DETAILED ACTION
Claims 1-12 are pending in the instant application.
2. Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 1-2, 4, 6-8 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for inhibition of (MALT1) and treating colorectal cancer, lung cancer, pancreatic cancer, mesothelioma, gastric cancer, duodenal cancer, ovarian cancer, breast cancer, renal cancer, thyroid cancer, bladder cancer, brain cancer, liver cancer, Hodgkin’s disease, testicular cancer, prostate cancer, small intestine cancer, does not reasonably provide enablement for treating (MALT1)-related 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 make and/or use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
1) The breadth of the claims.
2) The nature of the invention,
3) The state of the prior art,
4) The level of one of ordinary skill,
5) The level of predictability in the art,
6) The amount of direction provided by the inventor,
7) The existence of working examples,
8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The nature of the invention: The instant invention is drawn to method for treating (MALT1)-related disease, said method comprising administration of compound or pharmaceutically acceptable salt thereof according to claim 1.
The state of the prior art: As indicated by the prior art, there is not any association between (MALT1) inhibitors and treating (MALT1)-related disease. There is no guidance in the prior art that (MALT1) inhibitor could be useful to treat (MALT1)-related disease.
The predictability in the art: At present using (MALT1) inhibition to treat (MALT1)-related disease is purely speculative. It is noted that pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. They have not shown a nexus to treat diseases but have provided only reports in vitro which, absent a correlation to treat of diseases, are not sufficient to enable the invention.
The level of the skill in the art: The level of skill in the art is high.
Amount of guidance/working examples: Applicant provides examples of the test compounds to inhibit (MALT1) on pages 129-133. However, there is no guidance for using a therapeutically effective compound of Formula (I) to treat (MALT1)-related disease.
The breadth of the claims: The claims encompass a method for treating (MALT1)-related disease.
The quantity of experimentation needed: Since the guidance and teaching provided by the specification is insufficient for treating diseases associated with therapeutically effective amount of a compound of formula (I) is efficacious, one of ordinary skill in the art, even with high level of skill, is unable to use the instant compounds as claimed without undue experimentation.
Taking all of the above into consideration, it is not seen where the instant claims 1-2, 4, 6-8, for treating diseases associated with therapeutically effective amount of a compound of Formula (I) is efficacious, have been enabled by the instant specification.
3. Claims 1-6 are rejected under 35 U.S.C. 112, first paragraph, because the specification, does not reasonably provide enablement for preventing (MALT1)-related disease. The specification does not enable any person skilled in the art to which, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Applicants are not enabled to prevent (MALT1)-related disease. The only established prophylactics are vaccines not the 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. 1) As discussed above, preventing diseases requires identifying those patients who will acquire the disease before occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) The passage spanning line 31, page 39 to line 32, page 40 lists the diseases Applicant intend to treat. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to medical treatment and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will become afflicted before the fact. 6) The artisan using Applicants invention would be a Board Certified physician who specialized to treat diseases with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of disorder diseases generally. 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. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent disorders generally. That is, the skill is so low that no compound effective generally against disorders has ever been found let alone one that can prevent such conditions. 7) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases and on the multitude of compounds embraced by Formula (I).
The Examiner suggests deletion of the word “prevention”.
4. Claim Rejections - Obvious Double Patenting
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. See 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, 168 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130 (b).
Effective January 1,1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-12 are rejected under the judicially created doctrine obviousness-type double patenting as being unpatentable over the claims 1-4 of US 12,152,027. Although the conflicting claims are not identical, they are not patentably distinct from each other because the current invention embraces the invention claimed in the above patent.
Determination of the scope and content of the prior art (MPEP §2141.01)
‘027 claims analogues chemical compound in claims 1-4 as the instant claims 1-12.
Ascertainment of the difference between the prior art and the claims (MPEP §2141.02)
The difference between the instant claims 1-12 and the claims 1-4 of ‘027 patent is the claims are not word for word identical but the scope of the two sets of claims overlaps significantly with each other.
Finding of prima facia obviousness-rational and motivation (MPEP §2142.2143)
All the elements were known in prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/NILOOFAR RAHMANI/ Primary Examiner, Art Unit 1691
10/05/2026
