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 Objections
Claims 25-27, 34-35, and 40 are objected to because of the following informalities: in line 4 of claim 25, line 4 of claim 26, and line 4 of claim 27, the extra space should be deleted; in line 6 of claim 34, “the ring structure of first fork” should read “the ring structure of the first fork” for proper grammar; and in line 3 of claim 35 and line 3 of claim 40, the paratheses should be deleted. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 40 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 40 is dependent on claim 39, which is dependent on claim 35, and claim 40 is verbatim the same as claim 35. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 22-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tulleken et al. (Pub. No. 2014/0364882) in view of Lazic (Pub. No. 2015/0289876).
Regarding claim 22, Tulleken et al. discloses an anastomosis clip (10; FIGs. 6A-8H; [0101]) for connecting a first vessel to the side wall of a second vessel ([0104]), wherein the anastomosis clip comprises:
a first two prong fork (16) having a fork base (42) and two prongs (30) extending from the fork base to a tapered end part (Annotated FIG. 6B below: 30 extend from 42 to a tapered distal end), the tapered end parts tapering from a taper base (Annotated FIG. 6B) to a sharp tip (Annotated FIG. 6B),
a ring structure (46) defining a ring plane (FIG. 8A: 46 defines a plane), and
a clamping structure (40; [0101]) configured to clamp the first fork, in a closed position of the first fork, with a first clamping force towards the ring structure ([0101] 40 biases 16 and 46 together);
wherein the ring structure and the first fork are movable with respect to each other from an open position of the first fork to the closed position of the first fork ([0101] and FIGs. 8A-8H: 16 and 46 are moved together when 38 presses them together);
wherein, in the open position of the first fork, the ring structure and the first fork are arranged at a distance from each other (FIG. 8D);
wherein, in the closed position of the first fork: the prongs of the first fork extend along the ring plane (FIG. 8A), and the fork base of the first fork is located at a base side of the ring structure (FIGs. 6B and 8A: 42 lines up with the proximal side of 46) whilst the tapered end parts of the prongs of the first fork are located at a prong end side of the ring structure (FIG. 8A: the tapered portions of 30 are on the distal side of 46), the prong end side being, viewed along the ring plane, opposite the base side (FIG. 8A: 42 is proximal and the tapered portions are distal relative to 47);
wherein the ring structure has, for each of said prongs of the first fork, an associated supporting area associated to a said prong of the first fork (FIG. 8C: each 30 has an associated area of 46);
wherein each supporting area: has, viewed with respect to the fork base of the first fork, a distal end (FIG. 8C: the distal end of 46) and a proximal end (FIG. 8C: the proximal end of 46), and is configured to support a part of the associated prong when the first fork is, in the closed position of the first fork, clamped with the first clamping force towards the ring structure (FIGs. 8A and 8C: each area of 46 which contacts 30 helps to support 30 when closed by 38).
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Tulleken et al. does not disclose, when in the closed position of the first fork, a first distance from the fork base of the first fork to the sharp tip of the tapered end part of a said prong is at most as long as a second distance from the fork base of the first fork to the distal end of the associated supporting area such that, viewed in a transverse direction transverse to the ring plane, each said sharp tip is shielded by its associated supporting area. Instead, as illustrated in FIGs. 8A-8C, the sharp tips of 30 extend past the ring 46.
Lazic teaches in the same field of endeavor of methods of anastomosis (FIGs. 12A-12D; [0048]), and discloses a surgical clamp device (1; FIGs. 11-12D) with a first jaw (21a), a second jaw (21c), and a ring (21b), where, when the first jaw is closed, the two jaws and the ring are aligned such that their distal ends are at the same distance from the base of the device ([0047] the rings are identically sized and abut in the closed clip position; FIG. 12D) such that, viewed in a transverse direction transverse to a plane defined by the ring, the distal tip of each jaw is shielded by an associated supporting area of the ring (FIG. 11: 21b is shielded by 21a in the transverse view shown) for the purpose of properly lining up the two openings in the vessels (23,24) to be connected together ([0053] and FIGs. 12A-12D: the symmetry of 21a-21c allows for 21a to grab the opening of 23 and for 21c to grab the opening of 24 so that 22b can be used to clamp the two together without sewing).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first fork of Tulleken et al. to line up with the ring, as taught by Lazic, for the purpose of properly lining up the two openings in the vessels to be connected together. With such a modification, when in the closed position of the first fork, a first distance from the fork base of the first fork to the sharp tip of the tapered end part of a said prong of Tulleken as modified by Lazic is at most as long as a second distance from the fork base of the first fork to the distal end of the associated supporting area such that, viewed in a transverse direction transverse to the ring plane, each said sharp tip is shielded by its associated supporting area. Examiner notes that this modification will prevent the forks 30 and 32 from extending beyond the ring structure 46, which is described in [0093] of Tulleken et al. as being used to pierce the vessel wall. However, the function of piercing the vessel wall is only done when attaching vessels side-to-side, and that other embodiments where two vessels are joined together do not require the piercing function, so the modification by Lazic does not frustrate the intended purpose of Tulleken et al.
