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
Status of the Claims
Claims 1-15 are pending. Claims 1-15 are rejected.
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/IB2022/052838, filed 03/28/2022. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement(s) (IDS) dated 09/13/2023 has been considered.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 is objected to for being written in improper Markush format. Applicant may overcome the objection by, for instance, changing “or” in the second line to “and”. See MPEP 2173.05(h).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 5 and 9 are rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The term “about” in claims 5 and 9 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant may overcome the rejection by, for example, amending the claims to delete each instance of the term “about”.
Claim Rejections - 35 USC § 112(d)
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.
Claims 5, 6 and 9 are rejected under 35 U.S.C. 112(d) 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.
The claims recite “wherein the subject achieves” or “whereby the subject achieves” a percent change/reduction in facial Vitiligo Area Scoring Index (F-VASI), which appears to be merely functional and does not add a positive limitation. The clause merely states the inherent result of the limitations in the claim and does not add to the patentability or substance of the claim. Therefore, the claims do not properly limit the method described in parent claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 5-6, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. in “PF-06651600, a Dual JAK3/TEC Family Kinase Inhibitor”, ACS Chemical Biology, May 13, 2019, 14(6), pp. 1235-1242, as cited in the IDS dated 09/13/2023.
Xu et al. teach PF-06651600 as a Dual JAK3/TEC inhibitor useful in the treatment of vitiligo. See abstract. They also teach a method wherein mice were treated orally with a single 30 mg/kg dose of the drug. See last paragraph of p. 1239, first paragraph of p. 1240 and Figure 4A on page 1240:
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. Thus, claims 1-2 and 11 are anticipated wherein the method involves treating with 30 mg/kg of PF-06651600.
Regarding claims 5, 6 and 9, the limitations only define the conditions when the subject achieves a percent change in facial Vitiligo Area Scoring Index. The conditions only define the intended use/outcome and do not provide any specific active steps that are required for the method of treating vitiligo in the subject. Thus, the limitations are not given patentable weight towards the scope of the claims.
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.
(1 of 2) Claims 1-3, 5-7 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shanler et al. in WO 2019040706 A1, as cited in the IDS dated 09/13/2023, in view of Xu et al. in “PF-06651600, a Dual JAK3/TEC Family Kinase Inhibitor”, ACS Chemical Biology, May 13, 2019, 14(6), pp. 1235-1242, as cited in the IDS dated 09/13/2023.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Shanler et al. teach methods and compositions for the treatment of vitiligo using JAK/STAT modulating compounds. See abstract. Shanler et al. describe both topical and oral administration methods in paragraphs [0030]-[0032] and identifies specifically a pharmaceutically acceptable malonate salt of the compound of instant claim 1 in paragraph [0061]:
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.
Xu et al. teach PF-06651600 as a Dual JAK3/TEC inhibitor useful in the treatment of vitiligo. See abstract. They also teach a method wherein mice were treated orally with a single 30 mg/kg dose of the drug as discussed in the rejection under 35 USC 102 above. See last paragraph of p. 1239, first paragraph of p. 1240 and Figure 4A on page 1240.
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Shanler et al. do not disclose an example wherein the compound of the instant claims, also known as PF-06651600, was administered to a subject in need.
Xu et al. do not teach doses beyond 30 mg/kg, administration periods, or co-treatment with radiation.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
Shanler et al. teach the above embodiment wherein the malonate salt of compound PF-06651600 may be used to treat vitiligo. This compound is one of only 30 examples identified by Shanler et al. for the purpose of treating vitiligo. See for instance the abstract, paragraph [0031], or claim 1. Xu demonstrates PF-06651600’s ability to inhibit JAK3 in a mouse model. See page 1240, left column, first paragraph. Xu teaches that JAK3-selective inhibition “could potentially offer better efficacy/safety ratios in the clinic that would be advantageous for the treatment of various inflammatory diseases.” See page 1235, right column. Moreover, Shanler et al. teach that JAK3 can be a target “for inhibiting the immune mediated inflammatory responses driving immune mediated diseases such as, inter alia, alopecia areata and vitiligo” in paragraph [0025].
Therefore, a person having ordinary skill in the art would have been motivated to pursue the claimed method for treating vitiligo in a subject since PF-06651600 is taught by both Shanler and Xu, has demonstrated success of inhibiting JAK3 in an animal model, and has utility for treating vitiligo.
As it relates to dependent claims 2 and 10-15, Shanler discloses that the JAK/STAT modulating compound may be in an amount of about 20, 25, 50, 100 or 200 mg. See para. [0128] on page 45. They also state that the compound can be administered at least once daily in para. [0114]. Additionally, Shanler et al. advise that the dosage administered may need to be adjusted, subject to various factors:
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. See page 40. Additionally, Shanler et al. teach an example wherein the compound 5-((2-((4-fluoro-3-methoxy-5-methylphenyl)amino)-5-methylpyrimidin-4- yl)amino)benzo[d]oxazol-2(3H)-one hydrochloride is orally gavaged QD in mice at “various doses” and for example 50 mg/kg and 100 mg/kg:
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. See para [0165] on page 61.
A person having ordinary skill in the art would be motivated and expected to optimize the frequency of administration and/or dosage amounts. This is especially true since Applicants do not indicate how/why the cited dosage amounts of the claims are critical. Based on Shanler’s teachings of suitable dosages, the example of another JAK/STAT modulating compound at dosages of the instant claims, and motivation to optimize the dosages, the skilled artisan would have had a reasonable expectation of success in treating vitiligo at the instantly claimed dosages of 50 and 100 mg of claims 1 and 12-15.
Routine optimization of Shanler’s dosage would have led to the claimed dosages of 10 mg and 30 mg because Shanler also teaches a dose from about 0.0001 ug/kg body weight to about 60,000 ug/kg body weight. See for instance claim 5 on page 69:
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. As an example, for a person weighing 80 kg, this dosage amount ranges from 0.000008 mg to 4,800 mg. The skilled artisan would have found it obvious to optimize within this range because Shanler et al. teach administering the JAK/STAT modulator in this range, which includes 10 mg and 30 mg of instant claims 10 and 11.
As it relates to dependent claim 3, Shanler et al. teach that the modulating compound may be administered “at any interval to achieve the therapeutically desired effect, e.g. induction of maintenance of remission.” See para. [0114]. In the same paragraph, they teach administration periods ranging from 1 day to six months:
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. A person having ordinary skill in the art would have identified the presently claimed administration maintenance period of up to 20 weeks following the induction period through routine optimization given that this falls within the range provided by Shanler et al. Thus, claim 3 is obvious in view of the prior art.
As it relates to dependent claim 7, Shanler et al. teach conjunctive administration with one or more additional therapeutics, such as narrow-band UVB. See para. [0134] on page 48 as well as para. [0139] on page 50. They also disclose the predicted results wherein a subject is treated with UVB before administration of a topical solution of a JAK/STAT modulator. See page 65, point 9. A person having ordinary skill in the art would have identified UVB radiation as an additional treatment since Shanler et al. teach that this therapy can be administered in conjunction with the JAK/STAT modulator.
As it relates to dependent claims 5-6 and 9, the limitations only define the conditions when the subject achieves a percent change in facial Vitiligo Area Scoring Index. The conditions only define the intended use/outcome and do not provide any specific active steps that are required for the method of treating vitiligo in the subject. Thus, the limitations are not given patentable weight towards the scope of the claims. Since their parent claims are obvious in view of the prior art, so are claims 5, 6 and 9.
(2 of 2) Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Shanler et al. in WO 2019040706 A1 in view of Xu et al. in “PF-06651600, a Dual JAK3/TEC Family Kinase Inhibitor”, ACS Chemical Biology, May 13, 2019, 14(6), pp. 1235-1242, as cited in the IDS dated 09/13/2023, as applied to claims 1-3, 5-7 and 9-15 above, and further in view of Hamzavi et al. in “Parametric Modeling of Narrowband UV-B Phototherapy for Vitiligo Using a Novel Quantitative Tool: The Vitiligo Area Scoring Index” Arch Dermatol. 2004; 140: 677-683.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Shanler et al. teach methods and compositions for the treatment of vitiligo using JAK/STAT modulating compounds. See abstract. Shanler et al. describe both topical and oral administration methods in paragraphs [0030]-[0032] and identifies specifically a pharmaceutically acceptable salt of the compound of instant claim 1 in paragraph [0061].
Xu et al. teach PF-06651600 as a Dual JAK3/TEC inhibitor useful in the treatment of vitiligo. See abstract. They also teach a method wherein mice were treated orally with a single 30 mg/kg dose of the drug as discussed in the rejection under 35 USC 102 above. See last paragraph of p. 1239, first paragraph of p. 1240 and Figure 4A on page 1240.
Ascertaining the differences between the prior art and the claims at issue. (See MPEP § 2141.02)
Neither Shanler et al. nor Xu et al. teach a method wherein the subject has a body surface area involvement of 4-50% or a method wherein the co-treatment with narrow band ultraviolet B radiation therapy is administered for at least 24 weeks.
Hamzavi et al. does not teach a method wherein the subject is administered PF-06651600.
Considering objective evidence present in the application indicating obviousness or nonobviousness. (See MPEP § 2142-2144)
As it relates to dependent claim 4, Shanler et al. teach that the JAK/STAT modulating compound is expected to have a clinically significant improvement of disease as measured by assessment of response to treatment by clinical evaluation. They specifically indicate changes in the Facial Vitiligo Area Scoring Index for assessing improvements. See para. [0170] and [0171].
Hamzavi et al. teach the Vitiligo Area Scoring Index (VASI) as a “simple clinical tool” first used to “estimate the overall area of vitiligo patches at baseline and the degree of macular repigmentation within these patches over time.” See abstract, Objective and Main Outcome Measure sections on page 677. Hamzavi et al. treated patients with vitiligo involving “at least 5% of their total body surface”.
A person having ordinary skill in the art would be motivated to use the Vitiligo Area Scoring Index after seeing Shanler’s teaching that it is useful in observing changes in pigmentation as a result of vitiligo treatment. They further would have been motivated to use the method in subjects that had vitiligo in at least 5% of their total body surface area since that is what Hamzavi et al. teach in their treatment methodology. The skilled artisan would have had a reasonable expectation of success since Hamzavi et al. report success in validating and using VASI scoring for vitiligo patients. See abstract, Main Outcome Measure and Results sections. Thus, claim 4 is obvious.
As it relates to dependent claim 8, Shanler et al. teach conjunctive administration with one or more additional therapeutics, such as narrow-band UVB, as discussed in the above rejection under 35 USC 103. See para. [0134] on page 48 as well as para. [0139] on page 50. Hamzavi et al. teach treatment of vitiligo patients with narrowband UV-B for either 60 treatments or 6 months.
A person having ordinary skill in the art would have been motivated to identify a treatment period for administering narrowband UVB since Shanler et al. taught that the treatment could be used with the JAK/STAT inhibitor PF-06651600 and Xu et al. demonstrated its administration in a mouse model. The skilled artisan would have had a reasonable expectation of success in applying the 6 month (or approximately 24 week) treatment period since patients treated by Hamzavi et al. observed 42.9% repigmentation during said time period. See page 680, right column, third paragraph. Thus, claim 8 is obvious.
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 claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(1 of 3) Claims 1-15 Claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,116,368, in view of Shanler et al. in WO 2019040706 A1 and further in view of Xu et al. in “PF-06651600, a Dual JAK3/TEC Family Kinase Inhibitor”, ACS Chemical Biology, May 13, 2019, 14(6), pp. 1235-1242, as cited in the IDS dated 09/13/2023, and further in view of Hamzavi et al. in “Parametric Modeling of Narrowband UV-B Phototherapy for Vitiligo Using a Novel Quantitative Tool: The Vitiligo Area Scoring Index” Arch Dermatol. 2004; 140: 677-683.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in US ‘368 is directed to a pharmaceutically acceptable salt of 1-[(2S,5R)-2-methyl-5-(7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-2-propen-1-one and claim 6 is drawn to a method of treating vitiligo using said salt. Since instant claim 1 is drawn to a method for treating vitiligo by administering the cited compound or a pharmaceutically acceptable salt thereof, the claim is obvious.
