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 .
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 2020/198120 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 gaps (spaces between twists of 805) which are located 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 a central axis (horizontally oriented center axis of the twisted elements shown in fig. 8C) 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); and **wherein the support bands and the auxiliary matrix (860 is disclosed as being formed from polyurethane, which is a deformable elastic dielectric material) together define a deformable dielectric structure (fig. 8D) that elastically deforms in response to an external pressure acting on the tubular body (fig. 8D; par. 0106). Shah, strongly implies, but does not explicitly disclose that the plurality of electrodes (830) are “sensitive elements”; Shah does not disclose that the elastic deformation of said deformable dielectric structure [is capable of] functionally cooperating with the sensitive elements to generate signals representative of the pressure.
*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.
**NOTE: none of the newly added limitations in the final four lines of claim 1 have any understandable bearing or effect upon the claimed “method for the production of a diagnostic device”. The claims are directed to a method of manufacture and are not at all directed to a product or to the method of using a product. There is not a single step in the newly added language, nor does any of the new language further define any of the existing method steps. It is not found to be germane how the product is intended to be used or what capabilities the product may be intended to have. The Applicant is strongly encouraged to determine what the inventive concept of the method of manufacture may be and to claim as much, rather than to attempt to overcome the applicability of a prior art reference by virtue of defining the desired functionality or capabilities of the product to be formed. Nonetheless, it is quite clear that the combination of Shah and Sawan do in fact teach the newly added limitations directed to the desired use and capabilities of the product being formed by the actually claimed method of manufacture.
Sawan teaches that it is well known to perform a similar method (fig. 1; pars. 0009 and 0030-0035) wherein the electrodes (103, 106, 107) are sensitive elements (fig. 1; pars. 0011, 0015-0016 and 0032-0035); and **wherein the auxiliary matrix (silicon substrate: 501, and pressure-deformable membrane 503, as well as piezoelectric elements 509, 510) define a deformable dielectric structure (silicon is deformable, elastic and dielectric) that elastically deforms in response to an external pressure acting on the tubular body, the elastic deformation of said deformable dielectric structure functionally cooperating with the sensitive elements to generate signals representative of the pressure (figs. 5a-5g; pars. 0047-0055).
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 and their intended capability of cooperating (when the product is being used) with the deformable dielectric structure to generate pressure responsive signals. 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).
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
The Applicant has argued that Shah and Sawan do not disclose the intended capabilities and method of use of the product to be formed in the claimed method of manufacture. This argument is not compelling, as the claims are explicitly directed to a method of manufacture, and the newly added and argued limitations do not define the method of manufacture in any understandable manner. Nonetheless, the prior art rejection of claim 1 has been updated above to reflect the fact that Shah explicitly discloses that the support bands and the auxiliary matrix together define a deformable dielectric structure, made of polyurethane, which is a material having a material property of elasticity. It is well understood that elastic materials elastically deform in response to an external pressure, as this is the nature of elasticity. Further, it has been expressly shown above that Sawan teaches that it is a well known concept to use such elastically deformable bodies for the intended purpose of generating signals responsive to pressure. As such, even though the newly added limitations, directed to the intended use and capabilities of the product, do not further define the claimed method, the Examiner has still demonstrated that they are taught by the prior art.
Along the same line of argument, Applicant has also argued that: “There is nothing in Shah that suggests any deformation of the dielectric layer for signal generation, as claimed.” Again, the Applicant is respectfully reminded that the claims are not directed to a method of using a product, or even to the product itself. The claims are directed to a method of manufacture, and the argued limitation does not define the claimed method of manufacture at all. As such, this argument is not germane and is not found to be compelling.
Similarly, Applicant also asserted that: “The pressure sensors in Sawan are discrete components, which are structurally independent of any helical electrode geometry. That is, the pressure sensors of MEMS devices, while the helical structures relate to electrical signal acquisition (EMG), and not pressure sensing. Nothing in Sawan suggests using deformation of a dielectric support structure for generating pressure-representative signals in functional cooperation with the sensitive elements, as claimed.” This argument is not compelling for all of the reasons set forth above and for further reasons. It is quite clear that the cited elements from Sawan in fig. 1 are used in the pressure sensing device of figs. 5a-5g, as this is explicitly disclosed in pars. [0047-0049]. Nowhere in Sawan is it disclosed that the pressure sensors are “structurally independent of any helical electrode geometry”. In fact, fig. 1 of Sawan explicitly discloses that element 103 is a “Double-helix electrode” and in pars. [0030-0035] it is explicitly disclosed that the entire “system of FIG. 1 enables in situ measurement of…gastric and esophageal pressures, as well as acquisition, analog-to-digital conversion and transmission of these data” (par. 0035). Sawan further discloses that the elements of fig. 1 are used in conjunction with those of figs. 5a-5g, as they are not disclosed as separate embodiments, but rather a further definition of the system of fig. 1. The final quoted sentence of the Applicant’s argument simply has no basis in fact. There is simply no support for the assertion that “Nothing in Sawan suggests using deformation of a dielectric support structure for generating pressure-representative signals in functional cooperation with the sensitive elements, as claimed.” In reality, the entirety of pars. [0047-0055] is directed to exactly the intended use and capabilities of the product being formed by the method of claim 1.
According to the updated prior art rejections above, and the response to arguments herein, all of the currently presented claim limitations (including those directed to intended use and intended capabilities of the product being formed) have been shown to be taught by the prior art, and all arguments have been answered.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. For example, Källbäck et al. (US 2019/0254607 A1) is held to be particularly relevant to at least the subject matter of claim 1 (see: Title; Abstract; figs. 1-3; pars. 0034, 0037, 0050-0054 and 0061).
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.
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.
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, Thomas Hong can be reached at (571)272-0993. 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.
/JEFFREY T CARLEY/ Primary Examiner, Art Unit 3729
Prosecution Insights