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 -----5/3/2024, which is a national stage application of PCT/US2022/079516 filed 11/9/2022, which claims domestic priority to 63/375,137 filed 9/9/2022 and 63/263,813 filed 11/9/2021.
As filed, claims 1, 2, 4-11, 13-20, and 26-33 are pending; and claims 3, 12, and 21-25 are cancelled.
Election/Restrictions
Applicant’s election without traverse of Group I – Claims 1, 2, 4-11, 13-20, and 28-33 in the reply filed on 6/29/2026 is acknowledged.
Claims 26 and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/29/2026.
Regarding the election of species requirement, Applicant elected the species of
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, which is compound I-75 on pg. 70 of the instant specification. The claims, which read on the elected species, are instant claims 1, 2, 4-8, 13-20, and 29-33, according to Applicant’s reply filed 6/29/2026.
Claims 9-11 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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.
Because the Markush-type claim (i.e. claim 1) is considered as an improper Markush grouping (see rejection below), the entire scope of the Markush claim cannot be and was not searched. The Examiner only searched the elected species.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/2/2025 and 12/19/2025 has been considered by the Examiner.
Claim Rejections - Improper Markush Grouping
A “Markush” claim recites a list of alternatively useable species and may encompass a large number of alternative species. Federal Register, Vol. 76, No. 27, February 9, 2011, 7162-7175, 7166. A Markush claim may be rejected under the judicially approved ‘‘improper Markush grouping’’ doctrine when the claim contains an improper grouping of alternatively useable species. Id.
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. Id.
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 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. Id.
See also MPEP § 803.02 (Rev. 5, Aug. 2006):
Since the decisions in In re Weber, 580 F.2d 455, 198 USPQ 328 (CCPA 1978) and In re Haas, 580 F.2d 461, 198 USPQ 334 (CCPA 1978), it is improper for the Office to refuse to examine that which appli-cants regard as their invention, unless the subject mat-ter in a claim lacks unity of invention. In re Harnisch, 631 F.2d 716, 206 USPQ 300 (CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984). Broadly, unity of invention exists where com-pounds included within a Markush group (1) share a common utility, and (2) share a substantial structural feature essential to that utility.
Claims 1, 2, 4-8, 13-18, 20, and 29-33 are rejected as containing an improper Markush grouping.
Claims 1, 2, 4-8, 13-18, 20, and 29-33 are drawn to the Markush-type Formula (shown below).
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The formula, as shown above, includes structural core variables X1, X2, ring A, ring B, and R1. These variables represent a variety of different organic functional groups.
Claims 1, 2, 4-8, 13-18, 20, and 29-33 are drawn to an improper Markush group because the formula, as shown above, contains alternatively useable species that do not share a single structural similarity. The only structural feature shared by all species of the formula, as shown above, is the bonds between all the variables, which is not an art-recognized physical or chemical class.
Without a meaningful and common structural core that is shared by the species in the formula above, there can be no “single structural similarity.” In other words, a single structural similarity is lacking due to the fact that variables X1, X2, ring A, ring B, and R1, for example, prevents the core structure from being an art-recognized physical or chemical class.
There is no substantial core structure that is shared by all species within the formula above. In fact, the formula, as shown above, is drawn to multiple core structures, and claims a variety of species that are structurally distinct due to their unique core structures (i.e., ring A together with the 6-membered ring system to which it is fused form a bicyclic ring system of the following structures:
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).
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 CFR 41.31(a)(1) (emphasis provided).
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, 2, 4-8, 13-20, and 29-33 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.
Regarding claim 1, the claim, for instance, recites the following heteroatoms in parenthesis (as shown by boxes below) for instant variable R1, and it is unclear to the Examiner whether the heteroatoms in parenthesis are part of the limitations. Same scenarios also apply to instant variables R2-R12 and R. With such ambiguity, the metes and bounds of instant variables R1-R12 and R are unclear, which rendered the claims indefinite.
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Regarding 2, 4-8, 13-20, and 29-33, these claims are directly or indirectly dependent of claim 1, and they failed to correct the indefiniteness issue of claim 1, which rendered these claims indefinite.
Regarding claim 18, the claim recites the following formulas “IIa, IIb, IIb’, IIb’’. IIc, IIc’, IIc’’, IIc’’’, IIc’’’’, IIIa, IVa, Va, VIa, VIIa, VIIIa, or IXa” without providing structure. As a result, the claim does not stand alone and one must refer back to the specification to define the claimed invention to determine the metes and bounds of the claim and thus, the claim is rendered indefinite.
Regarding claim 19, the claim refers to compounds selected from Table A or Table A2, but does not provide the chemical structure of said compounds. Consequently, one must refer back to the specification to find the structures of said compounds. Claim must, under modern claim practice, stand alone to define an invention, and incorporation into claims by express reference to the specification is not permitted. Ex parte Fressola, 27 USPQ 2d 1608 (1993). Therefore, the claim is rendered indefinite.
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.
Claims 1, 5-8, 16-20, and 29-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemical Abstract Registry No. 851268-58-1, hereinafter CAS581.
Regarding claims 1, 5-8, 16-20, and 29-33, CAS581 teaches the following compound or pharmaceutical composition thereof (with unbuffered water), which meets all the limitations of these claims.
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Wherein:
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is
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, which is a tautomer of
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; instant variable X1 is CH; instant variable X2 is N; instant variable X3 is N; instant variable R3 is OR; instant variable R is H; instant variable R2 is H; instant variable R1 is -C(=O)OR, wherein instant variable R is H; instant ring B is
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; instant variable L is a bond; instant variable X5 is CR5; instant variable R5 is chlorine; instant variable X6 are CH; and instant variable m is 0.
Claims 1, 5-7, 13, 14, 18, 19, and 29-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAPLUS printout of “Reaction of chloropyrimidines. II. Synthesis of new diazepines and azaphenalenes from pyrrol[3,4-d]pyrimidines”, hereinafter Ried.
Regarding claims 1, 5-7, 13, 14, 18, 19, and 29-33, Ried, for instance, teaches the following compound, which meets all the limitations of these claims.
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Wherein:
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is
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, which corresponds to
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; instant variables X1 and X2 are N; instant variable X3 is CR15; instant variable R15 is NR2, wherein instant variable R is H; instant variable R2 is methyl; instant variable R1 is NR2, wherein one of instant variables R is n-propyl, while the other is H; instant ring B is
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; instant variable X7 is N; and instant variables X8-X12 are CH2.
Claim Objections
Claims 1 and 19 are objected to because of the following informalities:
Regarding claim 1, the claim recites the following limitations for instant ring B:
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, wherein a bond is missing between X11 and X12, which needs to be corrected.
Regarding claim 19, the claim recites the phrase, “A compound of Table A of Table A-2”, which contains typographical error.
Such typographical error can be corrected by reciting -- A compound of Table A or Table A-2 --.
Appropriate correction is required.
Conclusion
Claims 1, 2, 4-8, 13-20, and 29-33 are rejected.
Claims 1 and 19 are objected.
Claims 9-11 and 26-28 are withdrawn.
Claims 3, 12, and 21-25 are cancelled.
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.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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