DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s preliminary amendments received January 23, 2026 are acknowledged.
Claims 10-14 have been canceled.
Claims 1-9 and 15 are pending in the instant application.
Applicant’s election without traverse of the invention of group I, drawn to vaccines, in the reply filed on January 23, 2026 is acknowledged.
Claims 1-9 and 15 are under examination in this office action.
Information Disclosure Statement
The IDS forms received 11/15/2024 and 4/17/2025 are acknowledged and the references cited therein have been considered.
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.
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 1-9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Witvliet et al. (WO 2016/091998) in view of Kooijman et al. (WO 2021/001462).
Witvliet et al. disclose a vaccine for use in swine which combines non-replicative antigens from porcine circo virus type 2 (PCV2) and Mycoplasma hyopneumoniae (see entire document, particularly the title, abstract and claims). Notably it is disclosed that the Mycoplasma hyopneumoniae antigen can be a bacterin containing whole killed cells while the PCV2 antigen can be a subunit vaccine comprising recombinantly expressed ORF2 protein (see particularly page 9 and pages 12-14 as well as working examples 1-5). They further disclose that such a vaccine can comprise additional ingredients including adjuvants as well as additional antigens from organisms pathogenic to swine, including Lawsonia intracellularis, (see particularly pages 18-20 and 23-24). It is disclosed that a preferred embodiment comprises antigens from Mycoplasma hyopneumoniae, PCV2, Lawsonia intracellularis and PRRSV as these are important swine diseases and thus their combination into a single shot ready-to-use is very favorable for the livestock industry (see particularly page 24). All of such disease are taught as causing economic losses to livestock farmers (see particularly pages 1-7). These teachings differ from what is presently claimed in that they do not disclose that deoxynivalenol (DON) conjugated to a carrier protein as part of the swine vaccine composition.
Kooijman et al. disclose vaccines comprising conjugated deoxynivalenol (DON) that are to be administered to animals, including swine, to protect against mycotoxosis which causes anorexia, reduced food intake and ulcers (see entire document, particularly the title, abstract, page 1 and the claims). Notably, DON is disclosed as being conjugated to polypeptides larger than 10,000 Daltons, such as ovalbumin and keyhole limpet hemocyanin (see particularly claims 11 and 12 and examples 1-4). It is disclosed DON is also known in the art as vomitoxin, that ingestion of DON via infected grain causes mycotoxicosis in humans and farm animals, and that the disclosed vaccine provides protection against mycotoxicosis when tested in pigs (see particularly page 1 as well as working examples 1-4).
Therefore, it would have been obvious to ordinary artists at the time of the invention to combine the vaccines of Witvliet et al. and Kooijman et al. Artisans would have been motivated to do so for ease of administration as they are all taught as being administered to pigs as part of ordinary livestock care to protect livestock from harm and economic losses. Indeed, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In the instant case, the individual vaccines were known to protect pigs from things that make pigs ill and thus combining them would allow farmers to more readily keep their livestock from becoming sick. Given the clinical data disclosed for the vaccines of Witvliet et al. and Kooijman et al., artisans would readily expect them to work in combination, especially in view of the teachings of Witvliet et al. that their PCV2 + Mycoplasma hyopneumoniae is to be combined with vaccines against different harmful agents.
Claims 1-9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Witvliet et al. (WO 2016/091998) in view of Bao et al. (CN 104693304, of record, and see Google translation to which all citations will be directed) and in view of Baxter.
