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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 3, 2025 has been entered.
Status of Claims/Rejections
Claims 41, 44, 52, 54-58, and 63 are currently pending in the instant application. Claim 58 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Accordingly, claims 41, 44, 52, 54-57, and 63 are under examination on the merits in the instant application.
Any rejections not repeated in this Office action are withdrawn, and the following rejections are the only rejections applied in this application.
Claim Rejections - 35 USC § 112
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 41, 44, 52, 54-57, and 63 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.
Claims 41, 44, 52, 54-57, and 63 recite a broad limitation that “the crRNA guide sequence targets an SNP located in Exon 1 of the Rho gene” and simultaneously recite in the same claims a narrower limitation that “the crRNA comprises 17-20 contiguous nucleotides of SEQ ID NO:219”. It is noted that exon 1 of the Rho gene contains more than one SNP as evidenced by Table 1 of the instant specification. Hence, the newly added broad limitation reads on a crRNA targeting any SNP in exon 1 of the Rho gene, whereas the narrower limitation reciting a specific SEQ ID NO requires that the crRNA targets a specific SNP of a wild-type Rho. Hence, the simultaneous recitation of both the broad limitation and the narrower limitation pertaining to the crRNA target renders the metes and bounds of the claims indefinite because it is unclear whether the feature introduced by such narrower language that the crRNA comprises SEQ ID NO:219 is (a) merely exemplary of the remainder of the claims, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Solely for examination purpose, the broad limitation will be interpreted as claiming that “the crRNA guide sequence targets the rs7894 SNP in exon 1 of the Rho gene”, thereby reciting that SEQ ID NO:219 is not merely exemplary but is a required limitation for the claimed crRNA.
The claims also recite that “the Rho allele that does not have any mutations that cause or are associated with autosomal dominant retinitis pigmentosa has a nucleotide at the SNP that is not the wild-type nucleotide”. It is unclear how “the Rho allele that does not have any mutations” for the autosomal dominant retinitis pigmentosa can possibly have “the SNP that is not the wild-type nucleotide”. That is, if the Rho allele contains no mutation causing the genetic disease, retinitis pigmentosa, the Rho allele must have the wild-type SNP. Hence, the claims recite conflicting limitations regarding the Rho allele, thereby rendering the claims indefinite.
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.
Claims 41, 44, 52, 54-57, and 63 are 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. This includes a new matter rejection.
The factors to be considered when analyzing claims for compliance with the written description requirement include: (A) actual reduction to practice; (B) disclosure of drawings or structural chemical formulas; (C) sufficient relevant identifying characteristics (e.g., complete structure, partial structure, physical and/or chemical properties, structure/function correlation); (D) level of skill and knowledge in the art; and (E) predictability in the art.
Each of the factors (A)-(E) listed above is analyzed below.
(A) actual reduction to practice
The instant specification contains no actual working example pertaining to the instantly claimed method of inactivating the mutant Rho allele having autosomal dominant retinitis pigmentosa (ADRP)-causing mutations downstream of exon 1 of the Rho gene without affecting the wild-type Rho allele having no mutation in an isolated human cell comprising the two aforementioned Rho alleles, wherein the method is performed by delivering an RNA molecule comprising “17-20 of contiguous nucleotides of SEQ ID NO:219”.
(B) disclosure of drawings or structural chemical formulas
The instant specification merely lists SEQ ID NO:219 among SEQ ID NOs:1-3010 in Table 2 with mere information that SEQ ID NO:219 is related to SNP ID “s7”, which is disclosed as being “rs7984” whose “SNP location in the gene” is “Exon 1 of 5” as disclosed in Table 1.
(C) sufficient relevant identifying characteristics (e.g., structure/function correlation)
The instant specification does not provide any written description support for the required structure-function correlation for the specifically recited RNA molecule species of SEQ ID NO:219, much less for the structural variants comprising longer or shorter RNAs comprising a 17-mer fragment of SEQ ID NO:219. Note that the “crRNA” as claimed is not claimed with a specific length requirement. As such, the instantly claimed crRNA reads on a 17-mer sequence comprising a 17-mer fragment of SEQ ID NO:219 as well as a 30-mer sequence comprising a 17-mer fragment of SEQ ID NO:219, especially in light of claim 44 reciting that the gRNA comprising the crRNA “is up to 300 nucleotides in length.”
Now, as noted above, regarding the instantly claimed active agent, SEQ ID NO:219, the instant specification merely lists the SEQ ID NO in Table 2 without providing any actual function of the SEQ ID NO in relation to the instantly claimed method. Furthermore, there is no RNA species that are shorter or longer than the 20-mer of SEQ ID NO:219 having the claimed function of inactivating the mutant Rho allele while the other Rho allele having no mutation “remains intact.” As of the filing date sought in the instant case, guide RNAs of at least 20 nucleotides in length with the maximum length of 23 when the PAM sequence is NNGRRT were used for genome editing methods in mutant cells comprising mutant Rho alleles as evidenced by Burnight et al. (Molecular Therapy, 2017, 25:1999-2013, of record). See Table 2. Indeed, it is later reported in the art, after the filing date sought in the instant case, that gene editing efficiency is highly dependent on the length of the guide RNAs especially when tested in cells comprising a mutant Rho allele such that a 20-mer provided 89% editing efficiency in P23H mutant Rho cells, whereas a 19-mer provided 10.6% editing efficiency in P23H mutant Rho cells. See Figure 10 of Kantardzhieva et al. (US 2019/0153441 A1). Note that the post-filing reference by Kantardzhieva reflects the lack of prior art knowledge pertaining to using an RNA that is shorter than 20 nucleotides in length for genome editing in cells containing mutant alleles.
In the instant case, there is no teaching/evidence that crRNAs other than the 20-mer sequence of SEQ ID NO:219 provide the claimed end result of inactivating only the mutant Rho allele in an isolated human cell containing both the mutant Rho allele and the wild-type Rho allele, wherein the mutant Rho allele comprises ADRP-causing mutations downstream of exon 1.
Now, it is noted that the term/phrase “downstream of Exon 1” encompasses any genome location of the Rho allele that is 3’ to exon 1, thereby encompassing any and all locations (e.g., intron 1, exon 2, intron 2, exon 3, intron 3, exon 4, intron 4, exon 5), except exon 1 and any positions preceding exon 1. Hence, the isolated human cell that has been treated with SEQ ID NO:219 in the instantly claimed method comprises a wild-type, functional Rho allele without any ADRP-causing mutations and a mutant Rho allele that has mutation(s) anywhere 3’ to exon 1 of the Rho gene, wherein the mutant Rho allele “is inactivated” by the treatment of SEQ ID NO:219, while the wild-type allele containing no RP-causing mutations “remains intact.” The instant specification provides no written description whatsoever pertaining to the instantly claimed method that is performed with all of the currently recited limitations including the “isolated human cell” having the two specific Rho alleles, wherein only the Rho allele containing mutation(s) anywhere 3’ to exon 1 of the Rho gene “is inactivated”. As noted in factor (A) above, the instant specification is completely devoid of any actual method performed using the claimed crRNA comprising 17-20 nucleotides of SEQ ID NO:219, which inactivates the Rho allele having RP-causing mutations in genomic sequences 3’ to exon 1 of the Rho gene in an isolated human cell. In fact, the specification is so deficient to the extent that SEQ ID NO:219 is not even described to be associated with the Rho allele that is claimed to be “inactivated”, wherein the allele is required to comprises ADRP-causing mutations in genomic sequences 3’ to exon 1 of the Rho gene. In addition, even if the claimed method were to pertain to inactivating the wild-type Rho allele in a cell by contacting the RNA comprising 17-20 nucleotides of SEQ ID NO:219 for the sake of argument, the specification fails to adequately describe the required structure-function correlation for an RNA sequence shorter or longer than SEQ ID NO:219, which is 20 nucleotides in length, which was the art-recognized RNA length used in the CRISPR/Cas-mediated genome editing as of the filing date sought in the instant case, which is November 28, 2017, as explained in detail above.
