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 .
DETAILED ACTION
Election/Restrictions
Applicant elected following species in the reply filed on 04/23/2026,
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It’s noted the elected permeation enhancer comprises three-component: transcutol, oleyl alcohol and octyldodecanol.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election without argument has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-2, 5-10, 12-13, 16, 18-21, 23, 25-27, and 30 read on elected composition species.
Status of Claims
Claims 1-2, 5-10, 12-13, 16, 18-21, 23, 25-27, and 30 are pending and currently under examination in this office action.
Priority
This application 18/266,974 filed on 06/13/2023 is 371 of PCT/IB2021/062364 filed 12/28/2021, which claims benefit of priority to US provisional application 63/131,647 filed on 12/29/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted 06/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the relevant references disclosed in IDS are being considered by the examiner.
Claim Interpretation
Instant claimed compound A , N-[(1S)-1-(5-fluoropyrimidin-2-yl)ethyl]-3-(3-propan-2-yloxy-1H-pyrazol-5-yl)imidazo[4,5-b]pyridin-5-amine, has CAS # 1079274-94-4, is also known as AZD-7451, utatrectinib (See PubChem database CID 25115967, retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/25115967). AZD-7451 / utatrectinib is a tropomyosin receptor kinase (TRK) inhibitor with potential antineoplastic activity.
Claim 30 recites AUC 0-24 after the composition is administered topically to the skin of the subject. The AUC 0-24 is considered as the property of the composition and/or intended treatment outcome which does not further contribute to structural limitation of instantly claimed composition.
Claim Objections
Claim 21 reciting “according to any preceding claim” is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Claim 23 is also objected to due to dependency on claim 21.
Drawings
The drawings filed on 06/13/2023 are objected to because Figures 4-6 are blurry and not clear.
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.
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.
Claims 21, 23, 25 and 30 are rejected under 35 U.S.C. 112(b) 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 21 reciting “according to any preceding claim” , the scope of claim 21 is indefinite since it’s not clear which preceding claim(s) claim 21 depends on. Claim 23 is also rejected due to dependency on claim 21.
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 instant case, claim 25 recites the droplet size of the oil at broad ranges from 1 pm to 50 pm, and narrower range/limitation between 1 pm to 30 pm . 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 30 recites AUC0-24 after the composition is administered topically to the skin of the subject which is considered as the property of the composition and/or intended treatment outcome, does not further contribute to structural limitation of instantly claimed composition. An ordinary skilled in the art would not be appraised the scope of claim 30. As stated in MPEP 2173.05: “Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 30 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 30 depends on claim 1 and recites AUC 0-24 after the composition is administered topically to the skin of the subject. The AUC 0-24 is considered as the property of the composition and/or intended treatment outcome which does not further contribute to structural limitation of instantly claimed composition. Thus, claim 30 fails to further limit the pharmaceutical composition of claim 1 upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC§ 102
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 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 1-2, 5, 12 and 19-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Davies et al. ( US 8,486,966 B2, family member of WO 2008135785 A1, Applicant’s IDS dated 06/13/2023).
Davies disclosed a compound of Formula I as tropomyosin related kinases (Trks), pharmaceutical salt and pharmaceutical compositions thereof, and methods of treating proliferative disorders (e.g. (cancer, inflammatory disorders, psoriasis, etc. ) (See abstract, Col. 3, lines 40-65; Col. 4, lines 1-15, 39-58; claims 1-4). Davies explicitly discloses instant claimed compound A (See claim 1, Example 6) .
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Davies teaches pharmaceutical compositions comprising compound of Formula I and at least one pharmaceutically acceptable carrier, diluent, or excipient (See Col. 23, lines 24-27; claim 4).
Regarding claim 2, Davies teaches pharmaceutical compositions in various form for topical use, e.g. creams, ointments, emulsions, gels, or aqueous or oily solutions etc. (See Col. 23, lines 31-33). Davies also teaches embodiments of oil-in-water emulsions comprising variety of excipients (See Col. 23, lines 31-33; Col. 24, lines 40-50).
Regarding claim 5, Davies teaches variety of pharmaceutically excipient, e.g., propylene glycol, glycerol, 1,3-butanediol, fatty acid alcohol (e.g. cetyl alcohol), ethylene oxide derivatives with long chain aliphatic alcohols (e.g. heptadecaethyleneoxycetanol), etc. (See Col. 24, lines 1-67).
Regarding claim 12, Davies teaches embodiments comprising preservative ( ethyl or propyl p-hydroxybenzoate) and anti-oxidant (e.g. ascorbic acid) (See Col. 24, lines 18-19, 29-30).
Regarding claim 19-20, Davies teaches compounds of Formula (I) in various salt form, e.g. methanesulfonate, ethane sulfonate, etc. (See Col. 12, lines 54-67).
