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 .
Election/Restrictions
Applicant’s election without traverse of an enzyme in the reply filed on 6/24/2026 is acknowledged.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation 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.
Claims 29-31 and 43 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.
29-31 & 43. The upper limit of 5,000 nanometers was not in the original disclosure. Thus, this is new matter.
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.
Claims 29-31 & 43 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
29-31 & 43. The term "about" is a relative term which renders the claim indefinite. This term 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. MPEP § 2173.05(b).
Claim Rejections - 35 U.S.C. § 102
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.
Claims 21-22, 24-28, 32-36, 42, and 44 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Wang et al., U.S. Patent App. Pub. No. 2014/0336487 A1 [hereinafter Wang].
The body of the claim is generally written with parentheses following the limitations indicating the prior art's teachings and/or examiner notes.
21. A method of fabricating a tissue-penetrating electrochemical sensor for quantification of a chemical entity or a biochemical entity in a physiological fluid (microneedles for the quantification of glucose or glutamate in fluids such as transdermal fluid or cerebrospinal fluid; Wang [0088]-[0092], figs. 5A-5D), the method comprising:
applying a conducting polymer film to a surface of a working electrode (applying poly(o-phenylenediamine) film; Wang [0097]-[0098], [0120], figs. 5A-5C), the application comprising:
immersing an array of microelectrodes (bicomponent microneedle array electrode; or BMAE; id.) in a solution comprising a biorecognition element and a monomer precursor (solution of o-phenylenediamine, or o-Pd, and enzyme such as glutamine oxidase, or GluOx, and glucose oxidase, or GOx; id.), the array of microelectrodes comprising the working electrode (BMAE; id.); and
applying, during the immersion of the array of microelectrodes in the solution, a potential at the working electrode, the application of the potential resulting in an electrodeposition of the conducting polymer film on the surface of the working electrode (applying voltage to electropolymerize the PPD and GluOx/GOx to the BMAE; id.).
22. The method of claim 21, wherein the conducting polymer film is synthesized from the monomer precursor (rejected for similar reasons stated in the claim 21 rejection).
24. The method of claim 21, wherein the monomer precursor is dissolved in the solution (a solution means that the o-Pd was dissolved). Wang [0097]-[0098], [0120], figs. 5A-5C.
25. The method of claim 21, wherein the electrodeposition of the conducting polymer film comprises a co-electrodeposition of the biorecognition element and the monomer precursor (rejected for similar reasons stated in the claim 21 rejection).
26. The method of claim 21, wherein the biorecognition element comprises at least one of an enzyme, a biocatalyst, an inorganic catalyst, an ion-selective material, an antibody, aptamer, an oligonucleotide, an electrochemical redox mediator, a cell, and an organelle (enzymes GluOx and/or GOx). Wang [0097]-[0098], [0120], figs. 5A-5C.
27. The method of claim 21, wherein the monomer precursor comprises an organic monomer (rejected for similar reasons stated in the claim 21 rejection).
28. The method of claim 21, wherein the potential comprises a fixed potential or a time-varying potential (0.75 V, so fixed). Wang [0097]-[0098], [0120], figs. 5A-5C.
32-34. (Claim 32) The method of claim 21, wherein the array of microelectrodes further comprises another electrode, wherein the application of the potential comprises applying the potential between the working electrode and the other electrode, (claim 33) the method of claim 32, wherein the other electrode comprises a counter electrode or a reference electrode, (claim 34) the method of claim 21, wherein the array of microelectrodes further comprises a counter electrode and a reference electrode, wherein the application of the potential comprises applying the potential between the working electrode and at least one of the counter electrode and the reference electrode. (reference and counter electrodes). Wang [0097]-[0098], [0120], figs. 5A-5C.
35. The method of claim 21, wherein the array of microelectrodes comprises a plurality of working electrodes, wherein the application of the potential comprises applying the potential at each of the plurality of working electrodes, the application of the potential resulting in the electrodeposition of the conducting polymer film on a respective surface of each of the plurality of working electrodes (layer electropolymerized on BMAE). Wang [0097]-[0098], [0120], figs. 5A-5C.
