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 .
Claims 1-22 are currently pending and under examination.
Any rejection of record in the previous office actions not addressed herein is withdrawn. New grounds of rejection are presented herein that were not necessitated by applicant’s amendment of the claims since the office action mailed April 25, 2023. Therefore, this action is not final.
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.
Claims 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions (i.e., product of nature, a law of nature, a natural phenomenon, or an abstract idea) without significantly more. This is a new rejection.
Every claimed invention must be examined to determine whether the claimed invention complies with 35 U.S.C. 101, particularly whether the claimed invention falls within a 35 U.S.C. 101 judicial exception of non-patentable subject matter (e.g., an abstract idea, law of nature, natural phenomenon, natural product etc.). Phenomena of nature, though just discovered, natural products, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. See MPEP 2106. As per the “2019 Revised Subject Matter Eligibility Guidance” (Federal Register Vol. 84, No. 4, available 01-07-2019), claims drawn to a process, machine, manufacture or composition of matter are further analyzed according to a two-part process to determine if A) the claim(s) is/are “directed to” a judicial exception because the claims(s) recite(s) a judicial exception (i.e. prong one) that is not integrated into a practical application (i.e. prong two) and, if so, if B) the claim(s) provide(s) an inventive concept, i.e. recite(s) additional elements that amount to significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES
Claims 1-22 are directed to one of the statutory classes. Claims 1-11 are directed to a method for simultaneous detection of an antigen and an antibody that specifically binds said antigen (Process) and claims 12-22 a method of determining a broadly neutralizing antibody that binds to an antigen derived from a pathogen (Process).
Step 2A, Prong One — Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES
Claims 1-22 recite the abstract idea of receiving and processing data using mental steps. Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection (see MPEP 2106.04). Abstract ideas include mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, determining, evaluating, and organizing
information (See MPEP 2106.04(a)(2)). In particular, these abstract ideas include:
Aligning the antibody sequence to a reference library (mental process, the human mind is capable of receiving/ collecting data, observing/evaluating/determining and organizing information/data).
Constructing a UMI count matrix (mental process, the human mind is capable of receiving/ collecting data, observing/evaluating/determining and organizing information/data).
Determining a LIBRA-seq score (mental process, the human mind is capable of receiving/ collecting data, observing/evaluating, organizing information, mathematical relationships and mathematical calculations).
Determining that the antibody specifically binds an antigen if the LIBRA-seq score of the antibody for the antigen is increased in comparison to a control sample (mental process, the human mind is capable of receiving/ collecting data, observing/evaluating, organizing information, mathematical relationships and mathematical calculations).
Therefore, the claims recite elements that constitute one or more judicial exceptions.
Step 2A, Prong Two — Does the Claim Recite an Additional Elements that Integrate the Judicial Exception into a Practical Application? NO.
The Supreme Court has long distinguished between principles themselves, which are not
patent eligible, and the integration of those principles into practical applications, which are
patent eligible. However, absent are any additional elements recited in the claim beyond the
judicial exceptions which integrate the exception into a practical application of the exception.
The “integration into a practical application” requires an additional element or a combination of
additional elements in the claim to apply, rely on, or use the judicial exception in a manner that
imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort
designed to monopolize the exception.
The claim analysis continues with identifying additional elements beyond the judicial
exceptions that might evidence integration of the judicial exceptions into a practical application.
The steps or elements in addition to the judicial exceptions are: “allowing [a] plurality of barcode-labeled antigens to bind to [a] population of B-cells”, “introducing into each single cell emulsion a unique cell barcode-labeled bead [and] preparing a single cell cDNA library from the single cell emulsions” as well as “performing PCR amplification reactions to produce a plurality of amplicons [and] sequencing the plurality of amplicons”, which is not indicative of integration into practical application. These steps, recited at a high level of generality, comprise routine data gathering, which is considered an insignificant extra-solution activity. This data gathering is required for using the judicial exceptions. (See MPEP 2106.05(g)). There are no further/additional steps which applies either the identified judicial exception into practical application. Thus, a careful evaluation of the claim as a whole fails to reveal the practical application of the judicial exception to, e.g., effect an improvement to the functioning of a computer or other technology/technical field, effect a particular treatment or prophylaxis for a disease or medical treatment, implement a particular machine that is integral to the claim, or effect a transformation or reduction of a particular article to a different state or thing, or to apply the judicial exception in another meaningful way beyond generally linking its use to a particular technological environment. Accordingly, the claims do not integrate the judicial exception(s) into a practical application and is therefore directed to a judicial exception.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than
the Judicial Exception? NO.
