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 Group II (claims 22-26, 29-30, 35, and 45) in the reply filed on 7/15/2026 is acknowledged.
Applicant has canceled the claims drawn to other inventions, as well as claim 45, and has added claims 197-208, which all depend from claim 22. Thus, claims 22-26, 29-30, 35, and 197-208 are pending and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/12/2024, 3/26/2026, and 7/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: reference character 300 in para. 237 of the instant specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: The discussion of the figures in the instant specification does not appear to match the drawings provided. Figure 12 is referenced in para. 237, but no such figure is provided in the drawings. Additionally, the discussion of Figure 12 uses reference characters present in Figure 11, while the discussion of Figure 11 (para. 235) uses reference characters present in Figure 10. The discussion of Figure 10 (para. 231) also uses reference characters that appear in Figure 9. This section of the instant specification must be amended to clearly represent the figures provided in the drawings.
Appropriate correction is required.
Claim Objections
Claim 200 is objected to because of the following informality: in line 2, “a barcode of said barcode” should read “a barcode of said barcodes.” Appropriate correction is required.
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 25 and 204 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.
Claim 25 states “complexed with one or more plurality of nucleic acid binding proteins” in line 2. It is unclear if this should read “complexed with one or more nucleic acid binding proteins,” “complexed with a plurality of nucleic acid binding proteins,” or “complexed with one or more pluralities of nucleic acid binding proteins.” These options all have a slightly different scope in terms of the number and types of nucleic acid binding proteins required. As it is not clear which option is desired by Applicant, the scope of the claim is considered indefinite.
Claim 204 recites the limitation "said agent that binds to said dendrimer" in line 1. There is insufficient antecedent basis for this limitation in the claim, as no agent is recited earlier in the claim or in claims 202 and 22, from which this claim depends. Though the agent is stated to bind to the dendrimer, it is also generally unclear how it is to act in the method of claim 22 or in relation to the affinity tag of claim 202. Prior art will be considered to read on the claim if it recites streptavidin that is capable of binding (directly or indirectly) to a dendrimer.
Claim Interpretation
In para. 161 of the instant specification, it states, “The terms "connecting," "joining," and "ligation" as used herein, with respect to two polynucleotides, such as an adaptor oligonucleotide and a target polynucleotide, refers to the covalent attachment of two separate DNA segments to produce a single larger polynucleotide with a contiguous backbone.” There is no requirement when joining two polynucleotides that they be directly joined to one another, so long as a single continuous backbone is formed via covalent attachment. Thus, “joining” will be considered to read on both direct and indirect attachment of sequences to one another.
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.
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.
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 22-26, 29-30, 35, 197-201, and 205-208 are rejected under 35 U.S.C. 103 as being obvious over Munding et al. (US 2024/0084291 A1; cited in Applicant’s IDS).
The applied reference has a common Applicant and joint inventor with the instant application, though the inventive entity of the applied reference is as a whole different than that of the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Munding teaches methods for the generation of libraries from nucleic acid samples (Abstract). Para. 14 states that the method can involve a stabilized biological sample, where the sample comprises a nucleic acid molecule complexed to at least one binding protein (instant claim 25), contacting the nucleic acid molecule to a dendrimer to form a complex, and cleaving the nucleic acid molecule into a plurality of segments. The dendrimer can be conjugated with psoralen (para. 83; instant claims 26 and 199). The dendrimer can be PAMAM (para. 14; instant claim 201). Munding notes that the stabilized sample can be cross-linked nucleic or chromatin (para. 65; instant claims 23-24). The cleavage can be performed by DNase I, DNase II, micrococcal nuclease, a restriction endonuclease, or a combination thereof (para. 14; instant claim 30). After fragmentation, para. 14 then states that the cleaved segments can be attached at a junction. This attaching can be done via the use of a bridge oligonucleotide that contains a barcode sequence (para. 14; instant claims 35 and 197). Para. 96 notes that in the case where fragments contacted to dendrimers are barcoded, the fragments associated with a particular dendrimer can be barcoded in a partition, where the barcode is particular to the partition. Thus, the barcode would also be particular to a given dendrimer (instant claim 200). After the joining of the fragments, Munding teaches the obtaining of sequence information on each side of the junction, thus obtaining sequencing information for the plurality of fragments (para. 14; instant claim 198).
