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 .
Applicant' s arguments, filed 10/10/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 10/10/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-4, 6-11, 13, 15-19, 24-27, 29-32, and 34 are the currently pending claims. Claims 5, 12, 14, 20-23, 28, 33, and 35-104 have been previously canceled. Claims 3, 16-18, 24-27, 29-32, and 34 have been previously withdrawn; and claims 1-2, 4, 6-11, 13, 15, and 19 are under examination.
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.
Claims 2 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 2 recites “the article is configured for implantation submucosally or intramuscularly” (lines 1-2), but in view of Claim 1 now reciting “an endoscopic channel” as part of the “article”, it is unclear whether the endoscope is being implanted along with the polymeric component. The Examiner’s Interpretation is that “the article” in Claim 2 is referring to the polymeric component (and its substructures) and not to any external endoscope or working channel.
Claim 19 is likewise indefinite as it recites that “the article has a [dimension/value]” (lines 1-2), but in view of Claim 1 now reciting “an endoscopic channel” as part of the “article”, it is unclear whether the recited dimension pertains to (a) the polymeric component (e.g., outer diameter/width), (b) the electrode(s), (c) the microfluidic channel(s), or (d) the endoscopic channel itself. Multiple reasonable interpretations render the scope uncertain. The Examiner’s Interpretation is that “the article” in Claim 19 is referring to the polymeric component (and its substructures) and not to any external endoscope or working channel.
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 (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.
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.
Claims 1, 4, 6-11, 13, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jia et al. (20240057943), hereto referred as Jia, and further in view of Imran et al. (US 20020165589 A1), hereto referred as Imran.
Regarding claim 1, Jia teaches that an article comprises: a polymeric component having an aspect ratio of at least 10:1 (Jia, Fig. 1D, 1F; ¶[0094], ¶[0095]: Figures 1D and 1F visually show the elongated fiber with a length more than 10 times its width, supporting an aspect ratio greater than 10:1. The text describes that the fiber is constructed from a polycarbonate (PC) rod, wrapped with PVDF and PC layers, and then consolidated to form a polymeric fiber. Thus, the final polymeric component includes both the initial PC rod and the additional polymer layers, resulting in a polymeric component with the required aspect ratio); one or more electrodes disposed within the polymeric component, each electrode having a largest dimension aligned parallel to a largest dimension of the polymeric component (Jia, ¶[0094]; Fig. 1D, 1E: Jia describes that rectangular grooves are machined on the PC rod and filled with BiSn electrodes, and Fig. 1D/1E show the resulting fiber with the electrodes and channels running longitudinally within the fiber. This construction, together with standard fiber drawing practice, means that the largest dimension of the electrode is aligned with the largest dimension (length) of the fiber, as visually confirmed by the continuous, longitudinal electrode shown in the figures); and one or more microfluidic channels disposed within the polymeric component, each microfluidic channel having a largest dimension aligned parallel to the largest dimension of the polymeric component (Jia, ¶[0094]; Fig. 1D, 1E: Jia discloses a microfluidic channels formed from a rectangular groove in the PC rod and left hollow, and Fig. 1E shows four different colored fluids delivered along the length of the fiber via this channel. The fact that fluid can be delivered to multiple positions along the fiber confirms that the channel’s largest dimension is aligned with the fiber’s length, i.e., parallel to the largest dimension of the polymeric component).
Also regarding claim 1, Jia does not specifically teach that the article comprises an endoscopic channel wherein the polymeric component is sized and adapted to be at least partially inserted within the endoscopic channel and configured for esophageal and/or gastric implantation via the endoscopic channel. Rather, Jia teaches an elongated polymeric multifunctional fiber with longitudinally aligned electrodes and microfluidic channels suitable for implantation in soft tissue, but does not teach that the article is sized/adapted for insertion within an endoscopic channel or configured for esophageal or gastric implantation via such a channel. Jia’s fiber probes are designed for channel-based insertion (Jia, ¶[0013]) and are expressly dimensioned to slidably engage within channels with diameters “about 2000 μm, 1500 μm, 1000 μm, 500 μm, about 250 μm, about 200 μm or less” (Jia, ¶[0060]), demonstrating structural compatibility with lumen-based delivery.
