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
This action is in response to papers filed June 17, 2026. Applicant’s reply to the restriction/election requirement of April 20, 2026 has been entered. Claim 7 has been amended. Claims 1-7 are pending in the application.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of Chinese Patent Application No. 2023103859228, filed April 12, 2023 in the People’s Republic of China, has been received as required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1 and 2, is acknowledged. Applicant’s elections of i) “compound of formula a” as the species of compound, and ii) “TN-2-18-12” as the species of compound of formula a are both also acknowledged. The Examiner has determined that claims 1 and 2 read on the elected subject matter.
Accordingly, claims 3-7 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on June 17, 2026. Claims 1 and 2 are currently under examination.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite ingredients. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract introduces a “method of preparation” but does not recite the key requisite active steps.
3. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. However, this is precisely what the last line of the abstract does. The last line of the abstract should thus be deleted. The abstract is not intended to be a promotional advertisement for the product.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 2 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2, which depends from claim 1, appears to be directed to a composition “comprising” all four of the recited compounds. Claim 1, however, is directed to a compound of formula (a). One of ordinary skill in the art thus cannot make heads or tails out of the metes and bounds of the claimed subject matter.
***For examination at this time, claim 2 is being interpreted as intending to limit the compound of formula (a) to the set of recited compounds, and not to a composition comprising all of the recited compounds.
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.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2, which depends from claim 1, appears to be directed to a composition “comprising” all four of the recited compounds. Claim 1, however, is directed merely to a compound of formula (a), and not to a composition comprising e.g. a combination of two or more compounds of formula (a). Therefore, claim 2, as presented, fails to further limit and fails to include all the limitations of the claim upon which it depends.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Manoharan et al. (U.S. Patent Application Pub. No. 2009/0163705).
Applicant Claims
Applicant claims the following compound:
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Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Manoharan et al. disclose the compound of formula (I), in which X can be CH2, Y can be CR9R10, Z can be CR11R12; R1, R2, R4, R6, R9, R10, R11, and R12 can each be H; R3 and R5 can each be NR14C(O)R16, wherein R14 can be H, and R16 can be alkyl substituted with 2 NR18R19, wherein R18 and R19 can be alkyl or alkenyl (paragraphs 0009-0016, 0020, 0024, 0033, 0043, 0072, 0450, 0452).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Manoharan et al. do not specifically anticipate the presently claimed compound with one specific example or preferred embodiment. However, the Manoharan et al. disclosure is sufficient to render the claimed compound prima facie obvious within the meaning of 35 USC 103.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Manoharan et al., outlined supra, to arrive at the presently claimed compound.
Manoharan et al. disclose the compound of formula (I), and that the compound of formula (I) can be employed to deliver nucleic acid-based therapies such as siRNA (0490). Since Manoharan et al. disclose that X can be CH2, Y can be CR9R10, Z can be CR11R12; R1, R2, R4, R6, R9, R10, R11, and R12 can each be H; R3 and R5 can each be NR14C(O)R16, wherein R14 can be H, and R16 can be alkyl substituted with 2 NR18R19, wherein R18 and R19 can be alkyl or alkenyl; one of ordinary skill in the art would thus be motivated to thus arrive at the presently claimed compound, with the reasonable expectation that the resulting compound can be employed to deliver nucleic acid-based therapies such as siRNA.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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