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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/08/2026 has been entered. Applicant indicates on the Request for Continued Examination (RCE) Transmittal, that the response of 6/08/2026 be considered.
Claim status
Claims 1-12 are under examination.
Withdrawn Objection to Drawings
Sequence Compliance
The prior objection to Figure 1 of the Specification as not conforming to sequence rules, is withdrawn in light of Applicant’s amendment sequence listing filed 6/10/2026.
Claims Previously Indicated as Overcoming Rejections - 35 USC § 112(a)
The indication that the amended claims overcame the prior rejections as failing to comply with the written description and enablement requirements has been reconsidered. Rejection(s) based on the reconsideration follow.
New Claim Rejections - 35 USC § 112(a)
(Written Description)
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 1-12 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 encompasses a genus of Neisseria meningitidis single guide RNAs (Nme sgRNA) comprising a truncated Stem 2 region of 24 nucleotides relative to the full-length Nme sgRNA of SEQ ID NO:219, and a truncated repeat:anti-repeat regions relative the full-length Nme sgRNA of SEQ ID NO:219, while the specification describes a limited number of functional Nme sgRNA species comprising a specific truncated Stem 2 region of 24 nucleotides encoded by nucleic acid residues 78-101 of SEQ ID NO:220, combined with a specific truncated repeat:anti-repeat region encoded by nucleic acid residues 25-52 of SEQ ID NO:220, combined with a specific spacer length of 23 or 24 nucleotides.
Dependent claim 2 encompasses a genus of Nme sgRNA comprising a truncated Stem 2 region of 24 nucleotides corresponding to nucleic acid residues 78-101 of SEQ ID NO:220, while Applicant’s specification describes a limited number functional Nme sgRNA species comprising the truncated Stem 2 region of 24 nucleotides encoded by nucleic acid residues 78-101 of SEQ ID NO:220, which is combined with a specific truncated repeat:anti-repeat region encoded by nucleic acid residues 25-52 of SEQ ID NO:220 and combined with a specific spacer length of 23 or 24 nucleotides.
Dependent claim 3 encompasses a genus of Nme sgRNAs that are 101 nucleotides, while Applicant’s specification describes a single functional Nme sgRNA encoded by residues 1-101 of SEQ ID NO:220.
Dependent claims 4 and 5 encompass a genus of Nme sgRNAs from Nme1 or Nme2, while Applicant’s specification describes a limited genus of Nme1 sgRNA.
Dependent claims 6-8 encompass a genus of Nme sgRNA comprising a truncated repeat:antirepeat region corresponding to nucleic acid residues 25-76 of SEQ ID NO:219, while Applicant’s specification describes a limited number of Nme sgRNA comprising a truncated repeat:antirepeat region encoded by residues 25-52 of SEQ ID NO:220 with a length of 28 nucleotides.
Dependent claim 9 encompasses a genus of Nme sgRNAs that comprise a spacer of 24 nucleotides, while Applicant’s specification describes a limited number functional Nme sgRNA species comprising a spacer of 24 nucleotides combined with a specific truncated Stem 2 region of 24 nucleotides encoded by nucleic acid residues 78-101 of SEQ ID NO:220, which is combined with a specific truncated repeat:anti-repeat region encoded by nucleic acid residues 25-52 of SEQ ID NO:220.
Dependent claims 10-12 encompass a genus of Nme sgRNAs comprising modified nucleic acid residues.
Under the written description guidelines (see MPEP 2163) the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
ACTUAL REDUCTION TO PRACTICE
In regard to claim 1 encompassing a genus of hundreds of Nme sgRNA comprising a truncated Stem 2 region of 24 nucleotides relative to the full length SEQ ID NO:219 of 42 nucleotides, the specification provides a limited number functional Nme sgRNA comprising truncated Stem 2 region of 24 nucleotides. Specifically, the specification discloses SEQ ID NO:220, which comprises the following features with respect to the spacer, repeat:anti-repeat duplex, stem 1, and stem 2 (from Fig. 3):
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Applicant demonstrates that the 101 nucleotide long SEQ ID NO:220 encodes a functional sgRNA, which comprises a truncated stem 2 region encoded by nucleotides 78-101 of SEQ ID NO: 220, combined with a truncated repeat:anti-repeat region encoded by residues 25-52 of SEQ ID NO:220, combined with a spacer of 24 nucleotides. Furthermore, Applicant demonstrates that the spacer region of SEQ ID NO:220 (i.e., sgRNA #10) can be reduced from 24 nucleotides to 23 nucleotides (i.e., SEQ ID NO:221), and still retain function. Furthermore, Applicant demonstrates that a 3’ terminal “UA” dinucleotides can be included after the stem 2 region (i.e., SEQ ID NO:224), and still retain function.
