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 .
Claim Status
Claims 1-20 are currently pending.
Applicant’s election of Invention I Species I in the reply filed on February 24th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 4-6, 17, and 19-20 have been withdrawn from consideration. Claims 1-3, 7-12, 13-16, and 18-20 are currently under consideration.
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.
Claim 16 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.
Claim 16 recites the limitation "the distal portion" in line 9. It is unclear as to whether this is referring to the distal portion of the sidewall or the tube included distal portion with both having been introduced prior in the claim limitations. For the purpose of examination, “the distal portion” of line 9 is being interpreted to be referring to the tube included distal portion.
Claim Rejections - 35 USC § 102
(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) 16 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leeds (U.S. Publication 2020/0276056).
Regarding claim 16, Leeds discloses a medical device 101, comprising:
a sheath 103
a tube 107 having a sidewall (wall of tube 107 surrounding lumen through which wire 121 is located) defining a lumen (Fig. 3 space through center of tube 107 through which wire 121 is located) within the tube, wherein a plurality of openings 117 extend through a distal portion (portion aligned with porous material 109) of the sidewall and are in fluid communication with the lumen (¶0039 arrows in Fig. 11 used to illustrate flow direction of air which flows through ports into lumen), so that an application of suction (¶0039 negative pressure) within the lumen results in suction through the plurality of openings (¶0039 extending through ports 117); wherein the tube includes a distal portion (portion of tube encompassing element 109) having a contracted configuration inside the sheath (Fig. 8 shows contracted configuration) and an expanded configuration distal to the sheath (Fig. 9 shows expanded configuration when advanced distally past the sheath).
a porous (¶0033 porous) body 109 over at least the tube included distal portion, so that the suction through the plurality of openings results in suction through the pores of the porous body (Fig. 11 shows flow caused by suction such that suction is applied at outer surface of porous body through pores and flows through the porous body through the plurality of openings in the tube).
Regarding claim 18, Leeds discloses the medical device of claim 16. Leeds further discloses the plurality of openings being spaced along a distal length of the tube (openings 117 spaced down length of tube, see Fig. 11).
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) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leeds (U.S. Publication 2020/0276056) in view of Mikkaichi (U.S. Publication 2014/0031773).
Regarding claim 1, Leeds discloses a medical device 101, comprising: a tube 107 having a sidewall (wall of tube 107 surrounding lumen through which wire 121 is located) defining a lumen (Fig. 3 space through center of tube 107 through which wire 121 is located) within the tube, wherein a plurality of openings 117 extend through a distal portion (portion aligned with porous material 109) of the sidewall and are in fluid communication with the lumen (¶0039 arrows in Fig. 11 used to illustrate flow direction of air which flows through ports into lumen), so that an application of suction (¶0039 negative pressure) within the lumen results in suction through the plurality of openings (¶0039 extending through ports 117);
a support structure 109 coupled to the distal portion of the sidewall, the support structure having a contracted configuration (¶0032 Fig. 2 shows filler material in a compressed state) and an expanded configuration (¶0038 uncompressed state Fig. 9), and the support structure having support openings (¶0033 porous) through a wall of the support structure (porosity allows fluid flow from outer surface to tube placed in center of porous body as seen by fluid flow arrows present in Fig. 11 and thus is through the body/wall of the support structure), so that the suction through the plurality of openings results in suction through the support openings (Fig. 11 shows flow caused by suction such that suction is applied at outer surface of support structure through openings of support structure and flows through the porous body through the plurality of openings in the tube); the support structure being a porous body (¶0033 porous).
Leeds does not expressly disclose a support structure and a porous body positioned over at least a portion of the support structure as the support structure is the porous body.