Regarding claim 23, Tulleken et al. as modified by Lazic further discloses, when in the closed position of the first fork, the associated area overlaps at least 35% of the tapered end part (the modification by Lazic has the area of the ring structure 46 overlapping the entirety of the tapered end part of 30, which no longer extends past 46)
Regarding claim 24, Tulleken et al. as modified further discloses the supporting areas have, viewed from their proximal end to their distal end, an area length (FIG. 8A: the area of 46); and the area length is at least 2.0x the thickness of the prongs of the first fork (FIG. 8A: the area of 46 encapsulates both 30 and 32 when they dip within 46, so the area of 46 must be at least twice the thickness of one fork).
Regarding claim 25, Tulleken et al. as modified further discloses the supporting areas have, viewed from their proximal end to their distal end, an area length (FIG. 8A: the area of 46); and the area length is at most 6x the thickness of the prongs of the first fork (FIG. 8A: the area of 46 covers only the thickness of 30 and 32 when they dip into 46, so the area of 46 cannot be more than three or four times the thickness of one fork).
Regarding claim 26, Tulleken et al. as modified by Lazic further discloses the supporting areas have, viewed from their proximal end to their distal end, an area length (Tulleken et al. FIG. 8A: the area of 46); and the area length is equal to or larger than the length of the tapered end part (the modification by Lazic places the tapered end part of both 30 and 32 within 46, which makes the area of 46 at least twice as large as the length of the tapered end part of 30).
Regarding claim 27, Tulleken et al. as modified by Lazic further discloses the supporting areas have, viewed from their proximal end to their distal end, an area length (Tulleken et al. FIG. 8A: the area of 46); and the area length is at least 110% of the length of the tapered end part (the modification by Lazic places the tapered end part of both 30 and 32 within 46, which makes the area of 46 at least twice as large as the length of the tapered end part of 30).
Regarding claim 28, Tulleken et al. as modified by Lazic further discloses, when in the closed position of the first fork, a third distance from the fork base of the first fork to the taper base of the tapered end part of a said prong is at least as long as a fourth distance from the fork base of the first fork to the proximal end of the associated supporting area (the modification by Lazic makes the length from the base of 30 to the tapered tip the same as the length from the base of 30 to the distal edge of 46) such that, viewed in the transverse direction, each said taper base is supported by its associated supporting area (the modification by Lazic places the base of 30 as supported by 46).
Regarding claim 29, Tulleken et al. as modified by Lazic further discloses the tapered end parts of the prongs of the first fork each have a first taper with a first taper direction (Tulleken et al. FIG. 8A: the downward facing taper for 16A) and a second taper with a second taper direction (Tulleken et al. FIG. 8A: the upward facing taper for 16A); wherein the first taper direction is different from the second taper direction (Tulleken et al. FIG. 8A: the tapers of 16A go in different directions); and wherein, viewed in length direction of the prongs, the second taper has a shorter length than the first taper has (Tulleken et al. FIG. 8D: the taper of 16A which faces downward goes from the portion that goes into 46 to the tip, while the taper of 16A which faces upward only goes back to the portion which overlaps 46; since the modification by Lazic does not change this distinction, the upward facing taper is shorter than the downward facing taper).
Regarding claim 30, Tulleken et al. as modified further discloses, when viewed in the closed position of the first fork, the first taper direction is towards the associated supporting area (FIG. 8A: the downward facing taper for 16A faces towards 46) and the second taper direction is away from the associated supporting area (FIG. 8A: the upward facing taper for 16A faces away from 46).
Regarding claim 31, Tulleken et al. as modified further discloses the first taper direction and second taper direction are at an angle with respect to each other (FIG. 8A: the taper directions meet at the sharp tip, which puts them at an angle with respect to each other).
Regarding claim 32, Tulleken et al. as modified further discloses the tapered end parts of the first prongs of the first fork each have a ring facing surface, which, in the closed position of the first fork, faces the associated supporting area (FIG. 8A: each prong 30 has a downward facing surface towards 46); and, when in the closed position of the first fork, the ring facing surface lies parallel to and against the associated supporting area (FIG. 8A: the prongs 30 are lying against the surface of 46).
Regarding claim 33, Tulleken et al. as modified further discloses the supporting areas are recessed in the prong end side of the ring structure (FIG. 8A: the areas of 46 which support 30 are facing the prongs and recessed within 46).
