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 .
Response to Amendment
Newly amended claims 2, 10, 13-23, and 25-28 filed 2025 September 25 are examined on the merits. The 35 U.S.C. 112 (a) rejection is maintained against claims 26 and 27 is maintained because the art shows that prevention of the disorders recited in claims 26 and 27 is not possible at the time of filing.
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 26-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for the alleviation of myelofibrosis, polycythemia vera, rheumatoid arthritis, asthma, or psoriasis with a compound of formula (I) and non-enabling for the alleviation of the scope of disorders recited or the prevention of the scope of disorders claimed with a compound of formula (II). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treatment or prevention of JAK inhibited kinase disease with a compound of formula (II). Thus, the claims taken together with the specification imply a compound of formula (I) can treat or prevent a JAK inhibited kinase disease. The definition of treatment includes prevention (specification, page 21, third paragraph).
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The state of the prior art and (4) the predictability or unpredictability of the art:
DEANE (Best Practice & Research Clinical Rheumatology, 2013, 27, 467-485, cited in IDS) describes that more research is needed to understand how rheumatoid arthritis can be prevented (page 474, second paragraph to page 480, paragraph two).
MEYER (Clinical Cancer Research, 2014, 20(8), 2051-2059) describes the following ideas: JAK1 and JAK2 are linked to alleviation of myelofibrosis and polycythemia vera (page 2055, table 1); JAK2 is linked to alleviation of myelofibrosis (page 2055, table 1); JAK1 and JAK3 are linked to alleviation of rheumatoid arthritis or psoriasis (page 2055, table 1); and more research is needed to understand the therapeutic reach of JAK kinase inhibition.
KUDLACZ (European Journal of Pharmacology, 2008, 582, 154-161) describes describes that JAK-3 inhibitors can alleviate asthma (page 150, column 1, paragraph 3 to column 2, paragraph 1).
MENTER (Lancet, 2007, 370, 272-284) describes that the prevention of psoriasis requires more studies (page 280, column 1, paragraph 4 to column 2, paragraph 1).
The relative skill of those in the art:
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in the prevention or treatment of a JAK kinase inhibited disease).
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for the alleviation of myelofibrosis, polycythemia vera, rheumatoid arthritis, asthma, or psoriasis with a compound of formula (I).
The specification does not provide guidance for the alleviation of the scope of disorders recited or the prevention of the scope of disorders claimed with a compound of formula (I).
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to the alleviation of the scope of disorders recited or the prevention of the scope of disorders claimed with a compound of formula (I) and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Response to Amendment
This rejection is maintained because the art shows that the prevention of rheumatoid arthritis and psoriasis present challenges to overcome at the moment.
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.
Claim 28 is 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 28 depends on itself. Consequently the method of use is unclear.
Allowable Subject Matter
Claims 2, 10, 13-23, and 25 are allowed. Claims 26-28 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: CHENG (WO 2016139212, published 9 September 2016) describes compound S (page 63). Compound S does not anticipate or render obvious a compound of examined formula (I) because examined variable A cannot be substituted by a methylene-triazole group. Examined variable R1a cannot include a heteroaryl group.
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Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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