DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-15 are currently pending.
Election/Restrictions
3. Applicant’s election of Alzheimer’s disease for the species in the reply filed on August 10, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
4. Claims 1-15 are examined on the merits in regards to the elected species.
Claim Objections
5. Claims 3 and 4 are objected to because of the following informalities: a word or a phrase appears to be missing between “method” and “of” in line 1 of each of claims 3 and 4. Appropriate correction is required.
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.
6. Claims 1-8 and 15 are 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 a method of treating neuroinflammatory or neurodegenerative diseases, does not reasonably provide enablement for preventing neuroinflammatory or neurodegenerative diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s claims are broadly drawn to a method for prevention of neuroinflammatory or neurodegenerative diseases including Alzheimer’s disease. In order to be enabled for prevention of a condition, applicant must demonstrate that the invention is able to prevent the condition in each and every instance of that condition. Applicant’s specification does not set forth any evidence that the claimed product is able to prevent neuroinflammatory or neurodegenerative diseases for all potential patients. In addition, the art teaches that prevention of neuroinflammatory or neurodegenerative diseases such as Alzheimer’s disease is not accepted as possible (see “Preventing Alzheimer’s Disease: What Do We Know?” - https://www.nia.nih.gov/health/alzheimers-and-dementia/preventing-alzheimers-disease-what-do-we-know - accessed 8/2026). Thus, since applicant’s specification does not show prevention of neuroinflammatory or neurodegenerative diseases and the art acknowledges that prevention is not currently possible, a person of ordinary skill in the art would be forced to experiment unduly in order to determine if applicant’s invention actually function as claimed. Therefore, the claims are not considered enabled for the prevention of neuroinflammatory or neurodegenerative diseases.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 is indefinite because it refers to “the Daphne genkwa flower bud extract of claim 9”. However, claim 9 is directed to a method of treatment rather than the flower bud extract itself. Thus, it is improper and confusing to refer to claim 9 only in terms of the extract.
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.
8. Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (WO 2019/098699 – English translation).
This reference teaches a method for treating neuroinflammatory or neurodegenerative diseases including Alzheimer’s disease by administering a composition comprising a Daphne genkwa flower extract. The reference teaches that the extract is made using water or a C1-C5 alcohol. The reference teaches that the composition can be formulated as a food. The reference teaches that the reference inhibits inflammation in the microglia by inhibiting nitric oxide formation and proinflammatory cytokines such as IL-1b (see pages 1, 2, 5, and Examples 1-a, 4, and 5).
9. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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