DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of Group II (drawn to a method of treating a condition) in the Response filed on December 2, 2025 is acknowledged.
Claims 5, 13, 14, 16, 20, 24, and 25 have been canceled.
Claims 1-4, 6-12, 15, 17-19, 21-23, 26, and 27 are pending.
Claims 1-4, 6-12, 15, 22, 23, 26, and 27 have been withdrawn under 37 CFR 1.142(b) as being drawn to nonelected invention.
Claims 17-19 and 21 are currently under consideration as they read on the elected invention.
3. Claims 17-19 and 21 are objected to for being depended upon withdrawn claim 1. Applicant has elected Group II, drawn to a method of treating a condition in a human by administering a plant-derived recombinant sIgA produced by the method in Group I without traverse. As such, the claims in Group I has been withdrawn. Applicant is required to amend claim 17 in Group II to be independent claim.
For the purpose of examination and application of prior art, claim 17 (claims 18, 19, and 21 all depend upon claim 17) is read as a method of treating a condition in a human or non-human animal by administering an effective amount of a plant-derived sIgA.
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 17-19 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a method of treating a condition in a human or non-human animal subject by administering an effective amount of a plant-derived recombinant secretory immunoglobulin A (sIgA). Dependent claim 18 further recites that the condition is selected from the group consisting of inflammatory conditions, infections disease, cancer, auto-immune disease, and combination thereof. Dependent claim 19 further limits the condition to be a skin condition or condition of the lung or nasal mucosa.
The specification discloses that IgA in vivo exits in a monomeric form (mIgA) while most IgA in the mucosa and in secretions is presented as secretory IgA containing two complete IgA molecules with a J chain (e.g. see last paragraph in page 2 of the specification as-filed). Further, the instant specification discloses working examples of producing sIgA in rice grains where in each expression vector, the sIgA component optimized coding sequence is operably lined to the downstream of rice seed storage protein glutelin 1 gene promotes (e.g. see Example 1). The specification discloses that the rice-produced recombinant sIgA is an anti-TNF-α antibody (e.g. see page 28 of the specification as-filed).
The specification also discloses in vivo mouse study to shown that the sIgA administration has higher clinical score than control group (e.g. see Fig. 14). The other plant used to produce sIgA is Barley Grains (e.g. see Proof of Concept in Example 4). The specification discloses that other antibodies known to be therapeutic to autoimmune diseases such as Vedolizumab can also be produced in the same manner
There is insufficient written description encompassing a method of treating a condition in a huma or non-human animal subject by administering a plant-derived recombinant sIgA. . The plant-derived sIgA without antigen specificities do not encompass common structural elements essential to the common utility of treating an unidentified condition or a condition broadly encompass inflammatory conditions, infections disease, cancer, auto-immune disease.
Applicant is relying upon certain biological activities (e.g. treating a condition) and the disclosure of a limited number of antibodies known to be therapeutic to specific diseases wherein the antibodies were produced in rice and Barley Grain plants, as well as experimental mouse models to support an entire genus of plant-derived sIgAs without any antigen specificities for the treatment of a condition in a human or non-human animal subject. The reliance on the disclosed limited number of known sIgAs including anti-TNF-α sIgA produced in rice does not support the written description of any plant-derived sIgA for the method of treating a condition in a human or non-human animal subject.
It was well known that in vivo treatment by administering sIgA can be unpredictable. For example, Richards et al. (Human Vaccines & Immunotherapeutic 2022 18;2:e1964317, pages 1-8) teaches that recombinant sIgA1 and/or sIgA2 targeting bacterial surface antigens can reduce infection by the same bacteria in mouse models (e.g. see Abstract) but only when administered sIgA were administered shortly before or at the time the bacterial challenge (e.g. see Summary and perspectives in page 5).
There is insufficient written description of the claimed plant-derived recombinant sIgA broadly encompassed by the claimed method. There is a lack of disclosure of sufficient relevant identifying characteristics coupled with a known or disclosed correlation between function and structure of the broadly diverse plant-derived recombinant sIgA employed in the claimed methods.
In the absence of disclosure of relevant, identifying characteristics of the plant-derived recombinant sIgA and the conditions to be treated, there is insufficient written disclosure under 35 U.S.C. 112, first paragraph for the instant claims.
6. Claims 17-19 and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The breath of the claims encompasses a method of treating a condition in a human or non-human animal subject by administering an effective amount of a plant-derived recombinant secretory immunoglobulin A (sIgA). Dependent claim 18 further recites that the condition is selected from the group consisting of inflammatory conditions, infections disease, cancer, auto-immune disease, and combination thereof. Dependent claim 19 further limits the condition to be a skin condition or condition of the lung or nasal mucosa.