Witvliet et al. disclose a vaccine for use in swine which combines non-replicative antigens from porcine circo virus type 2 (PCV2) and Mycoplasma hyopneumoniae (see entire document, particularly the title, abstract and claims). Notably it is disclosed that the Mycoplasma hyopneumoniae antigen can be a bacterin containing whole killed cells while the PCV2 antigen can be a subunit vaccine comprising recombinantly expressed ORF2 protein (see particularly page 9 and pages 12-14 as well as working examples 1-5). They further disclose that such a vaccine can comprise additional ingredients including adjuvants as well as additional antigens from organisms pathogenic to swine, including Lawsonia intracellularis, (see particularly pages 18-20 and 23-24). It is disclosed that a preferred embodiment comprises antigens from Mycoplasma hyopneumoniae, PCV2, Lawsonia intracellularis and PRRSV as these are important swine diseases and thus their combination into a single shot ready-to-use is very favorable for the livestock industry (see particularly page 24). All of such disease are taught as causing economic losses to livestock farmers (see particularly pages 1-7). These teachings differ from what is presently claimed in that they do not disclose that deoxynivalenol (DON) conjugated to a carrier protein as part of the swine vaccine composition.
Bao et al. disclose the production of monoclonal antibodies that bind vomitoxin (aka deoxynivalenol, see page 3 of the instant specification as well as page 5 of the translation) and their administration as part of passive immunization of livestock including pigs to improve livestock health (see entire document). It is taught that deoxynivalenol in livestock causes anorexia, loss of appetite, muscle disorders, and vomiting after eating food contaminated with deoxynivalenol (see particularly page 5 of the translation). Notably, in order to obtain the antibodies that are passively administered, Bao et al. disclose immunizing a mouse with deoxynivalenol conjugated to an albumin carrier (see particularly section 2, “Preparation of antigens for immunization”). Thus administration of a conjugated DON vaccine for the purpose of eliciting an anti-DON antibody response is explicitly disclosed.
Baxter discloses that an advantage of active vaccination (i.e. administering an antigen to a subject such that the subject’s immune system mounts an antibody response) as compared to passive immunization (administering preformed antibodies to a subject) is time, in that active immunizations typically provide decades worth of protection (potentially lifelong) whereas passive immunization last 3 to 4 months at most (see entire document, particularly the section “Active and passive immunity”).
Therefore, it would have been obvious to an ordinary artisan to combine the vaccines of Witvliet et al. with a vaccine against deoxynivalenol. This is because all such vaccines would serve to protect the health of livestock such destined for sale based upon weigh such as pigs. Artisans would further have been motivated to use active rather than passive immunization against DON in order to gain the advantage of longer lasting efficacy of active versus passive vaccines as taught by Baxter. Given that mice were actively vaccinated in order to make the antibodies that would be used for passive immunization in the methods of Bao et al., artisans would have a more than reasonable expectation that the active vaccine of Bao could be used in other settings. Additionally, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
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, 4-9 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,084,768 in view of Kooijman et al. (WO 2021/001462).
The issued claims recite methods of administering vaccines to pigs wherein the vaccine combines non-live combinations of Lawsonia intracellularis, Mycoplasma hyopneumoniae, and porcine Circo Virus antigens, wherein such antigens are disclosed as being killed whole bacteria cells (see all issued claims, particularly claims 1, 4, and 6). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against deoxynivalenol (DON).
Kooijman et al. disclose vaccines comprising conjugated deoxynivalenol (DON) that are to be administered to animals, including swine, to protect against mycotoxosis which causes anorexia, reduced food intake and ulcers (see entire document, particularly the title, abstract, page 1 and the claims). Notably, DON is disclosed as being conjugated to polypeptides larger than 10,000 Daltons, such as ovalbumin and keyhole limpet hemocyanin (see particularly claims 11 and 12 and examples 1-4). It is disclosed DON is also known in the art as vomitoxin, that ingestion of DON via infected grain causes mycotoxicosis in humans and farm animals, and that the disclosed vaccine provides protection against mycotoxicosis when tested in pigs (see particularly page 1 as well as working examples 1-4).
Therefore, it would have been obvious to ordinary artists to add the anti-DOM vaccine of Kooijman et al. to those present in the issued claims. Artisans would have been motivated to do so for ease of administration as they are all taught as being administered to pigs as part of ordinary livestock care to protect livestock from harm and economic losses. Indeed, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In the instant case, the individual vaccines were known to protect pigs from things that make pigs ill and thus combining them would allow farmers to more readily keep their livestock from becoming sick.