The discussions and rationales regarding the obviousness of instant claims 2-15 under 35 USC 103 above are incorporated by reference. The claims of the patent are deemed to render obvious the instant claims since they embrace subject matter that would have been obvious to a person of ordinary skill in the art.
(2 of 3) Claims 1-15 Claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 12,077,533, in view of Shanler et al. in WO 2019040706 A1 and further in view of Xu et al. in “PF-06651600, a Dual JAK3/TEC Family Kinase Inhibitor”, ACS Chemical Biology, May 13, 2019, 14(6), pp. 1235-1242, as cited in the IDS dated 09/13/2023, and further in view of Hamzavi et al. in “Parametric Modeling of Narrowband UV-B Phototherapy for Vitiligo Using a Novel Quantitative Tool: The Vitiligo Area Scoring Index” Arch Dermatol. 2004; 140: 677-683.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in US ‘533 are directed to a method of treating alopecia by administering 1-[(2S,5R)-2-methyl-5-(7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-2-propen-1-one. Additionally, Shanler et al. teach that inhibitors of the JAK/STAT pathway are implicated in alopecia areata. See para. [0025]. Xu et al. also discuss the possible utility of PF-06651600 toward alopecia areata in the abstract. A person having ordinary skill in the art would be motivated to pursue a method wherein PF-06651600 is used to treat vitiligo given the teachings of its success toward vitiligo and the suggestion by both Shanler and Xu that it is useful in either vitiligo or alopecia treatments.
Since instant claim 1 is drawn to a method for treating vitiligo by administering the cited compound or a pharmaceutically acceptable salt thereof, the claim is obvious.
The discussions and rationales regarding the obviousness of instant claims 2-15 under 35 USC 103 above are incorporated by reference. The claims of the patent are deemed to render obvious the instant claims since they embrace subject matter that would have been obvious to a person of ordinary skill in the art.
(3 of 3) Claims 1-15 Claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8 and 11 of U.S. Patent No. 11,111,242, in view of Shanler et al. in WO 2019040706 A1 and further in view of Xu et al. in “PF-06651600, a Dual JAK3/TEC Family Kinase Inhibitor”, ACS Chemical Biology, May 13, 2019, 14(6), pp. 1235-1242, as cited in the IDS dated 09/13/2023, and further in view of Hamzavi et al. in “Parametric Modeling of Narrowband UV-B Phototherapy for Vitiligo Using a Novel Quantitative Tool: The Vitiligo Area Scoring Index” Arch Dermatol. 2004; 140: 677-683.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in US ‘242 are directed to methods of treating disorders and conditions such as rheumatoid arthritis, inflammatory bowel disease, Crohn’s disease and ulcerative colitis by administering 1-[(2S,5R)-2-methyl-5-(7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-1-piperidinyl]-2-propen-1-one.
Shanler et al. teach the above embodiment wherein the same compound, also known as PF-06651600, may be used to treat vitiligo. See for instance the abstract, paragraph [0031], or claim 1. Xu demonstrates PF-06651600’s ability to inhibit JAK3 in a mouse model. See page 1240, left column, first paragraph. Xu also discusses the possible utility of PF-06651600 toward rheumatoid arthritis and inflammatory bowel disease in the abstract. A person having ordinary skill in the art would be motivated to pursue a method wherein PF-06651600 is used to treat vitiligo given the teachings of its success toward vitiligo and the suggestion by both Shanler and Xu that it is useful in either vitiligo or other treatments including rheumatoid arthritis and inflammatory bowel disease of the patented claims.
Since instant claim 1 is drawn to a method for treating vitiligo by administering the cited compound or a pharmaceutically acceptable salt thereof, the claim is obvious.
The discussions and rationales regarding the obviousness of instant claims 2-15 under 35 USC 103 above are incorporated by reference. The claims of the patent are deemed to render obvious the instant claims since they embrace subject matter that would have been obvious to a person of ordinary skill in the art.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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