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 .
Claim Status
The amended claim set filed on 10 December 2025 is acknowledged. Claims 29, 31-32, and 36-37 are currently pending. Of those, claims 29, 31-32, and 36 are amended. There are no new claims and no claims are withdrawn. Claims 1-28, 30, 33-35, and 38-47 are cancelled. Claims 29, 31-32, and 36-37 will be examined on the merits herein.
Election/Restrictions
Applicant’s election of Group I (claims 29, 31-32, and 36-37) in the reply filed on 10 December 2025 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)).
Applicant’s election without traverse of: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated-15B, 18C, 19A, 19F, 22F, 23B, 23F, 24F, 33F, and 35B as the species of serotypes in claim 32 and (13Z,16Z)-N,N-dimethyl-3-nonyldocosa-13,16-dien-1-amine as the species of cationic lipid in claims 29, 31-32, and 36-37 in the reply filed on 10 December 2025 is acknowledged.
Priority
The instant application is a 371 of application PCT/US2022/014810 (filed 2 February 2022) and claims priority to U.S. Provisional application 63/145,653 (filed 4 February 2021). Therefore, the effective filing date of instant claims 29, 31-32, and 36-37 is 4 February 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 September 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 32 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 32 recites, “the at least one Streptococcus pneumoniae polysaccharide is selected from the group comprising serotypes:….” As written, it is unclear what serotypes and/or groups or serotypes are encompassed by the scope of the claim because of the use of open claim language (i.e., “the group comprising”). MPEP 2173.05(h)(I) states: “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group ‘consisting of’ (rather than ‘comprising’ or ‘including’) the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196.” In the interest of compact prosecution, the claim is interpreted to recite a closed group of alternative groups of serotypes, and the prior art search is limited to the elected group of serotypes (see para. 4 above). Clarification is requested.
Claim Rejections - 35 USC § 103
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.
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.
Claims 29, 31, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Burki et al. (WO 2020/058963 A1; herein “Burki”) in view of Gindy et al. (2019, EP 3,556,353 A2; cited in IDS; herein “Gindy”).
Regarding claims 29 and 31, Burki teaches an immunogenic composition comprising glycoconjugates from Streptococcus pneumoniae serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12 F, 14, 15A, 15B, 15C, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 31, 33F, and 35B conjugated to a carrier protein such as CRM197 (pg. 9, para. 2-3 and FIG. 9). Burki also teaches methods of conjugating S. pneumoniae polysaccharides with carrier proteins (pg. 23-27) and teaches that the administration of glycoconjugates of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12 F, 14, 15A, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F, and 35B results in the increased production of antibodies compared to antibody production in non-vaccinated rabbits (FIG. 9).
However, Burki does not teach a composition comprising at least one S. pneumoniae polysaccharide conjugate and a lipid nanoparticle comprising a cationic lipid such as (13Z,16Z)-N,N-dimethyl-3-nonyldocosa-13,16-dien-1-amine, as in claims 29 and 36, or a lipid nanoparticle further comprising a neutral lipid, a phospholipid, and a PEG lipid, as in claim 37.
Regarding claims 29 and 36, Gindy teaches immunological compositions comprising one or more antigens and lipid nanoparticles (para. 1) comprising one or more cationic lipids (para. 7). Gindy teaches that the cationic lipid may be (13Z,16Z)-N,N-dimethyl-3-nonyldocosa-13,16-dien-1-amine (para. 8, pg. 3, line 8). Gindy also teaches that the one or more antigens may be associated with infection caused by S. pneumoniae (para. 103) and that the antigen may be a fusion protein, capsular polysaccharide, or a toxoid (para. 104). Gindy teaches that the lipid nanoparticles may be used as an adjuvant or as a carrier for antigen delivery (para. 20) and are capable of inducing strong antibody and T cell responses to protein antigens (para. 22). Gindy also teaches that lipid nanoparticle adjuvants are advantageous compared to other adjuvants because they may enable modulation of the adaptive immune response, broaden immune responses, reducing antigen dose or number of doses, and enabling immunization of patients with weakened immune systems (para. 23).
