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 .
Claims 67-68, 71-72, 85, 88-89, and 90-100 are under consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/13/2026 has been entered.
Rejections/Objections Withdrawn
All rejections of all cancelled claims are rendered moot by claim cancellation.
All 35 USC 112 rejections have been withdrawn in view of claim amendments.
New Rejections
Claim Rejections - 35 USC § 112
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.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). 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.
Claims 97-100 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 methods of treating cancer in a subject expressing an amino acid sequence consisting of SEQ ID NOs: 1-8 and immunogenic fragments thereof, does not reasonably provide enablement for methods of treating cancer in a subject expressing amino acids that are variants of SEQ ID NOs: 1-8. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Instant claims 97-100 are drawn to methods treating cancer in a subject expressing a polypeptide comprising an amino acid sequence selected from the group consisting of SEQ ID NO:1-8, or an immunogenic fragment or variant thereof, the method comprising administering either a polypeptide of claim 88 (claim 97), a T cell population according to claim 90 (claim 98) or the APC population of claim 92 (claim 100). Please note that the polypeptides recited in claim 88 do not encompass any variant sequences derived from the any of the definite amino acids recited by any of the SEQ ID NOs of claim 88. Given that both the T cell population of claim 90 and the APC population of claim 92 are prepared by exposing the respective cells to the cells that recognize the definite SEQ ID NOs recited in instant claim 88.
When an antigenic peptide cancer vaccine comprising, a particular antigenic peptide is administered to a patient, that particular antigenic peptide gives rise to antigen-specific immune responses, such as antibodies and antigen-specific TCRs against the antigenic peptides administered. In order for such an antigenic peptide vaccine to treat cancer, the immune response elicited against the administered peptide must also elicit an immune response against an antigen of the cancer being targeted. Similarly, when a T cell or APC is treated with a particular peptidic cancer antigen, the T cells and APCs will develop an immune response wherein they recognize the peptidic cancer antigen(s) they were exposed to. In order such T cell and APC populations to be used to treat cancer, the T cells or APCs must also recognize an antigen of the cancer being targeted.
In the case where the antigenic peptide administered in the cancer vaccine is identical to a peptide antigen associated with the cancer being targeted, the administered antigenic peptide will elicit an immune response that recognizes the corresponding antigen associated with the cancer targeted and, as such, be capable of treating cancer. Similarly, in the case where the antigenic peptide recognized by the T cells or APCs administered is identical to a peptide antigen with the cancer being targeted, the administered T cells or APCs will recognize the corresponding antigen associated with the target cancer and, as such, be capable of treating cancer.
However, the claims are also directed toward methods of treating cancer in patients expressing variants of the antigens of SEQ ID NOS: 1-8. By definition, these antigen variants do not have the same amino acid sequence as the parental sequence and, as such, the variant sequences have different biochemical properties/structure compared to corresponding the parental sequence. Additionally, the claims subject to this rejection provide no guidance or limitations regarding which the degree of homology a variant antigenic peptide sequence must have with the parental sequence in order to be considered a “variant”.
It is well-accepted in the current state of the art that the structure/function regarding immunoglobin-antigen is poorly understood, to the point where on of skill in the art would be unable to deduce, a priori, whether or not the immune responses associated with the cancer vaccine of claim of claim 97, the T cell population of claim 98 or the APC population 100, all of which are antigen-specific responses against one of the explicitly defined antigenic sequences of claim 88, would also be able to recognize and initiate an immune response against variant sequences derived from the explicitly defined sequences that are associated with the patient’s cancer cells and therefore treat cancer.
This lack of known structure-function correlation creates the need for one of skill in the art to experimentally determine whether the vaccine of claim 97, the T cell population of claim 98 and/or the APC population of claim 100 are capable of recognizing one of the permissible peptide variants and therefore elicit an immune response against target cells associated with that permissible antigenic peptide variant. Also, the lack of structure/function correlation between immunoglobin/epitope binding means that one of skill in the art would need to repeat this experiment for each individual variant to be tested. Such a large volume of experiments is undue experimentation.