However, Mikkaichi, in the same field of endeavor of expanding suction devices for use internally in a patient, teaches a support structure (Fig. 2B, element 35) coupled to a distal portion of a sidewall of a tube 22, the support structure having a contracted configuration (Fig. 2A) and an expanded configuration (Fig. 2B), and the support structure having support openings (openings between 35A wires spaced around 38) through a wall (wall is being defined as “restrictive barrier” and thus the wall is the edge of the circumferential space created by element 35) of the support structure, so that the suction through opening of the catheter results in suction through the support structure; and a porous body 36 over at least a portion of the support structure, so that the suction through the support openings results in suction through pores of the porous body (¶0056 plurality of vacancies has plurality of holes and plurality of communication passages present between outer surface and inner surface in contact with expansion part which communicate with the lumen of suction catheter; ¶0057 suction using the sponge as a medium conducted) for the purpose of maintaining the suction conducting sponge (¶0057 suction using the sponge as a medium is conducted) in close contact with an inner surface of a bursiform cavity (¶0054 enlarged to a size so as to come in close contact with an inner surface of the bursiform cavity) during suction.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expanding porous body of Leeds to have included a support structure within the porous body, as taught by Mikkaichi since it has been held that a particular known technique was recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been capable of applying this known technique to a known device (method, or product) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art. This known technique of utilizing a support structure within a porous body to maintain the porous body in close contact with an inner surface of a cavity in which the device is placed would have yielded predictable results of maintaining the porous body in close contact through its default expanded orientation after being released from the sheathing tube during the provision of suction. This would result in more uniform suction being applied to the walls of the cavity through greater maintaining of contact with the walls of the cavity. See MPEP 2143.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the expanding support structure/porous body of Leeds that performs the function of expanding such that the expanded structure expands into wound in order to provide suction at the wound location through the porous body to the suction tube for the support structure and porous body of Mikkaichi since these elements perform the same function of expanding a suction providing end of catheter such that a porous body is in close contact with a surface of a body cavity to apply suction pressure to that surface through the porous body. Simply substituting one expanding porous body means for another would yield the predictable result of allowing a(n) a porous body to be expanded to contact a surface of a body cavity. See MPEP 2143.
Regarding claim 2, Leeds in view of Mikkaichi suggest the medical device of claim 1. Leeds further discloses the distal portion of the sidewall extending along an inside of the porous body 109 and as such the distal portion of the sidewall would extend along the inside of the wall of the support structure when modified in view of Mikkaichi as it would have been obvious to have modified/substituted the porous body/support structure of Leeds with the porous body and support structure of Mikkaichi as detailed above in the rejection of claim 1.
Regarding claim 3, Leeds in view of Mikkaichi suggest the medical device of claim 1. Leeds further discloses the plurality of openings being spaced along a distal length of the tube (openings 117 spaced down length of tube, see Fig. 11).
Regarding claim 9, Leeds in view of Mikkaichi suggest the medical device of claim 1. Leeds further discloses the porous body being a flexible sponge (¶0033 sponge, compressible).
Regarding claim 10, Leeds in view of Mikkaichi suggest the medical device of claim 1. Mikkaichi further suggests the porous body surrounding a circumference of the support device (See rejection of claim 1 above; Fig. 2b of Mikkaichi shows porous body 36 surrounding support structure 35).
Regarding claim 11, Leeds in view of Mikkaichi suggest the medical device of claim 1. Leeds in view of Mikkaichi do not expressly disclose or suggest the porous body being affixed to the support structure, however, Leeds teaches the porous body 109 being adhesively attached to the tube (¶0033 attached via an adhesive or fastener to tube) so as to permanently bond the filler material to the tube (¶0033 permanently bonded).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous body and support structure suggested by Leeds in view of Mikkaichi, to have been affixed to one another as taught by Leeds, for the purpose of bonding them together which would have the added benefit of not allowing the porous body to slip off the device while in use.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leeds (U.S. Publication 2020/0276056) in view of Mikkaichi (U.S. Publication 2014/0031773) in view of Vale et al. (U.S. Publication 2002/0107541).
Regarding claim 7, Leeds in view of Mikkaichi suggest the medical device of claim 1. Leeds in view of Mikkaichi suggest the support structure surrounding the tube with the tube extending through the center of the support structure (¶0041 109 is formed around the entire circumference of tube; Fig. 13 shows tube extending through 109, but do not expressly disclose how the support structure is attached to the tube and thus do not expressly disclose or suggest the support structure having an open proximal end through which the tube extends.
