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 .
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.
Current Status of 18/253,503
This Office Action is responsive to the amended claims received 18 May 2023.
Claims 1-19 and 21 are currently pending.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
The species of the compounds of formula (I) are too numerous to recite individually due to the Markush structures, but include the individual species of claim 16.
Applicants are requested to provide a species election of:
a species of claim 1, being a compound of formula (I), wherein all variables are specified (see, for example, the species within claim 16, from which Applicant may elect a species).
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, all claims are generic.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Where a single claim defines alternatives of a Markush group, the requirement of a technical interrelationship and the same or corresponding special technical features as defined in Rule 13.2, is considered met when the alternatives are of a similar nature. When the Markush grouping is for alternatives of chemical compounds, the alternatives are regarded as being of a similar nature where the following criteria are fulfilled:
(A) all alternatives have a common property or activity; AND
(B)(1) a common structure is present, that is, a significant structural element is shared by all of the alternatives; OR
(B)(2) in cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.
The phrase “significant structural element is shared by all of the alternatives” refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity.
The phrase “recognized class of chemical compounds” means that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention, i.e. each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
The chemical compounds of formula (I) of claim 1 are not regarded as being of similar nature because: (1) the alternatives do not all share a common structure and (2) the alternatives do not all belong to a recognized class of chemical compounds. The alternative species of formula (I) do not all share a common structure. Two exemplary species of the genus formula (I) are shown below. The first exemplary species is copied from page 109 of the instant specification, and the second is drawn based upon the limitations of instant claim 1.
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The first compound above contains a tricyclic N-heterocyclic moiety, a pyrimidine ring, and a phenyl ring, whereas the second compound above contains a spirocyclic moiety, two cyclopropane ring, two pyrrolidine rings, and two pyridine rings. The artisan could not substitute the first compound for the second and expect the same behavior, given their dissimilar structures. Therefore, the alternatives do not all belong to a recognized class of chemical compounds.
During a telephone conversation with YUEZHONG FENG on 7 November 2025 a provisional election was made without traverse to prosecute the invention of the first listed compound of claim 16, shown below.
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This species reads on claims 1-5, 15-19, and 21. Affirmation of this election must be made by applicant in replying to this Office action. Claims 6-14 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Current Status of 18/253,503
This Office Action is responsive to the election via telephone on 7 November 2025.
Claims 1-19 and 21 are currently pending.
Election/Restrictions
Applicant’s election without traverse of the first compound of instant claim 16 (shown below), in the telephone conversation on 7 November 2025 is acknowledged.
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The elected species has been determined to read on claims 1-5, 15-19, and 21. Claims 6-14 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.
A search for Applicant’s elected species retrieved applicable prior art and double patent art. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Priority
Applicant’s claim for the benefit of the prior-filed applications PCT/CN2021/134790 (filed 1 December 2021) and CN 202011400431.9 (filed 2 December 2020) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The Examiner has determined, for the purposes of the instant action, that the effective filing date of the instant claims is 1 December 2021, at least due to the lack of an English translation of the earlier priority document. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Information Disclosure Statement
The information disclosure statement (IDS) received on 18 May 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1-5 and 15 are objected to because of the following informalities: Within the definition of R1, claim 1 states “each of the above R1 groups optionally further substituted”. This phrase is missing the verb “is”. This problem seems to occur throughout claim 1, such as in the definition of R4. Applicant should find and correct all additional locations where a verb, being “is” or “are”, is missing in claims 1-5 and 15. Additionally, the phrase “together with aryl carbons”, within the section beginning with “or when m≥1”, is lacking the word “the” before “aryl carbons”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Within the section describing R5 and R6 forming a ring, claim 1 recites “form a 4-6 membered heterocyclyl, the 4-6 membered heterocyclyl optionally further substituted”. This phrase is grammatically incorrect. Applicant may choose to amend the quoted phrase as follows “form a 4-6 membered heterocyclyl, wherein the 4-6 membered heterocyclyl is optionally further substituted”. Appropriate correction is required.
Claims 1-5 and 15 are objected to because of the following informalities: Within the definition of R13, claim 1 recites “each of the above R13 groups independently optionally further substituted”. Either of the words “and” or “wherein” should be added immediately preceding this quoted phrase to improve readability, in addition to fixing the lack of “is” as discussed above. This type of problem occurs in additional places within claims 1-5 and 15, such as in the definition of R14, and Applicant should make an effort to find and correct all additional problems of this type. Appropriate correction is required.
Claims 15 is objected to because of the following informalities: Within the definition of R14, the word “from” appears to be misspelled as “form”. 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 1-5, 15-19, and 21 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.
Claim 1 recites “each of the above R2 and R3 together independently optionally further substituted”. The intended meaning of this phrase is unclear. It is unclear if the use of “together” within the quoted phrase above indicates that the optional substituents only apply to cyclic moieties formed from R2 and R3. Alternatively, the optional substituents may be intended to be present on any R2 and R3 groups, wherein the R groups are part of a ring or not. This renders claims 1-5, 15-19, and 21 indefinite. Applicant may choose to amend the quoted phrase above as follows “each of the R2 and R3 groups is independently optionally substituted”.
Claim 1 recites “or when m≥1, R1 and an adjacent R9… form a C5-6cycloalkyl or 5-6 membered heterocyclyl”. It is unclear whether this indicates: when m is greater than or equal to 1, the adjacent R1 and R9 groups must be formed into a ring; or when m is greater than or equal to 1, the adjacent R1 and R9 groups are optionally formed into a ring. This type of indefiniteness occurs in other locations in claim 1 and claim 2. This renders claims 1-5, 15-19, and 21 indefinite. All other potentially optional ring formations from multiple R groups should be clarified by the Applicant.
