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 .
Priority
Applicant has made no claim for the benefit of a prior-filed application and therefore the Effective Filing Date is 7 August, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7 August, 2024 is acknowledged and has been considered.
Status of the Application
Receipt is acknowledged of Applicant's claimed invention, filed 7 August, 2024, in the matter of Application N° 18/796,666. Said documents have been entered on the record.
No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot.
Thus, Claims 1-20 represent all claims currently under consideration.
Claim Objections
Claim 7 is objected to because of the following informalities: “orally” is listed twice.
Claims 17-18 are objected to because of the following informalities: “time” should be plural in the phrases “70 time a week” and “10 time a week”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating an inflammatory skin disease, does not reasonably provide enablement for preventing an inflammatory skin disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Regarding Claim 1, while the specification repeatedly refers to methods of “preventing or treating” inflammatory skin diseases and defines “prevention” generally as administration to a subject who has not yet been diagnosed with the disease but may be predisposed thereto, the disclosure does not reasonably enable the full scope of the claimed prevention methods. Specifically, the working examples and experimental data evaluate administration of the claimed compositions to subjects or disease models having existing inflammatory skin disease and assess therapeutic efficacy following administration. The specification does not provide guidance regarding prophylactic administration, including appropriate timing, dosing regimen, duration of treatment, patient selection, or experimental evidence demonstrating prevention of disease onset.
The claims encompass prevention of multiple inflammatory skin diseases having differing etiologies, including, for example, psoriasis, herpes simplex, shingles, eczema, and urticaria. The specification does not explain why therapeutic efficacy in subjects with established disease would reasonably predict prophylactic efficacy across this broad range of diseases, nor does it provide guidance sufficient to permit one of ordinary skill in the art to practice prevention across the full scope of the claims without undue experimentation.
For example, psoriasis is a chronic immune-mediated inflammatory disease. Although the specification provides therapeutic data relating to treatment of established disease (e.g., Pg. 19-20, Example 6), it provides no teaching or evidence that topical administration of the claimed compositions to an asymptomatic individual would prevent the subsequent development of psoriasis, nor does it provide guidance from which such prophylactic use could be practiced without undue experimentation.
Claims 2-20 are dependent from Claim 1, and fail to cure the deficiencies as stated above.
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 2-3 and 7-8 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 2 recites “wherein R1-R7 are independently selected from the group consisting of [list], or R6 and R7 are linked to each other to form a ring.” As written, the use of the disjunctive “or” renders it unclear whether the alternative embodiment in which R6 and R7 are linked to each other to form a ring is an alternative to the entire preceding limitation defining R1-R7, or merely an alternative definition for R6 and R7. Consequently, it is unclear whether, in the embodiment where R6 and R7 form a ring, the definitions of R1-R5 remain independently selected from the recited Markush group or are no longer defined by the claim. Accordingly, the metes and bounds of the claimed subject matter cannot be determined with reasonable certainty.
Regarding Claim 3, Claim 2 recites that the alkyl group, the alkoxy group, the cycloalkyl group, the cycloheteroalkyl group, and the ring in R1 to R7 may be substituted with one or more substituents. Claim 3 subsequently recites that “the substituent” is selected from the group consisting of [list]. However, it is unclear whether Claim 3 limits each of the one or more substituents, only one substituent where multiple substituents are present, or otherwise limits only a subset of the optional substituents recited in Claim 2.
Claims 7-8 recites the limitation “the composition agent”. There is insufficient antecedent basis for this limitation in the claim. Claim 1 introduces only “a composition,” which comprises a benzenesulfonamide derivative and a pharmaceutically or cosmetically acceptable excipient.
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 6 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 5 limits the inflammatory skin disease to the closed Markush group consisting of herpes simplex, shingles, eczema, psoriasis, urticaria, and any combination thereof. Claim 6 instead recites that the inflammatory skin disease is atopic dermatitis, which is not one of the alternatives recited in Claim 5.
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.
Claims 1, 5-8, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Musicki et al. (US 10,457,637 B2, published 29 October, 2019), hereinafter Musicki.
Regarding Claims 1 and 5-6, Musicki teaches a method of treating an inflammatory disorder and/or autoimmune disease, the method comprising administering an effective amount of a benzenesulfonamide derivative, to an individual subject in need thereof, wherein the inflammatory disorder and/or autoimmune disease is acne, atopic dermatitis and/or psoriasis, and further a pharmaceutical composition comprising a benzenesulfonamide derivative and a pharmaceutically acceptable carrier, wherein the composition is formulated for treating is acne, atopic dermatitis and/or psoriasis (‘637, Abstract and Col 245-246, Claims 7 and 10-11).
Regarding Claim 7-8, Musicki teaches pharmaceutical composition may be administered orally or topically (‘637, Col 72, Lines 54-55).
Regarding Claim 15, Musicki teaches the pharmaceutical composition is conditioned in a form that is suitable for topical application (‘637, Col 72, Lines 56-57).
Regarding Claim 16, Musicki teaches the pharmaceutical composition in the form of ointments, creams, milks, pomades, powders, impregnated pads, syndets, solutions, gels, sprays, mousses, suspensions, sticks, shampoos or washing bases. It may also be in the form of suspensions of microspheres or nanospheres or lipid or polymeric vesicles or of polymeric or gelled patches allowing controlled release (‘637, Col 72, Lines 63-67 and Col 73, Lines 1-5).
As such, Claims 1, 5-8, and 15-16 are anticipated by Musicki.
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 1-4 and 7-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tu et al. (US 2019/0201356 Al), hereinafter Tu.
Reference shares overlapping Applicant and Inventors with instant claims.
