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 .
Response to Applicants Arguments/Amendments
The instant set of claims have been amended to now recite, “at least one dendritic cell pulsed with two or more HER-3 CD4+ T cell epitopes and at least one HER-2 CD4+ T cell epitope, wherein at least one of the two or more HER-3 CD4+ T cell epitopes is located in the extracellular domain of HER-3, and wherein at least one of the two or more HER-3 CD4+ T cell epitopes is located in the intracellular domain of HER-3.” Because of this amendment, the former rejections are withdrawn and new rejections put forward. Because the dependency of claim 8 has been amended, the examiner has rejoined claim 8. The double patenting rejections are maintained because the required terminal disclaimers have not been filed.
Claims 1,3,7-9 are under examination.
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 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Czerniecki (AU2017201075)
Czerniecki discloses dendritic cells pulsed with HER3 CD4+ T cell epitopes and HER2 CD4+ T cell epitopes (Paragraphs,24,38,40,54, 79 and 134,221 of Czerniecki); the dendritic cells are used in a cancer treatment (Paragraph 56 of Czerniecki). Paragraph 134 of Czerniecki teaches that the composition used to pulse dendritic cells can include a chimeric peptide that contains two HER3 epitopes or a chimeric peptide that comprises a HER3 epitope and a HER2 epitope. An artisan would have been motivated to have pulsed the dendritic cells with both chimeric peptides since they both prime the dendritic cells to stimulate/proliferate T cells involved in the host immune response to cancer.
MPEP 2144 states "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
In this case, an artisan would have been motivated to have included both chimeric peptides into a composition used to pulse dendritic cells since both peptides can both be used as cellular vaccines to pulse antigen presenting cells such as dendritic cells so that these dendritic cells can be primed to contact/stimulate T cells (Paragraphs 26-27,54,56, 136 of Czerniecki). Paragraph 221 of Czerniecki states that intracellular HER3 epitopes can be used. Paragraph 230 of Czerniecki also states that extracellular HER3 epitopes can be used as in instant Claim 1.
Dependent Claims taught by Czerniecki
Paragraph 230/Protocol of Czerniecki teaches that dendritic cells can be properly matured before administration into a subject’s body by exposing these cells to IL-12 as in instant Claim 9.
Czerniecki teaches two distinct chimeric peptides that can be used to prime dendritic cells. One chimeric peptide possesses two HER3 epitopes and one chimeric peptide comprises a HER2 epitope and a HER3 epitope. An artisan would have been motivated to have pulsed the dendritic cells with both chimeric peptides since they can prime the dendritic cells to stimulate and proliferate T cells involved in responding to cancer. Given the teachings of the cited references and the level of skill of an ordinary 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 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 predicable results to one of ordinary skill in the art at the time of the invention (See KSR 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.Ds. 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.
Claims 1,3, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Czerniecki (AU2017201075) in view of Czerniecki II (WO 2017014810). Czerniecki II is already of record.
Czerniecki applies as above to teach claims 1 and 9. Czerniecki teaches that exterior HER-3 CD4+ T cell epitopes can be used to pulse dendritic cells. However, Czerniecki does not specify that the exterior HER3 epitope includes SEQ ID: 1. Czerniecki II teaches that an extracellular domain of HER3 possessing SEQ ID: 1 can be successfully used to pulse dendritic cells and change them into anti-cancer agents (Page 8, line 14: Pages 44-45, Materials and Methods Section—Protocol Overview Subsection of Czerniecki II). It would have been obvious to an artisan of ordinary skill in the art to have used an extracellular HER-3 CD4+ T cell epitope with SEQ ID: 1 to pulse dendritic cells. An artisan would have been motivated to have used Czerneicki II’s extracellular HER-3 CD4+ T cell epitope with SEQ ID: 1 to pulse dendritic cells because the dendritic cells are able to ingest such epitopes, break the epitopes down into smaller peptide fragments, and then present such peptides to T cells involved in responding to cancer ((Page 8, Pages 44-45, Materials and Methods Section—Protocol Overview Subsection of Czerniecki II) as in instant Claim 3.
