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 response and amendments received June 30, 2026 are acknowledged.
Claims 10-14 have been canceled.
Claims 1-9 have been amended.
Claims 1-9 and 15 are pending in the instant application.
Claims 1-9 and 15 are under examination in this office action.
Information Disclosure Statement
The IDS form received 6/30/2026 is acknowledged and the reference cited therein has 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 diseases 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.
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues on many grounds. Applicant begins by stating that Witvliet et al. do not teach a DON conjugate immunogen, a fact which was explicitly pointed out by the examiner in the rejection of record. Applicant further argues that there is a difference between an antigen from a pathogenic microorganism and a toxoid, that deoxynivalenol (DON) is not produced by a microorganism, and a teaching concerning adding additional antigens swine pathogens does not encompass conjugated DON.
These arguments have been considered and are not persuasive. Applicant is respectfully reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). While it is true that DON is not a microorganism, perhaps the most famous toxoid in all of vaccines is tetanus, and the tetanus toxin used to make the toxoid vaccine comes from the bacterium Clostridium tetani and such a vaccine was first made in the 1920s. Given the 100 year or so history of toxoids in vaccination, applicant’s assertions about differences between pathogenic microorganisms and toxins being so disparate that artisans would not think they could be combined seems highly implausible.
Applicant next argues that Kooijman et al. fail to disclose pathogen vaccines.
Such an argument is not persuasive as has already been discussed above since an obviousness rejection is based upon what would have bene obvious to an artisan based on the combined teachings of the art rather than simply looking through the narrow lens of each reference individually.
Applicant argues that the guidance set forth by In re Kerkhoven is not approparie as applicant believes the vaccines of Witvliet et al. and Kooijman et al. are for different purposes. More specifically, applicant appears to believe that a vaccine against a microorganism and a vaccine against a toxin are very different because a microorganism is alive while a toxin is not.
This argument is not persuasive. The purpose of a vaccine is to illicit an immune response, typically in the form of antibodies, that protects the individual receiving the vaccine. As set forth in the rejection of record, both Witvliet et al. and Kooijman et al. disclose that their vaccines are to be administered to pigs to protect them from harmful things in their environment.
Applicant next argues that Witvliet et al. teach away from making combination vaccines. Applicant appears to believe this because the background section of Witvliet et al. discusses a competitor who stopped pursing a particular combination vaccine strategy (see page 7 in particular). Applicant argues that antigenic interference is a known and serious obstacle in combination swine vaccines, and because of this applicant argues artisans would not have been motivated to add a third immunogenic component. Applicant argues that Kooijman et al. also discloses a failure of others in the past to vaccinate against DON, and to applicant this is evidence that the combination is not reasonably taught or suggested.
These arguments have been considered and are not persuasive. The background section of a patent typically discloses what other have done (or in the case of both Witvliet et al. and Kooijman et al. what other failed to do) and how the individuals filing the patent have made improvements over what was previously known, such as getting something to work that previously did not work. Both Witvliet et al. and Kooijman et al. demonstrate that their vaccines worked, and thus the failure of others prior to their filing simply demonstrates that Witvliet et al. and Kooijman et al. were able to successfully overcome the “known and serious obstacle” in making a combination vaccine. Further, rather than being dissuaded from adding a third (or forth or however many an artisan might desire) antigen into the successful PCV2/Mhyo vaccine of Witvliet et al. as applicant asserts, artisans would be motivated as a) the “known and serious obstacle” was overcome by Witvliet et al. such that they made a working vaccine and b) Witvliet et al. expressly teach adding in additional antigens from Lawsonia intracellularis and PRRSV (see most particularly page 24). Based upon a plain reading of Witvliet et al., if Witvliet et al. were not confident that they solved the issue involving combining multiple antigens into a single vaccine they would never supply the guidance and direction as set forth in their specification of page 24 concerning adding additional antigen specificities into their combined PCV2+Mhyo vaccine. Given that Witvliet et al. expressly teach adding in additional antigens, applicant’s assertions that artisans would be dissuaded from doing exactly that (i.e. making a three (or more) component vaccine) appears to be wholly unreasonable.
