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 .
Status of Claims
Claims 1-4 and 6-20 are pending in the instant application.
Claim 5 has been canceled.
Information Disclosure Statement
The Information Disclosure Statement filed June 9th, 2026 has been fully considered by the examiner, except where marked with a strikethrough.
Terminal Disclaimer
The terminal disclaimer filed on June 9th, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of U.S. Patent Nos. 8,039,462 and 8,999,972 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the objection to Claim 1. This objection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 1-19 under 35 U.S.C. 112(a) for being enabling for a composition comprising a compound of formula (I) in which R1 is H, F, Cl, Br, or R7 is a substituted methyl, R3 is (CH2)m, wherein m is 2 or 3, R4is N and R8 is X, R9 is H or alkyl, or -OR9 wherein R9 is alkyl, but not enabling for compositions comprising a compound of formula (I) for which these variables are otherwise defined. Applicant’s cancellation of Claim 5 renders the rejection thereof moot. This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejections of Claims 1-3 under 35 U.S.C. 112(b). These rejections are hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claims 1-4 and 15-19 under 35 U.S.C. 102(a)(1). This rejection is hereby withdrawn.
Applicant’s cancellation of Claim 5 renders the rejection of Claims 5, 6, 8, and 11 under 35 U.S.C. 103 moot. This rejection is hereby withdrawn.
Applicant’s filing of a terminal disclaimer, as noted above, is sufficient to overcome the rejections over Claims 1-2, 4, and 15 on the ground of nonstatutory double patenting. These rejections are hereby withdrawn.
Specification
In Applicant’s reply filed June 9th, 2026, the objection to the abstract as raised in the non-final rejection mailed March 9th, 2026 was not addressed. As such, this objection is maintained. For clarity of the record, the grounds of the objection are revisited below:
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract of the disclosure is objected to because it is fewer than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
The rejection of Claims 16-19 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 is maintained. 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.
Applicant has attempted to overcome this rejection by amending Claim 16 to read “A method for treating aging in a subject…” and points to Example 1 beginning at Page 34 of the instant specification, alleging this demonstrates treatment of an aged human.
The examiner does not find this argument persuasive.
As noted in the non-final rejection March 9th, 2026, Example 1 discloses absorption of compounds by an aged human, but no evidence of treatment resulting from the absorption is disclosed. For clarity of the record, the Wands factors considered in the non-final rejection are revisited below:
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a method of treating aging.
Breadth of the invention:
The scope of the claimed invention is broad. Treatment of aging would be interpreted by a person having ordinary skill in the art to include treating a variety of symptoms associated with aging.
State of the prior art and predictability in the art:
With respect to the active pharmaceutical ingredients instantly disclosed, Kelleher-Andersson (US 8,999.872 B2; cited in non-final rejection mailed March 9th, 2026; cited on Applicant’s Information Disclosure Statement filed October 16th, 2024; hereinafter referred to as Kelleher-Andersson) represents the state of the prior art.
Kelleher-Andersson discloses examples of compounds that read on the instantly claimed Formula (I) as recited at instant Claim 1. For example, at Claim 1 of Kelleher-Andersson,
PNG
media_image1.png
175
218
media_image1.png
Greyscale
is disclosed, which reads on the instantly recited Formula (I). Kelleher-Andersson teaches these compounds as administered in a method for stimulating neurogenesis and inhibiting neuronal degeneration in a mammal. No evidence is provided, therein, however, enabling the administration of compounds of formula (I) for the broadly claimed method of treating aging.
The invention is directed toward medicine and is therefore physiological in nature. 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).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Beginning at Page 34, Applicant sufficiently discloses examples to demonstrate the efficacy of absorption by an aged human, disclosing plasma concentrations from a variety of cohorts dosed with differing concentrations and frequency of doses of the API. No examples, however, have been disclosed to demonstrate the treatment of any of the broadly claimed diseases or disorders.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As alluded to above, a person having ordinary skill in the art would need to identify and/or develop metrics by which to evaluate the efficacy of the instantly claimed APIs in treating aging, with no assurance of success.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
The specification fails to provide enough support for the broadly claimed method of treating developmental delay, psychiatric disorders, neurodegenerative disease, neurological disorders, and aging.
Genentech Inc. v Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein a person having ordinary skill in the art would have to engage in undue experimentation to determine the efficacy of administration of a composition comprising instantly claimed APIs, with no assurance of success.
The following rejections are necessitated by amendment:
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 8,999,972 (cited in non-final rejection mailed March 9th, 2026; hereinafter referred to as U.S. Pat. No. ‘972).
