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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 17, 2025 has been entered.
Response to Amendment
In response to amendment filed October 17, 2025, claims 13, 17, 24 and 28 are amended. Claims 1-12, 16 and 19 were previously cancelled and no new claims are added. Claims 13-15, 17-18, and 20-33 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed October 17, 2025, with respect to the objections to the claims have been fully considered and are persuasive in view of the amendments. The objections of the claims have been withdrawn.
Applicant’s arguments, see Remarks, filed October 17, 2025, with respect to the rejection of claims 13-15, 17-18 and 20-33 under 35 U.S.C 112b have been fully considered and are persuasive in view of the amendments. The rejection of claims 13-15, 17-18 and 20-33 under 35 U.S.C 112b has been withdrawn.
Applicant's arguments filed October 17, 2025 with respect to the prior art rejections has been fully considered but they are not persuasive.
Applicant argues on p. 6-10 that Raniere does not teach or suggest the amended claim 13 and further argues on p. 11-14 that the cited prior art also do not teach or suggest the amended claim 13, Examiner respectfully disagrees as claim 13 is amended using limitations from claim 1 and claim 16 which were rejected by Raniere and which are now cancelled. Raniere teaches an article (see paragraph 0055, a sock #30), comprising a stretchable material (see paragraph 0055 and 0061, sock #34 may be expandable; #30 includes at least one wearable fitted material #39 which can be a sock #34), and a plurality of strain sensors (see paragraph 0055, sock #34 has a plurality of sensors #36; and see paragraph 0017, sensing unit comprises strain sensors) positioned in contact with the stretchable material such that stretching of the material is detectable by the plurality of strain sensors (see paragraph 0055 and Fig. 3, sensors #36 are operatively positioned within fitted material #39 which comprises sock #34 to detect and record changes in the pressure and/or tension in feet/foot). Raniere also teaches applying an external force comprising deformation pressure, rotation and/or flexion at one or more target regions of the body part to hold and manipulate and/or correct the body part (see paragraph 0061, map of pressure/tension caused about/around the body part which has been applied) and further teaches reading output from the plurality of strain sensors while the body part is held and manipulated and/or corrected (see paragraph 0063, #31 receives data from sensors #36 and converts those communications into three-dimensional information concerning shape of a patient’s body part such as a foot; and see paragraph 0057, #30 may be a station located in a doctor’s office therefore it would be used by a practitioner to apply pressure about/around the body part).
In response to applicant's argument on p. 14-15 that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 13-15, 17, 20-21, 25-26 and 31-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raniere (US 20140276235 A1; previously cited by applicant).
With respect to claim 13, Raniere discloses a method for providing a customized orthotic product (see paragraph 0055, custom orthotics manufactured using the information acquired by #30), comprising:
providing an article (see paragraph 0055, a sock #34), comprising a stretchable material (see paragraph 0055 and 0061, sock #34 may be expandable; #30 includes at least one wearable fitted material #39 which can be a sock #34), and a plurality of strain sensors (see paragraph 0055, sock #34 has a plurality of sensors #36; and see paragraph 0017, sensing unit comprises strain sensors) positioned in contact with the stretchable material such that stretching of the material is detectable by the plurality of strain sensors (see paragraph 0055 and Fig. 3, sensors #36 are operatively positioned within fitted material #39 which comprises sock #34 to detect and record changes in the pressure and/or tension in feet/foot);
placing an article onto a body part so that the stretchable material is stretched, at least in part (see paragraph 0061, placing feet into socks #34 to be expandable around the foot);
providing a computing device (see paragraph 0055, computer/server #31) operatively coupled to the article (see paragraph 0057, #31 may be connected to sock #34) and configured to receive output data from the plurality of stain sensors and to process the data to determine a three-dimensional shape of the body part (see paragraph 0063, #31 receives data from sensors #36 and converts those communications into three dimensional information concerning shape of a patient’s body part such as a foot and performs analysis of this information to generate parameters useful in manufacturing orthotics);
applying an external force comprising deformation pressure, rotation and/or flexion at one or more target regions of the body part to hold and manipulate and/or correct the body part (see paragraph 0061, map of pressure/tension caused about/around the body part which has been applied; and see paragraph 0057, #30 may be a station located in a doctor’s office therefore it would be used by a practitioner to apply pressure about/around the body part);
reading output from the plurality of strain sensors while the body part is held and manipulated and/or corrected, and determining the three-dimensional shape of the body part based on the output from the plurality of strain sensors (see paragraph 0063, #31 receives data from sensors #36 and converts those communications into three-dimensional information concerning shape of a patient’s body part such as a foot; and see paragraph 0057, #30 may be a station located in a doctor’s office therefore it would be used by a practitioner to apply pressure about/around the body part);
using the determined three-dimensional shape of the body part to design and/or fabricate the customized orthotic product (see paragraph 0063, #31 receives data from sensors #36 and performs analysis of this information to generate parameters useful in manufacturing orthotics; see paragraph 0008; and see paragraph 0061, using information to create an orthotic customized to shape of patients foot; further these limitations recite optional features, which such have been considered, they do not bear patentable weight).