Response to Arguments
This is a completely new grounds of rejection and, as such, no arguments/remarks are associated with it (see “Response to Arguments” beneath first NSDP rejection).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 67-68, 71-72, 85, 88-89, 90-92 and 94-100 is/are rejected under 35 U.S.C. 103 as being unpatentable over (Lee, et al., WO2004093804; Published 11/4/2004)
Note on claim interpretation: Claims 97-100 are directed to methods of treating a subject suffering from a cancer expressing a polypeptide comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 1-8 or an immunogenic fragment thereof. This encompasses patients suffering from a cancer expressing a polypeptide that is the immunogenic fragment ALRAVTLTAK, which is identical to instant SEQ ID NO: 18 and is an exemplary immunogenic fragment of instant SEQ ID NO: 5 (See Specification, p 53, lines 34-35). As such, all art rejections of claims 97-100 will be made with respect to methods of treating a subject suffering from a cancer expressing a polypeptide that is an immunogenic fragment of SEQ ID NO: 5 having the amino acid sequence ALRAVTLTAK.
Lee teaches on the subject of novel polynucleotides and polypeptides as well as diagnostic, prophylactic and therapeutic applications of such polynucleotides and polypeptides (Lee, Abstract). One of the polypeptides disclosed by Li is SEQ ID NO: 1305 of Li, which is a 792 AA protein, of which AAs 636-645 are a 100% match for instant SEQ ID NO: 18 (See Results in DAV; pairwise alignment reproduced below:
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198
689
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As such, SEQ ID NO: 1305 of Li comprises instant SEQ ID NO: 18. Regarding claims 67, 85, 88, and 94, Lee discloses that a method of treating a subject comprising administering a vaccine to said subject comprising a polypeptide of Lee or a polynucleotide encoding a polypeptide of Li chosen from at least one of Lee’s SEQ ID NOs: 1-1467, wherein the vaccine is a cancer vaccine (Lee, claims 113-114) and that the vaccine comprises an adjuvant (Lee, ¶ 0113). Regarding claim 94 specifically, Lee’s disclosure that the peptides and nucleic acids of Lee are administered as cancer vaccines means administration of the polypeptides of Lee stimulates anti-cancer immune responses in a patient. Regarding claim 68, Lee teaches that the adjuvant present in the vaccine of Lee is an aluminum salt adjuvant (Lee, ¶ 0223). Regarding claim 69, Lee teaches fusion proteins comprising the inventive polypeptides of Lee (Lee, ¶ 0244). Regarding claims 71-72, Lee discloses methods of preparing artificial mRNA encoding the inventive polypeptides via PCR amplification (Lee, ¶ 0377). Regarding claims 89-92, Li discloses cell culture methods wherein T cells or dendritic cells (Lee, claim 20) are cultured in the presence of any one of Lee’s polypeptides corresponding to Lee’s SEQ ID NOs: 733-1464 (Lee, claims 14, 19), wherein the T cells or dendritic cells proliferate in the medium (Lee, claim 22). Additionally, Lee teaches that the vaccines comprising the inventive antigens of Lee stimulate T cells that recognize and kill tumor cells directly. Moreover, Lee also teaches that dendritic cells present tumor antigens to T cells, leading to killer T cell activation (Lee, ¶ 0458). Additionally, Lee teaches that the inventive antigens of Lee are used to treat melanoma (Lee, ¶ 0448).
Lee does not teach a method of treating cancer comprised of administering a polypeptide specifically comprising SEQ ID NO:1305, and does not teach wherein the cancer expresses said polypeptide antigen comprising SEQ ID NO: 1305 or an immunogenic fragment thereof.
