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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/21/2026 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1 is/are amended and claim(s) 4-5 were previously canceled. Claim 25 is added. Claims 9 and 11-12 remain withdrawn. Claims 1-3, 6-8, 10, and 25 are now pending examination.
Response to Arguments
Applicant's arguments filed 9/21/2026 have been fully considered but they are not persuasive.
Regarding the amendment to claim 1 to include the limitation “a conducting coating that has been applied to the surgical suture material by coating the surgical suture material with a solution including PEDOT:PSS, sorbitol, and metal flakes that are mixed prior to being coated on the surgical material,” Applicant argues the amendment overcomes the rejection. Examiner respectfully disagrees. The addition of the limitation “mixed prior to being coated on the surgical material” is a process claim while the claim itself is directed to an apparatus, thus the amended limitation is a product-by-process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Further, "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). MPEP 2113.
Applicant’s argument merely states the process of forming the suture as claimed and the process according to the prior art are different, however, has not shown any evidence that the resulting products would not be substantially identical. Whether the PEDOT:PSS, sorbitol, and metal flakes are mixed prior to being coated on the surgical material or are coated in layers, or any other process would result in the same end product—a suture comprising a coating of PEDOT:PSS, sorbitol, and metal flakes. As such, the claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Thus, the rejection under Ho as modified by Lendlein, He, and Sober is maintained.
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.
Claim(s) 1, 6-8, 10, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ho et al. (US 20220401031 A1) (previously of record) in view of Lendlein et al. (US 20040015187 A1) (previously of record), He et al. (“Enhancements in the Mechanical Stretchability and Thermoelectric Properties of PEDOT:PSS for Flexible Electronics Applications”) (previously of record) and Sober et al. (WO 2023034258 A1) (previously of record).
Regarding claim 1, Ho teaches a suture, comprising:
a surgical suture material (silk) (Paragraph 0211; 0217; 0253); and
a conducting coating (PEDOT:PSS) that has been applied to the surgical suture material by coating the surgical suture material with a solution including PEDOT:PSS (Paragraph 0030; 0211; 0217).
Ho fails to explicitly disclose wherein an electrical conductivity of the suture is greater than 500 S/cm per 1964 µm2 of cross-sectional area of the suture and coating the surgical suture material with a solution including sorbitol and metal flakes.
Lendlein is directed to a suture and teaches a cross-sectional area of the suture of 1964 µm2 (as a diameter of 50 µm would result in an area of 1964 µm2) (Paragraph 0111).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ho with the teachings of Lendlein by incorporating a cross-sectional area of the suture of 1964 µm2 in order to use the suture in a variety of applications such as microsurgery (Lendlein Paragraph 0111), and Ho is silent to the diameter or cross sectional area of the suture. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ho such that a cross-sectional area of the suture of 1964 µm2, as taught by Lendlein, as both references and the claimed invention are directed to sutures.
Further, He is directed a PEDOT:PSS coated with sorbitol with an electrical conductivity over 1000 S/cm (Conspectus; Page 151 Paragraph 2).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ho and Lendlein such that the PEDOT:PSS is coated with sorbitol with an electrical conductivity over 1000 S/cm, as taught by He, as the references and the claimed invention are directed to PEDOT:PSS systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ho and Lendlein with the teachings of He by incorporating PEDOT:PSS coated with sorbitol with an electrical conductivity over 1000 S/cm in order to improve stretchability and conductivity of the PEDOT:PSS (He Page 151 Paragraph 2). Further, Ho discloses the conductivity of the electrically conductive suture is greater than 100 S/m (Paragraph 0008), which is maintained with such a modification.
Furthermore, Sober is directed to a suture/electrode system and teaches wherein the conducting coating (PEDOT:PSS) further includes metal particles (silver/gold compound) (Paragraph 0061; 0086).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Ho as modified by Lendlein and He such that wherein the conducting coating further includes metal particles, as taught by Sober, as the references and the claimed invention are directed to PEDOT:PSS. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ho as modified by Lendlein and He with the teachings of Sober by incorporating wherein the conducting coating further includes metal particles in order to improve durability and resistance to corrosion.
Lastly, the claimed phrase “PEDOT:PSS, sorbitol, and metal flakes that are mixed prior to being coated on the surgical material,” is being treated as a product by process limitation; that is, the phrase will be examined as “PEDOT:PSS, sorbitol, and metal flakes are coated on the surgical material”, which is taught by the combination above. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claims 6-7, Ho further discloses an insulating layer, wherein the insulating layer comprises Parylene-C (Paragraph 0031; 0211) .
Regarding claim 8, Ho further discloses wherein the insulating layer was applied to the surgical suture material after the conducting coating was applied to the surgical suture material (Paragraph 0217).
Regarding claim 10, Ho further teaches wherein the suture is capable of being used for electrophysiological signal acquisition, electrophysiological signal transmission, or electrical stimulation (Paragraph 0008; 0214).
Regarding claim 25, the claimed phrase “wherein the metal flakes have been formed by soaking a silicon wafer coated with metal in acetone and subjecting the wafer to ultrasonic vibrations” is being treated as a product by process limitation; that is, the phrase will be examined as merely being provided with metal flakes (see rejection of claim 1), as the process of forming the metal flakes does not differentiate from the structure of the metal flakes. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ho in view of Lendlein, He, and Sober and further in view of Teixeira (NPL titled “Tuning PEDOT:PSS low-impedance thin films with high charge injection for microelectrodes applications”) (previously of record).
Regarding claim 2, Ho as modified by Lendlein, He, and Sober teaches the suture of claim 1, but fails to explicitly disclose wherein an electro-chemical impedance of the suture is less than 10 kOhms at 1 kHz per 1964 µm2 of cross-sectional area of the suture.
However, Teixeira is directed to PEDOT:PSS microelectrodes and teaches an inherent property of PEDOT:PSS, namely an electro-chemical impedance of the PEDOT:PSS less than the claimed range of less than 10 kOhms at 1 kHz (Figure 8, 10(a)) (Teixeira shows Electrochemical Impedance Spectroscopy (EIS) data resulting in 100 ohms of impedance at 1kHz, which is less than 10 kOhms. When combined with the modified suture of Ho, would result in an electro-chemical impedance of the suture is less than 10 kOhms at 1 kHz per 1964 µm2 of cross-sectional area of the suture, as the silk inner material of the suture would add negligible electrochemical impedance.).
The combination of Ho as modified by Lendlein, He, and Sober with the teachings of Teixeira results in an electro-chemical impedance of the suture being less than 10 kOhms at 1 kHz per 1964 µm2 of cross-sectional area of the suture as the properties of PEDOT:PSS would be inherent.
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ho as modified by Lendlein, He, and Sober with the teachings of Teixeira by incorporating an electro-chemical impedance of the PEDOT:PSS is less than 10 kOhms at 1 kHz in order to improve efficacy of the coating.
Regarding claim 3, Ho as modified by Lendlein further discloses wherein a diameter of the suture is 50 µm (Paragraph 0111).
Conclusion
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/Z.J./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
