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
Applicant’s election without traverse of claims 21-22, 24, 29, 31-32, 35, and 40-42 in the reply filed on 10 June 2026 is acknowledged.
Claims 1-2, 4, 6-7, 12, 15, and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 June 2026.
Newly submitted claims 44 and 45, added in the amendment to the claims filed 10 June 2026, are directed to an invention that lacks unity with the invention elected in the reply filed 10 June 2026. The shared technical feature of the elected invention of claims 21-22, 24, 29, 31-32, 35, and 40-42 and newly submitted claims 44 and 45 is a system comprising an RNA-guided DNA binding protein or functional fragment thereof and a guide RNA configured to at least partially hybridize to a circulating free DNA of interest. This shared technical feature is not a special technical feature for the same reason described in the Requirement for Restriction mailed 15 April 2026 that Groups I and II lacked unity of invention because they shared the same technical feature. As the shared technical feature is not a special technical feature, newly submitted claims 44 and 45 lack unity of invention with the elected invention.
Accordingly, claims 44 and 45 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 3 June 2024 is/are considered, initialed, and attached hereto.
Claim Status
Claims 1-2, 4, 6-7, 12, 15, 18, 21-22, 24, 29, 31-32, 35, 40-42, and 44-45 are pending.
Claims 3, 5, 8-11, 13-14, 16-17, 19-20, 23, 25-28, 30, 33-34, 36-39, and 43 are canceled.
Claims 1-2, 4, 6-7, 12, 15, and 18 are withdrawn without traverse.
Claims 44-45 are withdrawn as being directed to an unelected invention (see Election/Restrictions section above).
Claims 21-22, 24, 29, 31-32, 35, and 40-42 are under examination.
Specification
The use of terms including, but not limited to, µ-slide, Platinum, and cutSmart, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 41 is objected to because of the following informalities: "fee" on line 2 should be spelled "free". Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 31 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 31 recites the limitation "the gRNA" in line 1. There is insufficient antecedent basis for this limitation in the claim. This limitation is interpreted as referring to the “guide RNA” recited in line 4 of claim 21 upon which claim 31 depends.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-22, 24, 31-32, 35, 40, and 42 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Shuber et al. (US 2018/0356410, published 13 December 2018, effectively filed 13 June 2017), herein Shuber.
Regarding claim 21, Shuber teaches a system for capturing circulating free DNA from a biological sample of a subject (“The method includes protecting a segment of a nucleic acid in a sample” [0011] method 101 of FIG. 1; “the sample includes plasma from the subject and the segment is circulating tumor DNA (ctDNA)” [0014]) comprising: an RNA-guided DNA binding protein, or a functional fragment thereof; and a guide RNA configured to at least partially hybridize to a circulating free DNA of interest (“Cas endonuclease/guide RNA complexes that bind to targets that flank a boundary of a genomic alteration, digesting unprotected nucleic acid, and detecting the segment” [0011]).
Regarding claim 22, Shuber teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Shuber above), further comprising a flow cell or fluidic chamber (“The method 101 may be performed in fluid partitions, such as in droplets on a microfluidic device” [0041]).
Regarding claim 24, Shuber teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Shuber above), further comprising a solid surface (“microfluidic device” [0041], microfluidic devices inherently comprise solid surfaces, such as tubing and walls that constrain the fluids).
Regarding claim 31, Shuber teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Shuber above), wherein the gRNA is bound to the RNA-guided DNA binding protein (“Cas endonuclease/guide RNA complexes” [0011]).
Regarding claim 32, Shuber teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Shuber above), wherein the RNA-guided DNA binding protein is a CRISPR-associated (Cas) protein (“Cas endonuclease” [0011]).
Regarding claim 35, Shuber teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Shuber above), wherein the circulating free DNA is microbial DNA or circulating tumor DNA (“the segment is circulating tumor DNA (ctDNA)” [0014]).
Regarding claim 40, Shuber teaches a device comprising at least one system as in claim 21 (“The method 101 may be performed in fluid partitions, such as in droplets on a microfluidic device” [0041], the microfluidic devices comprises the system that is taught by the method as discussed regarding claim 21).
Regarding claim 42, Shuber teaches a kit comprising at least one system as in claim 21 (“The kit 901 may include reagents 903 for performing the steps described herein. For example, the reagents 903 may include one or more of a Cas endonuclease 909, a guide RNA 927” [0059]).
Therefore, claims 21-22, 24, 31-32, 35, 40, and 42 are anticipated by Shuber.
Claims 21, 24, 29, 31-32, 35, 40, and 42 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Walter et al. (US 2019/0048415, published 14 February 2019, effectively filed 10 February 2016), herein Walter.