At Claim 1, U.S. Pat. No. ‘972 teaches a method comprising administration of a pharmaceutical composition comprising a compound including
PNG
media_image2.png
108
205
media_image2.png
Greyscale
, which is the compound instantly recited at Claim 20.
At Column 18, Last Paragraph, U.S. Pat. No. ‘972 teaches the pharmaceutical compositions of the invention can include lipids.
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.
Claims 1-4 and 6-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kelleher-Andersson (US 8,039,462 B2; hereinafter referred to as Kelleher-Andersson).
As noted in the non-final rejection, regarding Claim 1, at Column 29, Kelleher-Andersson teaches the following compound of Formula XII:
PNG
media_image3.png
253
315
media_image3.png
Greyscale
This compound reads on a compound of Formula (I) as recited at instant Claim 1 when the variables are defined as follows:
Two R1 variables are defined as H, and the third is defined as F.
R2 is S.
R3 is (CH2)m--, wherein m is 2.
R4 is N.
R6 is H.
Four R8- variables are R9, wherein R9 is H, and the fifth R8 is -OR9, wherein R9 is alkyl.
Additionally, this compound is the first compound recited at Claim 2.
With respect to the limitations regarding a pharmaceutical composition comprising a compound of formula (I) in a lipid formulation, at Column 29, Lines 54-56 teach administration of a pharmaceutical composition comprising a compound of Formula XII, above. At Column 17, Line 63 through Column 18, Line 4, Kelleher-Andersson teaches the pharmaceutical compositions are suitable for inclusion of excipients including lipids in an amount ranging from 1-99.99% by weight or volume.
Further, at Column 30, Kelleher-Andersson teaches a compound of Formula XIII:
PNG
media_image4.png
249
375
media_image4.png
Greyscale
This compound reads on a compound of formula (I) as recited at instant Claim 1 when the variables are defined as follows: One R1 is H, and the other two R1 variables are F.
R2 is O.
R3 is (CH2)m, wherein m is 2.
R4 is N.
R6 is H.
Four R8- variables are R9, wherein R9 is H, and the fifth R8 is -OR9, wherein R9 is alkyl.
This compound is the first compound recited at the third row of compounds in Claim 2 at Page 5 of the amended claims received June 9th, 2026.
With respect to the limitations regarding a pharmaceutical composition comprising a compound of formula (I) in a lipid formulation, at Column 29, Lines 65-67, Kelleher-Andersson teaches administration of a pharmaceutical composition comprising a compound of Formula XIII, above. At Column 17, Line 63 through Column 18, Line 4, Kelleher-Andersson teaches the pharmaceutical compositions are suitable for inclusion of excipients including lipids in an amount ranging from 1-99.99% by weight or volume.
Further, at Column 30, Kelleher-Andersson teaches a compound of Formula XIV:
PNG
media_image5.png
258
361
media_image5.png
Greyscale
This compound reads on a compound of formula (I) as recited at instant Claim 1 when the variables are defined as follows:
Two of the R1 variables are H, and the third is F.
R2 is O.
R3 is (CH2)m, wherein m is 3.
R4 is N.
R6 is H.
Four of the R8 variables are R9, wherein R9 is H, and the fifth is -OR9, wherein R9 is alkyl.
This compound is recited at Claim 2, at the third row, second entry of Page 5.
With respect to the limitations regarding a pharmaceutical composition comprising a compound of formula (I) in a lipid formulation, at Column 30, Lines 25-28 teach administration of a pharmaceutical composition comprising a compound of Formula XIV, above. At Column 17, Line 63 through Column 18, Line 4, Kelleher-Andersson teaches the pharmaceutical compositions are suitable for inclusion of excipients including lipids in an amount ranging from 1-99.99% by weight or volume.
At Column 36, Kelleher-Andersson teaches the following compound:
PNG
media_image6.png
248
399
media_image6.png
Greyscale
This compound reads on a compound of formula (I) as recited at instant Claim 1 when the variables are recited as follows:
Two of the R1 variables are H, and the third R1 is F.
R2 is S.
R3 is (CH2)m, wherein m is 3.
R4 is N.
R6 is H.
Four of the R8 variables are R9, wherein R9 is H, and the fifth R8 variable is -OR9, wherein R9 is alkyl.
Additionally, this compound is recited at instant Claim 4.
