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 .
Priority
The instant application is a national stage entry under 35 U.S.C. § 371 of PCT/JP2022/017328 (filed 04/08/2022). Acknowledgement is made of Applicants’ claim for priority to Japanese Application No. JP2021-066427 (filed 04/09/2021).
Claim Objections
Claim 19 is objected to because of the following informalities: there appears to be a typographical error; specifically, there is a comma after the word ‘administering’.
Appropriate 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 6-7, 9, 11, 13, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mu, et al. (Vaccines. 2021).
Mu, et al. teaches oral vaccination of grass carp against grass carp reovirus using a baculovirus expression system (Abstract).
Regarding claims: Mu, et al. teaches a method for oral vaccination of grass carp, wherein silkworm pupae inoculated with recombinant baculovirus are collected, freeze-dried, added to feed, then fed to grass carp (pg. 4; par. 2.7), wherein the recombinant baculovirus expresses the recombinant VP35-VP4 protein of grass carp reovirus (GCRV) II (pg. 2; par. 4). As the binomial nomenclature for silkworms is Bombyx mori, this reads on:
the pupa of an insect capable of being baculovirus-infected, which is infected with a recombinant baculovirus having DNA encoding an antigen protein introduced therein and then freeze-dried limitation recited in claim 1;
the oral vaccine composition comprising the pupa limitation recited in claim 3;
the functional food containing the pupa limitation recited in claim 6;
the method of producing a pupa for oral administration, comprising a step of infecting a larva or pupa of an insect capable of being baculovirus-infected with a recombinant baculovirus having DNA encoding an antigen protein introduced therein and freeze-drying a pupa having pupated from the infected larva or the infected pupa limitation recited in claim 7;
the method of producing an oral vaccine, comprising a step of infecting a larva or pupa of an insect capable of being baculovirus-infected with a recombinant baculovirus having DNA encoding an antigen protein introduced therein and freeze-drying a pupa having pupated from the infected larva or the infected pupa limitation recited in claim 9;
the wherein the insect is Bombyx mori limitations recited in claims 11 and 17; and
the method of inducing immunity to an antigenic protein in a subject by administering the pupa limitation recited in claim 13.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-7, 9, 11, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mu, et al. (Vaccines. 2021), as evidenced by Mutoloki, et al. (Front Immunol. 2015).
The teachings of Mu, et al. are set forth above; claims 1, 3, 6-7, 9, 11, 13, and 17 are anticipated by Mu, et al.
Regarding claim 5: It is set forth above Mu, et al. anticipates the oral vaccine composition of claim 3. Mu, et al. does not teach the composition as comprising 20% pupae by weight, as required by the instant claim, teaching the feed (i.e., the oral vaccine composition) as comprising 5% pupae instead (pg. 4; par. 2.7).
However, the percent composition of the pupae would have been routinely optimized by a person having ordinary skill in the art based on the immune response of the carp. Mu, et al. teaches a similar or lower protective efficacy compared to other studies comprising intraperitoneal administration of vaccines in grass carp, suggesting the much lower amount of protein (0.02 µg/g of recombinant protein/fish) as a potential factor (pg. 12; par. 4). Additionally, as evidenced by Mutoloki, et al., the dosage of antigen in feed pellets is key to the efficacy of oral vaccines (pg. 2; col. 2, pars. 2-3); thus, the art recognizes the dosage of antigen as an optimizable variable in oral vaccination of fish. That means the required dosage for vaccine efficacy is a result effective variable. Result effective variables would be optimized by routine experimentation by one having ordinary skill in the art. Furthermore, differences in dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such dosage is critical; see MPEP 2144.05(II)(A).
Therefore, the limitation recited in claim 5 is rendered obvious by Mu, et al.
Claims 1, 3-7, 9, 11, 13, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mu, et al. (Vaccines. 2021) in view of Kang, et al. (Polymers. 2018), further in view of Salmon Facts (“What Does Salmon Feed Contain?”; 2019), as evidenced by Mutoloki, et al. (Front Immunol. 2015).
The teachings of Mu, et al. are set forth above; claims 1, 3, 6-7, 9, 11, 13, and 17 are anticipated by Mu, et al.
Kang, et al. teaches considerations for oral vaccine delivery (Abstract).
Salmon Facts teaches dry pellet salmon feed (Subtitle).
Regarding claim 4: It is set forth above the feed of Mu, et al. anticipates the oral vaccine composition of claim 3. Mu, et al. does not teach the feed as comprising a solution containing an adjuvant, as required by the limitation recited in the instant claim.
However, Kang, et al. teaches adjuvants such as oil emulsions provide good immunostimulating effects (pg. 10; par. 5.2).
Thus, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the feed of Mu, et al. by incorporating an oil emulsion adjuvant as taught by Kang, et al. This conclusion of obviousness is based on the ‘teaching, suggestion, or motivation rationale’; one would be motivated to do so for the immunostimulating effects disclosed by Kang, et al. Further, as Salmon Facts teaches fish pellets contain fish oil (pg. 1; par. 1), one skilled in the art would have more than a reasonable expectation of success in the inclusion of an oil emulsion in the feed pellets of Mu, et al.
