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 .
Response to Restriction
Applicant’s election without traverse of MAP3/TEOS of Claim 20 as the species representative of the nitric oxide releasing co-condensed silica particles of the invention in the reply filed on 13 February 2025 is acknowledged.
Status of the Claims
Claims 1-7 and 10-23 are pending.
Claims 21-23 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-7 and 10-20 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants claim 1 is directed to methods of treating acne by the topical application of a particular composition. The examiner notes that the newly added terminal “wherein” clause concerning the reduction of P acnes counts represents not an affirmative limitation of the method claimed, but rather represents a result to be achieved by the practice of the affirmatively recited method steps. See Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003))(indicating that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”). Applicants claims combine into a single composition a ratio of between 3:1 and 1:5 parts of each of two components recited as containing defined concentrations of each of two viscosity increasing agents, a polyhydric alcohol, a buffer, an organic solvent, humectant, water repellant, an active pharmaceutical ingredient, and water. When combined as required by the claims into the composition to be applied, applicants compositions appear to contain between 0.17-22.5% polyhydric alcohol, 0.442-11.25% viscosity modifier, 0.0017-1.5% buffer, 11.974.25% water, 12.5-76.5% solvent, 0.5-17% humectant, and 0.125-12.75% water repellent. Dependent claims 2-7 narrow the pH, or identity or concentrations of each of the ingredients required by independent Claim 1. Claims 10-12 recite results which are to be observed following the completion of the method encompassed by the manipulative steps required by the claim, and are therefore afforded negligible patentable weight. See Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) (indicating that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”). Claim 13 describes methods of treating acne whereby an anhydrous nitric-oxide releasing composition is combined with a hydrogel and applied to the skin. Dependent claims 14-18 narrow the pH, or identity or concentrations of each of the ingredients required by independent Claim 13. Claim 19 specifies that the NO releasing component is a NO-releasing co-condensed silica particle, with Claim 20 specifying that the NO-releasing co-condensed silica particle is represented by MAP3/TEOS.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claims 1-7 and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over McCadden (U.S. 6,479,058), in view of Mak (U.S. 6,319,913), and Schoenfisch (U.S.PGPub. 2012/0021055).
McCadden describes methods of treating inflammatory reactions of the skin such as the acne of the instant claims by the topical application of a composition to the skin of a subject suffering such inflammatory reactions. (Col.1, L.10-22; Col.2, L.48-59). McCadden indicates these compositions may take the form of, among others, a gel which when combined with the teachings concerning the inclusion of water, would necessarily provide the hydrogel of the instant claims. (Col.7, L.29-34). McCadden indicates that the compositions used in such methods are to contain, among others, water, (Col.3, L.31-35), antifoaming agents such as dimethicone applicants identify as an exemplary water repelling agent, (Col.8, L.31-39), buffering agents including the lactic acid applicants identify as an exemplary buffer, (Col.8, L.40-43), emollients such as the glycerin applicants identify as an exemplary organic solvent, humectant, and polyhydric alcohol (Col.8, L.45-52), emulsion stabilizers and viscosity builders including each of the carbomers and hydroxypropyl cellulose applicants identify as an exemplary viscosity increasing agents (Col.9, L.13-17), which are also included as exemplary thickening agents (Col.9, L.50-54), and solvents including each of the isopropanol and hexylene glycol applicants identify as an exemplary solvents. (Col.37-40). While no particularly limiting quantities of each are recited by the McCadden reference, it must be remembered that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts of each of the water, antifoaming agents, buffers, emollients, viscosity builders and solvents are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by McCadden.
Despite this recitation, the McCadden reference does not describe the inclusion of the instantly claimed diazeniumdiolate modified polysiloxane macromolecules as the anti-inflammatory agent, nor is buffering the composition to a pH of between 3-8 or formulating the compositions so that an NO-donor is provided in a non-aqueous composition for combination with the remaining components of the topical hydrogel described.
Mak indicates that combinations of oleic acid, C1-4 alcohols, and glycols thickened by CARBOPOL carbomers or hydroxypropylcellulose serve as transdermal penetration enhancers which produce unexpectedly low levels of skin irritation. (Col.2, L.25-30; Col.4, L.20-25; Col. 5, L.9-19 & 36-49). Exemplary topical compositions are buffered to a pH of between 3-6. (Col.10, L.61-63).
Schoenfisch indicates that nitric oxide donors may suitably be employed as anti-inflammatory agents, [0308], while describing a variety of diazeniumdiolate modified polysiloxane macromolecules as suitable nitric oxide donors. (Examples 10-16, [0361-380]. MAP3/TEOS are each recited as combinable into the nitric oxide donors. See [0160-61; 0251-53; 0379-81 (“Table 6”)]. Schoenfisch indicates that while stable under ambient conditions, diazeniumdiolates decompose spontaneously in aqueous media. [0232]. Schoenfisch also indicates that the release of nitric oxide from particles incorporating NO donors such as diazeniumdiolates can be selectively triggered. [0263]. Schoenfisch also specifically indicates that the combinations according to the disclosure can refer to administrations of single or separate compositions to be combined prior to use. [0314-16].
It would have been prima facie obvious to one having ordinary skill in the art at the time of the instant invention to have incorporated the diazeniumdiolate modified polysiloxane macromolecules, including the newly claimed MAP3/TEOS, as anti-inflammatory nitric oxide donor agents into the topical anti-inflammatory hydrogel compositions suggested by McCadden as modified by Mak to treat acne as taught by McCadden. One having ordinary skill in the art would have been motivated to do so owing to the fact that McCadden specifically envisions the treatment of topical anti-inflammatory disorders including acne by the application of compositions suitable for reducing inflammation, and the NO donor diazeniumdiolate modified polysiloxane macromolecules described by Schoenfisch are acknowledged by the art as suitable for treating inflammation. Furthermore, because Schoenfisch indicates that diazeniumdiolates spontaneously release NO when in aqueous solutions, and that topical anti-inflammatory NO generating compositions may be formulated separately and combined with aqueous media when ready to use, it would have been prima facie obvious to have formulated the diazeniumdiolate in a non-aqueous composition until ready to apply to the skin. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Response to Arguments
Applicant's arguments filed 28 May 2024 concerning the rejection of the claims as obvious over the teachings of McCadden, Mak, and Schoenfisch have been fully considered.
Applicants argue that because each of McCadden, Mak, and Schoenfisch fail to teach the reduction of P acnes counts newly recited by the amended claims, these references cannot address the invention. As set forth above, this newly added language represents not an affirmative limitation of the method claimed, but rather represents a result to be achieved by the practice of the affirmatively recited method steps. See Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003))(indicating that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”). Applicants are reminded that in determining the meaning of language present in a claim, and therefore the scope of the invention defined, the objective reach of the language of the claim presented is controlling. See In re Hiniker Co., 150 F.3d 1362, 1369, 47 USPQ2d 1523, 1529 (Fed. Cir. 1998) (“[T]he name of the game is the claim.”). Method claim limitations define steps or acts to be performed, product claims discrete physical structures or materials. The method claimed, identifiable by the recited steps to be practiced, remains nothing more than the topical application of a particular composition to a subject having acne. Here, the art provides the required rationale for topically applying the composition claimed to a subject suffering the ailment to be treated. Applicants are reminded that the reason or motivation to modify a prior art reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). Furthermore, "the fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicants advance no arguments over those asserting that the newly added language concerning an observed reduction of P. acnes somehow distinguishes the present claims from the assembled prior art. As set forth above, it does not.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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