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 .
This office action is in response to the amendment filed 10/27/25. As directed by the amendment: claims 9-12 have been amended, claims 14-17 have been added, claims 1-8 remain withdrawn from consideration, and no claims have been cancelled. As such, claims 9-17 are examined below.
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 15 and 17 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.
Claim 15 contains the trademark/trade name Velcro. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe hook and loop connector and, accordingly, the identification/description is indefinite.
The term “about 118 grams” in claim 17 (emphasis added) is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear as to what qualifies, or does not qualify, as being ‘about 118 grams’.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 9-10, 12, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall (2016/0074203) in view of Geremtzes et al. (2020/0009288) and Karasahin (10,932,940).
Regarding claim 9, Hall discloses a 3D-printed orthopaedic cast for a body part of a user (see Hall abstract, Fig. 1-6, 13-15, para. 0002 and 0005 for example, cast 10), the cast including a base component formed of a first part and a second part, wherein the second part is connected with the first part to enable wrapping of the base component around the body part (see Fig. 1-6, base component defined by first and second parts 18 and 20, see para. 0029-0032), wherein the base component has a grid pattern forming interconnected pores on a surface (see Fig. 1-5, grid pattern forming pores 14 as shown, see also para. 0031); and a lock adapted to connect the first part with the second part to form the base component (see Fig. 6 and 13-15, lock defined by elements 40, including 42, and 44; see para. 0036, 0039, 0043); wherein the 3D-printed cast is formed after generation of a CAD of a modelled cast (see abstract, para. 0047-0048), and wherein the 3D-printed cast is rigid (see abstract, para. 0005-0006, 0030-0031, 0048). Hall is silent as to the surface having an edge thickness in a range of 2.5 mm to 3.5 mm; however, Geremtzes teaches a similar orthopaedic cast which includes pores on a surface having a range of 2.5 mm to 3.5 mm (see Geremtzes para. 0002-0003, 0065, Fig. 5 and 12-13 showing orthopaedic cast with pores, para. 0018 and 0067 disclosing thickness range of about 1.5 mm to about 5.0 mm which fully encompasses the claimed range, it being obvious to choose values such as 2.5-3 in order to provide desired properties). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Hall device to have a thickness in the range of 2.5 mm to 3.5 mm, as taught by Geremtzes, as this is a well-known set of values for such a device and in order to provide desired properties of the cast (rigidity, lightweight, see Geremtzes para. 0018 and 0067). The now modified Hall device is silent as to the cast being formed using finite element analysis of the modelled cast; however, this is a product-by-process which MPEP 2113 I states: "[E]ven 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). Furthermore, Karasahin discloses such a process of creating the orthopedic cast (see col. 2 ln. 33-58 and col. 3 ln. 15-49). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device’s cast to be constructed using finite element analysis, as taught by Karasahin, in order to provide a personalized cast for a user which exhibits known mechanical properties (Karasahin col. 2 ln. 33-58 and col. 3 ln. 15-49) and this would have been obvious application of known technique to a known device to provide improved results.
Regarding claim 10, the modified Hall device is silent as to the cast being formed of a polymeric or composite material being at least one of the claimed group; however, Geremtzes teaches a similar cast device which is made of such a material (see Geremtzes Fig. 5 and 12-13 showing cast; abstract, para. 0015, 0018 disclosing cast made of Polylactic Acid PLA). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device’s cast to be made of PLA, as taught by Geremtzes, as this a well-known type of material for such a cast and would have been obvious substitution of one known element for another and one would expect the modified Hall device to perform equally as well.
Regarding claim 12, the modified Hall device is silent as to including at least one removable spacer adapted to accommodate swelling of the body part; however, Karasahin device further includes at least one removable spacer adapted to accommodate swelling of the body part (see Karasahin Fig. 3 and col. 8 ln. 35-48, spacers 302). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device to include at least one removable spacer, as taught by Karasahin, in order to provide the ability of the device to conform to the user and accommodate swell of the user’s limb (see Karasahin Fig. 3 and col. 8 ln. 35-48, spacers 302).
