DETAILED ACTION This is the initial Office action for application 18/448,923 filed August 12, 2023. Claims 1-19, as originally filed, are currently pending. 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. 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. 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 appl icant regards as his invention. Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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. Claims 1 and 7 each recite the limitation “An orthopedic precast for use in combinations of the orthopedic”; however, there is insufficient antecedent basis for “the orthopedic”. Although the claims previously recite “An orthopedic precast”, the term “orthopedic” is used to describe the precast and not necessarily introduce an orthopedic. Further, it is unclear how a precast is intended to be used in combinations of an orthopedic since the precast is used for producing an orthopedic. For examination purposes, the above limitation of claims 1 and 7 have been interpreted as “An orthopedic precast for use in producing an orthopedic”. Claim 1 recites the limitation “responsive to applying heat of at least the melting temperature to the thermoplastic material and subsequent cooling, the first plurality of interwoven strands of the first thermoplastic material are interweaved to create one or more recessed areas for receipt of the one or more sensors” and claim 7 similarly recites the limitation “responsive to applying heat of at least the first melting temperature to the one or more layers of the interwoven strands of the first thermoplastic material and subsequent cooling, the one or more layers of the interwoven strands of the first thermoplastic material are interweaved to create one or more recessed areas within an orthosis formed in part by the one or more layers of the interwoven straps of the first thermoplastic material after heated for receipt of the one or more sensors”; however, these limitations appear to be directed to a process of using the precast to produce an orthopedic. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). See In re Katz Interactive Call Processing Patent Litigation , 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). MPEP 2173.05(p). For examination purposes, claims 1 and 7 have been interpreted to only encompass the structure of the precast which would be capable of forming an orthopedic having one or more recessed areas. Claim 2 recites the limitation “transitions to an orthosis …” which appears to be directed to the process of using the precast. For examination purposes, the above limitation of claim 2 has been interpreted as “configured to transition to an orthosis …”. Claim 8 recites the limitation “the one or more sensors are positioned … prior to the applying of the heat …” which appears to be directed to the process of using the precast. For examination purposes, the above limitation of claim 8 has been interpreted as “the one or more sensors are capable of being positioned … prior to the applying of the heat …”. Claims 3 -6 and 9 -12 are included in the rejection under 35 U.S.C. 112(b) based on their dependence from rejected claims 1 , 2, and /or 7. 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. Claim s 1 -3, 5-10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Romo, Jr. et al. (US 2022/0256939) in view of Cassit (US 2022/0104960) . Regarding claim 1, Romo discloses an orthopedic precast (precast 1300) for use in producing an orthopedic (precast 1300 becomes an orthosis) (Fig. 13; ¶ 0127-0128), the precast (1300) comprising: a first portion (first knitted portion 1310 + third knitted material) including a first plurality of interwoven (knitted) strands of a first thermoplastic material, the first thermoplastic material having a first melting temperature (lower melting point) (Fig. 13; ¶ 0127); and a second portion (second knitted portion 1320) coupled to the first plurality of interwoven strands of the first thermoplastic material (1310) (Fig. 13; ¶ 0127); wherein, responsive to applying heat of at least the first melting temperature to the first plurality of interwoven strands of the first thermoplastic material (1310) and subsequent cooling, the first plurality of interwoven strands of the first thermoplastic material are interweaved to create one or more recessed areas (aperture 1350) (Fig. 13; ¶ 0127-0128). However, Romo fails to teach one or more sensors. Cassit discloses an orthopedic precast (plate 110a) for use in producing an orthopedic (orthotic member 110b) comprising a first portion including a first thermoplastic material (thermoplastic polymer) and one or more sensors (sensors 120) (Fig. 1A -1B ; ¶ 0052 , 0054 , & 0056 ) . Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the precast taught by Romo to include one or more sensors as taught by Cassit for the purpose of measuring the healing process of a body part intended to be covered by the precast. The limitation “responsive to applying heat of at least the melting temperature to the thermoplastic material and subsequent cooling, the first plurality of interwoven strands of the first thermoplastic material are interweaved to create one or more recessed areas for receipt of the one or more sensors ” is interpreted as a product-by-process limitation regarding the production of an orthopedic using the claimed precast . “Even 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) (citations omitted). In the instant case, claim 1 is directed to a precast for use in producing an orthopedic, wherein the orthopedic would be the result of the process of applying heat and subsequent cooling of the precast. Therefore, claim 1 has been interpreted to only encompass the structure of the precast which would be capable of forming an orthopedic having one or more recessed areas. However, as noted above, Romo substantially teaches the process of producing the orthopedic from the precast as claimed. Further , a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, although Romo does not expressly teach that the one or more recessed areas (1350) are for receipt of the one or more sensors (120) taught by Cassit , the structure of the one or more recessed areas (1350) of the precast taught by Romo would be capable of receiving one or more sensors. Still further, Cassit discloses one or more recessed areas (holes 112) for receipt of the one or more sensors (Figs. 1A-1B; ¶ 0054 & 0058 ) such that it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the precast taught by Romo such that the first thermoplastic material is interweaved to create one or more recessed areas for receipt of the one or more sensors as taught by Cassit for the purpose of accommodating the one or more sensors within the precast . Regarding claim 2, the combination of Romo and Cassit discloses the invention substantially as claimed, as described above, and Romo further discloses that the orthopedic precast (1300) is configured to transition to an orthosis upon the first portion (1310) transitioning from a flexible state to a rigid state after partial melting and subsequent cooling of the first plurality of interwoven strands of the first thermoplastic material (Fig. 13; ¶ 0127-0128). Regarding claims 3, 5, and 6, the combination of Romo and Cassit discloses the invention substantially as claimed, as described above, and Cassit further discloses that the one or more sensors (120) include an accelerometer capable of detecting a gravitational acceleration to measure a tilt of the orthosis or a fall of a patient wearing the orthosis, a motion sensor capable of detecting usage of the orthosis, and/or a temperature sensor capable of detecting a potential infection associated with a wound or surgical incision proximate to placement of the orthosis when worn by a patient (¶ 0020, 0056, & 0059). Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the precast taught by the combination of Romo and Cassit to include an accelerometer , a motion sensor, and/or a temperature sensor as further taught by Cassit for the purpose of determining the movement , motility, and/or temperature of the patient. Regarding claim 7, Romo discloses an orthopedic precast (precast 1300) for use in producing an orthopedic (precast 1300 becomes an orthosis) (Fig. 13; ¶ 0127-0128), the precast (1300) comprising: one or more layers (first knitted portion 1310 + third knitted material) of interwoven (knitted) strands of a first thermoplastic material, the first thermoplastic material having a first melting temperature (lower melting point) (Fig. 13; ¶ 0127); wherein, responsive to applying heat of at least the first melting temperature to the one or more layers (1310) of the interwoven strands of the first thermoplastic material and subsequent cooling, the one or more layers (1310) of the interwoven strands of the first thermoplastic material are interweaved to create one or more recessed areas (aperture 1350) within an orthosis formed in part by the one or more layers (1310) of the interwoven straps of the first thermoplastic material after heated (Fig. 13; ¶ 0127-0128). However, Romo fails to teach one or more sensors. Cassit discloses an orthopedic precast (plate 110a) for use in producing an orthopedic (orthotic member 110b) comprising one or more layers of a first thermoplastic material (thermoplastic polymer) and one or more sensors (sensors 120) (Fig. 1A-1B; ¶ 0052, 0054, & 0056). Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the precast taught by Romo to include one or more sensors as taught by Cassit for the purpose of measuring the healing process of a body part intended to be covered by the precast. The limitation “responsive to applying heat of at least the first melting temperature to the one or more layers of the interwoven strands of the first thermoplastic material and subsequent cooling, the one or more layers of the interwoven strands of the first thermoplastic material are interweaved to create one or more recessed areas within an orthosis formed in part by the one or more layers of the interwoven straps of the first thermoplastic material after heated for receipt of the one or more sensors” is interpreted as a product-by-process limitation regarding the production of an orthopedic using the claimed precast . “Even 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) (citations omitted). In the instant case, claim 7 is directed to a precast for use in producing an orthopedic, wherein the orthopedic would be the result of the process of applying heat and subsequent cooling of the precast. Therefore, claim 7 has been interpreted to only encompass the structure of the precast which would be capable of forming an orthopedic having one or more recessed areas. However, as noted above, Romo substantially teaches the process of producing the orthosis from the precast as claimed. Further, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, although Romo does not expressly teach that the one or more recessed areas (1350) are for receipt of the one or more sensors (120) taught by Cassit , the structure of the one or more recessed areas (1350) of the precast taught by Romo would be capable of receiving one or more sensors. Still further, Cassit discloses one or more recessed areas (holes 112) for receipt of the one or more sensors (Figs. 1A-1B; ¶ 0054 & 0058) such that it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the precast taught by Romo such that the first thermoplastic material is interweaved to create one or more recessed areas for receipt of the one or more sensors as taught by Cassit for the purpose of accommodating the one or more sensors within the precast. Regarding claim 8, the combination of Romo and Cassit discloses the invention substantially as claimed, as described above, wherein the one or more sensors are capable of being positioned within the one or more layers of the interwoven strands of the first thermoplastic material prior to the applying of the heat to the one or more layers. Regarding claim 9, the combination of Romo and Cassit discloses the invention substantially as claimed, as described above, and Romo further discloses that the orthopedic precast (1300) is configured to transition to an orthosis upon the one or more layers (1310) of the interwoven strands of the first thermoplastic material transitioning from a flexible state to a rigid state after partial melting and subsequent cooling of the one or more layers (1310) of the interwoven strands of the first thermoplastic material (Fig. 13; ¶ 0127-0128). Regarding claims 10 , 12 , and 13 , the combination of Romo and Cassit discloses the invention substantially as claimed, as described above, and Cassit further discloses that the one or more sensors (120) include an accelerometer capable of detecting a gravitational acceleration to measure a tilt of the orthosis or a fall of a patient wearing the orthosis, a motion sensor capable of detecting usage of the orthosis, and/or a temperature sensor capable of detecting a potential infection associated with a wound or surgical incision proximate to placement of the orthosis when worn by a patient (¶ 0020, 0056, & 0059). Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the precast taught by the combination of Romo and Cassit to include an accelerometer , a motion sensor, and/or a temperature sensor as further taught by Cassit for the purpose of determining the movement, motility, and/or temperature of the patient. Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Romo in view of Cassit as applied to claims 1, 2, and 7 above, and in further view of Dempers et al. (US 2021/0338469) . The combination of Romo and Cassit discloses the invention substantially as claimed, as described above, and Cassit further discloses that other sensors may be user (¶ 0056). However, the combination of Romo and Cassit fails to teach that the one or more sensors include a moisture sensor. Dempers discloses an orthosis (device 100) comprising a first portion (sleeve 110) and one or more sensors ( 123), wherein the one or more sensors (123) include a moisture sensor capable of detecting a lack of dryness on a wound area proximate placement of the orthosis (100) when worn by a patient (Fig. 1; ¶ 0065 & 0081). Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the precast taught by the combination of Romo and Cassit such that the one or more sensors include a moisture sensor as taught by Dempers for the purpose of monitoring any discharge or drainage from a wound. Claim s 14, 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cassit (US 2022/0104960) in view of Romo, Jr. et al. (US 2022/0256939). Regarding claim 14, Cassit discloses an orthosis (orthosis 110) formed from an orthopedic precast (plate 110a), the orthosis (110) comprising: a first portion (orthotic member 110b) formed from one or more layers of a first thermoplastic material after an application of prescribed amount of heat and subsequently cooled (Figs. 1A-1B; ¶ 0052); and one more sensors (sensors 120) positioned within the first portion (110b) of the orthosis (110) (Fig. 1B ; ¶ 0054 & 0056). However, Cassit fails to teach that the first portion is formed from one or more layers of interwoven strands of the first thermoplastic material. Romo discloses an orthosis formed from an orthopedic precast (precast 1300), the orthosis comprising one or more layers (first knitted portion 1310) of interwoven (knitted) strands of a first thermoplastic material after an application of prescribed amount of heat and subsequently cooled (Fig. 13; ¶ 0010-0013 & 0127-0128). Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the orthosis taught by Cassit such that the first portion is formed from one or more layers of interwoven strands of the first thermoplastic material as taught by Romo for the purpose of enabling different knitting techniques to provide greater rigidity and/or maintain a flexible and/or elastic construction. Regarding claims 16, 18, and 19, the combination of Cassit and Romo discloses the invention substantially as claimed, as described above, and Cassit further discloses that the one or more sensors (120) include an accelerometer capable of detecting a gravitational acceleration to measure a tilt of the orthosis or a fall of a patient wearing the orthosis, a motion sensor capable of detecting usage of the orthosis, and/or a temperature sensor capable of detecting a potential infection associated with a wound or surgical incision proximate to placement of the orthosis when worn by a patient (¶ 0020, 0056, & 0059). Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Cassit in view of Romo as applied to claim 14 above, and in further view of Maher (US 2019/0350740). The combination of Cassit and Romo discloses the invention substantially as claimed, as described above, and Cassit further discloses that the first portion may be applicable to any type of orthosis depending on the injury or disorder (¶ 0051). However, the combination of Cassit and Romo fails to teach that the first portion corresponds to a front portion of a cervical collar. Maher discloses an orthosis (cervical collar 500) comprising a first portion ( bladder 50 6 ) and one or more sensors (1300A) positioned within the first portion (50 6 ) of the orthosis (500) , wherein the first portion (506) corresponds to a front portion of a cervical collar (500) (Fig. 13 ; ¶ 0003 & 0094-0095 ). Therefore, it would have been obvious to one having ordinary skill in the art, to modify the orthosis taught by the combination of Cassit and Romo such that the orthosis is a cervical collar and the first portion corresponds to a front portion of the cervical collar as taught by Maher for the purpose of providing the thermoplastic material and sensors in the form of an orthosis suitable for support ing a patient’s cervical portion of the spinal cord by immobilizing the head and neck region during treatment of chronic medical conditions or injuries . Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cassit in view of Romo as applied to claim 14 above, and in further view of Dempers et al. (US 2021/0338469). The combination of Cassit and Romo discloses the invention substantially as claimed, as described above, and Cassit further discloses that other sensors may be user (¶ 0056). However, the combination of Cassit and Romo fails to teach that the one or more sensors include a moisture sensor. Dempers discloses an orthosis (device 100) comprising a first portion (sleeve 110) and one or more sensors (123), wherein the one or more sensors (123) include a moisture sensor capable of detecting a lack of dryness on a wound area proximate placement of the orthosis (100) when worn by a patient (Fig. 1; ¶ 0065 & 0081). Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the orthosis taught by the combination of Cassit and Romo such that the one or more sensors include a moisture sensor as taught by Dempers for the purpose of monitoring any discharge or drainage from a wound. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Keri J. Nelson whose telephone number is FILLIN "Phone number" \* MERGEFORMAT 571-270-3821 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday, 9am - 4pm . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Rachael E. Bredefeld, can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5237 . 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. /KERI J NELSON/ Primary Examiner, Art Unit 3786 4/1/2026