Claims 1, 4-9 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,084,768 in view of Bao et al. (CN 104693304, of record, and see Google translation to which all citations will be directed) and in view of Baxter.
The issued claims recite methods of administering vaccines to pigs wherein the vaccine combines non-live combinations of Lawsonia intracellularis, Mycoplasma hyopneumoniae, and porcine Circo Virus antigens, wherein such antigens are disclosed as being killed whole bacteria cells (see all issued claims, particularly claims 1, 4, and 6). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against deoxynivalenol (DON).
Bao et al. disclose the production of monoclonal antibodies that bind vomitoxin (aka deoxynivalenol, see page 3 of the instant specification as well as page 5 of the translation) and their administration as part of passive immunization of livestock including pigs to improve livestock health (see entire document). It is taught that deoxynivalenol in livestock causes anorexia, loss of appetite, muscle disorders, and vomiting after eating food contaminated with deoxynivalenol (see particularly page 5 of the translation). Notably, in order to obtain the antibodies that are passively administered, Bao et al. disclose immunizing a mouse with deoxynivalenol conjugated to an albumin carrier (see particularly section 2, “Preparation of antigens for immunization”). Thus administration of a conjugated DON vaccine for the purpose of eliciting an anti-DON antibody response is explicitly disclosed.
Baxter discloses that an advantage of active vaccination (i.e. administering an antigen to a subject such that the subject’s immune system mounts an antibody response) as compared to passive immunization (administering preformed antibodies to a subject) is time, in that active immunizations typically provide decades worth of protection (potentially lifelong) whereas passive immunization last 3 to 4 months at most (see entire document, particularly the section “Active and passive immunity”).
Therefore, it would have been obvious to ordinary artists to add an anti-DOM vaccine to those present in the issued claims. This is because all such vaccines would serve to protect the health of livestock such destined for sale based upon weigh such as pigs. Artisans would further have been motivated to use active rather than passive immunization against DON in order to gain the advantage of longer lasting efficacy of active versus passive vaccines as taught by Baxter. Given that mice were actively vaccinated in order to make the antibodies that would be used for passive immunization in the methods of Bao et al., artisans would have a more than reasonable expectation that the active vaccine of Bao could be used in other settings. Additionally, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 1-7 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,568,954 in view of Kooijman et al. (WO 2021/001462).
The issued claims recite vaccines, methods of administering vaccines, and methods of making a vaccine for administration to swine wherein the vaccine comprises non-replicative antigens from Mycoplasma hyopneumoniae and ORF2 of porcine Circo Virus type 2 (see all issued claims, particularly claims 1, 5, and 16). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against deoxynivalenol (DON).
Kooijman et al. disclose vaccines comprising conjugated deoxynivalenol (DON) that are to be administered to animals, including swine, to protect against mycotoxosis which causes anorexia, reduced food intake and ulcers (see entire document, particularly the title, abstract, page 1 and the claims). Notably, DON is disclosed as being conjugated to polypeptides larger than 10,000 Daltons, such as ovalbumin and keyhole limpet hemocyanin (see particularly claims 11 and 12 and examples 1-4). It is disclosed DON is also known in the art as vomitoxin, that ingestion of DON via infected grain causes mycotoxicosis in humans and farm animals, and that the disclosed vaccine provides protection against mycotoxicosis when tested in pigs (see particularly page 1 as well as working examples 1-4).
Therefore, it would have been obvious to ordinary artists to add the anti-DOM vaccine of Kooijman et al. to those present in the issued claims. Artisans would have been motivated to do so for ease of administration as they are all taught as being administered to pigs as part of ordinary livestock care to protect livestock from harm and economic losses. Indeed, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In the instant case, the individual vaccines were known to protect pigs from things that make pigs ill and thus combining them would allow farmers to more readily keep their livestock from becoming sick.
Claims 1-7 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,568,954 in view of Bao et al. (CN 104693304, of record, and see Google translation to which all citations will be directed) and in view of Baxter.
