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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered.
Status of claims
Claims 1 and 7-12 as amended on 11/12/2025 are under examination in the instant office action.
Claims 16-19 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The response filed on 11/12/2025 indicates that claims 16-19 are withdrawn. But the text of these claims is missing. Thus, it is unclear whether applicants intended to cancel these claims or not. Please, in response to the office action provide appropriate correction or cancelation.
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.
Claims 1 and 8-12 as amended are rejected under 35 U.S.C. 103 as being unpatentable over US 8,288,142 (Uvarkina et al) in the light of evidence by US 10,632,061 (Constantine et al).
US 8,288,142 (Uvarkina et al) discloses a product for topical application to the skin or mucous membranes, wherein the product comprises at least 2 parts:
1) a preparation with a powder of hyaluronidase enzyme (col. 17, lines 5-7); the preparation is packed as a powder in a vial and, thus, is a “pulverulent composition” within the reasonable meaning of the claims. The powder with enzyme contains an anti-caking or excipient agent which is mannite in one of embodiments (col.17, lines 5-12). The list of suitable excipients or anti-caking agents comprises starch, rice (col. 17, lines 37-39), talc or talcum (col.18, line 65) that are anti-caking agents in view of specification par. 0056 of published application US 2022/0354766) as well as organic acid excipients (col. 18, line 13) including stearic acid (col. 19, line 57). The stearic acid is a common anti-caking agent in cosmetic products as evidenced by US 10,632,061 (Constantine et al); for example: see col. 6, lines 46-65 including line 63.
2) a liquid solution or a liquid buffer or a liquid solvent for dissolving the dry preparation with hyaluronidase (col. 17, lines 5-12) or water (col. 19, line 65).
Now as applied to claimed limitation about 3-20% of “pulverent composition” and 80-97% of liquid composition by weight of final formulation upon mixing together:
In particular, US 8,288,142 (Uvarkina et al) discloses a cosmetic cream (col.19, lines 50-60), wherein the combined weight of “pulverent composition” with hyaluronidase and stearic acid (anti-caking agent) in the final cream formulation is about 3%, thus, in the claimed range; and wherein water amount is added to make up 100; thus, liquid or water would be less than 97% or would fall in the claims range.
Further, the cited US 8,288,142 (Uvarkina et al) teaches incorporation of antimicrobial agents including antibiotics (col. 16, lines 9-13) or antimicrobial plant extract, for example: chestnut extract in amount 1-2% (col.19, line 63).
Furthermore, the cited US 8,288,142 (Uvarkina et al) teaches incorporation of a gelling agent that are gelatin (col.17, line 43; col. 18, line 16) and plant gums (col.17, line 42) including xanthan gum (col. 26, line 23 and line 35). Although the cited document US 8,288,142 (Uvarkina et al) does not explicitly state amount for gelling agent, it clearly teaches hyaluronidase-containing composition in forms of gel (col. 18, lines 4-5). The cited document recognizes that one of skill in the art can estimate effective amounts of components as intended for desirable effects (col. 6, lines 13-18). Thus, it would be obvious to one of skill in the art to optimize amount of components including gelling agent depending on specific applications and/or on desired final form of preparation.
The cited US 8,288,142 (Uvarkina et al) teaches that the hyaluronidase-containing formulation are adapted for topical application to skin and provided as cream or gel; for example: see col. 19, lines 50-65; and to col. 20, lines 1- 40. Thus, the cited formulation, or at least a skin cream and/or cream/gel, has “a viscosity enough not to flow when applied to the skin and fluidity sufficient to permit application to the skin” within the meaning of the claims.
The cited US 8,288,142 (Uvarkina et al) explicitly acknowledges that hyaluronidase enzyme promotes tissue permeability (col. 60, line 12); and the enzymatic complex of the formulation can be provided in liposomal form (col. 17, last line).
In particular, the cited US 8,288,142 (Uvarkina et al) discloses incorporation of hyaluronidase in amounts 0.1-0.3% for the total final composition, which is lower than claim-recited amounts 3-16% (claim 11).
However, the cited document US 8,288,142 (Uvarkina et al) clearly recognizes that one of skill in the art can estimate effective amounts of active agent, which is hyaluronidase, in animal models to establish desirable concentrations (col. 6, lines 13-18). Thus, it would be obvious to one of skill in the art to optimize amount of enzymatic complex with hyaluronidase and amount of liquid solvent carrier depending on specific applications and/or on degree of desirable effects.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1 and 7-12 as amended are rejected under 35 U.S.C. 103 as being unpatentable over US 8,288,142 (Uvarkina et al) and US 10,632,061 (Constantine et al) as applied to claims 1 and 8-12 above, and further in view of US 9,546,407 (Wald).
The cited US 8,288,142 (Uvarkina et al) is relied upon as above for a disclosure of a preparation for topical application to the skin wherein the preparation comprises hydrolytic enzymatic complex with hyaluronidase.
The cited US 8,288,142 (Uvarkina et al) also teaches incorporation of antimicrobial agents (col. 16, lines 9-10). But it is silent with regard to specific antimicrobial agents such as claim-recited chlorhexidine, for example.
However, it is known that chlorhexidine as an antimicrobial agent is used in mixtures with hydrolytic enzymes in compositions for topical or skin applications; for example: see US 9,546,407 (Wald) at abstract, at col. 4, lines 30-35.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to modify enzyme-containing topical preparation of US 8,288,142 (Uvarkina et al) by incorporation of antimicrobial agent including claim-recited chlorhexidine with a reasonable expectation of success because it is a common practice to incorporate antimicibial drugs into topical preparation for skin application as taught/suggested by US 8,288,142 (Uvarkina et al) and because antimicrobial agents including chlorhexidine have been used in mixtures with hydrolytic enzymes in compositions for topical or skin applications as evidenced by US 9,546,407 (Wald).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
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 7-12 as amended remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claim 1 recites a device with a composition comprising enzyme, which is hyaluronidase (claim 9), liquid or water, and generic agents including anti-caking agent, antibacterial agent and gelling agent. Hyaluronidase is a natural enzyme. Thus, claim as a whole is drawn to a mixture of natural components in their natural forms such as powder (“pulverulent” form) and liquid (“solvent”). Depending claims further recite incorporation of additional all-natural components including levulinate (claim 7) and vegetable gum (claim 8). Liposome is a naturally derived form for being formed by natural compounds phospholipids, cholesterol, etc. The claim-recited amounts of components do not appear to affect structural and biological function of components.
With respect to claim-recited “device” it is noted that the claimed device is generic and not different from a mere container for holding natural components.
This judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed product, and the claimed product as a whole is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Response to Arguments
Applicant's arguments filed on 11/12/2025 have been fully considered but they are not all found persuasive.
The rejection of claims under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, has been withdrawn in view of amendment to the claims.
The rejection of claims under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement (new matter) has been withdrawn in view of claim amendment and applicants’ arguments for the support of claim amendment at par. 0033 of the as-filed specification.
With regard to claim rejection under 35 U.S.C. 101 Applicants argue that claims are not directed to natural product but to a device (response page 2).
This argument is not found persuasive because the claimed device is generic and not different from a mere container for holding natural components without affecting or transforming structural and biological function of natural components therein.
No arguments were presented with regard to claim rejection under 35 USC § 103.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. 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.
Vera Afremova
February 25, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653