The specification discloses that IgA in vivo exits in a monomeric form (mIgA) while most IgA in the mucosa and in secretions is presented as secretory IgA containing two complete IgA molecules with a J chain (e.g. see last paragraph in page 2 of the specification as-filed). Further, the instant specification discloses working examples of producing sIgA in rice grains where in each expression vector, the sIgA component optimized coding sequence is operably lined to the downstream of rice seed storage protein glutelin 1 gene promotes (e.g. see Example 1). The specification discloses that the rice-produced recombinant sIgA is an anti-TNF-α antibody (e.g. see page 28 of the specification as-filed). The specification also discloses in vivo mouse study to shown that the sIgA administration has higher clinical score than control group (e.g. see Fig. 14). The other plant used to produce sIgA is Barley Grains (e.g. see Proof of Concept in Example 4).
The specification discloses that other antibodies known to be therapeutic to autoimmune diseases such as Vedolizumab can also be produced in the same manner.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The instant specification has not provided sufficient guidance and directions for the full breath of the claims. There is insufficient biochemical information (e.g. antigen specificity) that distinctly identifies the plant-derived recombinant secretory sIgA for treating a unspecified condition in a human or non-human animal.
Administering sIgA to treat diseases such as bacteria infections can be unpredictable. For example, Richards et al. (Human Vaccines & Immunotherapeutic 2022 18;2:e1964317, pages 1-8) teaches that recombinant sIgA1 and/or sIgA2 targeting bacterial surface antigens can reduce infection by the same bacteria in mouse models (e.g. see Abstract) but only when administered sIgA were administered shortly before or at the time the bacterial challenge (e.g. see Summary and perspectives in page 5).
Therefore, a person of skill in the art would not know which plant-derived recombinant sIgAs are essential or effective to treat a condition in a human or non-human animals including any or all inflammatory conditions, infectious disease, cancer, autoimmune disease or combination thereof and what particular targets for the sIgA identify essential or effective portions.
In view of the lack of predictability of the art to which the invention pertains and the lack of established protocols for treatment of conditions including inflammatory conditions, infectious disease, cancer, auto-immune diseases by administering any or all sIgA without antigen specificities; undue experimentation would be required to practice the claimed methods with a reasonable expectation of success, absent a specific and detailed description in applicant's specification of how to effectively practice the claimed methods and absent working examples providing evidence which is reasonably predictive that the claimed products would be able to treat the condition in a human or non-human animal subject.
7. 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.
8. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
9. Claims 17-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ariaans et al. (US 9,582,501, reference on IDS).
Claim 17 is drawn to a method of treating a condition in a human or non-human animal subject by administering an effective amount of a plant-derived recombinant secretory immunoglobulin A (sIgA). Dependent claim 18 further recites that the condition is selected from the group consisting of inflammatory conditions, infections disease, cancer, auto-immune disease, and combination thereof. Dependent claim 19 further limits the condition to be a skin condition or condition of the lung or nasal mucosa.
Ariaans et al. teach a method of treating an inflammatory disease or skin disorder in a human by administering a monoclonal secretory IgA antibody (sIgA) that binds and neutralizes human TNFα orally or topically (e.g. see claims 19-21). Ariaans et al. further teach that the sIgA was recombinantly produced in tobacco plant cells by transfecting the plant cell with cDNA sequences encoding secretion signal, heavy chain variable region, light chain, and J-chain (e.g. see Example 1). Therefore, the reference teachings anticipate the instant invention.
10. 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.
11. Claims 17-19 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 35, 36, 40, 41, 43, 44, 48, 60, and 61 of copending USSN 17/273,784 (the ‘784 application) in view of Ariaans et al. (US 9,582,501, reference on IDS).
This is a provisional nonstatutory double patenting rejection.
The instant claim 17 is drawn to a method of treating a condition in a human or non-human animal subject by administering an effective amount of a plant-derived recombinant secretory immunoglobulin A (sIgA). Dependent claim 18 further recites that the condition is selected from the group consisting of inflammatory conditions, infections disease, cancer, auto-immune disease, and combination thereof. Dependent claim 19 further limits the condition to be a skin condition or condition of the lung or nasal mucosa.
The claims in the ‘784 application are drawn to a stabilized prophylactic and/or therapeutic formulation comprising a therapeutically effective amount of IgA including a recombinant sIgA produced in a plant system, and a prophylactic or therapeutic method of administering the formulation to a subject as a food supplement.
The claims in the ‘784 application differ from the instant invention by not reciting treating inflammatory conditions including a skin condition.
Ariaans et al. teach a method of treating an inflammatory disease or skin disorder in a human by administering a monoclonal secretory IgA antibody (sIgA) that binds and neutralizes human TNFα orally or topically (e.g. see claims 19-21). Ariaans et al. further teach that the sIgA was recombinantly produced in tobacco plant cells by transfecting the plant cell with cDNA sequences encoding secretion signal, heavy chain variable region, light chain, and J-chain (e.g. see Example 1).
It would thus be obvious to one of skill in the art at the time the instant invention was filed to administer the formulations comprising the same or nearly the same sIgA recombinantly produced the a plant cell to a human or animal subject to treat a condition including skin condition. This is because Ariaans et al. teaches sIgA that binds human TNFα can be administered orally or topically to treat human skin conditions. Therefore, administering the therapeutically effective formulation containing recombinant sIgA produced in a plant system recited in the ‘784 application would be expected to be effective in treating human or animal skin condition.
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641