With respect to claim 14, all limitations of claim 13 apply in which Raniere further discloses displaying the three-dimensional shape of the body part on a display (see paragraph 0058, captured information displayed on #32; and see paragraph 0070, display three dimensional information).
With respect to claim 15, all limitations of claim 13 apply in which Raniere further discloses wherein a three-dimensional image of the shape of the body part is used to design a customized orthotic product by (1) fabricating the body part in three-dimensional form and designing the customized orthotic product using the fabricated body part, or (2) designing the customized orthotic product using the three-dimensional image of the shape of the body part, and fabricating the customized orthotic product in three-dimensional form from a designed image of the customized orthotic product (see paragraph 0062-0065, custom orthotic are created using the generated parameters via the processing done by #31).
With respect to claim 17, all limitations of claim 16 apply in which Raniere further discloses wherein the external force comprising deformation pressure, rotation and/or flexion to the one or more target region is applied by the practitioner's hands (see paragraph 0057, #30 may be a station located in a doctor’s office therefore it would be used by a practitioner to apply pressure about/around the body part).
With respect to claim 20, all limitations of claim 13 apply in which Raniere further discloses wherein the plurality of strain sensors at the one or more target regions are configured to detect at least one of pressure, compression, rotation, flexion and temperature (see paragraph 0017, sensing unit comprises pressure sensor and flex sensor).
With respect to claim 21, all limitations of claim 13 apply in which Raniere further discloses wherein the plurality of strain sensors are integrated or embedded within the stretchable material and/or positioned on the material surface (see paragraph 0061 and see Fig. 3, sensors #36 may be positioned in the material about/around the foot/joint).
With respect to claim 25, all limitations of claim 13 apply in which Raniere further discloses wherein the stretchable material is a textile (see paragraph 0020, the fitted material can be a textile) and the plurality of strain sensors are positioned on or integrated or embedded within, at least one yarn or fibre of the textile (see paragraph 0054, sensors are positioned in a fitted material wearable on a user’s foot; and see paragraph 0060, sensors may be fabric-based sensors).
With respect to claim 26, all limitations of claim 13 apply in which Raniere further discloses wherein the article is knitted or woven (see paragraph 0011, fitted material #39 that comprises sock #34 comprises a woven material).
With respect to claim 31, all limitations of claim 13 apply in which Raniere further discloses wherein the plurality of strain sensors are coated to provide a washable article; and/or wherein the article is in the form of a sleeve adapted to snugly fit over a part of the object (see paragraph 0060-0061 and Fig. 3, sock/sleeve #34 is adapted to fit around the body part that is measured in this case the foot of a patient).
With respect to claim 32, all limitations of claim 31 apply in which Raniere further discloses wherein the object is a limb of a patient (see paragraph 0060-0061 and Fig. 3, sock/sleeve #34 is adapted to fit around the body part that is measured in this case the foot of a patient).
With respect to claim 33, all limitations of claim 13 apply in which Raniere further discloses wherein one or more sensors configured to detect at least one of pressure, compression, force, temperature, volume, blood oxygen, pH, chemicals, skin surface moisture, flexion and rotation (see paragraph 0017, sensing unit comprises pressure sensor and flex sensor).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Raniere as applied to claim 13, and further in view of Hermanis (NPL: “Acceleration and magnetic sensor network for shape sensing”; previously cited).
With respect to claim 18, all limitations of claim 13 apply in which Raniere does not disclose wherein the three-dimensional shape of the body part is determined from sensor data using an algorithm/model that links inferred shape geometry to expected sensor readings; a loss function (L), measuring the degree of agreement between the sensor data and the expected sensor readings based on the inferred shape geometry; and an optimization function, iteratively modifying the inferred shape geometry in order to minimize the value of the loss function.
Hermanis teaches the three-dimensional shape of the body part is determined from sensor data using an algorithm/model that links inferred shape geometry to expected sensor readings; a loss function (L), measuring the degree of agreement between the sensor data and the expected sensor readings based on the inferred shape geometry; and an optimisation function, iteratively modifying the inferred shape geometry in order to minimise the value of the loss function (see section II and section III).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Raniere with the teachings of Hermanis to have utilized an algorithm because it would have resulted in the predictable result of comparing known geometries with mathematical models of subject (Hermanis: see section IV) for accurate representation for reconstruction (Hermanis: see section I).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Raniere as applied to claim 13, and further in view of Longinotti-Buitoni (US 20180199635 A1; previously cited).