Regarding Claim 3, at Table 1, Kelleher-Andersson teaches the following compound:
PNG
media_image7.png
308
358
media_image7.png
Greyscale
This compound additionally reads on a compound of Formula (I) as recited at Claim 1 when the variables are defined as follows:
Two R1 variables are H, and the third R1 is -O-R7, wherein R7 is a 1 carbon unsubstituted alkyl.
R2 is S.
R3 is (CH2)m, wherein m is 3.
R4 is N.
R6 is H.
Four of the R8- variables are H, and two of the R8 variables are R9, wherein R9 is alkyl.
Kelleher-Andersson teaches at Column 12, Lines 37-39 that compounds of Table 1 comprise embodiments of the invention including compositions comprising these compounds. At Column 17, Line 63 through Column 18, Line 4, Kelleher-Andersson teaches the pharmaceutical compositions are suitable for inclusion of excipients including lipids in an amount ranging from 1-99.99% by weight or volume.
Regarding Claim 15, Kelleher-Andersson teaches at Column 20, Line 36, oral administration via capsule. Regarding Claim 16, Kelleher-Andersson teaches at Column 37, Lines 24-29 that the aforementioned compositions can be administered to treat a condition including aging. Regarding Claim 17, Kelleher-Andersson teaches at several places administration of these compositions to a mammal, for example, at Column 29, Lines 49-55. Regarding Claim 18, at Column 17, Lines 39-42, Kelleher-Andersson teaches the beneficial effects can be observed after administration to animals including pets and farm animals. Regarding Claim 18, at Lines 39-42, Kelleher-Andersson additionally teaches administration of these compositions to humans.
Kelleher-Andersson does not teach a single embodiment of a composition with the recited ranges of vehicle, surfactant, and thickening agent.
To this end, the Applicant traversed the now-moot rejection under 35 U.S.C. 103 in the remarks filed June 9th, 2026. Applicant notes that Kelleher-Andersson only generally discloses the use of liposome, but does not teach the exact formulation as claimed. Applicant also notes that Kelleher-Andersson “does not place any emphasis on lipid formulations being preferred over any other formulation” and “the claimed invention results in higher Cmax, AUClast, MRTinf values compared to formulations which are not claimed in the present application.”
The examiner does not find this argument persuasive.
Kelleher-Andersson teaches at Column 21, Lines 60-63, the compositions contain the API in an amount ranging from 0.005% to 30% by weight. Kelleher-Andersson teaches the use of vegetable oil as a vehicle at Column 21, Lines 57. At Column 19, Lines 30-44, Kelleher-Andersson teaches the inclusion of surfactants. At Column 21, Lines 34-40, Kelleher-Andersson teaches the inclusion of thickening agents. Though Kelleher-Andersson is silent with respect to the specific amounts of vehicle, surfactant, and thickening agent to use, per MPEP 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.” Therefore, despite Applicant’s assertion that Kelleher-Andersson does not place any emphasis on lipid formulations being preferred, the teachings thereof would have reasonably instructed a person having ordinary skill in the art to arrive at the instantly claimed composition via routine optimization.
Regarding Claim 6, at Column 21, Lines 55-62, Kelleher-Andersson teaches vegetable oils as a suitable liquid carrier in the pharmaceutical compositions.
Regarding Claim 8, at Column 19, Line 35, Kelleher-Andersson teaches the inclusion of polyethylene glycol. At Column 20, Line 1, Kelleher-Andersson teaches the inclusion of lecithin. At Column 19, Line 57, Kelleher-Andersson teaches inclusion of cholesterol.
Regarding Claim 11, at Column 20, Line 46, Kelleher-Andersson teaches the inclusion of waxes.
Regarding Applicant’s assertion regarding improved results with respect to the higher Cmax, AUClast, and MRTinf values, this is not sufficient for patentability over Kelleher-Andersson.
Kelleher-Andersson, as noted above, teaches compositions with components overlapping the ranges instantly recited. Though the prior art is silent with respect to higher Cmax, AUClast, and MRTinf values, these higher values will naturally flow from the method made obvious by the prior art, since the same compounds are being administered to the same subjects. In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding the instantly observed higher Cmax, AUClast, and MRTinf values, by practicing the method made obvious by the prior art, one will observe these higher Cmax, AUClast, and MRTinf values, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage of higher Cmax, AUClast, and MRTinf values.
MPEP 2145, II. states, “The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious.”
As such, the practice of Claims 1-4, 6-19 would have been undertaken with a reasonable expectation of success.
Conclusion
Claims 1-4 and 6-20 are rejected.
No claim is allowed.
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 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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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, Jeffrey Murray can be reached at (571) 272-9023. 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.
/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights