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
Note that dependent claims will have the deficiencies of base and intervening claims.
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 20 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 20 requires “. . . ., wherein the polymer comprises a moiety derived from 4-vinylpyridine and a moiety derived from 3-[[2- (methacryloyloxy)ethyl]dimethylammonio]propane-1 sulfonate as the repeating unit. [italicizing by the Examiner]” Applicant’s speciation does not appear to disclose an example of such a “derived“ polymer. It would be helpful if Applicant would provide one or two examples of a polymer intended to be covered by claim 20 so some sense of the scope of the word “derived” in the claim may be better understood.
Claim Rejections - 35 USC § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13 and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Oviatt, Jr. et al. US 2010/0236923 A1 (hereafter “Oviatt”).
Addressing claim 13, Oviatt discloses a reagent layer for an electrochemical sensor (the Examiner is construing the “enzyme layer” in paragraphs [0008] and [0012] and in Oviatt claim 46 as the claimed reagent layer.), comprising: a polymer (“[0012] In another aspect of the first embodiment, the sensor comprises at least one salt comprising acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof, the at least one salt being: . . . ., (iv) associated with the enzyme layer; . . . .” See paragraph [0012]. Also, “[0065] In one aspect, the buffering agent is a polyelectrolyte . . . . Preferred polyelectrolytes are cationic polyelectrolyte salts, or polycations (polymers containing repeat linkages with positive charges) . . . . [italicizing by the Examiner]” See paragraph [0065].) having a proton accepting group in a repeating unit (this feature may be inferred form the following “[0010] In another aspect of the first embodiment, the buffering agent comprises a polyelectrolyte where the anion of the polyelectrolyte is acetate, bicarbonate, carbonate, or mixtures of the anions.[italicizing by the Examiner]” See paragraph [0010]. Also, ‘[0051] The term "polyelectrolyte" as used herein refers to a high molecular weight material having pendent ionizable groups.[italicizing by the Examiner]’ See paragraph [0051].) and having a buffering ability in a pH range of 6 to 8 (This feature ,may be inferred from the following, “It is generally known that when testing an electrochemical analyte sensor in vitro, the testing solution is buffered to simulate the pH of the actual end-use environment of the sensor. Typically, the buffer solution is PBS and the pH is adjusted to that of physiological fluids found in the test subject (e.g., blood, interstitial fluids, urine, etc.).[italicizing by the Examiner]” See paragraph [0006]. Also, “[0067] In one aspect, the buffering agent comprising acetate ion, carbonate ion, bicarbonate ion, or mixtures thereof are present in a molar concentration in excess of any other buffering agent. For example, the buffering agent is present in a molar (or molal) excess to that of the principle components of phosphate buffered saline (PBS) buffer, where a 1xPBS buffer solution would typically have a concentration of 137 mM NaCl, 10 mM Phosphate, 2.7 mM KCl, and a pH of 7.4, . . . .[italicizing by the Examiner]” See paragraph [0067].) and a weight average molecular weight of 10,000 or more and 1000000 or less (“The molecular weight of polyelectrolytes may range from at least about a thousand to at least about a million Daltons.[italicizing by the Examiner]” See paragraph [0051].); and an oxidoreductase “For example, in an embodiment for a glucose sensor, enzyme layer 23 may contain glucose oxidase, such as may be derived from Aspergillus niger (EC 1.1.3.4), type II or type VII.” See paragraph [0113].) capable of maintaining activity in the pH range for oxidizing or dehydrogenating an analyte (this feature may be inferred from the following, “The parameter being measured may be any analyte of interest that occurs in, or may be derived from, blood chemistry. In one embodiment, the analyte of interest may be hydrogen peroxide, formed from reaction of glucose with glucose oxidase, thus having a concentration that is proportional to blood glucose concentration.[italicizing by the Examiner] “ See paragraph [0112]. Also, “It is generally known that when testing an electrochemical analyte sensor in vitro, the testing solution is buffered to simulate the pH of the actual end-use environment of the sensor. Typically the buffer solution is PBS and the pH is adjusted to that of physiological fluids found in the test subject (e.g., blood, interstitial fluids, urine, etc.).[italicizing by the Examiner]” See paragraph [0006].).
Addressing claim 18, for the additional limitation of this claim note the following in Oviatt paragraph [0066]
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As for the polyhistidine being poly-L-histidine, since the stereochemistry is not specified in Oviatt, presumably it could be poly-D-histidine. In any event, “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities.” See MPEP 2144.09(I).
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.
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.
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.
Claims 14, 16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Oviatt in view of Fish et al. US 2003/0022266 A1 (hereafter “Fish”).
Addressing claim 14, as a first matter Oviatt meets all the limitations of underlying claim 13. See the above rejection of claim 13 under 35 U.S.C 102(a)(2). As for the proton accepting group being a heterocyclic nitrogen group, this feature is arguably implied by the listing in Oviatt paragraph [0066] of “poly-4-vinylpyridine [underlining added]” as being a possible polyelectrolyte or polyelectrolyte precursor. In any event, at the least Oviatt clearly discloses the proton accepting group being a nitrogen group, if not a heterocyclic nitrogen group:
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See also the last sentence of Oviatt paragraph [0039] noting “In a preferred aspect, the buffering agent is an aqueous soluble salt of ammonium, alkyl ammonium, . . . .”