Para. 621 notes that a psoralen PAMAM dendrimer can have the psoralen conjugated to the end of each dendrimer polymer, and can be used to contact a nucleic acid sample. The nucleic acid sample is then fragmented. The fragments are then end treated and adapter ligated, and then the psoralen is removed.
Thus, though Munding does not specifically state that the fragmentation occurs between the contact points of the psoralen with the nucleic acid molecule, the ordinary artisan would recognize that this is what occurs in para. 621. The fragmentation/cleavage reaction does not interrupt the binding of psoralen with the nucleic acid, as the psoralen is only removed after fragmentation occurs. Thus, the fragmentation would have to occur around the psoralen/nucleic acid binding sites, and so would occur between these binding site contact points. Though this occurs in a working example that is not the same exact embodiment as the teachings of Munding described above, it would also be prima facie obvious that the fragmentation in these above teachings would occur in the same manner. This would ensure the psoralen functions as intended and that the generated nucleic acid fragments remain attached to the dendrimer and are not lost within the reaction. This would allow the later joining of the fragments (and the sequencing of said joined fragments) to successfully occur, as the fragments would remain close to one another in space.
Thus, claims 22-26, 30, 35, and 197-201 are prima facie obvious over Munding.
Regarding claim 29, Munding teaches that the dendrimer may have 32-512 reactive groups (paras. 14 and 86). As described above in the rejection of claim 22, the reactive groups are the psoralen moieties that bind to the nucleic acids of the sample.
Regarding claim 205, para. 86 of Munding teaches that the dendrimer can have a weight of 5-125 kDa.
Regarding claims 206-207, Munding teaches throughout the reference that phase information can be determined (e.g. Abstract and paras. 93, 149, and 153). Para. 14 specifically states that sequencing can be done on the nucleic acid fragments to generate read pairs, and that sequencing can involve “mapping the first read pair to a set of contigs; and (i) assigning a variant in the set of contigs to a phase.”
Regarding claim 208, Munding teaches that the sample that the dendrimer contacts can comprise fewer than 1,000,000 cells (para. 14).
Claims 202-204 are rejected under 35 U.S.C. 103 as being obvious over Munding et al. (US 2024/0084291 A1; cited in Applicant’s IDS) in view of Nelson et al. (US 2016/0003815 A1).
Munding teaches the methods of claims 22-26, 29-30, 35, 197-201, and 205-208, as described above. The reference also generally teaches the use of biotin as a detectable label (e.g. paras. 15 and 99). Para. 135 notes that biotin tags can facilitate streptavidin-based isolation (see also para. 472). However, the reference does not clearly link biotin/streptavidin methods to their dendrimer methods.
Nelson teaches methods for detecting and measuring analytes (Abstract). The reference teaches general detection means, and notes that detector reagents can be labeled with biotin to allow labeled streptavidin to act as a visual detector (paras. 25-26). Paras. 61-62 note that a detection reagent can include a biotinylated dendrimer that can bind to fluorescently labeled streptavidin. This can create a biotinylated dendrimer that is attached to both an analyte and streptavidin (para. 63). Para. 62 notes that this binding can create a large signal for even a small amount of analyte.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to use the detection methods of Nelson in conjunction with the sequencing protocol of Munding. By contacting a sample with a dendrimer and then detecting said dendrimer with biotin/fluorescent streptavidin, one could see where the dendrimer is bound in a particular cross-linked sample. Then, combining this with sequencing information can provide localized sequence information for the types of samples encompassed by Munding above, such as for chromatin and nuclei. This biotin/streptavidin binding would also allow for the easy isolation of the nucleic acid fragments bound to the dendrimer from the rest of the sample (through means such as binding to a secondary biotinylated surface), which would allow for easy downstream processing of the nucleic acid fragments. These uses would be motivating to the ordinary artisan. As biotin/streptavidin binding is well known in the art, as evidenced by both Munding and Nelson, and the use of target-bound biotinylated dendrimers with labeled streptavidin has been used successfully in the art, as evidenced by Nelson, there would be a reasonable expectation of success.
