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 .
Election/Restrictions
Applicant’s election without traverse of Group I, encompassed by claims 1-48, drawn to compounds and a composition of Formula I, in the reply filed on 5/18/2026, is acknowledged.
Applicant has not pointed to any errors in Examiner’s analysis of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant further elected the following species, without traverse, as described below:
A single disclosed compound species that reads on Formula I: Applicant elects Compound 78, shown below:
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Applicant asserts that claims 1-3, 6, 9, 13, 15, 23-29, 32-43, and 46-48 encompass the elected species. Examiner contends that, of those claims listed above, claims 36-39 also do not read on the elected species and will be withdrawn from consideration, as well. Applicant has not pointed to any errors in Examiner’s analysis of the different species. The requirement is still deemed proper and is therefore made FINAL.
In the claims as filed on 5/18/2026, applicants have amended claim 36; cancelled no claims; and added no new claims. Claims 4-5, 7-8, 10-12, 14, 16-22, 30-31, 36-39, 44-45, and 49-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species. Therefore, claims 1-51 are currently pending, and claims 1-3, 6, 9, 13, 15, 23-29, 32-35, 40-43, and 46-48 are presently under examination.
Priority
The instant application is a 35 U.S.C. § 371 International Application of PCT/CN2022/104559, filed on July 8, 2022, which claims priority to International Application No. PCT/CN2021/105449, filed on July 9, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/27/2023 is in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. A signed copy of Form 1449 is included with this Office Action.
Claim Objections
Claims 1, 3, 6, 9, 13, 15, 23, and 46-48 are objected to because of the following informalities: in the preamble, the phrase “…or the tautomer” under Formula I is redundant. Examiner suggests amending it to read “…stereoisomer, or the tautomer of the stereoisomer” if that is what Applicant intends.
Claim 1 is objected to for the following informality: in the fourth provision, subsection (iii), does the “3-10 membered” limitation of “carbocyclic” also extend to the “heterocyclic, aromatic, or heteroaromatic” groups recited? Please clarify in the claim language. Appropriate correction is required.
Claim 32 is objected to because of the following minor informality: there is an additional word “is” in the phrase “independently selected from is halogen…”(emphasis added) that should be removed. Appropriate correction is required.
Claim 47 is objected to because of the following informalities:
Due to formatting or indenting issues, some of the numbered compounds in claim 47 are inappropriately numbered (see, for instance, compound 238 on page 11, where the “2” and “38” are on different lines). This type of error is repeated throughout the claim, and Examiner requests that Applicant’s cooperation in correcting these errors throughout. Appropriate correction is required.
The “NH” linkage in compounds 121-122 on page 27 is misaligned. Examiner requests the Applicant’s cooperating in correcting these errors to which the Applicant becomes aware. Appropriate correction is required.
Claim Rejections – Improper Markush Grouping
Claims 1-3, 6, 9, 13, 24-29, 32-35, and 40-43 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the Specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph). If (1) or (2) apply to a Markush grouping, a rejection under the judicially approved “improper Markush grouping” doctrine is proper.
The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
A small sampling of the variables is defined as seen below:
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As the artisan could observe, these compounds only share an amine linkage. There are no required structural features in common such that each member of Formula I would have at least one structural feature, which feature is essential to the activity/function of the claimed compound. One would not expect all of these compounds to be alternatively usable. The ring systems depicted above represent a sampling of the numerous and various core structures of the compound of Formula I as recited in claim 1. However, these core structures exhibit no discernible structural similarity. The 5-membered and 6-membered rings in each of these fused ring structures are all different. Furthermore, the Markush group of Formula I contains a plethora of nested variables in later claims, such as T1, T2, Rg, Rp, Rq, Rs. Clearly no ‘‘single structural similarity’’ can be seen. In the absence of evidence to the contrary, all compounds within the metes and bounds of the extraordinarily large Markush grouping of the instant claims cannot be individually envisioned and each expected to be functionally equivalent.
Since the dependent claims 2-3, 6, 9, 13, 15, 24-29, and 32-43 do not resolve the improper Markush grouping, they are similarly rejected.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR41.31 (a) (1).
Claim Rejections - 35 USC § 112(b)
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, 23, and 40-43 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 is rejected as vague and indefinite for its recitation, in the limitation of X4, that “X4 is nothing”. If said variable is “nothing”, then there were not be a variable at that position. Examiner recommends amending the claim to read, “X4 is a bond” if that is what the Applicant intends.
Claim 1 is rejected as vague for its recitation in the first provision of claim 1 that Ar1 is not the following structure:
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However, Ar1 is bonded to a 6-membered aromatic group, and specifically, in dependent claims, the Ar1 group is benzene. Examiner is unaware of any bonding motifs that allow for Applicant’s proposed valence on the fused bicyclic carbon, and even isomerization of the benzene ring does not create an aromatic structure (as required by the claim language), since it breaks Hückel’s rule, both shown below:
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Furthermore, the valency on the nitrogen N-oxide is exceeded.
