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, 13-18, 64-72, 74-76, 80, 88, and 91-97 are currently pending in the application.
Receipt is acknowledged of amendment / response filed on 06/09/2026 and that has been entered.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 07/02/2026, 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, 13-18, 64-72, 74-76, 80, 88, 91, and 94 drawn to a compound of Formula I or a pharmaceutically acceptable salt thereof and the elected species as set forth found to a compound I-145, such as,
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, with traverse, is acknowledged. The traversal is on the ground(s) that the remaining invention Groups should be rejoined and examined with the elected Group I, because “
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” (Response, page 1) and therefore, the search and examination of the entire Application can be made without undue burden to the Examiner. Applicant’s arguments (to withdraw the restriction requirements) have been fully considered and found partially persuasive and therefore, Examiner agreed to modify the restriction requirements to include and examine Groups II and III, claims 92-93 together with the elected invention of Group I, because they commensurate within the scope of the elected invention.
However, Applicant’s other arguments have been fully considered and found unpersuasive at this time, because the Invention groups I-V differ materially in structure and in element from each other and therefore, are capable of supporting their own patents. The invention Groups I-V each relates to a set of structurally diverse compounds [having different variable groups, which are attached directly and indirectly to the core Formula I], 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 structures of Formula I (EPL and TPL moieties) are further substituted by different variables R1, R2, and R3 etc., 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 claims commensurate in scope with the elected product /process 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 95-97 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 § 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 92-93 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 pre-AIA the applicant regards as the invention. The recitations of a compound in “Table 1 or 2” [claim 92, line 1 and page 10] and a compound in “Table 1-A or 2A” [claim 93, line 1 and page 10] render the claims indefinite because it is unclear from the claims what the Applicant is intending to encompass with these type of broad expressions “Table 1 or 2” and “Table 1-A or 2A” references, without disclosing the actual chemical names and/or chemical formula of compounds [confusion over the intended scope of a claims, see MPEP 2173.05(d)] and therefore, it is not possible to ascertain the metes and bounds of the claimed subject matter. The claims are indefinite because the claims do not itself define the invention but rely on external material and modern claim practice requires that the claims stand alone to define the invention. Ex parte Fressola, 27 USPQ2d 1608. Therefore, it is suggested to delete the expression “Table 1 or 2” and “Table 1-A or 2A” and/or amend the claims within the context and scope of the claims (e.g., disclosing the names and/or structures of the specific chemical formula of compounds that actually contemplated in the specification) 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
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