Fish discloses novel agents acting as co-factors for replacement of NAD(P)+/NAD(P)H co-enzyme systems in enzymatic oxido-reductive reactions. See paragraph [0003]. These novel agents may be used in a biosensor for transfer of electrons to an electrode. See Figure 4 and paragraph [0033]. A polymer support in the form of a membrane on an electrode may be provided for the novel agents. This polymer support includes an ionic group (“Y”) that functions as a buffer. See Fish Figure 4. paragraph [0033], and paragraphs [0081]-[0094]. The buffering ionic group may be imidazole. See paragraphs [0085] and [0090].
In light of Fish, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to the proton accepting group be a heterocyclic nitrogen group, such as imidazole, because it is prima facie obvious as simple substitution of one known element (buffering ionic group in a polymer membrane of an electrode ) for another to obtain predictable results (namely buffering capacity and pH range). See MPEP 2143(I)(B). This is especially so as Oviatt clearly allows, as indicated above, for different buffering ionic groups, including nitrogen groups.
Addressing claim 16, for the additional limitation of this claim recall from the rejection of underlining claim 14, ‘As for the proton accepting group being a heterocyclic nitrogen group, this feature is arguably implied by the listing in Oviatt paragraph [0066] of “poly-4-vinylpyridine [underlining added]” as being a possible polyelectrolyte or polyelectrolyte precursor.’ Also recall, regarding Fish, “The buffering ionic group may be imidazole. See paragraphs [0085] and [0090]. “
Addressing claim 21, as for ‘[a]n electrochemical sensor for detecting or quantifying an analyte, . . . .” see the Abstract, Figures 1-4, and paragraph [0002]. As for the sensor “comprising: a working electrode; a counter electrode; the reagent layer according to claim 13 disposed on the working electrode; . . . .”, see Figure 1 and paragraphs [0037], [0061], [0112], and [0113]. As for “. . . . and a protective membrane, . . . .” the Examiner is construing flux-limiting membrane 25 in Figure 3 and
paragraph [0113] as also functioning as a protective membrane. As for “. . . ., wherein the polymer does not substantially flow out…”, there is nothing to suggest that the flux-limiting membrane would allow the polymer to substantially flow out. See paragraphs [0087]-[0093]. This is especially so as Oviatt discloses. “ In one aspect, an electrochemical analyte sensor assembly may be configured for an intravenous insertion to a vascular system of a subject.[italicizing by the Examiner]” See
paragraph [0103].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Oviatt in view of Fish and Bertrand et al. US 2020/0155048 A1 (hereafter “Bertrand”).
Addressing claim 15, as a first matter Oviatt meets all the limitations of underlying claim 13. See the above rejection of claim 13 under 35 U.S.C 102(a)(2). Oviatt does not explicitly disclose having the proton accepting group be at least one selected from the group consisting of a phosphate group, a sulfo group, and a carboxy group in an ionization state; however, it will be noted that Oviatt clearly allows for different buffering ionic groups. For example, “ In a preferred aspect, the buffering agent is an aqueous soluble salt of ammonium, alkyl ammonium, alkali, alkali earth, or polycation, the salt comprising at least one of acetate ion, bicarbonate ion, carbonate ion, or mixtures thereof.” See the last sentence of paragraph [0039].
Fish discloses novel agents acting as co-factors for replacement of NAD(P)+/NAD(P)H co-enzyme systems in enzymatic oxido-reductive reactions. See paragraph [0003]. These novel agents may be used in a biosensor for transfer of electrons to an electrode. See Figure 4 and paragraph [0033]. A polymer support in the form of a membrane on an electrode may be provided for the novel agents. This polymer support includes an ionic group (“Y”) that functions as a buffer. See Fish Figure 4. paragraph [0033], and paragraphs [0081]-[0094]. The buffering ionic group may be phosphate or sulfate. See Fish paragraphs [0085] and [0090].
Bertand discloses biofluid sensing devices with pH-buffered EAB1 sensors. See the title. The sensors comprise a polymer buffering material. The polymer buffering material may comprise a zwitterion “configured with functional groups that include an amino acid and a carboxylic acid. See the Abstract, Figure 4, and paragraph [0041].
In light of Fish and Bertand, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to the proton accepting group be at least one selected from the group consisting of a phosphate group, a sulfo group, and a carboxy group in an ionization state because it is prima facie obvious as simple substitution of one known element (buffering ionic group in a polymer membrane of an electrode) for another to obtain predictable results (namely buffering capacity and pH range). See MPEP 2143(I)(B). In this regard consider the following in Bertand
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Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Oviatt in view of Kenneth Curry US 2010/0072062 A1 (hereafter “Curry”).
