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
Claims 1-4, 7, 13-18, and 22-32 are pending in the instant application. Claims 1-4, 7, 13-18, and 22-32 are rejected.
Information Disclosure Statements
The information disclosure statements filed on July 1, 2024, October 3, 2024, February 27, 2025, and March 20, 2026 have been considered and signed copies of form 1449 are enclosed herewith.
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.
Claim 32 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e., what compounds can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The instant claimed invention is highly unpredictable as discussed below: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statue. In the instant case, the claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic effects, whether or not the disease is affected by the administration of a compound of formula I or a pharmaceutically acceptable salt thereof would make a difference.
With regards to the treatment of disease and even more specifically autoimmune diseases (e.g., see [004]), this method could include many unrelated diseases (i.e., many of which have a different cause and, therefore, require a different treatment). There is not one class of compounds, let alone one compound, which can treat all of the diseases which could be included in the method mentioned above.
Hence, in the absence of a showing of correlation between all the various diseases claimed as capable of treatment through the administration of a compound of formula I or pharmaceutically acceptable salt thereof, one of skill in the art is unable to fully predict possible results from the administration due to the unpredictability.
The amount of direction or guidance present and the presence or absence of working examples
A disclosure should contain representative examples which provide reasonable assurance to one skilled in the art that the compounds which fall within the scope of a claim will possess the alleged activity. The only direction or guidance present in the instant specification is the listing of diseases Applicant considers as treatable by the administration of a compound of formula I or a pharmaceutically acceptable salt thereof, non-patent literature citations which disclose the involvement of JAK and more specifically TYK2 inhibitors in the treatment of some diseases (see page 2), kinase binding assays (see Example 14 on pages 75-79), and an assay measuring the phosphorylation of STAT5 in IFNa-stimulated CD3+ T cells (see Example 15 on pages 79-80). However, the specification does not contain evidentiary support that the administration would be able to treat all of the various diseases which could be considered a disease. Furthermore, there are no working examples to support the treatment of the instantly claimed diseases.
Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use of the instant compounds and pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, "the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved." See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The level of skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the administration of a compound of formula I or a pharmaceutically acceptable salt thereof for the treatment of the various claimed diseases, as a result necessitating one of skill to perform an exhaustive search for which diseases can be treated by the administration of a compound of formula I or a pharmaceutically acceptable salt thereof in order to practice the claimed invention.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what specific diseases are benefited by the administration of a compound of formula I or a pharmaceutically acceptable salt thereof.
Factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instantly claimed pharmaceutical composition. In view of the chemical nature of the invention and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and ”[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable".
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which specific diseases can be treated by the administration of a compound of formula I or a pharmaceutically acceptable salt thereof.
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)(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 1-4, 7, 13-18, and 22-32 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0257396 A1.
The 35 U.S.C. 102(a)(2) critical reference date of the U.S. patent application is entitled to the benefit of the filing date of the provisional applications under 35 U.S.C. 119(e) since the provisional applications properly support the subject matter relied upon to make the rejection in compliance with 35 U.S.C. 112(a). See MPEP 2136.03 III.
The compounds of formula I, or pharmaceutically acceptable salts thereof, wherein A is
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; pharmaceutical compositions thereof and a method of treating disease of the claims fit within the scope of the compounds of formula IV, or pharmaceutically acceptable salts thereof, wherein A is a 5-membered heteroarylene or specifically one selected from those listed in claim 6 and Z is a 5-membered heteroarylene; pharmaceutical compositions thereof and a method of treating disease claimed in US 2023/0257396 A1. See the claims. Therefore, a compound of formula I, or a pharmaceutically acceptable salt thereof, wherein A is
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; a pharmaceutical composition thereof and a method of treating disease of the claims is anticipated by the reference.
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.
Claim 1-4, 7, 13-18, and 22-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 4, 6, 8, 11, 13, 40, 53, 58, 63, 64, and 68-72 of copending Application No. 18/004,829 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The compounds of formula I, or pharmaceutically acceptable salts thereof, wherein A is
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; pharmaceutical compositions thereof and a method of treating disease of the claims fit within the scope of the compounds of formula IV, or pharmaceutically acceptable salts thereof, wherein A is a 5-membered heteroarylene or specifically one selected from those listed in claim 6 and Z is a 5-membered heteroarylene; pharmaceutical compositions thereof and a method of treating disease claimed in US 2023/0257396 A1. Therefore, at least some compounds of formula I, or pharmaceutically acceptable salts thereof, wherein A is
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; pharmaceutical compositions thereof and a method of treating disease of the claims are anticipated by those of the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
Prosecution Insights