Regarding claim 21, Walter teaches a system for capturing circulating free DNA from a biological sample of a subject (“systems for the detection and quantification of a target nucleic acid” [0181]; “A biological sample may be provided by removing a sample of cells from a subject” [0081]; “diagnosis of cancer from circulating tumor DNA and lncRNA in human blood serum” [0011]) comprising: an RNA-guided DNA binding protein (“Systems according to the technology comprise […] dCas9” [0181]), or a functional fragment thereof; and a guide RNA configured to at least partially hybridize to a circulating free DNA of interest (“Systems according to the technology comprise […] gRNA” [0181]; “diagnosis of cancer from circulating tumor DNA and lncRNA in human blood serum” [0011]; see also FIG. 3).
Regarding claim 24, Walter teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Walter above), further comprising a solid surface (“Systems according to the technology comprise, e.g., a solid support” [0181]; FIG. 3).
Regarding claim 29, Walter teaches the system of claim 24 (see 35 U.S.C. 102 rejection of claim 24 over Walter above), wherein the RNA-guided DNA binding protein is linked to the solid surface (“In some embodiments, the dCas9/gRNA complex is attached or fixed to a solid support” [0092]; FIG. 3).
Regarding claim 31, Walter teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Walter above), wherein the gRNA is bound to the RNA-guided DNA binding protein (“a dCas9/gRNA” [0181]; “dsCas9/gRNA complex” [0010]; FIG. 3).
Regarding claim 32, Walter teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Walter above), wherein the RNA-guided DNA binding protein is a CRISPR-associated (Cas) protein (“dCas9” [0181]).
Regarding claim 35, Walter teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Walter above), wherein the circulating free DNA is microbial DNA or circulating tumor DNA (“diagnosis of cancer from circulating tumor DNA and lncRNA in human blood serum” [0011]).
Regarding claim 40, Walter teaches a device comprising at least one system as in claim 21 (“In some embodiments, the dCas9/gRNA complex is attached or fixed to a solid support” [0092]; FIG. 3; as no particular limiting definition of the term “device” is provided in the instant specification, the term is given its broadest reasonable interpretation of including any tool or entity with a use, so the solid support with immobilized dCas9/gRNA complex is considered a device as it is an entity with the use of detecting nucleic acids that at least partially hybridize to the gRNA, such as the genomic DNA in FIG. 3 and the circulating tumor DNA recited in [0011]).
Regarding claim 42, Walter teaches a kit comprising at least one system as in claim 21 (“kits for the detection of a nucleic acid. For instance, in some embodiments are provided a kit comprising a solid support (e.g., a microscope slide, a bead, a coverslip, an avidin (e.g., streptavidin)-conjugated microscope slide or coverslip, a solid support comprising a zero mode waveguide array, or the like), a dCas9/gRNA” [0181]).
Therefore, claims 21, 24, 29, 31-32, 35, 40, and 42 are anticipated by Walter.
Claims 21-22, 24, and 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aalipour et al. (Nonpatent Literature Document Cite No 2 in IDS filed 3 June 2024)(“Deactivated CRISPR Associated Protein 9 for Minor-Allele Enrichment in Cell-Free DNA” Clin Chem 64(2), pages 307-316 (2018)), herein Aalipour.
Regarding claim 21, Aalipour teaches a system for capturing circulating free DNA from a biological sample of a subject (“dCas9 enrichment on adaptor ligated patient-derived amplicons from a cohort of 18 cfDNA samples from patients with NSCLC” page 313 right column paragraph 2, cfDNA is cell free DNA and equivalent to circulating free DNA) comprising: an RNA-guided DNA binding protein, or a functional fragment thereof; and a guide RNA configured to at least partially hybridize to a circulating free DNA of interest (“Recombinant 6x-His Tag conjugated dCas9 protein can be complexed with sgRNAs targeting mutations of interest” Figure 1 Legend; Figure 1).
Regarding claim 22, Aalipour teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Aalipour above), further comprising a flow cell or fluidic chamber (“dCas9-sgRNA complexes were formed by mixing designed sgRNAs and 6x His-tag-labeled recombinant dCas9 protein at a 5:1 ratio and incubating on ice for 15 min. Complexes were then incubated at a final concentration of 40 nmol/L or 200 nmol/L” page 309 left column paragraph 2, teaching that it the complexes are in liquid; Figure 1A, the tube depicted containing sample DNA and dCas9 complexes is thus a fluidic chamber).
Regarding claim 24, Aalipour teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Aalipour above), further comprising a solid surface (Figure 1A, the tube depicted is a solid surface).
