N1989
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 of Species and Status of the Claims
Applicant’s response to the Election of Species requirement elected without traverse is the compound:
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as the “single compound” and the “single disease” as Osteoarthritis encompassing claims 1-4, 18, and 34-37 in response the response filed April 1st 2026 is acknowledged. However, claim 37 reads on cancer and does not read on elected disease of osteoarthritis and is withdrawn from examination. Therefore, claims 1-4, 18, and 34-36 are pending and examined on their merits.
Priority
The present application is a U.S. National Stage application under 35 U.S.C. § 371 of International Patent Application No. PCT/GB2022/050421, filed February 16, 2022, which claims the benefit of Great Britain Patent Application No. 2102243.9, filed February 17, 2021.
Information Disclosure Statement
The Information Disclosure Statements filed on January 10th 2024 (44 references) and October 29th 2025 (1 reference) are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Improper Markush Grouping
Claims 1, 2, 18, 34-36 are rejected on the basis that independent claim 1 recites 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). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations.
First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use.
Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush groupings of formula (Ia), (Ib), (Ic) (Id) and (Ie), recited by the of independent claim 1 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons.
Independent claim 1 recites compounds of formula (Ia), (Ib), (Ic) (Id) and (Ie) as alternatives. Formula Ia is drawn so broadly such an exceptionally large number of compounds as to be unsearchable: RA1, RA2, and RA4 are each independently selected from the group consisting of -OH, -ORA5, halo, C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, which C1-6 alkyl, C2-6 alkenyl and C2-6 alkynyl groups are optionally substituted by one or more groups selected from halo, -OH and -OMe; and one RA1 , RA2 or RA4 group is ~---{labile linker]-X ; n is 0 to 5;
m is 0 to 5; and R5A is C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, which three groups are optionally substituted by one or more groups selected from halo, -OH and -OMe.
Claim 2 requires either fragment A or B. Because they lack a single structural similarity, compounds of formula Ia and the variants listed as (Ib), (Ic) (Id) and (Ie) are unlikely to exhibit a common biological activity across the entire separate genus, if any at all.
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.
Claim 1 and its dependent claims 2-4, 18, and 34-36 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 and its dependent claims are indefinite for identifying RA1 , RA2, and RA4 4 are each independently selected from the group consisting of -OH, -ORA5, halo, C1-6 alkyl, C2-6 alkenyl, C2-6 alkynyl, which C1-6 alkyl, C2-6 alkenyl and C2-6 alkynyl groups are optionally substituted by one or more groups selected from halo, -OH and -OMe; and one RA1, 1 , RA2 or RA44 group is
~---{labile linker]-X
One of ordinary skill in the art could not reasonably determine the metes and bounds of the claims from the claim language where RA1 , RA2, and RA4 can be both independently selected from a group of variables listed above and one of the variables is also a labile linker-X when the labile linker is not defined and the point of attachment to the particular carbon is indefinite.
Claims 34 and 35 are indefinite for the phrase “treating or preventing” a disease characterized by hyaluronan overproduction (as in claim 34) and a rheumatoid disease (as in claim 35). One of ordinary skill in the art could not reasonably determine the metes and bounds of the claims from the claim language because preventing a disease is indefinite and unclear how the claimed compounds prevent a disease. If a subject never develops a disease treated by said compounds, how would one skilled in the art determine the effectiveness or noneffectiveness of a particular treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL RANDALL GAUGER whose telephone number is (571)272-1325. The examiner can normally be reached M-F 7:30-5:00.
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/P.R.G./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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