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 .
Restriction/Election
Applicants’ election without traverse of PIP-74-1 and PIP-72-2 in the reply filed on 06/09/26 is acknowledged. Although this is not a complete response to the election of species, because the election requires one single species to be elected, the entirety of the 74 series of peptides was searched, and found free of the art, but not allowable. For purposes of prior art, the search was extended to PIP-45-1 and prior art was found; however, upon review of applicants issued patents, the claimed species have been previously searched and patented, rendering the search less burdensome to conduct over the prior art. Therefore, the election of species is withdrawn.
Claims 1-20 are under examination. An Office action on the merits follows.
Claim Rejections 35 USC 112(B)
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.
Claim 20 is 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 20 recites "use of at least one insecticidal peptide of claim 1," but does not recite any step as to how the use is carried out. This renders the claims indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
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 1-9 and 20 are rejected under 35 USC 101 as being drawn to a naturally occurring peptide and nucleotide product. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The MPEP states: “When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature." For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass 'n for Molecular Pathology v. Myriad Genetics, Inc.. 133 S. Ct. 2107, 2116-17, 106 USPQ2d 1972, 1979 (2013); University of Utah Research Foundation v. Ambry Genetics, 774F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014), As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76USPQ280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office's eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature". Claim(s) 1 and 7-9 is/are directed to naturally occurring peptides and nucleotides that encode them from sources such as Pseudomonas fluorescens (discussed in Rhodes) and Pseudomonas pastida:
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(JOURNAL OF BACTERIOLOGY, Oct. 2011, p. 5541–5542; teaching the complete sequence of strain s16, which reads on a naturally occurring sequence more than 80% identical to SEQ ID NO: 2). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they are simply naturally occurring peptides and nucleotides encoding them that have been isolated from these natural sources.
Therefore, although the specific peptides isolated from these naturally occurring species are drawn to the naturally occurring peptides and nucleotides (Step 2A: Yes).
As to step 2B, and whether they contain significantly more than the natural products, the MPEP states: “Where the claim is to a nature-based product in combination with non-nature based elements (e.g., a claim to "a yogurt starter kit comprising Lactobacillus in a container with instructions for culturing Lactobacillus with milk to produce yogurt"), the markedly different characteristics analysis should be applied only to the nature-based product limitation. For instance, for the yogurt starter kit example, the Lactobacillus would be analyzed for markedly different characteristics. The container and instructions would not be subject to the markedly different characteristics analysis as they are not nature-based products, but would be evaluated as additional elements in Step 2B if it is determined that the Lactobacillus does not have markedly different characteristics from any naturally occurring counterpart and thus is a product of nature exception. See, e.g. Funk Bros. Seed Co. v. Kalo Inoculant Co .,333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (although claims 7, 8, 13 and 14 recited an inoculant comprising a bacterial mixture and a powder base, only the bacterial mixture was analyzed).” MPEP 2106.04(b)
Claims 1-9 are all drawn to naturally occurring peptide and nucleotide sequences of the bacteria Pseudomona, without significantly more than the isolated products themselves. Although these specific sequences were not all known in the art at the filing date of the invention, and even if they have insecticidal capability or have been produced recombinantly they are still naturally occurring and read on a judicial exception (Step 2B: No). There is nothing of record to show that the peptides have been changed in any way such that they have markedly different characteristic from the naturally occurring products.
As such, claims 1-9 are drawn to a judicial exception. Claim 20 is unclear as to whether it is drawn to a product or method, so it also falls under the natural product exception.
Claim 20 is rejected under 35 U.S.C. 101 because it is drawn to a "use" of the claimed peptides with no operational limitations. Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. As such, without the claim being drawn to a method of use with operative steps, it is not a proper process.
