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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-5, in the reply filed on 09/18/2025 is acknowledged.
Claims 6-14 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected diagnostic device product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/18/2025.
Claim Objections
Claim 1 is objected to because of the following informalities: the hyphens “-” at the beginning of each clause should be removed, they serve no more purpose than the indentations, and are not consistently applied in the first place (there are three hyphens, but at least 5 step clauses) and will not be reproduced in the printed publications anyway (see the Pre-Grant Publication of this application: US 2024/0099646-A1). Further, in line 15 of claim 1, there is disclosed “the central channel”. For the sake of clarity and continuity, this should instead recite “the central through channel”. 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.
Claims 1-5 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 discloses “fills the gaps between the support bands” (lines 12-13; emphasis added), and “distributed along the central axis” (line 15; emphasis added). There is a lack of antecedent basis for these limitations in the claims. It is not clear if antecedent basis was inadvertently left out of the claims, or if these limitations should instead recite: “fills which are located between the support bands” and “distributed along a central axis”.
Claims 2-5 are also rejected as indefinite, so rendered by virtue of their dependency upon the indefinite subject matter of claim 1.
NOTE: All of the examined claims (i.e. claims 1-5) have been interpreted and examined as best understood according to the 112(b) rejections, above.
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 of this title, 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (WO 202/198120 A1), in view of Sawan et al. (US 2005/0159659 A1).
Regarding claim 1, Shah discloses a method for the production of a diagnostic device, *for endoscopic examinations (pars. 0006 and 0013), comprising the steps of: obtaining a blank (dielectric material: 805, 845, 850, 860) from a plastic material (polyimide, parylene) sheet; the blank comprising one or more support bands (805) provided with electrical tracks (825); providing a plurality of electrode elements (830) uniformly distributed along each band; wherein each sensitive element is configured to generate signals, and is connected to the electrical tracks for the transmission of signals (figs. 8A-8D; pars. 0103-0106); applying a first electrically conductive coating (seed layer for 615) on the blank in the area of the sensitive elements (fig. 6B; pars. 0087-0089 and 0103) (in par. 0103, it is disclosed that the method associated with figs 6A-6F is used to form the preliminary structures of those of 8A-8G); creating a main structure (helically twisted 805) from the blank, keeping the first electrically conductive coating radially on the inside of the main structure; and creating an auxiliary matrix (850, 860), which wraps the main structure and fills the gaps between the support bands, so as to obtain a tubular body (860) having a central through channel which is at least partially laterally delimited by said support bands; wherein said sensitive elements are distributed along the central axis and face the inside of the central channel (figs. 8C-8D; pars. 0105-0106); wherein the main structure is helix-shaped, that is, each support band extends helically around the central axis so that the main structure is bendable relative to a plurality of deformation axes with different directions to each other (pars. 0054-0055 and 0066). Shah, strongly implies, but does not explicitly disclose that the plurality of electrodes (830) are “sensitive elements”.
*NOTE: though the preamble of the claim indicates that the intended use of the product to be formed by the claimed method is “for endoscopic examinations” there is no indication of how this intended capability of the intended product informs or defines the method of manufacture in any way. There is no camera or imaging device manufactured at all. As such, the preamble is not found to breathe life into the claim and is not currently found to carry patentable weight. The cited prior art methods have been shown herein to teach all of the limitations of the claimed method and to demonstrate all of the claimed structures of the product to be formed as currently presented; as such, the intended use of the product is not found to be germane.
Sawan teaches that it is well known to perform a similar method (figs. 2A-2B; pars. 0009, 0036-0039) wherein the electrodes (200, 201, 202) are sensitive elements (figs. 2A-2B; pars. 0011, 0015-0016 and 0035).
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to have modified the current invention of Shah to incorporate the express recitation that the electrodes are sensitive elements of Sawan. POSITA would have realized that electrodes can be easily and readily used as sensing devices to achieve the desired usefulness of the intended product as an in vivo detection device. Moreover, there is no indication in the instant disclosure that any special sensitive element was devised or that any surprising results were derived from simply using the old method of Shah with the well-known sensing electrodes of Sawan. This combination would have been easily performed with knowledge of the commonly understood advantages and with reasonable expectations of success.
Regarding claim 2, Shah in view of Sawan teaches the method of claim 1 as detailed above, and Shah further discloses that the blank comprises two support bands (805) and sensitive elements (830), which are respectively defined by a partition provided with a central portion connecting the two support bands and two peripheral portions extending outwards from each support band; wherein the method comprises the step of connecting the peripheral portions of the same transverse partition in order to define each sensitive element (figs. 8A-8D).
Regarding claim 3, Shah in view of Sawan teaches the method of claim 1 as detailed above, and Shah further discloses that during the step of creation of the main structure, the blank is rolled so as to obtain a helix-shaped main structure, in which each support band extends around the central axis in a helical manner (figs. 8B-8D; pars. 0104-0106).
Regarding claim 4, Shah in view of Sawan teaches the method of claim 1 as detailed above, and Shah further discloses that during the step of creation of the main structure, the blank is arranged so that the support bands are arranged in a parallel manner around the central axis (fig. 8C).
Regarding claim 5, Shah in view of Sawan teaches the method of claim 1 as detailed above, and Shah further discloses a further step of applying a second electrically conductive coating (the electroplating after application of a seed layer); wherein this step takes place upstream of the step of creation of the main structure or downstream of the step of creation of the auxiliary matrix (par. 0089).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please refer to the concurrently mailed PTO-892, as all of those cited references are considered to be pertinent to the claimed invention. For example, Parks et al. (EP 2 417 906 A1) and Rong et al. (US 20130245412 A1) are held to be of particular relevance to the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey T Carley whose telephone number is (571)270-5609. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm.
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/JEFFREY T CARLEY/Primary Examiner, Art Unit 3729