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 .
The claim amendments dated 1/28/2026 are under consideration.
The amendments and arguments presented in the papers filed 1/28/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 8/15/2025 listed below have been reconsidered as indicated.
a) The rejections of claims 42-57 and 60-61 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn in view of the amendments to the claims.
b) The rejections of: claims 42, 43, 44, 45, 46, 47, 48, 56 and 57 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-36 and 38-53 of copending Application No. 17/241,146 (reference application); and claims 49, 50, 51, 52, 53, 54, 55, 60 and 61 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-36 and 38-53 of copending Application No. 17/241,146 in view of Beliveau (PNAS. 2012. 109(52):21301-21306; previously cited), are withdrawn in view of the terminal disclaimer filed on 1/28/2026 and approved on 2/25/2026.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
Priority
The present application was filed as a divisional of 16/095,456 (issued as US 11,021,741).
The ‘456 application included a restriction requirement dated 11/30/2020. The groups were defined as follows:
Group I, claim(s) 1-29, drawn to methods of attaching chromosomes.
Group II, claim(s) 30-41, drawn to methods of hybridizing to chromosomes.
Claims 1-29 were elected and prosecuted in the ‘456 application. Claims 30-41 were cancelled via Examiner’s amendment (Notice of Allowance, 2/12/2021).
Claim 42 of the present application, which corresponds Group II of the ‘456 application because it requires “hybridizing to the chromosome a plurality of oligonucleotides”, requires a step of “covalently attaching the chromosome to the matrix”. As a result, claim 42 now overlaps with the subject matter of Group I of the ‘456 application. Claim 42 is no longer independent and distinct from the subject matter of Group I of the ‘456 application.
The claims of the present application are not consonant with the restriction requirement made by the examiner in the ‘456 application. The present claims have been changed in material respects from the claims in the ‘456 application at the time the requirement was made. In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. The present claims are not consonant in scope with the claims subject to the restriction in the ‘456 application because the embodiments of present claim 30 were not part of the claims restricted in the ‘456 application. Furthermore, present claim 42 represents a combination of Groups I and II as defined in the restriction of the ‘456 application.
The present application is no longer a proper divisional application in view of the amendments to the claims. The prohibition on nonstatutory double patenting rejection does not apply for the reasons provided above. See MPEP 804.01.
Information Disclosure Statement
The listing of references in the specification or citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Drawings
The petition for Color Drawings filed 4/27/2021 was approved on 12/13/2022.
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 42-57 and 60-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 11,021,741 B2 in view of Beliveau (PNAS. 2012. 109(52):21301-21306; previously cited).
Regarding claim 42, at least claims 1, 24 and 25 of the ‘741 patent render obvious amended step (c).
Regarding present claims 45, 48, 52, 55, claims 6, 7, 8, 9 and 10 of the ‘741 patent are encompassed by the claim.
Regarding present claims 56-57, claims 13-18 of the ‘741 patent are encompassed by the claim.
Regarding claim 44, the ‘741 patent does not require the elements of the claim.
However, Beliveau teaches detecting the detectable labels (Figs. 2 and 3).
The ‘741 patent claims do not address present steps (a), (b), (d), (e) and (f) of claim 42.
However, Beliveau teaches hybridizing a plurality of oligonucleotides or probes to a chromosome (Fig. 1). The oligonucleotides have a genomic sequence that hybridizes with the chromosome and a F’ primer sequence that is not complementary to the chromosome (Fig. 1).
The plurality of oligonucleotides hybridized to the chromosome represents the structure of the chromosome in the cell (Figs. 2 and 3) and detects the structure of the chromosome (Fig. 3 and Fig. 5).
Regarding present claim 43, Beliveau teaches the plurality of oligonucleotides further includes one or more detectable labels and detecting the label (Fig. 1, 3 and 5).
Regarding present claims 44, 47 and 54, Beliveau teaches detecting the fluorescent labels with fluorescence microscopy (p. 20 of SI Appendix, SI methods).
Regarding present claim 46, Beliveau teaches detecting chromosome structure by hybridizing a second oligonucleotide comprising a detectable label to the non-genomic complementary region of the plurality of oligonucleotides (Fig. S12).
Regarding present claims 49, 50 and 51, Beliveau teaches amplifying a portion of the plurality of oligonucleotides using RCA (Fig. S12). The amplification products includes a detectable label through hybridization (Fig. S12) and detecting the fluorescent labels with fluorescence microscopy (p. 20 of SI Appendix, SI methods).
Regarding present claim 53, Beliveau teaches detecting chromosome structure by hybridizing a second oligonucleotide comprising a detectable label to the non-genomic complementary region of the plurality of oligonucleotides (Fig. S12). The probe hybridizes in a sequence specific manner, meaning the sequence of the probe is determined.
Regarding present claim 60, Beliveau teaches a plurality of probes comprising a genomic hybridizing portion, a non-genomic hybridizing portion that is hybridized to a circular piece of nucleic acids (Fig. S12). The circular piece includes a second non-complementary region that is then amplified via RCA (Fig. S12).
Regarding present claim 61, Beliveau teaches sequencing the amplification product using a specific probe of a known sequence and containing a label (Fig. S12) that would determine the sequence of the amplification product.
It would have been prima facie obvious to have modified the method of the ‘741 claims by incorporating the plurality of oligonucleotides that hybridize to a chromosome. The modification may entail adding the matrix attachment moieties of the ‘741 claims to the probes of Beliveau. Alternatively, one could add a labeling oligonucleotide to the probe of Beliveau. One would have been motivated to modify the method of the ‘741 claims because the it allows one to assess particular target regions within the chromosome. The modification has a reasonable expectation of success as it simply substitutes one approach to visualizing and detecting cell structures with another known approach to visualize and detect cell structures.
Response to the traversal of the double-patenting rejections
The Remarks argue a terminal disclaimer over the ‘741 patent, rendering the rejections moot (p. 8-9).
The terminal disclaimer was not approved. See Terminal Disclaimer review decision dated 2/25/2026 for additional details.
Conclusion
No claims allowed.
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THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/Primary Examiner, Art Unit 1682
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