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 . Claims 1-23 are pending; claims 1-20 are examined, claims 21-23 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-20 in the reply filed on 06 October, 2025 is acknowledged. Accordingly, claims 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because claim 8 recites “KTTKS”, which is a sequence of 5 amino acids, and “GQPR”, which is a sequence of 4 amino acids.
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities: “pharmacuetical” in claim 1 and “pharmceutical” in claim 7 should be recited as --- pharmaceutical ---. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: “botulinum toxin A (BoNT/A), BoNT/B, BoNT/C, BoNT/D, BoNT/E, BoNT/F, or BoNT/G” should be recited as --- botulinum toxin (BoNT) serotypes A, B, C, D, E, F, or G ---. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “nano-emuslisons” in line 1 should be recited as --- nano-emulsion ---. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “franesil” in line 2 should be recited as --- farnesil ---. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “vegetable oil, fish oil, sesame oil, soybean oil, tea oil, sunflower seed oil” in lines 3-5 appear to be repeated 3 times. Appropriate correction is required.
Claim 9 objected to because of the following informalities: “dronabinol)” in the last line should be recited as --- dronabinol ---. Appropriate correction is required.
Claims 12 and 13 are objected to because of the following informalities: “emolliants” in the last line of each claim should be recited as --- emollients ---. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “EGFs”, “KGFs”, “FGFs”, and “HGH” should each be preceded with their non-abbreviated terms, with abbreviations immediately after and in parentheses. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3, 5, 6, 8, 9, 11, and 17 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.
Claim 3 recites wherein the proteins are botulinum toxins or its complex or “its other forms”, which renders the claim indefinite because it is unclear what is encompassed by the recitation of “its other forms”. At best, para. [0045] discloses wherein other variants of toxin derived biomolecules could be heavy chain conjugated with therapeutic drugs or biomolecules, engineered light chain or toxin or any combination thereof. Thus it is not clear what is encompassed by the recitation of “its other forms,” such that one of ordinary skill in the art would know whether a form of botulinum toxin would infringe on the claimed invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “biomolecules”, and the claim also recites “antibodies” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 6 recites various amounts (% w/v) in parentheses, which renders the claim indefinite because the scope of the claim is unclear. It is not clear whether the limitations introduced by such parentheses are (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) required limitations of the claim. For the purposes of examination, the ranges are interpreted to be required. Examiner suggests amending the claims to positively recite the ranges, e.g., --- 0.5 to 5% w/v propylene glycol ---.
Claim 8 contains the trademark/trade names “Snap-8TM”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an octapeptide and, accordingly, the identification/description is indefinite.
Claim 8 contains the trademark/trade names “Argireline®”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a hexapeptide and, accordingly, the identification/description is indefinite
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitations (below, left), and the claim also recites the narrower statement of the ranges/limitations (below, right):
Broad recitation
Narrower statement
Pentapeptide
KTTKS
Tetrapeptide
GQPR
Hexapeptide
Argireline®
Tripeptide
GHK
Oligopeptides
octapeptide
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Moreover, it appears that the narrower statements may be referring to an abbreviation of specific peptide sequences, and thus should be clearly specified.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitations “oil triglyceride” and “vegetable oil”, respectively, and the claim also recites “sunflower seed oil” and “castor oil”, which are the respective narrower statement of the ranges/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 contains the trademarks/trade names “LabrafacTM Lipophile WL 1349 oil”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a medium chain triglyceride oil and, accordingly, the identification/description is indefinite.
Claim 11 contains the trademarks/trade names “Permulen TR1”, “Permulen TR2”, “RH-40”, “Tween-80”, and “Tween-60”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the following generic names: acrylates/C10-30 alkyl acrylate crosspolymer (not recited in the instant Specification); hydrogenated castor oil; polysorbate-80 (not recited in the instant Specification); and polysorbate-60 (not recited in the instant Specification), respectively, and, accordingly, the identification/description is indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation “therapeutic agents”, and the claim also recites “epidermal growth factors” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-5 and 7-20 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Singh et al. (US 2021/0346292 A1, 11/11/2021) (hereinafter Singh).
Regarding claim 1, 3, 4, 19 and 20, Singh discloses a method of treatment by topically administering an effective amount of pharmaceutical compositions comprising proteins of botulinum toxins or complex thereof, as an emulsion to treat local and systemic conditions including skin problems (claims 2 and 20). The proteins were emulsified with encapsulated microspheres and nanospheres (nanoparticles) (i.e. nanoemulsion) containing propylene glycol (0.3-6%), phenoxyethanol (0.1-5%), sodium hyaluronate (0.01-1%), caprylic/capric triglyceride (0.5-10%), hydrogenated castor oil (1-15%) and span-80 (0.01-6%) in water (claim 9, [0017]).