Regarding claim 37, Gindy teaches that the lipid nanoparticle further comprises non-cationic lipids, comprising cholesterol (i.e., a neutral lipid) and DSPC (i.e., a phospholipid), and a PEG-lipid (para. 11).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine the immunogenic composition of Burki with the lipid nanoparticle of Gindy, thereby arriving at the invention of claims 29, 31, and 36-37. The person of ordinary skill in the art would have been motivated to make the modification because Gindy teaches that their lipid nanoparticle composition has been shown to be a potent adjuvant, and has advantages over other adjuvants, such as enabling modulation of immune responses, reducing antigen dose, and allowing for immunization of patients with weakened immune systems. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because Gindy teaches that the lipid nanoparticle may be used with antigens that are fusion proteins, capsular polysaccharides, or toxoids, and the Pneumococcal conjugate composition of Burki comprises glycoconjugates (i.e., fusion proteins) comprising capsular polysaccharides and CRM197 (i.e., a toxoid). Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., S. pneumoniae polysaccharide conjugates, CRM197, lipid nanoparticle, (13Z,16Z)-N,N-dimethyl-3-nonyldocosa-13,16-dien-1-amine, neutral lipids, phospholipids, and PEG-lipids) were known in the art. In addition, combining these elements yields a composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 29, 31-32, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Burki (WO 2020/058963 A1) in view of Gindy (EP 3,556,353 A2) as applied to claims 29, 31, and 36-37 above, and further in view of Spencer et al. (2017, Clin. Vaccine Immunol.; herein “Spencer”).
The combination of Burki and Gindy and teachings with respect to claims 29, 31, and 36-37 are set forth in para. 13-18 above.
The teachings of Burki with respect to claims 29 and 31 also apply to claim 32.
However, neither Burki nor Gindy teach a S. pneumoniae polysaccharide conjugate composition comprising polysaccharides from serotype de-O-acylated 15B, as in claim 32.
Regarding claim 32, Spencer teaches S. pneumoniae strain BLS143, which contains a mutation in the wciZ gene, which encodes the O-acetyltransferase gene, thus resulting in the “15X” serotype, i.e., a nonacylated 15B serotype (Abstract and Table 1). Spencer teaches that monoclonal antibodies specific to the 15B polysaccharide serotype targets the O-acetyl group on the polysaccharide and that the 15C polysaccharide has a smaller and variable amount of O-acetylation (pg. 3, para. 2). Spencer also teaches that pool H serum, which is from patients that have previously been vaccinated with a 23-valent Sp. pneumoniae polysaccharide vaccine containing 15B serotype polysaccharide, contains antibodies which target all serogroup 15 capsules and can bind 15B, 15C, and 15X strains equally well (pg. 4, para. 1).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the composition of Burki and Gindy by substituting the 15B polysaccharide taught by Burki with the nonacetylated 15B polysaccharide taught by Spencer, thereby arriving at the claimed invention. The person of ordinary skill in the art would have been motivated to make the modification because Spencer teaches that that serotype 15C bacteria can evade protection by anti-serotype 15B antibodies that target the acetyl group of serotype 15B, but serotype 15C is affected by antibodies that target the shared core structure. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of successfully substituting the 15B polysaccharide with that of the de-O-acetylated 15B serotype because Burki teaches methods of producing glycoconjugates of S. pneumoniae polysaccharides for an immunogenic composition. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the combination of Burki and Gindy teaches a product that only differs from the claimed invention by the substitution of a single component (i.e., substitution of the 15B polysaccharide used); the substituted element (i.e., the de-O-acetylated 15B polysaccharide) was already known and already shown to function as a target for anti-serogroup 15 antibodies, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one polysaccharide for another with a reasonable expectation of success (i.e., the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing 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.
