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 .
Election/Restrictions
Applicant’s election of group I and the species No. 12 in Table 1, without traverse in the reply filed on 08/06/26 is acknowledged. The elected species reads on the group I claims: 1, 2, 7, 16-17, 20, 26, 42-43, 50, and 67-68.
The examiner searched applicant’s specifically elected species and ended up broadening the species to examples wherein R8 is also NR9R10 and wherein G1 is a direct bond and G2 is a direct bond or C=O. Accordingly, the claims being examined in this office action are 1-3 (with 3 only being examined with respect to group IA), 7, 16-17, 20, 25-26, 42-43, 50, 67-68.
Claims 5, are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/06/26.
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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites wherein L1 and L2 are each independently -O(C=O)-,…NRaC(=O)NRa,…wherein Ra is H or C1-C12 alkyl. It is unclear to the examiner if when there are 2 Ra’s present in the molecule as in NRaC(=O)NRa, if the Ra’s must be the same thing, e.g. both must be H or the same C1-C12 alkyl group, e.g. if one is methyl then the other must be methyl or if each Ra can be independent of one another, e.g. 1 is H and the other can be any of H or any C1-C12 alkyl? It is not clear from the specification of claims as originally filed whether when there is more than one Ra whether the Ra’s are the same as each other or can be independent and as such the metes and bounds of what applicant’s NRaC(=O)NRa are meant to encompass are unclear.
Claims 2-3, 7, 16-17, 20, 25-26, 42-43, 50, 67-68 are also rejected because they depend either directly or indirectly from claim 1 and include the limitations of claim 1 and do not resolve the issue with respect to when L1 and/or L2 are NRaC(=O)NRa as discussed above
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 7, 16, 17, 20, 25, 26, 42-43, 50, and 67-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, 12-14, 16-22, 27-28, 32, 34-36, and 48-50 of U.S. Patent No. 10221127 (‘127). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘127 claims an overlapping scope of the instantly claimed compounds of formula I, specifically wherein G3 is C4 alkylene, L1 and L2 are -C(=O)O, G1 is direct bond; G2 is C(=O) and R7 is C6-C16 alkyl, and R8 is NR8R9 which corresponds to the instant NR9R10, etc. ‘127 further teaches compositions comprising these overlapping compounds, and a therapeutic agent and pharmaceutically acceptable excipients or diluents. Thus, one of ordinary skill in the art would conclude that the instantly claimed invention is rendered obvious and/or anticipated by the compounds, nanoparticles, and compositions claimed in US10221127.
Claims 1-3, 7, 16, 17, 20, 25, 26, 42-43, 50, and 67-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32, and 35 of U.S. Patent No. 11712481 (‘481). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘481 claims an overlapping scope of the instantly claimed compounds of formula I, and further claims pharmaceutical compositions and lipid nanoparticles comprising these overlapping lipids and wherein the compositions can comprise the same excipients instantly claimed. Thus, one of ordinary skill in the art would conclude that the instantly claimed invention is rendered obvious and/or is anticipated by the claimed lipids, nanoparticles and compositions claimed in US11712481.
Claims 1-3, 7, 16, 17, 20, 25, 26, 42-43, 50, and 67-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 17-18 of U.S. Patent No. 12065396 for the same reasons which are discussed above with respect to US 11712481.
Claims 1-3, 7, 16, 17, 20, 25, 26, 42-43, 50, and 67-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11648324 for the same reasons which are discussed above with respect to US 11712481.
Claims 1-3, 7, 16, 17, 20, 25, 26, 42-43, 50, and 67-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11976019 for the same reasons which are discussed above with respect to US 11712481.
Claims 1-3, 7, 16, 17, 20, 25, 26, 42-43, 50, and 67-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-71 of U.S. Patent No. 12491261 for the same reasons which are discussed above with respect to US 11712481.
Claims 1-3, 7, 16, 17, 20, 25, 26, 42-43, 50, and 67-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12410121 for the same reasons which are discussed above with respect to US 11712481.
Claims 1-3, 7, 16, 17, 20, 25, 26, 42-43, 50, and 67-68 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 44, 59, of copending application 19296652 for the same reasons which are discussed above with respect to US 11712481.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 7, 25, and 43 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Otawa (JP09255638, from IDS).
Applicant’s claim:
--the compounds of revised formula (I) wherein the structural variants are as defined by the instant claims.
Otawa teaches compounds, e.g.
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which anticipates applicant’s claims 1-2, 7, 25, and 43 wherein G1 is a direct bond, G2 is a direct bond and R7 is a C2-alkyl which is substituted by OH, G3 is a C2 alkyl and R8 is OH, b and c are both 1, L1 and L2 are -C(=O)O-/-O(C=O)- as the instant claims do not specify the order/direction of the ester within the lipid chain, and wherein a and d are both 17, and R1a, R1b, R2a, R2b, R3a, R3b, R4a, R4b, R5 and R6 are all H (see pg. 6 compounds, e.g. right column 4th compound down in Japanese original document).
