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 .
DETAILED ACTION
1. Claims 1, 3-14, 23-26, 29, 31-46 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 1/23/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities:
The use of trademarked terms has been noted in this application on pages 40, 50, 52, 55. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
4. Claim 8 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.
See claim 8 as submitted 1/23/2023.
Claim 8 recites “membrane”. It is not clear what is being referred to. The term “membrane” does not appear to have antecedent basis in claim 1, which recites neither a membrane already nor appears to read on, recite, or require a particular structure with a membrane in it, or what component(s) is/are considered to be a membrane or form a membrane and how.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 1, 3-14, 23-26, 29, 31-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment uses and methods, does not reasonably provide enablement for uses and methods of prevention. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
See claims 1, 3-14, 23-26, 29, 31-46 as submitted 1/23/2023.
In making a determination as to whether an application has met the requirements forenablement under 35 U.S.C. 112 P 1, the courts have put forth a series of factors. See, In reWands, 8 USPQ2d 1400, at 1404 (CAFC 1988). The factors considered include (1) the quantityof experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6)the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) thebreadth of the claims. Id. While it is not essential that every factor be examined in detail, thosefactors deemed most relevant should be considered. In the present case, the factors deemedrelevant are those of: the breadth of the claims; the amount of direction and the working examples provided, and the quantity of experimentation necessary.
Breadth of the claims: Claim 1 recites composition for use in treating or preventing a (or “any”) disease comprising lipid-based particle comprising antigen and modulator. Claim 29 recites method of treating or preventing a (or “any”) disease comprising administration of said particle. Claims 3-14, 23-26, 31-46 depend on these claims. Such recitations read on complete prevention or prophylaxis of a (or “any”) disease by administration or use of a mere antigen and modulator (pattern recognition receptor agonist) in lipid-based particle.
The amount of direction and the working examples provided: The present specification appears to only disclose elicitation of immune responses. For example, Example 4 teaches elicitation in vivo in mice of IgG, T cell responses to the disclosed NanoSTING Trimer compositions (comprising spike protein of SARS-CoV-2); Examples 10, 11, 13, 14 further teach elicitation of antibody immune responses and T cells using nucleocapsid protein antigens of SARS-CoV-2. Example 15 teaches use of spike proteins or RSV antigens.
However, in view of the breadth of the claims, the present specification does not teach or provide evidence of prevention or prophylaxis of disease using the claimed antigens, much less for the breadth of recitation towards “any” disease. Thus, the skilled artisan would be required to conduct undue amount of experimentation in order to use the instantly claimed compositions
for use or methods in preventing a or any disease (See also MPEP 2164.01(c): When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 ).
As discussed above undue experimentation would be required to practice the claimedinvention commensurate with the scope of the claims. Reasonable correlation must exist betweenthe scope of the claims and scope of enablement set forth. In view of the quantity ofexperimentation necessary, the limited working examples, the lack of sufficient guidance
in specification, and the breadth of the claims, it would take undue trials and errors to
practice the claimed invention.
Claim Rejections - 35 USC § 102/103
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 (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.
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.
6. Claims 1, 3-5, 7, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46 are rejected under 35 U.S.C. 102((a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Moon et al. (WO2017223085)(cited in applicant’s IDS submitted 1/23/2023).
See claims 1, 3-5, 7, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46 as submitted 1/23/2023.
See also the 35 U.S.C. 112 rejections above.
Moon et al. teaches: compositions comprising nanoparticles (abstract); including liposomes (claim 53 of Moon et al.)(as recited in claims 1, 3); including DPPG (claim 214 of Moon et al.)(as recited in claim 4); DPPC, cholesterol (claim 214 of Moon et al.); modified with PEG, PEG2000 (p. 18)(as recited in claim 5); including antigens (p. 3)(as recited in claims 1, 29); adjuvant including STING agonists (claim 43 of Moon et al.)(as recited in claims 1, 13, 14, 29); antigen is conjugated to outer surface (p. 21)(as recited in claim 7); antigen encapsulated in nanoparticle (p. 25)(as recited in claim 9); lyophilization (p. 121)(as recited in claim 23); administration (p. 100)(as recited in claims 24, 29, 43); influenza antigen (p. 14)(as recited in claims 39, 40); subcutaneous administration (p. 102)(as recited in claim 42); to mammal (p. 52)(as recited in claim 45).
