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 § 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.
Claims 1-6 and 8-21 are 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 1 recites “the at least one first wing member and/or the at least one second wing member define the first and second longitudinal channels” (emphasis added to “and”). This contradicts the earlier part of the claim which recites that the channels are part of “the other of the first leg member and the second leg member”, meaning on one of the leg members and not both. It is therefore unclear what the scope of the claim is and what is meant by “define” in the statement “define the first and second longitudinal channels”.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 and 8-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 20190314026) in view of Smith (US 20050033333).
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Annotated Fig. 1 of the Thomas Reference
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Annotated Fig. 3C of the Thomas Reference
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Regarding claim 1, Thomas discloses (Fig. 1-7) a surgical clip (10) comprising:
a first leg member (12) having a first inner surface (surface of 60) with a concave curvature (As disclosed in fig. 3 and [0044]) and at least one first wing member extending laterally of the first inner surface (section of 12 that extends on either side of 66 and forms the channels; note that these sections resemble a wing in appearance and position as seen in figure 3B by the lateral extension of the parts from a central section; as such, these sections are interpreted as wing members; the fact that they are continuous with other sections of the device does not prevent them from being interpreted as wing members, especially given that the specification and claims set forth applicant’s wing members have a surface continuous with other parts of the device), the first leg member having a first thickness in a compression direction, a first width in a lateral direction defined by the at least one first wing member, and a first length in a longitudinal direction (As disclosed in fig. 1-7, the first leg (12) comprises a length, width, and thickness. It is noted that this first length, width, and thickness are measuring specifically the dimensions of the leg member and not the leg member in addition to a boss member or locking element) [0044-0045];
a second leg member (14) having a second inner surface (surface of central channel 71) with a convex curvature (As disclosed in fig. 3 and [0044]) and at least one second wing member (portion of 28 extending laterally from inner surface 71 and between adjacent teeth 70b as seen in figure 2; see above re. interpretation of “wing member”) extending laterally of the second inner surface, the second leg member having a second thickness in the compression direction, a second width in the lateral direction defined by the at least one second wing member, and a second length in the longitudinal direction (As disclosed in fig. 1-7, the second leg (14) comprises a length, width, and thickness. It is noted that this first length, width, and thickness are measuring specifically the dimensions of the leg member and not the leg member in addition to a boss member or locking element) [0044-0045];
a hinge member (16) pivotally coupling the first leg member (12) and the second leg member (14) [0044];
first (70a) and second (70b) rows of teeth extending from one of the first leg member (12) and the second leg member (14) (As disclosed in fig. 1 and [0049], two rows of teeth extend from the second inner surface (28) of the second leg (14)); and
first and second longitudinal channels (“First Longitudinal Channel” and “Second Longitudinal Channel.” See annotated Fig. 1 and 3C above);
wherein the first and second longitudinal channels (“First Longitudinal Channel” and “Second Longitudinal Channel.” See annotated Fig. 1 and 3C above) extend longitudinally along opposing lateral sides of the respective inner surface (22) of the other one of the first leg member (12) and the second leg member (14) (channels formed by wing members of leg and extend along sides of the inner surface);
wherein the at least one first wing member and/or the at least one second wing member define the first and second longitudinal channels (at least partially defines the first and second channels, wherein the wing member may include a portion of 60, such as 62a).
Thomas is silent to wherein the first width is greater than the first thickness along at least half of the first length, and/or the second width is greater than the second thickness along at least half of the second length.
In a similar field of endeavor, namely a surgical clip [Abstract], Smith discloses (Fig. 1) wherein the first width (W of first leg member 14. As disclosed in [0037], the first and second leg members have a width of 0.5 mm to 1.5 mm) is greater than the first thickness along at least half of the first length (h of first leg member 14. As disclosed in [0037], the first and second leg members have a thickness of 0.3 mm to 0.7 mm. As such, Smith discloses a first width that is greater than the first thickness along the length of the first leg member; note that any length of the leg may serve as a “leg member”), and the second width (W of second leg member 16. As disclosed in [0037], the first and second leg members have a width of 0.5 mm to 1.5 mm) is greater than the second thickness along at least half of the second length (h of the second leg member 16. As disclosed in [0037], the first and second leg members have a thickness of 0.3 mm to 0.7 mm. As such, Smith discloses a first width that is greater than the first thickness along the length of the first leg member; 1.5 is more than twice 0.7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Thomas have the width of the clip be 0.5 mm to 1.5 mm and the thickness of the leg member be 0.3 mm to 0.7 mm, having the width greater than the thickness of the clip , as taught by Smith, for the advantage that such a clip allows for use in a gastrointestinal hemostasis application [0037].
Regarding claim 2, Thomas and Smith disclose the surgical clip of claim 1. Smith further discloses (Fig. 1) wherein the first width is at least 1.5 times greater than the first thickness and the second width is at least 1.5 times greater than the second thickness (As previously cited above, as disclosed in [0037], the first and second leg members have a width of 0.5 mm to 1.5 mm and a thickness of 0.3 mm to 0.7 mm. As such, Smith discloses a range of first widths and second widths that are at least 1.5 times greater than the first and second thicknesses respectively; 1.5 is more than twice 0.7).
