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 .
Clarification / Status of application
From the outcome of pre-appeal brief conference held between the examiner and AU1658 SPE and TQAS, it has been decided to reopen the prosecution. Accordingly, (ii) a new non-final, with different interpretation of previously applied references and (ii) a new nonstatutory double patenting rejection follows in this office action. The examiner regrets if this is inconvenience to the applicants. In light of new grounds of rejection(s), applicants arguments are moot.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 18, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Prestegarden (US 2015/0038407 A1) in view of Immodulon (WO2016/207646A1; see IDS dated 03/03/2021).
For claim 18:
Prestegarden teaches an oligopeptide for treating cancer with the following sequence:
YGRKKRRQRRRGKTLRVAKAIYKRYIE (SEQ ID NO: 40) [see 0026 and claim 1], which is identical to applicants SEQ ID NO:1.
Prestegarden teaches that the above sequence contains all D-amino acids [see 0151 and claim 36-37].
Prestegarden further teaches that the compounds of the invention may be used in combination or conjunction with other anti-cancer agents, for example chemotherapy agents or anti-neoplastic agent or any agent which may be indicated for an oncological or haematological indication. The compounds of their invention may be used in combination with other therapeutic agents, for example to be administered together, in a single pharmaceutical formulation or composition, or separately (i.e. for separate, sequential or simultaneous administration). Thus, the compounds of the invention may be combined with a second (or further) therapeutically active agent, e.g. in a pharmaceutical kit or as a combined ("combination") product. [see 0142-0143].
The differences is that Prestegarden silent on a checkpoint inhibitor.
This difference can be cured with the teaching of Immodulon, which teaches a checkpoint inhibition by administering a blocking agent directed against CTLA-4 or PD-1 or PD-L1 etc., to treat cancer or a neoplastic disease, wherein blocking agent is an antibody is selected from the group consisting of ipilimumab, nivolumab, pembrolizumab, azetolizumab, tremelimumab, and combinations thereof [see claims 1-3].
Established case law says that if it is known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069. Thus, combining them flows logically from their having been individually taught in the prior art. In this case, both applicants oligopeptide and checkpoint inhibitor are known to inhibit cancer cells. Therefore, one would be motivated to combine the two drugs to see any combinational effects.
For claim 38:
Immodulon teaches a checkpoint inhibition by administering a blocking agent directed against CTLA-4 or PD-1 or PD-L1 etc, wherein blocking agent is an antibody is selected from the group consisting of ipilimumab, nivolumab, pembrolizumab, azetolizumab, tremelimumab, and combinations thereof [see claims 1-3].
For claim 39:
The recited limitations are properties of recited components in the kit.
Based on the definition of kit in the specification, claims can be interpreted as (i) the recited components exists in separate containers in a kit, or (ii) in the mixed form, i.e., composition.
In the first scenario, if they are not mixed, how the recited components enhance each other in the kit? So, it was obvious to keep two or more components in a kit for a desired utility.
In the second scenario, if the recited components in the mixed form, at the outset synergism is sensitive to conditions of the composition, such as pH, concentrations etc., and structural features of components, such as type of peptide or checkpoint inhibitor etc. In this case, there are no concentrations of components in the claimed composition.
Moreover, claims can read all possible checkpoint inhibitors. Interestingly, in the shown data in Fig.1, limited to recited monoclonal antibody, and it appears that there is no synergism until day 6. Established case law says “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support’. In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02(d)”.
In addition, established case law says that if it is known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069. Thus, combining them flows logically from their having been individually taught in the prior art. In this case, both applicants oligopeptide and checkpoint inhibitor are known to inhibit cancer cells. Therefore, one would be motivated to combine the two drugs to see any combinational effects.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components in the kit form, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed kit with a reasonable expectation of success.
Nonstatutory Double Patenting Rejection
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 18 and 38-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 8,754,042 B2 in view of Immodulon (WO2016/207646A1; see IDS dated 03/03/2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
For claims 18 and 38:
Claims of US patent teaches a kit comprising the oligopeptidic compound and a second therapeutically active agent [see claims 7 or 10], wherein the second therapeutically active agent is a chemotherapy agent, an anti-neoplastic agent, an antibiotic, an antiviral agent, or an antifungal agent etc., wherein oligopeptide compound is represented by SEQ ID NO:40, wherein SEQ ID NO:40 contains all D-amino acids [claims 1-10].
US patent explicitly does not teach checkpoint inhibitor. This can be cured with the following reasoning:
Chemotherapy agent and anti-neoplastic agent in the claims of US patent can be a checkpoint inhibitor. Regardless, Immodulon teaches a checkpoint inhibition by administering a blocking agent directed against CTLA-4 or PD-1 or PD-L1 etc, wherein blocking agent is an antibody is selected from the group consisting of ipilimumab, nivolumab, pembrolizumab, azetolizumab, tremelimumab, and combinations thereof [see claims 1-3].
Established case law says that if it is known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069. Thus, combining them flows logically from their having been individually taught in the prior art. In this case, both applicants oligopeptide and checkpoint inhibitor are known to inhibit cancer cells. Therefore, one would be motivated to combine the two drugs to see any combinational effects.
For claim 39:
The recited limitations are properties of recited components in the kit.
Based on the definition of kit in the specification, claims can be interpreted as (i) the recited components exists in separate containers in a kit, or (ii) in the mixed form, i.e., composition.
In the first scenario, if they are not mixed, how the recited components effective to enhance each other? So, it was obvious to keep two or more components in a kit for a desired utility.
In the second scenario, if the recited components in the mixed form, at the outset synergism is sensitive to conditions of the composition, such as pH, concentrations etc., and structural features of components, such as type of peptide or checkpoint inhibitor etc. In this case, there are no concentrations of components in the claimed composition.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed kit with a reasonable expectation of success.
Conclusion
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658