Claims 1 is rejected as vague and indefinite for the recitation of the phrase “optionally substituted heteroatom”. The specification, on page 10, defines the term “heteroatom” as “one or more of oxygen, sulfur, nitrogen, phosphorous…” and, on page 17, defines the term “optionally substituted” as “the replacement of a hydrogen radical in a given structure with the radical of a specified substituent.” Formula I shows a single bond for variables with said definition. Therefore, the atoms must always be substituted, even if it is with hydrogen, for a fulfilled valency, and thus the claims are vague and indefinite.
Claim 1 is rejected as vague and indefinite for its recitation, in the fourth proviso, that “Re is =O”. As with the above rejection, the initial limitation of Re includes “optionally substituted heteroatom” and Formula I shows a single bond for Re variable with said definition. Therefore, the atoms must always be substituted, even if it is with a hydrogen, for a fulfilled valency, and thus, Re can not be =O. Furthermore, the Re variable of Formula I is diagrammed as a single bond to the bicyclic ring system, not a double bond, so how can Re =O? By the same rationale, the first, second, and third provisions of claim 1 are also rejected as vague and indefinite for their use of diagrammed Re. Since it is unclear what the metes and bounds of “optionally substituted heteroatom” are for Re, it is also unclear what structures are included or excluded in these provisions.
Claim 1 is rejected as vague and indefinite for its recitation, in the second provision, wherein “Re is not -C(=O)OH or -C(=O)O(C1-C3 alkyl)”, which is not embraced by claim 1. The C(O) portion of the groups are not embraced by the definition of “substituted acyl” since a substituted acyl must replace a hydrogen.
Claim 23 is rejected to in its definition of the limitation for Ry. It is unclear why a definition for a variable Ry appears in the text of the claims, yet no such variable appears among the diagrammed compounds, or in the text of other claim limitations. As claim 23 depends upon claim 1 and does not include a diagrammed compound with an Ry variable or do not provide compound species that define that position, it is also rejected.
Claims 40-43 are rejected as vague and indefinite for their recitation that Re is =O. The initial limitation of Re includes “optionally substituted heteroatom” and Formula I shows a single bond for Re variable with said definition. Therefore, the atoms must always be substituted, even if it is with a hydrogen, for a fulfilled valency, and thus, Re can not be =O. Furthermore, the Re variable of Formula I is diagrammed as a single bond to the bicyclic ring system, not a double bond, so how can Re =O?
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), 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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 23, and 46-47 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 23, which depends on claim 1, broadens the scope of the claim from which it depends.
The formulae of VIIId, VIIIe, VIIIj, VIIIk, and VIIII of instant claim 23 all lack an Re of =O. The provision of claim 1 requires that in the absence of an Re of =O, then Ra can only be “optionally substituted cycloalkyl, optionally substituted heterocyclyl, optionally substituted aryl, and optionally substituted heteroaryl”. However, the limitation of Ra in claim 23 allows for the following: -ORx, -CH2Rx, and
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These additional groupings broaden the scope of claim 1 since it would allow for substitutions on Formulae VIIId, VIIIe, VIIIj, VIIIk, and VIIII that are not covered by claim 1.
Claim 46, which depends on claim 1, broadens the scope from which it depends in the same manner as described above for claim 23. The formula of VIIId-1 lacks an Re of =O, and if absent, claim 1 requires that Ra is ““optionally substituted cycloalkyl, optionally substituted heterocyclyl, optionally substituted aryl, and optionally substituted heteroaryl”. However, the limitation in claim 46 allows for Ra that is forbidden by claim 1. Therefore, claim 46 broadens the scope of claim 1.
Claim 47, which depends on claim 1, has multiple varieties of 112(d) issues with structures that fall outside the scope of the compound of Formula I of claim 1.
Compounds 104-107 (Claims, page 26), shown below, broaden the scope of claim 1:
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According to claim 1, when Ar1 is a 5- to 7-membered heterocyclyl (such as the piperidine above), Ra is selected from H only when p is an integer selected from 1, 2, and 3 and that at least one of the Re is =O. In the instant case of compounds 104-107, Ra is H but lacks the required =O. Therefore, claim 47 broadens the scope of claim 1.
Compounds 606, 609, 612, 624, 625, and 630 (Claims, page 45-46) also broaden the scope of claim 1. Here, the fused bicyclic structures contain a nitrogen atom at the ring fusion location. However, according to Formula 1 of claim 1, the ring fusion atoms have to be a carbon, as designated by the Markush structure, shown below. Therefore, claim 47 broadens the scope of claim 1.
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Compound 615 (Claims, page 45), shown below, broaden the scope of claim 1 in the recitation of a compound with a ring fusion between the left and right aromatic rings of Formula I. No limitation in claim 1 allows for a bond to be formed, or joined, here. As such, claim 47 broadens the scope of claim 1.
