claim 6 in the amendment filed on 10/30/2025. As previously explained, Voellmy further teaches wherein the small-molecule regulator-activated transactivator contains a modified ligand-binding domain from a human progesterone receptor and is activated by an antiprogestin such as mifepristone (column 24; Fig. 2).
Regarding claim 7, it is noted that no amendments were introduced to claim 7 in the amendment filed on 10/30/2025. As previously explained, Voellmy further teaches the replication-competent controlled herpesvirus further comprising an expressible exogenous gene for a repressor of the first replication-essential gene (columns 8, 9).
Regarding claim 8, it is noted that all of the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 06/30/2025. No new limitations were introduced in the amendment filed on 10/30/2025. Accordingly, the rejection under 35 U.S.C. 103 set forth in the previous Non-Final Office Action mailed on 06/30/2025 still applies to amended claim 8. As previously explained, Voellmy further teaches wherein the replication-competent controlled virus derives from a virus selected from the group consisting of an herpes virus simplex or varicella zoster virus (columns 12-14).
Regarding claim 10, it is noted that no amendments were introduced to claim 10 in the amendment filed on 10/30/2025. As previously explained, Voellmy further teaches an injectable composition comprising the replication-competent controlled herpesvirus of any of claims 1 (column 25, Example 1). Regarding the recitation of “an effective amount”, it is noted that the amount used is considered to be one determined by routine optimization according to one of skill in the art in view of the teachings of Voellmy.
Regarding claim 12, it is noted that no amendments were introduced to claim 12 in the amendment filed on 10/30/2025. As previously explained, Voellmy further teaches an exogenous gene for a transactivator that is the functionally linked to the first exogenous promoter and the first replication-essential gene is functionally linked to a transactivator-responsive promoter (columns 2, 3, 13).
Regarding claim 13, it is noted that no amendments were introduced to claim 13 in the amendment filed on 10/30/2025. As previously explained, Voellmy further teaches wherein the first exogenous promoter is a nucleic acid sequence that acts as a heat shock promoter as well as a transactivator-responsive promoter (columns 2, 3, 13; claim 6).
Regarding claim 14, it is noted that no amendments were introduced to claim 14 in the amendment filed on 10/30/2025. As previously explained, Voellmy further teaches wherein the transactivator is a small-molecule regulator-activated transactivator (columns 2, 3, 13).
Regarding claim 15, it is noted that no amendments were introduced to claim 15 in the amendment filed on 10/30/2025. As previously explained, Voellmy teaches the replication-competent controlled herpesvirus of claim 14. As indicated above Voellmy further teaches wherein the small-molecule regulator-activated transactivator contains a modified ligand-binding domain from a human progesterone receptor and is activated by an antiprogestin such as mifepristone (columns 13, 24; Fig. 2).
The rejections are maintained for reasons of record.
(Previous rejection, , maintained as to claim 9) Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Voellmy, in view of Wu et al., as applied to claims 1-8, and 10, 12-15 above, and further in view of Watanabe et al. (prior art of record).
See claim 9 as submitted on 10/30/2025.
Regarding claim 9, it is noted that no amendments were introduced to claim 9 in the amendment filed on 10/30/2025. As previously explained, the teachings of Voellmy and Wu et al. in combination rendered claim 1 prima facie obvious.
Neither Voellmy nor Wu et al. teach a replication-competent controlled virus is derived from an HSV-1 or HSV-2 and lacking a functional ICP47 gene.
However, Watanabe et al. teach a herpes simplex virus (HSV-1) wherein the ICP47 gene is implicated in immune evasion by a mechanism involving binding to the TAP peptide transporter and blocking MHC class I presentation. Watanabe et al. further teach that the absence of the ICP47 gene results in enhanced immunogenicity (Abstract, page 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have omitted the ICP47 gene of HSV-1 from the replication-competent controlled herpesvirus taught by Voellmy and Wu et al. for the benefit of formulating a viral construct with enhanced immunogenicity. See MPEP 2144.07.
One of ordinary skill in the art would have had reasonable expectation of success in formulating the replication-competent controlled herpesvirus comprising a SARS-CoV-2 antigen and lacking the ICP47 gene of HSV-1 given that the methods of vector cloning and controlled expression are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
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.
