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 . 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 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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, 8-10, and 79-88) in the reply filed on 04/01/2026 is acknowledged.
Claims 11 and 65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 1-5, 8-10, and 79-88 are currently under consideration.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 82 is objected to because of the following informalities: the recitation of “w/w/” should instead read –w/w--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “biorecognition element” in claim 1 and “passivation element” in claim 86.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 4 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 pre-AIA the applicant regards as the invention.
Claim 4 contains the trademark/trade name NAFION. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a specific hydrophilic polymer and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4, 8-10, 79, and 85 are rejected under 35 U.S.C. 103 as being unpatentable over by US Patent Application Publication 2021/0204878 (“Huang”) in view of US Patent Application Publication 2023/0363713 (“Poudineh”).
Regarding claim 1, Huang teaches [a] sensor configured to generate a signal that is indicative of a concentration of an analyte in a fluid (Abstract), the sensor comprising a working electrode comprising: an electrode material (¶ 0080, a working electrode); a biorecognition layer disposed at least partially on the electrode material and comprising a biorecognition element that selectively and reversibly binds to an analyte (¶ 0080, the working electrode being coated with sensing polymers such as aptamers – also see ¶ 0009, selectivity and reversibility, ¶¶s 0098, 0113, etc.); and [a] … hydrogel disposed on the biorecognition layer (¶ 0080, further coated with a porous hydrogel material for absorbing tissue fluid to facilitate contact with the microneedle).
Huang does not appear to explicitly teach that the hydrogel is partially desiccated.
Poudineh, in a similar sensor system, teaches that its hydrogel is initially at least partially desiccated (¶¶s 0120, 0363, 0364, etc., swelling from a dry state).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an at least partially desiccated hydrogel into Huang as in Poudineh, for the purpose of being able to extract more interstitial fluid for improved sensing (Poudineh: ¶¶s 0120, 0444, etc.), as already contemplated (Huang: ¶ 0080).
Regarding claim 4, Huang-Poudineh teaches all the features with respect to claim 1, as outlined above. Huang-Poudineh further teaches wherein the hydrogel comprises one or a combination of two or more hydrophilic polymers selected from the group consisting of: agarose (Poudineh: ¶¶s 0105, 0331, 0364, etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use agarose in the hydrogel of the combination, since it has been held to be within the ordinary skill of one in the art to select, as a matter of obvious design choice, a known material on the basis of its suitability for the intended use. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)), poly(urethane), poly(N-vinylpyrrolidone), poly(acrylamide), poly(acrylic acid), poly(methacrylic acid), poly(2-hydroxyethyl methacrylate), poly(acrylic acid-co-acrylamide), poly(N-isopropyl acrylamide), poly(2-acrylamido-2-methylpropane sulfonic acid), poly(ethylene glycol), poly(vinyl alcohol), poly(lactic acid), poly(glycolic acid), poly(glycolic acid-co-lactic acid), collagen, alginate, hyaluronic acid, heparin, glycosaminoglycans, chitosan, Nafion, carboxymethylcellulose, and cellulose acetate.
Regarding claims 8 and 9, Huang-Poudineh teaches all the features with respect to claim 1, as outlined above. Huang-Poudineh further teaches wherein the sensor further comprises a microneedle, and wherein the working electrode is coupled to the microneedle (Huang: Fig. 11D, working electrode 22 coupled to spur 222), wherein the sensor further comprises a microneedle array, and wherein the microneedle is part of the microneedle array (Huang: Abstract, Figs. 5A, 5B, 11D, etc.).
Regarding claim 10, Huang-Poudineh teaches all the features with respect to claim 1, as outlined above. Huang-Poudineh further teaches wherein the biorecognition element comprises an aptamer (Huang: ¶ 0080).
Regarding claim 79, Huang-Poudineh teaches all the features with respect to claim 1, as outlined above. Huang-Poudineh further teaches wherein the at least partially desiccated hydrogel comprises agarose (Poudineh: ¶¶s 0105, 0331, 0364, etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use agarose in the hydrogel of the combination, since it has been held to be within the ordinary skill of one in the art to select, as a matter of obvious design choice, a known material on the basis of its suitability for the intended use. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)).
