DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 03/31/2026 in which claims 1-5, 7, 9-14 were amended, and claims 6 and 8 were canceled, has been entered. Claims 15-28 were previously canceled.
Claims 1-5, 7, 9-14 are currently under examination on the merits.
Drawings
(Previous objection, withdrawn) Applicant’s amendments to the Drawings have overcome the objection previously set forth in the Non-Final Office Action mailed 10/01/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification have overcome the objection previously set forth in the Non-Final Office Action mailed on 10/01/2025.
Claim Objections
(Previous objections, withdrawn as to claims 1-14) Applicant’s amendments to claims 1-14 have overcome previous objections to those claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(Previous rejection, withdrawn as to claims 1-14) Claims 1-14 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 1-14 as submitted on 03/31/2026.
The previous rejections of claims 6 and 8 are moot in view of Applicant’s cancelation of these claims.
Applicant’s amendment to the instant claims filed on 03/31/2026 has overcome the previous rejection to the instant claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
(Previous rejection, withdrawn as to claims 6, 8, maintained and modified as necessitated by amendment as to claims 1-5, 7, 9-14) Claims 1-5, 7, 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al., in view of Lamphear, et al. Prior art of record.
See claims 1-5, 7, 9-14 as submitted on 03/31/2026.
The previous rejections of claims 6 and 8 are moot in view of Applicant’s cancelation of these claims.
Regarding claims 1-3, it is noted that all of the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 10/01/2025. No new limitations were introduced in the amendment filed on 03/31/2026. As previously explained, Howard et al. teach a method of producing a protective response (providing passive immunity protection, as recited in claim 1) to an animal against a Porcine Epidemic Diarrhea Virus (PEDV), a member of the Coronaviridae virus family, comprising oral administration of a composition of a plant or plant product comprising a Spike (S1) protein of PEDV (Abstract, Claim 1, ¶¶ [0009], [0018], [0031]-[0033], [0090], Example 1, Fig.1).
Howard et al. do not teach the limitation of administering the composition prior to farrowing.
However, Lamphear et al. teach a method of administering a viral antigen expressed in corn seed for oral delivery to gilts before farrowing, wherein the method can boost neutralizing antibody levels in the animals’ serum, colostrum and milk thereby effectively boosting lactogenic immunity to the offspring (Abstract, pages 2-4). Lamphear et al. further teach such method is appropriate for large-scale field trials preceding commercialization (Abstract, page 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the PEDV plant composition of Howard et al. into the method of boosting lactogenic immunity to swine offspring taught by Lamphear et al. (administering a viral antigen before farrowing) for the benefit of implementing large-scale field trials followed by commercialization. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating the PEDV plant composition of Howard et al. into the method of boosting lactogenic immunity to swine offspring taught by Lamphear et al. given that the methods of lactogenic immunity in pigs by administering plant-based vaccines are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 4, it is noted that all of the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 10/01/2025. No new limitations were introduced in the amendment filed on 03/31/2026. As previously explained, Howard et al. teach the use of chimeric and fusion proteins comprise a variant protein fused in-frame to a heterologous protein having an amino acid sequence not substantially homologous to the variant protein (¶¶ [0031-0033]). For example, one embodiment of Howard et al. provides the spike polypeptide fused to a dendritic cell targeting 5 sequence, (DC3), and/or a heat labile enterotoxin B subunit (LtB) peptide (Example 1, ¶ [0090], Fig.1).
Regarding claim 5, it is noted that all of the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 10/01/2025. No new limitations were introduced in the amendment filed on 03/31/2026. As previously explained, Howard et al. teach the use of a PEDV protein SEQ ID NO: 3 which shares 100% identity with instant SEQ ID NO: 3 which is expressed at levels of at least 10 mg/kg (Abstract) (alignment provided below, Qy is Howard et al.’s SEQ ID NO:3; Db is instant SEQ ID NO: 3). With respect to the recitation of “so that inflammatory cytokine levels are altered to reduce inflammation prior to infection” in claim 5, please see a detailed explanation below.
PNG
media_image1.png
794
622
media_image1.png
Greyscale
Regarding claims 7 and 9, it is noted that all of the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 10/01/2025. No new limitations were introduced in the amendment filed on 03/31/2026. As previously explained, Lamphear et al. further teach administering booster treatments prior to furrowing (Table 1, page 3). Group of animals A-C and E in Lamphear et al.’s teachings received an initial dose and two blocks of booster administration for a total of 3 times (Table 1, page 5).
Regarding claims 10 and 11, Howard et al. teach a composition of a plant or plant product comprising a Spike (S1) protein of PEDV, wherein the plant product is a maize seed which expresses the S1 protein and is administered with animal feed as ground meal (Claim 1, ¶¶ [0129], [0135], [0136]).
Regarding claims 5, 12-14, Lamphear et al. teach that many plant-based oral vaccines tested in animal studies can cause altered cytokine levels (page 3). It is noted that the recitations of “so that inflammatory cytokine levels are altered to reduce inflammation prior to infection”, “decreases cytokine inflammatory response by altering cytokine levels”, “said cytokine level that is altered includes one or more of GM-CSF, IFN gamma, IL-lalpha, IL-lbeta, IL-Ira, IL-2, IL-4, IL-6, IL-8, IL-10,IL- 12, IL18, or TNF alpha”, and “said cytokine level is one or more of GN- CSF, IFN gamma, and/or TNF alpha” in claims 5, 12, 13, and 14 respectively, do not impart additional method steps to be performed to the method of claim 1, but rather, these recitations refer to intended results of practicing the method of claim 1. Therefore, these recitations are considered to flow from the step of “administering” already present in the method of claim 1. Further, the indicated recitations in claims 5, 12-14 which merely state additional intended results of practicing the method of claim 1, do not add any distinct meaning or purpose to the manipulative step of “administering”. It is noted that the method recites “providing passive immunity protection” which does not require alterations in cytokine levels. In other words, the method as claimed refers to the introduction of antibodies to an animal’s offspring, and not to alterations in cytokine levels which are additional responses observed with plant-based oral vaccines of pigs (Lamphear et al. page 3). Accordingly, alterations of cytokine levels in response to an oral plant-based vaccine are not considered to add meaning or purpose to the claimed method of providing passive immunity protection as recited in claim 1. Further, it is noted that any method of providing passive immunity protection in the prior art having the all of the limitations recited in claim 1 would be capable of decreasing a cytokine inflammatory response by altering a cytokine level in an animal, wherein said cytokine level is one or more of GN- CSF, IFN gamma, and/or TNF alpha.