(Previous rejection, withdrawn as to claim 11, maintained as to claims 1-10, 12-15) Claims 1-10, 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 10 of US patent No. 12257300 B2, in view of US patent No. 7906312 B2 to Voellmy and Wu et al. (prior art of record).
See claims 1-10, 12-15 as submitted on 10/30/2025.
The previous rejections of claim 11 is moot in view of Applicant’s cancelation of this claim.
It is noted that all of the amendments to the instant claims were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 06/30/2025. No new limitations were introduced in the amendment filed on 10/30/2025. Accordingly, the rejection on the ground of nonstatutory double patenting set forth in the previous Non-Final Office Action mailed on 06/30/2025 still applies to the amended claims. As previously explained, as to claims 1-10, 12-15 of instant application, the patented claims are directed to a replication-competent controlled alpha-herpesvirus comprising a first exogenous promoter acting as a heat shock promoter controlling the expression of a first replication-essential gene of the alpha-herpesvirus, and a second exogenous promoter functionally linked to an exogenous gene from another pathogen.
The patented claims do not explicitly teach an exogenous gene of SARS-CoV-2, nor do they teach a third exogenous promoter functionally linked to a second replication-essential gene of the replication-competent controlled herpesvirus, a truncated ligand-binding domain from a progesterone receptor which is activated by an antiprogesting, and an exogenous gene for a repressor.
However, as indicated above, Voellmy teaches those claim elements. Specifically Voellmy teaches:
a third exogenous promoter functionally linked to a second replication-essential gene of the replication-competent controlled herpesvirus such as ICP4 and ICP27 for therapeutic use (columns 2, 13)
a truncated ligand-binding domain from a progesterone receptor which is activated by an antiprogesting such as mifepristone (column 24; Fig. 2).
expressible exogenous gene for a repressor of the first replication-essential gene (columns 8, 9)
Wu et al. teach the full genomic sequence of SARS-CoV-2 including the antigenic RBD region of SARS-CoV-2 S protein (Abstract, pages 265-267).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the claim elements stated above as taught by Voellmy and a sequence of SARS-CoV-2 as taught by Wu et al. into the replication-competent controlled herpesvirus as taught by claims 1, 3-5, 10 of US patent No. 12257300 B2 for the benefit of formulating a viral construct comprising a SARS-CoV-2 antigen under promoter control for therapeutic gene expression. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in formulating the replication-competent controlled herpesvirus comprising a SARS-CoV-2 antigen comprising the claim elements taught by Voellmy given that the methods of vector cloning and controlled formulation and expression are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, claims 1-10, 12-15 of instant application are rejected on the ground of nonstatutory double patenting.
(Previous rejection, withdrawn as to claim 11, maintained as to claims 1, 3-5, 8-10) Claims 1, 3-5, 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8 of US patent No. 7906312 B2, in view of Wu et al. and Watanabe et al. (prior art of record).
See claims 1, 3-5, 8-10 as submitted on 10/30/2025.
The previous rejections of claim 11 is moot in view of Applicant’s cancelation of this claim.
It is noted that all of the amendments to the instant claims were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 06/30/2025. No new limitations were introduced in the amendment filed on 10/30/2025. Accordingly, the rejection on the ground of nonstatutory double patenting set forth in the previous Non-Final Office Action mailed on 06/30/2025 still applies to the amended claims. As previously explained, as to claims 1, 3-5, 8-10 of instant application, the patented claims are directed to a replication-competent controlled alpha-herpesvirus comprising a first exogenous promoter acting as a heat shock promoter controlling the expression of a first replication-essential gene of the herpesvirus, and a second exogenous promoter functionally linked to an exogenous passenger gene.
The patented claims do not explicitly teach an exogenous gene of SARS-CoV-2, nor do they recite a replication-competent controlled virus is derived from an HSV-1 or HSV-2 and lacking a functional ICP47 gene to formulate a virus for therapeutic use.
However, Wu et al. teach the full genomic sequence of SARS-CoV-2 including the antigenic RBD region of SARS-CoV-2 S protein (Abstract, pages 265-267).