Thus, claims 202-204 are prima facie obvious over Munding in view of Nelson.
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 22-26, 29, 35, 197-201, and 205-208 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 11, 21, 28, and 30-21 of copending Application No. 18/270,027 in view of Munding et al. (US 2024/0084291 A1; cited in Applicant’s IDS).
Claim 1 of the ‘027 application states the use of a stabilized sample with a nucleic acid molecule bound to at least one nucleic acid binding protein, cleaving the molecule into multiple segments using a transposase, and joining the segments back together using a linker. Claim 7 of the ‘027 application then cites the sequencing of this final product. It is noted that the transposase recited in the claims acts as an endonuclease, and thus reads on the endonuclease of the instant claims. The claims however do not specify the use of a dendrimer as required in the instant claims
Munding teaches methods for the generation of libraries from nucleic acid samples (Abstract). Para. 14 states that the method can involve a stabilized biological sample, where the sample comprises a nucleic acid molecule complexed to at least one binding protein (instant claim 25), contacting the nucleic acid molecule to a dendrimer to form a complex, and cleaving the nucleic acid molecule into a plurality of segments. The dendrimer can be conjugated with psoralen (para. 83; instant claims 26 and 199). The dendrimer can be PAMAM (para. 14; instant claim 201). Munding notes that the stabilized sample can be cross-linked nucleic or chromatin (para. 65; instant claims 23-24). The cleavage can be performed by a transposase (para. 9). After fragmentation, para. 14 then states that the cleaved segments can be attached at a junction. This attaching can be done via the use of a bridge oligonucleotide that contains a barcode sequence (para. 14; instant claims 35 and 197). Para. 96 notes that in the case where fragments contacted to dendrimers are barcoded, the fragments associated with a particular dendrimer can be barcoded in a partition, where the barcode is particular to the partition. Thus, the barcode would also be particular to a given dendrimer (instant claim 200). After the joining of the fragments, Munding teaches the obtaining of sequence information on each side of the junction, thus obtaining sequencing information for the plurality of fragments (para. 14; instant claim 198).
Para. 621 notes that a psoralen PAMAM dendrimer can have the psoralen conjugated to the end of each dendrimer polymer, and can be used to contact a nucleic acid sample. The nucleic acid sample is then fragmented. The fragments are then end treated and adapter ligated, and then the psoralen is removed.
Thus, though Munding does not specifically state that the fragmentation occurs between the contact points of the psoralen with the nucleic acid molecule, the ordinary artisan would recognize that this is what occurs in para. 621. The fragmentation/cleavage reaction does not interrupt the binding of psoralen with the nucleic acid, as the psoralen is only removed after fragmentation occurs. Thus, the fragmentation would have to occur around the psoralen/nucleic acid binding sites, and so would occur between these binding site contact points. Though this occurs in a working example that is not the same exact embodiment as the teachings of Munding described above, it would also be prima facie obvious that the fragmentation in these above teachings would occur in the same manner. This would ensure the psoralen functions as intended and that the generated nucleic acid fragments remain attached to the dendrimer and are not lost within the reaction. This would allow the later joining of the fragments (and the sequencing of said joined fragments) to successfully occur, as the fragments would remain close to one another in space.
The ordinary artisan would recognize that the cleaving described in the ‘027 application could occur via any general method, so long as a transposase is used. The methods of Munding would allow for the cleavage of a nucleic acid molecule followed by the joining of the resulting nucleic acid fragments, and so would read on the methods of the ‘027 application.
Thus, claims 1 and 7 of the ‘027 application in view of Munding read on instant claims 22-26, 35, and 197-201.
Claim 11 of the ‘027 application specifies that the stabilized sample is a cross-linked sample, and so also reads on instant claim 22 in view of the teachings of Munding described above.
Claim 21 of the ‘027 application specifies that the linker sequence that joins the nucleic acid fragments is a barcode sequence. As this linker reads on the oligonucleotide of instant claim 35, and Munding describes barcodes unique to dendrimers as described above, this claim in view of Munding also reads on instant claim 200 in view of the teachings of Munding described above.
Claim 28 of the ‘027 application states that the stabilized sample comprises no more than 50,000 cells, which overlaps with the range described in instant claim 208, and so reads on this claim in view of the teachings of Munding described above.