Regarding Claims 1 and 7-8, Tu teaches a method for preventing or treating acne comprising administering a topical formulation including a benzenesulfonamide derivative, and a pharmaceutically or cosmetically acceptable excipient to a subject in need thereof (‘356, Abstract). Further, Tu discloses Acne is a skin disease and is considered as a chronic inflammation of hair follicles and oil glands (‘356, Pg 1, Para 0002), therefore there was a focus on developing a topical agent which provides strong antimicrobial and anti-inflammation effects (‘356, Pg 1, Para 0004).
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Regarding Claim 2, Tu teaches the benzenesulfonamide derivative in the topical formulation may be represented by formula (I), shown right, or a pharmaceutically acceptable salt thereof, wherein R1 to R7 are independently selected from the group consisting of H, a C1 -C6 linear or branched alkyl group, a C1 -C6 linear or branched alkoxy group, a C3-C6 cycloalkyl group, a C3-C6 cycloheteroalkyl group, an amino group, and a halo group, or R6 and R7 are linked to each other to form a ring, and wherein the alkyl, alkoxy, cycloalkyl, cycloheteroalkyl group and the ring are unsubstituted or substituted with one or more substituents (‘356, Pg 1, Para 0007-0009).
Regarding Claim 3, Tu teaches the substituent may be selected from the group consisting of phenyl, halo, oxo, ether, hydroxyl, carboxyl, amino, sulfa and sulfonamide group (‘356, Pg 1, Para 0009).
Regarding Claim 4, Tu teaches the benzenesulfonamide derivative may be selected from the group consisting of para-toluene sulfonamide, ortho-toluene sulfonamide, meta-toluene sulfonamide, N-ethyl-ortho-toluene sulfonamide, N-ethyl-para-toluene sulfonamide, N-cyclohexyl-para-toluene sulfonamide (‘356, Pg 1, Para 0010).
Regarding Claim 9, Tu teaches the pharmaceutically or cosmetically acceptable excipient may be a preservative, a lubricant, a suspending agent, a wetting agent, a flavoring agent, a thickening agent, a biocompatible solvent, a surfactant, a complexation agent, and any combination thereof (‘356, Pg 6, Para 0032).
Regarding Claim 10, Tu teaches the biocompatible solvent may be polyethylene glycol, propylene glycol, glycerol, sorbitol, ethanol, dimethyl sulfoxide, N-methyl-2-pyrrolidone (NMP), N,N-dimethylacetamide (DMA), glycofurol, acetone, isopropyl alcohol (IPA), triglyceride, benzyl benzoate, benzyl alcohol, solketal or any combination thereof (‘356, Pg 7, Para 0039).
Regarding Claim 11, Tu teaches the surfactant may be lecithin, macrogol 15 hydroxystearate, polyoxyethylene alkyl ether, polyoxyethylene castor oil, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene stearate, polyoxylglyceride, sorbitan ester, tocopheryl polyethylene glycol succinate (TPGS) or any combination thereof (‘356, Pg 7, Para 0040).
Regarding Claim 12, Tu teaches the complexation agent may be polyvinyl pyrrolidone or cyclodextrin (‘356, Pg 7, Para 0041).
Regarding Claim 13, Tu teaches the benzenesulfonamide derivative is present in an amount ranging from about 1 % to about 50% by weight (‘356, Pg 7, Para 0042). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP § 2144.05(I).
Regarding Claim 14, Tu teaches the pharmaceutically or cosmetically acceptable excipient is present in an amount ranging from about 30% to about 99% by weight (‘356, Pg 7, Para 0043).
Regarding Claim 15, Tu teaches the topical formulation is in a non-aqueous form suitable for topical administration (‘356, Pg 7, Para 0044).
Regarding Claim 16, Tu teaches the topical formulation may be in a form of a gel, a lotion, an ointment, an emulsifier, a paste or a cream (‘356, Pg 7, Para 0044).
Regarding Claims 17-18, Tu teaches the face acne was improved after applying the p-TSA-containing topical formulation (GW-S201) evenly to the subject's face for three or four times a day within one week (‘356, Pg 9, Para 0068, Example 5).
Regarding Claims 19-20, it would have been obvious to one of ordinary skill in the art at the time of the invention to continue administration of the topical composition for at least one, or two, week(s) because inflammatory skin diseases, such as psoriasis are not ordinarily resolved following a single application. A person of ordinary skill in the art would have understood that repeated administration over a clinically appropriate treatment period would have been routine to achieve and maintain the desired therapeutic effect. Selecting a treatment duration of at least one week or at least two weeks therefore constitute no more than routine optimization of an otherwise known treatment regimen.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of invention to employ the topical benzenesulfonamide compositions of Tu, which are disclosed for preventing or treating acne, in the treatment of other inflammatory skin diseases. Tu expressly recognizes acne as an inflammatory skin disease and attributes the therapeutic efficacy of the disclosed topical compositions to the antimicrobial and anti-inflammatory effects. Because inflammation is a common pathological component of inflammatory skin diseases, a person of ordinary skill in the art would have reasonably expected that a topical composition demonstrated to reduce cutaneous inflammation in acne would likewise provide therapeutic benefit in the treatment of other inflammatory skin diseases. Extending the known topical treatment from one inflammatory skin disease (acne) to other inflammatory skin diseases there represents no more than the predictable use of a known composition according to its established properties.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 7-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-4 and 7-10 of U.S. Patent No. 10,548,862 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patented and instant set of claims are directed to the same benzenesulfonamide compounds/compositions. The instant claims differ primarily in reciting treatment of a different inflammatory skin disease. However, such differences do not render the instant claims patentably distinct from the patented claims because modification would have been obvious to one of ordinary skill in the art in view of the common anti-inflammatory properties of the disclosed compounds.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
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