Regarding claims 2 and 5, Singh discloses wherein the composition comprises therapeutic protein including various serotypes of botulinum toxin and protein hormones (claim 4).
Regarding claims 7 and 8, Singh discloses wherein the compositions further comprises oligopeptides (claim 13).
Regarding claim 9, Singh discloses wherein the composition comprises soy-bean oil (claim 11).
Regarding claims 10 and 11, Singh discloses wherein the composition comprises water-soluble co-solvents and surfactants, including Tween® 80 (claim 12).
Regarding claims 12 and 13, Singh discloses wherein the composition further comprises humectants including propylene glycol, and emollients including zinc oxide (claim 14).
Regarding claims 14 and 15, Singh discloses wherein the composition further comprises a stabilizer including human serum albumin (claim 15).
Regarding claim 16, Singh discloses wherein the composition is a gel (claim 16).
Regarding claim 17, Singh discloses wherein the composition is emulsified proteins with retinoids (claim 17).
Regarding claim 18, Singh discloses wherein the composition is stabilized at a pH in between 5.5 and 8.0 (claim 18).
Claims 1-4, 7, 9-11 and 19-20 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Edelson et al. (US 2011/0212157 A1, 09/01/2011) (hereinafter Edelson).
Edelson describes a botulinum nanoemulsion formulation, comprising botulinum toxin type A, complexed or isolated, soybean oil, and Tween® 80 (Example 1; [0455]) and applied topically to a person in need thereof to treat wrinkles (Example 3). The term “botulinum toxin” refers to any neurotoxin produced by Clostridium botulinum and encompasses serotypes A-G ([0032]).
Accordingly, Edelson discloses a composition comprising: one or more proteins of Clostridium botulinum in a nano-emulsion ([0455]), wherein the protein comprises one or more from botulinum toxin A, B, C, D, E, F, or G ([0032]); Tween® 80 as surfactant; and soybean oil, applied topically to treat skin problems, which anticipates the claims instantly.
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 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. 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.
Claims 1-5 and 7-20 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2021/0346292 A1, 11/11/2021) (hereinafter Singh).
The disclosure of Singh is discussed in detail above. While Singh is believed to support a finding of anticipation, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, Singh will be interpreted as though it is not anticipatory insofar as this combination 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).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (US 2021/0346292 A1, 11/11/2021) (hereinafter Singh) in view of Baker et al. (US 2012/0064136 A1, 03/15/2012) (hereinafter Baker).
The disclosure of Singh is discussed in detail above, and differs from the instant claim insofar as not explicitly disclosing wherein the composition comprises saponin.
However, Baker discloses topical nanoemulsions ([0029]) comprising active agents including botulinum toxin ([0032]). The nanoemulsion may further comprise at least one surfactant ([0028]), including saponin ([0113]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included saponin in the composition of Singh since it is a known and effective surfactant suitable for topical nanoemulsions as taught by Baker.
Regarding the claimed amounts of saponin, it would have taken no more than the relative skills of the one of ordinary skill in the art to have arrived at the claimed range of saponin (i.e. 1 to 10% w/v) through routine experimentation based on the general guidance on level of emulsification desired. Moreover, in any case, the selection of appropriate w/v percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in % w/v. "[W]here 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." See MPEP § 2144.05(II)(A).
Claims 1-5, 7, 9-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Edelson et al. (US 2011/0212157 A1, 09/01/2011) (hereinafter Edelson).
The disclosure of Edelson is discussed above. While Edelson is believed to support a finding of anticipation, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, Edelson will be interpreted as though it does not anticipate the instant claims.
Edelson disclose topically applied ([0033]) nanoemulsions (i.e. nanoparticle composition) comprising at least one therapeutic agent including botulinum toxin (abs) useful in various cosmetic and medical applications ([0008]). The at least one therapeutic agent may be encapsulated by one or more nanoparticles ([0071]). The botulinum toxin is produced by Clostridium botulinum, and includes serotypes A, B, C, D, E, F, G, as isolated or part of a protein complex ([0032]) formulated with a stabilizing agent such as albumin ([0154]) including human serum albumin ([0157]). The at least one therapeutic agent includes a nucleic acid (i.e. instantly claimed biomolecule) (claim 150) or therapeutic antibodies ([0238]). The composition may further comprise surface active agents and/or emulsifiers including polyoxyethylene sorbitan (TWEEN® 60) and sorbitan monooleate (SPAN® 80) ([0283]); antimicrobial preservatives such as phenoxyethanol ([0285]); lubricating agents including hydrogenated vegetable oils ([0287]), for example, castor ([0288]); oils including soybean oil and dimethicone ([0288]) and medium chain triglycerides containing caprylic and capric acids (i.e. caprylic/capric triglyceride) ([0112]-[0114]); water and cosmetically acceptable solvents including propylene glycol in proportions of up to 70% by weight of the total composition ([0318]); and nicotinamide (i.e., vitamin B3 or niacinamide), which is thought to have anti-inflammatory activity and/or to result in increased synthesis of collagen ([0186]). The formulation may be a lotion ([0012]).
