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 .
Election/Restrictions and Claim Status
Applicant’s arguments filed 1/2/26 are acknowledged.
Previously, Group 3 and the species of SEQ ID NO: 4 were elected.
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 1-22 and 24 have been canceled.
Claims 23 and 25 are being examined.
Priority
The priority information is found in the filing receipt dated 6/22/21.
Claim Rejections - 35 USC § 103
The 103 rejection is maintained from the previous office action.
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.
Claims 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin (WO 2016/165101; first cited 11/2/22) in view of Kumar et al. (as cited with IDS 9/28/22; ‘Kumar’) in view of Budhu et al. (‘The role of cytokines in hepatocellular carcinoma’ Journal of Leukocyte Biology v80 December 2006 pages 1197-1213; ‘Budhu’; previously cited).
Lin teach a peptide of sequence QETAVSSHEQD (claim 11 and page 12 last complete paragraph) and broadly refer to derivatives thereof (claim 10). Lin teach the peptides for administering to subjects (claim 1). Lin teach that the peptide inhibits HCV replication (abstract) and teach for treating HCV infection (claim 1). Lin teach a wide range of the amount of the active ingredient (page 9 lines 20-22).
Lin does not teach a peptide as instantly claimed since the claims require for example PyroQ as the first residue. Lin does not administer to a cancer patient as recited in claim 23
Kumar teach that many biologically active peptides have an amino terminal pyroglutamic acid that occurs when the N-terminal residue is glutamine (page 291 last paragraph of column 1). Kumar teach that the pyroglutamic acid can form spontaneously and that the residue provides resistance from degradation (paragraph spanning columns 1-2 on page 291).
Budhu teach that hepatitis C virus is a major factor associated with the development of hepatocellular carcinoma (HCC) (abstract). Budhu teach antiviral strategies to treat patients with HCC related to HCV infection (page 1206 paragraph connecting columns 1-2). Budhu teach a strategy for patients with HCC that boosts the level of certain cytokines and specifically recites IL-2 and IL-12 and IFN-gamma (last paragraph page 1206) and relates them to induced cytolytic activity (last paragraph page 1206). Budhu teach the antitumor response of IL-12 was tested in a HCC mouse model and teach that the vector carrying IL-12 caused regression (page 1207 first complete paragraph). Budhu teach that therapies with primary HCC have shown substantial tumor regression with IL-12 therapy (page 1207 first complete paragraph). Budhu teach microparticles encapsulating IL-2 that protected a large percentage of mice from HCC (page 1207 2nd complete paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Lin because Lin teach a peptide with an N-terminal glutamine (claim 11) and Kumar teach that many biologically active peptides have an amino terminal pyroglutamic acid that occurs when the N-terminal residue is glutamine (page 291 last paragraph of column 1) and that the residue provides resistance from degradation (paragraph spanning columns 1-2 on page 291). Since Lin teach the peptides for administering to subjects (claim 1) one would have been motivated to substitute pyroglutamic acid for glutamine in the peptide of Lin (claim 11) to result in pyroQETAVSSHEQD. Further, Lin teach the peptides for administering to subjects specifically those with HCV (claim 1). Budhu teach that hepatitis C virus is a major factor associated with the development of hepatocellular carcinoma (HCC) (abstract). Budhu teach antiviral strategies to treat patients with HCC related to HCV infection (page 1206 paragraph connecting columns 1-2). Budhu teach a strategy for patients with HCC that boosts the level of certain cytokines and specifically recites IL-2 and IL-12 and IFN-gamma (last paragraph page 1206). Budhu teach immunotherapy by using IL-12 (first complete paragraph on page 1207). Thus one would have been motivated to administer to those with HCC based on the known advantageous effects. One would have had a reasonable expectation of success since methods of peptide synthesis were known (example 1 of Lin) as well as methods of administering.
In relation to the polypeptide of claim 23, as discussed above the prior art suggest pyroQETAVSSHEQD which is instant SEQ ID NO:1.
In relation to the administration and patient as recited in claims 23 and 25, Lin teach the peptides for administering to subjects (claim 1). Lin teach the peptides for administering to subjects specifically those with HCV (claim 1). Budhu teach that hepatitis C virus is a major factor associated with the development of hepatocellular carcinoma (HCC) (abstract). Budhu teach antiviral strategies to treat patients with HCC related to HCV infection (page 1206 paragraph connecting columns 1-2). Budhu teach a strategy for patients with HCC that boosts the level of certain cytokines and specifically recites IL-2 and IL-12 and IFN-gamma (last paragraph page 1206). Budhu teach immunotherapy by using IL-12 (first complete paragraph on page 1207). Thus one would have been motivated to increase the level of IL-2, IFN-gamma or IL-12.