Applicant’s last ground of argument is that working example 4 of the instant application demonstrates unexpected results. This appears to be because applicant believes that artisans would be convinced that the three (or more) components of the vaccine would negatively interfere with each other. Applicant argues the “absence of interference is unexpected in light of (i) Witvliet's own data showing substantial interference between just PCV2 and Mhyo, (ii) it was surprising that a conjugated DON molecule could function as a vaccine immunogen at all, given that, as stated in [0013] of the instant application, "[a]ctive protection by inducing an immune response against the mycotoxin has not been shown in the art for any mycotoxin.", and (iii) the general recognition in the art that combination vaccines frequently suffer from antigenic competition.” Applicant argues that for a novel combination of antigens (such as in a vaccine) “it can never be predicted that the new combination will be safe and efficacious” and that the prior art, such as a 2010 paper by Gillespie et al., instructs artisans to “Never mix vaccines unless the mixing is supported by the vaccine manufacturer”. Applicant then points out elements disclosed in working example 4 including data that intradermal administration appeared to work better than intramuscular control administrations, and argues that the combined vaccine displays a synergistic response as compared to an additive response when compared to the individual vaccine components administered separately. Applicant also asserts that “these unexpected results are directly commensurate on scope with the claims at issue” and states the rejection should be withdrawn.
These arguments have been considered and are not persuasive. With regard to applicant’s arguments about “(i) Witvliet's own data showing substantial interference between just PCV2 and Mhyo” applicant appears to be ignoring the fact that Witvliet et al. solved this very problem, a fact which would be apparent to artisans if they read the entire document. With regard to applicant’s arguments that the specification teaches that no protection against any mycotoxin has been shown in the art, such a teaching is at odds with the teachings of Kooijman et al. and Bao et al. Applicant appears to hold the opinion that combining vaccines is so unpredictable that unless actually reduced to practice with in vivo data artisans would firmly believe nothing works, and argues that artisans would do nothing except that which expressly told to them by the vaccine maker. In essence, applicant is arguing vaccine compositions must always be anticipated as nothing in this art can ever be obvious, and that the artisan is incapable of doing anything more than reading preprinted instructions for products already being commercially sold. Given that such an opinion essentially reads out an entire statute of US patent law, applicant’s opinion that vaccines can only be anticipated but are too unpredictable to be obvious is clearly unreasonable. Further, the artisan in the instant field is the person who designs and makes the vaccines, such people typically being highly skilled individuals holding Ph.D. and Doctor of Veterinary Medicine degrees (or both) and are not the farmers who jab their pigs with needles. Indeed, if artisans truly believed applicant’s quote from Gillespie et al. to “Never mix vaccines unless the mixing is supported by the manufacturer” than the instant invention could never have been made by applicant as such mixing was not already “supported by the manufacture” (see most particularly example 4 and note that the PCV2 and Mhyo vaccines appear to be commercially available products bought by applicant and that the mixing of such store bought reagents with conjugated DON certainly was not authorized by the directions/use sheet). While applicant assets the presence of unexpected results, argues the claims are commensurate in scope with such results, and points specifically to example 4 for data remonstrating the presence of unexpected results, a review of working example 4 shows it to be of narrower scope than that which is presently claimed. Specifically, in example 4, DON was conjugated to KLH and present in a particular oil-in-water emulsion at a specific dose, a limitation that does not appear to be in any pending claim, while the PCV2, Mhyo, and Lawsonia vaccines are specific named commercial products rather than the generic manifestations as recited in the instant claims. Further, animals in groups 2 and 5, in addition to receiving combination vaccines comprising DON-KLH, PCV2, Mhyo, (and in group 5 Lawsonia) these animals were first vaccinated with DON-KLH. Thus the in vivo data argued by applicant as supporting unexpected results a) was obtained using a protocol that utilized more reagents and process steps than just administering the claimed vaccine once to a pig, and b) utilized specific vaccine components disclosed in greater structural detail, including dosing amounts, than what is present in the instant claimed generic formulations. Thus the products used to generate the data in example 4 were of narrower scope than that presently recited, and no additional data demonstrating that other components, such as a PCV2 vaccine from a different manufacture or that is structurally distinct from “PORCILIS PCV M HYO” (such as those the specification discloses are on the market in the paragraph spanning pages 4 and 5 of the instant specification) also show the same “synergistic” results asserted by applicant as being present. It should be pointed out that given that the data was collected using more than just a single vaccination with a combination vaccine, separating results due just to the specific combination vaccine of the working examples from the totality of the process steps (which included separate DON-KLH administration at a particular dose and route) does not appear trivial. Thus, it is clear that the data of example 4 are much more limited than that which is presently claimed. The rejection is maintained.
