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 .
Claim Status
Claims 1-13 and 16-19 are pending.
Claims 1-13 and 16-19 are rejected.
No claims are allowed.
Drawings
The drawings filed on 09/23/2024 are objected to for the following reason:
Figures 2 and 3: Due to the grayscale resolution of the figures, the different plots are difficult to distinguish because the same symbol convention is used. Applicant is advised to use different symbols for the respective plots to facilitate identification. Applicant is further advised to consider increasing the font size of the figure labels, where appropriate, to compensate for resolution and improve readability.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Priority
Acknowledgment is made of applicant's claim for U.S. national stage of PCT/IB2022/052773 filed on 03/25/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/23/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 and 16-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The terms “low” and “high” in claims 1-3 and 5-6 are relative term which renders the claims indefinite. The terms “low” and “high” are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “low” in “low dynamic viscosity” (emphasis added) in claims 1-3 and 5 and the term “high” in “high molecular weight silicon compound having a high dynamic viscosity” (emphasis added) in claims 1-3 and 6 are not defined by the claims or in the specification.
Because the inventive concept concerns a topical pharmaceutical composition for the “treatment of inflammation and pain” (see instant application, objects of the invention), the relative viscosity characteristics of the claimed components may affect whether the composition provides the intended effect of controlling inflammation and pain. However, the claims or the specification do not define the scope of variation encompassed by the terms “low” and “high,” thereby failing to clearly distinguish compositions that would provide the intended effect from compositions that would not.
Claims 2, 3 and 5 recite the limitation "a volatile silicone or said volatile silicone.” There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites at least one volatile silicone. It is unclear whether the limitation following the term applies to some or all of the at least one volatile silicone.
Claims 3 and 6 recite the limitation "said high molecular weight silicon.” There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites at least one high molecular weight silicon. It is unclear whether the limitation following the term applies to some or all of the at least one high molecular weight silicon.
Claim 7 recites the limitation "said saturated aliphatic alcohol.” There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites at least one saturated aliphatic alcohol. It is unclear whether the limitation following the term applies to some or all of the at least one saturated aliphatic alcohol.
Claim 9 recites the limitation "said skin permeation enhancer.” There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites at least one skin permeation enhancer. It is unclear whether the limitation following the term applies to some or all of the at least one skin permeation enhancer.
Claim Objections
Claim 12 contains an apparent typographical error. The recited density range of “0.6 to 1/0 g/ml” lacks clarity and should be amended to “0.6 to 1.0 g/ml.”
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 (i.e., changing from AIA to pre-AIA ) 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 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.
[1] Claims 1-3, 5-10, 13, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pandya (IDS: WO2006100485A1, published 09/28/2006), as evidenced by Shahruzzaman et al. (“Shahruzzaman”) (Chapter 7 - Biological macromolecules as antimicrobial agents, Biological Macromolecules, Academic Press, 2022, Pages 165-202, published 11/26/2021).