The issued claims recite vaccines, methods of administering vaccines, and methods of making a vaccine for administration to swine wherein the vaccine comprises non-replicative antigens from Mycoplasma hyopneumoniae and ORF2 of porcine Circo Virus type 2 (see all issued claims, particularly claims 1, 5, and 16). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against deoxynivalenol (DON).
Bao et al. disclose the production of monoclonal antibodies that bind vomitoxin (aka deoxynivalenol, see page 3 of the instant specification as well as page 5 of the translation) and their administration as part of passive immunization of livestock including pigs to improve livestock health (see entire document). It is taught that deoxynivalenol in livestock causes anorexia, loss of appetite, muscle disorders, and vomiting after eating food contaminated with deoxynivalenol (see particularly page 5 of the translation). Notably, in order to obtain the antibodies that are passively administered, Bao et al. disclose immunizing a mouse with deoxynivalenol conjugated to an albumin carrier (see particularly section 2, “Preparation of antigens for immunization”). Thus administration of a conjugated DON vaccine for the purpose of eliciting an anti-DON antibody response is explicitly disclosed.
Baxter discloses that an advantage of active vaccination (i.e. administering an antigen to a subject such that the subject’s immune system mounts an antibody response) as compared to passive immunization (administering preformed antibodies to a subject) is time, in that active immunizations typically provide decades worth of protection (potentially lifelong) whereas passive immunization last 3 to 4 months at most (see entire document, particularly the section “Active and passive immunity”).
Therefore, it would have been obvious to ordinary artists to add an anti-DOM vaccine to those present in the issued claims. This is because all such vaccines would serve to protect the health of livestock such destined for sale based upon weigh such as pigs. Artisans would further have been motivated to use active rather than passive immunization against DON in order to gain the advantage of longer lasting efficacy of active versus passive vaccines as taught by Baxter. Given that mice were actively vaccinated in order to make the antibodies that would be used for passive immunization in the methods of Bao et al., artisans would have a more than reasonable expectation that the active vaccine of Bao could be used in other settings. Additionally, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 1-7 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,654,191 in view of Kooijman et al. (WO 2021/001462).
The issued claims recite vaccines, methods of administering vaccines, and methods of making a vaccine for administration to swine wherein the vaccine comprises non-replicative antigens from Mycoplasma hyopneumoniae and ORF2 of porcine Circo Virus type 2 (see all issued claims, particularly claims 1, 3 and 5). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against deoxynivalenol (DON).
Kooijman et al. disclose vaccines comprising conjugated deoxynivalenol (DON) that are to be administered to animals, including swine, to protect against mycotoxosis which causes anorexia, reduced food intake and ulcers (see entire document, particularly the title, abstract, page 1 and the claims). Notably, DON is disclosed as being conjugated to polypeptides larger than 10,000 Daltons, such as ovalbumin and keyhole limpet hemocyanin (see particularly claims 11 and 12 and examples 1-4). It is disclosed DON is also known in the art as vomitoxin, that ingestion of DON via infected grain causes mycotoxicosis in humans and farm animals, and that the disclosed vaccine provides protection against mycotoxicosis when tested in pigs (see particularly page 1 as well as working examples 1-4).
Therefore, it would have been obvious to ordinary artists to add the anti-DOM vaccine of Kooijman et al. to those present in the issued claims. Artisans would have been motivated to do so for ease of administration as they are all taught as being administered to pigs as part of ordinary livestock care to protect livestock from harm and economic losses. Indeed, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In the instant case, the individual vaccines were known to protect pigs from things that make pigs ill and thus combining them would allow farmers to more readily keep their livestock from becoming sick.
Claims 1-7 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,654,191 in view of Bao et al. (CN 104693304, of record, and see Google translation to which all citations will be directed) and in view of Baxter.
The issued claims recite vaccines, methods of administering vaccines, and methods of making a vaccine for administration to swine wherein the vaccine comprises non-replicative antigens from Mycoplasma hyopneumoniae and ORF2 of porcine Circo Virus type 2 (see all issued claims, particularly claims 1, 3 and 5). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against deoxynivalenol (DON).