Claim 30 of the ‘027 application states that the stabilized sample is stabilized nucleic. In view of the teachings of Munding described above, the stabilized sample can be a cross-linked sample, and this reference specifically notes the use of cross-linked nucleic. Thus, this claim also reads on instant claim 24 in view of the teachings of Munding described above.
Claim 31 of the ‘027 application recites that the stabilized sample comprises no more than 50,000 nucleic. This overlaps with the range described in instant claim 208 in the instance where uninuclear cells are used, and also overlaps with instant claim 24 in that it uses stabilized nucleic, which can be cross-linked, as described in view of Munding above. Thus, this claim also reads on instant claims 24 and 208 in view of the teachings of Munding described above.
Regarding claim 29, Munding teaches that the dendrimer may have 32-512 reactive groups (paras. 14 and 86). As described above in the rejection of claim 22, the reactive groups are the psoralen moieties that bind to the nucleic acids of the sample.
Regarding claim 205, para. 86 of Munding teaches that the dendrimer can have a weight of 5-125 kDa.
Regarding claims 206-207, Munding teaches throughout the reference that phase information can be determined (e.g. Abstract and paras. 93, 149, and 153). Para. 14 specifically states that sequencing can be done on the nucleic acid fragments to generate read pairs, and that sequencing can involve “mapping the first read pair to a set of contigs; and (i) assigning a variant in the set of contigs to a phase.”
Regarding claim 208, Munding teaches that the sample that the dendrimer contacts can comprise fewer than 1,000,000 cells (para. 14).
Thus, claims 1 and 7 of the ‘027 application in view of Munding also reads on instant claims 29 and 205-208, as these teachings of Munding may be used with the dendrimer teachings described above in the rejection of claim 22.
This is a provisional nonstatutory double patenting rejection.
Claims 202-204 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of copending Application No. 18/270,027 in view of Munding et al. (US 2024/0084291 A1; cited in Applicant’s IDS) and Nelson et al. (US 2016/0003815 A1).
Claims 1 and 7 of the ‘027 application in view of Munding read on the method of instant claim 22, as described above. Munding also generally teaches the use of biotin as a detectable label (e.g. paras. 15 and 99). Para. 135 notes that biotin tags can facilitate streptavidin-based isolation (see also para. 472). However, the reference does not clearly link biotin/streptavidin methods to their dendrimer methods.
Nelson teaches methods for detecting and measuring analytes (Abstract). The reference teaches general detection means, and notes that detector reagents can be labeled with biotin to allow labeled streptavidin to act as a visual detector (paras. 25-26). Paras. 61-62 note that a detection reagent can include a biotinylated dendrimer that can bind to fluorescently labeled streptavidin. This can create a biotinylated dendrimer that is attached to both an analyte and streptavidin (para. 63). Para. 62 notes that this binding can create a large signal for even a small amount of analyte.
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to use the detection methods of Nelson in conjunction with the protocol of the ‘027 application in view of Munding. By contacting a sample with a dendrimer and then detecting said dendrimer with biotin/fluorescent streptavidin, one could see where the dendrimer is bound to in a particular cross-linked sample. Then, combining this with sequencing information can provide localized sequence information for the types of samples encompassed by the ‘027 application in view of Munding above, such as for chromatin and nuclei. This biotin/streptavidin binding would also allow for the easy isolation of the nucleic acid fragments bound to the dendrimer from the rest of the sample (through means such as binding to a secondary biotinylated surface), which would allow for easy downstream processing of the nucleic acid fragments. These uses would be motivating to the ordinary artisan. As biotin/streptavidin binding is well known in the art, as evidenced by both Munding and Nelson, and the use of target-bound biotinylated dendrimers with labeled streptavidin has been used successfully in the art, as evidenced by Nelson, there would be a reasonable expectation of success.
Thus, claims 1 and 7 of the ‘027 application in view of Munding and Nelson read on instant claims 202-204.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA F GIAMMONA whose telephone number is (571)270-0595. The examiner can normally be reached M-Th, 7-5pm.
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/FRANCESCA FILIPPA GIAMMONA/Examiner, Art Unit 1681
