Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
2. Applicant's election with traverse of Group III, claims 101-107 in the reply filed on 05 November 2025 is acknowledged. The traversal is on the ground(s) that there would be no undue burden in searching all the claims together. This is not found persuasive because each independent claim, as evidenced by their different classifications, are broad enough so as to require independent searches for each separate invention.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
3. Claims 101 and 104 are objected to because of the following informalities: The abbreviates UBA, ESB and COB are not defined anywhere within this claim group. Although these abbreviations are defined in applicant’s specification the claims should stand on their own with regard to the language used to describe the invention. Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 101-107 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.
A. Claim 101 recites the phrase “contacting a sample comprising cells with UBAs and a mixture comprising labeled ESBs and unlabeled ESBs at a predetermined ratio.” It is unclear if applicant intends for this limitation to encompass embodiments wherein the mixture of labeled and unlabeled ESBs are already attached to the UBAs, as is seen in applicant’s drawings, or if this limitation specifically requires the contacting of cells with UBAs and a separate mixture of labeled and unlabeled ESBs. Additionally, claim 1 recites the phrase “wherein the cells are subjected to split pool synthesis.” It is unclear, based on the context of the claim and the applicant’s specification, how this phrase is intended to limit the claim. Many embodiments referring to split pool synthesis in applicant’s drawings and specification relate to the creation of a COB via the assembly of APS units. However, there are no APS monomers required in this claim. What steps are required to be considered “split pool synthesis?” Neither applicant’s specification nor their drawings seem to require the specific ligation of monomers in split pool synthesis, does this limitation encompass embodiments wherein oligonucleotide monomers are hybridized together? Or if different oligonucleotide monomers are simply adsorbed onto the surface of a cell? For these reasons this claim is unclear, and therefore it is indefinite.
B. The term “preferentially” in claims 102-103 is a relative term which renders the claims indefinite. The term “preferentially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear, based on the claims and applicant’s specification, how the term “preferentially” limits the association of ESBs with UBAs. Additionally, it is unclear how the first or second labeled ESB is “preferentially associated” with the UBAs over the first or second unlabeled ESB “by a factor of at least 10-fold.” Is the predetermined ratio of labeled and unlabeled ESBs “at least 10-fold?” Does the labeled ESB somehow bind more strongly to the UBA? How these limitations effect the metes and bounds of this claim are unclear and therefore the claim is indefinite. For the purpose of prosecution, this limitation is being interpreted as though there is at least 10-fold more labeled ESB than unlabeled ESB.
C. The term “preferentially” in claims 104-105 is a relative term which renders the claims indefinite. The term “preferentially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear, based on the claims and applicant’s specification, how the term “preferentially” limits the association of ESBs with COBs. Additionally, it is unclear how the first or second labeled ESB is “preferentially associated” with the COBs over the first or second unlabeled ESB “by a factor of at least 10-fold.” Is the predetermined ratio of labeled and unlabeled ESBs “at least 10-fold?” Does the labeled ESB somehow bind more strongly to the COB? How these limitations effect the metes and bounds of this claim are unclear and therefore the claim is indefinite. For the purpose of prosecution, this limitation is being interpreted as though there is at least 10-fold more labeled ESB than unlabeled ESB.
D. The term “preferentially” in claims 106-107 is a relative term which renders the claims indefinite. The term “preferentially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear, based on the claims and applicant’s specification, how the term “preferentially” limits the detection of labeled ESBs over unlabeled ESBs. Additionally, it is unclear how the first or second labeled ESB is “preferentially detected” over the first or second unlabeled ESB “by a factor of at least 10-fold.” Is the predetermined ratio of labeled and unlabeled ESBs “at least 10-fold?” Why is the unlabeled ESB detected at all? Is the labeled ESB “preferentially detected” over the unlabeled ESB by a factor of at least 10-fold by every possible detection modality? The limitations of this claim are unclear and therefore the claim is indefinite. For the purpose of prosecution, this limitation is being interpreted as though there is at least 10-fold more labeled ESB than unlabeled ESB.
Double Patenting
6. 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.
7. Claims 101-107 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10174310 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the contacting of cells, UBAs, labeled and unlabeled ESBs, and performing spilt pool synthesis on cells.
Claims 1 and 3 of the issued patent teach a method that has all the steps of instant claim 101.
This issued claims to not teach a method that includes all of the limitations of instant claim 101 in a single claim. However, it would have been prima facie obvious to one having ordinary skill in the art to have modified any one of the issued claims with the limitation wherein the amount of a target is quantified by multiplying the detected amount by the ratio of labeled and unlabeled UBAs in the UBA mixture to arrive at the instantly claimed invention with a reasonable expectation of success.
The limitations of instant claims 102-107 are taught in claim 2 of the issued patent.
8. Claims 101-107 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11214794 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the contacting of cells, UBAs, labeled and unlabeled ESBs, and performing spilt pool synthesis on cells.
Claims 1 and 3 of the issued patent teach all the limitations of instant claim 101.
This issued claims to not teach a method that includes all of the limitations of instant claim 101 in a single claim. However, it would have been prima facie obvious to one having ordinary skill in the art to have modified any one of the issued claims with the limitation wherein the amount of a target is quantified by multiplying the detected amount by the ratio of labeled and unlabeled UBAs in the UBA mixture to arrive at the instantly claimed invention with a reasonable expectation of success.
Conclusion
9. No claims are allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN ELLIS YOUNG whose telephone number is (703)756-5397. The examiner can normally be reached M-F 0730 - 1700.
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/BRIAN ELLIS YOUNG/Examiner, Art Unit 1684
/JULIET C SWITZER/Primary Examiner, Art Unit 1682