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 . Claims 1, 4-6, 8-10, 15, 17-18, 22-24, 26, 31, 33, 36-38, 41, 43, 46-47, 53 and 55 are pending in this application.
Response to Amendment
Applicant’s amendment filed 06/18/2026 in response to the previous Office Action (01/21/2026) is acknowledged. Rejection of claims 37 and 45 under 35 U.S.C. 101 (item 7) and 35 U.S.C. 112(b) (items 6a-6b) has been obviated. Even though applicants, applicant’s amendment that includes rejoinder of the method claims would raise new issues that needs further rejection.
Election/Restrictions
Applicant’s election without traverse of Group I and a species (Y = S, S(O), or S(O)2) in the reply filed on 12/18/2025 is acknowledged. Since the conditions for rejoinder are met, the invention of Group II is rejoined.
The claims are drawn to multiple inventions for reasons set forth in the restriction requirement. The claims are examined only to the extent that they read on the elected invention. Cancellation of the non-elected subject matter is recommended in response to this Office Action. The examiner recommends that applicants delete the non-elected species Y = S(O)N(Ry) from claim 1 also delete non-elected species (if present) from claim 41.
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.
Claim 53 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. It is recited a method of treatment, prevention and /or delay of progression of cancer in general, but the specification is not enabled for such a scope.
A number of factors are relevant to whether undue experimentation would be required to practice the claimed invention, including “(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
(1). Breadth of Claims: Claim 53 is directed to a method of treatment, prevention and /or delay of progression of cancer that comprises administering to a subject a therapeutically effective amount of a compound according to claim 1.
a. Scope of use - The scope of use that applicants intend to claim is very broad. For a compound or genus to be effective against cancer cells generally is contrary to medical science. Cancer is a disease, which can take place in virtually any part of the body. There is a vast range of forms that it can take, causes for the problem, and biochemical pathways that mediate cancer. There is no common mechanism by which all, or even most, cancers arise. Accordingly, treatments for a cancer or inhibition of cancer cells are normally tailored to the particular type of cancer cells present, as there is no, and there can be no “magic bullet” against cancer cells generally.
Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, such as viruses (e.g. EBV, HHV-8, and HTLV-1), exposure to chemicals such as tobacco tars, genetic disorders, ionizing radiation, and a wide variety of failures of the body's cell growth regulatory mechanisms. Different types of cancers affect different organs and have different methods of growth and harm to the body, and different vulnerabilities.
b. Scope of Compounds - The scope of the compounds is also broad. It is apparent that hundreds of thousands of combinations of compounds can be created from the definitions, owing especially to broad scope of X, R1-R6, and R6a.
(2). Direction of Guidance: The amount of direction or guidance is minimal. There is no guidance for the treatment or inhibiting cancer cells in general. As the rejection states, there is no enablement for the treatment, prevention and/or delay of progression of cancer in general.
(3). State of Prior Art: There is no evidence of record that compounds structurally similar to the these bicyclic tetrahydroazepine compounds or indeed are in use for the treatment, prevention and/or delay of progression of cancer in general.
(4). Working Examples: Test procedures and data are provided in the specification at pages 745-837, however, there is nothing in the disclosure regarding how this data correlates to the treatment, prevention and/or delay of progression of cancer in general.
(5). Nature of the Invention and Predictability: The invention is directed to the for the treatment, prevention and/or delay of progression of cancer in general. 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). Cancers are especially unpredictable due to their complex nature.
(6). The Quantity of Experimentation Necessary: Immense, because so many cancerous cells are covered; see part (1).
(7). The Relative Skill of Those in the Art: The relative skill is extremely very low. To this day, there is no magic bullet that can treat, prevent or delay of progression of cancer in general.
In order to overcome this rejection, applicants have to delete “prevention” from claim 53 and also recite specific cancers as it was suggested in the Restriction Requirement.
Claim Objections
Claim 38 is objected to because of the following informalities: In claim 38, the chemical structures recited for variable R4 are not clear. The compounds appear to be drawn as triplets and also overlap with each other as shown below.
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The first three phenyl appears to be the same, the second three appears to be a 2-pyridyl moieties. It is recommended that applicants redraw the compounds. Note that this issue was raised in previous Office Action.
Allowable Subject Matter
Claims 1, 4-6, 8-10, 15, 17-18, 22-24, 26, 31, 33, 36, 37, 41, 43 and 46-47 are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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/Kahsay Habte/
Primary Examiner, Art Unit 1624
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