Lee does not teach a method of treating cancer comprised of administering a population a population of T cells that have been stimulated and amplified ex vivo using the polypeptide of Lee’s SEQ ID NO: 1305 and does not teach wherein the cancer expresses said polypeptide antigen comprising SEQ ID NO: 1305 or an immunogenic fragment thereof. Lee does not teach a method of treating cancer comprised of administering a population a population of antigen presenting cells (such as dendritic cells) that have been stimulated and amplified ex vivo using the polypeptide of Lee’s SEQ ID NO: 1305 and does not teach wherein the cancer expresses said polypeptide antigen comprising SEQ ID NO: 1305 or an immunogenic fragment thereof.
It would be prima facie obvious to one of ordinary skill in the art to choose Lee’s peptide having Lee’s SEQ ID NO: 1305 as the antigenic polypeptide used in the methods of treating cancer of Lee. One of ordinary skill in the art would be motivated to do this in order to better treat cancer. One of ordinary skill in the art would have a reasonable expectation of success picking Lee’s SEQ ID NO:1305 as the specific antigenic peptide used in the methods of treating cancer of Lee because SEQ ID NO: 1305 is on the list of antigenic peptides Lee indicated as useful for cancer vaccines.
It would be prima facie obvious to one of ordinary skill in the art to form a method of treating a cancer patient expressing the immunogenic fragment ALRAVTLTAK, which is identical to instant SEQ ID NO: 18 and is also an immunogenic fragment of instant SEQ ID NO: 5 (see Specification, p 53, lines 34-35), said method comprising administering the patient the polypeptide vaccine of claim 88 comprising Lee’s SEQ ID NO: 1305 or the T cell population of claim 98, which has been activated to immunologically target Lee’s SEQ ID NO: 1305, or the APC population of claim 100, which has been activated to immunologically target Lee’s SEQ ID NO: 1305. One of ordinary skill in the art would be motivated to do this in order to better treat cancer. One of ordinary skill in the art would have a reasonable expectation of success to forming a method of treating a cancer patient expressing the immunogenic fragment ALRAVTLTAK, which is identical to instant SEQ ID NO: 18 and is also an immunogenic fragment of instant SEQ ID NO: 5 (see Specification, p 53, lines 34-35), said method comprising administering the patient the polypeptide vaccine of claim 88 comprising Lee’s SEQ ID NO: 1305 or the T cell population of claim 98, which has been activated to immunologically target Lee’s SEQ ID NO: 1305, or the APC population of claim 100, which has been activated to immunologically target Lee’s SEQ ID NO: 1305 because: the polypeptide vaccine of claim 88, the T cell population of claim 98 and the APC population of claim 100 all act by directing immune responses against epitopes located within Lee’s SEQ ID NO: 1305 and the fragment ALRAVTLTAK is contained within Lee’s SEQ ID NO: 1305. As such, one of ordinary skill would reasonably deduce that the ALRAVTLTAK-targeted immune responses elicited by the polypeptide vaccine of claim 88, the T cell population of claim 98 or the APC population of claim 100 would also elicit an immune response directed toward the cancer-associated ALRAVTLTAK and, as such, would induce an immunological anti-cancer response.
Response to Arguments
This is a completely new grounds of rejection and, as such, no arguments/remarks are associated with it (see “Response to Arguments” beneath first NSDP rejection).
Claim(s) 67-68, 71-72, 85, 88-100 is/are rejected under 35 U.S.C. 103 as being unpatentable over (Lee, et al., WO2004093804; Published 11/4/2004) as applied to claims 67-68, 71-72, 85, 88-89, 90-92 and 94-100 above and in further view of Bolhassani (Bolhassani, et al., Mol Canc (2011) 10:3).
The teachings of Lee are discussed above.
Lee does not teach endosomes comprising the antigenic peptides of Lee.
Bolhassani teaches on the subject of vaccine delivery systems for cancer therapy (Bolhassani, Abstract). Bolhassani teaches that the administration of exosomes derived from DCs loaded with tumor peptides induces a potent anti-tumor immune response with the final eradication of established tumors (Bolhassani, p 16, ¶ 3).
