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 .
Claim Status
Claims 10, 11, 13-20, 27, 28, 30-34 are cancelled.
Claims 1-9, 12, 21-29 and 35-37 are pending and presented for examination on the merits.
Priority
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Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 4/23/2024. It is noted, however, that applicant has not filed a certified copy of the foreign application as required by 37 CFR 1.55 and an attempt by the Office to retrieve the document on 9/23/2025 failed. MPEP 215.02(a) states: “Applicants continue to bear the ultimate responsibility for ensuring that the priority document is filed during the pendency of the application and before the patent is issued.” The effective filing date for the application of prior art is 08/20/2024.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 3/14/2025 and 5/30/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 35 and 37 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 35 and 37 are directed to compositions of matter but contain an action of a user “is administered”. The claiming a functional capability of a composition is permissible functional claiming, whereas claiming activities of a user of a composition in a composition of matter claim is impermissible and indefinite. See the analogous situation in MPEP 2173.05(p)(II): “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).” Correction is required.
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.
Claim(s) 1-9, 21-26, 29 and 36-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP4400491 published July 17, 2024; of record with a different inventive entity.
Regarding claims 1-5, EP4400491 discloses in claim 1:
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In claim 2:
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In looking to Table 1, EP4400491 disclose, for example, compound 27, which reads on compound (1):
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The other claimed compounds can be readily derived within the genus claimed by EP4400491.
Regarding claims 6-9, EP4400491 discloses:
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Regarding claims 21-26, 29 and 36, EP4400491 discloses:
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It is the Examiner’s position that the mRNA disclosed by EP4400491 in claim 11 inherently encodes at least one antigen or a fragment thereof or an epitope thereof, or encodes a certain therapeutic protein. EP4400491 discloses that is the function of the mRNA [0021]. Also the nucleic acid is naturally encapsulated in the lipid nanoparticle [0039, 0046].
Regarding claims 35 and 37, the intended use of the composition of “is administered to an injection site by intramuscular injection” is an intended use of the composition that does not further limit the claim. An intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Consequently, the prior art composition which recites the same components as instantly claimed can also be administered to an injection site by intramuscular injection.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over EP4400491 (published July 17, 2024; of record (IDS filed 3/14/25) with a different inventive entity) as applied to claims 1-9, 21-26, 29 and 36-37 above.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmaceutical formulation and possess conventional knowledge in drug delivery, material science, and physical chemistry to convert active pharmaceutical ingredients (APIs) into stable, effective medicines. They understand how to select excipients (inactive ingredients), optimize stability, and ensure compliance with regulatory standards (FDA, GMP). Their expertise covers formulation development, dosage form design for various conventional types of administration, and manufacturing processes.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
EP4400491 is discussed in detail above and that discussion is incorporated by reference. As discussed above EP4400491 anticipates instant claim 1. It is well settled that “a disclosure that anticipates under § 102 also renders the claim invalid under §103, for anticipation is the epitome of obviousness. See MPEP 1207.03(a)(II) states: “"lack of novelty is the epitome of obviousness." May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))”. Accordingly, the claims rejected under §102 above are also invalid under §103.
EP4400491 teaches methods for targeted delivery of the lipid nanoparticles to, for example skeletal muscle (Claim 10). EP4400491 also teach injection of the delivery system [0268].
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and EP4400491 is that EP4400491 do not expressly teach a method for delivering a drug by intramuscular injection of the drug delivery carrier. However, EP4400491 teaches skeletal muscle as a target organ and injection of the drug delivery carrier. One of ordinary skill in the art would have been motivated to do this because intramuscular injection is not only a conventional form of administration but also would get the drug delivery carrier directly to the target skeletal muscle. It is then obvious to intramuscularly inject the drug delivery carrier to the target organ skeletal muscle by the ordinary artisan with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the reference, 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 reference, especially in the absence of evidence to the contrary.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-9, 12, 21-29 and 35-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19132737. Although the claims at issue are not identical, they are not patentably distinct from each other because copending also teaches the same compounds as lipid nanoparticles claimed compound (Claims 1-3) and compositions of the compound with a pharmaceutically acceptable auxiliary material (Claim 18) a phospholipid, steroid such as cholesterol, or modified lipids (Claims 4, 6 and 17) including DOPE, DSPC, for example (Claim 5), or even a therapeutic/prophylactic agent nucleic acid (Claim 11) as well as conjugated lipids such as PEG2000-DSPE (Claim 8) with a molar ratio of compound to helper lipid of 1:(0.5-2) (Claim 9). The nucleic acid can be a natural nucleotide or nucleotide mimic (Claims 12 and 19) with a mass ratio of lipid nanoparticle to therapeutic agent of 10:1 to 100:1 (Claim 15). The copending also teaches methods for target delivery by administration of the lipid nanoparticles (Claim 10) to, for example, skeletal muscle (Claim 18).
The copending application does to expressly teach administration to an injection site by intramuscular injection. However, when the target organ is skeletal muscle, intramuscular injection is an obvious administration route to the ordinary artisan in this art. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/ Primary Examiner, Art Unit 1613
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