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 .
DETAILED ACTION
Priority
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, is acknowledged.
Status of Claims
Claims 1-13 and 15-19 are currently pending in the application.
Receipt is acknowledged of amendment / response filed on August 05, 2026 and that has been entered.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 11/05/2025, which has been entered in the file.
Response to Election/Restriction
In response to the restriction requirement Applicants have elected Group I, which includes claims 1-12, drawn to a compound of formula (I) or a pharmaceutically acceptable salt or prodrug thereof and the elected species as set forth and found to a compound M5, such as,
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, with traverse, is acknowledged. The traversal is on the ground(s) that the remaining invention Group II should be rejoined and examined with the elected Group I, because “[T]his application is now in condition for substantive examination” (Remarks, page 2) and therefore, the search and examination of the entire Application can be made without undue burden to the Examiner. Applicant’s arguments have been fully considered and found unpersuasive at this time because the Invention Groups I and II differ materially in structure and in element from each other and therefore, are capable of supporting their own patents.
The invention Groups I and II each relates to a set of structurally diverse compounds having different variable groups, which are attached directly and indirectly to the core formula
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, compositions comprising compounds, and their method of uses, which do not possess a substantial common core wherein a reference anticipating one would not necessarily render the other obvious. The core does not define a contribution over the art. The ring structure of formula is further substituted by different variables R1 and R2, which are broadly defined and when the compound of formula (I) is taken as a whole, a plethora of vastly different compounds are possible. Thus, these features are not considered ‘special technical features’ under PCT rules 13.1 and 13.2. Hence, the unity of invention is considered to be lacking and restriction of the invention in accordance with the rules of unity of invention is considered to be proper.
In addition, 35 U.S.C. 372 (b)(2) clearly states that unity of invention may be reexamined under 35 U.S.C. 121. Restriction was based on PCT Rule 13.1, 13.2 and Annex B part 1(b) together with 37 CFR 1.475 and 1.499 for lacking unity of invention because of lacking a significant structural element qualifying as the special technical features.
PCT Rule 13.2 states that the international 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).
PCT Rule 13.2 states that unity of invention referred to in Rule 13.1 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.
Annex B (2)(V) when dealing with alternatives, if it can be shown that at least one Markush alternative is not novel over the prior art, the question of unity of invention shall be reconsidered by the Examiner. Reconsideration does not necessarily imply that an objection of lack of unity shall be raised. If the Examiner finds one of the inventions unpatentable over the prior art the evidence or admission may be used in a rejection under 35 U.S.C. 103 (a) of the other invention. Nevertheless, the Examiner may reconsider to rejoin method of use claims commensurate in scope with the product claims when the case would be found in condition for allowance [provided those method claims are free from 35 U.S.C. §112 first (including written description, reach-through claim language and/or scope-enablement issues) and second paragraphs]. For these reasons, Applicant’s arguments are found unpersuasive and, since 35 U.S.C. 101 allows one patent per invention, the requirement for restriction (election of species) is still deemed proper.
Claims 13 and 15-19 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142 (b) as being drawn to a non-elected subject matter.
Applicants preserve their right to file a divisional on the non-elected subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. § 103(a), which forms the basis for all obviousness rejections, set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 8-9, and 12 are rejected under 35 U.S.C. § 103(a) as being un-patentable by Schoenbrunn et al (2017). Applicant claims a compound of formula (I) or a pharmaceutically acceptable salt or prodrug and the method of uses thereof.
Determination of the scope and content of the prior art (MPEP §2141.01)
Schoenbrunn et al (2017) teaches compounds that are inhibitors of BRD4 kinase and their compositions having similar utilities to those of instantly claimed invention.
Ascertainment of the difference between the prior art and the claims (MPEP §2141.02)
The difference between the instantly claimed compound and that of the reference herein lies in the selection of a single substitution in core formula (I), such as, presence of “hydrogen” for the instantly claimed compound instead of ‘methyl’ group substitution in the same position of the prior art compound
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, [Schoenbrunn et al (2017) : STN International CAPLUS data base, Accession Number : 2017 : 624756, a copy is provided with this Office action].