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Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
It is noted that, with respect to the rejection below, for the purposes of determining if a reference is a “printed publication” for the purposes of 102(a)(1), MPEP 2128 (states the following:
A reference is proven to be a "printed publication" "upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it." In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743, 148 USPQ 537, 540 (SDNY 1966))
Specifically, regarding electronic publications, such as online databases as prior art, the following is noted:
An electronic publication, including an online database or Internet publication (e.g., discussion group, forum, digital video, or social media post), is considered to be a "printed publication" within the meaning of 35 U.S.C. 102(a)(1) and pre-AIA 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)
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 the database entries below list the dates that the compounds were entered into the on-line database, the compounds were made publicly available as of those dates in the citation, and the claims are anticipated.
Claim(s) 1-3, 6, 9, 28-29, 32-33, and 40-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry database for CAS RN 2094934-42-4, which has an entry date of May 3, 2017. Since the entry date represents the date that the compound entered a publicly available database on STN, this represents the date that the compound was made available to the public.
The STN Registry database entry listed above discloses the following compound, which reads on Formula I, where X1, X2, X3, X4, X5, Y1, Y2, Y3, and Y4 are all carbon, Rb = H, Rc = CN, n = 0, m = 1, p = 2, Ar1 is a 6 membered heterocyclyl, and Ra is an optionally substituted heteroatom (here, NO2), when p is an integer selected from 1, 2, and 3 and at least one of the Re is =O and optionally substituted alkyl (here, -CH3).
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Each and every required element of the claim is taught and the claim is anticipated.
Claim 47 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry database for CAS RN 1539241-26-3, which has an entry date of February 14, 2014. Since the entry date represents the date that the compound entered a publicly available database on STN, this represents the date that the compound was made available to the public.
The compound, shown below, is a direct 102 of instantly claimed compound 104, of claim 47 (page 26).
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Claims 1-2, 6, 9, 13, 15, 28-29, and 40-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry database for CAS RN 1214931-75-5, which has an entry date of March 26, 2010. Since the entry date represents the date that the compound entered a publicly available database on STN, this represents the date that the compound was made available to the public.
The compound, shown below, teaches each and every element of the claim and the claim is anticipated.
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Claim(s) 1-3, 6, 9, 13, 24-25, 28-29, 40-44, and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heiko et al. (CN102939282A, published February 20, 2013, cited on IDS filed 12/27/2023)(hereinafter, ‘Heiko’).
Heiko discloses the following compounds (pages 273, 310-311), which read on Formula 1.
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Each and every required element of the claim is taught and the claim is anticipated.
Regarding claim 48, the abstract recites “the present invention further relates to pharmaceutical compositions comprising these compounds…”
Claim(s) 1-2, 6, 24, 26-29, 32-35, and 40-43 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dickson et al. (WO 2022/064430 A1, published March 31, 2022, claims priority to September 24, 2020)(hereinafter, ‘Dickson).
Dickson discloses the SN39748, Example 47, (page 93) which reads on Formula 1.
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Each and every required element of the claim is taught and the claim is anticipated.
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 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,890,168 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 reads on instant claim 1, where instant X1, X2, X3, X4, X5, Y1 and Y3 are all carbon, Y2, and Y4 are N, instant Rb is optionally substituted heteroatom, instant Rc is optionally substituted heteroatom, Rd is optionally substituted heteroatom, n = 1, m = 1, p = 0, Ar1 is a 5 membered heteroaryl, and instant Ra is R3 (e.g. substituted piperidine). Altogether, the reference patent specifies overlapping claim limitations to arrive at patentably indistinct compounds.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,133,898 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 reads on instant claim 1, where instant X1, X2, X3, X4, X5, Y1, Y2 and Y3 are all carbon, Y4 is N, instant Rb, Rc, Rd are H, n = 0 , m = 0, p = 2, Ar1 is a 6- membered heterocyclyl containing a =O group, and instant Ra is H. Altogether, the reference patent specifies overlapping claim limitations to arrive at patentably indistinct compounds.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 7,960,384 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 is drawn to a compound of formula, shown below:
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where “U is selected from the group consisting of CR5 and N; V is selected from the group consisting of CR4 and N; W is NR1, wherein R1 is absent when the atom to which it is bound forms part of a double bond; X is selected from the group consisting of CO, CS, SO, SO2 , C=NR8', CR8R8' and NR8, wherein R8 is absent when the atom to which it is bound forms part of a double bond; Y is selected from the group consisting of CO, CS, SO, SO2 , C=NR7, CR7R7 and NR7, wherein R7 is absent when the atom to which it is bound forms part of a double bond; Z is NR6 , wherein R6 is absent when the atom to which it is bound forms part of a double bond… R3 is selected from the group consisting…amino…each substituted or unsubstituted”.
Reference specification defines “substituted” (col 15, lines 34-39) where “a given moiety may consist of only hydrogen substituents through available valencies (unsubstituted) or may further comprise one or more non-hydrogen substituents through available valencies (substituted) that are not otherwise specified by the name of the given moiety. Altogether, the reference patent specifies overlapping claim limitations to arrive at patentably indistinct compounds.
Conclusion
All claims are rejected.
No claims are allowed.
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/L.A.B./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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