36. A method of fabricating a tissue-penetrating electrochemical sensor for quantification of a chemical entity or a biochemical entity in a physiological fluid, the method comprising: applying a conducting polymer film to a respective surface of each of a plurality of working electrodes, the application comprising: immersing an array of microelectrodes in a solution comprising a biorecognition element and a monomer precursor, the array of microelectrodes comprising the plurality of working electrodes; and applying, during the immersion of the array of microelectrodes in the solution, a potential at the plurality of working electrodes, the application of the potential resulting in an electrodeposition of the conducting polymer film on the respective surface of each of the plurality of working electrodes (rejected for similar reasons stated in the claims 21 and 35 rejections).
42. The method of claim 36, wherein the potential comprises a fixed potential or a time-varying potential (rejected for similar reasons stated in the claim 28 rejection).
44. The method of claim 36, wherein the array of microelectrodes further comprises another electrode comprising a counter electrode or a reference electrode, wherein the application of the potential comprises applying the potential between each of the plurality of working electrodes and the other electrode (rejected for similar reasons stated in the claims 32-24 rejections).
Claims 23 and 41 are rejected under 35 U.S.C. § 103 as being unpatentable over Wang as applied to claims 22 and 36 previously.
23 & 41. (Claim 23) The method of claim 22, wherein the biorecognition element is entrapped … in the conducting polymer film, (claim 41) the method of claim 36, wherein the conducting polymer film is synthesized from the monomer precursor, wherein the biorecognition element is entrapped … in the conducting polymer film (GluOx & GOx are immobilized in the polymer film). Wang [0097]-[0098], [0120], figs. 5A-5C.
Wang is silent on dispersed uniformly in the same embodiment.
However, Wang teaches that mixing homogenizes what’s being mixed. Wang [0153]. A person having ordinary skill in the art would have recognized not just this but also that it is desirable to homogenize in order to avoid areas with too low or too high of a concentration.
Therefore, it would have been obvious with a reasonable expectation of success to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aforementioned prior art’s solution to be mixed to homogenize the solution which in turn would uniformly disburse the biorecognition elements in the film in order to avoid areas with too low or too high of a concentration.
Claims 29-31 and 43 are rejected under 35 U.S.C. § 103 as being unpatentable over Wang as applied to claims 21, 28, and 36 previously, and further in view of Freeman et al., W.O. Int’l Pub. No. 2004/054455 A1 [hereinafter Freeman].
29-31 & 43. (Claim 29) The method of claim 28, wherein the potential is selected to result in a thickness of the conducting polymer film ranging from about 5 to about 5,000 nanometers, (claim 30) the method of claim 21, wherein the potential is applied for a specified time duration to result in a thickness of the conducting polymer film ranging from about 5 to about 5,000 nanometers, (claim 31) the method of claim 21, wherein the potential is selected to pass a specified amount of charge through the working electrode to result in a thickness of the conducting polymer film ranging from about 5 to about 5,000 nanometers, (claim 43) the method of claim 36, wherein the potential is selected to pass a specified amount of charge through each of the plurality of working electrodes to result in a thickness of the conducting polymer film on the respective surface of each of the plurality of working electrodes ranging from about 5 to about 5,000 nanometers. Wang is silent on this.
However, Wang’s layer must have some thickness.
Freeman teaches that a film thickness of 5 nm to several micrometers immobilizes GOx and GluOx and does not degrade the physicochemical properties of the deposited materials. Freeman p. 75 ll. 1-17, p. 76 ll. 1-27.
Therefore, it would have been obvious with a reasonable expectation of success to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the aforementioned prior art’s thickness to be 5 nm to several micrometers in order to have a thickness that would immobilize GOx and GluOx and/or alternatively does not degrade the physicochemical properties of the deposited materials.
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 21-28, 32-36, 41-42, and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-20 of U.S. Patent No. 10,092,207 B1.
Claims 21-36 and 41-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 9-19 of U.S. Patent No. 11,406,818 B2 and (2) claims 7-14 of U.S. Patent No. 10,492,708 B1.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims read on the application’s claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hosung Chung whose telephone number is (571) 270-7578. The examiner can normally be reached Monday-Wednesday, 9 AM - 6 PM CT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached on (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/HOSUNG CHUNG/Primary Examiner, Art Unit 1794
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