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 .
Priority
The instant application is a 371 of PCT/CN2022/081416, filed March 17, 2022.
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) by application no. PCT/CN2021081363 filed in the Chinese Patent Office on March 17, 2021, which papers have been placed of record in the file.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted August 24, 2023 and March 7, 2025 were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of form 1449 is enclosed herewith.
Election/Restrictions
5. Applicant's election with traverse of Group I in the reply filed on January 6, 2026 is acknowledged. The traversal is on the ground(s) that there is no serious burden on the Examienr. This is not found persuasive because the prongs have been met for a national stage lack of unity showing wherein there is no special technical feature that makes a contribution over the prior art. Therefore, when claims lack unity of invention, a restriction is appropriate. Burden has been evidenced by the extremely large genus of Formula I which requires multiple structure searches, in addition to the NPL searches that would be required for the full scope of conditions listed in the method claims. As such, Examiner would have a serious burden if searching the full scope of all claims without restriction and election of species.
The requirement is still deemed proper and is therefore made FINAL.
6. 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 (see MPEP 803.02). 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.
7. As per MPEP 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species
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, wherein Z1 is NCH3 and Z2 is N, Y1 is absent, R1 is 4-methoxycyclohexyl, R2 is 4-cyanophenyl, R3 is 1,2,2-trimethylpropyl, R’ is H, R” is H, makes a contribution over the prior art of record. Therefore, according to MPEP 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. If art is found on a non-elected species, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. Since art was found on a non-elected species, subject matter not embraced by the elected species is therefore withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Status of Claims
8. Claims 1-3, 15, 21-26, 38, 44-48, 50-51, 63, 69-72, 146-149, 153, 155-162 are pending in the instant application. Claims 15, 24, 38, 48, 50-51, 63, 69-72, 148-149, 153, and 155-162 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1-3, 21-23, 25-26, 44-47, 146, and 147 read on an elected invention and species and are therefore under consideration in the instant application.
Claim Objections
9. Claim 146 is objected to for being written in improper Markush format. As written, the word "and" should be added between the second to last and last species of the Markush series. See MPEP 2173.05(h). “When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper.”
Claim Rejections - 35 USC § 102
10. 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.
11. 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.
12. Claims 1-3, 21-22 and 147 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAplus Registry Number: RN 62237-39-2. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 62237-39-2, Entered STN: 16 Nov 1984].
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RN 62237-39-2 anticipates the instant claims wherein Z1 is CR4, R4 is CH3 and Z2 is NR4, R4 is H, Y1 is absent, R1 is phenyl, R2 is phenyl substituted with methyl, R3 is ethyl, R’ is H, R” is H.
Registry number 62237-39-2 is available as prior art as of 16 Nov 1984, the day it was indexed into the CAplus database.
Regarding the compositions of claim 147, comprising the anticipatory compounds and an excipient, the Registry entry for Registry no. 62237-39-2 discloses a mass solubility of 0.0033 g/L, in unbuffered water at pH 6.82. This teaching of water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compounds anticipate the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Conclusion
13. Claims 23, 25-26, and 44-47 are allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623