Regarding claim 31, Aalipour teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Aalipour above), wherein the gRNA is bound to the RNA-guided DNA binding protein (“dCas9-sgRNA complexes were formed” page 309 left column paragraph 2).
Regarding claim 32, Aalipour teaches the system of claim 21 (see 35 U.S.C. 102 rejection of claim 21 over Aalipour above), wherein the RNA-guided DNA binding protein is a CRISPR-associated (Cas) protein (“dCas9” page 309 left column paragraph 2; Figure 1).
Therefore, claims 21-22, 24, and 31-32 are anticipated by Aalipour.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 29 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Aalipour et al. (Nonpatent Literature Document Cite No 2 in IDS filed 3 June 2024)(“Deactivated CRISPR Associated Protein 9 for Minor-Allele Enrichment in Cell-Free DNA” Clin Chem 64(2), pages 307-316 (2018)), herein Aalipour, as applied to claims 21-22, 24, and 31-32 above, in view of Church et al. (US 2018/0320226, published 8 November 2018, effectively filed 19 August 2014), herein Church.
Regarding claim 29, Aalipour teaches the system of claim 24 (see 35 U.S.C. 102 rejection of claim 24 over Aalipour). However, Aalipour does not teach the system wherein the RNA-guided DNA binding protein is linked to the solid surface.
Regarding claim 29, Church teaches a similar system comprising Cas9-gRNA complexes attached to a surface that capture DNA that has a complementary portion to the gRNA when the DNA passes by the complexes (Figure 5A; “FIG. 5A is directed to a Cas9-gRNA complex being attached to a surface of a lateral flow test system. A population of DNA being investigated is loaded on the system and lateral flow displaces it to the Test Zone where the target-specific Cas9-gRNA binds to specific DNA. The rest of the DNA keeps flowing through the end of the assay and is capture by the Control Zone, while the target DNA stay bound to the Cas9-gRNA complex at the Test Zone” [0214]).
Regarding claim 40, Church teaches a device comprising Cas9-gRNA complexes immobilized on a surface that captures DNA that has a complementary portion to the gRNA when the DNA passes by the complexes (Figure 5A; “FIG. 5A is directed to a Cas9-gRNA complex being attached to a surface of a lateral flow test system. A population of DNA being investigated is loaded on the system and lateral flow displaces it to the Test Zone where the target-specific Cas9-gRNA binds to specific DNA. The rest of the DNA keeps flowing through the end of the assay and is capture by the Control Zone, while the target DNA stay bound to the Cas9-gRNA complex at the Test Zone” [0214]). Though Church does not teach that the target DNA is circulating free DNA and Aalipour teaches the system of claim 21 but does not teach a device comprising their system (see 35 U.S.C. 102 rejection of claim 21 over Aalipour), they otherwise teach similar systems where target DNA is captured by a Cas9/gRNA complex wherein the gRNA partially hybridizes to the target DNA and make up for each other’s deficiencies. Therefore, the combination of Aalipour and Church teaches a device comprising at least one system as in claim 21.
Regarding claim 41, the combination of Aalipour and Church teach the device of claim 40 as described above, and Aalipour further teaches multiplexing by simultaneously using two or more systems, wherein each system comprises a gRNA configured to hybridize to a different circulating free DNA of interest (“We performed multiplexed enrichment with use of the optimal concentration mixture determined previously (200 nmol/L ELREA dCas9, 40 nmol/L T790M dCas9, 200 nmol/L L858R dCas9)” page 313 right column paragraph 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the simple substitution of the cfDNA target taught in the system of Aalipour for the less specific DNA target in the system of Church (MPEP §2143 I. B.). Furthermore, one of ordinary skill in the art would be motivated to combine the teachings of Aalipour and Church because Aalipour teaches that their system is directed to the technical problem of detecting mutations in cell-free DNA (“detection of low allele frequence (AF) mutations in the cell-free DNA (cfDNA) of patients with cancer” Aalipour 307 right column paragraph 2) and Church teaches a convenient approach to solving the problem by applying a similar system to lateral flow assays that can be diagnostic assays (“In some embodiments, the assay is carried out as part of a lateral flow assay, a dipstick assay, a paper microfluidics assay, a dot blot assay a microarray assay. In some embodiments, the assay is a diagnostic assay” Church [0121]) (MPEP §2143. I. G.). One of ordinary skill in the art could have performed this substitution and would have found the results of this substitution predictable because both Aalipour and Church are in the same field of endeavor of capturing target DNA using a Cas9/gRNA complex and changing the target would not be expected to prevent the system from functioning. Therefore, the invention as a whole of claims 29 and 40-41 would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
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 21-22, 24, 29, 31-32, and 40-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 19-20, 26, and 31 of copending Application No. 19/115,078, herein ‘078. Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claims 21-24, claim 20 of ‘078 claims a system with the same limitations in either identical or equivalent language (the “channel fluidically connecting” in claim 20 of ‘078 is a species of fluidic chamber). Though claim 20 of ‘078 requires additional limitations, as it meets all limitations of instant claims 21-24 it anticipates instant claims 21-24.