In relation to the administration and patient as recited in claim 23, Lin teach the peptides for administering to subjects (claim 1). Lin teach the peptides for administering to subjects specifically those with HCV (claim 1). Budhu teach that hepatitis C virus is a major factor associated with the development of hepatocellular carcinoma (HCC) (abstract). Budhu teach antiviral strategies to treat patients with HCC related to HCV infection (page 1206 paragraph connecting columns 1-2). Budhu teach a strategy for patients with HCC that boosts the level of certain cytokines and specifically recites IL-2 and IL-12 and IFN-gamma (last paragraph page 1206). Budhu teach immunotherapy by using IL-12 (first complete paragraph on page 1207). Thus one would have been motivated to administer to those with HCC.
In relation to any outcome recited in claims 23 and 25, the prior art suggest administration of a peptide as claimed so such peptide would function as claimed. Lin teach a wide range of the amount of the active ingredient (page 9 lines 20-22). Further, Budhu recognizes lymphocytes (pages 1207-1208 connecting paragraph for example) and adaptive immune cells (last paragraph of column 1 on page 1197).
Response to Arguments - 103
Applicant's arguments filed 1/2/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that figure 3 shows inhibition of liver cancer by certain sequences, a close review of the figure shows that SEQ ID NOs: 1, 10, 17 and 21 appear to have no effect at 0.25, 0.5 and 0.75 mg/ml. Further, merely explaining data of a figure does not directly address the rejection (see previous replies to arguments about unpersuasive arguments related to unexpected results).
Although applicants argue that the results suggest effects of the peptides by stimulating spleen lymphocytes, it is noted that the active step of claim 23 is ‘administering’. Although the claim refers to ‘by increasing the level or stimulating the release of cytokines from a splenic lymphocyte’ a recitation of the outcome or intended outcome does not change the fact that the active step is administering. The claim limitations are addressed in detail above.
Although applicants argue that the references do not teach effectiveness by stimulating spleen lymphocytes, MPEP 2144 IV expressly recognizes that a rationale different from applicants is permissible. MPEP 2144 IV states: “It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” In the instant case, Budhu teach that hepatitis C virus is a major factor associated with the development of hepatocellular carcinoma (HCC) (abstract). Budhu teach antiviral strategies to treat patients with HCC related to HCV infection (page 1206 paragraph connecting columns 1-2). Lin teach peptides that inhibit HCV replication (abstract) and teach peptides for treating HCV infection (claim 1). Thus one would have been motivated to administer to those with HCC based on the known advantageous effects.
Although applicants argue that one could not believe that an active agent for treating hepatitis C is also effective in treating liver cancer, Budhu teach that hepatitis C virus is a major factor associated with the development of hepatocellular carcinoma (HCC) (abstract). Lin teach peptides that inhibit HCV replication (abstract) and teach for treating HCV infection (claim 1). An agent that is taught to inhibit HCV replication would be expected to be useful for treating HCC since Budhu teach that hepatitis C virus is a major factor associated with the development of hepatocellular carcinoma (HCC) (abstract).
Although applicants argue about the teachings of the references individually, 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).
Although applicants argue about expectations of having any bioactivity, Lin teach a peptide of sequence QETAVSSHEQD (claim 11 and page 12 last complete paragraph) and teach the peptide inhibits HCV replication (abstract) and teach for treating HCV infection (claim 1). Instant SEQ ID NO:1 is pyroQETAVSSHEQD. QETAVSSHEQD and pyroQETAVSSHEQD are identical except for the first residue. Based on the high sequence identity, one would have an expectation of similar functionality. Kumar teach that many biologically active peptides have an amino terminal pyroglutamic acid that occurs when the N-terminal residue is glutamine (page 291 last paragraph of column 1). Kumar teach that the pyroglutamic acid can form spontaneously and that the residue provides resistance from degradation (paragraph spanning columns 1-2 on page 291).
Any previous arguments have already been addressed and are not found persuasive with respect to the rejection set forth above. Those replies to arguments remain of record.
Conclusion
THIS ACTION IS MADE FINAL. 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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658