With respect to claim 22, all limitations of claim 13 apply in which Raniere does not disclose wherein the sensors are provided in channels formed in the stretchable material.
Longinotti-Buitoni teaches sensors provided in channels in a stretchable material (see paragraph 0124-0125, sensors is placed into a fabric strip with a upper and lower strip of fabric being a ribbon and covering strip where the sensor is sandwiched between to form a pocket in which the elastic sensor may stretch and contract without interference where the sensor may be a strain gauge sensor where it is interpreted that the pockets forms is a channel; and see paragraph 0083 and Fig. 57, branches of connected sensors may be transferred to a fabric to form a wearable garment).
It would have been obvious to one of ordinary skill in the at before the effective filing date of the claimed invention to have modified Raniere with the teachings of Longinotti-Buitoni to combine prior art elements according to known methods to yield predictable results of placing a sensor in a fabric garment in order to aid a sensor to stretch and contract without interference (Longinotti-Buitoni: see [0125]).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Raniere as applied to claim 13, and further in view of Wood (US 20140238153 A1; previously cited).
With respect to claim 23, all limitations of claim 13 apply in which Raniere does not disclose wherein the sensors are laminated on an elastomeric substrate.
Wood teaches sensors laminated on an elastomeric substrate (see paragraph 0066, multi-layered strain sensor is formed with elastomeric material by laminating with light pressure to bond the layers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Raniere with the teachings of Wood to combine prior art elements according to known methods to yield predictable results of laminating sensors to an elastic substrate in order to aid in attaching sensors to an elastic material (Wood: see [0066]).
With respect to claim 24, all limitations of claim 13 apply in which Wood further teaches wherein the elastomeric substrate is in the form of a strip (see paragraph 0066, multi-layered strain sensor is in strip form).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Raniere as applied to claim 13, and further in view of Rogers (US 20130041235 A1; previously cited).
With respect to claim 27, all limitations of claim 13 apply in which Raniere does not disclose wherein the sensors (a) are positioned less than about 5 mm apart, such as about 4 mm, about 3 mm, about 2 mm or about 1 mm apart; and/or (b) have a height or thickness of less than about 0.02 mm, less than about 0.015 mm or less than about 0.01 mm, such as 9 µm, 8 µm, 7 µm, 6 µm or 5 µm; and/or (c) have a width of less than about 1.5 mm, less than about 1.0 mm, less than about 0.85 mm, less than about 0.80 mm, or less than about 0.75 mm, such as 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm or 0.1 mm.
Rogers teaches sensors are positioned less than about 5mm apart, such as about 4 mm, about 3 mm, about 2 mm or about 1 mm apart (see paragraph 0016, sensors are separated by less than 2.0 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Raniere with the teachings of Rogers to have positioned sensors in a certain manner because it would have resulted in the predictable result of spatially arranging sensors over a flexible substrate in order to measure data over desired locations with a desired resolution (Rogers: see [0060]).
Claims 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Raniere as applied to claim 13, and further in view of Conner (US 20180303383 A1; previously cited).
With respect to claim 28, all limitations of claim 13 apply in which Raniere does not specifically teach an individual yarn including the plurality of strain sensors is encapsulated within a flexible cover.
Conner further teaches wherein an individual yarn including sensors is encapsulated within a flexible cover (see paragraph 0318, yarns has been coated or braided with aluminum which is flexible).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Raniere with the teachings of Conner to have encapsulated individual yarn within a flexible cover because it would have resulted in the predictable result of creating an electromagnetic energy pathway by filling a hollow non-conductive member with a conductive material (Conner: see [0270]).
With respect to claim 29, all limitations of claim 28 apply in which Conner further teaches wherein the flexible cover is a moisture or water-resistant flexible cover (see paragraph 0318, yarns has been coated or braided with aluminum which is known to be water resistant).
With respect to claim 30, all limitations of claim 28 apply in which Conner further teaches wherein the diameter of the individual yarn with cover is about 2.0 mm or less, about 0.7mm to about 1.0mm, about 0.75mm to about 0.95mm or about 0.8mm to about 0.9mm (see paragraph 0278, thickness within range of 1/64 to ¼ of an inch which is 0.34mm to 6.35mm).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIDHI N PATEL whose telephone number is (571)272-2379. The examiner can normally be reached Mondays to Fridays 9AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.N.P./Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791