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 .
Response to Amendment
The amendment filed 12/29/2025 has been received and made of record. As requested, claims 1 and 14-17 are currently pending and are being examined.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 14-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15 and 17 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly added claim 15 recites that the body has a glove configuration. Claim 1, as amended, recites that “the offload target is flush with the top side and flush with the bottom side of the brace, wherein the offload target comprises an opening over the pisiform”. Applicant’s original disclosure does not provide support for the glove embodiment having an offload target that is an opening and flush with the top and bottom of the brace body. The glove body is shown in Figure 13 is disclosed as having offload targets 19 that are removably attached offload targets ([0083]), whereas the flush offload targets are discussed with respect to the embodiments of Figure 8 ([0078]). Furthermore, claim 1 recites “the proximal end features a purlicue saddle”. The embodiment with the glove does not have the purlicue saddle at the proximal end. Therefore, claim 15 contains new matter.
Newly added claim 17 recites wherein “the offload target further comprises an inner layer”. While applicant’s original specification discloses that there can be an inner layer ([0076]), this is discussed with respect to the embodiment of Figure 6, whereas the offload targets being flush with the top side and bottom side are discussed with respect to the embodiment of Figure 8. There is no support for the offload support comprising an opening that is flush with the bottom side and top side of the brace while also comprising an inner layer. It is not disclosed how the inner layer is attached to the brace. One skilled in the art would expect that it could be attached by sewing to the top or bottom surface of the brace, but then it would not be flush with both the top and bottom surface of the brace. Therefore, the subject matter of claim 17 contains new matter.
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.
Claim 17 is 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.
Newly added claim 17 recites wherein “the offload target further comprises an inner layer”. While applicant’s original specification discloses that there can be an inner layer ([0076]), this is discussed with respect to the embodiment of Figure 6, whereas the offload targets being flush with the top side and bottom side are discussed with respect to the embodiment of Figure 8. It is unclear how the offload support comprises an opening while also comprising an inner layer that is flush with the bottom side and top side of the brace. It is not disclosed how the inner layer is attached to the brace. One skilled in the art would expect that it could be attached by sewing to the top or bottom surface of the brace, but then it would not be flush with both the top and bottom surface of the brace.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 and 14-17 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “an offload target that is located where the brace rests over a pisiform… the offload target comprises an opening over the pisiform”.
Claim Rejections - 35 USC § 102
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.
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 1, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lipshaw et al (US 2017/0354544 A1).
Regarding claim 1, Lipshaw discloses an off-loading wrist brace (Figures 1-2), comprising: a body (10) having a top side, a bottom side, a middle section (section between 24 and 40, Figure 1), a distal end (at 34), and a proximal end (29), wherein the proximal end features a purlicue saddle (band 32 is capable of being wrapped around and placed within a user’s perlicue; Figures 4-5), wherein the middle section between the distal end and the proximal end comprises an offload target (22) that is located where the brace rests over a pisiform (intended use, the wrap 10 is capable of being placed with aperture 22 over the pisiform), wherein the offload target is flush with the top side and flush with the bottom side of the brace (22 is an aperture and therefore flush), wherein the offload target comprises an opening (22) over the pisiform, wherein the brace is configured to compress a wrist to stabilize an ulnar ligament and decompress the pisiform to prevent pisiform-ligament complex syndrome (intended use; [0016]; Figures 1-5). It is noted that the claim no longer recites a thumb hole. Therefore, the device of Lipshaw is capable of use by placing the hole over a user’s pisiform and wrapping around the hand.
Regarding claim 14, Lipshaw discloses wherein the body has a linear configuration (Figure 1).
Regarding claim 16, Lipshaw discloses wherein the body has a linear splint body (Figure 1).
Claims 1 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prengler (US 5,451,201).
Regarding claim 1, Prengler discloses joint support apparatus (Figure 1) capable of placement on the wrist, comprising: a body (10) having a top side, a bottom side, a middle section, a distal end, and a proximal end (Figure 1), wherein the proximal end features a purlicue saddle (16 or 18 is capable of being wrapped around and placed within a user’s perlicue; Figures 1), wherein the middle section between the distal end and the proximal end comprises an offload target (40) that is located where the brace rests over a pisiform (intended use, the wrap 10 is capable of being placed with aperture 40 over the pisiform), wherein the offload target is flush with the top side and flush with the bottom side of the brace (40 is an aperture and therefore flush), wherein the offload target comprises an opening (40) over the pisiform, wherein the brace is configured to compress a wrist to stabilize an ulnar ligament and decompress the pisiform to prevent pisiform-ligament complex syndrome (intended use; Figures 1). It is noted that the claim no longer recites a thumb hole. Therefore, the device of Prengler is capable of use by placing the hole over a user’s pisiform and wrapping around the hand.
Regarding claim 17, Prengler further discloses wherein the offload target further comprises an inner layer (92;Figure 8).
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 Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARI K RODRIQUEZ/ Primary Patent Examiner, Art Unit 3786
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