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 (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.
Election/Restrictions
Applicant’s election of Invention I, drawn to an analyte sensor and system of claims 1-13 and 15 in the reply filed on 6/11/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim(s) 14 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/11/26.
Claim Objections
Claim 1 is objected to because of the following informalities: “the first layer” (lines 13-14) appears that it should be “the at least one first layer.”
Claim 1 is objected to because of the following informalities: “the second layer” (lines 19-20) appears that it should be “the at least one second layer.”
Claim 2 is objected to because of the following informalities: “the first layer” (line 1) appears that it should be “the at least one first layer.”
Claim 3 is objected to because of the following informalities: “the second layer” (line 1) appears that it should be “the at least one second layer.”
Claim 4 is objected to because of the following informalities: “the first layer” (line 1) appears that it should be “the at least one first layer.”
Claim 4 is objected to because of the following informalities: “the first layer” (line 2) appears that it should be “the at least one first layer.”
Claim 4 is objected to because of the following informalities: “the second layer” (line 3) appears that it should be “the at least one second layer.”
Claim 4 is objected to because of the following informalities: “the first layer” (line 4) appears that it should be “the at least one first layer.”
Claim 4 is objected to because of the following informalities: “the second layer” (line 5) appears that it should be “the at least one second layer.”
Claim 5 is objected to because of the following informalities: “the first layer” (line 1) appears that it should be “the at least one first layer.”
Claim 5 is objected to because of the following informalities: “the first layer” (line 2) appears that it should be “the at least one first layer.”
Claim 6 is objected to because of the following informalities: “the first layer” (line 1) appears that it should be “the at least one first layer.”
Claim 6 is objected to because of the following informalities: “the first layer” (line 2) appears that it should be “the at least one first layer.”
Claim 7 is objected to because of the following informalities: “the second layer” (line 1) appears that it should be “the at least one second layer.”
Claim 7 is objected to because of the following informalities: “the second layer” (line 2) appears that it should be “the at least one second layer.”
Claim 8 is objected to because of the following informalities: “the second layer” (line 1) appears that it should be “the at least one second layer.”
Claim 8 is objected to because of the following informalities: “the second layer” (lines 2-3) appears that it should be “the at least one second layer.”
Appropriate correction is required.
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(s) 4, 6, 8, 10-11, and 13 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.
For claim 4, the claim language “at least two fields of the first layer” is ambiguous. Claim 1, form which claim 4 depends, already recites “at least two fields of the first layer.” Therefore, it is unclear whether the same or different fields of the first layer are being referred to. The claim is examined under the former interpretation.
For claim 4, the claim language “the second layer is located on the second side of the substrate as at least two fields” is ambiguous. Claim 1, form which claim 4 depends, already recites “at least two fields of the second layer.” Therefore, it is unclear whether the same or different fields of the second layer are being referred to. The claim is examined under the former interpretation.
For claim 4, the claim term “the plane of the substrate” lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 6, the claim language “wherein the first layer is located on the first side of the substrate as at least two fields” is ambiguous. Claim 1, form which claim 4 depends, already recites “at least two fields of the first layer.” Therefore, it is unclear whether the same or different fields of the first layer are being referred to. The claim is examined under the former interpretation.
For claim 8, the claim language “wherein the second layer is located on the second side of the substrate as at least two fields” is ambiguous. Claim 1, form which claim 4 depends, already recites “at least two fields of the second layer.” Therefore, it is unclear whether the same or different fields of the second layer are being referred to. The claim is examined under the former interpretation.
For claim 10, the claim term “the stiffness of the ex-vivo portion” (lines 1-2) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 10, the claim term “the stiffness of the in-vivo portion” (line 2) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 11, the claim term “the region of the in-vivo portion” (line 3) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 11, the claim term “the region of the ex-vivo portion” (line 4) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 13, the claim term “the region of the in-vivo portion” (line 3) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 13, the claim term “the region of the ex-vivo portion” (line 4) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
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)(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) 1-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2021/0219885 to Wang et al. (hereinafter “Wang”).