Therefore, the modified method of Mu, et al. as set forth above renders obvious the limitation recited in claim 4.
Regarding claim 15: Following the above discussion, Mu, et al. does not teach the feed as comprising 20% pupae by weight, as required by the instant claim.
However, the percent composition of the pupae would have been routinely optimized by a person having ordinary skill in the art based on the immune response of the carp. Mu, et al. teaches a similar or lower protective efficacy compared to other studies comprising intraperitoneal administration of vaccines in grass carp, suggesting the much lower amount of protein (0.02 µg/g of recombinant protein/fish) as a potential factor (pg. 12; par. 4). Additionally, as evidenced by Mutoloki, et al., the dosage of antigen in feed pellets is key to the efficacy of oral vaccines (pg. 2; col. 2, pars. 2-3); thus, the art recognizes the dosage of antigen as an optimizable variable in oral vaccination of fish. That means the required dosage for vaccine efficacy is a result effective variable. Result effective variables would be optimized by routine experimentation by one having ordinary skill in the art. Furthermore, differences in dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such dosage is critical; see MPEP 2144.05(II)(A).
Therefore, the modified method of Mu, et al. as set forth above renders obvious the limitation recited in claim 15.
Claims 2, 8, 10, 12, 14, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gallei, et al. (US 2018/0080045) in view of Cardosa, et al. (US 2015/0056244).
Gallei, et al. teaches recombinant canine adenoviruses, methods of making them, and uses for them, including vaccine compositions (Abstract).
Cardosa, et al. teaches materials and methods for producing immunologically active antigens (Abstract).
Regarding claims 2, 8, 10, 12, 14, 18-19: Gallei, et al. teaches a method of producing a vaccine composition comprising a recombinant vector, wherein the method comprises introducing the vector into a host cell, cultivating the infected cells, harvesting the infected cells, and admixing said harvest with a pharmaceutically acceptable carrier (par. 0042), wherein the vector comprises a heterologous DNA encoding an antigenic epitope (pars. 0034-0035); additionally disclosed is an embodiment wherein the composition is lyophilized (par. 0141). Gallei teaches an embodiment wherein the host cell is an Sf9 or Sf21 cell, i.e., cells derived from Spodoptera frugiperda (par. 0054). Lastly, Gallei, et al. teaches a method of immunizing an animal comprising administering the vaccine to induce an immune response (par. 0048), wherein the vaccine may be administered orally (par. 0041).
Gallei, et al. does not teach the vector as a recombinant baculovirus vector, teaching the vector as a recombinant canine adenovirus vector instead (par. 0042).
However, Cardosa, et al. teaches baculoviruses as suitable recombinant viruses for the transfection of host cells such as Sf9 cells (par. 0154).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of Gallei, et al. by substituting the recombinant adenovirus for a recombinant baculovirus, as taught by Cardosa, et al. This conclusion of obviousness is based on the ‘substitution rationale’. The use of a recombinant baculovirus in place of a recombinant adenovirus is a predictable use of prior art elements according to their established functions as viral vectors, leading to the predictable result of delivery of genetic material into a host cell. This rationale aligns with the principle of a simple substitution of one known element for another to obtain predictable results; see MPEP 2143(I)(B). Further, as Cardosa, et al. teaches the use of recombinant baculoviruses to transfect the same cell type used in the method of Gallei, et al., one skilled in the art would have more than a reasonable expectation of success.
Thus, the modified method of Gallei, et al. set forth above renders obvious:
the cell capable of being baculovirus-infected which is infected with a recombinant baculovirus having DNA encoding an antigen protein introduced therein and then freeze-dried limitations recited in claim 2;
the method of producing a cell for oral administration, comprising a step of infecting a cell capable of being baculovirus-infected with a recombinant baculovirus having DNA encoding an antigen protein introduced therein and freeze-drying the infected cell limitations recited in claim 8;
the method of producing an oral vaccine, comprising a step of infecting a cell capable of being baculovirus-infected with a recombinant baculovirus having DNA encoding an antigen protein introduced therein and freeze-drying the infected cell limitations recited in claim 10;
the wherein the cell is from Spodoptera frugiperda limitation recited in claims 12 and 18; and
the oral vaccine composition comprising the cell limitation recited in claim 14; and
the method of inducing immunity to an antigenic protein in a subject by administering the cell limitation recited in claim 19.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gallei, et al. (US 2018/0080045) in view of Cardosa, et al. (US 2015/0056244), further in view of Murwitz (US 2011/0091522).
The teachings of Gallei, et al. and Cardosa, et al. are set forth above.
Murwitz teaches an edible chew pill jacket to be administered to a pet, animal, or human (Abstract).
Regarding claim 16: Following the above discussion, Gallei, et al. teaches an embodiment wherein the vaccine is administered to a canine, e.g., dogs (par. 0128). The modified method of Gallei, et al. does not teach the limitation recited in the instant claim.
