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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Claims 1-10 are pending.
Claims 1-10 are examined herein.
Claim Rejections - 35 USC § 112
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.
Claim 6 is 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.
In Claim 6 Applicant claims a process comprising synthesizing
(i) a miPEP that modulates the amount of a microRNA (miRNA), or
(ii) a nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise (the sequence of a) mature miRNA,
wherein said miPEP is encoded by an open reading frame (ORF) from 12 to 303 nucleotides in length contained in the 5' or 3' portion of the primary transcript sequence of the miRNA, and
wherein said miPEP was identified by: a) exogenously contacting a first plant cell expressing the miRNA with a peptide encoded by the ORF or a nucleotide encoding the peptide; and b) comparing between: i) a phenotype in the first plant cell expressing the miRNA in the presence of the peptide encoded by the ORF, the peptide having been present in the first plant cell independently of transcription of the primary transcript of the miRNA, and ii) the phenotype in a second plant cell of the same type as the first plant cell expressing the miRNA that had not been exogenously contacted with the peptide encoded by the ORF or the nucleotide encoding the peptide, wherein a change of the phenotype in the presence of the peptide relative to the phenotype in the absence of the peptide indicated that the ORF encodes the miPEP that modulates the amount of the miRNA.
Applicant describes the sequences of several identified and predicted miPEPs and the encoding ORFs from plants, insects and humans. (SEQ ID NO:1-208, 355-399). Applicant teaches working examples wherein introduction of micropeptides to plant tissues modulated the levels of the corresponding miRNAs. (p. 108-116). Applicant teaches examples wherein potential miPEPs were identified in Drosophila and a prophetic example in humans. (Specification p. 116-120).
Essential to the claim is miPEPs that have been identified by the method recited in the second wherein clause of Claim 6. Indeed, the only active steps of claim 6 are directed to synthesis of This identification could be or could have been performed by anyone. As such one of ordinary skill in the art could make a small peptide and infringe on the Claim 6 without any way of knowing that the peptide had been identified previously.
An examination of the miPEPs reveals no readily identifiable structural commonalities – although Applicant notes that the miPEPs tend to have a basic overall charge. A comparison of the primary transcripts of miRNAs as described by Applicant shows that while the sequences show significant identity between closely related species, more distantly related species show little or no identity in the 5’ and 3’ portions of the transcript. For example, SEQ ID NO:223 (Arabidopsis lyrata miRNA164a) and SEQ ID NO:224 (Arabidopsis thaliana) show high identity (over 80%) in the terminal portions of the sequences, while SEQ ID NO:223 and SEQ ID NO:230 (Oryza sativa miRNA164a) show little identity outside of the active and “mature” miRNA sequence (which shares 100% identity between SEQ ID NO:223 ad SEQ ID NO:230). Further, an analysis of all of the open reading frames in the 5’ and 3’ portions of SEQ ID NO:223 and 230 show no conserved structures between any of the polypeptides encoded thereby. Given that the claims encompass miPEPs from all eukaryotic species and the open reading frames of the 5’ and 3’ portions of the primary transcripts of the miRNAs are not conserved, one of ordinary skill in the art would not be able to distinguish those polypeptides with the required sequence length from those that are members of the recited genus without further description.
The scope of micropeptides as encompassed by the structural limitations of the claims is vast and the genus of micropeptides required by the claims is not adequately described. Without further description, it does not appear that Applicant was in possession of the recited genus of miPEPs or the nucleic acids encoding them at the time of filing.
Synthesizing micropeptides and small peptides is common in the art. (See, for example Freidinger, Roger M. "Design and synthesis of novel bioactive peptides and peptidomimetics." Journal of medicinal chemistry 46.26 (2003): 5553-5566 and Hamley, Ian W. "Small bioactive peptides for biomaterials design and therapeutics." Chemical reviews 117.24 (2017): 14015-14041) (entire articles). The structure of the miPEPs appears to be largely unpredictable with respect to a structure-function relationship. One of ordinary skill would not be apprised, in view of Applicant’s disclosure, whether any particular micropeptide that they happened to synthesize would be encompassed by the claimed subject matter.
See also Vas-Gath Inc. v. Mahurkar, which teaches that "the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his [or her] infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification.” Vas-Gath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991).
Because Applicant has not described the broadly claimed genus of miPEPs that are synthesized or the sequences that encode them, the claim is not adequately described in view of the teachings of the prior art.
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US 12024543.
