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 8-11 are pending in this application.
Response to Amendment
Applicant’s amendment filed 02/13/2026 in response to the previous Office Action (11/14/2025) is acknowledged. Rejection of claims 1-7 under 35 U.S.C. 102(a)(1) (items 3-5), under 35 U.S.C. 101 (item 6) and under 35 U.S.C. 112(b) (items 8a-8d) have been obviated. Applicants have deleted claims 1-7 that were drawn to antitumoral formulation and added new claims 8-11 that are drawn to a new invention (i.e. method of treating cancer). Even though applicant’s amendment overcome the rejections raised in the previous Office Action, said amendment raises new issue that needs further rejection.
Claim Rejections - 35 USC § 102
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.
Claims 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banos et al. EP 3112346 A1. Cited reference at paragraphs 7 and 10 discloses a method of treating cancer using an active ingredient of propyl propane thiosulfonate (PTSO) that is the same as applicants.
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Note than applicant’s arguments in the Remarks were relevant to the previous prior art rejection of claims 1-7 (antitumoral formulation). Applicants’ arguments in the Remarks in regard to a method of treating cancer that was not part of the rejection was carefully reviewed but the examiner disagrees with said arguments. Since the prior art discloses a method of treating cancer using PTSO compound, a 102(a)(1) rejection is proper.
Claims 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gou et al. CN 1895066 A. Cited Chinese reference that is cited in the International Search Report discloses Allium sativum (garlic) oil that can be used in the treatment of cancer and especially for the treatment of breast cancer, skin cancer, intestinal cancer and rectal cancer (p. 8, item 3 original document). It is known that PTSO is the main organosulfur compound present in Allium essential oil. It is therefore considered that the use of PTSO for the treatment of breast cancer, skin cancer, intestinal cancer and rectal cancer is implicitly disclosed by said reference.
Note than applicant’s arguments in the Remarks were relevant to the previous prior art rejection of claims 1-7 (antitumoral formulation). Applicants’ arguments in the Remarks in regard to a method of treating cancer that was not part of the rejection was carefully reviewed but the examiner disagrees with said arguments. Since the prior art teaches a method of treating cancer, the prior art rejection under 102(a)(1) is proper.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 8 and 10-11 are 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 the treatment 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: Claims 8 and 10-11 are directed to a method of treating cancer in general that comprises administering to a human in need thereof an effective amount of a compound of claim 8.
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.
(2). Direction of Guidance: The amount of direction or guidance is minimal. There is no guidance for the treatment cancer in general. As the rejection states, there is no enablement for the treatment of cancer in general.
(3). State of Prior Art: There is no evidence of record that compounds structurally similar to the PTSO compound are in use for the treatment of cancer in general, or anything remotely close to cancer in general.
(4). Working Examples: Test procedures and data are provided in the specification at pages 7-10, however, there is nothing in the disclosure regarding how this data correlates to the treatment of cancer in general embraced the instant claims.
(5). Nature of the Invention and Predictability: The invention is directed to the treatment 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 cancer in general.
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
8. 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
March 2, 2026