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 .
2. Applicant’s amendment filed on 02/17/2026 is acknowledged.
3. Claims 1-33 are pending. Claim 1 is independent.
4. Applicant’s election without traverse of Group I and the species of SEQ ID NO:1 and IL-15, claims 1-12 in the reply filed on 02/17/2026 is acknowledged.
5. Claims 13-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022,That Have Sequence Disclosures
6. 37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO’s patent electronic filing system (Patent Center) (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/patents-application-process/filing-online/legal-framework-efs-web), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Applicant has assigned a SEQ ID numbers 16-19 which are undefined in the sequence listing of the specification.
1.831 Requirements for patent applications filed on or after July 1, 2022, having nucleotide and/or amino acid sequence disclosures.
(a) Patent applications disclosing nucleotide and/or amino acid sequences by enumeration of their residues, as defined in paragraph (b) of this section, must contain, as a separate part of the disclosure, a computer readable Sequence Listing in XML format (a "Sequence Listing XML"). Disclosed nucleotide or amino acid sequences that do not meet the definition in paragraph (b) of this section must not be included in the "Sequence Listing XML." The "Sequence Listing XML" contains the information of the nucleotide and/or amino acid sequences disclosed in the patent application using the symbols and format in accordance with the requirements of §§ 1.832 through 1.834.
(b) Nucleotide and/or amino acid sequences, as used in this section and §§ 1.832 through 1.835, encompass:
(1) An unbranched sequence or linear region of a branched sequence containing 4 or more specifically defined amino acids, wherein the amino acids form a single peptide backbone; or
(2) An unbranched sequence or linear region of a branched sequence of 10 or more specifically defined nucleotides, wherein adjacent nucleotides are joined by:
(i) A 3' to 5' (or 5' to 3') phosphodiester linkage; or
(ii) Any chemical bond that results in an arrangement of adjacent nucleobases that mimics the arrangement of nucleobases in naturally occurring nucleic acids (i.e., nucleotide analogs).
(c) Where the description or claims of a patent application discuss a sequence that is set forth in the "Sequence Listing XML" in accordance with paragraph (a) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:" or the like in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application. Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier (§ 1.832(a) ), either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers (§ 1.832(a) ) in the Brief Description is clear.
(d) "Enumeration of its residues" means disclosure of a nucleotide or amino acid sequence in a patent application by listing, in order, each residue of the sequence, where the residues are represented in the manner as defined in paragraph 3(c)(i) or (ii) of WIPO Standard ST.26 (incorporated by reference, see § 1.839 ).
(e) "Specifically defined" means any amino acid or nucleotide as defined in paragraph 3(k) of WIPO Standard ST.26.
(f) "Amino acid" includes any D- or L-amino acid or modified amino acid as defined in paragraph 3(a) of WIPO Standard ST.26.
(g) "Modified amino acid" includes any amino acid as described in paragraph 3(e) of WIPO Standard ST.26.
(h) "Nucleotide" includes any nucleotide, nucleotide analog, or modified nucleotide as defined in paragraphs 3(f) and 3(g) of WIPO Standard ST.26.
(i) "Modified nucleotide" includes any nucleotide as described in paragraph 3(f) of WIPO Standard ST.26.
(j) A "Sequence listing XML" must not include any sequences having fewer than 10 specifically defined nucleotides, or fewer than 4 specifically defined amino acids.
[Added 87 FR 30806, May, 20, 2022, effective July 1, 2022]
It is noted that the XML sequence listing file contains no data for SEQ ID NOs 16-19 as the sequence identified by SEQ ID number in the table is “blank” in the XML file (i.e. no data). Giving SEQ ID Nos 16-19 in the specification sets up a situation wherein the application is logically inconsistent. Specifically, if an artisan looks at the sequence listing to determine what are SEQ ID NOs:16-19 they will find they are nothing at all. Applicant must remove all reference to SEQ ID NOs:16-19. For example, instant claim 10 must not recite SEQ ID NOs:16-19”. Similarly throughout the specification also cannot assign SEQ ID NOs:16-19. Note that such changes must be made at all occurrences everywhere in the specification, including figures, drawings, and text. Note also that this issue of inappropriately assigning SEQ ID numbers may apply to additional sequences other than SEQ ID NOs:16-19 and that no attempt has been made by the examiner to find and catalog all such errors throughout the specification.
Appropriate correction is required.
7. 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.