For claim 1, Wang discloses an analyte sensor for determining at least one analyte (Abstract), the analyte sensor comprising:
a substrate (212) (Figs. 2A-B) (para [0056]) which has a length (unlabeled, but as can be seen in Figs. 2A-B) and a width (unlabeled, but as can be seen in Fig. 5A) and which comprises a first side (unlabeled, but upper side shown in Fig. 5B) and a second side which opposes the first side (unlabeled, but lower side shown in Fig. 5B), an in-vivo portion (unlabeled, but distal portion shown in Fig. 4A), an ex-vivo portion (unlabeled, but proximal portion shown in Fig. 4A) and an intermediate portion wherein the intermediate portion connects the in-vivo portion with the ex-vivo portion (unlabeled, but the connecting portion between the distal and proximal portions shown in Fig. 4A),
at least one first conductive material (214a) (Fig. 5B) (para [0061]) which is located on the first side of the substrate (as can be seen in Fig. 5B),
at least one second conductive material (214b) (Fig. 5B) (para [0061]) which is located on the second side of the substrate (as can be seen in Fig. 5B),
at least one first layer (218a, 219b) (Fig. 5B) (para [0056] and [0060]) which is located on the first side of the substrate (as can be seen in Fig. 5B) and covers the first conductive material partially (as can be seen in Fig. 5B) and which has a varying thickness along the length of the substrate (as can be seen in Fig. 5B) and/or which is located on the first side of the substrate as at least two fields of the first layer which are separate from one another wherein each of the at least two fields extends over the whole width of the substrate,
at least one second layer (218b, 219c) (Fig. 5B) (para [0056] and [0060]) which is located on the second side of the substrate (as can be seen in Fig. 5B) and covers the second conductive material partially (as can be seen in Fig. 5B) and which has a varying thickness along the length of the substrate (as can be seen in Fig. 5B) and/or which is located on the second side of the substrate as at least two fields of the second layer which are separate from one another wherein each of the at least two fields extends over the whole width of the substrate.
For claim 2, Wang further discloses wherein the first layer comprises at least one material selected from the group consisting of a third conductive material, an insulating material, a sensing material, a biocompatibility material and a flux limiting material (para [0062]).
For claim 3, Wang further discloses wherein the second layer comprises at least one material selected from the group consisting of a fourth conductive material, an insulating material, a silver containing material, a biocompatibility material, a flux limiting material and a hydrophobic polymer material (para [0062]).
For claim 4, Wang further discloses wherein the first layer is located on the first side of the substrate as at least two fields of the first layer and wherein the second layer is located on the second side of the substrate as at least two fields (as can be seen in Fig. 5B and/or 5D), wherein a projection of the at least two fields of the first layer into the plane of the substrate and a projection of the at least two fields of the second layer into the plane of the substrate do not overlap (see Fig. 5D) (para [0066]).
For claim 5, Wang further discloses wherein the first layer has a varying thickness along the length of the substrate (as can be seen in Fig. 5B), and wherein the first layer comprises a material selected from the group consisting of an insulating material, a third conductive material, a biocompatibility material and a flux limiting material (para [0062]).
For claim 6, Wang further discloses wherein the first layer is located on the first side of the substrate as at least two fields (as can be seen in Fig. 5B), and wherein the first layer comprises at least one material selected from the group consisting of an insulating material, a third conductive material and a sensing material (para [0062]).
For claim 7, Wang further discloses wherein the second layer has a varying thickness along the length of the substrate (as can be seen in Fig. 5B) and wherein the second layer comprises at least one material selected from the group consisting of an insulating material, a fourth conductive material, a biocompatibility material, a silver containing material and a hydrophobic polymer material (para [0062]).
For claim 8, Wang further discloses wherein the second layer is located on the second side of the substrate as at least two fields (as can be seen in Fig. 5B), and wherein the second layer comprises at least one material selected from the group consisting of an insulating material, a fourth conductive material, a silver containing material and a hydrophobic polymer material (para [0062]).
For claim 9, Wang further discloses wherein the analyte sensor has a varying stiffness along its length (as can be seen in Fig. 5B, the thickness varying based on the number of layers (i.e., more layers = stiffer) along the length of the sensor).
For claim 10, Wang further discloses wherein the stiffness of the ex-vivo portion is smaller than the stiffness of the in-vivo portion (as can be seen in Fig. 5B, there is a space between 219a and 230 as well as a space between 219b and 218a).
For claim 11, Wang further discloses wherein the first layer has a varying thickness along the length of the substrate (as can be seen in Fig. 5B) and wherein the thickness of the first layer is higher in the region of the in-vivo portion of the substrate than the thickness of the first layer in the region of the ex-vivo portion (as can be seen in Fig. 5B, there is a space between 219a and 230 as well as a space between 219b and 218a).
For claim 12, Wang further discloses wherein the thickness of the first layer varies between 0.1 µm and 200 µm and/or the thickness of the second layer varies between 0.1 µm and 200 µm (para [0071]).
For claim 13, Wang further discloses wherein the second layer has a varying thickness along the length of the substrate (as can be seen in Fig. 5B) and wherein the thickness of the second layer is higher in the region of the in vivo portion of the substrate than in the thickness of the second layer in the region of the ex-vivo portion (as can be seen in Fig. 5B, there is a space between 219a and 230 as well as a space between 219b and 218a).
For claim 15, Wang further discloses an analyte sensor system (Abstract) comprising an analyte sensor according to claim 1 (see rejection of claim 1), an electronics unit (120, 170, and/or 180), the electronics unit being configured to electronically connect to the analyte sensor (as can be seen in Fig. 1) (para [0050]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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, Jennifer Robertson can be reached at (571) 272-5001. 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.
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
Prosecution Insights