Imran teaches the use of a flexible endoscope with a lumen or auxiliary channel through which tools and devices are inserted for gastric procedures (Imran, ¶[0069]; ¶[0070]). These passages show endoscopic access via the esophagus into the stomach for implantation.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jia in view of Imran to size and adapt the polymeric fiber for at least partial insertion within an endoscopic channel and configure it for esophageal and/or gastric implantation. Jia’s elongate fibers are mechanically suitable for insertion into narrow channels, and Imran provides direct teachings of endoscopic lumens and workflows for delivering elongate devices. In particular, the claimed sizing is consistent with Jia’s disclosed probe diameters (≤2000 μm, or ≤2 mm) that would readily fit within standard medical endoscope working channels of approximately 2–3 mm, confirming the feasibility of insertion. The combination of Jia and Imran therefore provides a predictable, minimally invasive solution that enhances safety, visualization, and procedural efficiency while maintaining compatibility with existing endoscopic delivery systems.
Regarding claim 4, the combined Jia and Imran teaches that the one or more electrodes comprise stimulating electrodes (Jia, ¶[0090]: “The interfacing can include one, two, three, or more of... applying an electrical stimulation through an electrode to the tissue at or near a site; detecting an electrical signal through an electrode in the tissue at or near a site…”, expressly describing electrodes that function as stimulating electrodes).
Regarding claim 6, the combined Jia and Imran teaches that each electrode comprises a conductive material, and wherein the conductive material comprises one or more selected from the group of stainless steel, gold, copper, platinum, platinum iridium, iridium oxide, a conductive fiber, and a carbon nanotube (Jia, ¶[0067]: “The electrode can include a conductive material selected from the group consisting of metals, metal alloys, and polymer composites. The electrode can include a metal or metal alloy selected from the group consisting of (Au), platinum (Pt), iridium, tungsten, titanium, titanium nitride, stainless steel, tantalum, BiSn alloy, BiSn alloy, ZnAl alloy, and InSn alloy,. The electrode can include a polymer composite comprising a carbon selected from the group consisting of graphene, graphite, carbon nanotubes, carbon nanofibers, amorphous carbon, and a combination thereof”, explicitly listing stainless steel, gold, platinum, and carbon nanotubes as electrode materials which are all conductive).
Regarding claim 7, the combined Jia and Imran teaches that the one or more electrodes are exposed to an external surrounding at predetermined locations along the polymeric component (Jia, ¶[0124]: "To expose multiple optical, electrical, and microfluidic interfacing sites along the fiber length, we used a femtosecond laser micromachining technique”, ¶[0126]: “with four electrodes exposed at a spacing of 50 μm and a size of 20 μm×20 μm is shown in FIG. 7D... The electrical performance of the exposed electrodes is validated using impedance measurements as shown in FIG. 9", showing that electrodes are exposed to external surroundings at predetermined, selectable locations along the polymeric fiber for electrical contact with tissue).
Regarding claim 8, the combined Jia and Imran teaches that the one or more electrodes are exposed to an external surrounding at a controlled spacing along the polymeric component (Jia, ¶[0126]: "with four electrodes exposed at a spacing of 50 μm and a size of 20 μm×20 μm is shown in FIG. 7D", with FIG. 1D and FIG. 7D illustrating that the electrodes are exposed at controlled, defined spacings along the length of the polymeric fiber).
Regarding claim 9, the combined Jia and Imran teaches that the controlled spacing is between 50 micrometers and 2 cm (Jia, ¶[0126]: "with four electrodes exposed at a spacing of 50 μm and a size of 20 μm×20 μm is shown in FIG. 7D", with FIG. 1D and FIG. 7D demonstrating an electrode spacing of 50 μm, which falls within the range of 50 micrometers to 2 cm).
Regarding claim 10, the combined Jia and Imran teaches that the one or more electrodes disposed within the polymeric component comprises at least 2 electrodes disposed within the polymeric component (Jia, ¶[0123]: "Fiber 3 (F3) with four electrodes, and Fiber 4 (F4) with four electrodes... "; ¶[0126]: "with four electrodes exposed at a spacing of 50 μm and a size of 20 μm×20 μm is shown in FIG. 7D", with FIG. 1D and FIG. 7D illustrating at least two electrodes disposed within the polymeric component).
Regarding claim 11, the combined Jia and Imran teaches that each of the one or more electrodes is exposed to an external surrounding via at least one electrode contact (Jia, ¶[0126]: "functional fiber (F3) with four electrodes exposed at a spacing of 50 μm and a size of 20 μm×20 μm is shown in FIG. 7D", with FIG. 1D and FIG. 7D illustrating electrodes that are exposed to the external environment via discrete electrode contacts along the length of the polymeric component).
Regarding claim 13, the combined Jia and Imran teaches that the one or more electrodes disposed within the polymeric component are coated by one or more polymers (Jia, ¶[0094], ¶[0097]: "a few layers of PVDF were rolled onto the electrode-filled rod to form the insulating layer, which was then followed by additional layers of PC for the stable thermal drawing process", showing that the electrodes are wrapped in polymer layers that, after consolidation and thermal drawing, result in a continuous polymer covering over the electrodes that is functionally equivalent to a polymer coating).
Regarding claim 15, the combined Jia and Imran teaches that the polymeric component comprises polycarbonate (Jia, (Jia, ¶[0057]: "The thermoplastic polymer can include polycarbonate, polymethyl methacrylate, polyvinyl chloride, polyolefin, polyamide, polyester, polyetherimide, cyclic olefin copolymer, polyvinylidene fluoride, polyvinyl alcohol, polyethersulfone, polyphenylsulfone, polysulfone, poly lactic-co-glycolic acid, polycaprolactone, polylactic acid, polystyrene, copolymers comprising any of the foregoing, or blends thereof", demonstrating that polycarbonate is explicitly identified as a suitable material for the polymeric component); ¶[0094], ¶[0097]: "Then the pre-structured rod was wrapped with a few layers of PVDF and an additional PC layer which subsequently formed a preform after the consolidation process" and "a few layers of PVDF were rolled onto the electrode-filled rod to form the insulating layer, which was then followed by additional layers of PC for the stable thermal drawing process", where the pre-structured rod is polycarbonate (PC), demonstrating that PC is a primary polymer used to fabricate the polymeric component).
Regarding claim 19, the combined Jia and Imran teaches that the article has a cross-sectional dimension of between 0.5 mm and 2.5 mm (Jia, ¶[0060]: " The flexible probes can have a diameter of about 2000 μm, 1500 μm, 1000 μm, 500 μm, about 250 μm, about 200 μm or less", where the "flexible probe" refers to the multifunctional polymeric fiber-based probes described throughout the reference and OA (i.e. the article); These probes are dimensioned specifically for implantation, with cross-sectional diameters ranging from at least 0.2 mm (200 μm) up to 2 mm, thus directly reading on the range of 0.5 mm to 2.5 mm).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jia et al. (20240057943), hereto referred as Jia, and further in view of Imran et al. (US 20020165589 A1), hereto referred as Imran, and further in view of Foley (20040162595), hereto referred as Foley.
The combined Jia and Imran teaches claim 1 as described above.
Regarding claim 2, the combined Jia and Imran does not teach that the article is configured for implantation submucosally or intramuscularly. Rather, Jia teaches an implantable fiber-based probes for interfacing with soft tissue, including neural tissue in the brain (Jia, ¶[0056]; Jia, ¶[0090]). However, Jia does not expressly state that the article is configured for implantation submucosally or intramuscularly. Foley teaches that implantable elongated articles containing electrodes are commonly placed in soft tissue, specifically within the muscular layers below the submucosa of the gastrointestinal tract (Foley, Fig. 3; ¶[0065]). It would have been prima facie obvious before the effective filing date of the claimed invention to modify the combined Jia and Imran in view of Foley to configure the article for implantation submucosally or intramuscularly. Foley provides clear anatomical rationale and demonstrates the feasibility and utility of such implantation sites for electrical, chemical, or sensing purposes. Combining the teachings of Jia (fiber-based multi-modal implant for tissue interfacing) with Foley (submucosal/intramuscular placement of electrodes) would have yielded predictable results, allowing the article to be used in a variety of soft tissue environments, including the submucosa and muscle layers. Such a combination enables broader clinical application and provides greater flexibility in targeting different tissue depths and types for sensing or stimulation, as required by specific medical needs.
Response to Arguments
Objections
Applicant's arguments filed 10/10/2025, page 6, regarding the previous Objections of claim 6 have been fully considered and are persuasive. The previous Objections have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 10/10/2025, page 6, regarding the previous 112(b) Rejections of claims 10 and 13 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn. However, there are new 112(b) rejections as shown above.
35 U.S.C. §102
Applicant's arguments filed 10/10/2025, pages 6-7, regarding the previous 102 Rejections of claims 1, 4, 6-11, 13, 15 and 19 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
35 U.S.C. §103
Applicant's arguments filed 10/10/2025, page 7, regarding the previous 103 Rejections of claim 2 has been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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