8. Claim 10 is 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.
Claim 10 recites SEQ ID NOs:16-19 which are undefined in the sequence listing of the specification and are not otherwise disclosed in the specification. As such, it is unclear what is meant by these recitations.
Correction is required.
9. 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.
10. Claims 1-9 and 11-12 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: the pharmaceutical composition wherein the epitope is selected from the group consisting of Seq ID NOs 1-15 and 20-29; does not reasonably provide enablement for: the pharmaceutical composition wherein the T cells are stimulated with “a KSHV antigen or an epitope thereof” of claim 1; “a KSHV cancer associated antigen” of claim 4 and claims dependent thereupon.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and or use the invention commensurate in scope with the claims. The specification disclosure does not enable one skilled in the art to practice the invention without an undue amount of experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The specification fails to provide guidance as to how to make and use the genus of compositions for pharmaceutical use. It would require an undue amount of experimentation for one of ordinary skill in the art to practice the claimed invention commensurate in the scope with the claims.
The art of Nalwoga et al. (PTO-892; Reference V) teaches that “studies investigating T cell responses to KSHV have been scarce. Earlier studies focused on KS patients from non-KSHV endemic areas. These studies selected a few KSHV peptides to investigate T cell responses to KSHV and the majority found varying results because individuals were responding to different KSHV peptides. More recently, we showed the heterogeneity of KSHV T cell responses by measuring interferon gamma (IFN-γ) in KS patients and controls from the USA using overlapping peptides from the entire KSHV proteome. This was a very important endeavour because KSHV encodes over 86 proteins and earlier studies had reported variations in KSHV-specific T cells in different individuals. Since KS and KSHV are endemic to sub-Saharan Africa, HIV is a major cofactor for KS development but infection with KSHV in endemic areas occurs in dependently of HIV infection. With no previous KSHVT cell reports in HIV uninfected individuals from KSHV and KS endemic regions, we used overlapping peptides from the entire KSHV proteome to show the heterogeneity of KSHV T cell responses in HIV uninfected individuals of all age groups from a KS and KSHV endemic region. Due to the lack of KS in the individuals tested, we had anticipated a robust KSHV T cell response comparable to T cell responses to other herpes viruses. However, KSHV T cell responses were weak and diverse compared to EBV and cytomegalovirus (CMV) T cell responses contradicting our previous anticipation. Moving forward, we need to understand how KSHV is controlled in individuals without KS disease.” (In particular, page 2, whole document).
As such, the specification is not enabled for KSHV-specific T cells from individuals which have not been previously exposed to KSHV wherein the T cells produce cytokines upon exposure to the KSHV antigen or epitope thereof wherein any KSHV antigen or epitope thereof is used to stimulate the cells. The specification is only enabled for using the peptides of SEQ ID NOs 1-15 and 20-29.
Although, the specification describes in vitro experiments, there is no correlation on this record between the in vitro studies and in vivo pharmaceutical use in currently available form for humans or animals. It is not enough to rely on in vitro studies where, as here, a person having ordinary skill in the art has no basis for perceiving those studies as constituting recognized screening procedures with clear relevance to efficacy in humans or animals (emphasis added). Ex parte Maas, 9 USPQ2d 1746
In view of the absence of a specific and detailed description in Applicant's specification of how to effectively use the genus of pharmaceutical compositions as claimed, absence of working examples providing evidence which is reasonably predictive that the genus of claimed pharmaceutical compositions are effective for in vivo use, and the lack of predictability in the art at the time the invention was made, an undue amount of experimentation would be required to practice the claimed pharmaceutical compositions with a reasonable expectation of success.
Substantiating evidence may be in the form of animal tests, which constitute recognized
screening procedures with clear relevance to efficacy in humans. See Ex parte Krepelka, 231
USPQ 746 (Board of Patent Appeals and Interferences 1986) and cases cited therein. Ex parte
Maas, 9 USPQ2d 1746.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
11. 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.
12. 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.
Claim 1. A pharmaceutical composition comprising a Kaposi sarcoma-associated herpesvirus (KSHV)-specific T cell (KST), wherein said KST:(1) derives from a naive T cell that has not been previously exposed to KSHV antigens; (2) has been exposed to, presented with, and/or stimulated by a KSHV antigen or an epitope thereof; and (3) produces a cytokine produced by activated T lymphocytes, upon exposure to said KSHV antigen or said epitope thereof
13. Claims 1 and 3-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chang et al.(PTO-892; Reference U).
Chang et al. teaches obtaining PBMC from marmosets innoculated with KSHV. The PBMC were obtained throughout the study. (In particular, page 8, whole document). The cells were purified for use in numerous assays including flow cytometry. (In particular, page 9, whole document).