(D) level of skill and knowledge in the art
The instantly recited RNA molecule species of SEQ ID NO:219 is a 20-mer RNA sequence (5’-UUCUUGGGUGGGAGCAGCCA) that corresponds to and is homologous to a 20-mer fragment in exon 1 of Rho carrying the SNP rs7984 of “A” (see underlined), which is not associated with the pathogenic “His allele” that causes ADRP. See pages 2005 and 2008-2009 and Figure 4 of Burnight et al. (Molecular Therapy, 2017, 25:1999-2013, of record). It was not known in the prior art that SEQ ID NO:219 that is associated with the wild-type “Pro allele” inactivates exclusively and only the mutant Rho allele having mutations downstream of exon 1 (thus any genomic location beginning intron 1) without affecting the wild-type Rho allele, which thus “remains intact.” As such, relevant prior art knowledge pertaining to the claimed method was non-existent.
(E) predictability in the art
Since there is no relevant prior art pertaining to the claimed method, there would have been no predictability of success for practicing the claimed method. Moreover, since the instant specification provides no substantial useful disclosure/teaching pertaining to the claimed method, despite the complete lack of pertinent prior art knowledge pertaining to the method as now claimed, the predictability level pertaining to the claimed method is deemed non-existent.
See MPEP §2163 teaching that “there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed.” (emphasis added).
In view of the totality of factors (A)-(E) analyzed above, it is clear that the instant specification fails to reasonably convey that the instant co-inventors had possession of the method as now claimed as of the effective filing date.
Now, the new matter issue is discussed below.
The instant claims recite that “the isolated human cell is composed of one Rho allele that has at least one disease-causing mutation downstream of Exon 1 that causes or is associated with autosomal dominant retinitis pigmentosa and one Rho allele that does not have any mutations”, wherein SEQ ID NO:219 inactivates the mutant Rho allele while the Rho allele without any mutations “remains intact.” The instantly recited cell is not described in the instant specification, nor is the claimed method that uses the recited cell in which only the mutant Rho allele having mutations downstream of exon 1 is inactivated, whereas the wild-type Rho allele having no mutation is not affected by SEQ ID NO:219. Hence, claims 41, 44, 52, 54-57, and 63 as now written introduce new matter that is not adequately described in the specification as originally filed.
In the remarks filed on November 3, 2025, applicant points out paragraphs 0008, 0026, 0078, 0116, 0118, 0119, 0151, 0121, and Table 2 as providing support for the amended claims. Nowhere in any of the passages and Table 2 pointed out by applicant is the claimed method with all of limitations described/supported. The examiner is unable to understand how applicant is able to assert that the claimed method as currently amended is described “in such full, clear, concise, and exact terms” as required by 35 U.S.C. 112(a) when the specification does not even contemplate using SEQ ID NO:219 that is explicitly described to pertain to a “wild type (REF) sequence” in the instantly claimed method of inactivating the mutant Rho allele comprising mutations downstream of exon 1, while the wild-type, functional Rho allele having no mutation should remain intact in the isolated human cells treated with SEQ ID NO:219 that is described as a guide sequence designed to target the “wild type (REF) sequence” that is associated with rs7984 SNP located in exon 1. Applicant argues, without any objective, factual, scientific evidence, that “Targeting rs7984 would thus be recognized as preferable to targeting rs2269736.” In addition, the examiner is unable to understand how this mere assertion without objective, factual evidence possibly supports that the instant specification itself demonstrates that the instant co-inventors had possession of the instantly claimed method as of the filing date sought in the instant case.
Regarding the newly added claim, claim 63, applicant argues that the frequency of rs7984 is “56.8% globally,” by pointing out an NCBI web address, which is not disclosed or incorporated by reference in the instant specification. Applicant also points out paragraph 0121 as providing support for claim 63. Applicant’s attention is directed to the fact that paragraph 0121 pertains to SNP that “is a disease-associated mutation” that is highly prevalent in a population. Indeed, the claims as previously amended on April 18, 2025 correctly recited the disclosure in paragraph 0121 such that “The mutant Rho allele has an SNP that is highly prevalent in the population while the functional Rho allele does not have that SNP”. Applicant’s attempts to piece together the disclosure pertaining to highly prevalent, disease-associated mutant SNPs in paragraph 0121 with the undisclosed NCBI web address are a far cry from showing that the instant specification as originally filed adequately supports that the instant co-inventors knew and contemplated the subject matter of claim 63 at the time the instant specification was originally filed or as of the filing date sought in the instant application.
