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 1-4,7,9 are under examination.
Restriction/Election
Applicant's election with traverse of Group I, HER-3 CD4+T cell epitopes, SEQ ID: 1 (an epitope from an extracellular domain) in the reply filed on June 23, 2025 is acknowledged. The traversal is on the grounds that both the group and species restrictions are improper because a requirement for restriction is only proper “if there is a patentable difference between the groups/species as claimed and there would be a serious burden on examiner if there is no restriction.” This is not found persuasive because the instant application is a 371 application, not an US application. Therefore, whether or not to restrict is based on unity of invention analysis, not factors such as relatedness and search burden. Under a 371/unity of invention analysis, groups and species should be kept together when there is a “special technical” feature among them which is not already known in the prior art. In this case the shared technical feature among the groups and species is a dendritic cell pulsed with a HER-2 or HER-3 CD4+ T cell epitope. This shared technical feature is not a special technical feature because such a pulsed dendritic cell was already taught in the prior art. Czerniecki (WO 2016011343) teaches a dendritic cell pulsed with at least one HER-3 CD4+ T cell epitope (Page 4, ln 32-Page 5, ln 7). The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 5-6,8,10-14,23,28-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III, HER-2 CD4+T cell epitopes, SEQ 2-17, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 23, 2025.
Examiner would like to point out that the unexamined claims which mention Taxol are indefinite because Taxol is a trademark.
Markush Rejection
Claims 1-4,7,9 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: HER-2 and HER-3 CD4+ T cell epitopes are distinct structurally and functionally. Furthermore, the sequences presented in the instant set of claims differ structurally and functionally. In response to this rejection, Applicant should either amend the claims to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Claim Rejections - 35 USC § 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)(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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Czerniecki I (WO 2017014810)
Czerniecki I discloses an anti-cancer therapy comprising at least one dendritic cell pulsed with at least one HER-3 CD4+ T cell epitope (Page 8, lines 14; Pages 44-45, Materials and Methods Section—Protocol Overview Subsection) as in instant Claim 1. Czerniecki I discloses SEQ ID:1 which is an extracellular domain (SEQ ID: 1, bottom of Page 17) as in instant claims 2-3. Czerniecki I teaches wherein the HER-3 CD4 T cell epitope is located in the intracellular domain of HER3 (several sequences on Page 18 are from intracellular domains) as in instant Claim 4.
The reference anticipates the claimed invention.
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.
Claims 1-4, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Czerniecki I (WO 2017014810) in view of Czerniecki II (AU 2017201074)
Czerniecki I applies as above to teach claims 1-4. Czerniecki I teaches using pulsed dendritic cells to treat cancer. Czerniecki I does not teach adding additional agents such as Taxol to an anti-cancer regime. Czerniecki II does teach adding an anti-cancer agent such as Taxol to an anticancer regime (Paragraph 5 of Czerniecki II). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have added an additional agent such as Taxol taught by Czerniecki II. An artisan would have been motivated to have added an additional agent such as Taxol since it can be used as a chemotherapeutic agent to combat cancer (Paragraph 227 of Czerniecki II). There would have been a high expectation for success because Taxol can be used successfully in cancer treatment (Paragraph 227) as in instant Claim 7
Czerneicki I does not teach exposing the cells to IL-12 before administration. However, Czerneicki II teaches that the dendritic cells can be manipulated to produce IL-12 (Claim 1 and Paragraph 156) which would cause cell activation before administration. It would have been obvious to an artisan of ordinary skill at the time of effective filing to have manipulated the dendritic cells to produce IL-12 as taught by Czerneicki II. An artisan would have been motivated to have had the cells produce IL-12 cytokine because it successfully encourages a protective T cell response against cancer (Claim 1 and Paragraph 156 of Czerneicki II). Because IL-12 generates a protective T cell response, there would be a high expectation for success (Paragraph 156 of Czerneicki II) as in instant Claim 9.
Czerniecki I recites a dendritic cell pulsed with at least one HER-3 CD4+Tcell epitope which can be used in a cancer treatment regime. However, Czerniecki I does not include anticancer agents and/or IL-12 exposure. However, an artisan of ordinary skill in the art would have been motivated to have included anticancer agents with the regime of Czerniecki I since agents such as Taxol taught by Czerniecki II can be used to successfully treat cancer. Furthermore, one would have been motivated to encourage IL-12 secretion/exposure in order to promote a more robust response from protective T cells. Given the teachings of the cited references and the level of the skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and immunology. Therefore, the level of ordinary skill in this art is high.
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.
Claims1-2,7,9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3,5 of copending Application No. 18/021,845 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 18/021,845 are a species of the instant set of claims. The anticancer composition of 18/021,845 features the same limitations as the instant set of claims but also mentions a fecal microbial transplant. Claims 1-2 of 18/021,845 recite the dendritic cells pulsed with HER3 epitopes. Instant claim 7 corresponds to claims 1 and 5. Instant claim 9 corresponds to claim 3 of 18/021,845. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2,9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/021,847 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 18/021,847 are a species of the instant set of claims. The anticancer composition of 18/021,847 features the same limitations as the instant set of claims and also mentions a fecal microbial transplant. Claims 1-2 of Application 18/021,847 correspond to instant claims 1-2. Instant claim 9 corresponds to claim 3 of Application 18/021,847. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,5-6 of copending Application No. 18/569,178 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 5-6 of 18/569,178 are species of the instant set of claims because they recite pulsed dendritic cells with HER-3 epitopes. Therefore, instant claims 1-3 correspond to claims 1 and 5-6 of 18/569,178. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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 by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights