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 .
Election/Restrictions
Applicant’s election without traverse of Group VIII, presently claims 68-72 and 79-87, in the reply filed on 8/28/2025 is acknowledged.
Claims 1-67, 73-78, and 88-97 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/28/2025.
Claims 68-72 and 79-87 are under consideration on the merits.
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 68-72, 80, 81, and 87 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 68 recites the broader recitation of generic providing, contacting, isolating, formulating, and two administering steps, and the claim also recites “an in vitro method” in the preamble which is the narrower statement of the afore-mentioned limitations. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The lack of clarity is further compounded in that the broadest reasonable interpretation of “tumor” and “administering” could read on both in vitro and in vivo embodiments but the claimed embodiment of systemic administration would necessarily limit the second administering step to the in vivo embodiment and so directly conflicts with and is mutually exclusive from “an in vitro method” as recited in the preamble. Applicant is reminded the examiner cannot import claim limitations from the specification to otherwise clarify the scope of the claims, see M.P.E.P. § 2111.01(II). Clarification and/or correction is required.
Claims 69 and 80 recite “preferred” conditions, which is exemplary claim language that does not precisely define the metes and bounds of the claims. It is not clear whether any conditions other than the recited conditions are part of the claimed invention; see M.P.E.P. § 2173.05(d). Correction is required.
Claim 81 recites the limitation "the in vitro method” at line 1, which lacks antecedent basis for this limitation in the claim. Claim 81 depends from claim 79 and claim 79 does not recite any “in vitro method”. Correction is required.
Claim 87 recites the limitation "the administration” at line 1, which antecedent basis for this limitation in the claim. Claim 87 depends from claim 85 and claim 85 does not recite any “site of administration”. Correction is required.
In so much that claims 69-72 depend from claim 68 and do not resolve the point of confusion, these claims must be rejected with claim 68 as indefinite.
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 and 79-87 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.
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.
Conclusion
No claims are allowed. No claims are free of the art.
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 7:00am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653