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, 3-9 and 11-19 are pending in the instant application.
Election/Restrictions
Applicant’s election with traverse of Group I,
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and the species of formula (II) in Example 2, which is disclosed on page 5 of the instant specification (reproduced below),
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in the reply filed on May 20, 2026 is acknowledged.
The traversal is on the ground(s) that: (1) the claimed subject matter of Groups I, II and III are sufficiently related such that an undue burden would not be presented to the Examiner by maintaining all of the claims in this application; and (2) the claims have been amended so that the present technical feature of the compound represented by formula (II) makes a contribution over the prior art.
Applicant’s arguments have been considered. The traversal is on the grounds that the full scope of the inventions of Groups I-III could be searched and examined without undue burden on the Examiner. This argument is not found persuasive because a search burden requisite is not the standard for a lack of unity of invention under 37 CFR 1.475. Further, unity of invention exists when there is a technical relationship among the claimed inventions involving a special technical feature. The expression “special technical feature” means those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. In the lack of unity requirement dated
April 1, 2026, it was stated that a pyrrolopyrimidine compound, was considered the technical feature and such technical feature is known in view of the compound of PubChem CID 56778049. As a result, a pyrrolopyrimidine compound is not a “special technical feature” since it has been shown that a pyrrolopyrimidine compound is known. The currently amended claims remain directed to a known pyrrolopyrimidine compound of formula (I). See prior art rejection below. Therefore, Applicant’s arguments are not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-9 and 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 20, 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements filed on September 27, 2023,
June 27, 2024 and August 5, 2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
Currently amended independent claim 1 claims both a compound of formula (I) and a more limited compound of formula (II). In considering and applying prior art, instant independent claim 1 has been interpreted as claiming both a crystal form of a compound of formula (I) or a salt or hydrate thereof and instant claim 1 is claiming a compound of formula (II).
Claim Objections
Claim 3 is objected to because of the following informalities: in claim 3, an “or” should be added before formula “(II-1)” (see line 4 of page 3).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1, 3-5 and 11-14 are 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.
Currently amended claim 1 is confusing because the claim first states that the compound is of formula (I) and provides a generic structure of formula (I) and then the claim 1 states a compound of formula (II). See claims 3-5 and 11-14 for same. It is not clear if Applicant is claiming a compound of formula (I) or a compound of formula (II) or both. Independent claim 1 and claims 3-5 and 11-14 are indefinite because the metes and bounds of the claims cannot be ascertained. Clarification is required.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation of “a compound represented by formula (I), a salt thereof or a hydrate of the salt thereof”, and the claim also recites “the compound represented by formula (I) is a compound represented by formula (II) acid in the salt is selected from maleic acid, hydrochloric acid and sulfuric acid” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Currently amended claim 1 is indefinite because there are variables in formula (I) {such as variables T1, D1, R3, etc.} in independent claim 1 which have not been defined in independent claim 1.
Currently amended claim 1 is unclear and confusing because of the phrase “acid in the salt is” (the last line of the claim). An “acid” has not been previously stated in claim 1. See claims 11-13 for same. Therefore, currently amended independent claim 1 and claims 11-13 are indefinite.
Claims dependent on independent claim 1 which do not resolve the problems in currently amended independent claim 1 are also found indefinite.
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.
Claims 1, 3-5 and 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,351,590. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 12,351,590 claims a compound which anticipates the instant claimed invention. See the 1st compound claimed in column 22 in claim 7 of U.S. Patent No. 12,351,590, which is the elected species in the instant application.
The instant application shares a common assignee {i.e., Guangzhou Joyo Pharmatech Co., Ltd} with
U.S. Patent No. 12,351,590. The instant application is not related to U.S. Patent No. 12,351,590 and thus, no
35 USC 121 shield exists here. See MPEP §804.01. Therefore, the claims in U.S. Patent No. 12,351,590 anticipate and/or render obvious the instant claimed invention.
Claims 1, 3-5 and 11-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 14-19, 23-31, 33 and 34 of copending Application No. 18/562,643 (reference application), US 2024/0238299. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in copending Application No. 18/562,643 are directed to a method of using a compound of formula I or a pharmaceutically acceptable salt thereof. The compound of formula I in copending Application No. 18/562,643 is the same compound as the elected species in the instant application.
The instant application shares a common inventor {i.e., Yongguo Li} with copending Application No. 18/562,643. The instant application is not related to copending Application No. 18/562,643 and thus, no
35 USC 121 shield exists here. See MPEP §804.01. Therefore, the claims in copending Application No. 18/562,643 anticipate and/or render obvious the instant claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 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 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, 3-5 and 11-14 are rejected under
35 U.S.C. 102(a)(1) and under 35 U.S.C. 102(a)(2) as being anticipated by Qian et al. {WO 2020/244,614 A1}. A machine generated English translation of the WO document has been provided with this Office Action and will be referred to hereinafter.
Qian et al. disclose Compound 1-13,
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, on pages 3 and 8 of the WO and in paragraph [0027] on page 3 and in paragraph [0065] on page 6 of the provided machine generated English translation of the WO. It is correct that Qian et al. is silent about the compound being in a crystalline form nor does Qian et al. provide X-ray powder diffraction pattern data, etc. of his Compound 1-13 as found in the instant claims. However, if mere silence were enough, then every anticipation could be overcome by simply putting in some limitation that the reference happened to be silent about, even if the material were exactly the same as the prior art. One could add limitations of physiochemical characteristics such as density, color, melting point, solubility in any solvent, etc. and then simply point to the silence of the reference. The claiming of a new use, new function or unknown property that is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In this case, the “unknown property” is a crystalline form, X-ray powder diffraction pattern data, etc. These are unknown because Qian et al. is silent about these properties. Qian et al., however, explicitly disclose Compound 1-13 and a process for preparing Compound 1-13, which includes the separation of stereoisomers. Therefore, Qian et al. anticipate the instant claimed invention.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. 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.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
July 15, 2026
Book XXIX, page 69
Prosecution Insights