Detailed Office 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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 04 December, 2025. Claims 1-20 are pending in the instant application. Applicants’ election with traverse of Group II (claims 1-10 and 18, directed toward expression vectors encoding HERV Gag/Pol HLA-A*0201 epitopes) was noted. Claims 11-17, 19, and 20 stand withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
37 C.F.R. § 1.57(d)
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g., see p. 26). Applicant is required to peruse the entire specification and delete any embedded hyperlinks and/or other forms of browser-executable code. See M.P.E.P. § 608.01.
Claim Objections
Claims 1-10 and 18 are objected to because of the following informalities:
- Claims 1, 3, 46, and 7 reference “epitopes of sequences SEQ ID NO: 1-7” which should read “one of the epitopes set forth in SEQ ID NOS.: 1-7”, or something similar thereto.
- Claim 8 references peptides “selected from the group consisting of SEQ ID NO. 8-14” which should read peptides “selected from the group consisting of SEQ ID NOS.: 8-14”, or something similar thereto.
- Claim 9 references peptides containing the amino acid residues of “sequences SEQ ID NO: 8-14” which should read “peptide containing the amino acid sequences of SEQ ID NOS.: 8-14”, or something similar thereto.
- Claim 10 references “Vaccine or immunogenic composition” which should read “A vaccine or immunogenic composition”, or something similar thereto.
35 U.S.C. § 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.
Claims 1-10 and 18 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
Claim 1 is directed toward a composition comprising: A) one or more expression vector(s) that induce(s) expression of 2, 3, 4, 5, 6 or 7 peptides in vivo, the peptides consisting of 9 to 100 amino acid residues, each peptide comprising at least one of the epitopes of sequences SEQ ID NO: 1-7, wherein each peptide comprises at least one different epitope with respect to the others; or B) an expression vector that induces expression of at least one peptide in vivo, said peptide consisting of 9 to 100 amino acids residues and comprising 2, 3, 4, 5, 6 or 7 of the epitopes of sequences SEQ ID NO: 1-7, wherein said peptide comprises at least two different epitopes from each other; and a pharmaceutically acceptable vehicle or excipient.
Claim 1 is confusing in referencing an expression vector(s) that induces 2, 3, 4, 5, 6 or 7 peptides. The precise structural characteristics and coding potential of each vector are not readily manifest. Are multiple peptides being expressed from a single vector? Is one vector capable of expressing two or three (or more) different peptides? Alternatively, are multiple peptides being expressed independently from different expression vectors? Are the same type of expression vectors (e.g., lentiviral, retroviral, etc.) used to express each peptide or are different types of expression vectors encompassed by the claims?
Claims 2-9 are confusing for referencing a composition that induces expression of one or more of the recited sequences, because it is not clear if the claims are referencing the first (A), second (B), or both sets of vectors.
Claim 18 is vague and indefinite for referencing a composition comprising a pharmaceutical excipient/vehicle that is an adjuvant. Adjuvants are specifically designed to boost the immune response to vaccines, whereas excipients are typically inert substances that maintain the physical and chemical properties of the drug/active ingredient. Excipients typically improve the stability, solubility, or other characteristics of the drug formulation. Amendment of the claim language to reference the vaccine/immunogenic composition of claim 10, wherein said composition further includes an adjuvant, would be acceptable.
Finally, amendment of the claim language to recite the actual epitopes would be beneficial (e.g., wherein the peptide comprises at least one of the following epitopes: FLQFKTWWI (SEQ ID NO.: 1), RLIPYDWEI (SEQ ID NO.: 2), KLIDCYTFL (SEQ ID NO.: 3), YLSFIKILL (SEQ ID NO.: 4), AMIPKDWPL (SEQ ID NO.: 5), YAMSNLFSI (SEQ ID NO.: 6), or SMDDQLNQL (SEQ ID NO.: 7).
35 U.S.C. § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless --
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The previous rejection of claims 1 and 3-9 under 35 U.S.C. § 102(a)(1) and (a)(2) as being clearly anticipated by Hardy et al. (U.S. Pat. No. 8,581,694 B2, issued 27 August, 2013), is hereby withdrawn in response to Applicants’ amendment.
Joint Inventors, Common Ownership Presumed
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 at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed 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.
35 U.S.C. § 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 of this title, 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 previous rejection of claims 10 and 18 under 35 U.S.C. § 103 as being unpatentable over Hardy et al. (U.S. Pat. No. 8,581,694 B2, issued 27 August, 2013), is hereby withdrawn in response to Applicants’ amendment.
Suggested Allowable Subject Matter
Applicants’ representative is invited to contact the Examiner to discuss suggested allowable subject matter.
Action Is Final
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See M.P.E.P. § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 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 extension fee pursuant to 37 C.F.R. § 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.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 26 March, 2026
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