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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-13 and 18-20 in the reply filed on 8/18/2025 is acknowledged.
Claim Objections
Claim 7 is objected to because of the following informalities: there is a typo is lines 3-4 (“further includes at a channel between the upper surface and the lower surface;”). Appropriate correction is required.
Claim 7 is objected to because of the following informalities: there is a typo is lines 3-4 (repetition of the word “a”). Appropriate correction is required.
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, 8-10, 13 and 18 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Cracaucer (US 6039714).
With respect to claim 1, Cracaucer discloses a device (see fig. 1-2 below) comprising: an elastically deformable body (e.g., 2+24) including a canopy (2) and a tube (24); the tube, while in an undeformed configuration (e.g., see fig. 1, 3 below), extending along a longitudinal axis (e.g., through 12/22/24, see fig. 1, 3 below), the tube having an interior surface (e.g., to receive fluid, see abstract) with a radius perpendicular to the longitudinal axis (see fig. 1-3 below), and an exterior surface (see fig. 1-3 below, note outer surface of 24); the canopy, while in the undeformed configuration, having: a lower surface (e.g., the inner surface) forming a concave curve (see fig. 1-3 below and note that this is considered to be the inner surface of 2 defined by a petal 6) extending from a first portion (e.g., where 2 and 24 meet) of the exterior surface to an outer edge (e.g. wherein the lower and upper surfaces of 2 meet- see fig. 1-3 below); and an upper surface (e.g., outer surface) forming a convex curve (see fig. 1-3 below and note that this is considered to be an upper/outer surface of 2 as defined by petal 6) extending from a second portion (e.g., same portion as the first portion) of the exterior surface to the outer edge (e.g., see fig. 1-3 below), configured with a portion of the upper surface (closer to distal end 10, see fig. 1-3 below) further from the longitudinal axis than a corresponding portion (on the same petal 6) of the lower surface (closer to proximate portion 8); and the canopy, while in a deformed configuration (e.g., during insertion into the stomach), configured with the portion of the lower surface further from the longitudinal axis than the portion of the upper surface (note that to insert 2 into the stomach wall, 2 is collapsed/folded inwards, meaning that the upper/outer surface of 2 is inverted/folded towards 24, making the lower/inner surface further from 12/22/24 than the upper/outer surface).
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As for claim 8, Cracaucer further discloses the device of claim 1, wherein the tube (36 is considered to be part of the tube in this interpretation) has a first thickness (36+24) proximal to the canopy and a second thickness (24) proximal to an end (distal end) of the tube, the first thickness greater than the second thickness (see fig. 3 above).
As for claim 9, Cracaucer further discloses the device of claim 1, wherein the canopy has a first thickness proximal to the tube and a second thickness proximal to the outer edge, the first thickness greater than the second thickness (see col. 4 lines 30-38, note that the canopy has tapering).
As for claim 10, Cracaucer further discloses the device of claim 1, wherein the deformed configuration is configured with at least a portion of the lower surface generally parallel to the longitudinal axis (note that as discussed above, when inserted, the canopy is inverted to enter the stomach).
As for claim 13, Cracaucer further discloses the device of claim 1, a cannula (e.g., 40) with a body extending along the longitudinal axis, an inner surface with an inner radius perpendicular to the longitudinal axis (see fig. 3 above), and an outer surface generally parallel with the inner surface (see fig. 3 above), wherein the interior surface of the elastically deformable body is coupled to the outer surface of the cannula (at 42, see fig. 3 above, col. 6 lines 37-47).
With respect to claim 18, Cracaucer discloses a cannula (36) comprising: a surgical port head (see fig. 3 above); a cannula shaft (e.g., 24)connected to the surgical port head, the cannula shaft extending along a longitudinal axis and having an inner surface with a radius perpendicular to the longitudinal axis (see fig. 1-3 above), and an outer surface (see fig. 1-3 above); and an elastically deformable surgical halo (2) affixed to the outer surface of the cannula (see fig. 1-3 above), the surgical halo including a body with a canopy (2) and a tube (40), the surgical halo in an undeformed configuration including: the tube extending along the longitudinal axis, the tube having an interior surface with a radius perpendicular to the longitudinal axis (see fig. 1-3 above and col. 6 lines 37-47), and an exterior surface (see fig. 3 above); and the canopy having a lower surface (e.g., inner surface) forming a concave curve extending from a first portion of the exterior surface to an outer edge (where the inner and out surfaces meet) and an upper surface (outer surface) forming a convex curve extending from a second portion of the exterior surface to the outer edge (see fig. 1-3 above).