As to claims 10, 26, 32-38, such results as recited are considered to flow from the composition and steps as already recited in claims 1, 29 on which the claims depend (See MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a wherein clause limited a process claim where the clause gave meaning and purpose to the manipulative steps ); In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a whereby clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention. Id. However, the court noted that a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat l Ass n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); …. See also MPEP 2112: 2112.01 Composition, Product, and Apparatus Claims: I. PRODUCT AND APPARATUS CLAIMS: WHEN THE STRUCTURE RECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TO THAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS ARE PRESUMED TO BE INHERENT: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); II. COMPOSITION CLAIMS; IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES: Products of identical chemical composition can not have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.).
As to claims 25, 31, 46, such recitations are considered to be an intended use (See MPEP 2111.02: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)).
Thus, Moon et al. anticipates or renders obvious the instantly claimed invention.
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 (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 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.
7. Claims 6, 8, 44 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. as applied to claims 1, 3-5, 7, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46 above.
See claims 6, 8, 44 as submitted 1/23/2023.
See also the 35 U.S.C. 112(b) rejection above as to claim 8.
See the teachings of Moon et al. above, including as to the components as recited in claim 6.
As to claim 6, such a ratio as recited is considered that to be determined by routine optimization to one of ordinary skill of the art in view of the teachings or suggestions of Moon et al., absent a showing of unexpected results (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
As to claim 8, it is noted Moon et al. also teaches: wherein antigen is associated with (absorbed/adsorbed) nanoparticle (p. 25); as well as wherein lipid molecules are membrane forming (p. 25); as well as wherein antigen is conjugated with a hydrophobic molecule (p. 25); wherein hydrophobic molecule is a lipid molecule (p. 25). In view of such teachings, such a recitation is considered to be an obvious embodiment in view of the teachings or suggestions of Moon et al.
As to claim 44, Moon et al. teaches wherein amounts for use depend on composition, manner, stage and severity as well as initial immunization followed by boosting (pp. 101-102). In view of such teachings or suggestions, the recitations of claim 44 are also considered to those determined by routine optimization to one of ordinary skill of the art in view of the teachings or suggestions of Moon et al., absent a showing of unexpected results (See MPEP 2144.05: II. ROUTINE OPTIMIZATION: A.Optimization Within Prior Art Conditions or Through Routine Experimentation: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. [W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
8. Claims 11, 12, 41 are rejected under 35 U.S.C. 103 as being unpatentable over Moon et al. as applied to claims 1, 3-5, 7, 9, 10, 13, 14, 23-26, 29, 31-40, 42-46 above, and further in view of Vilalata et al. (WO2005021707A2)(See PTO-892: Notice of References Cited).
See claims 11, 12, 41 as submitted 1/23/2023.
See the teachings of Moon et al. above.
Moon et al. does not teach wherein the antigen comprises a spike protein or portion thereof; wherein the antigen comprises a nucleocapsid protein or portion thereof; wherein the virus is selected from a severe acute respiratory syndrome coronavirus (SARS-CoV), a severe acute respiratory syndrome-related coronavirus (SARSr-CoV), a human coronavirus 229E (HCoV- 229E), a human coronavirus NL63 (HCoV-NL63), a human coronavirus OC43 (HCoV-OC43), a human coronavirus HKU1 (HCoV-HKU1), a Middle East respiratory syndrome-related coronavirus (MERS-CoV), a severe acute respiratory syndrome-related coronavirus 2 (SARS- CoV-2), a variant of SARS-CoV-2, or combinations thereof.