However, all of the functioning Nme sgRNA described by the Applicant share the same specific truncated Stem 2 region of 24 nucleotides encoded by nucleic acid residues 78-101 of SEQ ID NO:220, combined with a specific truncated repeat:anti-repeat region encoded by nucleic acid residues 25-52 of SEQ ID NO:220, and combined with a specific spacer length of 23 or 24 nucleotides.
Moreover, Applicant does not describe any other Nme sgRNA that comprise a Stem 2 region of 24 nucleotides with a truncated repeat:anti-repeat relative to full-length SEQ ID NO:219.
Furthermore, Applicant demonstrates that further changes to the spacer region and/or Stem 2 region results in non-functional or poorly functioning Nme sgRNAs. Specifically, Fig. 2 demonstrates that the Nme sgRNA of SEQ ID NO:217 (i.e., sgRNA #9 comprising a Stem 2 region of 26 nucleotides) causes almost a 10-fold reduction in Nme sgRNA activity. Furthermore, Fig. 2 demonstrates that further changes to the spacer region to 20 nucleotides (i.e., sgRNA #6) cause over a 10-fold reduction in Nme sgRNA activity. Finally, Fig. 2 demonstrates that changes to the Stem 2 region to generate a stem loop of only 20 nucleotides (i.e., sgRNA #3) results in a non-functional Nme sgRNA.
In regard to dependent claim 2 encompassing a genus of Nme sgRNA comprising a truncated Stem 2 region of 24 nucleotides corresponding to nucleic acid residues 78-101 of SEQ ID NO:220, as stated supra, Applicant only describes the truncated Stem 2 region of 24 nucleotides encoded by nucleic acid residues 78-101 of SEQ ID NO:220, combined with a specific truncated repeat:anti-repeat region encoded by nucleic acid residues 25-52 of SEQ ID NO:220, and combined with a specific spacer length of 23 or 24 nucleotides..
In regard to dependent claim 3 encompassing a genus of Nme sgRNAs that are 101 nucleotides, as stated supra, Applicant’s specification describes a single functional Nme sgRNA encoded by residues 1-101 of SEQ ID NO:220.
In regard to dependent claims 4 and 5 encompassing a genus of Nme sgRNAs from Nme1 or Nme2, Applicant only describes functional Nme sgRNA that are of Nme1 Cas9.
In regard to dependent claims 6-8 encompassing a genus of Nme sgRNA comprising a truncated repeat:antirepeat region corresponding to nucleic acid residues 25-76 of SEQ ID NO:219, as stated supra, Applicant specification describes a limited number functional Nme sgRNA species comprising specific truncated repeat:anti-repeat region encoded by nucleic acid residues 25-52 of SEQ ID NO:220, combined with a specific truncated Stem 2 region of 24 nucleotides encoded by nucleic acid residues 78-101 of SEQ ID NO:220, which is combined with a spacer of 23 or 24 nucleotides
In regard to dependent claim 9 encompassing a genus of Nme sgRNAs that comprise a spacer of 24 nucleotides, as stated supra, Applicant specification describes a limited number functional Nme sgRNA species comprising a spacer of 24 nucleotides combined with a specific truncated Stem 2 region of 24 nucleotides encoded by nucleic acid residues 78-101 of SEQ ID NO:220, which is combined with a specific truncated repeat:anti-repeat region encoded by nucleic acid residues 25-52 of SEQ ID NO:220.
Dependent claims 10-12 encompassing a genus of Nme sgRNAs comprising modified nucleic acid residues, as stated supra, Applicant only describes a limited genus of functional Nme sgRNA.
Furthermore, the phrase “relative to a full-length sequence of SEQ ID NO: 219” is not a distinguishing identifying characteristic of the claimed Nme sgRNA as is simply a measure of sequence length (i.e., the length of the Stem 2 region of SEQ ID NO: 219 is 42 nucleotides, the length of the repeat:antirepeat region of SEQ ID NO:219 is 52 nucleotides, and the length of the spacer of SEQ ID NO:219 is 24 nucleotides). The breadth of this relative comparison allows hundreds of possible truncated stem 2 regions that are 24 nucleotides in length and hundreds of possible truncated repeat:antirepeat regions, thereby producing a combined genus of tens of thousands of possible Nme sgRNAs.