Regarding claim 15, the modified Hall device is silent as to the lock being adapted to connect the first and second part being a Velcro based lock; however, Geremtzes teaches a similar cast device which includes plural parts connected together with a Velcro based lock (see Geremtzes Fig. 12-13, para. 0084, Velcro strap). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device’s lock to be a Velcro based lock, as taught by Geremtzes, as this would have been obvious substitution of one known element for another and one would expect the modified Hall device to perform equally as well.
Regarding claim 16, the modified Hall device is silent as to the cast being configured to withstand a compressive load in a range of 50 N to 300 N (note Hall discloses rigid cast in see abstract, para. 0005-0006, 0030-0031, 0048, Geremtzes para. 0067); however, Geremtzes discloses a similar cast made of polylactic acid (material disclosed in the instant application) in para. 0015 and 0018 and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device’s cast to be made of such a material, as taught by Geremtzes, as this a well-known type of material for such a cast and would have been obvious substitution of one known element for another and to modify the Hall cast to withstand compressive forces in a range of 50 N to 300 N, in order to optimize the strength of the cast for protection of the user’s limb. Furthermore, it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art. In re Aller, 200 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 17, the modified Hall device is silent as to the cast having a weight of about 118 grams; however, Geremtzes discloses a similar cast which has a weight of about 118 grams (see Geremtzes para. 0135, it being obvious to choose values at the upper end of this range which is about 118 grams). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device to have a weight of about 118 grams, as taught by Geremtzes, as this would have been obvious to try to provide a desired light weight to the device and one would expect the modified Hall device to perform equally as well.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall, Geremtzes, and Karasahin as applied to claim 9 above, and further in view of Shabah (2016/0213320).
Regarding claim 11, the modified Hall device is silent as to further including at least one probe adapter to deliver a localized adjuvant therapy including at least one of photo therapy and vibration therapy; however, Shabah discloses an orthopedic cast which includes a probe adapter configured to deliver vibration therapy (see Shabah Fig. 1-5 and para. 0125, “an integrated vibration actuator”). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device to include a vibrational probe adapter, as taught by Shabah, in order to provide therapy to promote bone growth and repair of the wounded limb (see Shabah para. 0125).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall, Geremtzes, and Karasahin as applied to claim 9 above, and further in view of Rivlin et al. (2017/0216078).
Regarding claim 12, the modified Hall device is silent as to including at least one removable spacer adapted to accommodate swelling of the body part; however, Rivlin discloses a similar cast device which includes such an element to accommodate swell of the body part (see Rivlin para. 0030 swelling zones of flexible materials, ratcheting or movable first and second engagement mechanisms 16a and 16b for example). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device to include at least one removable spacer, as taught by Rivlin, in order to provide the ability of the device to conform to the user and accommodate swell of the user’s limb (see Rivlin para. 0030).
Regarding claim 13, the modified Hall device is silent as to the orthopedic cast explicitly being water and sweat resistant (note that the modified Hall device would have some level of resistance); however, Rivlin discloses a similar orthopedic cast which is water/sweat resistant (see Rivlin para. 0027, see also para. 0038 which discloses the same materials as the instant application, ABS and PLA for example). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device to be made of a water/sweat resistant material as taught by Rivlin, as this would have been obvious substitution of one known element/material for another and one would expect the modified Hall device to perform equally as well.
Regarding claim 14, the modified Hall device is silent as to the grid pattern being a hexagonal grid pattern; however, Rivlin discloses a similar cast which includes a grid of pores in a hexagonal grid pattern (see Rivlin Fig. 1 and 3, para. para. 0044). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Hall device’s grid pattern to be a hexagonal grid pattern, as taught by Rivlin, as this would have been obvious substitution of one known element/shape or grid pattern for another and one would expect the modified Hall device to perform equally as well.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on the same combination of reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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/COLIN W STUART/Primary Examiner, Art Unit 3785