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 .
Applicant's arguments filed 12/29/25 have been fully considered but they are not persuasive. Applicant has amended independent claim 1 to add the limitation “wherein the activation of an immune response is treatment and/or prevention of a virus infection, of a bacterial infection, of a fungal infection, or of an autoimmune disease.” The limitation does not serve to distinguish over the prior art because in “preventing” applicant claims a prophylactic administration and as such the prior art administration would constitute a “prevention” as is claimed.
Further, as the prior art steps are the same ,i.e. “administration” the new limitations to claim 2 would necessarily be inherent to the prior art.
In response to applicant's arguments against 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).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-8, 10 & 13-14 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Xu et al(US 2013/028779).
Xu teaches a treatment of cancer by administering a Usp22 Inhibitor which is a small molecule inhibitor[0022-0025]. Xu teaches using any applicable inhibitor of the enzyme to facilitate this treatment including specifically antibodies, potein binding fragments, aptamers, antisense, interfering RNAs etc (see esp p 3-5). XU teaches measuring the gene product to determine the relative amount of Usp22 gene product (as in claims 10-11) for treatment (see at least Fig 6). Xu teaches testing potential inhibitor for their effect on Usp22 gene or enzyme (as in claims 13-14).
Xu discloses (paragraph 20) "In some embodiments, the positive modulator of
mono-ubiquitination of the histone comprises an inhibitor of a deubiquitinating
enzyme. In certain embodiments, the deubiquitinating enzyme is a ubiquitin-
specific protease. In certain embodiments, the ubiquitin-specific protease is at
least one of ubiquitin specific peptidase 22 (USP22), USP7/HAUSP, or another
deubiquitinase that can remove the ubiquitin moiety of histone H2B".
(paragraph 25): "Another embodiment provides a composition comprising at
least one negative modulator (inhibitor) of a deubiquitinating enzyme. Such a
composition may be used in connection with various methods according to
aspects of the invention. In certain embodiments, the deubiquitinating enzyme is
a ubiquitin-specific protease that inhibits mono-ubiquitination of a histone. In
certain embodiments, the histone is histone H2B. In certain preferred
embodiments, the composition comprises an inhibitor of least one of USP22,
USP7/HAUSP or another deubiquitinase that can remove the ubiquitin moiety of
histone H2B. In certain embodiments, the composition comprises at least one
inhibitor of the interaction of USP22 with one or more of ATXNL73, ATXN7 or
ENY2. In certain embodiments, the at least one inhibitor of USP22 interaction
with one or more of ATXNL73, ATXN7 or ENY2 may be a small molecule. In
certain embodiments, more than one small molecule is used, wherein the small
molecule is an inhibitor of USP22, ATXNL73, ATXN7 or ENY2. In certain
embodiments, two small molecule inhibitors are used".
Xu does not teach that the mechanism of their testament is “activating an immune response” but as the methods (and results) are the same, the “activation of an immune response” necessarily was inherent to the methods of Xu and a rejection of anticipation is required.
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.
Claims 1-2, 4-8, 10 & 13-14 remain rejected under 35 U.S.C. 103 as being obvious over Xu et al(US 2013/028779) and CHIPUMURO et al (FASEB JOURNAL, 2011) & Wang et al (Cell Communication and Signaling 2020)
Xu teaches a treatment of cancer by administering a Usp22 Inhibitor which is a small molecule inhibitor[0022-0025]. Xu teaches using any applicable inhibitor of the enzyme to facilitate this treatment including specifically antibodies, potein binding fragments, aptamers, antisense, interfering RNAs etc (see esp p 3-5). XU teaches measuring the gene product to determine the relative amount of Usp22 gene product (as in claims 10-11) for treatment (see at least Fig 6). Xu teaches testing potential inhibitor for their effect on Usp22 gene or enzyme (as in claims 13-14).
Xu discloses (paragraph 20) "In some embodiments, the positive modulator of
mono-ubiquitination of the histone comprises an inhibitor of a deubiquitinating
enzyme. In certain embodiments, the deubiquitinating enzyme is a ubiquitin-
specific protease. In certain embodiments, the ubiquitin-specific protease is at
least one of ubiquitin specific peptidase 22 (USP22), USP7/HAUSP, or another
deubiquitinase that can remove the ubiquitin moiety of histone H2B".
(paragraph 25): "Another embodiment provides a composition comprising at
least one negative modulator (inhibitor) of a deubiquitinating enzyme. Such a
composition may be used in connection with various methods according to
aspects of the invention. In certain embodiments, the deubiquitinating enzyme is
a ubiquitin-specific protease that inhibits mono-ubiquitination of a histone. In
certain embodiments, the histone is histone H2B. In certain preferred
embodiments, the composition comprises an inhibitor of least one of USP22,
USP7/HAUSP or another deubiquitinase that can remove the ubiquitin moiety of
histone H2B. In certain embodiments, the composition comprises at least one
inhibitor of the interaction of USP22 with one or more of ATXNL73, ATXN7 or
ENY2. In certain embodiments, the at least one inhibitor of USP22 interaction
with one or more of ATXNL73, ATXN7 or ENY2 may be a small molecule. In
certain embodiments, more than one small molecule is used, wherein the small
molecule is an inhibitor of USP22, ATXNL73, ATXN7 or ENY2. In certain
embodiments, two small molecule inhibitors are used".
Xu does not teach that the mechanism of their testament is “activating an immune response” but as the methods (and results) are the same, the “activation of an immune response” necessarily was inherent to the methods of Xu and a rejection of anticipation is required. Though Xu does not specifically mention the “immune response” it would have been obvious at the time the invention was filed to use the methods of Xu as an immune-based treatment/assay because Chipmuro and Wang both teach that the inhibition of Usp22 is effective at least in part because it causes immunological response . Chipumuro clearly teaches that shRNA directed against USP22 as well as the link between USP22 and H2B uquibitination and interferon regulatory factor 1 (IRF 1) and as such the methods of Xu, i.e. the inhibition of Usp22 (gene or enzyme) would be understood to be activating an immune response because of the effect on interferon. Chimpumuro’s teaching about interferon would further make it obvious to use the method of Xu to treat any infection because of the old and well known implications of interferon. Wang adds (paragraph bridging pages 2 and 3) siRNA against USP22 and
further (conclusions) "Moreover, USP22 depletion suppressed tumorigenesis
and promoted T cell-mediated cell killing".
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was made especially in the absence of evidence
to the contrary.
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 BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657