The Supreme Court has identified a number of considerations for determining whether a
claim with additional elements amounts to “significantly more” than the judicial exception(s)
itself. The claims as a whole are analyzed to determine whether any additional element/step, or
combination of additional elements/steps, in addition to the identified judicial exception(s) is
sufficient to ensure that the claim amounts to “significantly more” than the exception(s).
The eligibility analysis proceeds with identifying any additional elements or limitations,
separate from the judicial exceptions, that might potentially render the claims directed to a
judicial exception patent eligible. To render the claims patent- eligible, these elements must
comprise meaningful limitations that add to or transform the judicial exception to the effect that
it amounts to significantly more than the natural correlation or abstract idea itself - i.e. provide an
“inventive concept’. The elements that are in addition to the judicial exception comprise: allowing a plurality of barcode-labeled antigens to bind to a population of B-cells, introducing into each single cell emulsion a unique cell barcode-labeled bead and preparing a single cell cDNA library from the single cell emulsions, as well as performing PCR amplification reactions to produce a plurality of amplicons and sequencing the plurality of amplicons. When considered separately and in combination, these elements do not add significantly more to the judicial exception. These steps are well-understood, routine and conventional activities in the field. For example, Vigneault et al. (WIPO International Application Publication WO 2018/057051 A1, published March 29, 2018), cited on the IDS filed July 18, 2025, discloses allowing a plurality of barcode-labeled antigens to bind to a population of B-cells, introducing into each single cell emulsion a unique cell barcode-labeled bead and preparing a single cell cDNA library from the single cell emulsions, as well as performing PCR amplification reactions to produce a plurality of amplicons and sequencing the plurality of amplicons (Pages 1-3, [0003]-[0008], Page 4, [0014], Page 8, [0036], Page 14, [0073], Pages 54-55, [00250], Page 58, [00262] and Page 83, [00360]). The claims recite an abstract idea with additional elements. Because these elements are not inventive concepts, the claims do not integrate the abstract idea into a practical application. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). The claims therefore do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Accordingly, the claims do not qualify as patent-eligible subject matter.
For further information, please see the latest revision of MPEP 2104-2106 {Patent Subject Matter Eligibility Under 35 U.S.C. 101}, including MPEP 2106.04 {Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception} and 2106.05 {Eligibility Step 2B: Whether a Claim Amounts to Significantly More}, as well as the guidance on Subject Matter Eligibility, including the 2019 Guidance issued Jan. 7, 2019, and the October 2019 Update, provided on the USPTO website at https:/Awww.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter- eligibility.
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 1, 8-10, 15-18 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable claims 14-19 of copending Application No. 17/266,169 (reference application). This rejection is maintained.
Although the claims at issue are not perfectly identical, they are not patentably distinct from each other because the preambles are identical, as well as it appears that the majority of the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a method for simultaneous detection of an antigen and an antibody that specifically binds said antigen using those same steps. Therefore, the claims are not deemed to be patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably
indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments and amendments filed December 22, 2025, with respect to the rejections under 35 U.S.C. § 112 (b) and 103 have been fully considered and are persuasive. Therefore, these rejections have been withdrawn.
However, upon further consideration, new rejections under 35 U.S.C. § 101 are set forth
above.
Regarding the nonstatutory double patenting rejections, Applicant requests that these
rejections be held in abeyance until allowable subject matter is indicated. Therefore, these
rejections are maintained, as set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA DANIELLE PARISI whose telephone number is (571)272-8025. The examiner can normally be reached Mon - Friday 7:30-5:00 Eastern with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA D PARISI/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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