DETAILED CORRESPONDENCE
Application Status
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. Claims 1-2 are pending.
Priority
3. Acknowledgement is made of this continuation of U.S. Nonprovisional Application No. 18/008512, filed on 12/06/2022, which is a national stage entry of PCT/US21/37190, filed on 06/14/2021, which claims domestic priority to U.S. Provisional Application Nos. 63/188894 and 63/040718, filed on 05/14/2021 and 06/18/2020, respectively.
Information Disclosure Statement
4. The IDS filed on 10/04/2023 has been considered by the examiner and a copy of the Form PTO/SB/08 is attached to the office action.
Drawings
5. The Drawings filed on 10/04/2023 are acknowledged and accepted by the examiner.
Claim Objections
6. Claims 1-2 are objected to in the recitation of B. subtilis, and in the interest of improving claim form it is suggested that the genus and species be italicized and the name Bacillus be recited at least once in the claim.
Claim Rejections – 35 USC § 112(b)
7. 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.
8. Claims 1-2 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.
Regarding claims 1 and 2, the recitation of “comprising orally administering a therapeutically effective amount of an antimicrobial peptide… comprising the step of orally administering to the subject the therapeutically amount of a stable strain of a probiotic B. subtilis expressing cNK-2…comprising the step of orally administering to the subject the therapeutically effective amount of a stable strain of a probiotic B. subtilis to treat an Avian coccidiosis…” is indefinite because it is unclear if these are three distinct steps or variations of a single step recited in different ways. The metes and bounds of the claim cannot be ascertained from the limitations recited.
Furthermore, there is insufficient antecedent basis for the limitation “the therapeutically amount” in the claims. It is suggested that applicants clarify the meaning of the claim.
Claim Rejections - 35 USC § 103
9. 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.
10. Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lillehoj et al. (US Patent Application Publication 2012/0245082 A1; cited on IDS filed on 10/04/2023) in view of Lin et al. (Parasitology Research, 2015; examiner cited).
11. Claims 1-2 are drawn to method to treat a subject in need of a treatment comprising: orally administering a therapeutically effective amount of an antimicrobial peptide vectored composition comprising a bacterial protein expression vehicle expressing one or more recombinant antimicrobial peptide effector molecules, wherein the one or more recombinant antimicrobial peptide effector molecules are engineered from a NK-lysin gene and express functionally active NK-2, wherein the subject is poultry and said poultry are in need of treatment to maintain or restore gut microbiome, comprising the step of orally administering to the subject the therapeutically amount of a stable strain of a probiotic B. subtilis expressing cNK-2 to restore gut microbiome of said subject.
12. With respect to claims 1 and 2, Lillehoj et al. teach a method for treating chickens infected with avian coccidiosis by administering a therapeutically effective amount of a functionally active cNK-2 peptide that has been recombinantly produced [see Abstract; paragraphs 0004, 0009-0016, 0055].
However, Lillehoj et al. does not teach wherein the peptide is delivered orally or through a stable strain of a probiotic B. subtilis expressing said NK-2 peptide.
Lin et al. teach prebiotic strains of B. subtilis expressing Eimeria tenella 3-1E protein administering orally to chickens for the treatment of coccidiosis [see Abstract; p.3229, column 2]. Lin et al. teach that administration of the significantly increased the anti-coccidial index and reduced cecal lesion scores [see Abstract; p. 3235].
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to combine the teachings of Lillehoj et al. and Lin et al. to express cNK-2 peptides in the B. subtilis strains of Lin et al. to treat avian coccidiosis because Lillehoj et al. teach the treatment of avian coccidiosis by administering cNK-2 peptides. Lin et al. teach B. subtilis can be used as a prebiotic strain expressing proteins for the treatment of avian coccidiosis. One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability and require simple substitution of one known element for the other to express cNK-2 peptides in B. subtilis because Lin et al. acknowledges that B. subtilis can be used as a prebiotic strain expressing proteins for the treatment of avian coccidiosis. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
13. 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.
14. Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,814,628. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of the ‘628 application recite a method to treat a subject in need of a treatment comprising: orally administering a therapeutically effective amount of an antimicrobial peptide vectored composition comprising a bacterial protein expression vehicle comprised of a whole cell Bacillus subtilis transformed with a replicable plasmid DNA expression construct codon-optimized for expressing functionally active NK-2, wherein the subject is poultry and said poultry are in need of treatment for Avian coccidiosis.
Conclusion
15. Status of the claims:
Claims 1-2 are pending.
Claims 1-2 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656