DETAILED ACTION
Response to Amendment
Claim Interpretation
The amendments filed on 3/2/2026 has amended specific structure into the retention feature and actuating mechanism. These limitations are no longer interpreted under 35 USC 112(f).
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, 3, 5-6, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chin et al. (US 5,267,970; hereafter Chin).
In regard to claim 1, Chin discloses a device (60; see Figs. 5-6) for retaining a medical device (S) comprising: a body (61) comprising a material (“friction-providing material; see col. 5, lines 25-28) having a substantially tube-like shape with a top end and a bottom end (see Fig. 5-6); a channel (62) through said body from said top end to said bottom end and comprising a retaining state (see Fig. 5) having a size adapted to compress against an inserted medical device in said channel (see col. 5, lines 8-28) and a widened state (see Fig. 6) having a size adapted to permit changes to a degree of insertion of said inserted medical device (see col. 5, lines 8-28); a retention feature (66 or at least forward portion of 66) comprising a spring (“generally metal clip” at col. 4, line 68, “elastic property of its metal” at col. 5, line 2) at least partially disposed within said material of said body (“embedded in the deformably resilient body of the sleeve-holding member 61” at col. 5, lines 2-4); an attachment feature (65) proximal to said bottom end having an attachment surface adapted to conform to a portion of an animal subject (see col. 5, lines 29-33); and an actuating mechanism (67) adapted to alter the retention of an said inserted medical device in said channel, said actuating mechanism connected to said spring comprising a pair of handles (67 are two handles) comprising a pressed position (Fig. 6) and a released position (Fig. 5); wherein said pressed position is adapted to expand said spring to deform said channel to said widened state (see arms of 66 spreading apart as 62 widens in Fig. 6), and said released position (Fig. 5) is adapted to permit contraction of said spring to permit said channel to return to said retaining state (see Fig. 5 and associated portions of the specification).
In regard to claim 3, Chin discloses wherein said spring is selected from the group consisting of a leaf spring (66 can be characterized as a leaf spring due to its material and shape).
In regard to claim 5, Chin discloses wherein said pair of handles (67) extend outside said material of said body (see Figs. 5-6).
In regard to claim 6, Chin discloses wherein said attachment feature comprises an adhering feature (see col. 5, lines 29-30).
In regard to claim 11, Chin discloses wherein said body (61) comprises a flexing portion (“deformably resilient body of the sleeve-holding member 61” at col. 5, lines 2-4) adapted to adjust the angle of said channel (the deformable area can change its angle).
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) 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chin.
In regard to claim 9, Chin teaches the device of claim 1, but Chin does not specifically teach wherein said attachment feature comprises at least one handling feature adapted to aid in removal of said device from a surface. However, Chin teaches a similar embodiment (Fig 9-10; col 6, In 12-26), wherein an attachment feature (75; Fig 9-10; col 6, In 12-26) comprises at least one handling feature adapted to aid in removal of said device from a surface (77; Fig 9-10; col 6, In 12-26).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the at least one handling feature taught by the second embodiment of Chin with the referenced embodiment of Chin, in order to improve means of removal of the device from the patient.
In regard to claim 10, Chin teaches the device of claim 9, wherein the at least one handling feature comprises a protrusion of said attachment feature (Fig 9-10; col 6, In 12-26).
Claim(s) 1-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maxson et al. (US 5,137,520; hereafter Maxson) in view of Chin.
In regard to claim 1, Maxson discloses a device (1; Figs. 7-8) for retaining a medical device (19) comprising: a body (2) comprising a material (see col. 3, lines 17-22) having a substantially tube-like shape with a top end and a bottom end (see Fig. 7-8); a channel (“passage” in col. 4, lines 34-37) through said body from said top end to said bottom end and comprising a retaining state (see col. 5, lines 19-35) having a size adapted to compress against an inserted medical device in said channel (see col. 5, lines 19-35) and a widened state (see col. 5, lines 19-35) having a size adapted to permit changes to a degree of insertion of said inserted medical device (see col. 5, lines 19-35); a retention feature (15) comprising a spring (“torsional spring 15” at col. 5, lines 20-22); an attachment feature (3) proximal to said bottom end having an attachment surface (4) adapted to conform to a portion of an animal subject (see col. 5, lines 5-8); and an actuating mechanism (16, 17) adapted to alter the retention of an said inserted medical device in said channel, said actuating mechanism connected to said spring comprising a pair of handles (16 and 17 are two handles) comprising a pressed position and a released position (see col. 5, lines 19-35); wherein said pressed position is adapted to expand said spring to deform said channel to said widened state (see col. 5, lines 19-35), and said released position is adapted to permit contraction of said spring to permit said channel to return to said retaining state (see col. 5, lines 19-35).
Maxson fails to at least partially disposed within said material of said body as is recited in claim 1.
In a similar art, Chin discloses a retention feature (66 or at least forward portion of 66) comprising a spring (“generally metal clip” at col. 4, line 68, “elastic property of its metal” at col. 5, line 2) at least partially disposed within said material of said body (“embedded in the deformably resilient body of the sleeve-holding member 61” at col. 5, lines 2-4).
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 device of Maxson with the embedded retention feature of Chin as embedding the spring is an equivalent means for attaching the spring to the resilient body and substituting equivalents is considered well within the skill of the ordinary artisan. With this combination, a high degree of success is anticipated since the retaining feature would still have the recited positions and work equally well whether attached to the outside or embedded within the material.
In regard to claim 2, Maxson discloses wherein said retention feature (15) comprises an elastic portion (“torsional spring 15” at col. 5, lines 20-22) that is continuous around said channel (see Figs. 7-8) adapted to compress against said inserted medical device in said channel in said retaining state of said channel and adapted to elastically widen or expand in said widened state of said channel.
In regard to claims 3-4, Maxson discloses wherein the spring is a torsion spring (“torsional spring 15” at col. 5, lines 20-22).
In regard to claim 5, Maxson discloses wherein pair of handles (16-17) extend outside said material of the body (see Figs. 7-8).
In regard to claim 6, Maxson discloses wherein said attachment feature (3) comprises an adhering feature (13).
In regard to claim 7, Maxson discloses further comprising a pull away film (14) adapted to cover at least a portion of said adhering feature (13) to prevent adhesion prior to removal of said pull away film.
In regard to claim 8, Maxson discloses wherein a portion of said pull away film (14) comprises a non-removable portion (14 does not need to be totally removed)
In regard to claim 9, Maxson discloses wherein said attachment feature (3) comprises at least one handling feature (30) adapted to aid in removal of said device from a surface (a user could pull on 30 to help remove the device from the patient).
In regard to claim 10, Maxson discloses wherein said at least one handling feature (30) comprises a protrusion (35) of said attachment feature.
In regard to claim 11, Maxson discloses wherein said body comprises a flexing portion adapted to adjust the angle of said channel (see col. 3, lines 17-22; material is capable of flexing).
In regard to claim 13, Maxson discloses wherein said elastic portion forms a continuous ring seal around said inserted medical device (see col. 3, lines 8-16, col. 3, lines 33-39, see col. 6, lines 30-46).
Response to Arguments
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive.
In response to the applicant’s arguments that Maxson and Chin fail to disclose the disputed limitations, the examiner respectfully disagrees. Maxson as modified by Chin does teach a spring within the material of the body. Chin explicitly discloses the spring (66) within the body (see Figures 5-6). The applicant also argues that neither reference teaches widening but the examiner notes that any increase in diameter from a clamped or closed position is a form of widening. The new limitations are addressed in the action above.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783