US 11,116,828 B2
Claims 29, 31-32, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 9, 12, 15, 23-24, 32, 34, 36-37, 38, 40-42, 44-46, and 48-49 of U.S. Patent No. 11,116,828 (‘828) in view of Burki (WO 2020/058963 A1) and Gindy (EP 3,556,353 A2).
Regarding instant claim 29, the ‘828 claims teach compositions comprising at least one S. pneumoniae polysaccharide carrier protein conjugates (‘828 claims 1, 9, 12, 15, 32, 34, 36-37, 38, 40-42, 44-46, and 48-49). The ‘828 claims teach that the composition may further comprise an adjuvant (‘828 claims 7 and 24).
Regarding instant claim 31, the ‘828 claims teach that the carrier protein is CRM197 (‘828 claims 6, 9, 12, 15, 23, 32, 34, 36-37, 40-42, 44-46, and 48-49).
Regarding instant claim 32, the ‘828 claims teach that the composition may comprise polysaccharide conjugates from the group S. pneumoniae serotypes consisting essentially of: 3, 7F, 19A, 22F, 33F, 6A, 15A, 16F, 23A, 23B, 24F, 31, 35B, 8, 9N, 10A, 11A, 12F, de-O-acetylated 15B, 17F, and 20A (‘828 claim 34); 3, 7F, 19A, 22F, 33F, 6A, 15A, 16F, 23A, 23B, 24F, 31, 35B, 8, 9N, 10A, 11A, 12F, 15C, 17F, and 20A (‘828 claim 36); 3, 7F, 19A, 22F, 33F, 6A, 15A, 16F, 23A, 23B, 24F, 31, 35B, 8, 9N, 10A, 11A, 12F, 15B, 17F, and 20A (‘828 claim 37); : 3, 7F, 19A, 22F, 33F, 6A, 15A, 16F, 23A, 23B, 24F, 31, 35B, 8, 9N, 10A, 11A, 12F, de-O-acetylated 15B, 17F, and 20 (‘828 claim 42).
However, the ‘828 claims do not teach a composition comprising at least one S. pneumoniae polysaccharide conjugate and a lipid nanoparticle comprising a cationic lipid, including (13Z,16Z)-N,N-dimethyl-3-nonyldocosa-13,16-dien-1-amine as the cationic lipid, as in instant claims 29 and 36, a composition comprising S. pneumoniae polysaccharide conjugates from serotypes, 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 18C, 19A, 19F, 22F, 23B, 23F, 24F, 33F, and 35B in the same composition, as in instant claim 32, or a lipid nanoparticle further comprising a neutral lipid, a phospholipid, and a PEG lipid, as in instant claim 37.
The teachings of Burki and Gindy with respect to instant claims 29, 31-32, and 36-37 are set forth in para. 13-16 above.
Therefore, it would have been prima facie obvious, to a person of ordinary skill in the art, to combine the S. pneumoniae polysaccharide conjugate composition of the ‘828 claims with that of Burki and further combine the resulting multivalent composition with the lipid nanoparticle of Gindy, thereby arriving at the invention of the instant claims. The person of ordinary skill in the art would have been motivated to combine the polysaccharide conjugate compositions in order to make a composition that provides protection against a broader range of infectious S. pneumoniae serotypes, as is taught by Burki. And one would be motivated to combine the polysaccharide conjugates with the lipid nanoparticle because Gindy teaches that their lipid nanoparticle composition has been shown to be a potent adjuvant, and has advantages over other adjuvants, such as enabling modulation of immune responses, reducing antigen dose, and allowing for immunization of patients with weakened immune systems. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because Gindy teaches that the lipid nanoparticle may be used with antigens that are fusion proteins, capsular polysaccharides, or toxoids, and the Pneumococcal conjugate compositions of the ‘828 claims and Burki comprise glycoconjugates (i.e., fusion proteins) comprising capsular polysaccharides and CRM197 (i.e., a toxoid). Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., S. pneumoniae polysaccharide conjugates, lipid nanoparticles, CRM197, (13Z,16Z)-N,N-dimethyl-3-nonyldocosa-13,16-dien-1-amine, and neutral lipids, phospholipids, and PEG lipids) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
In the interest of space, the remaining double patenting rejections are presented in an abbreviated form. The following table lays out the support for each limitation of the instant claims (see column labels at the top of the table) in the claims of each patent or co-pending application (see row labels on the left of the table). An asterisk indicated that the reference claim partially supports the limitation(s) of an instant claim.
