DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicant’s Amendments and Remarks, filed 6 July 2026, in the matter of Application N° 19/436,348. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 3, 4, 36-40, 43, 44, 46, and 52-56 have been canceled. No claims have been added.
Claims 1, 2, 25, and 26 have been amended. The amendment to claim 1 changes “silicon” to “silicate” and incorporates the limitations of canceled claim 3. Claim 2 has been amended to add the language that the silicate comprises silicon. However, the previously recited silicon to biotin ratio range remains.
Claim 25 has been amended to change “silicon” to “silicate” and to add that the intended subject of the claimed composition is a human subject. Claim 26 has been amended to depend from claim 25, add the language that the silicate comprises silicon, and to add that the intended subject of the claimed composition is a human subject.
No new matter has been added.
Thus, claims 1, 2, 6, 7, 10, 13, 14, 18, 19, 25, 26, 28, 29, 34, and 35 now represent all claims currently under consideration.
Information Disclosure Statement
One new Information Disclosure Statement (IDS) filed 6 July 2026 is acknowledged and has been considered.
Withdrawn Rejections
Rejections under 35 USC 102
Applicant’s amendments to claim 1 adding the limitations of claim 3 to the independent claim are sufficient in overcoming both of the previously raised anticipation rejections over “Mintel” and Komorowski et al. (Curr Dev Nutr; 2019). Said rejections are withdrawn.
Rejections under Double Patenting
Applicant’s amendments to the copending ‘884 application cancelling claims 1, 10, and 25 (Statutory rejection) and claims 1, 4, 10, 12, 14, 15, 18, 19, 25, and 26 (Nonstatutory rejection) are persuasive in overcoming both of the previously raised double patenting rejections. Said rejections are withdrawn.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 6 April 2026 since the art that was previously cited continues to read on the amended and previously recited limitations.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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, 2, 6, 7, 10, 13, 14, 18, 19, 25, 26, 28, 29, 34, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US Pre-Grant Publication Nº 2018/0071264 A1; IDS reference) in view of Komorowski (US Pre-Grant Publication Nº 2017/0135969 A1; IDS reference), Komorowski et al. (Curr Dev Nutr; 2019; IDS reference), and further evidenced by Boone (The K-Zone: Biophysical Data Tables: Standard Man; 2006) and Yaman et al. (DDDT; 2016). [emphasis added to reflect canceled claims]
The limitations of claims 1, 6, 7, 10, 13, 14, 18, 25, 28, 29, 34, and 35 are discussed above. The limitations of claims 2, 19, and 26 are directed to amounts of the ingredients or mass ratio relationships of ingredients to one another.
Nelson discloses an oral composition comprising an effective amount of magnesium biotinate and a pharmaceutically acceptable vehicle, carrier, or diluent wherein the amount within the practiced composition ranges between about 10 µg to about 1,000 µg (1 mg) (see e.g., claims 1, 2, and 35). The amount of magnesium biotinate is further defined in the reference as ranging even higher, such as 10 mg, and as high as 10,000 mg or magnesium biotinate. See ¶[0011] and ¶[0037]. Such is considered to teach the
D-biotin is disclosed as being used to prepare magnesium biotinate with the resulting form being magnesium D-biotinate (see e.g., claim 36).
Further, the practiced oral compositions are disclosed as being formulated as controlled release dosage forms. Included therein, are more specific forms of release, such as extended release. See ¶[0075]. Paragraph [0077] further pairs the controlled release formulation with physical representations of such dosage forms as soluble or erodible matrices, such as a pill or a lozenge, gels, and pastes. Paragraph [0081] additionally teaches that other oral forms include tablets, capsules powders, elixirs, syrups, and suspensions.
Where Nelson is deficient is with respect to the instant limitations directed to arginine, inositol, and more specifically, an inositol-stabilized arginine-silicate complex.
Komorowski ‘969 discloses administering a composition comprising an effective amount of arginine silicate inositol (ASP) in order to treat and/or promote hair growth (see e.g., Abstract; claims). Paragraph [0007] discloses and defines “arginine silicate inositol” as being synonymous with “inositol-stabilized arginine silicate” and “arginine-silicate-inositol complex”. Formulation of this compound is further defined in ¶[0016] as having a molar ratio of arginine to silicate to inositol ranging from about 1:1:1 to about 3:3:2, and more specifically, a molar ratio of about 1:1:1 to about 2:2:1.
