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 .
DETAILED ACTION
The preliminary amendment dated 20 March 2023, in which claims 5-20 have been amended, is acknowledged.
Claims 1-20 are pending in the instant application.
Claims 4-14 are withdrawn, as being drawn to a non-elected invention.
Claims 1-3, 15-20 are examined on their merits herein.
Priority
The instant application is a Continuation of U.S. Patent Application 16/332,763, filed on 12 March 2019, now abandoned, which is a National Stage entry of International Application No. PCT/US2017/054282, filed on 29 September 2017, which claims priority from U.S. Provisional Patent Application No. 62/402,543, filed on 30 September 2016.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 13 January 2023, 23 August 2023, 22 January 2024, 31 January 2024, 21 March 2024, 10 April 2024, 26 August 2024, 19 November 2024, 26 March 2025, 9 September 2025, 29 January 2026, 27 March 2026 and 2 June 2026, are acknowledged and considered.
Election/Restrictions
Applicant’s election with traverse of Group (II), drawn to a method for treating, inhibiting, or reducing hair loss; improving or stimulating hair growth; treating, inhibiting, or reducing pigmentation loss; and/or improving or stimulating pigmentation production in a subject which comprises administering to the subject a therapeutically effective amount of one or more alpha-ketobutyrate compounds and/or one or more glutarate compounds, claims 1-2, or
to a method of stimulating new hair growth in a subject in need thereof, comprising administering to the subject a composition comprising a therapeutically effective amount of a compound of Formula I, claims 3, 15-20, in the reply filed on 4 February 2026, is acknowledged. Claims 4-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Applicant traverses the requirement for restriction (Response of 4 February 2026, page 2, last paragraph, page 3, first paragraph) on the basis that it would not be an undue burden to examine all claims since the subject matter of Groups I, II is linked by a common inventive concept.
This is not found persuasive. The examiner maintains that inventions I, II are related respectively as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the process as claimed can be used with a different product, for example, any known composition used to stimulate hair growth. Further, the inventions of Groups I, II require a different field of search.
The requirement of restriction is herein maintained and is made FINAL.
Applicant’s election without traverse of compounds of formula (I) as the compound(s) administered in the method, in the reply of 4 February 2026, and the election of
alpha-ketobutyrate as the species of a compound of formula (I) (see interview of 5 June 2026) to be administered in the method, is acknowledged.
The elected species alpha-ketobutyrate (a-KB) is a compound of instant claims 1, 2, and
PNG
media_image1.png
152
232
media_image1.png
Greyscale
is a compound of formula (I) of claim 3
PNG
media_image2.png
130
208
media_image2.png
Greyscale
to which the following definitions apply: R1 is -OR7; R2 and R3, together with the atom to which they are bound, form an oxo; R4 = R5 = R6 = H; R7 = H.
Claims 1-3, 15-20 read on the elected species.
In the interest of compact prosecution, the examiner has extended the search to include (in addition to Applicant’s elected species) alpha-ketoglutarate (a-KG), which is a glutarate compound of instant claim 1, is a compound of instant claim 2, and
PNG
media_image3.png
162
331
media_image3.png
Greyscale
is a compound of formula (I) of instant claim 3
PNG
media_image2.png
130
208
media_image2.png
Greyscale
to which the following definitions apply: R1 is -OR7; R2 and R3, together with the atom to which they are bound, form an oxo; R4 = R5 = H; R6 is -COOR7; R7 = H.
Claims 1-3, 15-20 have been examined to the extent they read on the elected species alpha-ketobutyrate (a-KB) or alpha-ketoglutarate (a-KG), and the following objections and rejections are made below.
Claim objection
Claims 4-14, while currently withdrawn, are objected to because of the following informality: The withdrawn claims are objected to for being presented in a non-compliant form. Specifically, the claims are withdrawn because of the election made by the Applicant on 4 February 2026. As such, claims 4-14 should be identified as "(Withdrawn)" until such time as examiner rejoins the claims for examination. Appropriate correction is required. See MPEP 714(C).
Claims 1 is objected to because the recitation “in a subject” should read --in a subject in need thereof--.
