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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/04/25 has been entered.
Response to Arguments
Applicant’s arguments, filed 12/04/25, with respect to the rejection of claims under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2015/0141268) in view of Walt et al. (US 6,377,721) have been fully considered but they are not persuasive. Applicant has amended claim 1 to recite “wherein the solid support comprises addressable loci at a density of at least 10 X 10⁶ addressable loci per cm², wherein each addressable locus supports synthesis of an oligonucleotide having a different sequence than oligonucleotides synthesized on the other addressable loci”. Applicant has also amended claim 45 to recite “wherein the solid support comprises addressable loci supporting synthesis of oligonucleotides at a density of about 1 oligonucleotide per 25 nm² to about 1 oligonucleotide per 75 nm², and each addressable locus comprises a diameter up to about 1000 nm”. Applicant then argued that the additional features added in the amended claims are not taught or suggested by the cited prior art. See pages 7-8 of Applicant’s Remarks.
Applicant has argued that Rothberg and Walt do not disclose a solid support that supports synthesis of an oligonucleotide. The Examiner respectfully disagrees and submits both the Rothberg and Walt references teach a solid support that supports synthesis of an oligonucleotide. With respect to the Rothberg reference, the Examiner directs Applicant to Paragraph 0160 where Rothberg discloses attaching the nucleic acid to the bottom of the well of their device. With respect to the Walt reference, the Examiner first directs Applicant to column 12, lines 55-64 and column 14, lines 23-40 of Walt which teach the anchoring of compounds to the bottom of the wells of their device. The Examiner then directs Applicant to column 31, line 55 – column 33, line 60 where Walt discloses screening for oligonucleotides using the compounds in the wells.
Applicant has also argued that Rothberg and Walt do not disclose the feature of “wherein each addressable locus supports synthesis of an oligonucleotide having a different sequence than oligonucleotides synthesized on the other addressable loci”. The Examiner agrees that this feature is not recited by Rothberg. However, the Examiner directs Applicant to column 31, line 55 – column 33, line 60 of Walt. In columns 31-33, Walt teaches forming a library based on the use of a plurality of different nucleic acids in different wells.
Claim Rejections - 35 USC § 112
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.
Claims 1-3, 5, 6, 10, 13, 16 and 18 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. Claim 1 recites the limitation "the other addressable loci" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim.
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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.
Claims 1-3, 5, 6, 10, 13, 16, 18 and 43-53 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2015/0141268) in view of Walt et al. (US 6,377,721). The Examiner submits this rejection was applied in Paragraphs 8-16 of the Final Rejection mailed 08/13/25. The rejection remains in effect. The rejection has been slightly rewritten to address the amendments to claims 1 and 45. However, since the grounds of rejection remain the same and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114, the Office Action has been made Final.
Rothberg teaches an active source pixel integrated device for detection and analysis of biological and chemical compounds. The embodiments of the device most relevant to the instant claims are shown in Figures 3-1 to 3-7F.
Regarding claims 1, 16, 45 and 53 - As shown in Figures 3-1 to 3-7F, Rothberg teaches a device for polymer synthesis, comprising: a solid support, wherein the solid support comprises a plurality of wells (3-210), wherein each of the wells comprises: a) a synthesis surface (3-211) located in a bottom region of each of the wells; b) a light-emitting layer (3-245) in addressable communication with the synthesis surface and situated below the synthesis surface; and c) a CMOS driver (see Paras 0018, 0203 and 0474) located in addressable communication with the light-emitting layer. See Paragraphs 0200- 0233. Rothberg recites a well diameter of 20 nm to 1 micron in Paragraph 0210. Rothberg recites a device having up to 10 million wells, but Rothberg does not teach the specific well density wherein the solid support comprises addressable loci at a density of at least 10 x10⁶ addressable loci per cm². Rothberg also does not teach that each addressable locus supports synthesis of an oligonucleotide having a different sequence than oligonucleotides synthesized on the other addressable loci.
Walt teaches a biosensor array. The embodiment of the device most relevant to the instant claims is shown in Figures 1-3 and described in columns 6-14. The biosensor array is comprised of a plurality of etched wells for holding cells. The array may include up to 100 million or 2 billion etched cells for holding cells or compounds for synthesis and analysis. The wells are formed in a square centimeter of space on a substrate. See columns 11 and 12 of Walt. Walt further teaches forming a library of compounds from a sample based on the use of a plurality of different nucleic acids in different wells in column 31, line 55 – column 33, line 60 of Walt. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the well density from the device of Walt with the device of Rothberg. One of ordinary skill in the art would add the well density to Rothenberg to provide an increased number of wells per square centimeter for high throughput analysis of compounds as taught by Walt. The Examiner further submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the use of different nucleic acid compounds in different wells from Walt with the device of Rothberg. One of ordinary skill in the art would add the different nucleic acid compounds in different wells to Rothberg in order to form a library of nucleotides or analytes from a sample as taught by Walt. With respect to the new limitation of claim 45, the Examiner submits that Rothberg teaches a device having up to 10 million wells (Paragraph 0180) with each well having a single oligonucleotide (Paras 0160 and 0166). As previously noted, Walt teaches up to 2 billion cells on a substrate of a square centimeter. The Examiner submits the combination of Rothberg and Walt would result in a device capable of supporting synthesis of oligonucleotides at a density of about 1 oligonucleotide per 25 nm² to about 1 oligonucleotide per 75 nm² as recited in the claim.
Regarding claims 5, 6, 10 and 13 - Rothberg teaches the excitation source may provide visible radiation at a wavelength between about 350 nm and about 750 nm, near-infrared radiation at a wavelength between about 0.75 micron and about 1.4 microns, and/or short wavelength infrared radiation at a wavelength between about 1.4 microns and about 3 microns in Paragraph 0259.
Regarding claims 18 and 46 - Rothberg recites a well depth of about 50 nm to about 500 nm in Paragraph 0210.
Regarding claims 43, 47 and 48 - Rothberg discloses a transparent oxide layer (3-25/3-610/3-620) having a roughened surface comprised of surface plasmon structures in Paragraphs 0217-and Figures 3-6 to 3-7F.
Regarding claim 44 - Rothberg is silent as to the thickness of the transparent oxide layer, but teaches a silicon dioxide layer of about 150 nm in Paragraph 0382. The Examiner takes the position that the difference between the prior art is one of relative dimensions and the device. In Gardner V. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claims 49-53 - In Figure 4-3B and Paragraph 0280, Rothberg teaches an integrated semiconductor light emitting diode that may be fabricated adjacent to a sample well, in some implementations. A semiconductor LED may comprise a plurality of layers, as depicted in the drawing. The layers may include an electron transport layer 4-352, a hole blocking layer 4-354, and emissive layer 4-356, a hole transport layer 4-357, and an electron blocking layer 4-359, in some implementations. The stack of layers may be electrically contacted by an anode and cathode as described in connection with FIG. 4-3A. The LED structure depicted in FIG. 4-3B may be used for other types of LEDs, including but not limited to OLEDs, PhOLEDs, and a quantum dot LEDs (QLEDs).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798
January 9, 2025 /CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798