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 1-10 are pending and examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group III, as drawn to the elected species apolipoprotein, in the reply filed on 7/15/25 is acknowledged.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 person shall be entitled to a patent unless –
(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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (U.S. Patent Publication No. 2070031379).
Lee teaches apolipoprotein for treating cancer (title, abstract, claims).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 2 and/or 3 depending back to claim 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over the apolipoprotein teachings of Lee et al. (U.S. Patent Publication No. 2070031379) in view of the T-cell co-stimulator agonist teachings of Palese et al. (U.S. Patent Publication No. 20180256655) and/or in view of the CD4-positive T-cell depleting antibody teachings of Shitara (.“First-in-human phase 1 study of IT1208, a defucosylated humanized anti-CD4 depleting antibody, in patients with advanced solid tumors”. J Immunother Cancer. 2019 Jul 24;7(1):195. doi: 10.1186/s40425-019-0677-y)
As for instant claim 11, Lee teaches apolipoprotein for treating cancer (title, abstract, claims).
As for instant claim 12, Palease teach T-cell co-stimulator agonists for treating cancer (title, abstract, claims).
As for instant claim 13, Shitara (.“First-in-human phase 1 study of IT1208, a defucosylated humanized anti-CD4 depleting antibody, in patients with advanced solid tumors”. J Immunother Cancer. 2019 Jul 24;7(1):195. doi: 10.1186/s40425-019-0677-y) as cited in instant specification paragraph 81 teach T-cell co-stimulator agonist such as IT1208 for treating cancer:
[0081] The medicament of the present invention may be used in combination with a CD4-positive T-cell depleting antibody in addition to a T-cell co-stimulator agonist. Examples of the CD4-positive T-cell depleting antibody include humanized anti-CD4 antibodies “IT1208” (J Immunother Cancer. 2019 Jul. 24; 7(1):195. doi: 10.1186/s40425-019-0677-y.), “MAX.16H5” (Front Immunol. 2019 May 24; 10:1035. doi: 10.3389/fimmu.2019.01035.), and “cM-T412” (J Clin Invest. 1997 May 1:99(9):2225-31. doi: 10.1172/JCI119396.). A combined use with the CD4-positive T-cell depleting antibody can provide an enhanced anti-cancer effect on non-target cancer tissue.
As a matter of law, "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 (here 3 known cancer agents), in order to form a third composition which is to be used for the very same purpose." In re Susi, 169 USPQ 423, 426 (CCPA 1971); In re Kerkhoven, 205 USPQ 1069 (CCPA 1980). As a result, it would have necessarily been prima facie obvious to one of ordinary skill in the art to combine the compositions taught in the prior art to arrive at the instantly claimed invention.
Thus, the combination of apolipoprotein with either of the known cancer agents of claim 12 and/or 13 would have been prima facie obvious in view of the recognized caselaw to this effect recited above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
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