Bao et al. disclose the production of monoclonal antibodies that bind vomitoxin (aka deoxynivalenol, see page 3 of the instant specification as well as page 5 of the translation) and their administration as part of passive immunization of livestock including pigs to improve livestock health (see entire document). It is taught that deoxynivalenol in livestock causes anorexia, loss of appetite, muscle disorders, and vomiting after eating food contaminated with deoxynivalenol (see particularly page 5 of the translation). Notably, in order to obtain the antibodies that are passively administered, Bao et al. disclose immunizing a mouse with deoxynivalenol conjugated to an albumin carrier (see particularly section 2, “Preparation of antigens for immunization”). Thus administration of a conjugated DON vaccine for the purpose of eliciting an anti-DON antibody response is explicitly disclosed.
Baxter discloses that an advantage of active vaccination (i.e. administering an antigen to a subject such that the subject’s immune system mounts an antibody response) as compared to passive immunization (administering preformed antibodies to a subject) is time, in that active immunizations typically provide decades worth of protection (potentially lifelong) whereas passive immunization last 3 to 4 months at most (see entire document, particularly the section “Active and passive immunity”).
Therefore, it would have been obvious to ordinary artists to add an anti-DOM vaccine to those present in the issued claims. This is because all such vaccines would serve to protect the health of livestock such destined for sale based upon weigh such as pigs. Artisans would further have been motivated to use active rather than passive immunization against DON in order to gain the advantage of longer lasting efficacy of active versus passive vaccines as taught by Baxter. Given that mice were actively vaccinated in order to make the antibodies that would be used for passive immunization in the methods of Bao et al., artisans would have a more than reasonable expectation that the active vaccine of Bao could be used in other settings. Additionally, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 1-9 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,130,699 in view of Kooijman et al. (WO 2021/001462).
The issued claims recite methods of administering vaccines to pigs wherein the vaccine combines non-live combinations of Lawsonia intracellularis, Mycoplasma hyopneumoniae, and porcine Circo Virus type 2 ORF2 antigens, wherein such antigens are disclosed as being killed whole bacteria cells (see all issued claims, particularly claims 1, 4, and 7). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against deoxynivalenol (DON).
Kooijman et al. disclose vaccines comprising conjugated deoxynivalenol (DON) that are to be administered to animals, including swine, to protect against mycotoxosis which causes anorexia, reduced food intake and ulcers (see entire document, particularly the title, abstract, page 1 and the claims). Notably, DON is disclosed as being conjugated to polypeptides larger than 10,000 Daltons, such as ovalbumin and keyhole limpet hemocyanin (see particularly claims 11 and 12 and examples 1-4). It is disclosed DON is also known in the art as vomitoxin, that ingestion of DON via infected grain causes mycotoxicosis in humans and farm animals, and that the disclosed vaccine provides protection against mycotoxicosis when tested in pigs (see particularly page 1 as well as working examples 1-4).
Therefore, it would have been obvious to ordinary artists to add the anti-DOM vaccine of Kooijman et al. to those present in the issued claims. Artisans would have been motivated to do so for ease of administration as they are all taught as being administered to pigs as part of ordinary livestock care to protect livestock from harm and economic losses. Indeed, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In the instant case, the individual vaccines were known to protect pigs from things that make pigs ill and thus combining them would allow farmers to more readily keep their livestock from becoming sick.
Claims 1-9 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,130,699 in view of Bao et al. (CN 104693304, of record, and see Google translation to which all citations will be directed) and in view of Baxter.
The issued claims recite methods of administering vaccines to pigs wherein the vaccine combines non-live combinations of Lawsonia intracellularis, Mycoplasma hyopneumoniae, and porcine Circo Virus type 2 ORF2 antigens, wherein such antigens are disclosed as being killed whole bacteria cells (see all issued claims, particularly claims 1, 4, and 7). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against deoxynivalenol (DON).