Czerniecki teaches that dendritic cells can be pulsed with HER3 CD4+ T cell epitopes so that they are able to direct/stimulate/help to proliferate T cells. Czerniecki fails to teach that such HER3 extracellular epitopes contain SEQ ID: 1. However, Czerniecki II teaches that HER3 extracellular epitopes possessing SEQ ID: 1 can be pulsed into dendritic cells so that those dendritic cells are then able to induce proliferation and an immune response in T cells (Page 8, line 14: Pages 44-45, Materials and Methods Section—Protocol Overview Subsection of Czerniecki II). Therefore, pulsing the dendritic cells with a HER3 extracellular epitope allows the dendritic cells to stimulate the T cells so they are able to respond to cancer cells that express HER3. Given the teachings of the cited references and the level of the skill of an ordinary 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 predicable results in one of ordinary skill in the art at the time of the invention (See KSR Internation 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.
Claims 1,7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Czerniecki (AU2017201075) in view of Barret (WO 2018219956)
Czerniecki applies as above to teach claims 1 and 9. Czerniecki fails to teach including the anticancer agents of claims 7-8 when administering the primed dendritic cells (Paragraph 113 of Czerniecki). However, Barrett teaches that the anti-cancer agents recited in claims 7-8 can be added to its main therapy to improve the effectiveness of the cancer treatment (Page 34, lns 10-15; Page 35, ln 14; Page 41, ln 32). Barrett’s additional anti-cancer agents include the following: paclitaxel, a PD1 inhibitor, and a PDL1 inhibitor (Page 34, lns 10-15; Page 35, ln 14; Page 41, ln 32). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have included the anti-cancer agents such as paclitaxel, a PD1 inhibitor, or a PDL1 inhibitor when administering Czerniecki’s therapeutic dendritic composition. An artisan would have been motivated to have included these agents because of their anti-cancer properties (Page 35, ln 14; Page 41, ln 32 of Barret). Because paclitaxel, PD1 and PDL1 inhibitors can be successfully combined with other cancer therapies to treat cancer (Abstract: Page 34, lns 1015; Page 35, ln 14; Page 41, ln 32 of Barret), there would be a high expectation for success using these agents with the pulsed dendritic cells taught by Czerniecki as in instant Claims 7-8.
Czerniecki teaches creating a therapeutic dendritic cell composition by pulsing the dendritic cell population with HER-3 and HER-2 CD4+ T cell epitopes. Czerniecki does not teach the inclusion of agents such as paclitaxel, PD1 inhibitor, and/or a PDL1 inhibitor. However, an artisan would have been motivated to have combined such agents with the anti-cancer dendritic cell therapy composition of Czerniecki because of their anti-cancer properties. Given the teachings of the cited references and the level of the skill of an ordinary 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 predicable results in one of ordinary skill in the art at the time of the invention (See KSR Internation 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.
Claims1,7,9 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) in view of Czerniecki (AU 2017201075). Claims 1-2 of 18/021,845 recite the dendritic cells pulsed with HER3 OR HER2 epitopes. An artisan would have been motivated to have used both the HER3 and HER2 epitopes to pulse dendritic cells since both epitopes can successfully prime dendritic cells so they are able to stimulate/proliferate T cells involved in an immune response. Furthermore, an artisan would have been motivated to use more than one HER3 epitope since multiple HER3 epitopes are capable of priming dendritic cells (Paragraphs 38,134 of Czerniecki). Czerniecki teaches that intracellular and extracellular HER epitopes can be used. Paragraph 221 of Czerniecki (AU 2017201075) states that intracellular HER3 epitopes can be used. Paragraphs 15-20, 230 of Czerniecki(AU 2017201075) states that extracellular HER3 epitopes can be used. Instant claim 7 corresponds to claims 1 and 5 of Application 18/021,845. 