29(a)
29(b)
31
32
36
37
US 11,219,680
1
-
4
3*
-
-
US 11,491,216
1, 17
-
1, 17
1*, 17*
-
-
US 11,642,406
1, 4, 7
-
1, 4, 7
1, 4, 7
-
-
US 11,850,278
1
-
1
1*
-
-
US 12,016,914
1, 2
-
1, 2
2
-
-
US 12,097,250
1, 4, 7
-
1, 4, 7
1*
-
-
US 12,280,107
1, 2
-
1, 2
1*, 2*
-
-
17/934,379
31
-
31
31*, 37*
-
-
17/934,396
19
-
19
20*-21*
-
-
17/935,856
48
-
48
-
-
-
17/935,864
19-21
-
19-20
19-21
-
-
17/935,871
31, 36
-
31
31, 36
-
-
18/263,289
39-40, 48, 51, 54
39*, 43*, 48*, 51*, 54*
41, 48, 51, 54
45, 48
43*, 44*, 51*, 54*
-
18/665,887
1
-
32-34
5, 10, 15, 20, 28-29
-
-
18/665,951
1, 12
-
2, 12
3
-
-
18/792658
1-2
-
1-2
1*, 2
-
-
18/812,253
1
-
1
-
-
-
US 11,219,680
Claims 29, 31-32, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,219,680 ('680) in view of Burki (WO 2020/058963 A1) and Gindy (EP 3,556,353 A2).
The teachings of the ‘680 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Burki and Gindy and the rationale for combining are the same as that presented in the rejection over US 11,116,828 above.
US 11,491,216
Claims 29, 31-32, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 11,491,216 ('216) in view of Burki (WO 2020/058963 A1) and Gindy (EP 3,556,353 A2).
The teachings of the ‘216 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Burki and Gindy and the rationale for combining are the same as that presented in the rejection over US 11,116,828 above.
US 11,642,406
Claims 29, 31-32, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 7 of U.S. Patent No. 11,624,406 (‘406) in view of Gindy (EP 3,556,353 A2).
The teachings of the ‘406 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Gindy and the rationale for combining with the composition of the ‘406 claims are the same as that presented in the 103 rejection above (see para. 15-18).
US 11,850,278
Claims 29, 31-32, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,850,278 ('278) in view of Burki (WO 2020/058963 A1) and Gindy (EP 3,556,353 A2).
The teachings of the ‘278 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Burki and Gindy and the rationale for combining are the same as that presented in the rejection over US 11,116,828 above.
US 12,016,914
Claims 29, 31-32, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,016,914 (‘914) in view of Gindy (EP 3,556,353 A2).
The teachings of the ‘914 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Gindy and the rationale for combining with the composition of the ‘914 claims are the same as that presented in the 103 rejection above (see para. 15-18).
US 12,097,250
Claims 29, 31-32, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 7 of U.S. Patent No. 12,097,250 ('250) in view of Burki (WO 2020/058963 A1) and Gindy (EP 3,556,353 A2).
The teachings of the ‘250 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Burki and Gindy and the rationale for combining are the same as that presented in the rejection over US 11,116,828 above.
US 12,280,107
Claims 29, 31-32, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,280,107 ('107) in view of Burki (WO 2020/058963 A1) and Gindy (EP 3,556,353 A2).
The teachings of the ‘107 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Burki and Gindy and the rationale for combining are the same as that presented in the rejection over US 11,116,828 above.