Bao et al. disclose the production of monoclonal antibodies that bind vomitoxin (aka deoxynivalenol, see page 3 of the instant specification as well as page 5 of the translation) and their administration as part of passive immunization of livestock including pigs to improve livestock health (see entire document). It is taught that deoxynivalenol in livestock causes anorexia, loss of appetite, muscle disorders, and vomiting after eating food contaminated with deoxynivalenol (see particularly page 5 of the translation). Notably, in order to obtain the antibodies that are passively administered, Bao et al. disclose immunizing a mouse with deoxynivalenol conjugated to an albumin carrier (see particularly section 2, “Preparation of antigens for immunization”). Thus administration of a conjugated DON vaccine for the purpose of eliciting an anti-DON antibody response is explicitly disclosed.
Baxter discloses that an advantage of active vaccination (i.e. administering an antigen to a subject such that the subject’s immune system mounts an antibody response) as compared to passive immunization (administering preformed antibodies to a subject) is time, in that active immunizations typically provide decades worth of protection (potentially lifelong) whereas passive immunization last 3 to 4 months at most (see entire document, particularly the section “Active and passive immunity”).
Therefore, it would have been obvious to ordinary artists to add an anti-DOM vaccine to those present in the issued claims. This is because all such vaccines would serve to protect the health of livestock such destined for sale based upon weigh such as pigs. Artisans would further have been motivated to use active rather than passive immunization against DON in order to gain the advantage of longer lasting efficacy of active versus passive vaccines as taught by Baxter. Given that mice were actively vaccinated in order to make the antibodies that would be used for passive immunization in the methods of Bao et al., artisans would have a more than reasonable expectation that the active vaccine of Bao could be used in other settings. Additionally, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 1-9 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,130,698 in view of Witvliet et al. (WO 2016/091998) in view of Kooijman et al. (WO 2021/001462).
The issued claims recite methods of administering vaccines to livestock wherein the vaccine combines antigens of Lawsonia intracellularis and porcine Circo Virus type 2 ORF2 antigen (see all issued claims, particularly claim 1). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against Mycoplasma hyopneumoniae or deoxynivalenol (DON).
Witvliet et al. disclose a vaccine for use in swine which combines non-replicative antigens from porcine circo virus type 2 (PCV2) and Mycoplasma hyopneumoniae (see entire document, particularly the title, abstract and claims). Notably it is disclosed that the Mycoplasma hyopneumoniae antigen can be a bacterin containing whole killed cells while the PCV2 antigen can be a subunit vaccine comprising recombinantly expressed ORF2 protein (see particularly page 9 and pages 12-14 as well as working examples 1-5). They further disclose that such a vaccine can comprise additional ingredients including adjuvants as well as additional antigens from organisms pathogenic to swine, including Lawsonia intracellularis, (see particularly pages 18-20 and 23-24). It is disclosed that a preferred embodiment comprises antigens from Mycoplasma hyopneumoniae, PCV2, Lawsonia intracellularis and PRRSV as these are important swine diseases and thus their combination into a single shot ready-to-use is very favorable for the livestock industry (see particularly page 24). All of such disease are taught as causing economic losses to livestock farmers (see particularly pages 1-7).
Kooijman et al. disclose vaccines comprising conjugated deoxynivalenol (DON) that are to be administered to animals, including swine, to protect against mycotoxosis which causes anorexia, reduced food intake and ulcers (see entire document, particularly the title, abstract, page 1 and the claims). Notably, DON is disclosed as being conjugated to polypeptides larger than 10,000 Daltons, such as ovalbumin and keyhole limpet hemocyanin (see particularly claims 11 and 12 and examples 1-4). It is disclosed DON is also known in the art as vomitoxin, that ingestion of DON via infected grain causes mycotoxicosis in humans and farm animals, and that the disclosed vaccine provides protection against mycotoxicosis when tested in pigs (see particularly page 1 as well as working examples 1-4).
Therefore, it would have been obvious to ordinary artists to add the anti-DOM vaccine of Kooijman et al. and the anti-Mycoplasma hyopneumoniae vaccine of Witvliet et al. to those present in the issued claims. Artisans would have been motivated to do so for ease of administration as they are all taught as being administered to pigs as part of ordinary livestock care to protect livestock from harm and economic losses. Indeed, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In the instant case, the individual vaccines were known to protect pigs from things that make pigs ill and thus combining them would allow farmers to more readily keep their livestock from becoming sick.
