DETAILED ACTION
This office action is in response to the amendment filed on 3/19/2026.
Claims 1-4,6,16 have been amended. Claims 1-17 are pending in this present application.
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 1-17 are 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.
Claim 1 recites in part “upon application of a first torque that is less than a first torque threshold, …. Upon application of a second torque that is greater than the first torque threshold….. in order to inhibit movement of the ball upon application of the second torque.” However, there is no support in the original disclosure for the amended claim 1. According to applicant’s Pub U.S 2025/0000545 on 01/02/2025 disclose “wherein the engagement between the first and second annular members allows for the trocar fixation assembly to be shifted between at least a first configuration, in which the ball member is movable with respect to the first and second annular members, a second configuration, in which the ball member is gradually movable with respect to the first and second annular members, and a third configuration, in which the ball member is fixed with respect to the first and second annular members “see paragraph 011, but does not disclose “upon application of a first torque that is less than a first torque threshold, …. Upon application of a second torque that is greater than the first torque threshold….. in order to inhibit movement of the ball upon application of the second torque.” Thus, the claim contains subject matter which was not described in the specification in such a way to reasonably convey to one skilled in the relevant art the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
As to claims 2-17 are also rejected on 112 first paragraph due to their dependency from claim 1.
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.
Claim(s) 1, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryan U.S 20210068917.
Claim 1: Ryan discloses a fixation assembly 1 capable of holding a trocar (see Fig. 1, 6) comprising a fixation device (nut 26, collet 13, ball 4; see Fig. 6) and a medical dressing (34, 35), wherein said fixation device comprises: a skin attachment element comprising a first annular member 13 disposed about a longitudinal center line,
a ball member 4 arranged in said first annular member (see Figs 1, 6), wherein said ball member comprises a channel 5 extending through said ball member, wherein the channel 5 is configured to receive a trocar therethrough, and being capable of receive a trocar, and a second annular member 26 disposed about said longitudinal center line and being configured to engage with said first annular member, wherein the engagement between said first and second annular members allows for said fixation assembly to be shifted between at least: a first configuration, in which said ball member is movable with respect to said first and second annular members (when the nut 26 is barely tightened against collet 13), “upon application of a first torque that is less than a first torque threshold, …. Upon application of a second torque that is greater than the first torque threshold….. in order to inhibit movement of the ball upon application of the second torque.” (see 112-first issue rejection above), a second configuration, in which said ball member is gradually movable with respect to said first and second annular members (when the nut 26 is beginning to tighten against collet 13), and a third configuration, in which said ball member is fixed with respect to said first and second annular members (when the nut 26 is fully tightened against collet 13); (note that the first, second and third configuration are achieved depending on how tight the nut 26 is screwed unto collet 13).
Claim 17: Ryan discloses wherein the channel defines a groove (ribs 19/20) that is configured to threadedly engage a male thread 26 the trocar as best seen in fig. 6.
Response to Arguments
Applicant's arguments filed on 3/19/2026 have been fully considered but they are not persuasive. The applicants argue that Ryan fails to disclose that the ball member is capable of or size to receive a trocar. The examiner disagrees. It is noted that figures 1,6 discloses that a fixation assembly 1 is capable of holding a trocar with a ball 4 that has a channel 5 that is size to receive a needle 37 in fig 7. It is noted that a trocar is defined as a sharp pointed surgical instrument fitted within a cannula. In this case, needle 37 is met the definition of a trocar and having a ball member that is capable of or sized to receive a trocar/needle. Therefore, it meets the claim as amended in claim 1.
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.
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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