DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ response to the Requirement for Restriction, filed 6 July 2026, in the matter of Application N° 18/841,884. 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 1, 4, 5, 10-12, 14, 18-20, and 23-26 have been canceled.
Claims 36 and 40 have been amended to recite that the composition comprises an active ingredient mixture comprising silicon and biotin.
No claims have been added.
No new matter has been added.
Applicants’ election of Group II (claims 36-38), with traverse, is acknowledged.
Applicants traverse the restriction on the grounds that Groups II and III both contain methods involving a shared special technical feature over Komorowski.
In response, the Examiner respectfully submits that Applicants’ remarks are unpersuasive and that the disclosure of Komorowski, as discussed herein below, provides a showing in the art demonstrating that the purported combination is known in the art.
Per PCT Rule 13.1, the international application shall relate to a group of inventions so linked as to form a single general inventive concept or a “unity of invention” (see MPEP §1850). Per PCT Rule 13.2, said “unity of invention” is fulfilled by defining a special technical feature that is shared amidst the claimed inventions. The Rule further specifies that “[t]he expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.” The recitation of generic subject matter in the base claims is sufficient enough to demonstrate a lack of unity amidst the groups set forth in the previous Office Action.
This is clearly evidenced by Komorowski as cited. Therein, the disclosure of the combination of biotin and arginine silicate complex and its resulting effects demonstrates that the alleged special technical feature shared now between Groups II and III is, in fact, known in the art.
As such, the instantly alleged special technical feature, is respectfully not considered to provide a contribution over the prior art as required above.
The restriction requirement is hereby made FINAL. The remaining claims 40, 41, and 45 (Group III) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement between the composition and method claims.
Thus, claims 36-38 are presented and represent all claims currently under consideration.
Information Disclosure Statement
Four Information Disclosure Statements (IDS) filed 15 November 2024, 20 May 2025, 17 April 2026, and 6 July 2026 are acknowledged and have been considered.
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.
Claims 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kalman et al. (J Clin Exp Dermatol Res; published 21 January 2021; IDS reference of record).
The limitations recited by the elected invention are directed to a method of improving the appearance of a subject’s skin, hair, or nails comprising administering a composition comprising an active ingredient mixture comprising silicon and biotin.
The article published by Kalman reports on a study examining the safety and efficacy of a product called Lustriva™ (a novel source of biotin and silicon) at both high dose (LHD) and a low dose (LLD) (see Abstract).
High-dose Lustriva™ is disclosed as comprising 146.5 mg inositol-stabilized arginine silicate (ASI) with 11.7 mg magnesium biotinate providing 10 mg silicon and 10 mg biotin (a 1:1 mass ratio of silicon to biotin). Low-dose Lustriva™ is disclosed as comprising 146.5 mg inositol-stabilized arginine silicate (ASI) with 3.5 mg magnesium biotinate providing 10 mg silicon and 3 mg biotin (a 3.3:1 mass ratio of silicon to biotin)(see Study products 1 and 2; pg. 3).
The reference reports that both low and high doses are effective at providing an increase of hair thickness and a decrease in facial wrinkles. The LHD significantly increased hair thickness and reduced facial wrinkles compared to the placebo and the performing better than the LLD blend (see Abstract).
The reference is thus considered to clearly anticipate the claimed invention.
Claims 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Komorowski et al. (Curr Dev Nutr; 2019; IDS reference of record).
The limitations of the claimed invention are discussed above.
Komorowski discloses orally administering a study product containing a novel combination of inositol-stabilized arginine silicate (ASI) complex and magnesium biotinate (MgB) (see Objectives). Test Group 2 received ASI+ Low dose MgB (140 mg human equivalent dose of ASI and 1.5 mg MgB). Test Group 3 received ASI+ High dose MgB (140 mg human equivalent dose of ASI and 10 mg MgB) (see Methods).
Hair and nail growth of the test subjects was measured to determine efficacy of the administered composition (see Methods).
Visual observations revealed greater hair growth in both treatment groups compared to control, however, the effect was more pronounced in group 3 (i.e., the High MgB dose). A similar result is reported out with respect to nail growth (see Results).
The reference is thus considered to clearly anticipate the claimed invention.
All claims have been rejected; no claims are allowed.
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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