Absent evidence to the contrary, the reference PBMC compositions of Chang et al. comprise KSHV-specific T cells and composition is not incompatible with pharmaceutical use.
While the reference is silent about the composition producing cytokines by active T lymphocytes upon exposure to KSHV antigen or an epitope thereof, the reference composition is the same as the claimed pharmaceutical composition. Applicant is reminded that no more of the reference is required than that it sets forth the substance of the invention. The claimed functional limitations would be inherent properties of the referenced composition. Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
Claims 4-5 are included in this rejection because the recitation of KSHV antigen comprising KSHV cancer associated antigen of claim 4; and said KSHV antigen comprising vFLIP, vIL-6, vCyclin, vGPCR, vIRF-3 and/or a combination thereof of claim 5 is inherent in the inoculation with KSHV because KSHV infection comprises and/or induces all of the recited KSHV antigens.
Claims 3 and 6-12 are included in this rejection because the patentability of a product does not depend on its method of production. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985) See MPEP 2113. The inoculation of the marmoset with KSHV results in a pharmaceutical composition which is indistinguishable from the claimed pharmaceutical composition recited in claims 3 and 6-12. The exposure was in vivo rather than in vivo but the resulting claimed composition is the same.
The reference teachings anticipate the claimed invention.
14. Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sabbah et al.(PTO-892; Reference W).
Sabbah et al. teaches isolating PBMCs from seronegative donors and stimulating them using overlapping peptide libraries that spanned vFLIP, vCyclin, Kaposin, and LANA, excluding the acidic repeat. Peptides (Mimotopes) were synthesized based on the BC-1 sequence of KSHV (accession NC_003409) as 15mers overlapping by 10 and used in pools containing 10 to 13 peptides, each at a final concentration of 2 g/mL. (In particular, page 2084, Figure 1B, whole document). Figure 1B shows IFN-gamma production in some samples, particularly sample AE which was stimulated with vFLIP.
Absent evidence to the contrary, the reference PBMC compositions of Sabbah et al. comprise KSHV-specific T cells and composition is not incompatible with pharmaceutical use.
Claims 4-10 are included in this rejection because the recitation of KSHV antigen comprising KSHV cancer associated antigen of claim 4; said KSHV antigen comprising vFLIP, vIL-6, vCyclin, vGPCR, vIRF-3 and/or a combination thereof of claim 5; and the epitope comprises SEQ ID NO:1 of claim 10 are inherent in the vFLIP stimulation of the PBMC cells.
The reference teachings anticipate the claimed invention.
15. Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roshan et al.(PTO-892; Reference X).
Roshan et al. teaches investigating T-cell responses to the whole KSHV proteome using IFN-γ ELISpot.
Participants were tested for antibodies to KSHV using ELISA assays detecting anti-KSHV IgG against the lytic antigen K81 and the latent antigen LANA, encoded by ORF73. Individuals who tested positive for either antigen on one or more occasions were classified as KSHV seropositive, while the remainder were considered seronegative. 13 seronegative individuals were selected. The characteristics of the selected individuals are described in Supplementary Table 1.
Using ~7,500 overlapping 15mer peptides we generated one to three peptide pools for each of the 82 KSHV ORFs. IFN-γ ELISpot analysis of PBMCs. The patients detected widely varied responses. Fifty six of the 82 ORFs were recognized by at least one individual but there was little overlap between participants. Responses to at least one ORF pool were observed in all 19 patients and in 7 seropositive donors. 3 seronegative donors had weak responses to one ORF. (In particular, abstract, page 109409).
Absent evidence to the contrary, the reference PBMC compositions of Roshan et al. comprise KSHV-specific T cells and composition is not incompatible with pharmaceutical use.
Claims 4-10 are included in this rejection because the recitation of KSHV antigen comprising KSHV cancer associated antigen of claim 4; said KSHV antigen comprising vFLIP, vIL-6, vCyclin, vGPCR, vIRF-3 and/or a combination thereof of claim 5; and the epitope comprises SEQ ID NO:1 of claim 10 are inherent in the reference method.
The reference teachings anticipate the claimed invention.
16. No claim is allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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April 4, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641