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 .
Election Restrictions
Applicant’s election without traverse of Group I, claims 1-14 drawn to a method for providing passive immunity protection to an animal from the effects of Coronavirus infection, in the reply filed on 08/28/2025 is acknowledged.
Further, Applicant’s election of species SEQ ID NO: 3 in claim 5 over a telephonic call with Ms. Andrea Sherk (attorney of record) on 09/19/2025 is acknowledged.
Claims 15-28 have been canceled, in the reply filed on 08/28/2025.
Claims 1-14 are under examination on the merits.
Priority
Applicant’s claim for domestic benefit of prior-filed provisional application No. 63/202,264 filed on 06/03/2021 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 09/14/2022, 10/19/2022, 12/27/2022. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 06/03/2022. The drawings are objected to because the labels should read “FIG.” instead of “FIGURE”.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the term “iBlot” on page 34, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that ‘iBlot’ is merely an example and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
Claim Objections
Claims 1-14 are objected to because of the following informalities:
On claims 1, 2, 3, 5, 10 the recitations of “Coronavirus” (claims 1, 2, 3, 5), “Spike” (claim 1), and “Protein” (claim 10) do not need to be capitalized. These recitations should read “coronavirus”, “spike”, and “protein”. Appropriate correction is required.
The indefinite article “a” is missing in claim 1 between “effects of” and “coronavirus” on line 2, and again between “protein of” and “coronavirus” on line 4. Appropriate correction is required.
The recitation in claim 5 of “10mg/kg”, should read “10 mg/kg” with a space between the number and “mg/kg”. Appropriate correction is required.
The indefinite article “a” is missing in claim 10 between “product is” and “seed” on line 1. Appropriate correction is required.
The indefinite article “a” is missing in claim 12 between “decreases” and “cytokine inflammatory response” on line 1. Appropriate correction is required.
Claims 3-14 are missing a comma after the recitations of “The method of claim [number]”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are 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.
Claim 1 recites “providing passive immunity protection to an animal”, the term as referred to in instant Specification (page 32) and as it is known in the art (see for example, Hayden et al., 2015, cited in Applicant’s IDS submitted on 09/14/2022) refers to the introduction of antibodies. However, claim 1 recites “administering to said animal prior to farrowing a composition of a plant or plant product comprising a Spike (S1) protein of Coronavirus” which is an antigen and not an antibody. In light of the Specification (Example 1, page 32), it appears that the passive immunity is being provided to the offspring of the animal to which the composition comprising the antigen (a coronavirus spike S1 protein) is administered and not to “said animal” itself. In other words, an animal is given an antigen comprising a coronavirus spike S1 protein, said animal will produce antibodies against said antigen and those antigens provide passive immunity protection to the animal’s offspring. As currently written, the claim indicates that an animal is being administered an antigen (a composition of a plant or a plant product comprising a spike (S1) protein of a coronavirus) and not an antibody prior to farrowing. Hence, the claim is unclear. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claim 1 was interpreted herein consistent with the Specification as referring to the providing passive immunity protection to the offspring of an animal which is administered a composition of a plant or plant product comprising a Spike (S1) protein of a coronavirus prior to farrowing.
Claim 2 is missing a period at the end of the claim. The lack of a period renders the claim indefinite because it is not clear if the claim includes further limitations.
Claim 12 recites "wherein said cytokine level" (line 1). There is insufficient antecedent basis for this recitation in the claim because claim 13 depends on claim 1 which has no mention of a cytokine level. For purposes of compact prosecution and applying prior art, claim 13 was interpreted herein to depend on claim 12 which mentions a cytokine level.
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPub US 2020/0080101 A1 to Howard et al. effectively filed on 09/12/2018 (cited in Applicant’s IDS submitted on 10/19/2025), in view of Lamphear, Barry J et al. “A corn-based delivery system for animal vaccines: an oral transmissible gastroenteritis virus vaccine boosts lactogenic immunity in swine.” Vaccine vol. 22,19 (2004): 2420-4. Published 06/23/2004. (Cited in Applicant’s IDS submitted on 09/14/2022).
See claims 1-14 as submitted on 08/28/2025.
Regarding claims 1-3, 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. 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, 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, 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.
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Regarding claims 6 and 8, 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).
Regarding claims 7 and 9, 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 a 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 (see interpretation of claim 20 in rejections under 35 USC § 112), 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, claims 1-14 were 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.
Claims 1-14are 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).
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.
Conclusion
No claims are allowed.
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-F 8-5.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1671
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1671