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 1-2, 8-12 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,820,596. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of ‘596 teaches PIP-45-1 and PIP-45-2, claim 4 teaches recombinant nucleotide encoding the polypeptides, meeting the limitations of instant claims 1, 2, 8 and 9. Claims 5 and 6 of ‘596 teach a DNA construct comprising the polynucleotides with a heterologous regulator element and a transgenic plant comprising the construct, which meets instant claims 10 and 11. Claims 7 and 8 teach method of inhibiting or controlling insecticidal pests with the claimed peptides and polynucleotides, meeting instant claim 12. Instant claims 18 and 19 are met because claims 8 and 9 of ‘596 teach controlling lepidoptera and pest resistant to a Bt toxin. Claim 20 is met by the teachings of claim1 of ‘569, teaching the same use for the same peptides.
Claims 1, 3-4, 8, 10-11, 13, 14 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,231,460. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of ‘460 teaches PIP-64-1 and PIP-64-2, claim 7 teaches recombinant nucleotide encoding the polypeptides, meeting the limitations of instant claims 1, 3, 4 and 8. Claim 10 of ‘460 teach a DNA construct comprising the polypeptide with a heterologous regulatory element, which meets instant claims 10. Claims 11 and 12 of ‘460 teach a transgenic plant comprising a DNA construct, meeting instant claim 11. Claims 13 and 14 of ‘460 teach method of inhibiting or controlling insecticidal pests with the claimed peptides and polynucleotides, meeting instant claims 13 and 14. Instant claims 18 and 19 are met because claims 15 and 16 of ‘460 teach controlling lepidoptera and pests populations resistant to a Bt toxin. Instant claim 20 is met by the teachings of claim 1 of ‘460, teaching the same use for the same peptides.
Claims 1, 7-11 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,448,648. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1-2 of ‘648 teaches PIP-77 and PIP-77, claim 4 teaches recombinant nucleotide encoding the polypeptides, meeting the limitations of instant claims 1 and 7-9. Claims 5 and 6 of ‘648 teach a DNA construct comprising the polynucleotides encoding P-77 and a transgenic plant, which meets instant claims 10 and 11. Claims 7 and 8 teach method of inhibiting or controlling insecticidal pests with the claimed peptides and polynucleotides, meeting instant claim 17. Instant claims 18 and 19 are met because claims 8 and 9 of ‘648 teach controlling lepidoptera and pest resistant to a Bt toxin. Claim 20 is met by the teachings of claim 1 of ‘648, teaching the same use for the same peptides.
Claims 1, 6, 8-11, 16 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,203,619. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of ‘619 teach PIP-75 polypeptides and claims 3-4 teach recombinant polynucleotides encoding the polypeptides, meeting the limitations of instant claims 1, 6 and 8-9. Claims 5 and 6 of ‘619 teach a DNA construct comprising the polynucleotides encoding P-75 and a transgenic plant comprising the construct, which meets instant claims 10 and 11. Claims 7 and 8 teach of ‘619 teach a method of inhibiting or controlling insecticidal pests with the claimed peptides and polynucleotides, meeting instant claim 16. Instant claims 18 and 19 are met because claims 8 and 9 of ‘619 teach controlling lepidoptera/coleoptera and pest populations resistant to a Bt toxin. Claim 20 is met by the teachings of claim 1 of ‘648, teaching the same use for the same peptides.
Claims 1, 5, 8-11, 15 and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,780,891. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of ‘891 teach PIP-74-1 and PIP-74-2 polypeptides and claims 3-4 teach recombinant polynucleotides encoding the polypeptides, meeting the limitations of instant claims 1, 5 and 8-9. Claims 5 and 6 of ‘891 teach a DNA construct comprising the polynucleotides encoding P-74 polypeptides and a transgenic plant comprising the construct, which meets instant claims 10 and 11. Claims 7 and 8 teach of ‘891 teach a method of inhibiting or controlling insecticidal pests with the claimed peptides and polynucleotides, meeting instant claim 15. Instant claims 18 and 19 are met because claims 8 and 9 of ‘891 teach controlling lepidoptera/coleoptera and pest populations resistant to a Bt toxin. Claim 20 is met by the teachings of claim 1 of 891, teaching the same use for the same peptides.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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