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
Claims 1-24 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 1-20, drawn to a compound of formula A) in the reply filed on 8/28/2025 is acknowledged. No species of formula A was elected.
Claims 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II, there being no allowable generic or linking claim. Thus, Claims 1-20 are being examined on the merits herein.
The requirement is deemed proper and is therefore made final.
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 1-12 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 regards as the invention.
The phrase which appears in Claim 1, “derivative…is used in” is ambiguous, describing a compound, a use, and a possible method. It appears potentially at least two statutory categories of invention are claimed in the ‘hybrid’ claim. See MPEP 2173.05(q). Applicant is requested to clearly distinguish a category of invention under 35 USC 101 for each claim. Claims 2-12 are rejected by virtue of dependency.
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 1, 2-13, and 15-20 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.
Claims 1 and 13 recite “the group comprising the following segments”. Comprising is an inclusive term which does not preclude any structures not enumerated in the list that follows:
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. The group is not limited to these structures as written and may include dipropylamino, ethyl-methylamino, etc. To properly limit the scope of the NR’R” to the above groups, applicant is advised to use “selected from the group consisting of” language.
Claims 3-12 and 15-20 are rejected by virtue of dependency.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sheng (WO2018233483, published 6/05/2018, filed as CN109111400 in 6/23/2017, cited in 4/15/2022 IDS).
102(a)(1): Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
102(a)(2): The applied reference has a common assignee, applicant, and/or joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The above regarding the statutory exemptions is true assuming applicant can perfect priority with respect to the Chinese PCT application to which the instant filing claims priority.
Sheng teaches the same compounds, I-1 through II-8, in examined Claims 2 and 14 in Table 1 of Page 4 (OG document). Sheng teaches forming compositions with the compounds and carriers and excipients (ENG: Page 6).
Regarding limitations concerning modes of use, Sheng describes the taught compounds as pharmaceutical. Therefore, they are necessarily capable of carrying out the use limitation as described in Claim 1.
Regarding the limitations of particular salts, the claim language does not restrict the compound to be selected to salts. Rather, the language restricts the acceptable salts to those listed and not free base forms of compounds of formula A.
Claims 1, 3-11, 13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Faraji (Medicinal Chemistry Research (2019) 28:974–983, published 5/23/2019).
Faraji teaches compounds encompassed by the claimed genus of formula A in Claims 1 and 13. For example, Faraji teaches compound 6g:
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; wherein n and NR1R2 are
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, respectively.
The compound applies to the following definitions of examined formula A in that R2 is H; R3 is H; and NR’R” is
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.
Regarding limitations concerning modes of use, Faraji describes the taught compounds as pharmaceutical. Therefore, they are necessarily capable of carrying out the use limitation as described in Claim 1.
Regarding the limitations of particular salts, the claim language does not restrict the compound to be selected to salts. Rather, the language restricts the acceptable salts to those listed and not free base forms of compounds of formula A.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sabatini (J. Med. Chem. 2011, 54, 5722–5736) in view of Ansel (Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 10th. Wolters Kluwer Health. 2013. Page 102).
Sabatini teaches NorA efflux pump inhibitor Compound 22j,
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, on Page 5726, Table 1, in which the following definitions of examined formula A apply: R3 is H; R2 is H; X is N-R1, wherein R1 is C1 alkyl, methyl; and NR’R” is
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. Sabatini teaches a shorter alkyl group which bridges O and piperidinyl, ethylene, as opposed to the claimed propylene. However, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
With respect to Claims 12 and 17-20, Sabatini does not teach the use of carriers to form compositions with compound 22j.
Ansel teaches “Drug substances are seldom administered alone; rather they are given as part of a formulation in combination with one or more nonmedicinal agents that serve varied and specialized pharmaceutical functions. Selective use of these nonmedicinal agents, referred to as pharmaceutical ingredients or excipients, produces dosage forms of various types. The pharmaceutical ingredients solubilize, suspend, thicken, dilute, emulsify, stabilize, preserve, color, flavor, and fashion medicinal agents into efficacious and appealing dosage forms”
Therefore, one of skill in the art would find the above modification, the addition of a methylene group obvious, and expect the compound to possess the same NorA efflux pump inhibitory properties. Further, the same artisan, as instructed by Ansel, would not administer the composition alone but with carriers and excipients to formulate “efficacious and appealing dosage forms”. One would expect success in doing so before the filing date of the instant application because Ansel teaches drugs broadly are formulated into compositions.
Regarding limitations concerning modes of use, Sabatini describes the taught compounds as pharmaceutical. Therefore, they are necessarily capable of carrying out the use limitation as described in Claim 1.
Regarding the limitations of particular salts, the claim language does not restrict the compound to be selected to salts. Rather, the language restricts the acceptable salts to those listed and not free base forms of compounds of formula A.
Claims 1, 3-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Faraji (Medicinal Chemistry Research (2019) 28:974–983, published 5/23/2019) in view of Ansel (Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. 10th. Wolters Kluwer Health. 2013. Page 102).
Faraji teaches compounds encompassed by the claimed genus of formula A in Claims 1 and 13. For example, Faraji teaches compound 6g:
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; wherein n and NR1R2 are
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, respectively.
The compound applies to the following definitions of examined formula A in that R2 is H; R3 is H; and NR’R” is
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.
Regarding limitations concerning modes of use, Faraji describes the taught compounds as pharmaceutical. Therefore, they are necessarily capable of carrying out the use limitation as described in Claim 1.
Regarding the limitations of particular salts, the claim language does not restrict the compound to be selected to salts. Rather, the language restricts the acceptable salts to those listed and not free base forms of compounds of formula A.
With respect to Claims 12 and 17-20, Faraji does not teach the use of carriers to form compositions with compound 22j.
Ansel teaches “Drug substances are seldom administered alone; rather they are given as part of a formulation in combination with one or more nonmedicinal agents that serve varied and specialized pharmaceutical functions. Selective use of these nonmedicinal agents, referred to as pharmaceutical ingredients or excipients, produces dosage forms of various types. The pharmaceutical ingredients solubilize, suspend, thicken, dilute, emulsify, stabilize, preserve, color, flavor, and fashion medicinal agents into efficacious and appealing dosage forms”
Therefore, one of skill in the art would, as instructed by Ansel, not seek to administer the composition alone but with carriers and excipients to formulate “efficacious and appealing dosage forms”. One would expect success in doing so before the effective filing date because Ansel teaches drugs broadly are formulated into compositions.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627