However, Vale, in the same field of endeavor of expandable support structures for expanding into a cavity of body (Abstract, expanded position for extension across a blood vessel) teaches an expandable support structure 111 having an open proximal end 294 for the purpose of fixing the support structure relative to a tubular sleeve 104 extending therethrough (¶0085).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the support structure as suggested by Leeds in view of Mikkaichi to have included an open proximal end as taught by Vale for the purpose of fixing the support structure relative to a tubular sleeve 104 extending therethrough (¶0085 of Vale).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leeds (U.S. Publication 2020/0276056) in view of Mikkaichi (U.S. Publication 2014/0031773) and further in view of Lashinski et al. (U.S. Publication 2022/0022854).
Regarding claim 8, Leeds in view of Mikkaichi suggest the medical device of claim 1. Leeds further discloses the support structure, in the expanded configuration, comprising a distal bulbous region (109 forms bulbous shape as it approaches distal tip 119) and the tube having a proximal region 111 such that a lip region (region at which 109 tapers to base of element 111) having a cross-sectional dimension smaller than a cross-sectional dimension of the distal bulbous region and a cross-sectional dimension of the proximal region is between the distal bulbous region (bulbous form of 109) and the proximal region 111.
Neither Leeds or Mikkaichi expressly disclose or suggest the lip or proximal region being incorporated as part of the support structure.
However, Lashinski, in the same field of endeavor of medical devices to be placed in cavities within a patient, teaches an expandable structure (¶0297 contact member in expanded state) comprising a distal bulbous region 304, an intermediate lip region 308 and a proximal region 310 that are of a unitary structure (¶0300 contact member, retention element, and the securing element can be integrally formed) for the purpose of securing the contracted tissue in a contracted state (¶0302 securing element 310 can be advanced into the tissue that has constricted around an outside surface of the implant so as to secure the tissue in the constricted state).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the support structure of Leeds in view of Mikkaichi to have included the intermediate lip region and proximal region as taught by Lashinski for the purpose of securing the tissue once in a constricted state in relation to the device (¶0302 of Lashinski securing element 310 can be advanced into the tissue that has constricted around an outside surface of the implant so as to secure the tissue in the constricted state).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leeds (U.S. Publication 2020/0276056) in view of Mikkaichi (U.S. Publication 2014/0031773) in view of Locke et al. (U.S. Publication 2022/0370255).
Regarding claim 13, Leeds in view of Mikkaichi suggest the medical device of Claim 1. Leeds in view of Mikkaichi further suggest the porous body extending from a distal end to a proximal end of the support structure (support structure located within porous body as suggested by Mikkaichi, see above rejection of claim 1) but do not expressly disclose or suggest the porous body comprising strips of material extending from a distal end to a proximal end of the support structure.
However, Locke, in the same field of endeavor of negative pressure therapy for internal cavities (Abstract), discloses a porous body (manifolds 40) for distributing negative pressure within the cavity including open-celled foam strips (¶0047 open-celled foam strips) to evenly distribute the negative pressure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the porous body of Leeds in view of Mikkaichi that performs the function of distributing negative pressure for the porous body of Locke since these elements perform the same function of distributing negative pressure to an internal cavity. Simply substituting one negative pressure distributing means for another would yield the predictable result of allowing a(n) negative pressure providing device to provide an evenly distributed application of negative pressure. See MPEP 2143.
Allowable Subject Matter
Claims 12, 14, and 15 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.
The following is a statement of reasons for the indication of allowable subject matter: Leeds in view of Mikkaichi suggest the medical device of claim 1. Claim 12 further limits the claim such that the porous body further comprises multiple stacked layers of porous material capable of being individually removed through a distal opening in the support structure and an interior of the support structure.
Prior art references Locke et al. (U.S. Publication 2022/0370255), Collinson et al. (U.S. Publication 2019/0262182), Wales et al. (U.S. Publication 2021/0267813), and Sharma et al. (U.S. Publication 2013/0110066) all disclose porous bodies for use within internal cavities of a patient that comprise multiple layers of porous material capable of being removed from the internal cavity, however, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Leeds in view of Mikkaichi, with the teachings of these references in such a way as to have the porous body layers be capable of being removed through a distal opening in the support structure and an interior of the support structure as there is no motivation or teaching present in the art for one of ordinary skill to have arrived at such an arrangement.
As such, if rewritten in independent form including all of the limitations of the base claim and any intervening claims, Claims 12, 14, and 15 would be considered allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burke et al. (U.S. Publication 2021/0260335) discloses a tube with an expandable device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781