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 .
Election/Restrictions
Applicant’s election of invention I in the reply filed on 5/14/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 62 and 67 have been cancelled.
Claims 7, 13, 17, 18, 51, 59-61 and 68-80 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/19/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(Prior rejection maintained and extended to newly presented claims and amended claims)
Claims 7, 13, 17, 18, 59-61 and 68-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 17, 19, 33 and 34 of U.S. Patent No. 11,712,481 in view of Hope et al. (infra).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention is drawn to a method of administering a nucleic acid that is encapsulated by a lipid nanoparticle that comprises a neutral lipid, cationic lipid, steroid and a polymer conjugated lipid. The cationic lipid and polymer conjugated lipid appear to be same as those used by the instant method in view of the additional teachings of Hope et al. (infra). While the patented invention does not discuss mol concentrations fo the polymer-conjugated lipid or if the nucleic acid is mRNA that encodes an immunogenic protein, the teachings of Hope et al. (see below) cure this deficiency. Therefore, one of ordinary skill in the art would be motivated to adapt the teachings of Hope et al. with the methods of ‘481 to arrive at an invention that is an obvious variant of the instant invention.
Response to arguments:
Applicant’s have not presented a specific argument against this rejection. The examiner has maintained this rejection based on the obviousness of the instant invention in view of the patented invention of ‘481 and Hope et al.
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 51 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.
MPEP 2173.05 (s) states:
(Rejections withdrawn in view of amendments)
[Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim. See MPEP § 608.01(m) for information pertaining to the treatment of reference characters in a claim.] Presently, the claimed information of Tables 1 to 12 as recited in claim 51 does not meet the requirements of an “exceptional circumstances where there is no practical way to define the invention in words”.
Claim 60 depends from a cancelled claim, it is suggested that claim 60 be amended to depend from a currently pending claim.
(New Rejection Necessitated by Amendments)
Claim 51 depends from a cancelled claim, it is suggested that claim 51 be amended to depend from a currently pending claim. It is therefore unclear which claim dependent claim 51 is attempting to further limit.
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.
(Rejection withdrawn in view of amendment) Claim 60 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 60 depends on a cancelled claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
(New Rejection Necessitated by Amendment) Claim 51 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 51 depends on a cancelled claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(Prior rejection maintained and extended to newly presented claims and amended claims)
Claim(s) 7, 13, 17, 18, 59-61 and 68-80 are rejected under 35 U.S.C. 102a1 as being anticipated by Hope et al. (WO/18/081480).
The claimed invention is drawn to:
A method for delivering a nucleic acid to a primate in need thereof, comprising administering a lipid nanoparticle (LNP) to the primate, the LNP comprising:
a nucleic acid, or a pharmaceutically acceptable salt thereof, encapsulated within the LNP;
a cationic lipid having a structure of Formula II or Formula III and a mol percent of 45-50 based on total moles of lipids in LNP;
a neutral lipid;
a steroid; and
a polymer-conjugated lipid at a 2.0 to 3.5 mol percent of the total moles of lipids in the LNP,
wherein a plurality of the LNPs has a mean particle diameter ranging from 40 nm to 70 nm.
The LNP comprises from 2.2 to 3.3, 2.3 to 2.8, 2.1 to 2.5, or 2.5 to 2.9 mol percent of the polymer-conjugated lipid.
The polymer-conjugated lipid comprises the following structure as defined by claims 13, 17 and 18:
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n is an integer ranging from 30 to 60, each R’ and R” is a saturated alkyl having from 8 to 14 carbon atoms.
The cationic lipid more specifically comprises the following structures:
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; or
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The nucleic acid is an antisense or mRNA sequence, if the sequence is an mRNA it is capable of translating an immunogenic protein.
The administration comprises administering via intravenous routes.
