DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 16th, 2026 has been entered.
Response to Amendment
The amendment filed July 16th, 2026 is acknowledged. Regarding the Office Action mailed April 16th, 2026:
Maintained, modified, or new rejections are set forth below, as necessitated by the amendments. Responses to arguments, if necessary, follow their respective rejection sections.
Any previous rejections not reiterated below are withdrawn in view of the amendments or further considerations.
Claim Summary
Claims 2, 12, and 22-23 have been amended. Claims 1, 9, and 19 have been canceled. Claims 2-8, 10-18, and 20-23 are pending. Claims 2-8, 10-18, and 20-23 are under examination and discussed in this Office action.
Claim Rejections - 35 USC § 112(a) – New – Necessitated by Amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
Claims 22 and 23 recite the limitation “wherein the IVTT is performed in the presence of glycerol at a concentration that does not exceed 10% (w/w)”. As written, this limitation reads that the in vitro transcription and translation is performed with glycerol that does not exceed 10% weight by weight. This limitation is not described in the specification such that the Applicant has possession of the claimed limitation.
Turning to the specification, there is no description of IVTT being performed in the presence of glycerol. There is several mentions of using a reticulocyte lysate reagent to produce proteins (see pages 11, 16, 23, 25, 28) as well as a further reference to a rabbit reticulocyte lysate-(RRL) based IVTT system for protein expression and capture in situ, but there is no further description of what other aspects may be included in this reagent or system, such as glycerol. Therefore, there is no description for “wherein the IVTT is performed in the presence of glycerol at a concentration that does not exceed 10% (w/w)”.
Given the lack of description related to presence of glycerol in IVTT, the currently claimed “wherein the IVTT is performed in the presence of glycerol at a concentration that does not exceed 10% (w/w)” is considered new matter that is not adequately described in the instant disclosure, and claims 22 and 23 are rejected.
Claim Rejections - 35 USC § 103 – New – Necessitated by Amendment and Further Considerations
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-8, 10-18, and 20-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Labaer (US 20020192673 A1; previously cited), in view of Leamon (US 20060040297 A1).
Regarding instant claim 2, Labaer teaches a method of detecting protein-protein interactions using a high-density nucleic acid programmable array (HD-NAPPA), the method comprising: (a) expressing a plurality of nucleic acids attached to surfaces of a plurality of nanowells in an HD-NAPPA, wherein the surfaces of the plurality of nanowells are functionalized with a plurality of capture reagents (Page 12, paragraph [0125]; Page 30, paragraphs [0337] and [0338]), and wherein the plurality of nucleic acids each encode a peptide (Page 12, paragraphs [0125] and [0126]; Page 36, paragraphs [0434]-[0436]); (b) adding a sample to the plurality of nanowells, wherein the sample comprises co-expressing at least one query nucleic acid encoding the at least one query polypeptide in the plurality of nanowells (Page 12, paragraphs [0125] and [0126]); and (c) detecting the query polypeptide using a detection label (Page 12, paragraph [0128]); wherein each nanowell of the plurality of nanowells in the HD-NAPPA comprises a diameter that is from about 10% to about 95% of the center-to-center spacing between each nanowell of the plurality of nanowells in the HD-NAPPA (Page 30, paragraph [0331]: presented diameters can be from about 10% to about 95% of the center-to-center spacing based on the also provided center-to-center distances).
Labaer does not directly teach wherein expressing comprises in vitro transcription and translation (IVTT). However, Labaer does teach that the nucleic acids of the array are contacted with a translation effector to translate them into amino acid sequences (Page 12, paragraph [0125]; Page 30, paragraph [0337]). Labaer also teaches the use of an expression vector for expression of a coding region of interest, and the use of commercially available in vitro transcription/translation kits to generate the proteins of interest (Page 33, paragraph [0391]). Therefore, it would be obvious that expressing comprises in vitro transcription and translation (IVTT).
Labaer does not teach wherein each of the plurality of nanowells comprises a depth from about 10 µm to about 150 µm.
Leamon, in a reasonably pertinent field, teaches arrays for performing nucleic acid or protein related analysis (Page 3, paragraph [0028]), wherein a depth of chambers (e.g. wells) on the array can be 10 to 100 µm (Pages 20-21, paragraph [0220]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the array of Labaer with the well depth of Leamon. Since Leamon teaches microwell arrays for nucleic acid assays, which is reasonably pertinent to the array as described in Labaer, one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because, as stated by Leamon, “wells…are preferably of sufficient dimension and order to allow for (i) the introduction of the necessary reactants into the chambers, (ii) reactions to take place within the chamber and (iii) inhibition of mixing of reactants between chambers” (Leamon, Page 21, paragraph [0219]).
Regarding instant claim 3, Labaer, in view of Leamon, teaches the method of claim 2. Labaer further teaches wherein each nucleic acid of the plurality of nucleic acids is attached to a different nanowell of the plurality of nanowells (Page 13, paragraph [0133]).