Addressing claim 22, as a first matter Oviatt meets all the limitations of underlying claim 13. See the above rejection of claim 13 under 35 U.S.C 102(a)(2). Oviatt does not explicitly disclose wherein the electrochemical sensor is a lactic acid sensor. However, though Oviatt exemplifies that electrochemical sensor with a glucose sensor embodiment, it is clearly not so limited. See Oviatt paragraph [0048].
Curry discloses an electrochemical sensor similar to that of Oviatt (compare Curry Figures 1 and 2 with Oviatt Figures 1 and 2). Curry further discloses, “Accordingly, in certain embodiments, the redox reactive species can include glucose oxidase or a glucose dehydrogenase, . . . . Alternatively, the redox reactive species can be a lactate oxidase or lactate hydrogenase.[italicizing by the Examiner]” See Curry
paragraph [0030]. This implies that the analyte in Curry may be glucose or lactic acid.
In light of Curry to instead have the electrochemical sensor of Oviatt instead be a lactic acid sensor is prima facie obvious as simple substitution of one known element (reagent enzyme) for another to obtain predictable results (namely sensing lactic acid instead of glucose). See MPEP 2143(I)(B).
Allowable Subject Matter
Claims 17 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
a) the International Search Report for international application no. PCT/JP2023/026089 cites five “X” documents. The Written Opinion, based on an English language translation obtained by the U.S. Examiner, uses the “X” documents, which are labeled Documents 1-5, to reject various claims. However, none of these documents, based on English language translations or equivalents provided by Applicant or obtained by the U.S. Examiner2, meet all of the features of claim 13 of U.S. application 18/996166, which is the sole independent claim.
For example, JP 2-102455, which is particularly turned to for having the polymer be polyvinylimidazole, does not disclose a reagent layer for an electrochemical sensor, but for an optical sensor. See the last two full paragraphs on page 6 of Applicant provided translation (“These color reaction reagent . . . .” and “In the absorbance method . . . .”). Also, the polyvinylimidazole is not part of the reagent layer, but part of a binding layer for binding the reagent layer to a support. See page 7 of Applicant provided translation. Additionally, the weight average molecular weight of the polyvinylimidazole is not indicated.
JP 2012-11208 A based on English language equivalent US 6,134,461 discloses using copolymers of poly(1-vinyl imidazole) as an electron transfer agent. Moreover, it is complexed with osmium. See col. 20:30-52. So, it is not clear that it could also function as a buffering agent. Additionally, the weight average molecular weight of the poly(1-vinyl imidazole)is not indicated.
b) the Extended European Search Report issued August 5, 2026 in European Patent Application No. 23842940.1 cites eight “X” documents. Five of them are the same “X” documents cited in the International Search Report for international application no. PCT/JP2023/026089. However, none of the three remaining “X” documents meet all of the features of claim 13 of U.S. application 18/996166, which is the sole independent claim.
US 20210347926 A1 discloses using poly(vinylpyridine) or poly(vinylimidazole) as an oxidation-reduction polymer. Moreover, it is complexed with a transition metal, such as osmium. See paragraphs [0015] and [0016]. So, it is not clear that it could also function as a buffering agent. Additionally, the weight average molecular weight of poly(vinylpyridine) or poly(vinylimidazole) is not indicated.
Regarding WO 2021/009559 A1 none of the polymers listed in the referenced paragraphs [0200]-[0202] that could be construed as having a buffering capability appear to be in the reagent, but in a separate layer, such as a limiting membrane or an antifouling layer. Additionally, the weight average molecular weight of any of these polymers is not indicated.
Regarding WO 2010/007391 A, referenced page 9, line 22, along with
claim 22 only discloses an enzyme reagent layer comprising a cation exchange polymer such as polymeric derivatives of imidazole or poly(histidine). The weight average molecular weight of any of these polymers is not indicated nor is the buttering ability of any of them. At best, WO 2010/007391 A is redundant with Oviatt applied in the prior art rejections above.
c) in claim 17 the combination of limitations requires the following underlined feature
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In contrast, although Oviatt as modified by Fish discloses that the proton accepting group in the polymer may be imidazole (see the rejection of claim 14 under 35 U.S.C 103 above) there is no suggestion of the polymer being specifically polyvinylimidazole.
d) in claim 19 the combination of limitations requires the following underlined feature
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In contrast, although Oviatt as modified by Fish and Bertand discloses that the proton accepting group in the polymer may be phosphate (see the rejection of claim 15 under 35 U.S.C 103 above) there is no suggestion of the polymer being specifically sodium polyphosphate.
e) in claim 20 the combination of limitations requires the following underlined feature
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In contrast, although Oviatt discloses a variety of possible polymer compositions (see Oviatt paragraph [0066]), having the polymer comprises a moiety derived from 4-vinylpyridine and a moiety derived from 3-[[2- (methacryloyloxy)ethyl]dimethylammonio]propane-1 sulfonate as the repeating unit does not appear to be suggested. .
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 Electrochemical aptamer-based (“EAB”). See paragraph [005].
2 Namely, US 6,134,461 (JP 201-11208 A), US 20170191955 A1 (JP 2019-50610 A), and
US 20050281729 (WO 2004/112174 A1).
Prosecution Insights