Regarding claim 3, Thomas and Smith disclose the surgical clip of claim 2. Smith further discloses (Fig. 1) wherein the first width is at least 2 times greater than the first thickness and the second width is at least 2 times greater than the second thickness (As previously cited above, as disclosed in [0037], the first and second leg members have a width of 0.5 mm to 1.5 mm and a thickness of a thickness of 0.3 mm to 0.7 mm. As such, Smith discloses a range of first widths and second widths that are at least 2 times greater than the first and second thicknesses respectively; 1.5 is more than twice 0.7).
Regarding claim 4, Thomas and Smith disclose the surgical clip of claim 1. Smith further discloses (Fig. 1) wherein the first width is greater than the first thickness along at least about two-thirds of the first length, and the second width is greater than the second thickness along at least about two-thirds of the second length (As previously cited above, as disclosed in [0037], the first and second leg members have a width of 0.5 mm to 1.5 mm and a thickness of 0.3 mm to 0.7 mm along the length of the first and second leg members. As such, Smith discloses the first and second width being greater than the first and second thickness along the length of the leg members; note that any length of leg may serve as being a “leg member”).
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Annotated Fig. 1 of the Thomas Reference
Regarding claim 5, Thomas and Smith disclose the surgical clip of claim 1. Thomas further discloses (Fig. 1-7):
at least one first boss member (33) on the first leg member (12) [0046]; and
at least one second boss member (42) on the second leg member (14) [0047],
wherein the first width is substantially the same as a width of the surgical clip at the at least one first boss member (33), and/or the second width is substantially the same as a width of the surgical clip at the at least one second boss member (42) (As seen in annotated fig. 1 and fig. 3, the “Portion of the First Leg Member at First Boss Member” is substantially the same as a width of the first leg member, as the width of the first leg member does not change until the notch (36) and tapered surfaces (34) note that the leg member “at” the boss member does not include the boss member itself) [0046].
Regarding claim 6, Thomas and Smith disclose the surgical clip of claim 1. Thomas further discloses (Fig. 1-7) wherein the first width is substantially the same as a width of the hinge member (16), and/or the second width is substantially the same as the width of the hinge member (16) (As disclosed in [0044], the hinge is integrally formed with the first and second leg member and would therefore have substantially the same width).
Regarding claim 8, the at least one first wing member includes a pair of first wing members, and/or the at least one second wing member includes a pair of second wing members (figure 3B).
Regarding claim 9, a distal portion of the at least one first wing member is spaced proximally from a distal end of the first leg member (figure 8; wing member ends distally before distal end of leg member at 132/133) and/or a distal portion of the at least one second wing member is spaced proximally from a distal end of the second leg member.
Regarding claim 10, the at least one first wing member has a thickness less than the first thickness and/or the at least one second wing member has a thickness less than the second thickness (figure 3B; wing members do not include entire thickness of leg).
Regarding claim 11, the at least one first wing member and/or the at least one second wing member includes an inner surface that is beveled (surface 64 may form part of the wing member).
Regarding claim 12, the at least one first wing member includes an outer surface that is continuous with an outer surface of the first leg member (figure 3B) and/or the at least one second wing member includes an outer surface that is continuous with an outer surface of the second leg member.
Regarding claim 13, each of the at least one first wing member has a width no greater than about a quarter of the first width and/or each of the at least one second wing member has a width no greater than about a quarter of the second width (figure 3B; wherein “about” makes the claim broad and the figure serves as support for this limitation being met by the reference; any lateral portion of device may also serve as the “wing” and would at least partially define the channel).
Regarding claim 14, the at least one first wing member and/or the at least one second wing member includes a side surface that is substantially flat (figure 3B).
Regarding claim 15, Thomas and Smith disclose the surgical clip of claim 1. Thomas further discloses (Fig. 1-7):
a hook member (30) on a distal portion (20) of the first leg member (12) [0046]; and
a tip member (40) on a distal portion (26) of the second leg member (14) [0047],
wherein the hook member (30) is configured to receive the tip member (40) to retain the surgical clip (10) in a closed configuration (As disclosed in fig. 3-3A and [0047]).
Regarding claim 16, Thomas and Smith disclose the surgical clip of claim 1. Thomas further discloses (Fig. 1-7) wherein, in a closed configuration, the first longitudinal channel (“First Longitudinal Channel” See annotated Fig. 1 above) is configured to receive the first row of teeth (70A), and the second longitudinal channel (“Second Longitudinal Channel” See annotated fig. 1 above) is configured to receive the second row of teeth (70B) (As disclosed in fig. 3 and [0050]).
Regarding claim 21, the first width of the at least one first wing member and the second width of the at least one second wing member are substantially the same (see figure 3C below).
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Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 20190314026) in view of Smith (US 20050033333) as applied to claim 1 above, and further in view of Morris (US 20070083218).