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 diseases 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).
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues on many grounds. Applicant argues that the data of Witvliet et al. concerning efficacy data when components were mixed relative to being separate would dissuade artisans from adding additional components. Applicant argues that neither Bao et al. nor Baxter remedy the issue of antigenic interference. Applicant reiterates the opinion that working example 4 demonstrates unexpected results and therefore the rejection should be withdrawn.
These arguments have been considered and are not persuasive. As discussed at greater length earlier in this office action, Witvliet et al. successfully made a combination vaccine comprising PCV2 and Mhyo and explicitly instructs artisans to add additional components to such a vaccine (see particularly pages 23 and 24 of Witvliet et al. ). Given that Witvliet et al. teach artisans to add additional components, applicant’s assertions that artisans would be dissuaded from adding additional components (such as a third (or fourth, etc.) antigen seems unreasonable as it is completely the opposite of what the reference explicitly teaches. With regard to unexpected results, as has been discussed earlier in this office action the instant claims are not commensurate in scope with that which was done in working example 4, and especially in view of applicant’s repeated assertions concerning unpredictability in this art, there appears to be no data to support the extrapolation of such narrow circumstances to the breadth of what is presently claimed. The rejection is maintained.
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.
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the issued claims do not teach a combination comprising DON, that a vaccine comprising DON is only taught by Kooijman et al. and that since Kooijman et al. do not disclose a working example of their DON vaccine combined with another vaccine the rejection is improper as the art is in applicant’s opinion too unpredictable absent experimental data concerning reduction to practice (in other words the invention must be anticipated or no rejection can be made). Applicant reiterates assertions of unexpected results based upon instant working example 4.
These arguments have been considered and are not persuasive. Arguments concerning combining teachings and applicant’s position that unless it was actually reduced to practice it cannot be obvious are not persuasive as is discussed in greater detail earlier in this action. Similarly, the data disclosed in working example 4 of the instant specification concerns products and administration protocols narrower in scope than that which is present claimed as is also discussed in greater detail earlier in this action. As such applicant’s arguments are not persuasive.
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).
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that Bao et al. did not actively vaccinate livestock and that Baxter does not discuss DON and simply indicates that the effects of active immunization last longer than passive immunization (i.e. administration of exogenous pre-formed antibodies of a desired antigen specificity), and therefore artisans would not arrive at what has been claimed absent hindsight reconstruction. Applicant also alleges the presence of unexpected results based upon eth data of working example 4.
This argument is not persuasive. As set forth in the rejection of record, the issued claims combine various antigens that make pigs sick, and Bao et al. teaches that Don makes pigs sick. Contrary to applicant’s assertions, there is no great intellectual leap in adding in additional antigens that make pig sick into a vaccine that already comprises multiple antigens such as those of the issued claims. With regard to unexpected results, the data supplied as part of working example 4 is considerably narrower than that which is present claimed as has bene discussed at length earlier in this office action and will not be repeated for the sake of brevity. See above. The rejection is maintained.
