DETAILED ACTION
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 Amendments
Applicant's amendments filed 5/12/2026 to claims 68-70, 80, and 81 have been entered. Claims 12-21 and 32-44 are canceled. Claims 98-103 have been added. Claims 1-11, 22-31, and 45-103 remain pending, of which claims 68-72, 79-87, and 98-103 are being considered on their merits. Claims 1-11, 12-31, 45-67, 73-78, and 88-97 remain withdrawn from consideration. References not included with this Office action can be found in a prior action.
The instant claim amendments have overcome the 35 U.S.C. § 112(b) rejections of record, which are withdrawn.
Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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 68-72, 79-87, and 98-103 are rejected under 35 U.S.C. 103 as being unpatentable over Bosch et al. (WO 2017/048875; provided in the IDS dated 8/06/2024) in view of Kagan et al. (WO 2016/115097; provided in the IDS dated 8/06/2024).
In view of the indefiniteness rejections above and in the interest of compact prosecution, for claim 68 and dependent claims 69-72 this rejection addresses the embodiment of the providing, contacting, isolating, and formulating steps being performed in vitro and the two administering steps being performed in vivo in subjects.
Bosch teaches a method for producing an anti-tumor response in vitro and in an individual, the method comprising: 1) providing immature dendritic cells, 2) contacting the immature dendritic cells in vitro with an effective amount of a dendritic cell maturation agent with IFNγ for 10-19 hours; under culture conditions suitable for inducing maturation of the immature dendritic cells, 3) isolating the maturing dendritic cells prior to full maturation; formulating the maturing dendritic cells for administration; 4) administering the maturing dendritic cells intratumorally to subjects such as to reduce tumor size (see the single working example at p31-44, particularly p32 “Preparation of activated DCs” for the providing and contacting steps, the paragraph spanning p20-21 reading on the isolating step and partial maturation of the dendritic cells, the paragraph spanning p34-35 for the formulating and intratumor administration steps, and the paragraph spanning p41-42 for reduction in tumor size), reading in-part on claims 68 and 79. Bosch routes of administration including intravenous, intradermal, and intranodal (the paragraph spanning p5-6), reading in-part on the administration of an inflammation-activating lipid of claims 68 and 79. Bosch teaches dendritic maturation agents comprising TLR3, TLR4, TLR7, and/or TLR9 agonists (the paragraph spanning p19-20), reading on claims 71 and 82. Bosch teaches obtaining the dendritic cells from skin, spleen, bone marrow, thymus, lymph nodes, umbilical cord blood, or peripheral blood (claim 11), reading on claims 71 and 82. Bosch teaches wherein the dendritic cell precursors are obtained from a healthy individual subject HLA-matched to the individual subject to be treated (claim 14), reading on claims 72 and 83. Bosch teaches wherein the isolated maturing dendritic cells are cryopreserved and are thawed prior to administration (the paragraph spanning p24-25 and p27, lines 5-20), reading on claim 84. Bosch teaches administering the dendritic cells either simultaneously and subsequent to other treatments for the tumor (the paragraph spanning p27-28), reading in-part on claims 85-87. Bosch teaches inactivated Bacillus Calmette-Guerin (BCG), lipopolysaccaharide (i.e. LPS), 4-amino-2-ethoxymethyl-α,α-dimethyl-1H-imidazol[4,5-c]quinolin-1-5 ethanol, 1-(2- methylpropyl)-1H-imidazo[ 4,5-c ]quinolin-4-amine, and poly[I]:poly[C(12)U]. (page 13, line 17 through page 14, line 2), reading on claims 98-103.
Regarding claims 68, 79, 85, and 86, Bosch does not teach administering any species of inflammation-activating lipid to an individual or to subjects. Regarding claims 70 and 81, Bosch does not teach the embodiment of oxidized 1-palmitoyl-2-arachidonyl-sn-glycero-3- phosphorylcholine (i.e. oxPAPC). Regarding claim 87, Bosch does not teach topical administration of the inflammation-activating lipid.
Kagan teaches that oxidized 1-palmitoyl-2-arachidonyl-sn-glycero-3- phosphorylcholine (i.e. oxPAPC) promotes the activation of the inflammasome in dendritic cells (Example 3), reading in-part on claims 68 and 79. Kagan teaches that oxPAPC is non-toxic to dendritic cells (Example 9) and is a potent adjuvant supplement that promotes T-cell mediated adaptive immunity when administered at an effective dosage to subjects (Example 10), reading on claims 68, 79, 85, and 86. Kagan teaches the adjuvant lipid formulated as a pharmaceutical composition compatible with its intended route of administration, such as parenteral, intravenous (e.g. systemic), systemic transmucosal, and systemic transdermal (e.g. topical) administration (p29, the 1st three paragraphs under “Pharmaceutical Compositions” and p31, paragraph starting “Systemic administration…”), reading in-part on claims 85-87.
Regarding claims 68, 80, 79, 81, 85, 86, and partially for claim 87, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further administer/co-administer the oxPAPC as a species of inflammation-activating lipid of Kagan to the subjects being administering partially matured dendritic cells for the treatment of tumors in the methods of Bosch. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Bosch and Kagan are directed towards dendritic cell compositions and dendritic cell-based immunity. The skilled artisan would have been motivated to do so because Kagan teaches that that oxidized 1-palmitoyl-2-arachidonyl-sn-glycero-3- phosphorylcholine (i.e. oxPAPC) promotes the activation of the inflammasome in dendritic cells, is non-toxic to dendritic cells, and is a potent adjuvant supplement that promotes T-cell mediated adaptive immunity when administered at an effective dosage to subjects. Therefore, the addition of oxPAPC would likely and predictably improve upon the dendritic cell administration and tumor treatment methods of Bosch.
Regarding claim 87, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further administer the oxPAPC of Kagan topically to the subjects being administering partially matured dendritic cells for the treatment of tumors in the methods of Bosch. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Bosch and Kagan are directed towards dendritic cell compositions and dendritic cell-based immunity, and because both Bosch and Kagan contemplate multiple known routes of administration. The skilled artisan would have been motivated to do so because Kagan teaches topical administration as one of several exemplary routes of administration to deliver the adjuvant and inflammation-activating lipid(s) to subjects for treatment, and so would predictably deliver the oxPAPC of Kagan to the subjects in need of treatment for tumors of Bosch; see M.P.E.P. § 2141 (I), in that when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 22-28 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
Applicant’s specific remarks traversing the 35 U.S.C. § 103 rejection of record start at page 27 of the reply, where Applicant alleges that Kagan is deficient by not teaching every element of method claim 68. This is not found persuasive because Kagan is not applied alone under any rejection under 35 U.S.C. § 102, but in combination with Bosch under 35 U.S.C. § 103, and so the claimed invention becomes obvious when the references are considered together as a whole rather than each alone. Applicant further asserts that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Furthermore, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, none of Applicant’s arguments address the specific rationale to combine Kagan and Bosch and what the combination of the prior art references would (or would not) reasonably suggest to a person of ordinary skill in the art.
Conclusion
No claims are allowed. No claims are free of the art.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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