The Prior Art
Hope et al. teach methods of using lipid nanoparticles (LNPs) to deliver nucleic acids to a subject (in vivo). [see page 1-technical field] The formulation of lipid nanoparticles for the delivery of mRNA nucleic acids to a subject. [see example 1] While example 1 employs a mouse for studying the effects of the lipid nanoparticle, Hope et al. also teach that these animal models or human or non-human primates can also be used for testing lipid based compositions that transport nucleic acids that are capable of expressing a desired protein. [see page 11, lines 16-25] It is also taught that compositions that may be administered to a subject or patient may take the form of one or more dosage units, where for example, tablet may be a single dosage unit, and a container comprising LNPs in aerosol form may hold a plurality of dosage units. [see pages 89, lines 18-21] The mRNA sequences can encode an immunogenic protein. [see page 88, lines 17-21]
The LNP comprises a cationic lipid, a neutral lipid, a polymer conjugated lipid and a steroid. One example of a lipid nanoparticle comprises the molar ratios of cationic lipid: DSPC: cholesterol and PEG-lipid of: 50:0-10:28.5-38.5:1.5-1.7 or 47.5:10:40.8:1.7. These examples teach the claimed molar ratio of cationic lipid to neutral lipid (DSPC) of about 5:1, which is within the range of 2:1 to 8:1 [new claim 76], the cationic lipid to steroid (cholesterol) of about 1.75:1 [new claim 79] and molar ratio of cationic lipid to polymer conjugated lipid (PEG-lipid) of 28:1 or 33:1, which are within the claimed ranges of 100:1 and 20:1 [new claim 80]. An additional example of a LNP of Hope et al. is that of Trial No. 6, which possesses the following mol percent of each component, cationic Lipid:47.3, DSPC:9.0, cholesterol:40.7, and PEGylated lipid: 3.0. [see Table 5] or the lipid nanoparticle of claim 73 which possesses a polymer conjugated lipid in a concentration of 1.0 to 2.5 molar precent (which teach claims 68-71). [see page 27, lines 22-24 and page 172]
Hope et al. further teach that their polymer conjugated lipid is:
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[See Example 90]
Hope et al. teach that their cationic lipid is:
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[See pages 35 and 36]
With more specific options, which teach claims 72-75, being Formula II-15 [see page 54];
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and Formula III-45 [see page 69].
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Hope also teach that One route of administration is via injection. [see page 89, lines 7-12]
Therefore, Hope et al. anticipate the instant invention.
Response to arguments:
Applicant presents the following arguments in traversal of the rejection:
Hope et al. do not the administration of a LNP to a primate and noe of the examples in Hope et al. teach an LNP that comprises a cationic lipid with formula II or III and a polymer-conjugated lipid with a 2.0 to 3.5 mole percent. The only working example of delivering a LNP that encapsulates a nucleic acid sequences involves delivering such a composition to mice, and not a primate. Lastly, the examples of the LNP formulations provided does not statisfy the “at once envisage” standard and therefore, Hope et al. do not anticipate the claimed invention.
In response, Hope et al. clearly states that a subject should receive LNPs what possess the ability to deliver nucleic acid sequences which express proteins in the subject. Specific examples of such a subject include mice, monkeys and humans or patients. While Hope et al. does not provide a working example involving a primate and in view of MPEP 2121 and 2121.01, “Prior art is presumed to be operably/enabling…When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability.” and “A reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the effective filing date of the claimed invention for applications or patents subject to the first inventor to file provisions of the AIA or at the time the invention was made for applications or patents subject to pre-AIA law.”. In addition, the claimed method is drawn to a method of delivering a nucleic acid to a primate in need thereof by administering a LNP that has encapsulated a nucleic acid. Therefore, the Hope et al. at a minimum anticipate carrying out this method involving a primate. Furthermore, with regard to the argument pertaining to the specific compositions of the LNP not be suggested or taught, such as the mole percentage of cationic lipid, neutral lipid, steroid and polymer-conjugated lipid, Hope provides at least one example of such an LNP that comprises 45-50 mole percent of a cationic lipid and 2.0 to 3.5 mol percent of a polymer-conjugated lipid in Table 5 which encapsulated mRNA at 86.3% [see Trial No. 6]
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Furthermore, the argument that the requirements of the teachings of Hope et al. do not render one of ordinary skill in the art to be able to “at once envisage” the claimed LNP, Hope et al. provides many options of formulating a LNP that would fall within the scope of the claimed genus. (From MPEP 2131.02 III: “…If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be "at once envisaged."…” For example, Embodiment 2 on page 27 (see section posted below) of Hope et al. yields another lipid nanoparticle that falls within the scope of the claimed genus.
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Therefore, one of ordinary skill in the art would at once envisage the claimed LNP based on the teachings of Hope et al. It is determined that Hope et al. anticipates the instant invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN P BLUMEL/ Primary Examiner, Art Unit 1671
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