Claims 19 and 21 each recite “mutation of EFGR exon 20”. The meaning of the EFGR acronym is unknown, as it is not defined within the claims or the specification. This renders claims 19 and 21 indefinite. Applicant may choose to amend these claims to recite EGFR instead of EFGR, with sufficient support being cited.
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 1-2, 15, 18-19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
TALLEY 2020 (EP 3,705,478 A1; Publication Date 9 September 2020).
TALLEY teaches the compound shown below as compound 23 on page 11, and teaches the same compound in claim 8 on page 41 therein.
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This compound falls within the genus of instant claim 1. Defining the variables of instant claim 1 as follows produces compound 23 of TALLEY: R1 is F; R2 and R3 are each methyl; Z is N; R9 is H; m is 1; X and Y are each N; Q is CH; R4 is methyl; R5, R7, and R8 are each methyl; and R6 is H. Claim 9 of TALLEY teaches pharmaceutical compositions of the compounds therein. Paragraph [0037] of TALLEY teaches that the pharmaceutical compositions therein include a pharmaceutically acceptable diluent or carrier. TALLEY teaches that the compounds therein were used to inhibit the proliferation of a human lung cell cancer cell line with L858R/T790 mutations (Table 3 and paragraphs [0117]-[0119]).
Regarding claim 15: Instant claim 15 limits the definitions of R12-16, but does not require them to be present. Therefore, the compound of TALLEY above reads on instant claim 15 as long as is does not contain an R12-16 group that falls outside of the scope of instant claim 15.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 15, 17-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over:
TALLEY 2020 (EP 3,705,478 A1; Publication Date 9 September 2020).
Teachings of TALLEY are described in the 35 USC 102 rejections above.
Regarding claim 17: TALLEY teaches the following synthetic reaction on page 30 therein, within the exemplary synthetic scheme labeled “Example 12”. This reaction is not specifically taught to be applied to a compound within TALLEY that falls within the scope of instant claim 1.
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It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, that the above synthetic reaction on page 30 of TALLEY could be applied to all of the compounds therein, with the exception of compounds that contain incompatible moieties, such as additional nucleophilic moieties. Therefore, upon reading the teachings of TALLEY, one of ordinary skill in the art understood that the reaction of acryloyl chloride with the relevant primary amine would be useful to produce compound 23 of TALLEY.
Claims 1-5, 15-16, 18-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over:
TALLEY 2020 (EP 3,705,478 A1; Publication Date 9 September 2020)
in view of:
SHERIDAN (Sheridan, R.P. “The Most Common Chemical Replacements in Drug-Like Compounds” J. Chem. Inf. Comput. Sci. 2002, 42, 103-108.).
Teachings of TALLEY are described in the 35 USC 102 rejections above.
Regarding claims 3-5 and 16: The instantly elected species, shown below, falls within claim 1 of TALLEY, but is not specifically enumerated by TALLEY.
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TALLEY teaches the compound shown below as compound 23 on page 11, and teaches the same compound in claim 8 on page 41 therein.
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The compound of TALLEY above is distinct from the instantly claimed species, only because the TALLEY compound has a fluoro substituent at a position where the instantly claimed compound contains a methyl substituent.
SHERIDAN investigated chemical moiety replacements that were frequently made within drug-like molecules (abstract). SHERIDAN teaches that the chemical moiety replacements that were determined through their method are useful, as they “may be worth considering in lead development projects” (introduction section). In other words, the chemical moiety replacements identified by SHERIDAN were taught to be useful when designing derivatives of biologically active molecules. Specifically, Figure 6 of SHERIDAN shows that a fluoro to methyl replacement was found to be one of the most frequent replacements performed within drug-like molecules, according to their algorithm B method.
One of ordinary skill in the art, reading the teachings of TALLEY, would have understood that altering the R3 group of TALLEY (claim 1) is shown by the examples within TALLEY to be critical to the efficacy of the molecules therein (claim 7 and Table 3). One of ordinary skill in the art, seeking to improve the efficacy of the compounds of TALLEY, would begin with the specifically enumerated compounds of claim 8 of TALLEY, and would apply standard moiety replacements to the molecules therein to produce derivative molecules.
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to apply the most common moiety replacements known in the art (taught by SHERIDAN) to the specifically enumerated compounds of TALLEY, including compound 23 of TALLEY, for the purpose of increasing the efficacy of the compounds of TALLEY as oncolytic drugs. This would lead the artisan to envisage the replacement of the fluoro moiety of compound 23 of TALLEY with a methyl group, resulting in the instantly elected species. The artisan would have expected success in this moiety replacement, because SHERIDAN teaches that this particular moiety replacement is one of the most common performed on drug-like molecules.
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 1-2, 15, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1, 12-14, and 16 of copending Application No. 18/576,252 (referred to below as the ‘252 application).
Although the claims at issue are not identical, they are not patentably distinct from each other because: Claim 12 of the ‘252 application teaches the compound below, which reads on instant claims 1-2 and 15.
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Claim 13 of the ‘252 application teaches the synthesis of the compounds therein through the reaction of acryloyl chloride with the relevant primary amine, which reads on instant claim 17. Claim 14 of the ‘252 application teaches pharmaceutical compositions of the compounds therein. Claim 16 of the ‘252 application teaches a method of treating a metastatic disease in a subject through administering a compound therein, wherein the metastatic disease is caused by hyperproliferation and dysfunction in cell death induction.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625