In view of the foregoing, claims 41, 44, 52, 54-57, and 63 introduces new matter that is not supported and described by the instant specification in the manner required by 35 U.S.C. 112(a).
Claims 41, 44, 52, 54-57, and 63 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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.
The instant claims as amended now require that the Rho allele comprising ADRP-causing mutations downstream of exon 1 of the Rho gene “is inactivated” by SEQ ID NO:219, while the wild-type having no mutation is unaffected in an isolated human cell comprising the Rho allele that is to be inactivated and the wild-type allele.
As amply explained in detail in the written description rejection above, neither the prior art nor the instant specification teaches the method as now claimed. That is, the instant specification contains no enabling disclosure (e.g., actual working example) pertaining to the claimed method with all of recited method steps/materials. Further, there was no predictability pertaining to the claimed method in view of the complete lack of relevant prior art knowledge and the complete lack of an enabling disclosure in the instant specification. Hence, an undue amount of experimentation would be necessary for one of ordinary skill having no relevant knowledge and having no appropriate guidance commensurate in scope with the claims to practice the method as now claimed.
It is noted that applicant previously submitted “EXHIBIT 1” on October 24, 2022 showing % editing in fibroblasts and U2OS cell lines transfected with SEQ ID NO:219 and SpCas9, wherein “EXHIBIT 1” contains a statement that “SEQ ID NO: 219 has high activity at the rs7984 SNP position in both fibroblast and U2OS cell lines.”
The aforementioned “EXHIBIT 1” of record is far from enabling the claimed method as now written because there is no disclosure that “both fibroblast and U2OS cell lines” comprise the two specifically required Rho alleles as now claimed: one mutant Rho allele having ADRP-causing mutations “downstream of Exon 1” and one wild-type Rho allele without any mutation.
Most importantly, the aforementioned “EXHIBIT 1” of record contains no objective, factual evidence that SEQ ID NO:219 delivered to an isolated human cell inactivates the mutant Rho allele having ADRP-causing mutations “downstream of Exon 1” without affecting the wild-type Rho allele having no mutation. That is, there is no experimental showing that SEQ ID NO:219 has the expressly required differential function for the two different alleles required to be present in the instantly claimed isolated human cell.
In view of the foregoing, it is concluded that the instant specification fails to provide an enabling disclosure commensurate in scope with the claims as currently amended.
In the remarks filed on November 3, 2025, applicant merely states that “SEQ ID NO:219 can be used to selectively inactivate a Rho allele having mutations downstream of the target for SEQ ID NO:219.” (emphasis added). In response, it is noted that applicant’s mere assertion without any objective, factual evidence is not sufficient to support that the instantly claimed method that contradicts the prior art knowledge is fully enabled. That is, applicant’s speculative mere possibility that SEQ ID NO:219 “can be used” in the claimed method without any factual evidence is far from enabling the claimed method.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 41, 44, 52, 54-57, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Burnight et al. (Molecular Therapy, 2017, 25:1999-2013, of record) in view of GenBank NCBI Reference Sequence number NM_000539.2 (February 2008).
Solely in the interest of compact prosecution, the instant claims are interpreted as being drawn to a method of inactivating a Rho allele containing the “A” base at the rs7984 SNP without affecting the Rho allele containing the “G” base at the rs7984 SNP in a cell comprising contacting the cell with SEQ ID NO:219 in view of the multiple issues under 35 U.S.C. 112(b) and 112(a) as set forth hereinabove. That is, the claims as currently written are deemed so indefinite and inoperable especially in view of the complete lack of sufficient support in the specification.
Burnight discloses a method of using “[C]ontrol guides targeting the Pro allele” of the Rho gene. See page 2005.
Burnight teaches that one can “test allele-specific targeting in patient cells”, wherein the cells of the autosomal dominant retinitis pigmentosa patient contains “the His allele”. See page 2005.
