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 amendment filed on May 13, 2026 is acknowledged.
Claims 1-16, 19-25, and 27 have been canceled.
Claims 28 and 29 have been added.
Claims 17, 18, 26, 28, and 29 are pending and currently under consideration.
3. In view of the abandonment of the copending USSN 17/273,784, the previous provisionally nonstatutory double patenting rejection has been withdrawn.
4. In view of applicant’s amendment, following rejections are set forth.
5. 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.
6. 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.
7. Claims 17, 18, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Virdi et al. (PNAS 2013 110;29:11809-11814).
Virdi et al. teach a fully assembled sIgA anti-Enterotoxigenic Escherichia coli (ETEC) in the form of VHH-IgA (VHH-IgA, J chain and Secretory component) produced in Arabidopsis thaliana seeds (e.g. see Abstract and Fig. 2). Virdi et al. further teach that the sVHH-IgA was fed to piglet orally and is effective in oral passive immunization in preventing ETEC infection (e.g. see paragraph spanning left and right col. in page 11813).
Therefore, the reference teachings anticipate the instant invention.
8. 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.
9. Claims 17, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Virdi et al. (PNAS 110;29:11809-11814) in view of Christou (WO 99/66026).
The teachings of Virdi et al. have been discussed above.
The reference teachings differ from the instant invention by not describing plants including rice seeds.
Christou teaches rice (rice seed), wheat, corn, oat, or sorghum plants can be transformed with expression cassettes for safe production of mammalian polypeptides such as antibodies (e.g. see Abstract and pages 2 and 9). Christou teaches that plants offer a number of potential advantages for production of polypeptide of industrial or medical utility (e.g. see lines 11-15 in page 1). Christou teaches that seeds can be harvested and processed for isolation and purification of the polypeptide followed by formulation into a composition (e.g. see lines 10-17 in page 22).
In working example 7, Christou teaches Guy’s 13 antibody, a sIgA with specificity to Streptococcal antigen I/II cell surface adhesion protein of the oral pathogen Streptococcus mutans, was expressed in transgenic rice including four components of the sIgA: heavy chain, light chain, J-chain, and secretory component (e.g. see pages 31 and 47). Fully assembled sIgA was detected in rice callus lines up to 800 ng/g (e.g. see page 31 and claim 20).
It would thus be obvious to one of ordinary skill in the art at the time the instant invention was filed to combine the teachings of Virdi et al. and Christou to produce the sVHH-IgA that was known to be therapeutic for treating ETEC infection when administered orally to piglets. An ordinary skill in the art would have been motivated to produce sVHH-IgA in plants such as rice seed because Christou teaches rice, wheat, corn, oat or sorghum plants can be used to produce therapeutic sIgA safely for pharmaceutical uses. Given the detailed methods of producing sIgA in rice seeds disclosed in Christou and given the availability of the therapeutic sVHH-IgA antibody as disclosed in Virdi et al., an ordinary skill in the art would have been motivated to produce the therapeutic sVHH-IgA disclosed in Virdi et al. in rice seeds following the detailed protocols disclosed in Christou with a reasonable expectation of success.
10. Claims 17, 18, 26, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Christou (WO 99/66026) in view of Ma et al. (Nature Medicine 1998 4;5:601-606).
Christou teaches rice (rice seed), wheat, corn, oat, or sorghum plants can be transformed with expression cassettes for safe production of mammalian polypeptides such as antibodies (e.g. see Abstract and pages 2 and 9). Christou teaches that plants offer a number of potential advantages for production of polypeptide of industrial or medical utility (e.g. see lines 11-15 in page 1). Christou teaches that seeds can be harvested and processed for isolation and purification of the polypeptide followed by formulation into a composition (e.g. see lines 10-17 in page 22).
In working example 7, Christou teaches Guy’s 13 antibody, a sIgA with specificity to Streptococcal antigen I/II cell surface adhesion protein of the oral pathogen Streptococcus mutans, was expressed in transgenic rice including four components of the sIgA: heavy chain, light chain, J-chain, and secretory component (e.g. see pages 31 and 47). Fully assembled sIgA was detected in rice callus lines up to 800 ng/g (e.g. see page 31 and claim 20).
The teachings of Christou differ from the instant invention by not describing a method of treating a mucosal condition in a human by orally administer the sIgA.
However, antigen I/II was a known carcinogenic dental pathogen from Streptococcus mutans and was also known to be a target of protective immunity. For example, Ma et al. teach Gay’s 13 sIgA/G comprising heavy chain consists of mouse γ1 and α domain, light chain, J chain and the secretory component was produced tobacco plants and purified (e.g. see page 601). Ma et al. further teach that the antibody was administered orally to human harbored oral S. mutans directly to the teeth (e.g. see right col. in page 603). Ma et al. teach that the sIgA/G can provide an advantage over IgG in mucosal environment and suggest agents produced in transgenic plants may lead to the development for other microbial infections affecting mucosal sites including gastrointestinal, respiratory and genitourinary systems of both human and other animals (e.g. see right col. in page 605).
It would thus be obvious to one of ordinary skill in the art at the time the invention was filed to combine the teachings of references to produce the well-known Guy’s 13 antibody sIgA in rice seeds. An ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success because Christou teaches fully functional Guy’s 13 antibody sIgA produced in rice seeds offer safe production of the antibody for medical utility and Ma et al. teach tobacco plant produced Guy’s 13 antibody sIgA/G can be administered in mouth to treat S mutan infection in human. As such, administering the Guy’s 13 sIgA antibody produced in rice seeds disclosed by Christou orally to treat bacterial infection in teeth in human or non-human animals would be well within the skill of an artisan.
11. No claim is allowed.
12. 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.
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
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