DETAILED ACTION
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 . 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.
Election/Restrictions
Applicants elected treating and/or prevention of cognitive deterioration or enhancement of cognitive ability using the formulation of claim 1 without traverse in the reply filed on 27 April, 2025.
Applicants have stated that they believe their election reads on claims with specific keratins. Applicants were required to elect a single, discrete, and disclosed treatment course. They did not elect specific keratin species. Therefore, claims drawn to specific keratin species are properly withdrawn.
Applicants state that they have amended claim 8 to read on the elected disorder. They have not. They elected preventing cognitive deterioration, not treatment of it.
Claims Status
Claims 1-4 and 6-18 are pending.
Claims 1, 8, and 18 have been amended
Claims 2-4 and 6-17 have been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Objections
The objection to the title due to it describing an invention different than the claimed invention is hereby withdrawn due to amendment.
Withdrawn Rejections
The rejection of claims 1 and 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to the basis of the ratio is hereby withdrawn due to amendment.
The rejection of claims 1 and 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what keratins are included in the ratio is hereby withdrawn due to amendment.
The rejection of claim 18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what was covered by “and the like” is hereby withdrawn due to amendment.
The rejection of claim(s) 1 and 18 under 35 U.S.C. 102(a)(1) as being anticipated by Shing et al (Br. J. Sports Med. (2006) 40 p797-801) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 18 are rejected under 35 U.S.C. 101 because they read on a judicial exception, a natural phenomenon.
The Supreme Court has given a three part test for determination of eligibility under this statute:
1) Is the invention a process, machine, manufacture, or composition of matter?
2a) If the invention passes the first test, does a judicial exception apply?
2b) If a judicial exception applies, is there anything beyond the judicial exception?
Applying the test:
1) The invention is drawn to a composition, a composition of matter, passing the first test.
2a) Applicants have demonstrated that human and bovine colostrum both contain keratin and β-lactoglobulin (fig 5-7), demonstrating that natural products read on the claims. While it is not clear what the amount of each protein is, that is not sufficient to make the claims patent eligible.
2b) The claim limitations can be met by a combination of naturally produced compounds. There is no evidence of record that the combination produces anything beyond what would be seen in the natural product. Thus, the claims lack eligibility.
response to applicant’s arguments
Applicants argue that the material must be purified, isolated, or concentrated, and are combined in a non-natural ratio, that it provides cognitive benefits, and is configured for oral or other therapeutic routes.
Applicant's arguments filed 12 Nov, 2025 have been fully considered but they are not persuasive.
Applicants argue that the material must be purified, isolated, or concentrated, are combined in a non-natural ratio, and are configured for oral or other therapeutic routes. It is not clear how this overcomes the rejection. In essence, applicants are stating that the claimed formulation passes the hand of man test, but that test has been superseded by the three part test used in the rejection due to a number of Supreme Court rulings.
Applicants argue that the formulation provides cognitive benefits, esp. synergy at the claimed ratios. Applicants have not demonstrated that the combination provides any more benefits than the materials would be expected to based on their individual effects.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1 and 18 are 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 1, and claims dependent on it, has an intended use of “boosting cognitive ability or preventing cognitive deterioration.” It is not clear what this means. Boosting cognitive ability could mean clearing brain fog from insufficient sleep or some disorders, it could mean improving intelligence, it could mean improving focus (such as stimulants for ADHD) or memory, or some other meaning. Cognitive deterioration, while used as a catch all term for the effects of various types of dementia in the art, suffers from the same issues.
response to applicant’s arguments
Applicants argue that these terms are well known in the art, and point to examples of how they are used in their disclosure.
Applicant's arguments filed 12 Nov, 2025 have been fully considered but they are not persuasive.
Applicants argue that the terms are well known in the art. However, they have not introduced onto the record any reference that provides an art recognized definition of the terms. If they are common and well understood/defined in the art, it should be relatively easy to find such a reference. While the terms are used in the art, they appear to mean whatever the person using them wants them to mean. Note that cognitive impairment from head trauma is radically different from cognitive impairment due to aging (without dementia), and both have very little in common with cognitive impairment due to blind spots caused by mental illness.
Applicants point to descriptions of potential embodiments in their disclosure, but these are not definitions. At best, they provide a minimum level of embodiments that are covered, but are silent if the terms cover other embodiments.
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.
Claim(s) 1 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cassano et al (Front. Neurol. (2016) 10(368)) in view of Lamiot et al (WO 2007038870, cited by applicants) and Kelly et al (WO 2006099309, cited by applicants).
