DETAILED ACTION
Preliminary Amendment filed on 02/20/2024 is acknowledged. Claims 1-38 are cancelled. Claims 39-58 are pending in the application and are considered on merits.
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 .
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.
Claim 39-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-10 of U.S. Patent No. 12,263,179 and claim 1-12 of U.S. Patent No. 12,266,425. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the currently patented claims expressly recite the same subject matter, it would have been obvious to one of ordinary skill in the art at the time the invention was made to employ both device and methods, as recited in both sets of claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 39-58 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more.
Step 2A, Prong One – Judicial Exception
Claim 39 is directed to a judicial exception, namely an abstract idea and a natural phenomenon.
The claim recites a computer-implemented method for assessing T cell receptor β chain complementary determining region 3 (TCRβ CDR3) sequences by assessing sequences determined from a subject for the presence or absence of one or more sequences set forth in SEQ ID Nos: 1–1996. This limitation encompasses comparing biological sequence data from a subject to a predefined reference set and identifying matches, which constitutes data analysis, comparison, and classification, an abstract mental process. Such a comparison could be performed mentally or with pen and paper, and the claim does not recite any specific algorithm or technical mechanism for performing the assessment.
Further, the claim relies on naturally occurring TCRβ CDR3 sequences, which are products of nature. The claimed method merely detects whether such naturally occurring sequences are present or absent in a sample and does not modify or transform them.
Accordingly, claim 39 is directed to a judicial exception.
Step 2A, Prong Two – Integration into a Practical Application
Claim 39 does not integrate the judicial exception into a practical application. The claim does not recite:
Any specific improvement to computer technology,
Any particular sequencing technique, data structure, or algorithm,
Any transformation of the biological material, or
Any concrete diagnostic decision or treatment step tied to the assessment result.
The recited “computer-implemented” limitation merely invokes a generic computer to perform the abstract comparison and does not impose a meaningful limit on the judicial exception.
Step 2B – Inventive Concept
Claim 39 does not include additional elements that amount to significantly more than the judicial exception. The claim merely adds generic computer implementation to the abstract idea of comparing naturally occurring biological sequences to a known list. The use of a predefined database of sequences (SEQ ID Nos: 1–1996) represents data content rather than a technical innovation and does not constitute an inventive concept.
Claims 40–45 depend directly or indirectly from claim 39 and therefore include all the limitations of claim 39, which is directed to assessing TCRβ CDR3 sequences for the presence or absence of one or more sequences set forth in SEQ ID Nos: 1–1996.
The additional limitations recited in claims 40–45 do not remove the claims from the judicial exception.
Claim 40 limits the assessment to a subset of sequences (SEQ ID Nos: 1–1281), which merely narrows the data being compared and does not change the nature of the abstract comparison.
Claims 41 and 42 recite identifying or suspecting the subject as having inflammatory bowel disease or Crohn’s disease–like symptoms, which are contextual field-of-use limitations and do not alter the underlying abstract idea.
Claim 43 recites that the assessed sequences comprise 10,000 or more TCRβ CDR3 sequences, which merely specifies the quantity of data analyzed and does not add a technical improvement.
Claim 44 recites that the sequences were determined by amplification and high-throughput sequencing of genomic DNA, which describes data acquisition steps that are conventional and do not alter the focus of the claim.
Claim 45 limits the sample type to peripheral blood or gut tissue, which merely specifies the source of naturally occurring material.
Accordingly, claims 40–45 remain directed to the same judicial exception as claim 39.
Claims 40–45 do not integrate the judicial exception into a practical application. None of the additional limitations recite:
A specific improvement to sequencing technology,
A particular algorithm or unconventional computational technique,
A transformation of the biological sample based on the assessment result, or
A concrete diagnostic or treatment action tied to the assessment.
Instead, the claims merely apply the abstract comparison to a particular disease context, data size, sample type, or conventional sequencing method, which amounts to field-of-use limitations and insignificant extra-solution activity.
Claims 40–45 do not include additional elements that amount to significantly more than the judicial exception. The dependent limitations merely narrow the scope of the abstract idea or add well-understood, routine, and conventional activities, such as high-throughput sequencing, analyzing large data sets, or selecting a biological sample source.
The claims therefore lack an inventive concept sufficient to transform the abstract idea into patent-eligible subject matter.
Conclusion
Accordingly, claims 39–45 are not patent eligible under 35 U.S.C. §101 because it is directed to an abstract idea and/or natural phenomenon and lacks additional elements sufficient to transform the judicial exception into patent-eligible subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797
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