Watanabe et al. teach a herpes simplex virus (HSV-1) wherein the ICP47 gene is implicated in immune evasion by a mechanism involving binding to the TAP peptide transporter and blocking MHC class I presentation. Watanabe et al. further teach that the absence of the ICP47 gene results in enhanced immunogenicity and can be used in a vector for therapeutic use such as in vaccines (Abstract, page 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the teachings of Wu et al. about a sequence of SARS-CoV-2 and of Watanabe et al. about the omission of the HSV-1 ICP47 gene into the replication-competent controlled herpesvirus as taught by claims 1-3, 6-8 of US patent No. 7906312 B2 for the benefit of formulating a viral construct with enhanced immunogenicity comprising a SARS-CoV-2 antigen under promoter control for therapeutic gene expression such as in a vector vaccine. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in formulating the replication-competent controlled herpesvirus comprising a SARS-CoV-2 antigen and no ICP47 gene given that the methods of vector cloning and controlled expression are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, claims 1, 3-5, 8-10 of instant application are rejected on the ground of nonstatutory double patenting.
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
Applicant contends on page 9 of the Remarks submitted on 10/30/2025:
[T]he specification defines "essentially inactive" as meaning that a promoter is at least about 50 times, more preferably at least about 100 times and most preferably at least about 500 times higher in cells where the promoter is active, e.g., in cells of a selected inoculation site, than in cells of nerve ganglia and other nerve tissue (specification, page 4, lines 8-12). In the working examples, the specification teaches experimental results obtained with an exemplary promoter that is active in cells in a selected inoculation site of a mammalian subject, skin cells, and essentially inactive in cells of nerve ganglia of the mammalian subject (see e.g., page 14, Table 1; see also, pages 33-34, Tables 2 and 3).
In response:
As indicated above, the Specification (page 4) states that the term "essentially inactive" “refers to transcript levels of the gene that is naturally controlled by the chosen third exogenous promoter as published in professional databases.” However, such definition still renders the claim indefinite because the indicated term relies on access to online databases that are continually being updated and modified as technology improves. Further, databases present experimental values which can differ from one database to another. The examples presented in the Specification (for example, page 14, Table 1) refer to measurements in a single experiment wherein no control values are presented and wherein such the human keratin 1 promoter values appear to derive from the BioGPS database as explained in the Specification (page 13, ¶ 3, lines 6-8). Further, while a difference in promoter activity may be observed between levels of promoter activity in keratinocytes and those in dorsal root ganglia, keeping in mind that no control values are provided, it is herein maintained that such an example does not provide a standard for ascertaining the requisite degree of promoter activity or inactivity, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, one of ordinary skill in the art would not be reasonably apprised to know how small or large of a difference in promoter activity is encompassed by the claimed invention.
Applicant contends on page 10 of the Remarks submitted on 10/30/2025:
Here, a person of ordinary skill in the art would not have been motivated at the time of the current invention, April 24, 2020, to combine the teachings of the '312 patent, that does not disclose any viral sequences or vaccines for viral diseases, but exclusively discloses herpesvirus-based vaccines for research and cell-based therapies, e.g., cancer therapies, with Wu disclosing a recently reported new RNA virus strain from the family of Coronaviridae referred to as "2019-nCoV" (Wu, abstract, stating that "a severe respiratory disease was recently reported" and "the first patient was hospitalized on 12 December 2019").
In response:
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); see also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (discussion of reliance on legal precedent); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988) (references do not have to explicitly suggest combining teachings); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985) (examiner must present convincing line of reasoning supporting rejection); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993) (reliance on logic and sound scientific reasoning). See MEPE 2144.
In the instant case, one of ordinary skill in the art would have been motivated before the effective filing date to combine the teachings of Voellmy, Wu et al. and Watanabe et al. as explained above in detail for the benefit of formulating a vector under promoter control with enhanced immunogenicity. Further motivation derives from the fact that as of April 24, 2020 there were no therapeutic options to combat a rapidly emerging and alarming global health crisis driven by the newly identified SARS-CoV-2 virus. It is noted that the instant rejection is in view of instant claim language. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The term “conditionally replicating virus” is not part of the instant claim language. The instant claims require a “replication-competent controlled herpesvirus”. It is herein maintained that the cited prior art provided clear teachings and suggestions of how to arrive at the claimed invention before the effective filing date as well as clear motivations i.e., to formulate of a replication-competent controlled vector with increased immunogenicity to deliver exogenous genes to target cells. To reiterate, in addition to the clear motivations provided by the cited prior art, there is also a clear rationale deriving from knowledge generally available to one of ordinary skill in the art before the effective filing date, i.e., the urgent need at the time of filing of therapeutic options to combat a rapidly emerging and alarming global health crisis driven by the newly identified SARS-CoV-2 virus. Therefore, on the contrary, one of ordinary skill in the art would have been motivated with reasonable expectation of success to combine the teachings of the cited prior art and arrive at the claimed invention before the effective filing date.