In regard to claims 1-3 and 5-9, Pandya teaches a topical composition (page 1, lines 3-4) comprising diclofenac (page 7, line 15) and dimethicone, which is a polydimethylsiloxane (page 5, lines 5-6) and corresponds to the claimed high molecular weight silicon compound having a high dynamic viscosity (see instant application, page 9, lines 6-11). Pandya further teaches that suitable dimethicones have a viscosity of from about 20 cSt to about 1250 cSt (page 5, lines 12-14). As noted in the instant application, the high molecular weight silicon compound has a dynamic viscosity higher than 40 cP, preferably from 40 to 400 cP, and may be selected from polydimethylsiloxanes (see instant application, page 9, lines 6-11). Accordingly, the viscosity ranges overlap (assuming a fluid density of approximately 1 g/cm3, such that 1 cSt [Symbol font/0xBB] 1 cP). Pandya additionally teaches wherein the composition comprises hexamethyldisiloxane, which corresponds to the claimed volatile silicon compound having a low dynamic viscosity, e.g., lower than 5 cP (see instant application, page 8, lines 16-19 and page 10, lines 14-16)); and isopropyl alcohol, which corresponds to the claimed solvent (Table 2, composition T9). The composition may comprise 2% diclofenac (Table 2, composition T9), about 5 wt. % to about 50 wt. % dimethicone and hexamethyldisiloxane (page 5, lines 5-8 and 21-22), and 26% isopropyl alcohol (Table 2, composition T9). Pandya further teaches that the solvent may comprise a mixture of isopropyl alcohol and ethyl alcohol (page 11, lines 12-13). The monohydric aliphatic alcohol is typically present in an amount of from about 20 wt. to about 50 wt. % (page 12, lines 1-3). Pandya teaches that the composition may further comprise at least one penetration enhancer. Pandya further teaches that suitable penetration enhancers include triglyceride fatty acids (page 10, lines 15-19). As evidenced by Shahruzzaman, triglyceride are lipids composed of three fatty acids esterified to a glycerol backbone through ester linkages (section 7.2.3.1, lines 1-3). Accordingly, the triglyceride fatty acids taught by Pandya corresponds to the claimed fatty acid esters limitation. The penetration enhancer is typically present in an amount of from about 1 wt. % to about 15 wt. % (page 10, lines 22-23).
In regard to claim 10, Pandya teaches wherein the composition that may include one or more pharmacologically active compounds, including camphor (page 7, lines 28-29). Pandya further teaches that the active compound is typically present in an amount of about 0.1 wt.% to about 10 wt.% based on the total weight of the composition (page 10, lines 5-13).
In regard to claim 13 reciting wherein the topical pharmaceutical composition is administered by vaporization, this is merely a recitation of the intended use of the claimed composition. Pandya teaches wherein the composition may be in the form of sprayable liquids (page 12, line 11). As noted in the specification on page 14, line 7, the composition of the invention is in the form of a solution which is easily vaporizable. Therefore, since the composition of Pandya is a liquid, the composition of Pandya is capable of being administered by vaporization, whether the prior art discloses such use or not.
In regard to claims 16, 18 and 19, Pandya teaches administering the topical pharmaceutical composition comprising a pharmacologically active compound to a human or animal body (page 6, lines 9-13; claim 20, inter alia). Pandya further teaches that suitable pharmacologically active compounds include nonsteroidal anti-inflammatory drugs (NSAIDs), such as diclofenac (page 6, lines 17-18; page 15, lines 3-4, inter alia).
In regard to claim 17, Pandya teaches topical NSAIDs, such as diclofenac, as anti-rheumatic agents and further teaches treatment of rheumatism using NSAIDs, such as diclofenac (page 7, lines 26-27; page 15, lines 3-4, inter alia).
The prior art discloses a topical composition (page 1, lines 3-4) comprising diclofenac (page 7, line 15), dimethicone (i.e., claimed high molecular weight silicon compound having a high dynamic viscosity) (page 5, lines 5-6), hexamethyldisiloxane, (i.e., claimed volatile silicon compound having a low dynamic viscosity (Table 2), isopropyl alcohol, (i.e., claimed solvent (Table 2), and a penetration enhancer (page 10, lines 15-19). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
[2] Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Pandya (IDS: WO2006100485A1, published 09/28/2006) in view Zoppetti et al. (“Zoppetti”) (IDS: WO2014009793A1, published 01/16/2014).
The teachings of Pandya are discussed above.
Pandya does not explicitly teach a topical pharmaceutical composition comprising diclofenac as a salt with an amine selected from methylamine, triethylamine, pyrrolidine, piperidine, morpholine, 1-ethylpiperidine, 2-aminoethanol, dimethylaminoethanol, diethylaminoethanol, epolamine, and piperidineethanol, and wherein the composition has a density of from 0.6 to 1.0 g/mL at 25 [Symbol font/0xB0]C.