Burnight teaches that 20-mer guide RNAs are designed by identifying the PAM sequence, which is “NGG” for S. pyogenes Cas9 and NNGRRT for S. aureus Cas9. See page 2005.
Burnight discloses a partial nucleotide sequence of Pro allele (P23) having “A” at rs7984 SNP, which is followed by the “NGG” PAM sequence for SpCas9. See the following portion of Figure 4I, wherein “CGG” corresponding to the “NGG” PAM sequence is boxed.
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Burnight does not disclose the Rho nucleotide sequence upstream of what is shown above. However, the Rho nucleotide sequence was already publicly available in the art as evidenced by the GenBank Number NM_000539.2.
It would have been obvious to one of ordinary skill in the art before the effective filing date to target the wild-type, non-disease-associated rs7984 SNP in the Rho “Pro allele” in a human cell comprising both the “Pro allele” and the “His allele” in vitro with SpCas9 and a 20-mer gRNA of 5’-UUCUUGGGUGGGAGCAGCCA. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to test “Pro allele”-specific targeting in human cells comprising both alleles because it was an art-recognized goal to
“test allele-specific targeting in patient cells” as taught by Burnight, who also taught use of guide RNAs “targeting the Pro allele” as well as 20-mer guide RNA designs when SpCas9 is used. Since a nucleotide sequence pertaining to the rs7984 SNP in the “Pro allele” was known in the art as evidenced by Burnight and the GenBank Number NM_000539.2, and since one of ordinary skill in the art was equipped with the skills to clearly identify the “NGG” PAM sequence pertaining to the rs7984 SNP in the “Pro allele”, one of ordinary skill in the art would have had a reasonable expectation of success in identifying the “CGG” PAM sequence as well as the preceding 20-mer sequence as shown below in relation to the sequence information disclosed in the GenBank Number NM_000539.2, wherein the “CGG” PAM is boxed and the 20-mer sequence is underlined.
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Accordingly, one of ordinary skill in the art would have had a reasonable expectation of success in obtaining SEQ ID NO:219 and using SEQ ID NO:219 in a human cell comprising both Pro and His alleles, thereby testing the Pro-allele-specific inactivation by the 20-mer guide RNA pertaining to the rs7984 SNP associated with the wild-type Pro allele of the Rho gene.
In view of the foregoing, claims 41, 44, 52, 54-57, and 63 as interpreted above, which is the only possible way to use SEQ ID NO:219, would have been prima facie obvious before the effective filing date.
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 41, 44, 52, 54-57, and 63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 and 17-19 of copending Application No. 17/428,253 in view of Burnight et al. (Molecular Therapy, 2017, 25:1999-2013, of record) in view of GenBank NCBI Reference Sequence number NM_000539.2 (February 2008).
Solely in the interest of compact prosecution, the instant claims are interpreted as being drawn to a method of inactivating a Rho allele containing the “A” base at the rs7984 SNP without affecting the Rho allele containing the “G” base at the rs7984 SNP in a cell comprising contacting the cell with SEQ ID NO:219 in view of the multiple issues under 35 U.S.C. 112(b) and 112(a) as set forth hereinabove. That is, the claims as currently written are deemed so indefinite and inoperable especially in view of the complete lack of sufficient support in the specification.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are encompassed by and rendered obvious by the ‘253 claims drawn to a method of editing “Rhodopsin” in a mammalian cell comprising contacting the cell with a CRISPR/SpCas9 system. Note that the reference claims in the ‘253 application are not directed to editing mutant or pathogenic “Rhodopsin”.
It would have been obvious to edit a wild-type Rhodopsin allele in a mammalian cell comprising the wild-type allele and a mutant allele by contacting the cell with SEQ ID NO:219 because it was an art-recognized goal to “test allele-specific targeting in patient cells” as taught by Burnight and because one of ordinary skill in the art was equipped with knowledge and skills necessary to obtain SEQ ID NO:219 when targeting the rs7984 SNP of the wild-type allele in view of the nucleotide sequence information and the guide RNA identification methodologies known in the art as taught by the GenBank information and Burnight for the same reasons explained in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Conclusion
No claim is allowed.
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/DANA H SHIN/Primary Examiner, Art Unit 1635