As noted by para. [0030] of the instant Specification, propylene glycol is a humectant and dimethicone is an emollient.
The prior art is not anticipatory insofar as this combination 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).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Edelson et al. (US 2011/0212157 A1, 09/01/2011) (hereinafter Edelson) in view of Delgado-González et al. (US 2015/0079137 A1, 03/19/2015) (hereinafter Delgado).
The disclosure of Edelson has been discussed in detail above, and differs from the instant claim insofar as not explicitly disclosing wherein the composition comprises a claimed peptide.
However, Delgado discloses cosmetic and/or dermopharmaceutical compositions for the treatment and/or prevention of wrinkles (abs) as nanoemulsions ([0052]). The compositions comprise anti-wrinkle and/or antiaging agent including sodium hyaluronate and Argireline® (INCI: acetyl hexapeptide-8) ([0064]).
Edelson discloses wherein the composition may comprise at least one therapeutic agent. Accordingly, it would have been obvious to one of ordinary skill in the art to have included Argireline® in the composition of Edelson since it is a known and effective anti-wrinkle and/or antiaging agent suitable for topical nanoemulsions as taught by Delgado.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Edelson et al. (US 2011/0212157 A1, 09/01/2011) (hereinafter Edelson) in view of Delgado-González et al. (US 2015/0079137 A1, 03/19/2015) (hereinafter Delgado), further in view of Baker et al. (US 2012/0064136 A1, 03/15/2012) (hereinafter Baker).
The disclosures of Edelson and Delgado have been discussed above.
It would have been obvious to one of ordinary skill in the art to have included sodium hyaluronate in the composition of Edelson since it is a known and effective anti-wrinkle and/or antiaging agent suitable for topical nanoemulsions as taught by Delgado.
Edelson and Delgado differ from the instant claim insofar as not explicitly disclosing wherein the composition comprises saponin.
However, Baker discloses topical nanoemulsions ([0029]) comprising active agents including botulinum toxin ([0032]). The nanoemulsion may further comprise at least one surfactant ([0028]), including saponin ([0113]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included saponin in the composition of Edelson since it is a known and effective surfactant suitable for topical nanoemulsions as taught by Baker.
Regarding the claimed amounts of propylene glycol, the claimed amounts (i.e. 0.5 to 5% w/v) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. up to 70% by wt.). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding the claimed amounts of phenoxyethanol, sodium hyaluronate, caprylic/capric triglyceride, Span® 80, and saponin, although the prior art does not explicitly disclose amounts of each component, these are result effective variables because they are preservatives, anti-wrinkle agent, oils, emulsifying agents and surfactants, respectively. Therefore it would have taken no more than the relative skills of the one of ordinary skill in the art to have arrived at the claimed ranges of phenoxyethanol, sodium hyaluronate, caprylic/capric triglyceride, Span® 80, and saponin (i.e. 0.1 to 1% w/v; 0.1 to 1% w/v ; 0.5 to 5% w/v; 0.1 to 1% w/v; and 1 to 10% w/v, respectively) through routine experimentation based on the general guidance on desired preservative, anti-wrinkle, oily phase, and emulsification desired. Moreover, in any case, the selection of appropriate w/v percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in % w/v. "[W]here 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." See MPEP § 2144.05(II)(A).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Edelson et al. (US 2011/0212157 A1, 09/01/2011) (hereinafter Edelson) in view of Taylor (US 2006/0018931 A1, 01/26/2006).
The disclosure of Edelson has been discussed in detail above, and differs from the instant claim insofar as not explicitly disclosing a pH range.
However, Taylor discloses wherein the stability of botulinum toxin compositions may be enhanced by incorporating a pH buffer ([0077]) to a pH range of approximately 4 to about 7.5 ([0078]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have stabilized the composition of Edelson such that the pH is within the range of about 4 to about 7.5 since it is a known and effective range suitable for botulinum containing compositions as taught by Taylor. The claimed range (i.e. between 5.5 and 8.0) would have been obvious from selecting from this range.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY M TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Friday 10:00 AM - 6:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached at (571) 272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612