Accordingly, Applicant demonstrated by a reduction to practice to a limited number of functional Nme sgRNAs (e.g., SEQ ID NOs:220, 221, 224) comprising a comprising a specific truncated Stem 2 region of 24 nucleotides encoded by nucleic acid residues 78-101 of SEQ ID NO:220, combined with a specific truncated repeat:anti-repeat region encoded by nucleic acid residues 25-52 of SEQ ID NO:220, and combined with a specific spacer length of 23 or 24 nucleotides. Furthermore, Applicant did not adequately set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the thousands of Nme sgRNAs comprising any truncated Stem 2 region of 24 nucleotides, combined with any truncated repeat:anti-repeat region and combined with any spacer length.
DISCLOSURE OF STRUCTURE
The Applicant has provided limited genus of functional Nme sgRNA comprising truncated Stem 2 regions of 24 nucleotides and a truncated repeat:antirepeat region relative to SEQ ID NO:219. Certainly, with the help of an oligo synthesizer, a skilled artisan could eventually make the claimed genus of thousands of Nme sgRNAs. The wild-type full length Nme sgRNA of SEQ ID NO:219 was known in the prior art and was shown to be functional (see Fig. S1 of Hou et al., PNAS, 2013, 110:15644-15649, see IDS filed 12/13/2024).
However, the prior art is silent with respect to functional Nme sgRNAs comprising any truncated Stem 2 regions of 24 nucleotides combined with any truncated repeat:antirepeat region relative to the full-length SEQ ID NO:219. Furthermore, neither the specification nor the art indicate a relationship between the structure of the claimed genus of truncated sgRNA and the ability to make and use functional Nme sgRNA comprising any truncated Stem 2 regions of 24 nucleotides combined with any truncated repeat:antirepeat region relative to the full-length SEQ ID NO:219.
SUFFICIENT RELEVANT IDENTIFYING CHARACTERISTICS
The breadth of the claims encompass a genus of thousands of Nme sgRNAs comprising any truncated Stem 2 region of 24 nucleotides combined with any truncated repeat:antirepeat region relative to the full-length SEQ ID NO:219, yet the present specification provides no guidance nor description which manner to make the truncations in Stem 2 and repeat:antirepeat regions beyond residues 78-101 of SEQ ID NO:220 and residues 25-52 of SEQ ID NO:220, respectively, that would result in functional Nme sgRNA, therefore the skilled artisan would not know what rational approach to take to make the genus of thousands of truncated Nme sgRNA with any predictable outcome on their function. Therefore, it is incumbent on the Applicant to provide this nexus between structure and function, in order to be given credit for possession of the claimed genus of truncated Nme sgRNA.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
The method of making the claimed invention was not well established. Although truncated Nme sgRNA were known in the state of the art, one of skill in the art would neither expect nor predict the ability to generate functional Nme sgRNA according to the claimed genus of truncations.
At the time of filing, there was no prior art directed to generating functional Nme sgRNA comprising a truncated Stem 2 region of 24 nucleotides.
The closest prior art Lee et al. (Mol Ther, 2016, 24:645-654, see IDS filed 12/13/2024), teaches a Nme sgRNA[AltContent: textbox ([img-media_image2.png])] comprising a truncated stem 2 region of 38 nucleotides (relative to the full length stem 2 region of 42 nucleotides of SEQ ID NO:219) (see excerpt from Fig. 1b adjacent). Furthermore, the stem 2 truncation by Lee is a terminal truncation that is offset by an added polyU tract, and Lee provides no guidance for how to make a functional Nme sgRNA with a truncated stem 2 region of 24 nucleotides.
Furthermore, Lee teaches the Nme sgRNA further comprises a truncated repeat:antirepeat region of 40 nucleotides (relative to the full length repeat:antirepeat regions of 52 nucleotides of SEQ ID NO:219). However, this is a single specific repeat:antirepeat truncation that is combined with a specific stem 2 truncation to make a functional Nme sgRNA, and provides no guidance for how to make a functional Nme sgRNA with any truncated stem 2 region of 24 nucleotides and any truncated repeat:antirepeat relative to SEQ ID NO:219.