Finding of prima facie obviousness--rational and motivation (MPEP §2142-2413)
It would have been prima facie obvious to one having ordinary skill in the art at the time of the invention was made since Schoenbrunn et al teaches compounds which are generic to the instantly claimed compounds. It is well established that the substitution of hydrogen for alkyl (Me) on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963). Therefore, in the instant case, one skilled in the chemical art would be motivated to choose to replace an alkyl (Me) group with a hydrogen atom or vice versa in view of the known teaching of the art, since one would have reasonable expectation that such modification would make similar compounds and expected to possess similar properties differing only in degree in view of the known teaching of the art.
The claimed compounds and their compositions are so closely related structurally to the homologous and /or analogous compounds of the reference as to be structurally and methodically obvious, therefore in the absence of any un-obviousness or unexpected properties. Moreover, any other differences are but obvious structural and/or methodically modifications, which would be apparent to one skilled in the chemical art that can use similar substitutions, would expect to have the same or essentially the same results and therefore, is obvious, absent evidence to the contrary. Since the core compound of the formula (I) is not novel and the novelty (if any) belongs to the selection of substitutions, a great caution should be exercised to determine the patentability of the claimed invention. Therefore, in looking at the instant claimed compound as a whole, the claimed compound of the formula (I) would have been suggested to one skilled in the art, unless unobvious or unexpected results can be shown.
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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-12 are rejected under the judicially created doctrine of obviousness-type double patenting, as being unpatentable over claims 1 and 12 of co-pending application No. 19/159,949 (US ‘949). This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same art recognized subject matter. A reference anticipating one set of claim will render the other obvious and it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, since US ‘949 teaches the generic compounds, compositions and their method of uses which are similar to the instantly claimed inventions. The subject matter claimed in the instant application is fully recited and covered in the claims of US ‘949 co-pending application. Therefore, the disclosure of US ‘949 co-pending application that teaches many permutation and combinations, which would easily place Applicant’s invention in possession of the public before the effective filing date of the claimed invention. The indiscriminate selection of “some'' among “many'' is prima facie obvious, In re Lemin, 141 USPQ 814 (1964). Therefore, in the instant case, one skilled in the chemical art would be motivated to choose to replace variable substitutions in permutation and combinations in core structure of formula (I) to obtain the desired compounds, in view of the known teaching of the art, such as,
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(claim 1 of US ‘949 co-pending application). The claimed compounds and their compositions are so closely related structurally to the homologous and /or analogous compounds of the reference as to be structurally and methodically obvious, therefore in the absence of any un-obviousness or unexpected properties. Moreover, any other differences are but obvious structural and/or methodically modifications, which would be apparent to one skilled in the chemical art that can use similar substitutions, would expect to have the same or essentially the same results and therefore, is obvious, absent evidence to the contrary.
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.
Claim 1 is 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 pre-AIA the applicant regards as the invention.
The expression “TG-101209” [recited in claim 1, line 11, page 2 and all other occurrences, if any], renders the claim indefinite because the claim does not itself define the invention but relies on external material and modern claim practice requires that the claim must stand alone to define the invention and incorporation into claim by express reference to the specification is not permitted (Ex parte Fressola, 27 USPQ 2d 1608).
Further, claim 1 is recited the limitation “TG-101209”, where the lack of antecedent basis makes the scope of the claim indeterminate (it is not clear what the Applicant is intending to encompass with this limitation). There is an insufficient antecedent basis for this limitation in the claim. It is suggested to rewrite the claim as an independent form including all of the limitations and /or chemical structure of “TG-101209” in the base claim and any intervening claims in order to overcome the rejection.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Golam Shameem, Ph.D. whose telephone number is (571) 272-0706. The examiner can normally be reached on Monday-Thursday from 7:30 AM - 6:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks, Ph.D. can be reached at (571) 270-7682.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist, whose telephone number is (571) 272-1600.
/GOLAM M SHAMEEM/Primary Examiner, Art Unit 1621
