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 .
DETAIL ACTION
This office action is a response to a 371 application filed -----10/26/2023, which is a national stage application of PCT/CN2022/090847 filed 5/4/2022, which claims foreign priority to CN202111049227-1 filed 9/8/2021; and CN202110904652.8 filed 8/7/2021; and CN202110487046.0 filed 5/4/2021.
As filed, claims 1-19 are pending, wherein claims 1, 5, and 10 are independent claims.
Election/Restrictions
Applicant's election with traverse of Group I – Claims 1-14, 16, and 17 in the reply filed on 3/6/2026 is acknowledged.
Regarding the restriction requirement, the traversal, in summary, is on the ground(s) that Groups I and II shall be considered respectively as a combination of a product and a process of use of said product, which have unity of invention.
This is not found persuasive because compound of instant formula (I), (II-1), and (II-2) that is common between Groups I and II is not a special technical feature that defines a contribution over the prior art. See prior art rejection below. Therefore, claims 1-19 are not so linked as to form a single general inventive concept and lack of unity of invention. The vastness of the claimed subject matter and the complications in understanding the claimed subject matter impose a serious burden on the search and examination of the claimed subject matter. Since the claims do not relate to a single general inventive concept under PCT Rule 13.1 and lack the same or corresponding special technical features, the claims lack unity of invention.
Regarding the election of species requirement, the Applicant made their election, which is shown below, with traverse. The traversal, in summary, is on the ground(s) that Applicant’s election of a specific species is merely intended to aid the Examiner in the search and examination of the present application. The species election is by no means indicative of Applicant’s willingness to ultimately limit the invention to the elected species. Applicant understands that consistent with an election of species requirement, other species will be considered within the elected “generic” claims encompassing the elected species upon an indication of allowable subject matter with respect to the elected species.
The Examiner agrees with Applicant’s remarks and will proceed with examination under the guidance of MPEP 803.02. However, at this time, as mentioned in the previous office action, the instant application still claims a compound of instant formula ((I), (II-1), or (II-2), which are drawn to patentably distinct species and contains patentably distinct structural cores. As such, the compound of instant formula (I), (II-1), or (II-2) still lacks unity of invention and thus, the election of species requirement is appropriate.
The restriction and election of species requirement is still deemed proper and is therefore made FINAL.
Claims 15, 18, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/6/2026.
Regarding the election of species requirement, Applicant elected the species
PNG
media_image1.png
176
154
media_image1.png
Greyscale
, which is compound 7 found in Example 1 of the instant specification). The claims, which read on the elected species, are instant claims 1, 5, 8, and 10-19, according to Applicant’s reply filed 3/6/2026. Since claims 15, 18, 19 were previously withdrawn because they were drawn to non-elected invention of Group II, only claims 1, 5, 8, 10-14, 16, and 17 will be examined herein.
Claims 2-4, 6, 7, and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species . Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does makes a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/11/2024 and 6/12/2025 has been considered by the Examiner.
The information disclosure statement (IDS) submitted on 10/26/2023 has been considered by the Examiner except Cite No. 2 under the section of “NON-PATENT LITERATURE DOCUMENTS”, where it was lined through.
The abovementioned publication in Cite No. 2 is drawn to a same publication in Cite No. 1 under the section of “NON-PATENT LITERATURE DOCUMENTS” in the IDS filed 6/12/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112 fourth paragraph
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
Subject to the following paragraph [concerning multiple dependent claims], 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 (emphasis added).
Claims 11 and 12 are rejected under the fourth paragraph of 35 U.S.C. § 112 and under 37 CFR § 1.75(c), as being of improper dependent form for failing to further limit the subject matter of a previous claim. Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form.
Regarding claims 11 and 12, the claim is directly or indirectly dependent upon claim 10. The subject matter in claim 10 is drawn to a compound of instant formula (II-2). The subject matter in claims 11 and 12 is drawn to a limited embodiment of instant formula (II-2).
The scope of claims 11 and 12 is broader than scope of claim 10 because claims 11 and 12 include species that are outside of instant variable L of instant formula (II-2) (see representative examples below, as shown by boxes). Because the scope of claims 11 and 12 is broader than claim 10, the claims failed to further limit the subject matter thereof, and fail to comply with the formal requirements set forth in the fourth paragraph of 35 U.S.C § 112.
The Examiner suggests that the claims be amended in a manner such that the scope of claims 11 and 12 is commensurate with the scope of claim 10.
Claim 10:
PNG
media_image2.png
234
184
media_image2.png
Greyscale
PNG
media_image3.png
58
572
media_image3.png
Greyscale
Claim 11:
PNG
media_image4.png
254
236
media_image4.png
Greyscale
PNG
media_image5.png
80
564
media_image5.png
Greyscale
Claim 12:
PNG
media_image6.png
292
258
media_image6.png
Greyscale
PNG
media_image5.png
80
564
media_image5.png
Greyscale
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.
(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, 5, 14, and 16 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Foreign Patent Application Publication No. WO2020156311 (see IDS filed 12/26/2023) and its machine-generated English translation, hereinafter Gao.
Regarding claims 1, 5, 14, and 16, Gao, for instance, teaches the following compound or pharmaceutical composition thereof as TYK2 inhibitors, which meets all the limitations of these claims.
PNG
media_image7.png
72
884
media_image7.png
Greyscale
(WIPO publication, abstract)
PNG
media_image8.png
218
198
media_image8.png
Greyscale
(WIPO publication, pg. 9, line 8, first compound)
Wherein: instant variable L is deuterated alkylamino; instant variable P is O; instant variable U is N; instant variable E is C; instant variable R7 is H; instant ring A is
PNG
media_image9.png
82
108
media_image9.png
Greyscale
; instant ring B is
PNG
media_image10.png
84
70
media_image10.png
Greyscale
, wherein instant variables T and G are N, instant variable Z is NRB, wherein instant variable RB is methyl, and instant variable Y is CRA1, wherein instant variable RA1 is H; instant variable X is NH; instant variable Q is -C(O)-; and instant ring C is
PNG
media_image11.png
106
104
media_image11.png
Greyscale
, wherein instant variable n is 1 and instant variables R1-R5 are H.
PNG
media_image12.png
402
1350
media_image12.png
Greyscale
(machine-generated English translation, paragraph 0154)
Claim Objections
Claims 1, 5, 10, and 11 are objected to because of the following informalities:
Regarding claims 1, 5, 10, and 11, the claims recite the phrase:
PNG
media_image13.png
60
598
media_image13.png
Greyscale
The abovementioned expression can be clarified by reciting – ring C is alkyl . . . – and – and ring C is selected from . . . --.
Regarding claim 5, the claim recites the following phrase, which contains typographical error:
PNG
media_image14.png
184
586
media_image14.png
Greyscale
PNG
media_image15.png
44
160
media_image15.png
Greyscale
The Examiner finds that m1 = 3 or 4 is mistakenly included because S(O)m1 in the abovementioned phrase can only be 0, 1, or 2. Such typographical error needs to be corrected.
Appropriate correction is required.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 13 and 17 are objected to as being dependent upon an objected base claim, but would be allowable if the objection of the base claim is corrected.
Conclusion
Claims 1, 5, 11, 12, 14, and 16 are rejected.
Claims 1, 5, 8, 10, 11, 13 and 17 are objected.
Claims 2-4, 6, 7, 9, 15, 18, and 19 are withdrawn.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PO-CHIH CHEN/Primary Examiner, Art Unit 1621