Furthermore, the prior art of Wolfe et al. (US2015/0191744, filed 12/16/2014, published 7/09/2015) demonstrates that a Nme sgRNA nearly identical to that of Lee (2016) comprising the same truncated Stem 2 and the same truncated repeat:anti-repeat duplex (i.e., nmsgRNAm3) but did not have the polyU tract on the 3’ end was unable to localize dCas9-GFP to the genomic DNA of a cell compared to the wild-type Nme sgRNA comprising SEQ ID NO:219 (see Fig. 15G). Thus, nearly identical Nme sgRNAs with the same truncated Stem 2 and repeat:anti-repeat regions did not predictably generate a functional Nme sgRNA.
Furthermore, the prior art of Church (US2015/0259684, published 9/17/2015, see IDS filed 12/13/2024) teaches making and using a Nme sgRNA, but explicitly teaches “the complete 3’tracrRNA sequence was always included, as truncations are known to be detrimental” (Example XVII, [0144]). Thus, any truncations involving the repeat region of the repeat:antirepeat region would have needed to be tested empirically to ensure functionality. Furthermore, in regard to truncating the repeat:anti-repeat region relative to other type II Cas9 crRNA, Church provides an alignment of the crRNA repeat regions from several Cas9 species (see Fig. 12A, excerpt below). However, as can be seen from the alignment, the Nme crRNA comprises less than 50% identity (17/36 nucleotides) with the better characterized S. pyogenes crRNA. Thus, these was no manner a priori for one to predict the effects of truncations in the repeat:antirepeat region by comparison with other Cas9 orthologues.
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Finally, the post-filing art by Applicant as published in Sun et al., (Mol Cell, 2019, 76:938-952, see IDS filed 12/13/2024) evidences that truncations of Stem 2 of the sgRNA were unpredictable with respect to their effects on Nme1 Cas9 activity. Sun evidences that “Nme1Cas9 makes extensive hydrogen-bond contacts and stacking interaction with the sgRNA” (p. 4, Results, 2nd para.), and that unlike most stem-loop 2 sgRNA nucleotides, the stem-loop 2 of the Nme sgRNA “is flipped out and stabilized by stacking by the side chains of the Nme1Cas9, wherein “truncation of stem-loop 2 reduced Nme1Cas9 activity, wherein the sgRNA lacking stem-loop 2 exhibited no activity” (p. 2, Results, 3rd para.). Thus, the prior art, Applicant’s specification and their post-filing work evidence that not just any truncation in the Nme sgRNA stem-loop 2 to just 24 nucleotides and not just any truncation in the repeat:antirepeat relative to SEQ ID NO:219 could predictably make a functional Nme sgRNA as broadly as claimed.
Applicant has claimed a genus of thousands of Nme sgRNA comprising any truncated Stem 2 region of 24 nucleotides and any truncated repeat:antirepeat regions relative to SEQ ID NO:219, yet the specification has disclosed only limited number of such truncated sgRNA, and has not set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of truncated Nme sgRNA. Furthermore, the state of the art indicated that making the claimed genus of truncated Nme sgRNA was not well established and would require undue experimentation to make and use these truncated Nme sgRNA as broadly as claimed, and one of skill in the art would neither expect nor predict making and using a truncated Nme sgRNA produced according to the claimed genus of thousands of truncated Nme sgRNA beyond those described as comprising the specific truncated Stem 2 region of 24 nucleotides encoded by nucleic acid residues 78-101 of SEQ ID NO:220, combined with the specific truncated repeat:anti-repeat region encoded by nucleic acid residues 25-52 of SEQ ID NO:220, and combined with a specific spacer length of 23 or 24 nucleotides.
CONCLUSION
Therefore, the Examiner concludes that there is insufficient written description of the instantly claimed genus of Nme sgRNA comprising any truncated Stem 2 region of 24 nucleotides and any truncated repeat:antirepeat region relative to full length SEQ ID NO:219. Specifically, there is limited description of the structure-function relationship between the claimed genus of truncations and their ability to produce a functional Nme sgRNA, and the Examiner further concludes a skilled artisan would find the specification inadequately describes the claimed genus of truncated Nme sgRNA.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 10/15/2025 directed to 112(a) issues of written description are again being acknowledged.
