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 .
Claims 1, 2, 4, 8, 10, 11, 13, 15-21, 30, 32, and 50-52 are pending in the instant application. Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 1, 2, 4, 8, 10, 11, 13, 16, 30, 32, and 50-52 are rejected. Claims 15 and 21 are objected.
Information Disclosure Statements
The information disclosure statements filed on March 8, 2023 and November 10, 2025 have been considered and signed copies of form 1449 are enclosed herewith.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 2, 4, 8, 10, 11, 13, 15-21, 30, 32, and 50-52, and the species of Compound 135 in the response filed on November 10, 2025 is acknowledged. The restriction requirements are still deemed proper and are hereby made final.
The examiner will follow the guidelines of MPEP 803.02 wherein once a species is elected, it is examined for compliance with all applicable statutes for patentability and if compliance is found, then the examination is expanded to a reasonable number of elected species to determine whether they also comply with the statute. The examiner will determine whether the entire scope of the claims is patentable according to MPEP 803.02.
Applicant's elected species appears allowable over the prior art of record. Therefore, according to MPEP 803.02: should no prior art be found that anticipated or renders obvious the elected species, the search of the Markush-type claim will be extended. If prior art is found that anticipated or renders obvious the Markush-type claim with respect to a nonelected species, the Markush-type claim shall be rejected and claims to the nonelected species held withdrawn from further consideration. The search of the Markush-type claim has been extended to the non-elected species wherein:
G3 is -CH2CH2-; R4 is -CH2CH2OH; R3 is C1-C12 alkyl or C3-C8 cycloalkyl; G1 and G2 are C2-C12 alkylene; and the remaining variables are as defined in the claims.
As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 1, 2, 4, 8, 10, 11, 13, 15, 16, 21, 30, 32, and 50-52 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
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 30 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.
Specifically, claim 30 refers to tables in the specification. Claims must, under modern claim practice, stand alone to define an invention, and incorporation into claims by express reference to the specification is not permitted. Ex parte Fressola, 27 USPQ 2d 1608 (1993). This rejection can be overcome by amending the claim to include the structures found in the tables referenced.
Claim Rejections - 35 USC § 102
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 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, 2, 4, 8, 10, 11, 13, 16, 32, and 50-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2006/138380 A2.
WO 2006/138380 A2 discloses nitrogen-containing lipids or salts thereof (see abstract or claims), compositions comprising a nitrogen-containing lipid or salt thereof and a therapeutic or prophylactic agent, lipid nanoparticles comprising a nitrogen-containing lipid or salt thereof, pharmaceutical compositions comprising a nitrogen-containing lipid or salt thereof and a pharmaceutically acceptable excipient or diluent, and a method of delivering a therapeutic or prophylactic agent to a mammalian cell or organ. See [0056], [00225], [00243], [00248], and [00249].
The reference specifically discloses, for example, the lipid NE103 (see pages 153 and 154) which anticipates a compound of Formula (I) wherein G3 is -CH2CH2-; R4 is -CH2CH2OH; R3 is C2 alkyl substituted with hydroxy; G1 and G2 are C2 alkylene; and L1 and L2 are -C(=O)NRbRc and -C(=O)NReRf, respectively, wherein Rb and Re are H and Rc and Rf are C14 alkyl.
Therefore, a compound of Formula (I), composition, lipid nanoparticle, pharmaceutical composition, and the method of delivering a therapeutic or prophylactic agent to a mammalian cell or organ is anticipated by the reference.
Claim Objections
Claims 15 and 21 are objected for depending on a previously rejected claim. However, even if the claims are amended to be in independent form, they would still not be in condition for allowance because they contain non-elected subject matter. In other words, the subject matter or species which are not embraced by the elected embodiment or the identified nonelected species have been withdrawn from further consideration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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