Vilalata et al. teaches: raising immune response against SARS; SARS CoV polypeptide [0014]; use of spike, nucleocapsid proteins [0026].
One of ordinary skill in the art would have been motivated to use antigen as taught by Vilalata et al. with the composition as taught by Moon et al. Moon et al. teaches use of antigen, and Vilalata et al., which also teaches use of antigen, teaches such an antigen already known and used in the art (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using antigen as taught by Vilalata et al. with the composition as taught by Moon et al. There would have been a reasonable expectation of success given the underlying materials (antigens as taught by Moon et al. and Vilalata et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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.
9. Claims 1, 4-7, 9-14, 23-26, 29, 31-44, 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 17-40 of copending Application No 18/100456.
See claims 1, 4-7, 9-14, 23-26, 29, 31-44, 46 as submitted 1/23/2023.
Claims 1-14, 17-40 of copending Application No 18/100456 recite a composition comprising: a lipid-based particle and a modulator, wherein the modulator is a pattern recognition receptor agonist, an activator of the immune system, or a combination thereof; antigen; spike protein molecule; nucleocapsid protein; agonist of STING pathway; DPPC, DPPG, cholesterol, DPPE-PEG2000 in a 10:1:1:1 ratio; associated with an outer surface; lyophilized; method of administering; intranasal delivery; inhalational delivery; at least one dose; respiratory pathogen; virus; influenza virus; coronavirus; SARS-CoV-2.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 4-7, 9-14, 23-26, 29, 31-44, 46 and claims 1-14, 17-40 of copending Application No 18/100456 recite a composition for use in treating or preventing a disease in an animal comprising: a lipid-based particle comprising an antigen and a modulator, wherein the modulator is a pattern recognition receptor agonist; spike protein molecule; nucleocapsid protein; agonist of STING pathway; DPPC, DPPG, cholesterol, DPPE-PEG2000 in a 10:1:1:1 ratio; associated with an outer surface; lyophilized; method of administering; intranasal delivery; inhalational delivery; at least one dose; respiratory pathogen; virus; influenza virus; coronavirus; SARS-CoV-2.
As to claims 10, 26, 32-38, such results as recited are considered to flow from the composition and steps as already recited in claims 1, 29 on which the claims depend (See MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a wherein clause limited a process claim where the clause gave meaning and purpose to the manipulative steps); In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a whereby clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention. Id. However, the court noted that a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat l Ass n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003).
As to claims 25, 31, 46, such a recitation is considered to be an intended use (See MPEP 2111.02: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Claims 3, 8, 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 17-40 of copending Application No 18/100456 as applied to claims 1, 4-7, 9-14, 23-26, 29, 31-44, 46 above and further in view of Moon et al. (cited above).
See claims 3, 8, 45 as submitted 1/23/2023.
See the recitations of claims 1-14, 17-40 of copending Application No 18/100456 above.
Claims 1-14, 17-40 of copending Application No 18/100456 do not recite: liposome;
wherein at least a portion of the antigen is integrated into a membrane of the lipid-based particle; mammal.
See the teaching of Moon et al. above.
One of ordinary skill in the art would have been motivated to use particle, antigen and subject as taught by Moon et al. with the particle as recited in claims 1-14, 17-40 of copending Application No 18/100456. Claims 1-14, 17-40 of copending Application No 18/100456 recite lipid based particle, antigen and subject, and Moon et al., which also teaches lipid based particle, antigen and subject, teaches such a particle and subject as well as such an association of antigen to particle (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using particle, antigen and subject as taught by Moon et al. with the particle as recited in claims 1-14, 17-40 of copending Application No 18/100456. There would have been a reasonable expectation of success given the underlying materials (lipid based particles comprising antigen as taught by Moon et al. and recited in claims 1-14, 17-40 of copending Application No 18/100456) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection.
11. Claims 1, 3-10, 13, 14, 23-26, 29, 31-40, 42-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97-100, 105-120
of copending Application No. 18/034312 in view of Moon et al. (cited above).