However, Murwitz teaches a chew pill jacket for the discrete delivery of a medicament, wherein a tasty treat is provided on the outside while medication or treatment is provided on the inside; with this arrangement, the animal is more likely to favor the taste of the treat and ingest the needed medication or treatment without difficulty (par. 0010). For use with dogs, the chew pill jacket may comprise meat-based components (par. 0025).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have further modified the method of Gallei, et al. by using the meat-based chew pill jacket of Murwitz for delivery of the vaccine composition. This conclusion of obviousness is based on the ‘teaching, suggestion, or motivation rationale’; one would be motivated to use the meat-based chew pill jacket so the dog would be more likely to ingest the vaccine without difficulty, as disclosed by Murwitz. Additionally, as Murwitz discloses use of the chew pill jacket for delivery of medications and treatments, one skilled in the art would have more than a reasonable expectation of success.
Thus, the meat-based chew pill jacket containing the vaccine composition, as set forth above, renders obvious the functional food containing the cell limitation recited in claim 16.
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 1-5, 7-15, and 17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, and 9-11 of copending Application No. 18/870,285 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-3, 14: Copending claim 1 teaches an oral vaccine composition against porcine circovirus associated diseases, comprising the pupa or cell of a baculovirus infectious insect, which is subjected to an infection treatment with a recombinant baculovirus, into which porcine circovirus type 2 protein-encoding DNA is introduced, and a freeze-drying treatment; this reads on instant claims 1, 2, 3, and 14.
Regarding claim 4: Copending claim 3 teaches the oral vaccine composition further comprises a solution containing an adjuvant; this reads on instant claim 4.
Regarding claims 5, 15: Copending claim 4 teaches the oral vaccine composition comprises at least 20% by weight of the pupa with respect to the total weight of the composition; this reads on instant claims 5 and 15.
Regarding claims 7, 9, 11, 17: Copending claim 6 teaches a method for producing an oral vaccine against porcine circovirus associated diseases, comprising a step of allowing a recombinant baculovirus, into which porcine circovirus type 2 protein-encoding DNA is introduced, to infect into the larva or pupa of a baculovirus infectious insect, and freeze-drying a pupa formed from the larva after the infection, or the pupa after infection; copending claim 9 teaches the insect is a silkworm. These copending claims read on instant claims 7, 9, 11, and 17.
Regarding claims 8, 10, 12, 18: Copending claim 7 teaches a method for producing an oral vaccine against porcine circovirus associated diseases, comprising a step of allowing a recombinant baculovirus, into which porcine circovirus type 2 protein-encoding DNA is introduced, to infect into baculovirus infectious cells, and freeze-drying the cells after infection; copending claim 10 teaches the cells are derived from Spilosoma imparilis, Antheraea pernyi, Bombyx mori (silkworm), Spodoptera frugiperda, or Trichoplusia ni. These copending claims read on instant claims 8, 10, 12, and 18.
Regarding claims 13, 19: Copending claim 11 teaches a method for immunizing a pig against a porcine circovirus, comprising a step of administering the composition according to claim 1 to the pig; this reads on instant claims 13 and 19.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 6 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of copending Application No. 18/870,285 in view of Murwitz (US 2011/0091522).
The teachings of Murwitz are set forth above.
Regarding claims 6, 16: Copending claim 1 teaches an oral vaccine composition against porcine circovirus associated diseases, comprising the pupa or cell of a baculovirus infectious insect, which is subjected to an infection treatment with a recombinant baculovirus, into which porcine circovirus type 2 protein-encoding DNA is introduced, and a freeze-drying treatment; copending claim 11 teaches a method for immunizing a pig against a porcine circovirus, comprising a step of administering the composition according to claim 1 to the pig. The claims of copending Application No. 18/870,285 do not teach the oral vaccine composition administered to the pig in a functional food containing the composition, as required by the instant claims.
However, Murwitz teaches a chew pill jacket for the discrete delivery of a medicament, wherein a tasty treat is provided on the outside while medication or treatment is provided on the inside; with this arrangement, the animal is more likely to favor the taste of the treat and ingest the needed medication or treatment without difficulty (par. 0010). The chew pill jacket may be composed of a fruit component, having a texture like dried fruit or a fruit roll-up, or it may be composed of chocolate and/or caramel confections (par. 0027).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of copending Application No. 18/870,285 by using the chew pill jacket of Murwitz for administering the vaccine composition to the pig. This conclusion of obviousness is based on the ‘teaching, suggestion, or motivation rationale’; one would be motivated to use the chew pill jacket so the pig would be more likely to ingest the composition without difficulty, as disclosed by Murwitz. Additionally, as Murwitz discloses use of the chew pill jacket for delivery of medications and treatments, one skilled in the art would have more than a reasonable expectation of success. This renders obvious the limitations recited in claims 6 and 16.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA PRONZATI whose telephone number is (571)270-5725. The examiner can normally be reached Monday - Friday 9:00a - 5:00p ET.
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/GINA PRONZATI/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633