Davies collectively teaches pharmaceutical composition comprising instant compound A and salt thereof, and pharmaceutical excipients (e.g. propylene glycol , cetyl alcohol, anti-oxidant, etc.) that read on instant permeation enhancer/ pharmaceutical excipients. As such, Davies anticipates instant claimed invention.
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.
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.
Claims 1-2, 5-10, 12, 16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 8,486,966 B2, family member of WO 2008135785 A1, Applicant’s IDS dated 06/13/2023) , in view of Osborne et al. (AAPS PharmSciTech . 2018 Nov 12;19(8):3512–3533. doi: 10.1208/s12249-018-1196-8, Skin Penetration and Permeation Properties of Transcutol®—Neat or Diluted Mixtures).
The collective teachings of Davies are elaborate in preceding 102 rejection and applied as before. Davies collectively teaches topical pharmaceutical composition comprising instant claimed compound A and salt thereof, and other pharmaceutical excipients, e.g. fatty acid alcohol /cetyl alcohol) , etc. for treating disease associated with cell proliferation (e.g. cancer, inflammatory disorders, psoriasis, etc.).
Regarding claim 18, Davies teaches the amount of active ingredient in a single dosage form vary depending upon the host treated and the particular route of administration, e g. from 0.5 mg to 4 g, 1mg to about 500 mg, etc. (See Col. 25, lines 9-24). A skilled artisan would have known to explore/optimize the amount of active ingredient for desired treatment outcome.
Davies is silent about the limitation “ at least two permeation enhancer” and one of these permeation enhancers is diethylene glycol monoethyl ether.
Osborne teaches Transcutol® (i.e. diethylene glycol monoethyl ether, DEGEE) is a safe solubilizer and enhancer for topical/transdermal delivery of broad range of drug, and its enhancing effect on drug solubilization, percutaneous absorption rate, etc.(See whole article). Osborne teaches (FDA) lists DEGEE for topical (up to 49.9%) and transdermal (up to 5%) routes of administration (See page 3513, right column).
Osborne teaches variety chemical enhancers by functional category and chemical classification, e.g. octyl dodecanol, oleyl alcohol, glycols, etc. (See Table 1, page 3513). Osborne further teaches effect of Transcutol binary solvent blends on drug penetration/permeation wherein DEGEE is mixed/combined with a variety enhancer, e.g. MCT, PG, PGML, PGMC, OA, IPM, propylene glycol laurate (PGL), or sucrose esters, etc. wherein Transcutol blends can dramatically increase the skin flux of certain pharmaceutical active ingredients (See p.3522, Fig.8). Osborne teaches various ratio of Transcutol blends, e.g. 10% TRC: 50% PG, (See p.3522, right column), or 40:60 ratio of TRC/PGMC or TRC/PGML or 2:1:7 combination of TRC/OA/PEG showed the highest in vitro permeation profiles, in the Sprague-Dawley rat skin model (See p. 3523, left column; p3525, right colulmn ).
It would have been obvious to one of the ordinary skilled in the art before the effective filing date of instant application to incorporate permeation enhancer Transcutol® (i.e. diethylene glycol monoethyl ether) in combination with other enhancer(s) taught by Osborne into the topical composition of compound A taught by Davies , together with experimentation/ optimization of the active and inactive ingredients based on general knowledge of pharmaceutical composition. A skilled artisan would be motivated to incorporate Transcutol® (i.e. diethylene glycol monoethyl ether) blend with other permeation enhancers(e.g. octyl dodecanol, oleyl alcohol, etc.) because Osborne teaches diethylene glycol monoethyl ether is one of the most commonly used permeation enhancer that combines with other permeation enhancers for topical delivery of active drug. A skilled artisan would reasonably expect the combination of permeation enhancers comprising diethylene glycol monoethyl ether would provide better drug penetration/permeation of compound A. 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. MPEP 2144.05.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with optimization based on general knowledge of permeation enhancer and pharmaceutical composition. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-2, 5-10, 12-13, 16, 18-20, 26, 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 8,486,966 B2, family member of WO 2008135785 A1, Applicant’s IDS dated 06/13/2023) , in view of Sonti et al. (US20180064656A1).
The collective teachings of Davies are elaborated in preceding 35 USC 102 and 103 rejection and applied as before. Davies collectively teaches topical pharmaceutical composition comprising instant claimed compound A and salt thereof, and other pharmaceutical excipients, e.g. fatty acid alcohol /cetyl alcohol) , etc. for treating disease associated with cell proliferation (e.g. cancers inflammatory disorders, psoriasis, etc.).
Davies is silent about “ at least two permeation enhancer” and one of these permeation enhancers is diethylene glycol monoethyl ether.
