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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/01/2025 has been entered.
Amended claims 14-21 are pending.
Filing of clean copy of the claims is suggested.
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.
Claim(s) 14-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Imai WO2020050253 A1 2020-03-12 (equivalent to English US 20210205326), Imai WO2017188365, Werner WO 2018104305 (previously provided), Burnstock, Curr Opin Pharmacol. 2017 December ; 37: 131–141, Burnstock, Purinergic Signalling (2016) 12:59–67 (previously provided); Rani, Intest Res 2016;14(4):297-304 (previously provided), and Vuerich, Frontiers in Immunology, Purinergic Signaling, Front. Immunol. 11:1882, 2020.
Imai, 20210205326 at page 18, [0284] teaches the specific compound of instant claim 14 as does Imai Japanese WO2017188365 at page 258, [0354] and at page 282 second listed. (RN1447803-11-3).
According to the above Imai(s), the compound has antagonistic activity on P2X4 receptors.
P2X4 receptor activity is inexorably linked to the inflammatory diseases is well-known in the art, for example,
Werner teaches P2X4 antagonist for use in the treatment of gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), diarrhea-dominant IBS and Crohn's disease. Based on the P2X4 antagonising activity, the compounds are useful for the relief of pain and inflammation of a variety of conditions including IBS and IBD (claims 12, 14; page 24, lines 22-23; page 24, line 34 - page 25, line 2; page 25, lines 25-28; page 26, lines 6-13; page 27, line 33 -
page 28, line 21; page 31, lines 13-16).
Burnstock 2016 teaches P2X4 receptors and Gut inflammation (Title and Abstract); Burnstock 2016 page 8 concludes that Antagonists of P2X receptors, and P2X7R and P2X3R, in particular, are potential therapeutic targets for treating IBD, IBS and motility disorders; Rani, teaches Irritable bowel syndrome and inflammatory bowel disease overlap syndrome: pieces of the puzzle are falling into place (Title and Abstract) and Vuerich, titled Control of Gut Inflammation by Modulation of Purinergic Signaling, concludes that Mounting clinical evidence and research data support the
involvement of purinergic signaling alterations in IBD pathogenesis. Note that these NPL documents are Review articles and correspond to the limitations of dependent claims 15-21 inexorably linked to IBS and IBD. Such linkages can be found, using word search technique in these Review articles.
As such the recited active ingredient, its inherent biological property and the linkage of the said biological property to the recited disease state are explicitly taught in the references cited here.
As such there is nothing unobvious is seen in the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-21 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inflammatory bowel disease is Crohn's disease or ulcerative colitis, does not reasonably provide enablement for preventing irritable bowel syndrome or inflammatory bowel disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The determination that "undue experimentation" would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the relevant factual considerations.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art.
All the factors have been considered with regard to the claims, with the most relevant factors discussed below:
The specification is not enabling for preventing any disease.The only established prophylactics are vaccines not the small molecule compounds such as present here. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted. The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. As discussed above, preventing diseases requires identifying those patients who will acquire the disease before the disease occurs.
According to the instant specification, the term “prevention” is a concept comprising preventing onset of a “diseased” or “abnormal” symptom, state, or disease before an outbreak thereof and an action or a method therefor. Hence, "preventing" refers to the prophylactic treatment of a subject in need thereof. This would require extensive and potentially open-ended clinical research on healthy subjects having or susceptible the recited disease states. There is no working example of such a preventive procedure in man or animal in the specification. That Compound B could be useful for treating IBS and IBD on the bases of DNBS-induced colitis model, See Examples 10 and 11 showing improve macroscopic damage scores of colonic tissue and improvement in microscopic damage to colon tissue. Extension of ex vivo or in vitro data to real life use of the recited compounds does not find support in the instant specification. Applicant is encouraged to provide data or citations for preventing reperfusion injury with reversible succinate dehydrogenase inhibitors. The claims rejected are drawn to clinical use of medicine and are therefore physiological in nature. The state of the art is that no general procedure is art-recognized for determining which patients generally will become afflicted with the disease before the fact. The artisan using Applicants invention would be a Board Certified physician in treating diseases with an MD degree and several years of experience. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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