Regarding claim 17, Thomas and Smith disclose the surgical clip of claim 1. Thomas and Smith do not disclose a first proximal extension extending from the first leg member toward the hinge member; and a second proximal extension extending from the second leg member toward the hinge member.
In a similar field of endeavor, namely a surgical clip [Abstract and 0001], Morris discloses (Fig. 1-2B and 3) a first proximal extension (56) extending from the first leg member (12) toward the hinge member (16) [0024]; and
a second proximal extension (58) extending from the second leg member (14) toward the hinge member (16) [0024].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the invention to modify the device of Thomas and Smith to have a first and second proximal extension, as taught by Morris, for the advantage that the extensions allow for the clip to secure itself onto tissue with a “C” shaped configuration, which is advantageous for ligation [0024].
Regarding claim 18, Thomas, Smith, and Morris disclose the surgical clip of claim 17. Morris further discloses (Fig. 1-2B and 3) wherein the first proximal extension (56) comprises an inner surface having a convex curvature (As stated in [0024], extension (56) is merely a continuation of first leg (12). First leg (12) has a concave curvature, thus the first extension (56) has a concave curvature), and the second proximal extension (58) comprises an inner surface having a convex curvature (As stated in [0024], extension (58) is merely a continuation of second leg (14). Second leg (14) has a convex curvature, thus the second extension (58) has a convex curvature).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 20190314026) in view of Smith (US 20050033333) as applied to claim 1 above, and further in view of Whiting (US 20090171380).
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Annotated Fig. 5 of the Whiting reference
Regarding claim 19, Thomas and Smith disclose the surgical clip of claim 1. Thomas and Smith do not disclose a first inner member at a proximal portion of the first leg member; and a first aperture at a proximal portion of the second leg member, wherein the first aperture is configured to receive the first inner member in a closed configuration to resist the surgical clip from inverting and/or rotating, and the first inner member does not latch and/or interlock with the first aperture.
In a similar field of endeavor, namely a surgical clip [Abstract and 0002], Whiting (Fig. 4-5 and 7) discloses a first inner member (234A) at a proximal portion (202A) of the first leg member (202) [0037-0042]; and
a first aperture (“First Aperture.” See annotated fig. 5 above) at a proximal portion (204A) of the second leg member (204), wherein the first aperture is configured to receive the first inner member (234A) in a closed configuration (Fig. 7) to resist the surgical clip from inverting and rotating, and the first inner member does not latch and interlock with the first aperture (As seen in fig.7, the clip is in a closed configuration and is resisting a rotation and it does not latch or interlock with the first aperture).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the invention to modify the device of Thomas and Smith to include a first inner member and aperture, as taught by Whiting, for the advantage that this configuration allows for a better grip on and less damage to tissue when grasping [0042].
Regarding claim 20, Thomas and Smith disclose the surgical clip of claim 1. Thomas and Smith do not disclose a second inner member at a proximal portion of the second leg member; and a second aperture at a proximal portion of the first leg member, wherein the second aperture is configured to receive the second inner member in a closed configuration to resist the surgical clip from inverting and/or rotating, and the second member does not latch and/or interlock with the second aperture.
Whiting (Fig. 4-5 and 7) discloses a second inner member (234B) at a proximal portion (204A) of the second leg member (204); and
a second aperture (“Second Aperture.” See annotated fig. 5 above) at a proximal portion (202A) of the first leg member (202), wherein the second aperture is configured to receive the second inner member in a closed configuration (Fig. 7) to resist the surgical clip from inverting and rotating, and the second member does not latch and interlock with the second aperture (As seen in fig.7, the clip is in a closed configuration and is resisting a rotation and it does not latch or interlock with the second aperture).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the invention to modify the device of Thomas and Smith to include a second inner member and aperture, as taught by Whiting, for the advantage that this configuration allows for a better grip on and less damage to tissue when grasping [0042].
Response to Arguments
Applicant's arguments filed 11/03/2025 have been fully considered but they are not persuasive. In response to applicant’s argument that Thomas and Smith, either taken alone or in combination, fail to disclose or make obvious at least one first wing member on the first leg member and at least one second wing member on the second leg member, the Examiner respectfully disagrees.
As set forth above and in figure 3C below, Thomas does disclose wing members as claimed.
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Merriam-Webster dictionary defines “wing” as “an appendage or part resembling a wing in appearance, position, or function”
Note that these sections resemble a wing in appearance and position as seen in figure 3B by the lateral extension of the parts from a central section (central channel 71 and central section 66); as such, these sections are interpreted as wing members; the fact that they are continuous with other sections of the device does not prevent them from being interpreted as wing members, especially given that the specification and claims set forth applicant’s wing members have a surface continuous with other parts of the device. Also note that the use of the term “members” further broadens the interpretation of the phrase “wing members” in that they are not claimed as “wings” but “members” that are further limited by the term “wing”. Therefore, any “member” that resembles a “wing”, is in a lateral position like a “wing” or forms part of a “wing” is interpreted to be a wing member.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC J ROSEN whose telephone number is (571)270-7855. The examiner can normally be reached Monday-Friday 930am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edward Lefkowitz can be reached at (571) 272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772