Sonti teaches topical pharmaceutical oil-in-water O/W emulsion composition (e.g. cream or lotion) comprising active ingredient and pharmaceutical acceptable excipients(e.g. penetration enhancer, co- solvent , antioxidant, pH adjusting agent, etc.) for treating dermatological condition/ disorder (e.g. inflammatory skin disease, psoriasis , etc.) (See abstract, [0127]- [0131], [0395]-0397], claims 1-34).
Regarding penetration enhancer and limitation of claims 5-6 and 10, Sonti teaches topical pharmaceutical emulsion composition comprises penetration enhancer wherein the penetration enhancer is a mixture of two or more penetration enhancers, e.g. alcohol, fatty alcohols , fatty acids , fatty acid esters, etc. at various amount from about 0.5 % to about 40 % by weight , etc. (See [0155]-0165]). Sonti explicitly teaches diethylene glycol monoethyl ether and mixture thereof as exemplary penetration enhancers in various amount (See [0162], Examples 1-8, Table 1- 10) . Sonti teaches topical pharmaceutical emulsion composition comprises co-solvent, e.g. diethylene glycol monoethyl ether(i.e. Transcutol ), propylene glycol, octyldodecanol (Eutanol G), etc. (See [0148], [0150], [0153]) and the co-solvent or mixture of two or more co-solvents may function as a penetration enhancer (See [0155]).
Regarding claims 7-8, Sonti teaches exemplary fatty alcohol penetration enhancer, e.g. oleyl alcohol , cetyl alcohol , stearyl alcohol , decanol , tridecanol , etc. and mixtures thereof (See [0159]). Sonti teaches octyldodecanol (Eutanol G) as co-solvent which may function as a penetration enhancer (See [0148],[0153]).
Regarding claim 9, Sonti teaches embodiments comprising combination/mixture of diethylene glycol monoethyl ether and propylene glycol at various ratio, e.g. 1:5, (See Examples 1-8, Table 1- 10). It would have been prima facie obvious to explore the combination of diethylene glycol monoethyl ether with oleyl alcohol and optimize the ratio thereof wherein oleyl alcohol is considered as equivalent penetration enhancer as propylene glycol.
Regarding claim 10, Sonti teaches embodiments comprising diethylene glycol monoethyl ether and mixture thereof, in various amount, from about 0.5 % to about 40 % by weight, e.g. 2% (See [0165], Examples 1-8, Table 1- 10).
Regarding antioxidant of claims 12-13 and 16, Sonti teaches topical pharmaceutical emulsion compositions comprise an antioxidant or combination thereof, e.g. butylated hydroxytoluene ( BHT ) , butylated hydroxyanisole ( BHA ) , tocopherol, etc. at various amount/concentration, from
about 0.01 % to 1 % by weight, 0.05 % by weight or about 0.1%, based on the total weight of the composition (See [0122]-[0126]).
Regarding claim 25, Sonti teaches the emulsion is an oil-in-water o/w cream (See [0102], [0129]-[0130]). Sonti teaches oil-in- water cream comprising diethylene glycol monoethyl ether and propylene glycol (See [0288]). Sonti teaches embodiments with various droplet size, e.g. from about 0.05 to about 35 microns, etc. (See [0066]-[0074], [0463]- [0467], claim 24).
Regarding claim 26 , Sonti teaches variety of pH adjusting agent, e.g. citric acid/citrate, edetate/ edetic acid, etc. in an amount from about 0.01 % to about 10 % by weight , based on the total weight of the composition (See [0132]-0135], [0207]), wherein pH is adjusted between about 2 to about 6 , about 4 to about 6 , etc. ( See [0135],[0171], [0201]).
Regarding claim 27, Sonti teaches embodiments comprising surfactant with various hydrophilic / lipophilic balance (HLB) value, wherein lipophilic surfactants tend to form water-in- oil (W/O ) emulsions , and hydrophilic surfactants tend to form oil-in- water ( O/W ) emulsions, wherein weighted average of the HLB values of the two or more non - ionic surfactants is from about 1 to about 10 (See [0105]-[0106]).
Regarding claim 30, Sonti teaches evaluation/measurement of AUC for the active ingredient after administration ( See [0350]-[0354]).
Sonti collectively teaches topical pharmaceutical composition (e.g. cream or lotion) comprising active ingredient and penetration enhancer (e.g. diethylene glycol monoethyl ether, propylene glycol, etc. and combination thereof ), and other pharmaceutical acceptable excipients (e.g. antioxidant, pH adjusting agent, etc.) for treating dermatological condition/ disorder (e.g. inflammatory skin disease, psoriasis , etc.).