See claims 1, 3-10, 13, 14, 23-26, 29, 31-40, 42-46 as submitted 1/23/2023.
Claims 97-100, 105-120 of copending Application No. 18/034312 recite composition comprising STING pathway modulator; lipid based particle; DPPC, DPPG, cholesterol, DPPE-PEG2000; 10:1:1:1 ratio; single dose; intranasal administration; inhalational administration; mammal; antigen.
Claims 97-100, 105-120 of copending Application No. 18/034312 do not recite: liposome; particle association; lyophilization; respiratory pathogen; virus.
See the teachings of Moon et al. above.
One of ordinary skill in the art would have been motivated to use particle and antigen as taught by Moon et al. with the particle as recited in claims 97-100, 105-120 of copending Application No. 18/034312. Claims 97-100, 105-120 of copending Application No. 18/034312 recite lipid based particle and antigen, and Moon et al., which also teaches lipid based particle and antigen, teaches such a particle as well as such an association of antigen to particle (See MPEP 2144.06: Substituting equivalents known for the same purpose).
As to claims 10, 26, 32-38, such results as recited are considered to flow from the composition and steps as already recited in claims 1, 29 on which the claims depend (See MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a wherein clause limited a process claim where the clause gave meaning and purpose to the manipulative steps); In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a whereby clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention. Id. However, the court noted that a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat l Ass n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003).
As to claims 25, 31, 46, such recitations are considered to be an intended use (See MPEP 2111.02: During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)).
One of ordinary skill in the art would have had a reasonable expectation of success for using particle and antigen as taught by Moon et al. with the particle as recited in claims 97-100, 105-120 of copending Application No. 18/034312. There would have been a reasonable expectation of success given the underlying materials (lipid based particles comprising antigen as taught by Moon et al. and recited in claims 97-100, 105-120 of copending Application No. 18/034312) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claims 11, 12, 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97-100, 105-120 of copending Application No. 18/034312 in view of Moon et al. as applied to claims 1, 3-10, 13, 14, 23-26, 29, 31-40, 42-46 above and further in view of Vilalata et al. (cited above).
See claims 11, 12, 41 as submitted 1/23/2023.
See the teachings of claims 97-100, 105-120 of copending Application No. 18/034312 in view of Moon et al. above.
Claims 97-100, 105-120 of copending Application No. 18/034312 in view of Moon et al. do not recite wherein the antigen comprises a spike protein or portion thereof; wherein the antigen comprises a nucleocapsid protein or portion thereof; wherein the virus is selected from a severe acute respiratory syndrome coronavirus (SARS-CoV), a severe acute respiratory syndrome-related coronavirus (SARSr-CoV), a human coronavirus 229E (HCoV- 229E), a human coronavirus NL63 (HCoV-NL63), a human coronavirus OC43 (HCoV-OC43), a human coronavirus HKU1 (HCoV-HKU1), a Middle East respiratory syndrome-related coronavirus (MERS-CoV), a severe acute respiratory syndrome-related coronavirus 2 (SARS- CoV-2), a variant of SARS-CoV-2, or combinations thereof.
See the teachings of Vilalata et al. above.
One of ordinary skill in the art would have been motivated to use antigen as taught by Vilalata et al. with the composition as recited in claims 97-100, 105-120 of copending Application No. 18/034312 in view of Moon et al. Claims 97-100, 105-120 of copending Application No. 18/034312 in view of Moon et al. teaches use of antigen, and Vilalata et al., which also teaches use of antigen, teaches such an antigen already known and used in the art (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using antigen as taught by Vilalata et al. with the composition as recited in claims 97-100, 105-120 of copending Application No. 18/034312 in view of Moon et al. There would have been a reasonable expectation of success given the underlying materials (antigens as taught by as recited in claims 97-100, 105-120 of copending Application No. 18/034312 in view of Moon et al. and Vilalata et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection.
Conclusion
13. No claims are allowed.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672