17/934,379
Claims 29, 31-32, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31 and 37 of copending Application No. 17/934,379 (‘379) in view of Gindy (EP 3,556,353 A2) and Spencer (2017, Clin. Vaccine Immunol.). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘379 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Gindy and the rationale for combining with the composition of the ‘379 claims are the same as those set forth in para. 15-18 above.
The teachings of Spencer and rationale for combining with the combined product of the ‘379 claims and Gindy are the same as those set forth in para. 23-25 above.
17/934,396
Claims 29, 31-32, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 of copending Application No. 17/934,396 (‘396) in view of Gindy (EP 3,556,353 A2) and Spencer (2017, Clin. Vaccine Immunol.). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘396 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Gindy and the rationale for combining with the composition of the ‘396 claims are the same as those set forth in para. 15-18 above.
The teachings of Spencer and rationale for combining with the combined product of the ‘396 claims and Gindy are the same as those set forth in para. 23-25 above.
17/935,856
Claims 29, 31, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 48 of copending Application No. 17/935,856 (‘856) in view of Burki (WO 2020/058963 A1) and Gindy (EP 3,556,353 A2). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘856 claims relevant to instant claims 29 and 31 are presented in the table above.
The teachings of Burki and Gindy and the rationale for combining are the same as that presented in the rejection over US 11,116,828 above.
17/935,864
Claims 29, 31-32, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 of copending Application No. 17/935,864 (‘864) in view of Gindy (EP 3,556,353 A2) and Spencer (2017, Clin. Vaccine Immunol.). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘864 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Gindy and the rationale for combining with the composition of the ‘864 claims are the same as those set forth in para. 15-18 above.
The teachings of Spencer and rationale for combining with the combined product of the ‘864 claims and Gindy are the same as those set forth in para. 23-25 above.
17/935,871
Claims 29, 31-32, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 of copending Application No. 17/935,871 (‘871) in view of Gindy (EP 3,556,353 A2) and Spencer (2017, Clin. Vaccine Immunol.). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘871 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Gindy and the rationale for combining with the composition of the ‘871 claims are the same as those set forth in para. 15-18 above.
The teachings of Spencer and rationale for combining with the combined product of the ‘871 claims and Gindy are the same as those set forth in para. 23-25 above.
18/263,289
Claims 29, 31-32, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39-41, 43-45, 48, 51, and 54 of copending Application No. 18/263,289 (‘289) in view of Gindy (EP 3,556,353 A2). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘289 claims relevant to instant claims 29 and 31-32 are presented in the table above.
However, the ‘289 claims do not teach a lipid nanoparticle comprising the cationic lipid.
The teachings of Gindy and the rationale for combining with the composition of the ‘289 claims are the same as those set forth in para. 15-18 above.
18/665,887
Claims 29, 31-32, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 10, 15, 20, 28-29, and 32-34 of copending Application No. 18/665,887 (‘887) in view of Gindy (EP 3,556,353 A2). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘887 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Gindy and the rationale for combining with the composition of the ‘887 claims are the same as those set forth in para. 15-18 above.
18/665,951
Claims 29, 31-32, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 12 of copending Application No. 18/665,951 (‘951) in view of Gindy (EP 3,556,353 A2). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘951 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Gindy and the rationale for combining with the composition of the ‘951 claims are the same as those set forth in para. 15-18 above.
18/792,658
Claims 29, 31-32, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18/792,658 (‘658) in view of Gindy (EP 3,556,353 A2). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘658 claims relevant to instant claims 29 and 31-32 are presented in the table above.
The teachings of Gindy and the rationale for combining with the composition of the ‘658 claims are the same as those set forth in para. 15-18 above.
18/812,253
Claims 29, 31, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/812,253 (‘253) in view of Burki (WO 2020/058963 A1) and Gindy (EP 3,556,353 A2). This is a provisional nonstatutory double patenting rejection.
The teachings of the ‘253 claims relevant to instant claims 29 and 31 are presented in the table above.
The teachings of Burki and Gindy and the rationale for combining are the same as that presented in the rejection over US 11,116,828 above.
Conclusion
No claim is allowed.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645