Applicant claims a process comprising: a) identifying an open reading frame (ORF) from 12 to 303 nucleotides in length contained in the 5' or 3' portion of the primary transcript sequence of a microRNA (miRNA); b1) exogenously contacting a first plant cell expressing the miRNA with a peptide encoded by the ORF or a nucleotide encoding the peptide; and b2) comparing between: i) a phenotype in the first plant cell expressing the miRNA in the presence of the peptide encoded by the ORF, the peptide being present in the first plant cell independently of transcription of the primary transcript of the miRNA, and ii) the phenotype in a second plant cell of the same type as the first plant cell expressing the miRNA that has not been exogenously contacted with the peptide encoded by the ORF or the nucleotide encoding the peptide, wherein a change of the phenotype in the presence of the peptide relative to the phenotype in the absence of the peptide indicates that the ORF encodes a miPEP that modulates the amount of the miRNA; and c) synthesizing (i) the miPEP that modulates the amount of the miRNA, or (ii) a nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise mature miRNA (Claim 1), the process of claim 1, wherein the nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise the mature miRNA is operably linked to a heterologous promoter (Claim 2), the process of claim 1, wherein the synthesis in step c) is chemical synthesis or synthesis in a cell that transgenically expresses the miPEP that modulates the amount of the miRNA or the nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise the mature miRNA (Claim 3), the process of claim 3, further comprising the step d) of isolating the miPEP from the cell that transgenically expresses the miPEP (Claim 4), the process of claim 4, further comprising the step e) of formulating the miPEP isolated in step d) for administration to a plant or part thereof (Claim 5), the process of claim 4, wherein the nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise the mature miRNA is operably linked to a heterologous promoter (Claim 7), the process of claim 4, wherein the synthesizing is chemical synthesis or synthesis in a cell that transgenically expresses the miPEP that modulates the amount of the miRNA or the nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise the mature miRNA (Claim 8), the process of claim 8, further comprising the step d) of isolating the miPEP from the cell that transgenically expresses the miPEP (Claim 9), the process of claim 9, further comprising the step e) of formulating the miPEP isolated in step d) for administration to a plant or part thereof (Claim 10).
Applicant further claims a process comprising synthesizing (i) a miPEP that modulates the amount of a microRNA (miRNA), or (ii) a nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise mature miRNA, wherein said miPEP is encoded by an open reading frame (ORF) from 12 to 303 nucleotides in length contained in the 5' or 3' portion of the primary transcript sequence of the miRNA, and wherein said miPEP was identified by: a) exogenously contacting a first plant cell expressing the miRNA with a peptide encoded by the ORF or a nucleotide encoding the peptide; and b) comparing between: i) a phenotype in the first plant cell expressing the miRNA in the presence of the peptide encoded by the ORF, the peptide having been present in the first plant cell independently of transcription of the primary transcript of the miRNA, and ii) the phenotype in a second plant cell of the same type as the first plant cell expressing the miRNA that had not been exogenously contacted with the peptide encoded by the ORF or the nucleotide encoding the peptide, wherein a change of the phenotype in the presence of the peptide relative to the phenotype in the absence of the peptide indicated that the ORF encodes the miPEP that modulates the amount of the miRNA (Claim 6).
The reference patent, US 12024543, claims as follows:
1. A process comprising: a) identifying an open reading frame (ORF) from 12 to 303 nucleotides in length contained in the 5′ or 3′ portion of the primary transcript sequence of a microRNA (miRNA); b1) exogenously contacting a first plant cell expressing the miRNA with a peptide encoded by the ORF or a nucleotide encoding the peptide; and b2) comparing between: i) a phenotype in the first plant cell expressing the miRNA in the presence of the peptide encoded by the ORF, the peptide being present in the first plant cell independently of transcription of the primary transcript of the miRNA, and ii) the phenotype in a second plant cell of the same type as the first plant cell expressing the miRNA that has not been exogenously contacted with the peptide encoded by the ORF or the nucleotide encoding the peptide, wherein a change of the phenotype in the presence of the peptide relative to the phenotype in the absence of the peptide indicates that the ORF encodes a bioactive miPEP that modulates the amount of the miRNA; c) synthesizing (i) the miPEP that modulates the amount of the miRNA, or (ii) a nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise mature miRNA; and d) introducing into a third plant cell (i) the miPEP that modulates the amount of the miRNA, or (ii) the nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise mature miRNA resulting in the increase of the amount of the miRNA that encodes the miPEP in its primary transcript sequence, wherein the synthesizing step c) is not performed endogenously in the third plant cell, and wherein the third plant cell expresses the miRNA.
2. The process of claim 1, wherein the nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise the mature miRNA is operably linked to a heterologous promoter.
3. The process of claim 2, further comprising the step of expressing the miPEP in the third plant cell.
4. The process of claim 3, further comprising the step of isolating the miPEP from the third plant cell.
5. The process of claim 1, wherein the introducing in step d) comprises: formulating the miPEP that modulates the amount of the miRNA or the nucleic acid encoding the miPEP that modulates the amount of the miRNA and that does not comprise the mature miRNA for administration to a plant or part thereof; and administering the formulation to the plant or part thereof.
6. The process of claim 1, wherein the synthesis in step c) is chemical synthesis or synthesis in a cell that transgenically expresses the miPEP that modulates the amount of the miRNA or the nucleic acid sequence encoding the miPEP that modulates the amount of the miRNA and that does not comprise the mature miRNA.
As is readily apparent from the claims of the instant application and the reference application, the instantly claims represent a genus of the species claimed in the reference patent (claiming the same process with one less step). Otherwise every limitation recited in the instant application are claimed in the reference application. As such, the instant claims are prima facie obvious in view of the claims of the reference patent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES A LOGSDON whose telephone number is (571)270-0282. The examiner can normally be reached M-F 8:30 - 5:00 pm.
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/CHARLES LOGSDON/Primary Examiner, Art Unit 1662