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 The non-compliant amendment mailed 5/19/2026 was inadvertently submitted in this case in error and is being withdrawn in lieu of this Office action. The examiner regrets any inadvertent inconvenience.
Applicant’s amendment filed 2/24/2026 is acknowledged. Claims 25-43 are pending. All of the arguments have been thoroughly reviewed and considered.
Any rejection not reiterated in this action has been withdrawn as being obviated by the amendment of the claims.
This action is made Final.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Previous Rejections
Status:
(a) The double patenting rejection is maintained and discussed below.
(b) The prior art rejection directed to clams 25-43 as being unpatentable over Lin et al in view of Rabinowitz is withdrawn in view of Applicant’s amendment of the claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/24/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 25-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10626443 {US Patent No. ‘443). An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined 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).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims 25-43 of the instant invention and the claims 1-21 of US Patent ‘442 are directed to a method of for identifying a nucleic acid fragmentation pattern in a subject by analyzing cell-free deoxyribonucleic acid (DNA) fragments in a biological sample from the subject, the cell-free DNA fragments originating from normal cells and potentially from disease cells, comprising:(a) obtaining the biological sample from the subject; (b) enriching the biological sample for a set of cell-free DNA fragments having ends that are mappable to one or more loci associated with a disease, wherein the enriching comprises hybridizing at least one probe to both a 5' end and a 3' end of each of the cell-free DNA fragments having ends that are mappable to one or more loci associated with a disease, wherein a first sequence along a 3' end of the at least one probe is complementary to a first target sequence comprising a 3' most nucleotide of the cell-free DNA fragment, or a second sequence along a 5' end of the at least one probe is complementary to a second target sequence comprising a 5' most nucleotide of the cell-free DNA fragment; (c) subjecting the set of cell-free DNA fragments enriched in (b) or derivatives thereof to sequencing to obtain a plurality of sequences; (d) aligning the plurality of sequences to a reference to determine genomic positions for the plurality of sequences, the genomic positions including positions corresponding to the ends of the cell-free DNA fragments; and (e) identifying a set of loci with specific fragmentation patterns in the plurality of sequences, wherein the set of loci correspond to the one or more loci associated with a disease (see both the claim 1 of the instant invention and the claim 1 of US Patent ’443). The claims 2-21 of US ‘443 embodies the limitations of 25-43 of the instant invention.
The claims 25-43 of the instant invention and the claims 1-21 of US Patent ‘443 only differs slightly in wording. Thus, the claims 25-43 of the instant invention falls entirely within the scope of the claims 1-21 of US patent 10626443. As the court stated in In re Goodman, 29 USPQ2d 2010 (CAFC 1993), “a second application-- "containing a broader claim, more generical in its character than the specific claim in the prior patent"--typically cannot support an independent valid patent. Miller, 151, U.S. at 198; See Stanley, 214 F.2d at 153. Thus, the generic invention, as noted above is "anticipated" by the species of the patented invention. Cf., Titanium metal corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that an earlier species disclosure in the prior art defeats any generic claims). This court's predecessor has held that, without a terminal disclaimer, the species claims preclude issuance of the generical application. "In re Van Ornum, 686 F.2d 937, 944, 214 USPQ 761, 767 (CCPA 1982); Schneller, 397 F.2d at 354".
Response to Arguments
Applicant traverses the rejection on the following grounds: Applicant states that the current rejection be held in abeyance until otherwise allowable subject of the claims.
The examiner acknowledges Applicant’s arguments but notes that the Office longer hold rejections in abeyance until indication of allowable subject matter. MPEP 1504.06 makes clear that the specification may be used to show that a later patent may not be patentably distinct and the later patent may be invalid under statutory or nonstatutory double patenting rules. A proper terminal disclaimer is required to overcome the double patenting rejections noted above. Applicant’s arguments are not found persuasive.
Conclusion
No claims are allowed. However, an updated search did not reveal new prior art over the claimed invention. Therefore, the claims are deemed free of the prior art.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681
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