Claims 1-9 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,130,699 in view of Witvliet et al. (WO 2016/091998), in view of Bao et al. (CN 104693304, of record, and see Google translation to which all citations will be directed) and in view of Baxter.
The issued claims recite methods of administering vaccines to livestock wherein the vaccine combines antigens of Lawsonia intracellularis and porcine Circo Virus type 2 ORF2 antigen (see all issued claims, particularly claim 1). Such claims differ from what is presently claimed in that the issued claims do not include a vaccine that protects against Mycoplasma hyopneumoniae or deoxynivalenol (DON).
Witvliet et al. disclose a vaccine for use in swine which combines non-replicative antigens from porcine circo virus type 2 (PCV2) and Mycoplasma hyopneumoniae (see entire document, particularly the title, abstract and claims). Notably it is disclosed that the Mycoplasma hyopneumoniae antigen can be a bacterin containing whole killed cells while the PCV2 antigen can be a subunit vaccine comprising recombinantly expressed ORF2 protein (see particularly page 9 and pages 12-14 as well as working examples 1-5). They further disclose that such a vaccine can comprise additional ingredients including adjuvants as well as additional antigens from organisms pathogenic to swine, including Lawsonia intracellularis, (see particularly pages 18-20 and 23-24). It is disclosed that a preferred embodiment comprises antigens from Mycoplasma hyopneumoniae, PCV2, Lawsonia intracellularis and PRRSV as these are important swine diseases and thus their combination into a single shot ready-to-use is very favorable for the livestock industry (see particularly page 24). All of such disease are taught as causing economic losses to livestock farmers (see particularly pages 1-7).
Bao et al. disclose the production of monoclonal antibodies that bind vomitoxin (aka deoxynivalenol, see page 3 of the instant specification as well as page 5 of the translation) and their administration as part of passive immunization of livestock including pigs to improve livestock health (see entire document). It is taught that deoxynivalenol in livestock causes anorexia, loss of appetite, muscle disorders, and vomiting after eating food contaminated with deoxynivalenol (see particularly page 5 of the translation). Notably, in order to obtain the antibodies that are passively administered, Bao et al. disclose immunizing a mouse with deoxynivalenol conjugated to an albumin carrier (see particularly section 2, “Preparation of antigens for immunization”). Thus administration of a conjugated DON vaccine for the purpose of eliciting an anti-DON antibody response is explicitly disclosed.
Baxter discloses that an advantage of active vaccination (i.e. administering an antigen to a subject such that the subject’s immune system mounts an antibody response) as compared to passive immunization (administering preformed antibodies to a subject) is time, in that active immunizations typically provide decades worth of protection (potentially lifelong) whereas passive immunization last 3 to 4 months at most (see entire document, particularly the section “Active and passive immunity”).
Therefore, it would have been obvious to ordinary artists to add an anti- Mycoplasma hyopneumoniae and an anti-DOM vaccine to those present in the issued claims. This is because all such vaccines would serve to protect the health of livestock such destined for sale based upon weigh such as pigs. Artisans would further have been motivated to use active rather than passive immunization against DON in order to gain the advantage of longer lasting efficacy of active versus passive vaccines as taught by Baxter. Given that mice were actively vaccinated in order to make the antibodies that would be used for passive immunization in the methods of Bao et al., artisans would have a more than reasonable expectation that the active vaccine of Bao could be used in other settings. Additionally, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 1-9 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,280,035 in view of Witvliet et al. (WO 2016/091998).
The issued claims recite methods of protecting swine against deoxynivalenol (DON) by administering a vaccine comprising DON conjugated to carrier proteins including keyhole limpet hemocyanin and ovalbumin (see all issued claims, particularly claim 1 and 10). Such claims are recited as protecting animals against loosing average daily weight, liver damage, stomach ulcers, and kidney damage (see particularly issued claim 11). Such claims differ from the presently claimed invention in that vaccination against other antigens including porcine circo virus type 2 (PCV2), Mycoplasma hyopneumoniae, and Lawsonia intracellularis is not disclosed.