However, Zoppetti teaches pharmaceutical and veterinary topical compositions comprising diclofenac, preferably as an organic base salt and, more particularly, as a second or tertiary amine salt, including cyclic tertiary amine salts (Abstract). Zoppetti also teaches that the compositions provide anti-inflammatory and analgesic activity following topical application with deep penetration of the active ingredient through the skin to the subdermal tissues and are useful for treating musculoskeletal disorders, including inflammations and associated pain (Abstract; page 1, lines 5-12). Additionally, Zoppetti teaches diclofenac salts including diclofenac methylamine, diethylamine, triethylamine, pyrrolidine, piperidine, morpholine, 1-ethylpiperidine, 2-aminoethanol, dimethylaminoethanol, diethylaminoethanol, pyrrolidinethanol (epolamine), and piperidinethanol (pages 7-8). Zoppetti further teaches compositions having a density (w/v) from 0.6 to 1.0 g/mL (claim 11).
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 MPEP 2144.07. Pandya teaches a composition comprising diclofenac. Accordingly, it would have been obvious to have incorporated the diclofenac salt of Zoppetti into the composition of Pandya since it is a known and effective diclofenac compound, which treats musculoskeletal disorders, including inflammations and associated pain as taught by Zoppetti.
It further would have been obvious to one of ordinary skill in the art to have formulated the composition of Pandya to have a density of 0.6 to 1.0 g/mL since Pandya does not disclose a density for the composition and this density is a known and effective density for topical compositions comprising diclofenac as taught by Zoppetti.
[3] Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Pandya (IDS: WO2006100485A1, published 09/28/2006) in view of Zoppetti et al. (“Zoppetti”) (IDS: WO2014009793A1, published 01/16/2014) and DuPont™ (Liveo™ ST-Dimethiconol 40, published 09/11/2020).
The teachings of Pandya are discussed above.
Pandya does not explicitly teach that the topical pharmaceutical composition comprises 3% to 6% Dimethiconol 40.
However, DuPont™ teaches that Dimethiconol 40 is a clear, colorless, hydroxyl-terminated polydimethylsiloxane fluid suitable for use as a silicone topical excipient.
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 MPEP 2144.07. Pandya teaches a composition comprising polydimethylsiloxanes as an emollient (page 5, line 6) and wherein the amount of emollient is from about 5 wt. to about 50 wt. %. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated Dimethiconol 40 into the composition of Pandya since it is a known and effective polydimethylsiloxane for topical compositions as taught by Dupont.
The combined teachings of Pandya and Dupont do not teach wherein the composition comprises 2% to 15% isopropyl myristate and wherein the volume ratio of ethanol/isopropanol is 1:0.4 to 1:3.
However, Zoppetti teaches pharmaceutical and veterinary topical compositions comprising diclofenac formulated for administration by a vaporization (spray) system for external use (Abstract). Zoppetti further teaches that the compositions provide anti-inflammatory and analgesic activity following topical application with deep penetration of the active ingredient through the skin to the subdermal tissues and are useful for treating musculoskeletal disorders, including inflammations and associated pain (Abstract; page 1, lines 5-12). Zoppetti further teaches a saturated aliphatic alcohol mixture in an amount of 10% to 40% by volume of the solution and teaches that the saturated alcohol mixture is preferably an ethanol/isopropanol mixture having a volume ratio ranging from 1:0.3 to 0.3:1 (v/v). Zoppetti additionally teaches a skin permeation enhancer in an amount of 2% to 15% by volume of the solution, with isopropyl myristate being a particularly preferred permeation enhancer (page 11, lines 13-19; claims 9).
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 MPEP 2144.07. Pandya discloses a mixture of isopropyl alcohol and ethyl alcohol. Accordingly, it would have been obvious to have formulated the ethanol/isopropanol mixture to have a volume ratio ranging from 1:0.3 to 0.3:1 (v/v) since this is a known and effective volume ratio of ethyl alcohol and isopropyl alcohol used for topical compositions as taught by Zoppetti.
Pandya discloses wherein the composition comprises about 1 wt. % to about 15% penetration enhancer. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated isopropyl myristate into the composition of Pandya since it is a known and effective permeation enhancer as taught by Zoppetti.
Conclusion
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/ALI M. ALAOUIE/ Examiner, Art Unit 1614
/TRACY LIU/ Primary Examiner, Art Unit 1614
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