Regarding claim 85, Huang-Poudineh teaches all the features with respect to claim 10, as outlined above. Huang-Poudineh further teaches wherein the aptamer is functionalized with a redox reporter molecule (Huang: ¶¶s 0035, 0062, etc.).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Huang-Poudineh in view of US Patent Application Publication 2022/0145027 (“Kato”).
Regarding claims 2 and 3, Huang-Poudineh teaches all the features with respect to claim 1, as outlined above. Huang-Poudineh does not appear to explicitly teach wherein the at least partially desiccated hydrogel has a moisture content of about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, or about 90%, or wherein the at least partially desiccated hydrogel has a moisture content of about 0% (although Poudineh does teach measuring a swelling ratio based on dry and wet mass (¶ 0364 – also note the relation of mass to weight), and teaches swelling ratios of e.g. 100-200% (Figs. 4A, 8, 15D, etc.)).
Kato teaches that moisture content is based on a change in weight compared to a dry state (no moisture content), the dry state achieved after drying for 16 hours (¶¶s 0147 and 0148).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to desiccate the hydrogel of the combination to e.g. 0% or 10% moisture content (already implied by the discussion of a “dry” state), thereby achieving a low moisture content “dry” weight as taught by Kato, for the purpose of improved extraction of interstitial fluid (Poudineh: ¶¶s 0120, 0444, etc.; Huang: ¶ 0080). Further, the moisture content is a known results-effective variable because it can be changed as desired to achieve different swelling characteristics or polymer structures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to achieve a moisture content between 0% and 90%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Huang-Poudineh in view of US Patent Application Publication 2024/0393288 (“Heikenfeld’288”).
Regarding claim 5, Huang-Poudineh teaches all the features with respect to claim 1, as outlined above. Huang-Poudineh does not appear to explicitly teach wherein the hydrogel has a thickness of between about 0.001 μm and about 1000 μm, between about 0.01 μm and about 100 μm, between about 0.1 μm and about 10 μm, between about 0.05 μm and about 500 μm, between about 0.1 μm and about 200 μm, or between about 1 μm and about 1000 μm.
Heikenfeld’288 teaches using a hydrogel thickness of e.g. 100 microns as a protective layer (¶ 0125).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a thickness of e.g. 100 microns for the hydrogel of the combination, as in Heikenfeld’288, as a simple substitution with predictable results (Heikenfeld’288: ¶ 0125, protecting the electrode while allowing free motion of aptamers), and as an obvious matter of design choice, since such a modification would have involved a mere change in the size/proportion of a component. A change in size or proportion is generally recognized as being within the level of ordinary skill in the art. See In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Claims 80-82 are rejected under 35 U.S.C. 103 as being unpatentable over Huang-Poudineh in view of US Patent Application Publication 2019/0134598 (“Tran”), as evidenced by non-patent publication “Agarose.” Sigmaaldrich.com, 2016, www.sigmaaldrich.com/US/en/product/sial/a0169?msockid=25895e36709969fa1c90496171b36860. Accessed 13 May 2026 (“Sigma”).
Regarding claims 80-82, Huang-Poudineh teaches all the features with respect to claim 79, as outlined above. Huang-Poudineh does not appear to explicitly teach wherein the agarose has an electroendosmosis of between about 0.09 and about 0.14, wherein the agarose has a melting point of between about 75 degrees Celsius and about 97 degrees Celsius, wherein the agarose has a sulfate content of less than about 0.20% w/w/.
Tran teaches using e.g. Type I-A, low EEO agarose to form a hydrogel (¶ 0028).
Sigma teaches that Type I-A agarose has an EEO of 0.09-0.13, a melting point of 86.5-89.5 °C, and sulfate content less than or equal to 0.20 % (Properties section).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Type I-A agarose in the combination as in Tran, since it has been held to be within the ordinary skill of one in the art to select, as a matter of obvious design choice, a known material on the basis of its suitability for the intended use. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)).