It would be prima facie obvious to one of ordinary skill in the art to combine the antigenic peptide taught by Lee of Lee’s SEQ ID NO: 1305 with the endosome-encapsulated antigenic peptide delivery system of Bolhassani. The net result of this combination would be the antigenic peptide of Lee’s SEQ ID NO: 1305 encapsulated in DC-derived endosomes. One of ordinary skill in the art would be motivated to do this in order to better treat cancer. One of ordinary skill in the art would have a reasonable expectation of success encapsulating the antigenic peptide of Lee’s SEQ ID NO: 1305 because Lee teaches that Lee’s SEQ ID NO: 1305 is an antigenic peptide that elicits anti-tumor responses and Boulhassani teaches that encapsulation of peptidic antigens within DC-derived endosomes induces a potent anti-tumor immune response with the final eradication of established tumors.
Response to Arguments
This is a completely new grounds of rejection and, as such, no arguments/remarks are associated with it (see “Response to Arguments” beneath first NSDP rejection).
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.
Claim 67-68, 71-72, 85, 88, and 94 and 97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-10, 12-15, 19, 25-26, 28, 31, 35, 37 and 39 of copending Application No. 18/046,675 (Published as US 2023/0167163 A1 on 6/1/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims are directed to immunogenic compositions and uses of immunogenic compositions comprising an immunostimulant and a peptide having a sequence comprising instant SEQ ID NO: 3 (same as SEQ ID NO: 8 of the ‘675 application).
Regarding claims 67-69, 85 and 88 the ‘675 application is directed to fusion proteins comprising instant SEQ ID NO: 3 (copending claim 1) comprising the same immunostimulants as instant claim 68 (copending claim 28) and any method of combining the peptide of instant SEQ ID NO: 3 with the recited immunostimulants would be following the method of instant claim 85. Regarding instant claims 71-72, copending claim 15 is directed to artificial nucleic acids that are RNA encoding the peptide of instant SEQ ID NO: 3 that have been codon optimized for expression in a human host cell, wherein the artificial nucleic acid is comprised within an AAV vector (note—this inherently produces mRNA encoding instant SEQ ID NO: 3 due to the fact that the nucleic acids encoding SEQ ID NO: 3 are in a viral vector).
Regarding the peptide administration limitations of instant claim 97, copending claim 35 is directed toward methods of treating cancer expressing instant SEQ ID NO: 3 Please note that instant claim 35 also reads on the method of stimulating an immune response in a subject limitation of claim 93. Regarding instant claim 99, copending claim 37 is directed to methods of treating melanoma.
The ’375 application does not teach that an immunostimulant is present in the composition administered in the recited treatment claims of the copending application.
It would be prima facie obvious to one of ordinary skill in the art to add one of the immunostimulants of copending claim 28 to the composition comprising the fusion protein comprising instant SEQ ID NO: 3 prior to administration to the subject. One of ordinary skill in the art would be motivated to do this in order to better treat cancer. One of ordinary skill in the art would have a reasonable expectation of success adding one of the immunostimulants of copending claim 28 to the composition prior to administration because the claimed method is a method of treating cancer and adding immunostimulants to antigens prior to administration is very routine in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 7/ 13/2026 have been fully considered but they are not persuasive.
The only arguments supplied addressing a rejection still standing are the arguments regarding the provisional NSDP rejection. Applicant invokes MPEP 804 part 1(b), which mandates that if a provisional NSDP is the only standing rejection for an instant application with an earlier patent term date than the reference application that the instant application should be permitted to issue. This provisional NSDP is not the only standing rejection because this Office Action contains new grounds of rejections.
Claim 67-68, 71-72, 85, 88-89, 90-92 and 94-100 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-10, 12-15, 19, 25-26, 28, 31, 35, 37 and 39 of copending Application No. 18/046,675 (Published as US 2023/0167163 A1 on 6/1/2025) as applied to claims 67-68, 71-72, 85, 88, and 94 and 97 above and in further view of (Lee, et al., WO2004093804; Published 11/4/2004)
The teachings of the ‘675 are discussed above.