Cassano et al state that inflammation plays a role in brain fog (1st page, 5th paragraph, continues to 2nd page, 1st column, 1st paragraph). An antioxidant that reduces levels of inflammatory cytokines is suggested to help patients with the disorder (2nd page, 1st column, 1st paragraph).
The difference between this reference and the examined claims is that this reference does not discuss keratin or lactoglobulin.
Lamiot et al discuss a formulation comprising β-lactoglobulin for treating inflammation (abstract). This is used for prophylaxis or treatment of an inflammatory disease or related disorder in a subject (p9, 2nd paragraph). The composition can be formulated for oral administration as an emulsion, suspension, dispersion, solution, or liquid (p14, 4th paragraph). This reference discusses β-lactoglobulin containing formulations to reduce inflammation.
Kelly et al discuss keratin formulations to reduce inflammation (abstract). These are administered orally (p10, 3d paragraph) and added to a drink (p11, 5th paragraph). Examples of powders intended to be mixed into drinks (example 3, p14, 3d and 4th paragraphs) and a beverage formulation (example 5, p15, 1st paragraph) are mentioned.
Therefore, it would be obvious to use the formulation of Lamiot et al, to reduce the inflammation causing the brain fog of Cassano et al and improve the cognitive ability of the patient. As Cassano et al clearly state that inflammation is the cause, and suggest therapeutics aimed at inflammation, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Furthermore, it would be obvious to add the keratin material of Kelly et al, to reduce the inflammation causing the brain fog of Cassano et al. Note that it is prima facie obvious to combine two compositions taught as useful for the same purpose (MPEP 2144.06(I)).
Cassano et al teach that brain fog can be caused by inflammation, and suggest reducing inflammation. Lamiot et al teach a formulation comprising β-lactoglobulin to reduce inflammation, while Kelly et al teach a formulation comprising keratin for the same purpose. Alternatively, the material is administered to a patient, it will inherently prevent cognitive impairment. While the references do not specify the ratio, this is the same as determining the proper amount of each drug, which is considered optimization rather than inventive (MPEP 2144.05(II)(A)). Thus, the combination of references render obvious claim 1.
Both Lamiot et al and Kelly et al discuss oral administration, with Kelly et al discussing drinks, rendering obvious claim 18.
response to applicant’s arguments
Applicants argue that the rejection does not cover the ratio, the purification level, the cognitive function, goes through each reference individually to show why they do not anticipate the claims, that there is no expectation that the combination will yield cognitive benefits rather than adverse interactions, that the claimed formulation is synergistic, and that the ratio is not routine optimization.
Applicant's arguments filed 12 Nov, 2025 have been fully considered but they are not persuasive.
Applicants argue that the rejection does not describe the ratio. This is incorrect; it is a result of optimization. The courts have ruled that concentration is not a patentable distinction absent secondary considerations, because it is a parameter that is routinely optimized (MPEP 2144.05(II)(A)).
Applicants argue that the purification level of the two ingredients is not described. That is not a claim limitation except as product by process.
Applicants argue that the rejection does not mention cognitive function. That is incorrect; it is linked via reduction in inflammation.
Applicants have demonstrated that none of the cited references anticipate the claims. It is not clear how this overcomes the rejection; it is not a rejection under 35 USC 102; there is no requirement that every limitation be found in a single reference.
Applicants argue that there is no expectation that the combination yield cognitive benefits. That is incorrect. The rejection establishes that both ingredients will reduce inflammation, which is tied to cognitive benefits. Applicants suggest that a person of skill in the art would assume that they would interact poorly, but there is no evidence beyond applicant’s word.
Applicants argue that the claimed formulation is synergistic, so it is beyond mere optimization. This has not been demonstrated. Applicants point to example 9, but that shows some sort of cognitive benefit of a single formulation. There is a note that changing the ratio of the various keratins (but not the ratio of total keratin to lactoglobulin) will give different results, but that is not evidence of synergy.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 15 of copending Application No. 17/767,056 (US 20220378870) (reference application).
Competing claim 1 describes compositions comprising keratin and β-lactoglobulin. Competing claim 3 specifies the amounts of the two ingredients, with the ranges described by the two claim sets being very similar. Competing claim 15 describes food formulations identically with examined claim 18. While the competing claims do not give the same ratio as the examined claims, the concentrations specified by the competing claims generate a range of ratios that overlap with the examined claims, rendering them obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
response to applicant’s arguments
Applicants request reconsideration based on amendments to the claims.
Applicant's arguments filed 12 Nov, 2025 have been fully considered but they are not persuasive.
Applicants have not pointed to how the amendments to the claims overcome the rejection, nor is it immediately obvious.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone 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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658