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 .
Status of Claims
A new claim set was filed on 3/19/25 with the following:
Amended claims
Newly canceled claims
1-30
Newly added claims
31-51
Previously canceled claims
Previously withdrawn claims
Claims under instant examination
31-51
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 31-51 are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. (US 2008/0107646; published: May 8, 2008) in view of Fraser et al. (US 20150056276; published: Feb. 26, 2015) and Fischer (US 2015/0150904; published: 6/4/15).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Chung et al. is directed to method of ameliorating pruritus (Title). Chung et al. teach a method for preventing, treating or ameliorating pruritus caused by skin, mucosa or systemic disorder (e.g., psoriasis), wherein the method comprises administering to a subject with pruritus an effective amount of a formulation consisting essentially of a phenylbutyric acid (claimed component a) or short-chain fatty acid derivative and a pharmaceutically acceptable carrier (claimed component d), salt or solvate thereof (limitation of instant claims 31 and 41-42; Abstract and [0025]). Chung et al. teach that the other short chain fatty acid of 2-6 carbons in length include butyric acid (claimed component a) and propionate (limitation of instant claims 31; [0020]).
Chung et al. teach wherein the formulation is formed into a capsule (claims; i.e., orally administered) or in the form of a topical gel applied to the affected skin six times per day for 1 week (limitation of instant claims 31-33, 40-41, 43 and 51; [0039]).
Examiner’s note: with regards to instant claims 41-44, the broadest reasonable interpretation includes all ingredients in one formulation administered together. There is no requirement in the claim that they are administered separately and/or at different times. Chung et al. teach wherein the abovementioned formulation is administered in combination with a second agent such as a vitamin and wherein the formulation and the second agent are administered simultaneously or sequentially [see claims].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
With regards to the amount of ingredients, Chung et al. do not teach specifically wherein the butyric acid or pharmaceutically acceptable salt (e.g., salt of butyrate) in the composition is from about 800 to about 1800 mg, as required by instant claims 34, 41 and 45.
Chung et al. do not teach wherein the composition further comprises a therapeutically effective amount of Vitamin D3 (from about 50 IU to about 200 IU or about 50 IU), as required by instant claims 31, 38-39, 41-42 and 49-50. However, such deficiencies are cured by Fraser et al.
Fraser et al. is directed to compositions comprising omega-3 fatty acids and vitamin D for psoriasis (Title). Fraser et al. teach that a combination of Vitamin D and omega-3 fatty acids synergistically inhibit the proliferative/pro-inflammatory activity of key cells involved in the generation of psoriatic lesions (CD4+ T-cells and keratinocytes) ([0026]). And more specifically, Fraser et al. teach the incorporation of Vitamin D3 (see entire reference; e.g., claim 257) and wherein the total daily dosage of vitamin D may range in an amount from about 1000 to about 6000 IU.
Chung et al. do not teach wherein the first pharmaceutical composition further comprises a source of magnesium (e.g., magnesium salt) in an amount from about 10 to about 20 mg (e.g., about 10 mg), as required by instant claims 31, 35-37, 41-42 and 46-48. However, such deficiency is cured by Fischer.
Fischer is directed to a dietary supplement composition as a prophylactic and treatment for skin diseases such as psoriasis (Title). Fischer teaches that its composition comprises a phase II liver detoxification component having glycine and magnesium (Abstract). Fischer teaches that the magnesium is present in the orally administered composition in an amount of about 30 mg (which overlaps about 20 mg when you take into account +/- 10% for the term “about”). As indicated in MPEP §2144.05(I): “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding the concentration of butyrate and vitamin D3 as specified in claims 34, 38-39, 41, 45 and 49-50, MPEP §2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Chung et al. teach wherein the short-chain fatty acid derivative contains 2-6 carbons in length such as butyrate and is present in an amount ranging from about 0.00001 to about 100.00% by weight of the formulation (claims). More specifically, Chung et al. teach that the phenylbutyric acid derivative or short-chain acid active ingredient in a topical skin care composition is present in a dosage of 1 to 1000 mg, which overlaps with the claimed ranges (e.g., from about 800 mg to about 1800 mg of butyric) ([0023]; see MPEP §2144.05). Fraser et al. teach the incorporation of Vitamin D3 and wherein the total daily dosage of vitamin D may range in an amount from about 1000 to about 6000 IU. It is noted that this is the daily dose and a person of ordinary skill in the art would understand that human patients acquire some vitamin D3 from the environment (see [0022]) and their nutrition (for example, in fish and eggs). The Applicants' specification provides no evidence that the selected concentration range in claims 34, 38-39, 41, 45 and 49-50 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to numerous factors (e.g., age, weight, sex, disease and stage of disease of patient, as well as patient’s baseline vitamin D3 amount), it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the concentration. One of ordinary skill in the art would have been motivated to change the concentration as this could be expected to be advantageous for providing the optimal dose for the patient.
The disclosures of Chung et al. and Fraser et al. are each directed to methods of treating pruritis (associated with psoriasis) and its symptoms by administering a composition (orally or topically). Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine their respective teachings and to further incorporate vitamin D3 (and omega-e fatty acids) into the composition of Chung et al., as instantly claimed, with a reasonable expectation of success, at the time of the instant application. A person of ordinary skill would have been motivated to do so because Fraser et al. teach that vitamin D3-containing compositions help treat psoriasis.
Chung et al. and Fischer are both directed to methods of treating skin diseases such as psoriasis and its symptoms by administering a composition orally. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the composition of Chung et al. by further incorporating magnesium to achieve the predictable result of obtaining a composition suitable for treating psoriasis. One of ordinary skill in the art would have been motivated to do so because Fischer teaches that it is advantageous for phase II liver detoxification (Abstract). Fischer teaches that this phase 2 liver detoxification of salicylate in the patient enables patients suffering from skin diseases to eat a wider variety of foods without adverse effect.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been 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.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 31-51 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 31, 40, 51, 54 and 57-59 of copending Application No. 17/584,125 (allowed but not issued yet). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same method of treating psoriasis in a subject in need thereof, the method comprising orally administering a composition to the subject comprising a therapeutically effective amount of butyric acid or a pharmaceutically acceptable salt thereof (from about 100 mg to about 6 g or about 800 mg to about 1800 mg; i.e., overlapping ranges), a source of magnesium (from about 10 mg to about 20 mg), vitamin D3 (from about 50 IU to about 200 IU). It is noted that the ‘125 method represents a species (with regards to additional ingredients such as propionic acid or a pharmaceutically acceptable salt thereof (from about 20 mg to 200 mg) and apremilast (from about 20 mg to about 200 mg)) within the scope of the instantly claimed genus. Thus, the instant claims and the application claims are obvious variants.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 31-51 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,065,217. Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same method of treating psoriasis in a subject in need thereof, the method comprising orally administering a composition to the subject comprising a therapeutically effective amount of butyric acid or a pharmaceutically acceptable salt thereof (from about 100 mg to about 6 g or about 800 mg to about 1800 mg; or specifically about 800 mg), a source of magnesium (salt, from about 10 mg to about 20 mg; or specifically about 10 mg), vitamin D3 (from about 50 IU to about 200 IU; or specifically about 50 IU), administered three times a day for at least one week. It is noted that the ‘217 method represents a species (with regards to additional ingredients such as propionic acid or a pharmaceutically acceptable salt thereof (from about 20 mg to 200 mg) and the type of psoriasis being treated – psoriatic lesions) within the scope of the instantly claimed genus. Thus, the instant claims and the application claims are obvious variants.
Conclusion
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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