It would have been obvious to one of the ordinary skilled in the art before the effective filing date of instant application to modify the topical composition of compound A taught by Davies by incorporating permeation enhancer taught by Sonti, together with experimentation/ optimization of the active and inactive ingredients based on general knowledge of pharmaceutical composition. A skilled artisan would be motivated to incorporate. diethylene glycol monoethyl ether combination with other permeation enhancers/cosolvent (e.g. octyl dodecanol, oleyl alcohol, etc.), and reasonably expect the combination of permeation enhancers would provide better drug penetration/permeation of compound A for treating dermatological condition/ disorder (e.g. inflammatory skin disease, psoriasis , etc.).
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with optimization based on general knowledge of permeation enhancer and pharmaceutical composition. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-2, 5-10, 12-13, 16, 18-21, 23, 25-27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 8,486,966 B2, family member of WO 2008135785 A1, Applicant’s IDS dated 06/13/2023 ), in view of Sonti et al. (US20180064656A1) and Merchant et al. ( US 2017/0152273 A1).
The collective teachings of Davies and Sonti are elaborated in preceding 35 USC 102 and 103 rejection and applied as before. Davies collectively teaches topical pharmaceutical composition comprising instant claimed compound A and salt thereof, and other pharmaceutical excipients, e.g. fatty acid alcohol /cetyl alcohol) , etc. for treating disease states associated with cell proliferation (e.g. cancers inflammatory disorders, psoriasis, etc.)
Sonti collectively teaches topical pharmaceutical composition (e.g. cream or lotion) comprising active ingredient and penetration enhancer (e.g. diethylene glycol monoethyl ether, propylene glycol, etc. and combination thereof ), and other pharmaceutical acceptable excipients (e.g. antioxidant, pH adjusting agent, etc.) for treating dermatological condition/ disorder (e.g. inflammatory skin disease, psoriasis , etc.). Sonti teaches variety of pH adjusting agent, e.g. citric acid/citrate, edetate/ edetic acid, etc. in an amount from about 0.01 % to about 10 % by weight wherein pH is adjusted between about 2 to about 6 , about 4 to about 6.
Davies and Sonti are silent about and specific pH adjusting agent of claim 21 and 23.
Merchant teaches topical pharmaceutical formulation comprising active ingredient and variety of pharmaceutical excipients/ permeation enhancers for treating inflammatory-related conditions, such as atopic dermatitis and/or psoriasis(See abstract, [0001], [0006]-[0007], Examples 1-8, claims 1-39).
Regarding pH adjusting agent recited in claim 21, 23, Merchant teaches Trolamin at 0.84% (See Example 2). A skilled artisan would have known to optimize the amount of Trolamin and ratio to the active ingredient for the desired pH range.
Regarding claim 6-10, Merchant teaches solvent study with Transcutol (i.e. diethylene glycol monoethyl ether), oleyl alcohol, propylene glycol, etc. (See Table 5 and 6). Merchant explicitly teaches embodiments comprising active ingredient, combination of propylene glycol/oleyl alcohol/ octyldodecanol, pH adjusting agent (Trolamine), antioxidant (BHT), and other pharmaceutical excipients, (See Example 2, [0504]).
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It would have been prima facie obvious to explore the combination of diethylene glycol monoethyl ether with oleyl alcohol and octyldodecanol, and optimize the ratio thereof wherein diethylene glycol monoethyl ether is considered as equivalent penetration enhancer as propylene glycol.
Regarding the antioxidant recited in instant claims 12-13 and 16, Merchant teaches embodiments comprising antioxidant (e.g. butylated hydroxytoluene, butylated hydroxyanisole, tocopherol, etc.) from about 0.01% (w/w) to about 1% (w/w) (See [0064]-[0065], claim 11-13, Example 2).
Regarding claim 18, Merchant teaches various amount/concentration for variety of active ingredient and salt thereof, e.g. at about 0.1% to about 3.0% (w/w), etc. (See [0029]-[0032], claims , Examples)
Regarding claim 27, Merchant teaches emulsifier with an hydrophilic-lipophilic balance (HLB) value of 4-6 was desired for a water-in-oil type emulsion (See 0147]).
It would have been obvious to one of the ordinary skilled in the art before the effective filing date of instant application to further explore/modify the topical composition comprising compound A taught by Davies with the combined teachings of topical composition comprising penetration enhancer/solvent by Sonti and Merchant, together with experimentation/ optimization of the active and inactive ingredients based on general knowledge of pharmaceutical composition , and arrive at instant claimed invention with reasonable expectation of success. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to further optimize combination of penetration enhancer and other inactive ingredients and amount thereof for desired penetration profile and stability. A skilled artisan would be motivated to further explore combination of penetration enhancer comprising diethylene glycol monoethyl ether and reasonably expect the combination of permeation enhancers would provide better drug penetration/permeation of compound A for treating dermatological condition/ disorder. 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. MPEP 2144.05.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with optimization based on general knowledge of pharmaceutical composition. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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/JARED BARSKY/ Primary Examiner, Art Unit 1628
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