Regarding instant claim 4, Labaer, in view of Leamon, teaches the method of claim 2. Labaer further teaches wherein the plurality of capture reagents bind an epitope tag expressed by the plurality of nucleic acids (Page 31, paragraphs [0361]-[0363]).
Regarding instant claim 5, Labaer, in view of Leamon, teaches the method of claim 4. Labaer further teaches wherein the plurality of capture reagents comprise an antibody or an epitope tag-binding fragment thereof (Page 31, paragraphs [0361]-[0363]).
Regarding instant claim 6, Labaer, in view of Leamon, teaches the method of claim 2. Labaer further teaches wherein detecting the query polypeptide comprises binding of the at least one query polypeptide to the peptide encoded by and expressed from at least one of the plurality of nucleic acids (Page 12, paragraphs [0125] and [0126]; Page 36, paragraphs [0434]-[0436]).
Regarding instant claim 7, Labaer, in view of Leamon, teaches the method of claim 2. Labaer further teaches wherein detecting the query polypeptide comprises the detection label binding to at least a portion of the query peptide (Page 12, paragraph [0128]).
Regarding instant claim 8, Labaer, in view of Leamon, teaches the method of claim 2. Labaer further teaches wherein the plurality of nanowells are arranged in the HD-NAPPA to minimize protein diffusion (Page 30, paragraphs [0337] and [0338]).
Regarding instant claim 10, Labaer, in view of Leamon, teaches the method of claim 8. Labaer further teaches wherein each nanowell of the plurality of nanowells in the HD-NAPPA comprises a center-to-center spacing from about 20 nm to about 400 µm (Page 30, paragraph [0331]).
Regarding instant claim 11, Labaer, in view of Leamon, teaches the method of claim 2. Labaer further teaches wherein each of the plurality of nanowells comprises a diameter from about 15 nm to about 0.75 mm (Page 30, paragraph [0331]).
Regarding instant claim 12, Labaer teaches a method of detecting protein-protein interactions using a high-density nucleic acid programmable array (HD-NAPPA), the method comprising: (a) expressing a plurality of nucleic acids attached to surfaces of a plurality of nanowells in an HD-NAPPA (Page 12, paragraph [0125]; Page 30, paragraphs [0337] and [0338]), wherein the plurality of nucleic acids each encode a peptide (Page 12, paragraphs [0125] and [0126]; Page 36, paragraphs [0434]-[0436]); (b) exposing the plurality of nanowells to a substrate functionalized with a plurality of capture reagents (Page 14, paragraph [0145]); (c) adding a sample to the plurality of nanowells, wherein the sample comprises co-expressing at least one query nucleic acid encoding the at least one query polypeptide in the plurality of nanowells (Page 12, paragraphs [0125] and [0126])); and (d) detecting the query polypeptide using a detection label (Page 12, paragraph [0128]); wherein each nanowell of the plurality of nanowells in the HD-NAPPA comprises a diameter that is from about 10% to about 95% of the center-to-center spacing between each nanowell of the plurality of nanowells in the HD-NAPPA (Page 30, paragraph [0331]: presented diameters can be from about 10% to about 95% of the center-to-center spacing based on the also provided center-to-center distances).
Labaer does not directly teach wherein expressing comprises in vitro transcription and translation (IVTT). However, Labaer does teach that the nucleic acids of the array are contacted with a translation effector to translate them into amino acid sequences (Page 12, paragraph [0125]; Page 30, paragraph [0337]). Labaer also teaches the use of an expression vector for expression of a coding region of interest, and the use of commercially available in vitro transcription/translation kits to generate the proteins of interest (Page 33, paragraph [0391]). Therefore, it would be obvious that expressing comprises in vitro transcription and translation (IVTT).
Labaer does not teach wherein the plurality of nanowells comprise a depth from about 10 µm to about 150 µm.
Leamon, in a reasonably pertinent field, teaches arrays for performing nucleic acid or protein related analysis (Page 3, paragraph [0028]), wherein a depth of chambers (e.g. wells) on the array can be 10 to 100 µm (Pages 20-21, paragraph [0220]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the array of Labaer with the well depth of Leamon. Since Leamon teaches microwell arrays for nucleic acid assays, which is reasonably pertinent to the array as described in Labaer, one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because, as stated by Leamon, “wells…are preferably of sufficient dimension and order to allow for (i) the introduction of the necessary reactants into the chambers, (ii) reactions to take place within the chamber and (iii) inhibition of mixing of reactants between chambers” (Leamon, Page 21, paragraph [0219]).
Regarding instant claim 13, Labaer, in view of Leamon, teaches the method of claim 12. Labaer further teaches wherein each nucleic acid of the plurality of nucleic acids is attached to a different nanowell of the plurality of nanowells (Page 13, paragraph [0133]).
Regarding instant claim 14, Labaer, in view of Leamon, teaches the method of claim 12. Labaer further teaches wherein the plurality of capture reagents bind an epitope tag expressed by the plurality of nucleic acids (Page 31, paragraphs [0361]-[0363]).
Regarding instant claim 15, Labaer, in view of Leamon, teaches the method of claim 14. Labaer further teaches wherein the plurality of capture reagents comprise an antibody or an epitope tag-binding fragment thereof (Page 31, paragraphs [0361]-[0363]).
