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 .
The preliminary amendment filed on 1/3/2024 is acknowledged. Claim 4 is amended. Claims 1-7 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 1/16/2024 has been considered. A signed copy is enclosed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a formulation comprising Bacillus subtilis and palatability enhancers or attractants or a carrier, among other agents. Despite being drawn to a composition of matter, the claim is directed a judicial exception because it encompasses a naturally occurring organism lacking markedly different characteristics from its natural counterpart. The claim recites a formulation comprising Bacillus subtilis NRRL 50391, which appears to be a naturally occurring bacterium. The claim does not recite any structural, functional, or genetic modification to the bacterium that would render it “markedly different” from naturally occurring Bacillus subtilis. The addition of a carrier, including clay, kaolin, or water, among other agents, does not alter the bacterium itself. The materials recited are themselves naturally occurring substances and do not impart any markedly different characteristics to the bacterium. The claim does not impose meaningful limitations on the natural bacterium or integrate the exception into a practical application that is different than the functional characteristics of the natural bacterium.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 1-7 are rejected 35 U.S.C.§ 112, first paragraph, as containing 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.
It is apparent that the bacterial strain Bacillus subtilis strain No. 5 NRRL 50391 is required to practice the claimed invention. As such it must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the strain.
It is not apparent if the bacterial strain is readily available to the public.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that:
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
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 1-7 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 pre-AIA the applicant regards as the invention.
Claim 1 is rendered indefinite by the phrase “chemical-free”. Every substance is made of chemicals, so it is not clear how anything could be chemical-free. Further, specific chemicals are recited in the claims as being required.
Claim 1 is rendered indefinite by the term “preferably”. Description of examples or preferences is properly set forth in the specification rather than the claims. The term "preferably" renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 is indefinite because it is not clear what is required by the claim since the Markush language used is not clear. First, the use of “among other agents” opens the Markush group so the claim limits are explicitly left undefined. Further, based on comma usage and “or”, it is not clear whether the “among other agents” only applies to carriers or to the entire claim.
Claim 4 is indefinite because the claim limits are explicitly left undefined by the terms “including but not limited to” and “etc”. Further, the way commas are used leaves the Markush group confusing since “a protein source” appears to be part of the list of starch sources.
Claim 5 is rendered indefinite by the phrase “a proportion of 5 to 30%”. A proportion requires one thing in an amount compared to something else. It is not clear what is being compared here. Further, it is not clear how the comparison is made. For example, if the claim is intended to mean percentage of starch in the total formulation, this could be by dry weight, by volume, or some other measure.
Claim 6 is rendered indefinite by the phrase “a proportion of 7 to 35%”. A proportion requires one thing in an amount compared to something else. It is not clear what is being compared here. Further, it is not clear how the comparison is made. For example, if the claim is intended to mean percentage of protein in the total formulation, this could be by dry weight, by volume, or some other measure.
Claim 7 is indefinite because the grammar of the claim renders the Markush group unclear. The various combinations of commas and semi-colons do not seem to group components into reasonable choices. Multiple words are used more than once (see for example, ultra-low volume and emulsifiable). Further, the claim states that the “formulation is in the form of a…”. For the claim to make sense grammatically, there needs to be a noun following this phrase. For example, “a formulation in the form of a suspension capsule for seed treatment”. However, many of the members of the Markush group are just adjectives. This does not make sense. For example, one could not have “a formulation in the form of a emulsifiable”. These lists of adjectives might be intended to modify a noun, but the way the claim is written, it is not clear what would apply to what.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 requires that the formulation further comprise spores of Bacillus subtilis strain No. 5 NRRL 50391. However, the parent claim already requires that the formulation require these spores. Therefore, the claim does not further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim 1-2 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 8586027. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to biological, chemical-free, insecticide formulation for the control of insect pests on plants, CHARACTERIZED in that said formulation comprises Bacillus subtilis strain No. 5 NRRL 50391, at concentrations from 10 to 1012 spores/g, palatability enhancers or attractants, a carrier selected from clays, kaolin, talc, zeolite, water, vegetable oils, paraffinic or non-paraffinic minerals among other agents. As discussed above in the rejection under 35 USC 112b, one could not have a chemical-free formulation. Therefore, for the purposes of double patenting, this limitation is being ignored as an error. Also, as discussed above, it is not clear what members of the Markush are required. Therefore, the “or” and “among other agents” at the end of the claim is considered to make the whole list of agents a single Markush group.
The patented claims are drawn to a composition lacking antibiotics comprising Bacillus subtilis NRRL B-50391 at a concentration of 108 spores/g and a zeolite carrier. With regard to claim 7, the composition is considered to be a bait in any of its forms as well as being dispersible.
Claim Rejections - 35 USC § 102
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.
Claims 1-2 and 7are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Valdes et al (US Patent 8586027, 2013; IDS filed 1/16/2024).
The instant claims are drawn to biological, chemical-free, insecticide formulation for the control of insect pests on plants, CHARACTERIZED in that said formulation comprises Bacillus subtilis strain No. 5 NRRL 50391, at concentrations from 10 to 1012 spores/g, palatability enhancers or attractants, a carrier selected from clays, kaolin, talc, zeolite, water, vegetable oils, paraffinic or non-paraffinic minerals among other agents. As discussed above in the rejection under 35 USC 112b, one could not have a chemical-free formulation. Therefore, for the purposes of double patenting, this limitation is being ignored as an error. Also, as discussed above, it is not clear what members of the Markush are required. Therefore, the “or” and “among other agents” at the end of the claim is considered to make the whole list of agents a single Markush group.
Valdes et al disclose a composition lacking antibiotics comprising Bacillus subtilis NRRL B-50391 at a concentration of 108 spores/g and a zeolite carrier (see claim 2). With regard to claim 7, the composition is considered to be a bait in any of its forms as well as being dispersible.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/ Primary Examiner, Art Unit 1645