Regarding instant claim 31, claim 20 of ‘078 recites an equivalent limitation (“one or more guide RNAs […] optionally bound to the plurality of RNA-guided DNA binding proteins or functional fragment thereof”), but the limitation in claim 20 of ‘078 is recited as being optional and therefore does not restrict its scope. However, as the limitation is explicitly states as an option, it would be immediately apparent to one of ordinary skill in the art that the system of instant claim 31 is an obvious variation of claim 20 of ‘078.
Regarding instant claim 29, claim 26 of ‘078 claims the plurality of RNA-guided DNA binding proteins being linked to a solid surface (both the magnetic particle and location on the interior surfaces of the channel as recited in claim 26 of ‘078). Though claim 26 of ‘078 requires additional limitations, as it meets all limitations of instant claim 29 it anticipates instant claim 29.
Regarding instant claim 32, claim 31 of ‘078 recites identical language. Though claim 31 of ‘078 requires additional limitations via its dependency on claim 20, as it meets all limitations of instant claim 32 it anticipates instant claim 32.
Regarding instant claim 40, claim 1 of ‘078 claims a device with the same limitations in identical or equivalent language. Though claim 1 of ‘078 requires additional limitations, as it meets all limitations of instant claim 40 it anticipates instant claim 40.
Regarding instant claim 41, claim 19 of ‘078 claims a device with the same limitations in identical or equivalent language. Though claim 19 of ‘078 requires additional limitations via its dependency on claim 1, as it meets all limitations of instant claim 41 it anticipates instant claim 41.
Therefore, instant claims 21-22, 24, 29, 31-32, and 40-41 are not patentably distinct from claims 1, 19-20, 26, and 31 of ‘078.
Claims 35 and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of copending Application No. 19/115,078, herein ‘078, in view of Shuber et al. (US 2018/0356410, published 13 December 2018, effectively filed 13 June 2017), herein Shuber.
This is a provisional nonstatutory double patenting rejection.
Regarding instant claim 35, claim 20 of ‘078 anticipates the system of instant claim 21 as discussed in the double patenting rejection of instant claim 21 above. However, claim 20 of ‘078 does not recite the circulating free DNA being microbial DNA or circulating tumor DNA. This deficiency is made up for in the teachings of Shuber.
Regarding instant claim 35, Shuber teaches a similar system to claim 20 of ‘078 of isolating target DNA using gRNA that partially hybridizes to the target DNA and an RNA-guided DNA binding protein (“Cas endonuclease/guide RNA complexes that bind to targets that flank a boundary of a genomic alteration, digesting unprotected nucleic acid, and detecting the segment” [0011]). Shuber also teaches that the target DNA may specifically be circulating tumor DNA (“may be used to detect and describe mutations and/or alterations in circulating tumor DNA in a blood or plasma sample” [0010]).
Regarding instant claim 42, Shuber teaches a kit comprising the system (“The kit 901 may include reagents 903 for performing the steps described herein [0059]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the simple substitution of circulating tumor DNA as the target DNA in the system taught by Shuber for the more generically recited cfDNA of interest in claim 20 of ‘078 (MPEP §2143 I. B.). One of ordinary skill in the art could have performed this substitution and would have found the results of this substitution predictable because both are concerned with the same field of endeavor of capturing DNA using Cas9/gRNA complexes and the use of a specific type of DNA would as the DNA of interest would not be expected to prevent the system from functioning. Therefore, the invention as a whole of instant claims 35 and 42 would have been prima facie obvious variants of the claimed system of claim 20 of ‘078 to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Salk et al. (US 2021/0010065, published 14 January 2021, effectively filed 15 March 2018) teaches systems similar to those of Shuber et al.
Lo et al. (US 2022/0328135, effectively filed 12 April 2021) teaches a system for enriching targeted long DNA molecules from cell-free DNA using dCas9/sgRNA complexes.
Conclusion
Claims 21-22, 24, 29, 31-32, 35, and 40-42 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey Lawrence Bellah whose telephone number is (571)272-1024. The examiner can normally be reached M-Th, 7:30-5 ET.
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/JEFFREY BELLAH/Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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