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.
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the issued claims do not teach a combination comprising DON, that a vaccine comprising DON is only taught by Kooijman et al. and that since Kooijman et al. do not disclose a working example of their DON vaccine combined with another vaccine the rejection is improper as the art is in applicant’s opinion too unpredictable absent experimental data concerning reduction to practice (in other words the invention must be anticipated or no rejection can be made). Applicant reiterates assertions of unexpected results based upon instant working example 4.
These arguments have been considered and are not persuasive. Arguments concerning combining teachings and applicant’s position that unless it was actually reduced to practice it cannot be obvious are not persuasive as is discussed in greater detail earlier in this action. Similarly, the data disclosed in working example 4 of the instant specification concerns products and administration protocols narrower in scope than that which is present claimed as is also discussed in greater detail earlier in this action. As such applicant’s arguments are not persuasive.
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).
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that Bao et al. did not actively vaccinate livestock and that Baxter does not discuss DON and simply indicates that the effects of active immunization last longer than passive immunization (i.e. administration of exogenous pre-formed antibodies of a desired antigen specificity), and therefore artisans would not arrive at what has been claimed absent hindsight reconstruction. Applicant also alleges the presence of unexpected results based upon eth data of working example 4.
This argument is not persuasive. As set forth in the rejection of record, the issued claims combine various antigens that make pigs sick, and Bao et al. teaches that Don makes pigs sick. Contrary to applicant’s assertions, there is no great intellectual leap in adding in additional antigens that make pig sick into a vaccine that already comprises multiple antigens such as those of the issued claims. With regard to unexpected results, the data supplied as part of working example 4 is considerably narrower than that which is present claimed as has bene discussed at length earlier in this office action and will not be repeated for the sake of brevity. See above. The rejection is maintained.
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.
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the issued claims do not teach a combination comprising DON, that a vaccine comprising DON is only taught by Kooijman et al. and that since Kooijman et al. do not disclose a working example of their DON vaccine combined with another vaccine the rejection is improper as the art is in applicant’s opinion too unpredictable absent experimental data concerning reduction to practice (in other words the invention must be anticipated or no rejection can be made). Applicant reiterates assertions of unexpected results based upon instant working example 4.
These arguments have been considered and are not persuasive. Arguments concerning combining teachings and applicant’s position that unless it was actually reduced to practice it cannot be obvious are not persuasive as is discussed in greater detail earlier in this action. Similarly, the data disclosed in working example 4 of the instant specification concerns products and administration protocols narrower in scope than that which is present claimed as is also discussed in greater detail earlier in this action. As such applicant’s arguments are not persuasive.
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).
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that Bao et al. did not actively vaccinate livestock and that Baxter does not discuss DON and simply indicates that the effects of active immunization last longer than passive immunization (i.e. administration of exogenous pre-formed antibodies of a desired antigen specificity), and therefore artisans would not arrive at what has been claimed absent hindsight reconstruction. Applicant also alleges the presence of unexpected results based upon eth data of working example 4.
This argument is not persuasive. As set forth in the rejection of record, the issued claims combine various antigens that make pigs sick, and Bao et al. teaches that Don makes pigs sick. Contrary to applicant’s assertions, there is no great intellectual leap in adding in additional antigens that make pig sick into a vaccine that already comprises multiple antigens such as those of the issued claims. With regard to unexpected results, the data supplied as part of working example 4 is considerably narrower than that which is present claimed as has bene discussed at length earlier in this office action and will not be repeated for the sake of brevity. See above. The rejection is maintained.
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.
