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 .
Restriction/Election
Applicant's election with traverse of Group I (Claims 1 and 14) in the reply filed on December 2, 2025 is acknowledged. The traversal is on the grounds that the prior art reference cited, Sotiriadou, does not teach the MUC (79-87) peptide of SEQ ID:1. Applicants further argue that the reference does not further teach priming the dendritic cells while they are in an “immature state.” This is not found persuasive because when the dendritic cells present the MUC peptide antigens to the T cells, the antigens are all broken into tiny pieces so the original intact MUC antigenic peptide is no longer present. Therefore, the cytotoxic T cells do not possess MUC antigenic peptides. Furthermore, the activated cytotoxic T cells in the claimed composition are activated to kill cancer cells as are the T cells taught in the Sotiriadou reference. Both the cytotoxic T cells in the Sotiriadou reference cited in the restriction and the cytotoxic T cells recited in the claims are activated so that they kill cancer cells, performing the same function. The cytotoxic T cell populations taught in the Sotiriadou reference and the cytotoxic T cells recited in the claims are the same cell type, cytotoxic T cells. Applicants also argue that the restriction should be withdrawn because the claim has been amended to state that the dendritic cells are immature. This amendment was not present at the time the restriction was originally made. The examiner has drafted a rejection in which the immaturity of dendritic cells was shown to be taught by the prior art. Claims 4-10,12-13,19-24,26-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups II-IV, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 02,2025.The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
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.
Claims 1 and 14 are 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. Applicants appear to be claiming an autologous population of cytotoxic CD8+ T lymphocytes that were activated when immature by autologous dendritic cells capable of presenting pieces of antigenic peptide MUC (79-87) of SEQ ID NO:1 to the T cells. Although the claims mainly recite a pharmaceutical formulation that has cytotoxic T cells, there is mention of antigen presenting cells (dendritic cells) and also non-adherent cells that comprise (CD4T+ lymphocytes, B lymphocytes, platelets, neutrophils, basophils, eosinophils, etc). It is not clear if all these cells are present or only the activated cytotoxic T cells. For purposes of examination, the examiner will assume that the composition is only composed of activated cytotoxic T cells.
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 14 are rejected under 35 U.S.C. 103 as being unpatentable over Qin (WO2019184459) in view of McKenzie (US 6,548,643) and Rooney (WO2018187356).
Qin teaches a pharmaceutical composition for inducing an immune response in a human or animal subject suffering from a pathological disease or disorder (cancer), comprising autologous activated cytotoxic CD8+ T lymphocytes (CTLs) (Abstract, Page 6, Page 8 of Qin) activated by autologous primed mature dendritic cells of the human or animal subject (Pages 1-2 and 6-8 of Qin), said autologous primed mature dendritic cells presenting an antigenic peptide (Pages 6-8 of Qin), wherein the activated CTLs are derived from an autologous population of peripheral blood mononuclear cells (PBMCs) isolated from peripheral blood of the same human or animal subject (Pages 6 and 8 of Qin); wherein the activated CTLs are able to recognize the antigenic peptide (Abstract, Page 6, and Page 8 of Qin); wherein the CTLs have been activated by the autologous primed mature dendritic cells presenting the antigenic peptide, wherein the dendritic cells have been isolated from the same human or animal subject as the CTLs (Pages 6 and 8 of Qin), wherein the CTLs have been activated by co-culturing CD8+ T cells derived from the population of PBMCs with the autologous primed mature antigen-presenting dendritic cells (Page 6, last paragraph and Page 8, first full paragraph) as in instant Claim 1.
Qin teaches that antigenic peptides can be delivered to T cells by autologous dendritic cells. Qin does not teach that the antigenic peptide is a MUC (79-87) peptide of SEQ ID: 1. However, McKenzie teaches that MUC (79-87) antigenic peptide of SEQ ID 1 can be used successfully in immunotherapies designed to target cancer (Column 1 and Column 8 of McKenzie). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have use used the antigenic peptide possessing a MUC (79-87) peptide of SEQ ID: 1. An artisan would have been motivated to have used such an antigenic peptide since it can help the immune system to successfully target tumor/cancer cells for destruction (Columns 1 and 8 of McKenzie). Because the antigenic peptide MUC (79-87) can be used to successfully target cancer cells, there would have been a high expectation for success (Columns 1 and 8 of McKenzie) as in instant Claim 1.
Qin does not specify that the antigen presenting dendritic cells used to present the antigenic peptide are immature dendritic cells. However, Rooney teaches that immature dendritic cells can be used to present antigens (Paragraph 359 of Rooney). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used immature dendritic cells to present the antigenic peptide. An artisan would have been motivated to have activated a cytotoxic T cell with an immature dendritic cell since such cells are effective antigen presenting cells (Paragraphs 357-359 of Rooney). Because this particular type of dendritic cell (immature dendritic cell) can effectively present antigens, there would have been a high expectation for success as in instant Claim 1.
Dependent Claims taught by Qin
Qin teaches that its composition can be used for a treatment of cancer (Page 1 of Qin) as in instant Claim 14.
Qin teaches that a T cell composition can be activated by dendritic cells through the presentation of a antigenic peptide. Qin does not teach that the antigen is MUC (79-87) peptide from sequence 1. However, an artisan would have been motivated to have used the MUC (79-87) antigenic peptide from sequence 1 because that sequence portion is commonly found in tumor cells. Administering such a peptide sequence assists the immune cells in targeting cancer cells. There would have been a strong motivation for using that precise antigenic MUC peptide because it is known to be able to assist immune cells such as cytotoxic T cells with successfully targeting cancer cells. 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 combinations 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. These people will have practical knowledge in immunotherapy. 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.
Claims 1 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9 of copending Application No. 19,496,444(reference application) in view of McKenzie (US 6,548,643). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 19/496,444 are a species of the instant claims under examination. The claim 1 of 19/496,444 recites a composition with ex vivo activated autologous CD8+ cytotoxic T lymphocytes (mentioned in the instant claim set) and also other cells, not mentioned in the instant claim set, such as activated autologous dendritic cells and activated autologous plasma cells. Claim 1 of Application 19/496,444 does not specifically state what the immune cells are activated with. However, Park teaches that the antigenic MUC (79-87) peptide of SEQ ID:1 can be used to activate immune cells to become cytotoxic cells capable of killing cancer/tumors. Therefore, it would have been obvious to have used this antigenic peptide to have activated the immune cells such as cytotoxic T cells recited in claim 1 of Application 19/496,444. Furthermore, instant claim 14 corresponds to claims 8-9 of Application 19/496,444. 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.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638