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.
Claims 1-20 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:
a) claim 1 requires
PNG
media_image1.png
148
714
media_image1.png
Greyscale
Applicant’s as -filed specification defines a “natural polymer compound” as follows
PNG
media_image2.png
262
692
media_image2.png
Greyscale
Claim 2, though, states,
PNG
media_image3.png
104
684
media_image3.png
Greyscale
These underlined phrases in claim 2 (“cellulose and its derivatives”, “chitosan and its derivatives”, and “starch and its derivatives”), though, allow for non-natural polymer compounds, such as cellulose acetate. Applicant is requested to clarify the scope of each of these phrases relative to “natural polymer compound” as defined in Applicant’s specification.
b) claim 1 states,
PNG
media_image4.png
88
690
media_image4.png
Greyscale
The scope of the term “sensitive moiety” is not clear as it appears to be a term unique to Applicant, as used here, and is undefined by Applicant. If Applicant is being his own lexicographer, please heed MPEP
2173.05(a). Applicant is requested to provide two or three examples of a sensitive moiety that is not an enzyme.
c) independent claim 15 requires
PNG
media_image5.png
60
678
media_image5.png
Greyscale
The scope of the term “sensitive moiety” is not clear as it appears to be a term unique to Applicant, as used here, and is undefined by Applicant. If Applicant is being his own lexicographer, please heed MPEP
2173.05(a). Applicant is requested to provide two or three examples of a sensitive moiety that is not an enzyme (see claim 17).
d) claim 17 requires
PNG
media_image6.png
122
714
media_image6.png
Greyscale
Is not the “a sensitive moiety immobilized with the oxidized natural polymer compound as a cross-linking agent…” of clam 17 the sensitive moiety immobilized in underlying claim 15 (“immobilizing a sensitive moiety in . . . .)?
e) claims 19 and 20 are indefinite because none of the indicated concentrations have an associated unit (for example, in claim 19 – “a concentration of the sensitive moiety is within a range of 0.5% to 20%; . . . .”).
f) claim 19 has the following underlined limitations
PNG
media_image7.png
196
688
media_image7.png
Greyscale
Should not all highlighted occurrences of the article “a” be replaced with – the – as in claim 20? Otherwise, the claim may be interpreted to mean that the sensitive moiety, oxidized natural polymer, and enzyme stabilizer may each have more than one concentration at the same time, and the. temperature of the cross-linking reaction may be more than one temperature.
Allowable Subject Matter
Claims 1 and 15 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 2-14 and 16-20 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 combination of limitations in claim 1 requires the following underlined features
PNG
media_image8.png
146
724
media_image8.png
Greyscale
a)(i) The Written Opinion for international application no. PCT/CN2023/100831 deems claims 1-25 to have novelty, but lack an inventive step. The claims are rejected over CN 114027834 A, referred to as D1, with an English language translation provided by Applicant, together with a thesis by Jian Xia, referred to as D2, based on an English language translation obtained by the U.S. Examiner. The claim 1 rejection acknowledges that D1 discloses “. . . ., and adding a crosslinking agent glutaraldehyde into an enzyme solution; and spin-coating the polyurethane outer membranes on the first surface and the second surface.” So, the rejection turns to D2 for “an oxidized natural polymer compound is used as a sensitive element fixed by a crosslinking agent, and the oxidized natural polymer compound is obtained by means of oxidation treatment of a natural polymer compound.” However, D2 discloses an optical not an electrode -based biosensor:
PNG
media_image9.png
584
624
media_image9.png
Greyscale
Also, the Written Opinion provides no motivation to replace the polyurethane membrane in D1 with the cellulose membrane of D2. The Written Opinion just states, “ Inventive Step - The described difference is disclosed in D2. It would be obvious to a person skilled in the art to arrive at the technical solutions of claim 1 and 15 by combining D1 and D2.”
a)(ii) The EPO Communication for application no. 23821472.0 – 1111/4343316 PCT/CN2023100831 cites fifteen documents (D1 – D15). However, the claims are rejected primarily, if not completely, over documents D1-D3.
D1, CN 111796016 A, based on an English language translation provided by Applicant, though, does not disclose “. . . ., wherein the enzyme membrane layer includes a sensitive moiety immobilized with an oxidized natural polymer compound as a cross-linking agent, and the oxidized natural polymer compound is obtained by oxidizing a natural polymer compound.” The EPO Communication states,
PNG
media_image10.png
680
1364
media_image10.png
Greyscale
However, as best understood by the U.S. Examiner the cellulose filter paper does not function as an enzyme membrane, but as an electrode substrate or support. In fact, the paper is coated with hydrophobic material except where the electrode is located. It is the electrode or the reagent on the electrode that is treated with periodate, not the paper. For example,
PNG
media_image11.png
1010
1400
media_image11.png
Greyscale
D2, WO 01/27626 A2, does not disclose “. . . ., wherein the enzyme membrane layer includes a sensitive moiety immobilized with an oxidized natural polymer compound as a cross-linking agent, and the oxidized natural polymer compound is obtained by oxidizing a natural polymer compound.” While the paper in D2 is oxidized with periodate, this is done before any reagent contacts the paper and after washing of the paper with deionized water:
PNG
media_image12.png
534
880
media_image12.png
Greyscale
PNG
media_image13.png
804
882
media_image13.png
Greyscale
D3, EP 0214805 B1, does not disclose “. . . ., wherein the enzyme membrane layer includes a sensitive moiety immobilized with an oxidized natural polymer compound as a cross-linking agent, and the oxidized natural polymer compound is obtained by oxidizing a natural polymer compound.” The rejection in the EPO Communication based D3 states
PNG
media_image14.png
418
1316
media_image14.png
Greyscale
However, there is no indication of periodate functioning as a cross-linking agent. D3 clearly discloses that the periodate oxidizes the surface -OH groups of the aldehyde groups so that a protein or enzyme may be attached to the pullan:
PNG
media_image15.png
144
692
media_image15.png
Greyscale
PNG
media_image16.png
416
712
media_image16.png
Greyscale
One of ordinary skill in the art would expect that if any cross-linking is to occur during manufacture of the biosensor that it would occur during the earlier photo-polymerization of the pullan:
PNG
media_image17.png
129
694
media_image17.png
Greyscale
a)(iii) The Official Action in Russia Application No. 2024138614 mailed on April 11, 2025, based on an English language translation provided by Applicant and as best understood by the U.S. Examiner, rejects claim 1 of the Russian application over US 2017108459 A1, referred to as D1, together with JPH 01152357 A, referred to as D2, based on an English language translation provided by Applicant. However, neither D1 nor D2 discloses “. . . ., wherein the enzyme membrane layer includes a sensitive moiety immobilized with an oxidized natural polymer compound as a cross-linking agent, and the oxidized natural polymer compound is obtained by oxidizing a natural polymer compound.” In particular, none of the possible crosslinking agents listed in paragraphs [0054]-[0061] of D1 (the cross-linking agent appears unspecified in D2) is an oxidized natural polymer compound as defined by Applicant in the US application(nor has the Russian Office Action pointed out any particular listed cross-linking agent):
PNG
media_image18.png
256
716
media_image18.png
Greyscale
b) claims 2-14 depend directly or indirectly from allowable claim 1.
c) the discussion above regarding the allowability of claim 1 also applies to independent claim 15.
d) claims 16-20 depend directly or indirectly from allowable claim 15.
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.
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, 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDER S NOGUEROLA/Primary Examiner, Art Unit 1795
Prosecution Insights