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 1,9 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) in view of Czerniecki (AU 2017201075). Although the claims at issue are not identical, they are not patentably distinct from each other. The anticancer composition recited in claims 1-2 of 18/021,847 feature a pulsed dendritic cell that was pulsed with HER2 or HER3 epitope and also mentions a fecal microbial transplant. An artisan would have been motivated to have used both the HER3 and HER2 epitopes to pulse the dendritic cells since both epitopes can successfully prime dendritic cells to successfully stimulate and proliferate T cells that respond to cancer. Furthermore, an artisan would have been motivated to use more than one HER3 epitope since multiple HER3 epitopes are capable of priming dendritic cells. Czerniecki teaches that intracellular and extracellular HER3 epitopes can be used to prime dendritic cells. Paragraph 221 of Czerniecki (AU 2017201075) states that intracellular HER3 epitopes can be used to prime dendritic cells. Paragraphs 15-16, and 230 of Czerniecki(AU 2017201075) also states that extracellular HER3 epitopes can be used to prime dendritic cells. The combination of the claims of 18/021,847 and Czerniecki teach the limitations recited in 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 is 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) in view of Czerniecki (AU 2017201075). Although the claims at issue are not identical, they are not patentably distinct from each other. Claims1 and 5-6 18/569,178 recite pulsed dendritic cells with HER-3 epitopes or HER-2 epitopes. An artisan would have been motivated to have used both the HER3 and HER2 epitopes to pulse dendritic cells since both epitopes can successfully prime dendritic cells so they are better able to fight cancer cells. Furthermore, an artisan would have been motivated to use more than one HER3 epitope since multiple HER3 epitopes are capable of priming dendritic cells. Czerniecki teaches that intracellular and extracellular HER epitopes can be used. Paragraph 221 of Czerniecki (AU 2017201075) states that intracellular HER3 epitopes can be used. Paragraph 230 of Czerniecki(AU 2017201075) also states that extracellular HER3 epitopes can be used. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 3 of copending Application No. 19/150,713(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 3 of Application 19/150,713 recite an anticancer-composition with dendritic cells that are pulsed with oncodrivers such as a HER2 epitope or a HER3 epitope. An artisan would have been motivated to have used both the HER3 and HER2 epitopes since both epitopes can successfully prime dendritic cells so they are able to stimulate T cells involved in cancer defense. Furthermore, an artisan would have been motivated to use more than one HER3 epitope since multiple HER3 epitopes are capable of priming dendritic cells. Czerniecki teaches that intracellular and extracellular HER3 epitopes can be used. Paragraph 221 of Czerniecki (AU 2017201075) states that intracellular HER3 epitopes can be used. Paragraph 230 of Czerniecki(AU 2017201075) also states that extracellular HER3 epitopes can be used. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,6-7,9,14-15 of copending Application No. 19/150,723 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1,6-7,9,14-15 recite the dendritic cells that are also exposed to HER2 or HER3 epitopes. An artisan would have been motivated to have used both the HER3 and HER2 epitopes since both epitopes can successfully prime dendritic cells so they are able to stimulate T cells to respond to cancer cells that express HER2/HER3. Furthermore, an artisan would have been motivated to use more than one HER3 epitope since multiple HER3 epitopes are capable of priming dendritic cells. Czerniecki teaches that intracellular and extracellular HER epitopes can be used. Paragraph 221 of Czerniecki (AU 2017201075) states that intracellular HER3 epitopes can be used. Paragraph 230 of Czerniecki(AU 2017201075) also states that extracellular HER3 epitopes can be used. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3,7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3,7-8, and 9 of copending Application No. 19/484,644(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Application 19/484,644 recites a dendritic cell pulsed with at least one HER-3 CD4+ T cell epitope and/or at least one HER-2 CD4+ T cell epitope. Claim 1 of Application 19/484,644 does not mention that the dendritic cells can be pulsed with two HER-3 CD4+ T cell epitopes (one intracellular and one extracellular). However, Czerniecki teaches that intracellular and extracellular HER epitopes can be used. Paragraph 221 of Czerniecki (AU 2017201075) states that intracellular HER3 epitopes can be used. Paragraphs 15-16 230 of Czerniecki(AU 2017201075) also states that extracellular HER3 epitopes can be used. Instant claim 3 corresponds to claim 3 of Application 19/484,644. Instant claim 7-8 correspond to claims 7-8 of Application 19/484,644. Instant claim 9 corresponds to claim 9 of Application 19/484,644. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims stand rejected.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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