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 07/08/2026 is acknowledged.
3. Claims 1-3, 6-9, 11-23, 26-29 and 31-34 are pending.
4. Claims 13-23, 26-29 and 31-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim.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.
5. Claims 1-3, 6-9, 11-12 and 34 are under consideration.
6. Applicant’s IDS document filed on 07/08/2026 has been considered.
7. 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.
8. Claims 1-3, 6-9, 11-12 and 34 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 an epitope wherein the epitope comprises any one or more of the amino acid sequences of SEQ ID NOs: 1-15 and 20-29. 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 specification is enabled for a pharmaceutical composition for treating a disease caused by or associated with Kaposi sarcoma associated herpesvirus (KSHV) wherein the T cells have been exposed ex vivo with an epitopes selected from the group consisting of SEQ ID NOs 1-15 and 20-29. The specification is not enabled for a pharmaceutical composition for treating a disease caused by or associated with Kaposi sarcoma associated herpesvirus (KSHV) wherein the T cells have been exposed ex vivo with an epitopes comprising any one or more of the amino acid sequences of SEQ ID NOs 1-15 and 20-29. The claim term “comprising” opens up the epitopes to include any number of additional amino acids added onto the N- and/or C-terminus of the recited peptides. Applicant is not enabled for using the genus of any epitope comprising any one or more of SEQ ID NOs 1-15 and 20-29 to produce a pharmaceutical composition for treating a disease caused by or associated with Kaposi sarcoma associated herpesvirus (KSHV) because the T cells can be stimulated by the additional non-disclosed sequence.
As argued previously the art of Nalwoga et al. (PTO-892 mailed on 04/09/2026; 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, producing a pharmaceutical composition with he ability to treat a disease caused by or associated with Kaposi sarcoma associated herpesvirus (KSHV) is unpredictable and the use of epitopes which comprise additional undisclosed amino acids is not enabled. 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.
9. No claim is allowed.
10. 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 extension fee 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 date of this final action.
11. 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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September 19, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
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