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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 27, 2026; August 14, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on August 14, 2024 are accepted.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Staib et al. (US 10.422,765 B2) (“Staib”) in view of Mamidi et al. (US 2024/0350485 A1) (“Mamidi”).
Regarding claim 1, Staib discloses A glucose diffusion control layer solution for a continuous blood glucose-measuring biosensor, comprising (Abstract and entire document):
a hydrophilic material; and a hydrophobic material (Col. 3 line 54 -col. 4, “As noted above, the diffusion barrier includes a block copolymer, such as a single block copolymer having at least one hydrophilic block and at least one hydrophobic block.”),
wherein the hydrophobic material comprises a styrene block copolymer (Claim 25, styrene block copolymer as the hydrophobic material).
Staib fails to disclose wherein the hydrophilic material comprises an aliphatic polyether-based thermoplastic polyurethane, and
However, in the same field of endeavor, Mamidi teaches wherein the hydrophilic material comprises an aliphatic polyether-based thermoplastic polyurethane, and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the solution as taught by Staib to include wherein the hydrophilic material comprises an aliphatic polyether-based thermoplastic polyurethane as taught by Mamidi to have desirable properties ([0154], “Accordingly, it can be advantageous to utilize a combination of two different polymeric materials, rather than making the system housing entirely of the water-swelling hydrophilic, drug-permeable second material, to achieve desired mechanical properties of the tube.”).
Regarding claim 5, Staib as modified discloses The glucose diffusion control layer solution of claim 1, Staib discloses wherein the hydrophilic material and hydrophobic material have a weight ratio of 1:0.1 to 4 (Col. 12 discussing ratio of hydrophilic to hydrophobic blocks).
It would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal ratio, including a weight ratio of 1:0.1 to 4. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the weight ratio of 1:0.1 to 4, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 6, Staib as modified discloses A glucose diffusion control layer for a continuous blood glucose-measuring biosensor, Staib as modified further discloses which is prepared by drying the glucose diffusion control layer solution of claim 1 (Staib, Abstract and entire document, diffusion control layer for analyte sensors).
Regarding claim 7, Staib as modified discloses A continuous blood glucose-measuring biosensor, Staib as modified further discloses comprising the glucose diffusion control layer of claim 6 (Staib, Abstract and entire document, diffusion control layer for analyte sensors).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Staib in view of Mamidi in further view of Simpson et al. (US 2019/0290474 A1) (”Simpson”).
Regarding claims 2-4, Staib as modified discloses The glucose diffusion control layer solution of claim 1, wherein the aliphatic polyether-based thermoplastic polyurethane has a specific gravity of 1.0 to 1.2 g/cm3 according to the ASTM D792 measurement method, and a shore hardness of 78 to 88A according to the ASTM D2240 measurement method, and wherein the aliphatic polyether-based thermoplastic polyurethane has a flexural modulus of 2,400 to 3,400 psi according to the ASTM D790 measurement method, an ultimate tensile of 1,700 to 2,700 psi in a dry state and an ultimate tensile of 900 to 1,900 psi in a wet state according to the ASTM D412 measurement method, and an ultimate elongation of 540 to 1,540 psi in a dry state and an ultimate elongation of 320 to 920 psi in a wet state according to the ASTM D412 measurement method (Mamidi: [0121 – 0130] properties of Tecophilic HP-93A-100.).
Staib as modified fails to disclose wherein the styrene block copolymer has a specific gravity of 0.9 to 1.1 g/cm3 according to the ISO 1183-1 measurement method, and a shore hardness of 60 to 80A according to the ISO 48- 4 measurement method. wherein the styrene block copolymer has a tensile strength of 8.2 to 10.2 MPa according to the ISO 37 measurement method, an elongation at break of 414 to 614% according to the ISO 37 measurement method, and a tear strength of 15 to 25 N/mm according to the ISO 34-1 measurement method.
However, in the same field of endeavor, Simpson teaches wherein the styrene block copolymer has a specific gravity of 0.9 to 1.1 g/cm3 according to the ISO 1183-1 measurement method, and a shore hardness of 60 to 80A according to the ISO 48- 4 measurement method. wherein the styrene block copolymer has a tensile strength of 8.2 to 10.2 MPa according to the ISO 37 measurement method, an elongation at break of 414 to 614% according to the ISO 37 measurement method, and a tear strength of 15 to 25 N/mm according to the ISO 34-1 measurement method (FIG. 6 and [0039] and [0127 – [0130], Thermolast, properties of).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the solution as taught by Staib as modified to include wherein the styrene block copolymer has a specific gravity of 0.9 to 1.1 g/cm3 according to the ISO 1183-1 measurement method, and a shore hardness of 60 to 80A according to the ISO 48- 4 measurement method. wherein the styrene block copolymer has a tensile strength of 8.2 to 10.2 MPa according to the ISO 37 measurement method, an elongation at break of 414 to 614% according to the ISO 37 measurement method, and a tear strength of 15 to 25 N/mm according to the ISO 34-1 measurement method as taught by Simpson to obtain desired hardness/qualities of the material ([0127 – 0130]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791
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