Claim 2 is objected to because it recites “the one or more glutarate compounds” twice. For clarity, claim 2 is to recite that the one or more glutarate compounds is selected from alpha-ketoglutarate (a-KG) and 2-hydroxypentanedioate (2-HG).
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 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.
(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.
Claims 1-3, 15-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hu et al. (US 8,470,880, published 25 June 2013, cited in IDS).
Hu teaches (Title, Abstract) a method of reducing hair loss, as in instant claims 1, 2, and facilitating hair growth and/or regrowth, as in instant claim 3, comprising administering to a subject in need thereof a composition comprising alpha-ketoglutaric acid (one of the 4 alpha-keto acids listed in claim 3, Hu).
MPEP 2131.02. III. A generic disclosure will anticipate a claimed species covered by that disclosure when the species can be “at once envisaged” from the disclosure.
Alpha-ketoglutaric acid (a-KG) is a glutarate compound of instant claim 1, is a compound of instant claim 2, and
PNG
media_image3.png
162
331
media_image3.png
Greyscale
is a compound of formula (I) of instant claim 3
PNG
media_image2.png
130
208
media_image2.png
Greyscale
to which the following definitions apply: R1 is -OR7; R2 and R3, together with the atom to which they are bound, form an oxo; R4 = R5 = H; R6 is -COOR7; R7 = H.
The composition comprising alpha-ketoglutaric acid also comprises an excipient, and is administered to the scalp of a mammal in need of such treatment (column 3, lines 32-33, column 4, lines 30-32), thus to an area on the subject absent of hair to stimulate new hair growth, as in instant claim 3.
Hu teaches that the subject treated suffers from alopecia (column 1, lines 15-22), as in instant claim 16, which can result from surgery, or trauma/injury (column 1, lines 15-19), as in instant claim 15.
Hu teaches that administration of the composition of the invention increases the rate at which terminal hair appears on the skin of the mammal (column 1, lines 35-37), thus increases the growth rate of hair, as in instant claim 20.
Hu teaches (column 1, lines 27-28) that administration of the composition of the invention provides thicker or richer hair coat, which is consistent with the weight of hair being greater relative to that prior to administration of the composition, as in instant claim 18.
While Hu does not explicitly teach the limitations of instant claims 17-20, the claimed limitations appear to be a result or property of the administration of the effective amount of the composition comprising alpha-ketoglutaric acid. As such, the claimed limitations appear to be met by the prior art. In the instant case, the claimed increase in the number of hair follicles, greater weight of hair, faster increase in hair shaft length, and increased growth rate of a hair, are inherently associated with treatment of alopecia by administering a composition comprising alpha-ketoglutaric acid taught by Hu. Therefore, practicing the method of Hu would inherently practice the method herein claimed.
Since Hu teaches administration of a composition comprising the very same compound alpha-ketoglutaric acid, using the same administration route- topically, to the same patient population, patients suffering from alopecia, to treat said patients, said compound upon administration will elicit the same effect on the hair, as in instant claims 17-20.
As such, claims 1-3, 15-20 are anticipated by Hu.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 1-3, 15, 17-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Huang et al. (WO 2016/003854, published 7 January 2016, cited in IDS).
Huang teaches ([0010]) a method of treating hair loss, hair thinning, hair graying/reducing pigmentation loss (page 2, lines 13, 17-18) as age-related symptoms, with alpha-ketobutyrate, as in instant claims 1, 2.
Huang teaches that the alpha-ketobutyrate compound is alpha-ketobutyric acid (page 1, [0010], lines 5,6]
PNG
media_image1.png
152
232
media_image1.png
Greyscale
, which is a compound of formula (I) of claim 3
PNG
media_image2.png
130
208
media_image2.png
Greyscale
to which the following definitions apply: R1 is -OR7; R2 and R3, together with the atom to which they are bound, form an oxo; R4 = R5 = R6 = H; R7 = H.
The alpha-ketobutyrate compound is administered as a composition comprising an excipient/carrier ([0012], [0065]), as in instant claim 3. The pharmaceutical formulations of the invention are administered topically [0063], as in instant claim 3.
