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 .
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.
Claim 14 is 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 14 recites the limitation "the voltage" in line 3. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “a voltage” is one way to resolve the indefiniteness issues.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2 and 11-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (Hypersensitive Electrochemical Biosensors based on Nanowell Array Structures for Point of Care Technology, cited in IDS filed 07/28/2022, Full Copy added to the record).
Regarding claim 2, Lee discloses a method of manufacturing a biosensor (pg. 13-16/3.3. Wafer-scale Fabrication of New NWA Electrode), the method comprising:
forming a buffer layer on a substrate layer (Figure 1.5., see: (i) SiO2 deposition onto 6-inch wafer);
forming a metal layer on the buffer layer (Figure 1.5., see: (ii) Au deposition);
forming a desired patterned electrode by patterning the metal layer using a first photolithography process (Figure 1.5., see: (iii) Micro-electrode Patterning, (iv) Au Etching and PR removal; Figure 1.4., see: “photolithography masks”);
forming an inorganic insulation layer on the desired patterned electrode (Figure 1.5., see: (v) SiO2 deposition);
forming a plurality of a nanowell on the inorganic insulation layer by exposing an area of the desired patterned electrode using a second photolithography process (Figure 1.5., see: (vi) Nanowell array patterning, (vii) SiO2 etching and PR removal; Figure 1.4., see: “photolithography masks”); and
washing the plurality of the nanowell with a sulfuric acid (H2SO4) solution to remove an impurity from the desired patterned electrode exposed by the plurality of the nanowell (pg. 23-24/Novelty 5: Regeneration of electrode, see: “regeneration was performed by using 10 mM H2SO4/CV and 5 mM K3Fe(CN)6/CV with sweep method for remove organic layer on the electrode and succeed to regenerate by 20 times”); and
washing the plurality of the nanowell by a ferricyanide etching, thereby removing impurities on the plurality of a nanowell of the desired patterned electrode (pg. 23-24/Novelty 5: Regeneration of electrode, see: “regeneration was performed by using 10 mM H2SO4/CV and 5 mM K3Fe(CN)6/CV with sweep method for remove organic layer on the electrode and succeed to regenerate by 20 times”).
Regarding claim 11, Lee further discloses the ferricyanide etching is performed at a temperature in a range of 15-25 °C (pg. 79/2.2. Electrochemical Analysis of DropSens Electrode, see: “room temperature”; room temperature is 20 °C) for 1 to 10 seconds (pg. 42-44/2. Electrochemical Analysis of NWA, see: “Pulse width is 0.05 s”; pg. 79/2.2. Electrochemical Analysis of DropSens Electrode, see: “total of 71 measurement points that were used in the software analysis”; 71 measurement points * 0.05 s = 3.55 s).
Regarding claim 12, Lee further discloses the desired patterned electrode comprises gold (Au) (Figure 1.5., see: (iii) Micro-electrode Patterning, (iv) Au Etching and PR removal).
Regarding claim 13, Lee further discloses the inorganic insulation layer comprises SiO2 or Si3N4 (Figure 1.5., see: (v) SiO2 deposition).
Regarding claim 14, Lee further discloses washing the plurality of the nanowell with the sulfuric acid (H2SO4) solution by immersing the plurality of the nanowell in the sulfuric acid (H2SO4) solution (pg. 114-117/1.2. Research Objective, see: “dust or organic layer on the Au electrode is cleaned completely by dipping in Piranha solution (mixture of sulfuric acid and hydrogen peroxide)”) and applying the voltage of 1.0-1.5 V (pg. 120/2.4. Experimental procedure of cleaning, see: “CV was performed with a scan rate of 200 mV/sec in -1.2V to 1.2V”) for 1-5 minutes (pg. 114-117/1.2. Research Objective, see: “for 1 minute”).
Regarding claim 15, Lee further discloses a pitch ratio of the plurality of the nanowell is defined as a size of each nanowell to the shortest distance between adjacent nanowell, wherein the pitch ratio is 1 : 3 or less (pg. 40-42/1. Optical analysis of NWA electrode, see: “Each NWA structure had a diameter of 400 nm width an interwell spacing of 200 nm”).
Regarding claim 16, Lee further discloses the washing the plurality of the nanowell with a sulfuric acid (H2SO4) solution is performed for a duration of 1 to 10 seconds (Figure 6.15., see: regeneration period which extends between 22.0 and 23.0 seconds).
Regarding claim 17, Lee further discloses the washing the plurality of the nanowell by a ferricyanide etching comprises applying a voltage (pg. 42-44/2. Electrochemical Analysis of NWA, see: “Potential is scanned between -300 mV to 700 mV at 100 mV/s scan rate”).
Regarding claim 20, Lee further discloses the ferricyanide etching is performed by immersing the plurality of the nanowell in a mixed solution of K3Fe(CN)6 and KCI (pg. 42-44/2. Electrochemical Analysis of NWA, see: “5 mM K3Fe(CN)6 + 0.1 M KCl as electrolyte”).
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.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Hypersensitive Electrochemical Biosensors based on Nanowell Array Structures for Point of Care Technology, cited in IDS filed 07/28/2022, Full Copy added to the record), in view of by Suri (Fabrication of Nanoelectrode Arrays for Dopamine Detection, cited in IDS filed 07/28/2022).
Regarding claims 18-19, Lee does not explicitly disclose the voltage being 1.25-1.5 V for one or two cycles.
Suri (Figure 3.15; Table 1) teaches that it was known in the art at the time of the invention that increasing the applied voltage increases the forward peak voltage, peak separation, and peak current ratio. Therefore the forward peak voltage, peak separation, and peak current ratio are variables that can be modified, among others, by varying the applied voltage. For that reason, the applied voltage, would have been considered a result effective variable by one having ordinary skill in the art, before the effective filing date of the claimed invention. As such, without showing unexpected results, the applied voltage cannot be considered critical. Accordingly, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have optimized, by routine experimentation, the applied voltage in the method disclosed by Lee to obtain the desired forward peak voltage, peak separation, and peak current ratio (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
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 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,435,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader scope of the instant claim would fully encompass the narrower subject matter defined by the prior art claims.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,435,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader scope of the instant claim would fully encompass the subject matter defined by the prior art claim.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,435,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader scope of the instant claim would fully encompass the subject matter defined by the prior art claim.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 11,435,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader scope of the instant claim would fully encompass the subject matter defined by the prior art claim.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,435,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader scope of the instant claim would fully encompass the subject matter defined by the prior art claim.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,435,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader scope of the instant claim would fully encompass the subject matter defined by the prior art claim.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,435,311. While the prior art patent does not recite a washing duration, one having ordinary skill in the art, before the effective filing date of the claimed invention, would have optimized, by routine experimentation, the washing duration in order to maximize electrode regeneration while minimizing wear and tear (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,435,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader scope of the instant claim would fully encompass the subject matter defined by the prior art claims.
Claims 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,435,311 in view of Suri (Fabrication of Nanoelectrode Arrays for Dopamine Detection, cited in IDS filed 07/28/2022). While the prior art patent recites a broader voltage range, one having ordinary skill in the art, before the effective filing date of the claimed invention, would have optimized, by routine experimentation, the applied voltage in the recited method to obtain the desired forward peak voltage, peak separation, and peak current ratio (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,435,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the broader scope of the instant claim would fully encompass the subject matter defined by the prior art claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2 and 11-20 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.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 5712721254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT J EOM/ Primary Examiner, Art Unit 1797