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) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cracaucer (US 6039714), as applied to claim 1 above, in view of Acosta (US 20090281500).
As for claims 2-4, Cracaucer does not appear to teach wherein the elastically deformable body further includes a marker component, and the marker component includes a material visible outside of the visible spectrum of light; wherein the material is a radiopaque marker; and wherein the radiopaque marker is a radiopaque substance and the elastically deformable body is formed of a material that includes the radiopaque substance.
Acosta, also drawn to body access devices, teaches wherein the elastically deformable body (534, see para. 86) further includes a marker component (536, see para. 92), and the marker component includes a material visible outside of the visible spectrum of light (see para. 92); wherein the material is a radiopaque marker (536, see para. 92); and wherein the radiopaque marker is a radiopaque substance and the elastically deformable body is formed of a material that includes the radiopaque substance (see para. 92) in order to allow for visualization of the device during the procedure (see para. 92).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Cracaucer, wherein the elastically deformable body further includes a marker component, and the marker component includes a material visible outside of the visible spectrum of light; wherein the material is a radiopaque marker; and wherein the radiopaque marker is a radiopaque substance and the elastically deformable body is formed of a material that includes the radiopaque substance, in view of Acosta, in order to allow visualization of the device during the procedure.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cracaucer (US 6039714), as applied to claim 1 above, in view of Seminara (US 20070049860).
As for claims 5-7, Cracaucer teaches wherein: the deformable body further includes a channel between the upper surface and the lower surface (see fig. 1-3 above and abstract, note that 24 is a tube) but does not teach further comprising a retrieval component coupled with the elastically deformable body; wherein the retrieval component includes a radiopaque marker; a first portion of the retrieval component is disposed within the channel; and a second portion of the retrieval component is disposed around at least part of the tube.
Seminara, also drawn to access devices used in the body, teaches a retrieval component (e.g., radiopaque sponge, see para. 42) coupled with the body (24) (see fig. 11); wherein the retrieval component includes a radiopaque marker (see para. 42); and a first portion (e.g., handle of 1) of the retrieval component is disposed within the channel (see fig. 12); and a second portion (e.g., 5) of the retrieval component is disposed around (e.g., within the vicinity of) at least part of the tube (see fig. 12-14), in order to provide a tool that is used to quickly and safely clear tissue, amongst other uses, under visualization during surgery (see abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Cracaucer, wherein: the deformable body further includes a channel between the upper surface and the lower surface (see fig. 1-3 above and abstract, note that 24 is a tube) but does not teach further comprising a retrieval component coupled with the elastically deformable body; wherein the retrieval component includes a radiopaque marker; a first portion of the retrieval component is disposed within the channel; and a second portion of the retrieval component is disposed around at least part of the tube, in view of Seminara, in order to provide a tool that is used to quickly and safely clear tissue, amongst other uses, under visualization during surgery.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest the device including wherein the radius in a second deformed configuration is greater than the radius in the undeformed configuration, as set forth in claim 11.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest the device including wherein the radius in a second deformed configuration is greater than the radius in the undeformed configuration, and the canopy, while in the second deformed configuration, is configured with the lower surface forming the concave curve and the upper surface forming the convex curve, as set forth in claim 12.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest the device including wherein the outer surface of the cannula includes a groove with a radius perpendicular to the longitudinal axis, and wherein a portion of the interior surface of the surgical halo is deformed inward at a location corresponding to the groove, as set forth in claim 19.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest the device including wherein the exterior surface of the cannula has dimensions greater than the radius of the interior surface of the surgical halo in the undeformed configuration, and wherein the surgical halo exerts an inward compressive force toward the longitudinal axis while the surgical halo is in a deformed state with the radius being greater than the radius in the undeformed configuration, as set forth in claim 20.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Allowable Subject Matter
Claims 11-12 and 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20080086167 (fig. 2, 5, 7).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773