Regarding claim 34, Tulleken et al. as modified by Lazic further discloses the clip further comprises: a second two prong fork (18) having a fork base (42) and two prongs (32) extending from the fork base to a free end part (Annotated FIG. 6B below: 32 extend from 42 to a distal end),), the free end parts of the prongs of the second fork tapering to a sharp tip (Annotated FIG. 6B), and a further clamping structure (40; FIG. 7B: each 40 goes to one of 16 and 18) configured to clamp the second fork, in a closed position of the second fork, towards the ring structure of the first fork ([0101] the two 40 biases 16 and 18 together on either side of 46); wherein the ring structure and second fork are movable with respect to each other between an open position of the second fork (FIG. 8D) and the closed position of the second fork (FIG. 8F); wherein, in the open position of the second fork, the ring structure and second fork are arranged at a distance from each other (FIG. 8D); and, wherein, in the closed position of the second fork and viewed with respect to the ring plane: the first fork is arranged at one side of the ring plane (FIG. 8A: 16 is on top) and the second fork is arranged at the other side of the ring plane (FIG. 8A: 18 is on the bottom), the prongs of the second fork extend along the ring plane (FIG. 8A), the fork base of the second fork is located at the base side of the ring structure (FIG. 8A: the proximal base of 18 is at the proximal side of 46) whilst the free end parts of the prongs of the second fork are located at the prong end side of the ring structure (FIG. 8A: the distal ends of 18 are on the distal side of 46), and the free end parts of the prongs of the second fork lie submerged in an inner space bounded by the ring structure (the modification by Lazic places the tips of 18 within the area of 46 in the same manner as for 16) such that, in the closed position of the second fork, the sharp tips of the second fork are shielded by the ring structure (the modification by Lazic shields the tips of 18 behind 46 in the same manner as for 16).
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Regarding claim 35, Tulleken et al. as modified further discloses, when in the closed position of the second fork, the second fork is clamped towards the first fork with a second clamping force ([0101] 16 and 18 are moved together by 40), the second clamping force being directed opposite to the first clamping force (FIG. 8A: the force on 18 is up towards 46 while the force on 16 is down towards 46); and the second clamping force is smaller than the first clamping force ([0111] 18 can be bent prior to being actuated by 40, which reduces the force necessary to move and clamp 18 relative to 16 as 16 has to move a greater distance).
Regarding claim 36, Tulleken et al. as modified further discloses the ring structure further has a left side part connecting the base side with the prong end side (FIG. 8C), and, opposite to the left side part, a right side part connecting the base side with the prong end side (FIG. 8C); wherein the left side part and right side part have, viewed in radial direction of the ring structure, a radial thickness (FIG. 8C); and wherein said length of the supporting areas is larger than the radial thickness (FIG. 8C: 46 is wider than 16 and 18).
Regarding claim 37, Tulleken et al. as modified further discloses the ring structure further has a left side part connecting the base side with the prong end side (FIG. 8C), and, opposite to the left side part, a right side part connecting the base side with the prong end side (FIG. 8C); and wherein, in the closed position of the first fork, a section of a right of said prongs of the first fork extends parallel to the right side part of the ring structure (FIG. 8A: a portion of each 30 is parallel to 46 in the proximal-to-distal direction), whilst a second of a left one of said prongs of the first fork extends parallel to the left side part of the ring structure (FIG. 8A: a portion of each 30 is parallel to 46 in the proximal-to-distal direction).
Regarding claim 38, Tulleken et al. as modified by Lazic further discloses, when in the closed position of the first fork, said section of the right prong of the first fork and said section of the left prong of the first fork lie submerged in the inner space bounded by the ring structure (the modification by Lazic places the tips of 16 within the area of 46 in the same manner as for 16).
Regarding claim 39, Tulleken et al. as modified further discloses the ring structure further has a left side part connecting the base side with the prong end side (FIG. 8C), and, opposite to the left side part, a right side part connecting the base side with the prong end side (FIG. 8C); and wherein, in the closed position of the second fork, a section of a right of the prongs of the second fork extends parallel to the right side part of the ring structure (FIG. 8A: a portion of each 30 is parallel to 46 in the proximal-to-distal direction), whilst a second of a left one of the prongs of the second fork extends parallel to the left side part of the ring structure (FIG. 8A: a portion of each 30 is parallel to 46 in the proximal-to-distal direction).
Regarding claim 40, Tulleken et al. as modified further discloses, when in the closed position of the second fork, the second fork is clamped towards the first fork with a second clamping force ([0101] 16 and 18 are moved together by 40), the second clamping force being directed opposite to the first clamping force (FIG. 8A: the force on 18 is up towards 46 while the force on 16 is down towards 46); and the second clamping force is smaller than the first clamping force ([0111] 18 can be bent prior to being actuated by 40, which reduces the force necessary to move and clamp 18 relative to 16 as 16 has to move a greater distance).
Regarding claim 41, Tulleken et al. as modified by Lazic further discloses, when in the closed position of the second fork, said section of the right prong of the second fork and said section of the left prong of the second fork lie submerged in the inner space bounded by the ring structure (the modification by Lazic places the tips of 18 within the area of 46 in the same manner as for 16).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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