Applicant argues that the specification provides sufficient written description of the truncated sgRNA both by literal disclosures of the truncated regions, and by reductions to practice of sgRNA comprising the claimed truncated regions. In regard to the later, Applicant points to the 100 nt Nme sgRNA of construct #11 described in Fig. 2, as well as the sgRNAs of #11 and #13 described in Fig. 3, which perform with higher editing efficiency than the wt sgRNA as shown in Fig. 5. Furthermore, Applicant argues that the Examiner has acknowledged two functional sgRNA (i.e., those encoded by SEQ ID NOS:220 and 221), which are encompassed by instant claims and demonstrate Applicant was in possession of the broader genus of claimed Nme sgRNA.
Applicant's arguments have been fully considered but they are not persuasive.
As a first matter, in regard to the literal support for the claimed genus of truncated Nme sgRNA, as stated in the pending rejection the written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
In regard to Applicant’s descriptions of the functional truncated sgRNA, it must be noted that Figs 2-4 use a total of three sgRNA, which are all based on the truncated repeat:antirepeat and truncated stem 2 of SEQ ID NO:220. In other words, although SEQ ID NO:221 has a 23 nucleotide spacer compared to the 24 nucleotide spacer of SEQ ID NO:220, and although SEQ ID NO:224 comprises a 3’ terminal “UA” dinucleotides after the stem 2 region compared to flush 3’ terminus of SEQ ID NO:220, all of the functioning Nme sgRNA described by the Applicant share the same truncated repeat:antirepeat sequence and the same truncated stem 2 sequence as SEQ ID NO:220.
Thus, Applicant has claimed a broad genus of any truncated stem 2 region as long as it is 24 nucleotides and is “relative” to the wt sgRNA of SEQ ID NO:219. The breadth of this limitation allows hundreds of possible truncations given the wt sgRNA stem 2 region has 42 nucleotides in length. This genus of claimed stem 2 truncated sgRNA is further complicated by the hundreds of possible truncated repeat:antirepeat regions (which is 52 nucleotides in length in the wt sgRNA of SEQ ID NO:19), thereby producing a combined genus of tens of thousands of possible Nme sgRNAs. As stated in the pending rejection, lack of written description arises when a broad claim is presented but the disclosure only describes a narrow species with no evidence that Applicant was in possession of the broader genus of tens of thousands of species. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc).
New 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.
Claims 1-12 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 drawn to a truncated sgRNA sequence “relative to” a full-length sequence of SEQ ID NO: 219. The phrase “relative to” is not defined by the claim nor used anywhere in the specification to identify sgRNA sequences, and it is unclear if the sequence of the truncated sgRNA actually comprises the sequence of SEQ ID NO: 219 (or portion thereof) or if this phrase is simply a measure of sequence length (i.e., the length of the Stem 2 region of SEQ ID NO: 219 is 42 nucleotides). The instant claims lack clarity because the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement. In other words, claiming a sequence “relative to” another sequence raises doubts as to the actual content of the claimed sequence. Dependent claims 2-12 are included in the basis of the rejection because although they recite and encompass the truncated sgRNA of claim 1, they do not clarify the nature of the truncated Stem 2 region, truncated repeat anti-repeat region, nor spacer region relative to SEQ ID NO:219.
Claim 2 is drawn to the Nme sgRNA that comprises a region of SEQ ID NO:220, which is indefinite because SEQ ID NO:220 is a DNA sequence not an RNA sequence.
Maintained 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-12 stand provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claim 92 of copending Application No. 17/964,611. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the Nme sgRNA of cited application anticipates the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. Specifically, cited copending application claim 92 comprises a Nme sgRNA comprising a truncated Stem 2 region relative to SEQ ID NO:219, which is 24 nucleotides in length and with a truncated repeat:anti-repeat region relative to SEQ ID NO: 219 (e.g., copending SEQ ID NO:108). The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific to modified nucleosides. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 6/08/2026 are acknowledged.
Applicant argues that the provisional double patenting rejection is improper because cited application was filed after instant application.
Applicant's arguments have been fully considered but they are not persuasive.
In response to Applicant's argument, MPEP 804 (1)(b)(i) indicates a provisional double patenting rejection should be withdrawn when it is the only rejection remaining.
Claims 1-9 stand provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 58-72 of copending Application No. 18/612,111. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the AAV Nme sgRNA comprising a stem 2 region of 24 nucleotides relative to SEQ ID NO:219 (cited claims 58 and 66) and a truncated repeat:anti-repeat region relative to SEQ ID NO:219 (cited claims 68-60) of cited application anticipates the composition of instant application the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific with respect the sgRNA being in an AAV vector. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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