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. The preliminary amendment filed October 30, 2024 has been received and entered.
3. Claims 1-8 are currently pending.
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.
4. Claims 1-8 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 treating Alzheimer’s disease, does not reasonably provide enablement for preventing Alzheimer’s 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 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 of preventing 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 Alzheimer’s disease in all instances in all patients. In addition, the art teaches that prevention of Alzheimer’s disease is not currently accepted as possible (see “Can Alzheimer’s Disease Be Prevented?” https://www.alz.org/alzheimers-dementia/research-and-progress/prevention ; page 4). Thus, since applicant’s specification does not show prevention of Alzheimer’s disease 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 Alzheimer’s disease.
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.
5. Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soo (KR 20200094590 A – English translation).
This reference teaches a method of treating symptoms associated with Alzheimer’s disease by administering a composition comprising a mulberry fruit extract fermented with lactic acid bacteria. The reference teaches that the fruit extract is obtained by extraction with hot water, ultrasonic, water, or a C1-C4 alcohol. The reference taches that the lactic acid bacteria can be Lactobacillus brevis DF01 and/or Pediococcus acidilactici K10. The reference teaches that the fermentation is performed by inoculating 0.1 to 5 parts by weight of the bacteria to 100 parts by weight of the mulberry fruit extract and the fermentation is carried out at 25 to 30°C for 2 to 5 days. The reference teaches that donepezil is also useful in treating Alzheimer’s disease (see paragraphs 4-8, 24, 25, 27-29, and 54).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
6. Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hee (KR 20050067131 A – English translation) in view of Soo (KR 20200094590 A – English translation).
Hee teaches a method for treating Alzheimer’s disease by administering an extract from mulberry fruit (see pages 1-3). The reference does not specifically teach that the extract is fermented with lactic acid bacteria.
However, Soo teaches a mulberry fruit extract that is fermented with lactic acid bacteria. The reference teaches that the fruit extract is obtained by extraction with hot-water extraction, ultrasonic extraction, water, or a C1-C4 alcohol. The reference taches that the lactic acid bacteria can be Lactobacillus brevis DF01 and Pediococcus acidilactici K10. The reference teaches that the fermentation is performed by inoculating 0.1 to 5 parts by weight of the bacteria to 100 parts by weight of the mulberry fruit extract and the fermentation is carried out at 25 to 30°C for 2 to 5 days. The reference teaches that donepezil is also useful in treating Alzheimer’s disease (see paragraphs 4-8, 24, 25, 27-29, and 54).
Soo specifically states that the fermented fruit extract is an improvement on the extract taught in Hee (i.e. KR 20050067131 (see paragraph 22)). Thus, an artisan of ordinary skill would reasonably expect that the method of treating Alzheimer’s disease taught by Hee would be improved if the mulberry fruit extract was fermented as taught by Soo. This reasonable expectation of success would have motivated the artisan to modify Hee to include the fermentation of the extract as taught by Soo. Thus, applicant’s claims are considered to be an obvious modification of what was known in the art at the time of the invention.
7. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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