The daily dosage of ASI is disclosed by the reference as ranging from about 1 mg/kg to about 2,500 mg/kg or more of body weight, and more narrowly from about 2 mg/kg body weight, from about 3 mg/kg body weight, from about 4 mg/kg body weight, etc. See ¶[0017]. With respect to the body weight considered, the Examiner submits that Boone discloses the weight or mass of the “standard man” as being 70 kg. Further definition of the ASI compound is provided in the state of the art by Yaman, for instance, such that arginine silicate inositol complex is compositionally defined as: arginine 49.5%, silicon 8.2%, and inositol 25% (see Abstract).
Thus, with these available disclosures, it would be well within the purview of the ordinarily skilled artisan to calculate that a daily dosage of about 1-4 mg of ASI/kg body weight would elicit about 5.7-23 mg of silicon in the practiced composition. Such is considered to teach and suggest the amounts of silicon as instantly recited in claims 3 and 26.
Regarding the practiced dosage forms of Komorowski ‘969, the Examiner acknowledges that the reference focuses on topical delivery of the practiced compositions (i.e., gels, etc.) (see e.g., claims 1 and 4).
MPEP §2123(I) states that “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments.” MPEP §2123(II) also states that “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.”
In the instant case, the Examiner submits that the ‘969 reference additionally teaches that the ASI active may not only be co-administered with another agent, but also that administration may be accomplished orally. See ¶[0073].
Komorowski ‘969 is lastly recognized as being deficient in that it does not disclose that the co-administered agent is magnesium biotinate as instantly claimed.
As discussed above, each of the teachings of Nelson and Komorowski ‘969 are deficient in that they do not teach administering one of the two required compounds of the instantly recited composition. Nelson does not disclose administering ASI and Komorowski does not disclose administering magnesium biotinate.
However, both references expressly disclose administering their respective compositions for the purpose of promoting hair growth. MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”
In the instant case, the article published Komorowski et al. (Curr Dev Nutr; 2019), as discussed above, expressly discloses orally administering a product containing magnesium biotinate and inositol-stabilized arginine-silicate complex with demonstrated results in promoting hair and nail growth (see Objectives, Methods, and Conclusion).
Thus, based on the combined teachings of each of the contributing references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicant’s arguments with regard to the rejection of claims 1, 2, 6, 7, 10, 13, 14, 18, 19, 25, 26, 28, 29, 34, and 35 under 35 USC 103(a) as being unpatentable over the combined teachings of Nelson et al., Komorowski (‘969), Komorowski et al. (CDN; 2019), Boone, and Yaman et al. have been fully considered but they are not persuasive.
Applicant’s initial traversal of the rejection is that Komorowski (CDN) fails to cure the defects of Nelson and the ‘969 Komorowski references, specifically as Komorowski (CDN) is primarily directed to treating rats. The Applicant does acknowledge that Komorowski (CDN) does provide two specific human-equivalent dose values, but fails to explicitly disclose the actual amount of either component as instantly claimed.
A similar assertion is made following Applicant’s discussion of the alleged unexpected results presented in Examples 5 and 6 of the instant specification.
The Examiner, in response, respectfully disagrees with Applicant’s remarks directed to the Komorowski (CDN) reference and summarily maintains the rejection for the reasons already of record.
Applicant’s amendments to claims 25 and 26 indicating that the intended recipient of the claimed composition is a human subject is not persuasive. The recipient is broadly and reasonably interpreted as being an intended use of the of composition at issue and does not further limit the claimed invention in a compositional manner.
Secondly, and more critically, the disclosure relied upon by the Examiner in the Komorowski (CDN) reference is and remains a critical nexus in the art that supports the previously raised obviousness rationale combining the teachings of Nelson and the ‘969 Komorowski disclosures.
As previously argued, Nelson and the ‘969 references each disclose one component of the recited composition and that they are both used to promote hair growth in mammals such as humans. While neither reference discloses the other component, their sharing of a common use supports a prima facie showing of obviousness consistent with MPEP §2144.06(I). The Komorowski (CDN) supports this rationale by disclosing the combined use of both components and that said combination promotes hair and nail (keratin) growth. That the Komorowski (CDN) reference does not disclose amounts that read on the recited ranges is not germane to the argument. Disclosure of administering the combination to mammals (i.e., rats and humans) and showing hair growth is also considered to nullify Applicant’s assertion of unexpected results.
Again, the Nelson and ‘969 references disclose their respective components and in amounts that read on the recited ranges for the purposes of promoting hair growth. That is, hair growth is understood as resulting through use of the individual components. The reasonable expectation is that together, the two components would accomplish the same result. Komorowski (CDN) affirms this point.
Applicant’s arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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