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 1-18 are currently pending.
Election/Restrictions
3. Applicant's election with traverse of Ganoderma lucidum in the reply filed on June 19, 2026 is acknowledged. The traversal is on the ground(s) that a search and examination of all of the species would not be burdensome. This is not found persuasive because each species requires separate consideration and search of the prior art. Thus, a search of all of the species would be burdensome.
The requirement is still deemed proper and is therefore made FINAL.
4. Claims 1-18 are examined on the merits in regards to the elected species.
Specification
5. The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Paragraph 69 of the specification includes an incorporation by reference to “Patent Nos. 1481718 and 1686480” but does not list the full citation of these patents, specifically the country code is not stated. Full citation of these references is needed and if any essential subject matter from these patents has not been included into the specification, it must be added as discussed above.
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 1-18 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 Alzheimer’s disease, dementia, or brain function degeneration, does not reasonably provide enablement for preventing Alzheimer’s disease, dementia, or brain function degeneration. 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 Alzheimer’s disease, dementia, or brain function degeneration. 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, dementia, or brain function degeneration 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 9-2026). Thus, since applicant’s specification does not show prevention of Alzheimer’s disease, dementia, or brain function degeneration 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, dementia, or brain function degeneration.
Claim Rejections - 35 USC § 103
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 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.
7. Claim(s) 1-7, 9, 10, 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yao (CN 10683204 A – English translation) in view of He (CN 101407833 A – English translation).
Yao teaches a method for treating Alzheimer’s disease, cognitive decline, and dementia by administering a purified beta-glucan extract from Ganoderma lucidum. The reference teaches that the method reduces oxidative stress, improves memory, promotes the growth of neural cells, improves learning, and improves spatial learning. The reference teaches that the extract is administered orally (see paragraphs 2, 4, 5, 6, 12-18, 24, 46 and 47). While the reference teaches that the beta-glucan is purified, the reference does not teach that purity is 60% or above.
However, He teaches beta-glucan extracted from G. lucidum that has a purity of 82%. The reference teaches that the purified beta-glucans have improved safety and activity (see abstract and paragraphs 7, 73). Thus, an artisan of ordinary skill would reasonably expect that the method of Yao would be improved if a beta-glucan with a high purity such as that taught by He was used in the method. This reasonable expectation of success would have motivated the artisan to modify Yao to use a beta-glucan composition with a purity above 60%.
The references do not specifically teach that the administration of the beta-glucan has all of the same effects claimed by applicant the claims. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The references do not specifically teach administering the beta-glucan in the amounts claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Varying the concentration of an active ingredient within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed dosage of the ingredient produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient dosage would have been obvious before the effective filing date of applicant’s claimed invention.
8. Claim(s) 8, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yao (CN 10683204 A – English translation) in view of He (CN 101407833 A – English translation) as applied to claims 1-7, 9, 10, 13-18 above, and further in view of Chen (US 11,130,976).
The teachings of Yao and He are discussed above. Yao teaches that the polysaccharide is extracted from the G. lucidum by mixing the G. lucidum with water, centrifuging, drying, and purifying the beta-glucan to obtain a beta-glucan with a molecular weight between 5-100 KDa (see paragraphs 12-18). The reference does not specifically teach using ultrasonic disruption on a mycelium culture medium to obtain a crude extract or filtering three times with filter membranes of 0.8 to 3 micrometers, 0.22 to 0.5 micrometers, and 0.22 micrometers. The references also do not specifically teach formulating the beta-glucan as claimed by applicant in claims 11 and 12.
However, Chen teaches a method for extracting purified beta-glucan from mushrooms such as G. lucidum. The reference teaches extracting a mycelium culture medium. The medium is subjected to ultrasonic disruption to obtain a crude extract. The disruption is described as being useful to fully release all the functional molecules from the mycelium. Next, the insoluble material is removed by centrifugation and the solution is filtered using a 0.2 micrometer filter to sterilize the solution. This filtration step is not repeated three times; however, an artisan would reasonably expect that repetition of a filtration would be a routine optimization and would result in increased purity and sterilization of the product. Chen teaches that the solution can be mixed with excipients and freeze dried (see column 6, lines 21-54 and column 7, lines 33-35). Thus, an artisan of ordinary skill would reasonably expect that the extraction procedure taught by Yao could be improved if the addition of the ultrasonic disruption and filtrations steps as taught by Chen were incorporated into the process. In addition, an artisan of ordinary skill would reasonably expect that ultrafiltration membranes having a molecular weight cutoffs of over 100 KDa and below 5 KDa could be used to isolate the 5-100 KDa beta-glucan taught by Yao. Thus, the process steps claimed by applicant in claims 8, 11, and 12 are considered to be an obvious modification of what was known in the art prior to the effective filing date.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
Prosecution Insights