Since Huang teaches administration of a composition comprising the very same compound alpha-ketobutyric acid, using the same administration route- topically, to the same patient population, patients suffering hair loss, hair thinning and hair graying due to aging (thus aging as a condition that decreases or inhibits hair growth, as in instant claim 15), to treat said patients, said compound upon administration will elicit the same effect on the hair, as in instant claims 3, 15, 17-20.
While Huang does not explicitly teach the limitations of instant claims 17-20, the claimed limitations appear to be a result or property of the administration of the effective amount of the composition comprising alpha-ketobutyric acid. As such, the claimed limitations appear to be met by the prior art. In the instant case, the claimed increase in the number of hair follicles, greater weight of hair, faster increase in hair shaft length, and increased growth rate of a hair, are inherently associated with treatment of alopecia by administering a composition comprising alpha-ketobutyric acid taught by Huang. Therefore, practicing the method of Huang would inherently practice the method herein claimed.
Alternatively, it would have been obvious for a person of ordinary skill in the art to use the teachings of Huang to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to administer alpha-ketobutyric acid in a method of reducing hair loss, and facilitating hair growth and/or regrowth, because Hu teaches that alpha-ketobutyrate is effective to treat, for example, hair loss, hair thinning, hair graying/hair pigmentation loss as age-related symptoms. Thus, the person of ordinary skill in the art would have administered alpha-ketobutyric acid to a subject suffering from hair loss, hair thinning, hair graying/hair pigmentation loss as age-related symptoms, with the expectation of achieving therapeutic effect, i.e. reduced hair loss and increased new hair growth.
As such, claims 1-3, 15, 17-20 are anticipated or rendered obvious by Huang.
Claims 1-3, 15, 17-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Huang et al. (WO 2015/123229, published 20 August 2015, cited in IDS).
Huang teaches ([0059], [0060]) a method of treating hair loss, hair thinning, hair graying/reducing pigmentation loss (page 8, [0059], lines 7-8, [0060], line 5) as age-related symptoms, by administering to a subject in need thereof at least one glutarate compound [0058], as in instant claims 1, 2.
Huang teaches that the glutarate compound is alpha-ketoglutarate a-KG [0064], or is a 2-HG compound [0061] such as 2-hydroxypentanoate [0065], which is a compound of instant claim 2.
Alpha-ketoglutarate (a-KG) is a glutarate compound of instant claim 1, is a compound of instant claim 2, and
PNG
media_image3.png
162
331
media_image3.png
Greyscale
is a compound of formula (I) of instant claim 3
PNG
media_image2.png
130
208
media_image2.png
Greyscale
to which the following definitions apply: R1 is -OR7; R2 and R3, together with the atom to which they are bound, form an oxo; R4 = R5 = H; R6 is -COOR7; R7 = H.
The alpha-ketoglutarate compound is administered as a composition comprising an excipient/carrier ([0058]), as in instant claim 3. The pharmaceutical formulations of the invention are administered topically, as in instant claim 3.
Since Huang teaches administration of a composition comprising the very same compound alpha-ketoglutarate, using the same administration route- topically, to the same patient population, patients suffering hair loss, hair thinning and hair graying due to aging (thus aging as a condition that decreases or inhibits hair growth, as in instant claim 15), to treat said patients, said compound upon administration will elicit the same effect on the hair, as in instant claims 3, 15, 17-20.
While Huang does not explicitly teach the limitations of instant claims 17-20, the claimed limitations appear to be a result or property of the administration of the effective amount of the composition comprising alpha-ketoglutarate. As such, the claimed limitations appear to be met by the prior art. In the instant case, the claimed increase in the number of hair follicles, greater weight of hair, faster increase in hair shaft length, and increased growth rate of a hair, are inherently associated with treatment of alopecia by administering a composition comprising alpha-ketoglutarate taught by Huang. Therefore, practicing the method of Huang would inherently practice the method herein claimed.