Witvliet et al. disclose a vaccine for use in swine which combines non-replicative antigens from porcine circo virus type 2 (PCV2) and Mycoplasma hyopneumoniae (see entire document, particularly the title, abstract and claims). Notably it is disclosed that the Mycoplasma hyopneumoniae antigen can be a bacterin containing whole killed cells while the PCV2 antigen can be a subunit vaccine comprising recombinantly expressed ORF2 protein (see particularly page 9 and pages 12-14 as well as working examples 1-5). They further disclose that such a vaccine can comprise additional ingredients including adjuvants as well as additional antigens from organisms pathogenic to swine, including Lawsonia intracellularis, (see particularly pages 18-20 and 23-24). It is disclosed that a preferred embodiment comprises antigens from Mycoplasma hyopneumoniae, PCV2, Lawsonia intracellularis and PRRSV as these are important swine diseases and thus their combination into a single shot ready-to-use is very favorable for the livestock industry (see particularly page 24). All of such disease are taught as causing economic losses to livestock farmers (see particularly pages 1-7).
Therefore, it would have been obvious to ordinary artists at the time of invention to add the vaccines of Witvliet et al. to the inventions of the issued claims. Artisans would have been motivated to do so for ease of administration as they are all taught as being administered to pigs as part of ordinary livestock care to protect livestock from harm and economic losses. Indeed, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In the instant case, the individual vaccines were known to protect pigs from things that make pigs ill and thus combining them would allow farmers to more readily keep their livestock from becoming sick.
Claims 1-9 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-25 of copending Application No. 19/094,116 in view of Witvliet et al. (WO 2016/091998).
The copending claims recite methods of protecting swine against deoxynivalenol (DON) by administering a vaccine comprising DON conjugated to carrier proteins including keyhole limpet hemocyanin and ovalbumin (see all copending claims, particularly claims 15 and 23). Such claims are recited as protecting animals against loosing average daily weight, liver damage, stomach ulcers, and kidney damage (see particularly copending claim 24). Such claims differ from the presently claimed invention in that vaccination against other antigens including porcine circo virus type 2 (PCV2), Mycoplasma hyopneumoniae, and Lawsonia intracellularis is not disclosed.
Witvliet et al. disclose a vaccine for use in swine which combines non-replicative antigens from porcine circo virus type 2 (PCV2) and Mycoplasma hyopneumoniae (see entire document, particularly the title, abstract and claims). Notably it is disclosed that the Mycoplasma hyopneumoniae antigen can be a bacterin containing whole killed cells while the PCV2 antigen can be a subunit vaccine comprising recombinantly expressed ORF2 protein (see particularly page 9 and pages 12-14 as well as working examples 1-5). They further disclose that such a vaccine can comprise additional ingredients including adjuvants as well as additional antigens from organisms pathogenic to swine, including Lawsonia intracellularis, (see particularly pages 18-20 and 23-24). It is disclosed that a preferred embodiment comprises antigens from Mycoplasma hyopneumoniae, PCV2, Lawsonia intracellularis and PRRSV as these are important swine diseases and thus their combination into a single shot ready-to-use is very favorable for the livestock industry (see particularly page 24). All of such disease are taught as causing economic losses to livestock farmers (see particularly pages 1-7).
Therefore, it would have been obvious to add the vaccines of Witvliet et al. to the inventions of the copending claims. Artisans would have been motivated to do so for ease of administration as they are all taught as being administered to pigs as part of ordinary livestock care to protect livestock from harm and economic losses. Indeed, as set forth in MPEP 2144.06, the courts have long ruled that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). In the instant case, the individual vaccines were known to protect pigs from things that make pigs ill and thus combining them would allow farmers to more readily keep their livestock from becoming sick.
No claims are allowable.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641