Claims 83 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Huang-Poudineh in view of US Patent Application Publication 2024/0036039 (“Heikenfeld’039”) and US Patent Application Publication 2019/0144919 (“Jackson”).
Regarding claims 83 and 84, Huang-Poudineh teaches all the features with respect to claim 1, as outlined above. Huang-Poudineh does not appear to explicitly teach wherein the biorecognition layer degrades at a rate of not more than about 3% per day when stored at an ambient temperature of between about 15 degrees Celsius and about 30 degrees Celsius, and an ambient humidity of between about 10% and about 80% relative humidity, or wherein the degradation of the biorecognition layer is measured based on a reduction of a signal produced by the electrode material when placed in a liquid comprising the analyte compared to a reference signal strength.
Heikenfeld’039 teaches an aptamer sensor that degrades only about 36% per week in a shelf-stable storage state (Abstract, Fig. 2B, ¶ 0056, etc. – also see Figs. 3B and 4B, showing even less degradation), as measured by a reduction in sensor signal when placed in a sensing state (Fig. 2B, ¶ 0018, voltammogram). The storage state is achieved by incorporating a storage material which can include sugar, polymers, biomolecules, non-aqueous fluids, an inert gas, a vacuum, etc. (¶¶s 0006-0008, 0031).
Jackson teaches that ambient storage conditions include a relative humidity from about 35% to about 75% and a temperature from about 15 °C to about 35 °C (¶ 0124).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to achieve a degradation rate of about 3% per day (in ambient/shelf-stable conditions) in the combination as in Heikenfeld’039 and Jackson, according to the teachings of Heikenfeld’039, for the purpose of improving the stability of the sensor during storage (Heikenfeld’039: ¶ 0003). Further, the degradation rate is a known results-effective variable that can be changed as desired based on storage conditions, including storage material (as evidenced by Heikenfeld’039). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to achieve a degradation rate of about 3% per day, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 86 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Huang-Poudineh in view of US Patent Application Publication 2023/0329592 (“Heikenfeld’592”).
Regarding claims 86 and 87, Huang-Poudineh teaches all the features with respect to claim 1, as outlined above. Huang-Poudineh does not appear to explicitly teach wherein the biorecognition layer further comprises a passivation element disposed at least partially on the electrode material, wherein the passivation element comprises one or more of thiol-based small molecules and zwitterions.
Heikenfeld’592 teaches, in a similar sensor, using a thiol-based small molecule passivation element (¶¶s 0021, 0032, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the passivation element of Heikenfeld’592 into the combination for the purpose of sensing only at target sites, and as is conventional (Heikenfeld’592: ¶¶s 0021, 0027, etc.).
Claim 88 is rejected under 35 U.S.C. 103 as being unpatentable over Huang-Poudineh-Kato in view of US Patent Application Publication 2024/0393288 (“Heikenfeld’288”).
Regarding claim 88, Huang-Poudineh-Kato teaches all the features with respect to claim 2, as outlined above. Huang-Poudineh-Kato does not appear to explicitly teach wherein the moisture content is a percentage of buffered saline in the at least partially desiccated hydrogel.
Heikenfeld’288 teaches using phosphene buffered saline (PBS) in the manufacture process of an electrochemical aptamer sensor (¶ 0114).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use PBS in the manufacture of the sensor of the combination, as in Heikenfeld’288, since it has been held to be within the ordinary skill of one in the art to select, as a matter of obvious design choice, a known material on the basis of its suitability for the intended use. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). Thus, any amount of PBS remaining after desiccation can be used as a reference (and note that this amount, which might otherwise be considered part of the moisture content, is now excluded). Considering that the hydrogel is dried (even completely dried) based on the teachings of Poudineh and Kato, its moisture content is now e.g. 0% or 10% of any other element, including PBS.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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