The ‘675 Application does not teach a method of producing a population of T cells or a population of dendritic cells, said method comprising stimulating the cells with the antigenic peptide of instant SEQ ID NO: 3 and also amplifying the cells. The ‘675 Application does not teach that the resultant activated T cell population or dendritic cell population are administered in a method of treating cancer expressing instant SEQ ID NO: 3.
Li discloses cell culture methods wherein T cells or dendritic cells (Lee, claim 20) are cultured in the presence of any one of Lee’s polypeptides corresponding to Lee’s SEQ ID NOs: 733-1464 (Lee, claims 14, 19), wherein the T cells or dendritic cells proliferate in the medium (Lee, claim 22). Additionally, Lee teaches that the vaccines comprising the inventive antigens of Lee stimulate T cells that recognize and kill tumor cells directly. Moreover, Lee also teaches that dendritic cells present tumor antigens to T cells, leading to killer T cell activation (Lee, ¶ 0458).
It would be prima facie obvious to use the antigenic peptide of instant SEQ ID NO: 3 of the ‘675 application as the stimulating antigen used in the method of antigen-specific, activated T cells or dendritic cells to produce T cells or dendritic cells that recognize and induce immune responses against instant SEQ ID NO:3 and administer the resultant T cell population or dendritic cell population in a method of treating cancer in a patient having cancer expressing SEQ ID NO: 3. One of ordinary skill in the art would have a reasonable expectation of success forming this method because: 1) Lee teaches a method of making activated, antigen-specific T cell populations and dendritic cell populations by stimulating the cells in culture with the target antigen to yield T cell populations and dendritic cell populations reactive the target antigen, 2) one of ordinary skill in the art would realize that if the antigenic peptide of instant SEQ ID NO: 3 were used as the stimulating antigen in the method activated T cell and dendritic cell production of Lee would result in T cell populations or dendritic cell populations immune reactive to the SEQ ID NO:3 expressed by the patient’s cancer and, as such, would direct an immune response against the tumor cells, thereby treating cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 67-68, 71-72, 85, 88-100 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-10, 12-15, 19, 25-26, 28, 31, 35, 37 and 39 of copending Application No. 18/046,675 (Published as US 2023/0167163 A1 on 6/1/2025) and (Lee, et al., WO2004093804; Published 11/4/2004) as applied to claims 67-68, 71-72, 85, 88-89, 90-92 and 94-100 Bolhassani (Bolhassani, et al., Mol Canc (2011) 10:3).
The teachings of the ‘675 Application and Lee are discussed above.
The teachings of the ‘675 Application and Lee does not teach endosomes comprising the antigenic peptide of instant SEQ ID NO:3.
Bolhassani teaches on the subject of vaccine delivery systems for cancer therapy (Bolhassani, Abstract). Bolhassani teaches that the administration of exosomes derived from DCs loaded with tumor peptides induces a potent anti-tumor immune response with the final eradication of established tumors (Bolhassani, p 16, ¶ 3).
It would be prima facie obvious to one of ordinary skill in the art to combine the antigenic peptide taught by the ‘675 Application, which is identical to instant SEQ ID NO: 3 with the endosome encapsulated antigenic peptide delivery system of Bolhassani. The net result of this combination would be the antigenic peptide of the ‘675 application corresponding to SEQ ID NO: 3 encapsulated in DC-derived endosomes. One of ordinary skill in the art would be motivated to do this in order to better treat cancer. One of ordinary skill in the art would have a reasonable expectation of success encapsulating the antigenic peptide corresponding to instant SEQ ID NO: 3 taught by the ‘675 application because the ‘675 Application teaches the peptide corresponding to instant SEQ ID NO: 3 is an antigenic peptide that elicits anti-tumor responses and Boulhassani teaches that encapsulation of peptidic antigens within DC-derived endosomes induces a potent anti-tumor immune response with the final eradication of established tumors.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 67-68, 71-72, 85, 88-100 are rejected.
No claims are allowed.
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/SYDNEY VAN DRUFF/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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