Alternatively, it would have been obvious for a person of ordinary skill in the art to use the teachings of Huang to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to administer alpha-ketoglutarate in a method of reducing hair loss, and facilitating hair growth and/or regrowth, because Hu teaches that alpha-ketoglutarate is effective to treat, for example, hair loss, hair thinning, hair graying/hair pigmentation loss as age-related symptoms. Thus, the person of ordinary skill in the art would have administered alpha-ketoglutarate to a subject suffering from hair loss, hair thinning, hair graying/hair pigmentation loss as age-related symptoms, with the expectation of achieving therapeutic effect, i.e. reduced hair loss and increased new hair growth.
As such, claims 1-3, 15, 17-20 are anticipated or rendered obvious by Huang.
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.
Claims 1-3, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US 8,470,880, published 25 June 2013, cited in IDS).
Hu teaches (Title, Abstract) a method of reducing hair loss, as in instant claims 1, 2, and facilitating hair growth and/or regrowth, as in instant claim 3, comprising administering to a subject in need thereof a composition comprising an alpha-keto acid (column 5, lines 43-45, also claim 3) which is
PNG
media_image4.png
102
144
media_image4.png
Greyscale
pyruvic acid or
PNG
media_image5.png
252
228
media_image5.png
Greyscale
, which are direct structural homologs of Applicant’s elected species alpha-ketobutyric acid
PNG
media_image1.png
152
232
media_image1.png
Greyscale
.
Alpha-ketobutyric acid is a compound of formula (I) of claim 3
PNG
media_image2.png
130
208
media_image2.png
Greyscale
to which the following definitions apply: R1 is -OR7; R2 and R3, together with the atom to which they are bound, form an oxo; R4 = R5 = R6 = H; R7 = H.
The composition comprising the alpha-keto acid of the invention also comprises an excipient, and is administered to the scalp of a mammal in need of such treatment (column 3, lines 32-33, column 4, lines 30-32), thus to an area on the subject absent of hair to stimulate new hair growth, as in instant claim 3.
Hu teaches that the subject treated suffers from alopecia (column 1, lines 15-22), as in instant claim 16, which can result from surgery, or trauma/injury (column 1, lines 15-19), as in instant claim 15.
Hu teaches that administration of the composition of the invention increases the rate at which terminal hair appears on the skin of the mammal (column 1, lines 35-37), thus increases the growth rate of hair, as in instant claim 20.
Hu teaches (column 1, lines 27-28) that administration of the composition of the invention provides thicker or richer hair coat, which is consistent with the weight of hair being greater relative to that prior to administration of the composition, as in instant claim 18.
It would have been obvious for a person of ordinary skill in the art to use the teachings of Hu to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been motivated to administer alpha-ketobutyric acid in a method of reducing hair loss, and facilitating hair growth and/or regrowth, because Hu teaches that alpha-keto acid pyruvic acid (alpha-ketopropionic acid), or alpha-ketoisovaleric acid, which are direct homologs of alpha-ketobutyric acid, are effective to reduce hair loss, and to stimulate/facilitate hair growth and/or regrowth. Thus, the person of ordinary skill in the art would have administered alpha-ketobutyric acid to a subject suffering from hair loss/alopecia, with the expectation of achieving therapeutic effect.
In the absence of unexpected results, stereoisomers are considered obvious variants of each other. "Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties". In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
The person of ordinary skill in the art would have reasonably expected that administration of a composition comprising a direct structural homolog of an alpha-keto acid taught by Hu, using the same administration route- topically, to the same patient population, patients suffering from hair loss/alopecia, to treat said patients, will result in therapeutic effect by eliciting the same effect on the hair, as in instant claims 17-20. The person of ordinary skill in the art would have evaluated the efficacy of alpha-ketobutyric acid in the method of reducing hair loss or stimulating hair growth, by determining the number of hair follicles, the weight of hair, the growth rate of hair prior to administration of the therapeutic agent and at different times upon administration, because such steps of measuring efficacy in a method of treatment are routine, well within the skill of the artisan.
As such, claims 1-3, 15-20 are rejected as prima facie obvious.
Conclusion
Claims 1-3, 15-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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 S. LUNDGREN can be reached at (571)272-5541. 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.
/IRINA NEAGU/Primary Examiner, Art Unit 1629
Prosecution Insights