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 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.
Claim(s) 1-3, 5-6, 9, 12-13, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burdick (10,232,097).
With respect to claim 1, Burdick discloses a medical device, as shown in figure 4B, comprising an implant 101 having a plurality of openings, as disclosed in column 3, lines 57-58, and a tube 102 having a lumen therethrough, as disclosed in column 4, lines 9-11. A body 110 extends from a distal portion of the tube 102 to a proximal portion of the implant 101, as shown in figure 5, such that the plurality of openings are in fluid communication with the lumen, as disclosed in column 4, lines 24-45. A grasping portion is configured to be grasped by a second medical device, as disclosed in column 9, lines 13-25.
With respect to claim 2, the grasping portion comprises a sutured loop, as disclosed in column 9, lines 22-25, which anticipates the limitations of a tab, strap, or opening.
With respect to claim 3, the body 110 comprises reversible attachment means such as threading and snaps, as disclosed in column 6, lines 56-60, and therefore can be removably coupled to the tube.
With respect to claim 5, a distal opening of the body 110 is configured to receive the proximal portion of the implant 101 and a proximal opening of the body is configured to receive the distal portion of the tube 102, as shown in figure 5.
With respect to claim 6, the distal opening of the body 110 can be defined to have a first portion distal to a second portion.
With respect to claim 9, a vacuum source 105 supplies a negative pressure to the implant 101, as shown in figure 1.
With respect to claim 12, the grasping portion includes a suture 103 extending radially outward from the implant 101, as shown in figure 1 and disclosed in column 9, lines 17-25 which anticipates the limitation of a tab.
With respect to claim 13, a protruding portion of the suture 103 extends radially beyond the outer surface of the implant 101, as shown in figure 1.
With respect to claim 19, Burdick discloses a medical device, as shown in figure 4B, comprising an implant 101 having a plurality of openings, as disclosed in column 3, lines 57-58, and a tube 102 having a lumen therethrough, as disclosed in column 4, lines 9-11. The tube 102 is configured to couple to a vacuum source 105, as shown in figure 1. A body 110 couples the implant 101 to the tube 102, as shown in figure 5, such that the plurality of openings are in fluid communication with the lumen, as disclosed in column 4, lines 24-45. A grasping portion is configured to be grasped by a second medical device, as disclosed in column 9, lines 13-25, the grasping portion including a tab or strap 103, as shown in figure 1.
Claim Rejections - 35 USC § 103
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 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) 4, 7-8, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burdick (10,232,097).
With respect to claim 4, Burdick discloses all aspects of the claimed invention with the exception of the distal portion of the body being wider than the proximal portion of the body. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the distal portion of the body of Burdick wider than the proximal portion since it has been held that changes in shape or proportion are a matter of design choice absent evidence the claimed shape is significant (see MPEP 2144.04(IV)).
With respect to claim 7, Burdick discloses all aspects of the claimed invention with the exception of the body including a lumen extending from the distal opening to the proximal opening. The body of Burdick connects the implant to the vacuum tube, and Burdick discloses a desire for the lumen of the tube to be in fluid communication with the implant. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the body of Burdick with a lumen extending from the distal opening to the proximal opening to achieve the predictable result of maintaining fluid communication between the tube and the implant.
With respect to claim 8, Burdick discloses all aspects of the claimed invention with the exception of the proximal portion of the implant being compressed within the body. Burdick discloses that the implant is compressible, but remains silent as to it being compressed within the body. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the proximal portion of the implant of Burdick compressed within the body to achieve the predictable result of providing a tight fit between the implant and the body.
With respect to claim 16, Burdick discloses a medical device, as shown in figure 4B, comprising an implant 101 having a plurality of openings, as disclosed in column 3, lines 57-58, and a tube 102 having a lumen therethrough, as disclosed in column 4, lines 9-11. A body 110 extends from a distal portion of the tube 102 to a proximal portion of the implant 101 and couples the implant to the tube, as shown in figure 5, such that the plurality of openings are in fluid communication with the lumen, as disclosed in column 4, lines 24-45. A grasping portion is configured to be grasped by a second medical device, as disclosed in column 9, lines 13-25.
Burdick discloses all aspects of the claimed invention with the exception of the body tapering radially inward from the distal end to the proximal end. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the body of Burdick taper radially inward from the distal end to the proximal end since it has been held that changes in shape or proportion are a matter of design choice absent evidence the claimed shape is significant (see MPEP 2144.04(IV)).
With respect to claim 17, the distal opening of the body 110 can be defined to have a first portion distal to a second portion. Burdick discloses all aspects of the claimed invention with the exception of the body being angled. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the body of Burdick angled since it has been held that changes in shape or proportion are a matter of design choice absent evidence the claimed shape is significant (see MPEP 2144.04(IV)).
Allowable Subject Matter
Claims 10-11, 14-15, 18, and 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.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not disclose that the grasping portion is an opening formed on a radially outer surface of the body, a ring positioned over the implant and the body, or the body includes the grasping portion. The closest prior art of record, Burdick, discloses a grasping portion that is attached to the implant, as shown in figure 1, not the body, and therefore the prior art of record does not disclose nor fairly suggest the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patents and Publications 12,350,429; 2015/0148785; and 2021/0230230 disclose endoluminal medical devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNNE ANDERSON whose telephone number is (571)272-4932. The examiner can normally be reached Monday-Friday 10-6.
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/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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