Applicant contends on page 10 of the Remarks submitted on 10/30/2025:
Claims 1-15 are rejected under the judicially created doctrine of "obviousness-type" double patenting over claims 1, 3-5 and 10 of U.S. Patent No. 12,257,300 (hereinafter the '300 patent) in view of Voellmy (U.S. Patent No. 7,906,312) and Wu et al. (2020). Applicant traverses and respectfully asserts that the pending claims are patentable over claims 1-15 of U.S. Patent No. 12,257,300 (hereinafter the '300 patent) in view of the '312 patent and Wu because one skilled in the art would not have been motivated to combine the references, given the state of the art and the unpredictability of replication-competent vaccines in general and of any vaccines for the newly discovered 2019-nCoV in particular.
In response:
As indicated above, it is herein maintained that the cited prior art provided clear teachings and suggestions of how to arrive at the claimed invention before the effective filing date as well as clear motivations i.e., to formulate of a replication-competent controlled vector with increased immunogenicity to deliver exogenous genes to target cells. In addition to the clear motivations provided by the cited prior art, there is also a clear rationale deriving from knowledge generally available to one of ordinary skill in the art before the effective filing date, i.e., the urgent need at the time of filing of therapeutic options to combat a rapidly emerging and alarming global health crisis driven by the newly identified SARS-CoV-2 virus. Therefore, on the contrary, one of ordinary skill in the art would have been motivated with reasonable expectation of success to combine the teachings of the cited prior art and arrive at the claimed invention before the effective filing date.
Response to Declaration under 37 C. F. R. § 1.132
Applicant’s 37 CFR 1.132 Declaration filed on 10/30/2025 has been thoroughly reviewed and considered.
The Declaration under 37 CFR 1.132 filed on 10/30/2025 is insufficient to overcome the rejection of instant claims as set forth in this Office Action because of the reasons explained below.
It is noted that the Declaration under 37 CFR 1.132 filed on 10/30/2025 by Mr. Richard Voellmy has a potential bias in favor of instant Application given that Mr. Voellmy is the sole inventor of instant Application. Accordingly, the statements in the Declaration under 37 CFR 1.132 filed on 10/30/2025 may not represent unbiased assessments of the teachings of the cited prior art.
Turning to the arguments provided in Applicant’s Declaration, the Examiner acknowledges Mr. Voellmy’s explanation and experimental results in regards to generation of broadly neutralizing antibodies against beta-coronaviruses with the claimed replication-competent controlled herpesvirus. As indicated above, the instant rejection is in view of instant claim language. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The instant claims do not mention nor require any limitation in regards to generating broadly neutralizing antibodies against coronaviruses or any other pathogen. It is noted that intended use of in a claim, for example, intended use of a replication-competent controlled herpesvirus as a vaccine, does not carry patentable weight. Accordingly, neither the arguments nor the data presented in the Declaration provide evidence of nonobviousness to overcome the rejections of record.
Further, as to the alleged unexpected results, it is noted that the instant claims read on any antigen of SARS-CoV-2, not just a spike protein antigen. As such, the result comprising broadly neutralizing antibodies against beta-coronaviruses is not considered unexpected, especially when the SARS-CoV-2 antigen introduced comprises regions of a spike protein that are highly conserved among beta-coronaviruses (for example, an antigen comprising a full-length spike protein). In fact, such a result would be considered entirely expected and consistent with the prior art (see also Bloom et al. 2018, Lu et al. 2010 cited in Applicant’s IDS submitted on 10/19/2022). It is not clear why Applicant refers to such a result as unexpected (Remarks, page 12). More importantly, as indicated above, the generation of broadly neutralizing antibodies against coronaviruses or any other pathogen is not a limitation of the instant claims and therefore it is of no relevance to overcome the rejections of record.
The references to the cited prior art explained above teach and suggest the exact embodiment instantly claimed. Applicant’s 37 CFR 1.132 Declaration including inventor opinion was fully reviewed and considered, but in view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672