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the issued claims do not teach a combination comprising DON, that a vaccine comprising DON is only taught by Kooijman et al. and that since Kooijman et al. do not disclose a working example of their DON vaccine combined with another vaccine the rejection is improper as the art is in applicant’s opinion too unpredictable absent experimental data concerning reduction to practice (in other words the invention must be anticipated or no rejection can be made). Applicant reiterates assertions of unexpected results based upon instant working example 4.
These arguments have been considered and are not persuasive. Arguments concerning combining teachings and applicant’s position that unless it was actually reduced to practice it cannot be obvious are not persuasive as is discussed in greater detail earlier in this action. Similarly, the data disclosed in working example 4 of the instant specification concerns products and administration protocols narrower in scope than that which is present claimed as is also discussed in greater detail earlier in this action. As such applicant’s arguments are not persuasive.
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).
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that Bao et al. did not actively vaccinate livestock and that Baxter does not discuss DON and simply indicates that the effects of active immunization last longer than passive immunization (i.e. administration of exogenous pre-formed antibodies of a desired antigen specificity), and therefore artisans would not arrive at what has been claimed absent hindsight reconstruction. Applicant also alleges the presence of unexpected results based upon eth data of working example 4.
This argument is not persuasive. As set forth in the rejection of record, the issued claims combine various antigens that make pigs sick, and Bao et al. teaches that Don makes pigs sick. Contrary to applicant’s assertions, there is no great intellectual leap in adding in additional antigens that make pig sick into a vaccine that already comprises multiple antigens such as those of the issued claims. With regard to unexpected results, the data supplied as part of working example 4 is considerably narrower than that which is present claimed as has bene discussed at length earlier in this office action and will not be repeated for the sake of brevity. See above. The rejection is maintained.
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 diseases 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.
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that neither the issued claims nor the cited art disclose combining all the recited antigen specificities into a single vaccine (i.e. the instant claimed invention isn’t anticipated) and since applicant is of the opinion that the art is so unpredictable that noting can be found obvious the rejection must be withdrawn. Applicant reiterates their opinion concerning the alleged presence of unexpected results in working example 4 of the instant specification.
These arguments have been considered and are not persuasive. Applicant’s unpersuasive arguments concerning the art being too unpredictable to allow for combining antigens has been discussed at length earlier in this office action and will not be repeated here. Similarly, as has been discussed earlier in this office action, the working examples are of significantly narrower scope, and rely upon the presence of additional process steps that do not use the present claimed vaccine composition and thus any alleged unexpected results, particularly their ability to be extrapolated to more generic constructs such as those presently claimed, does not appear to be reasonable or correct. The rejection is maintained.
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).
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that since the rection requires four references to arrive at what is claimed the instant claimed invention cannot be obvious. Applicant is remined that the courts have long ruled that reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991). Further 4 documents (1 issued claims and 3 prior art references) hardly seems to be an excessive number and in no way is “strong evidence” of nonobviouness as applicant has asserted. The rejection is maintained.
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 losing 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.
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant repeats arguments discussed previously concerning the unpredictability of combining antigen vaccines and argues that while the issued claims recite a DON vaccine the examiner’s reliance on the teachings of Witvliet et al. to supply the PCV2 and Mhyo antigens is improper as the art is too unpredictable.
These arguments have been considered and are not persuasive. Specifically, arguments about unpredictability have been found non-persuasive as discussed at length earlier in this action and will not be repeated here. See above. The rejection is maintained.
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 losing 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.
Applicant's arguments filed June 30, 2026 have been fully considered but they are not persuasive. Applicant repeats arguments discussed previously concerning the unpredictability of combining antigen vaccines and argues that the copending application is later filed and thus a terminal disclaimer is unnecessary for the instant claims to be allowed.
These arguments have been considered and are not persuasive. Specifically, arguments about unpredictability have been found non-persuasive as discussed at length earlier in this action. See above. With regard to the provisional nature of the rejection, given that multiple other rejections are present, the guidance set forth in MPEP 804(I)(B)(1)(b)(i) is premature. The provisional rejection is maintained.
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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