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 .
Election/Restrictions
1. Applicant’s election without traverse of the invention of Group I (drawn to a recombinant nucleic acid encoding kalium rhodopsin) and the species of human cell in the reply filed on 06/26/2026 is acknowledged.
Upon further considerations, the requirement for election between the different species of cells recited in claims 5-7 is withdrawn.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 2, 8-11, 17, 18, 22-26, 28, 33-52, and 54-57 have been cancelled. Claims 1, 3, 4, 12-16, 19-21, 27, 29-31, and 53 have been amended.
Claims 12-16 and 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 3-7, 27, 29-32, and 53 are under examination.
Claim Objections
2. Claim 4 is objected to because of the recitation “a recombinant”. Correction to “the recombinant” is required.
3. Claim 32 is objected to because of the recitation “a nucleic”. Correction to “the nucleic” is required.
Claim Rejections - 35 USC § 101
4. 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.
5. Claims 27-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite a nucleic acid encoding a kalium rhodopsin having an amino acid sequence at least 90% identical to SEQ ID NOs: 1 or 2. Leonard (Open Biol., 2018, p. 1-23) teaches the putative rhodopsins Hypho2016_00006030 and Hypho2016_00006031, which are encoded by the H. catenoides genome (see paragraph bridging p. 9 and 10). As evidenced by the attached Sequence Alignments, the amino acid sequence of Hypho2016_00006030 is 91.4% identical to the claimed SEQ ID NO: 2; the amino acid sequence of Hypho2016_00006031 is identical to the claimed SEQ ID NO: 1. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no evidence that the claimed nucleic acids encoding SEQ ID NO: 1 and 2 are any different from the naturally-occurring DNAs and mRNAs encoding Hypho2016_00006030 and Hypho2016_00006031. Thus, the recited nucleic acids are products of nature, i.e., the claims recite a judicial exception. This judicial exception is not integrated into a practical application because the claims simply recite nucleic acids. There are no additional components imparting a marked difference in the claimed nucleic acids as compared to the naturally-occurring ones. Therefore, the rejection under 35 U.S.C. 101 is appropriate.
Claim Rejections - 35 USC § 112(d)
6. 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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
7. Claim 31 is rejected under 35 U.S.C. 112(d) or pre-AIA 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 30 depends upon claim 27. Since claim 27 recites an encoding nucleic acid, the RNA recited in claim 30 must necessarily be an mRNA.
Thus, by reciting that the nucleic acid is an mRNA, claim 31 fails to further limit the subject matter of the parent claim 30, which already recites an mRNA.
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.
Claim Rejections - 35 USC § 103
8. 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.
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.
9. Claims 1, 3-7, 27, 29-32, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Leonard et al. (Open Biol., 2018, p. 1-23), in view of both Spudich et al. (U.S. 2018/0305417) and Santangelo et al. (U.S. 2019/0300856).
Leonard et al. teach the putative rhodopsins Hypho2016_00006030 and Hypho2016_00006031, which are encoded by the H. catenoides genome (see paragraph bridging p. 9 and 10). As evidenced by the attached Sequence Alignments, the amino acid sequence of Hypho2016_00006030 is 91.4% identical to the claimed SEQ ID NO: 2; the amino acid sequence of Hypho2016_00006031 is identical to the claimed SEQ ID NO: 1. Thus, Leonard et al. teach DNAs and mRNAs encoding a rhodopsin having an amino acid sequence at least 90% identical to SEQ ID NO: 1 and 2 (claims 1 and 27).
However, Leonard et al. do not teach that the nucleic acids are isolated (claim 27). Spudich et al. teach the need for characterizing novel rhodopsins; characterizing entails cDNA cloning, expression in host cells (such as isolated human cells, non-human mammalian cells, and yeast cells), and use in optogenetic applications; Spudich et al. teach using viral vectors for the expression of rhodopsins in mammalian host cells (see Abstract; [0008]-[0010]; [0077]; [0081]; [00111]; [0116]; [0133]; [0137]; [0140]; [0172]; Example 1.2). One of skill in the art would have found obvious to cDNA clone and characterize Hypho2016_00006030 and Hypho2016_00006031, as taught by Spudich et al., to achieve the predictable result of determining their capabilities to be used as optogenetic tools. By doing so, one of skill in the art would have isolated cDNAs encoding Hypho2016_00006030 and Hypho2016_00006031 (claim 27).
By following the teachings in Spudich et al., one of skill in the art would have also obtained the cDNAs, would have included the cDNAs in viral vectors, and would have used the viral vectors to express the cDNAs in human, non-human, or yeast host cells (i.e., the cDNAs are operably linked to a promoter) (claims 1, 3-7, 29, 32, and 53).
With respect to claims 30 and 31, Santangelo et al. teach that rhodopsins could be expressed in cells by using an mRNA (see [0009]-[0010]; [0013]; [0041]; Examples 1-2). One of skill in the art would have found obvious to modify Leonard et al. and Spudich et al. by using mRNAs, to achieve the predictable result of expressing Hypho2016_00006030 and Hypho2016_00006031 in the host cells.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
10. No claim is allowed. No claim is free of prior art.
SEQ ID NOs: 3-6 are human codon-optimized, and thus, not naturally-occurring. SEQ ID NOs: 3-6 are also free of the prior art of record because the prior art of record does not teach or render these sequences obvious.
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/ILEANA POPA/ Primary Examiner, Art Unit 1633
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