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 47-89, in the reply filed on May 7, 2026 is acknowledged.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 47-88 are rejected under 35 U.S.C. 103 as being unpatentable over Shelverton (US 2019/0160255).
With reference to claim 47, Shelverton discloses a cannula for conveying body fluids (abstract), the cannula comprising:
a tubular body extending in an axial direction from a proximal end to a distal end, wherein the body defines a continuous inner cavity from the proximal end to the distal end and comprises at least two rows of holes [0018] in a distal region of the body, wherein the at least two rows of holes are axially spaced from each other and each comprise at least two holes, wherein the holes in each of the at least two rows of holes open from the inner cavity in a radial direction and are spaced apart from one another in a circumferential direction, wherein a first row of holes of the at least two rows of holes is arranged distally to a second row of holes of the at least two rows of holes as set forth in the figures.
The difference between Shelverton and claim 47 is the explicit recitation that the first total opening area of holes of the first row of holes to a second total opening area of holes of the second row of holes has a specific ratio.
It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the cannula of Shelverton with the desired ratio because Shelverton sets forth throughout the disclosure that the size, shape and/or formation of the openings may be varied to suit variable patient build and vessel depth as set forth in [0076-0078].
With reference to claims 48-51, 53, 55, 57 and 62-63, see the figures of Shelverton, especially figures 2-3 and 9-10.
As to claim 52, see the rejection of claim 47.
With reference to claims 54 and 68-69, see the figures of Shelverton, especially figures 2-3 and 9-10.
Additionally, Shelverton provides substantially circularly formed holes as set forth in [0086].
As to claim 56, Shelverton teaches the invention substantially as claimed as set forth in the rejection of claim 47.
The difference between Shelverton and claim 56 is the explicit recitation that the distal region of the body extends from the distal end of the body in the proximal direction 30 to 60 cm.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dimensions of Shelverton as desired since it has been held that the mere change in size and/or shape of an element previously set forth in the prior art is considered to be within the level of ordinary skill in the art.
Additionally, Shelverton provides the motivation to adjust the length as set forth in [0108].
As to claim 58, Shelverton teaches the invention substantially as claimed as set forth in the rejection of claim 47.
The difference between Shelverton and claim 58 is the explicit recitation that the number of holes of each of the at least two rows of holes decreases from the distal end to the proximal end.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dimensions of the openings of Shelverton as desired since it has been held that the mere change in size and/or shape of an element previously set forth in the prior art is considered to be within the level of ordinary skill in the art.
Additionally, Shelverton provides the motivation to adjust the opening sizes for the specific benefits disclosed in [0109-0111].
With reference to claims 59-61, Shelverton teaches the invention substantially as claimed as set forth in the rejection of claim 47.
The difference between Shelverton and claims 59-61 is the explicit recitation that the rows have a specific a number of holes.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the number of holes of Shelverton as desired since it has been held that the mere duplication of essential working parts of a device and/or the change in size and/or shape of an element previously set forth in the prior art is considered to be within the level of ordinary skill in the art.
Additionally, Shelverton provides the motivation to adjust the opening sizes for the specific benefits disclosed in [0077] where Shelverton recognizes that the amount of holes may be used to provide the desired surface area.
As to claim 64, Shelverton discloses a cannula wherein the holes of the at least two rows of holes are substantially circular, ellipsoidal, and/or elongated as set forth in [0086].
With reference to claim 65, see figure 9.
As to claim 66, see figure 10.
Regarding claims 67 and 70-72, see figures 2-3
As to claims 73-74 and 79, see at least one of openings (230) as shown in figure 2. Additionally, any opening may function an inlet and/or outlet (cl. 79).
As to claim 75, see figure 3.
With reference to claims 76-78 and 80-84, see the rejection of claim 47.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the distance, ratio and/or total opening area as taught by Shelverton as desired because Shelverton sets forth throughout these parameters may be adjusted as desired as set forth in [0025-0033] and [0076-0078].
As to claim 85, Shelverton discloses a cannula wherein the proximal end of the body defines an outlet (220) that is fluidically couplable to a circulatory support system, an oxygenator, and/or a pump as shown in figures 2-3.
With reference to claims 86-88, Shelverton teaches the invention substantially as claimed.
The cannula includes a plurality of adjustable openings as discussed in the rejection of claim 47.
As such the cannula is adapted to (i.e., fully capable) to perform as claimed.
The applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim 89 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. (US 9,782,534) and further in view of Shelverton (US 2019/0160255).
Kelly et al. (hereinafter “Kelly”) discloses a circulatory support system (col. 2, lines 4-16) comprising:
a cannula (10) comprising:
a tubular body extending in an axial direction from a proximal end to a distal end, wherein the body defines a continuous inner cavity from the proximal end to the distal end and comprises at least two rows of holes in a distal region of the body, wherein the at least two rows of holes are axially spaced from each other and each comprise at least two holes, wherein the holes in each of the at least two rows of holes open from the inner cavity in a radial direction and are spaced apart from each another in the circumferential direction, wherein a first row of holes of the at least two rows of holes is arranged distally to a second row of holes of the at least two rows of holes as shown in figures 1-2.
The difference between Kelly and claim 89 is the explicit recitation that the first total opening area of holes of the first row of holes to a second total opening area of holes of the second row of holes has a specific ratio.
Shelverton teaches an analogous cannula with a variable ratio as set forth in [0078].
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the ratio of Kelly in view of the teachings of Shelverton to provide the desired result to suit variable patient build and vessel depth as well as to prevent undesirable backtracking of fluid as taught by Shelverton in [0078].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELE M KIDWELL whose telephone number is (571)272-4935. The examiner can normally be reached Monday-Friday, 7AM-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELE KIDWELL/ Primary Examiner, Art Unit 3781
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