Regarding instant claim 16, Labaer, in view of Leamon, teaches the method of claim 12. Labaer further teaches wherein detecting the query polypeptide comprises binding of the at least one query polypeptide to the peptide encoded and expressed from at least one of the plurality of nucleic acids (Page 12, paragraphs [0125] and [0126]; Page 36, paragraphs [0434]-[0436]).
Regarding instant claim 17, Labaer, in view of Leamon, teaches the method of claim 12. Labaer further teaches wherein detecting the query polypeptide comprises the detection label binding to at least a portion of the query peptide (Page 12, paragraph [0128]).
Regarding instant claim 18, Labaer, in view of Leamon, teaches the method of claim 12. Labaer further teaches wherein the plurality of nanowells are arranged in the HD-NAPPA to minimize protein diffusion (Page 30, paragraphs [0337] and [0338]).
Regarding instant claim 20, Labaer, in view of Leamon, teaches the method of claim 12. Labaer further teaches wherein each nanowell of the plurality of nanowells in the HD-NAPPA comprises a center-to-center spacing from about 20 nm to about 400 µm (Page 30, paragraph [0331]), and wherein each of the plurality of nanowells comprise a diameter from about 15 nm to about 0.75 mm (Page 30, paragraph [0331]).
Regarding instant claim 21, Labaer, in view of Leamon, teaches the method of claim 12. Labaer further teaches wherein each of the plurality of nanowells comprises a diameter from about 15 nm to about 0.75 mm (Page 30, paragraph [0331]).
Claims 22 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Labaer (US20020192673A1; previously cited) and Leamon (US 20060040297 A1), as applied to claims 2-8, 10-18, and 20-21, and further in view of Buchberger (US 20040053405 A1).
Regarding instant claims 22 and 23, Labaer, in view of Leamon, teaches the methods of claims 1 and 12. Labaer further teaches that components for translation may include an additive such as glycerol (Page 31, paragraph [0359]).
Neither reference teaches wherein the IVTT is performed in the presence of glycerol at a concentration that does not exceed 10% (w/w).
Buchberger, in a reasonably pertinent field, teaches IVTT reaction solutions comprising glycerol (Page 4, paragraph [0081]), preferably at a concentration of 1-10% (Page 5, paragraphs [0087]-[0088]). While there are no associated concentration units associated with the taught range, it is noted that the courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Thus, the claimed range merely represents routine optimization of the values of the cited prior art.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Labaer, in view of Leamon, with the added glycerol of Buchberger. Since Buchberger teaches on reagents for IVTT, which is reasonably pertinent to the method of Labaer, in view of Leamon, one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because glycerol is a protein stabilizing-compound (Buchberger, Page 4, paragraph [0081]).
Response to Arguments
Applicant's arguments filed July 16th, 2026 have been fully considered but they are not persuasive.
At Page 6 through Page 7 of the Remarks filed July 16th, 2026, the Applicant notes that claims 2, 12, 23, and 24 have been amended to address the Examiner’s position that the claims did not previously recite IVTT in the independent claims and did not include a claim limitation related to glycerol concentration. In response to this, it is noted that as currently presented, the cited references teach or make obvious these amendments and the rest of the claims as currently presented.
At Page 8 of the Remarks filed July 16th, 2026, the Applicant argues on the teachings of Demidenko and Pocker, specifically regarding how they indicate that lower glycerol concentrations are preferable if glycerol is included in transcriptional and enzymatic reactions. In response to this, it is noted that these references were used to support the arguments in the previous Office Action, but were not a part of the previous 103 rejections. They have not been included as a part of the rejections above, and therefore have no bearing on what is taught and not taught in the rejections as currently presented.
At Page 9 of through Page 10 of the Remarks filed July 16th, 2026, the Applicant reiterates details of the invention from the specification regarding the selection of well dimensions. The Applicant argues that the evidence provided in the description and examples is consistent with the amended claims, and the cited references do not teach or suggest the claimed methods as a whole. In response to the Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., lines 1-6 of paragraph 4 on Page 9 of the Remarks filed July 16th, 2026) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The further assertion that the amended claims are consistent with the evidence provided in the specification is not persuasive given that the rejections as presented above teach all aspects of the claims.
At Page 10 of the Remarks filed July 16th, 2026, the Applicant argues that claims 22 and 23 are independently patentable given the recitation of presence of glycerol that does not exceed 10% (w/w), and the lack of teaching of this limitation in the previously cited references. In response to this argument, it is noted that as currently cited above, this limitation is taught in the prior art and therefore the argument is not persuasive.
It is noted that the rest of Applicant’s arguments related to the 103 rejections on Pages 6 to 9 of the Remarks filed July 16th, 2026 are directed to the use of the Binkert reference. Given that the rejection no longer relies on Binkert, the Applicant’s arguments with respect to claims 2-8, 10-18, and 20-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
All claims stand rejected.
This Office Action includes new rejections necessitated by the amendments and further considerations.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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