Accordingly, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Previous rejection, withdrawn as to claims 6, 8, maintained and modified as necessitated by amendment as to claims 1-5, 7, 9-14) Claims 1-5, 7, 9-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10 of US Patent No. 11,566,255 B2 to Howard et al., in view of Lamphear et al. (previously cited).
See claims 1-5, 7, 9-14 as submitted on 03/31/2026.
The previous rejections of claims 6 and 8 are moot in view of Applicant’s cancelation of these claims.
It is noted that all of the amendments to the instant claims were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 10/01/2025. No new limitations were introduced in the amendment filed on 03/31/2026. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method of producing a protective response (providing passive immunity protection, as recited in claim 1) to an animal against a Porcine Epidemic Diarrhea Virus (PEDV), a member of the Coronaviridae virus family, comprising oral administration of a composition of a plant or plant product comprising a Spike (S1) protein of PEDV (Abstract, Claim 1, ¶¶ [0009], [0018], [0031]-[0033], [0090], Example 1, Fig.1).
The patented claims do not include the limitations of administering the composition to an animal prior to farrowing and of administering the composition 3 times.
However, Lamphear et al. teach those precise limitations. As indicated above, Lamphear et al. teach a method of administering a viral antigen expressed in corn seed for oral delivery to gilts before farrowing, wherein the method can boost neutralizing antibody levels in the animals’ serum, colostrum and milk thereby effectively boosting lactogenic immunity to the offspring (Abstract, pages 2-4). Further, Lamphear et al. teach administering booster treatments prior to furrowing (Table 1, page 3). Group of animals A-C and E in Lamphear et al.’s teachings received an initial dose and two blocks of booster administration for a total of 3 times (Table 1, page 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated with reasonable expectation of success the teachings of Lamphear et al. to the patented claims for the benefit of implementing large-scale field trials followed by commercialization.
Response to Arguments
Applicant's arguments filed 03/31/2026 have been fully considered but they are not persuasive.
Applicant contends on page 8 of the Remarks submitted on 03/31/2026:
“Howard et al. does not demonstrate that an administered plant-produced PDEV S1 protein can increase levels of neutralizing antibodies in the colostrum or milk in a female pig to sufficient levels to confer immunity to suckling piglets.
While Lamphear et al. shows that an oral corn-based TGEV vaccine when administered as a booster to gilts results in increased levels of neutralizing antibodies in the colostrum and early milk, Lamphear et al. does not demonstrate that the levels of neutralizing antibodies in the milk were sufficient to confer immunity when administered to piglets. In fact, at the end of Lamphear et al., it states that future studies "will include an assessment of whether the lactogenic immunity observed here results in protection being conferred to piglets." (p. 2424, second column of Lamphear et al.).
In the instant case, Applicant submits that a prima facie case of obviousness has not been made at least on the basis that it was not predictable that the administration of a plant-produced PDEV Si protein such as one taught by Howard et al. would have resulted in sufficient levels of neutralizing antibodies in a female pig's milk to confer immunity when administered to piglets, particularly given that Lamphear et al. notes that one must assess whether the level of antibodies within milk are sufficient to confer protection to piglets.
In contrast with the cited references, the instant inventors have demonstrated in Example 1 that 53% of the piglets nursing on dams that were administered a plant-produced PDEV Si protein survived a challenge with PEDV, whereas greater than 90% of the piglets that nursed on dams that were not vaccinated died following challenge. The plant-produced PDEV Si protein was even more effective than the commercially available killed virus vaccine that was parenterally administered. Only 37% of the piglets nursing on dams that were administered the killed virus vaccine survived the PEDV challenge.”
In response:
Applicant's arguments against the references individually are not persuasive because 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). As explained above and previously, Howard et al. were cited for teaching a method of producing a protective response to an animal against PEDV comprising oral administration of a composition of a plant or plant product comprising a Spike (S1) protein of PEDV; and Lamphear et al. were cited for teaching a method of administering a viral antigen expressed in corn seed for oral delivery to gilts before farrowing, wherein the method can boost neutralizing antibody levels in the animals’ serum, colostrum and milk thereby effectively boosting lactogenic immunity to the offspring. All of the limitations of the claimed invention are clearly taught by the cited prior art, as explained above in detail. Further, The instant rejection is in view of instant claim language. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claimed method only requires administering to a dam prior to farrowing a plant or plant product comprising the spike protein from a coronavirus and then feeding the dam’s milk to the piglet. As outlined above, the cited prior art teaches the claimed method.
It is noted that the instant claims do not require nor recite limitations with respect to sufficient levels of neutralizing antibodies in a female pig's milk to confer immunity when administered to piglets. Therefore, Applicant’s arguments in reference to the alleged efficacy of the claimed method are of no relevance to overcome the rejections of record.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached on (571)270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
Prosecution Insights