This compound reads on and anticipates the instant claims as they are currently written.
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 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 1-3, 7, 16, 17, 20, 25, 26, 42-43, 50, 67-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tam et al. (WO2016/176330 with priority to 04/27/2015, from IDS) in view of Patani et al. (Chem. Rev. 1996, 96, 3147-3176, from IDS).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1-3, 7, 16, 17, 20, 25-26, 42, 43, and 50, Tam broadly teaches an overlapping scope of the instantly claimed compounds of formula I, wherein their L1 and L2, G1, G2, G3, Ra, R1a and R1b , R2a and R2b, R3a and R3b, R4a and R4b, R5, R6, and R7, a, b, c, d all overlap in scope with the instantly claimed group or have the exact same scope, and Tam further teaches wherein the instantly claimed R8 group is the instantly claimed NR9R10 (it is referred to as NR8R9 in Tam (See entire document; abstract; compound II-9 on pg. 84; pg. 75, ln. 6-pg. 88, end of table inclusive; claims; examples), see for instance compound II-9 found on pg. 84
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which is homologous to the instantly claimed compound below:
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wherein II-9 and the above compound compounds only differ in that the two N atoms are linked by 3 CH2 groups for G3 in II-9 instead of the instantly claimed 4 CH2 groups for G3 in the instant claims and the above compound which is expressly claimed in claim 50.
Regarding claim 1, Tam also teaches isolated compound 9b see scheme in Example 8 and pg. 140, ln. 5-pg. 141, ln. 3, which is homologous to the compound claimed in wherein G2 is a direct bond and R7 is CH3, as Tam teaches G2 being a direct bond and R7 being H and hydrogen and methyl groups are homologous and/or only differ by the successive addition of CH2 and the MPEP states, “Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious.” In rePayne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979), and “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or 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). It is also obvious to switch the H for a methyl group because Patani teaches that methyl groups are known bioisosteric replacements of hydrogen atoms (See pg. 3152-3154, section 4).
Regarding claims 67-68, Tam teaches compositions which comprise the homologous compounds of Formula I and methods of administering therapeutic agents to patients in need thereof by preparing or providing compositions comprising the homologous lipids to those of the instant formula I and/or broadly comprise/can be compounds of instant formula I and administering these compositions to the patients in need thereof and Tam further teaches pharmaceutical compositions comprising lipid nanoparticles and a diluent/excipient which comprise the compounds of formula I and/or the specifically exemplified homologous examples of instant formula I that are discussed above (See entire document; abstract; pg. 1, ln. 1-15; pg. 3, ln. 24-pg. 5, ln. 11, inclusive; pg. 14, ln. 14-21; pg. 8, ln. 9-23; pg. 40, ln. 11-pg. 50, ln. inclusive; pg. 108, ln. 11-pg.119, ln 3; pg. pg. 119, ln. 30-pg. 124, ln. 19; pg. 124, ln. 22-pg.; 127, ln. 15; claims; examples; lipid nanoparticles with formula II (which overlaps with the instant formula I): see pg. 88, ln. 2-8, compound II-9 on pg. 84 which is homologous to the compound instantly claimed and shown above).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding the instant claims, Tam does not specifically teach express examples of compounds of formula I wherein R8 is OH as is instantly elected. However, Tam does teach structurally similar lipids to those instantly elected see examples in Table 3 wherein the equivalent position off of the nitrogen atom is OH and as such it would have been obvious to substitute the NR8R9 of Tam for the OH that is instantly claimed and expect that these compounds would also function as lipids because Tam demonstrates throughout the reference that the groups which come off the nitrogen atom are not particularly limited as long as they include at least one long chain lipid/fatty groups (See entire document; examples; claims).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to form the instantly claimed compounds wherein G3 is specifically C4-C5 alkylene when R8 is NR9R10 as is instantly claimed because the disclosed compounds of Tam as discussed above only differs by a single CH2 group from the instantly claimed compound in claim 50 and further Tam specifically discloses that G3 can be C1-C6 alkylene and that all of these compounds are useful as lipids for delivering nucleic acid therapeutic agents as are instantly claimed. One of ordinary skill in the art would have been motivated to form the claimed compounds when looking to Tam because, “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or 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), and further because Patani teaches that methyl groups are known bioisosteric replacements of hydrogen atoms (See pg. 3152, section 4).
It also would have been obvious to form the instantly elected compounds having an OH for R8 because it would have been obvious to substitute the NR8R9 of Tam for the OH that is instantly claimed and expect that these compounds would also function as lipids because Tam demonstrates throughout the reference that the groups which come off the nitrogen atom are not particularly limited as long as they include at least one long chain lipid/fatty groups (See entire document; examples; claims).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art 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 would have been 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X 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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/ERIN E HIRT/Primary Examiner, Art Unit 1616
Prosecution Insights