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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/21/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-12, 14, 16, 18, 21, 24, 26 and 56-59 have been considered but are moot because the new ground of rejection over Michler et al. US 2007/0149988 in view of Glithero et al. US 2008/0208324.
Michler et al. teaches an occlusion device 30 for occluding a left atrial appendage extending from a lateral wall of a left atrium of a heart (paragraph 0011) but fails to explicitly disclose wherein at least the connecting portion biases movement of the first and second clamping portions towards one another or bias the occlusion device toward the closed configuration.
Glithero et al. teaches a method for occluding a left atrial appendage (paragraph 0002) comprising an occlusion device (for example, 800 or 1000), comprising a first clamping portion (820 or 1010), a second clamping portion (830 or 1020), and a connecting portion (810 or 1020) movably connecting the first and second clamping portion wherein the first and second clamping portions are configured to transition between an open configuration (figures 11, 13 or 16) and the closed configuration (figures 12, 14 or 15), wherein distal ends of the first and second clamping portions at the second end of the occlusion device are not coupled in either the open or closed configuration (paragraph 0088, 0089; spring force is applied, no latch required to secure tissue between the clamping members). Examiner notes the clamping members may be biased toward one another with a lip or latch 824 (figure 11) or alternatively may be biased toward one another by a spring configured to urge the device into the closed configuration (figure 15, paragraphs 0088, 0089), the clamping portions remaining not coupled as the members don’t require a latch to connect, but only biased together to hold the tissue therebetween, wherein the occlusion device is configured to transition between an open configuration and a closed configuration (open configuration figure 16, closed configuration figure 15, open and biased to the closed configuration), wherein the connecting portion is configured to bias the occlusion device or first and second clamping members toward each other (paragraphs 0088, 0089, with spring hinge 1030 moving the first and second clamping members toward each other), wherein the second clamping portion and the first clamping portion are configured to pivot relative to one another as the occlusion device is transitioned between the open configuration and the closed configuration (paragraph 0088, 0089, with hinge).
Applicant argues the amendment to claims 56 and 57 overcome the 35 USC 112 rejection. However, examiner respectfully disagrees.
Regarding claim 56, the specification fails to explicitly disclose that the outer surface of the connecting portion is not tapered relative to the inner surface. The mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. MPEP 2173.05(I). Examiner notes the connecting portion curves around from the first and second clamping members, the tip of the connecting portion (202 or 402, figures 2C, 4C) may be considered to be tapered relative to the inner surfaces, for example, as shown in figure 2A and 2C below.
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Regarding claim 57, the specification fails to explicitly disclose wherein: a first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width. Examiner notes the figures disclose a first and second width, but do not disclose explicit dimensions or relationships to one another. The figures, for example, Fig. 4A-4C do not clearly establish the width of the connecting portion is greater than the width of the first or second clamping portion, as the depicted widths are sufficiently similar that the claimed relationship cannot be reliably ascertained from the figures. Further, the specification indicates the relative dimensional relationships may differ from those illustrated in the drawings. Accordingly, there is not sufficient support or explicit relationships for those dimensions or written description for the subject matter.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 3-14, 16, 18, 21 and 24 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 discloses “a first clamping portion for positioning along a first side of the left atrial appendage” and “a second clamping portion movably connected to the first clamping portion for positioning along an opposite side of the left atrial appendage” on lines 3-6.
Examiner notes this language should be “a first clamping portion configured for positioning along a first side of the left atrial appendage” and “a second clamping portion movably connected to the first clamping portion and configured for positioning along an opposite side of the left atrial appendage”.
Claim 1 discloses “an inner surface which faces toward the left atrial appendage” and “an outer surface disposed opposite the inner surface to face away from the left atrial appendage” on lines 10-12.
Examiner notes this language should be “an inner surface configured to face toward the left atrial appendage” and “an outer surface disposed opposite the inner surface and configured to face away from the left atrial appendage”.
Claim 1 discloses “a concave surface extending between the inner surface and the outer surface to face away from the lateral wall” and “a convex surface extending between the inner surface and the outer surface and disposed opposite the concave surface to face toward the lateral wall” on lines 14-18.
Examiner notes this language should be “a concave surface extending between the inner surface and the outer surface and configured to face away from the lateral wall” and “a convex surface extending between the inner surface and the outer surface and disposed opposite the concave surface and configured to face toward the lateral wall”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-12, 56 and 57 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 8 and 9 disclose “a second connecting portion is connected to the first clamping portion and the second clamping portion and positioned at an opposite second end of the occlusion device”. and “the first connecting portion and the second connecting portion form an enclosed loop” respectively. These limitations are directed to an embodiment as shown for example in figure 6A, 6D comprising a second connecting portion and enclosed loop. However, claim 1 discloses wherein the second end of the first clamping portion and a second end of the second clamping portion are not coupled directed to an alternative embodiment (figures 2A and 4A). There is insufficient support for the combination of these limitations in a single embodiment.
Regarding claim 56, the specification fails to explicitly disclose that the outer surface of the connecting portion is not tapered relative to the inner surface. The mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. MPEP 2173.05(I). Examiner notes the connecting portion curves around from the first and second clamping members, the tip of the connecting portion (202 or 402, figures 2C, 4C) may be considered to be tapered relative to the inner surfaces.
Regarding claim 57, the specification fails to explicitly disclose wherein: a first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width. Examiner notes the figures disclose a first and second width, but do not disclose explicit dimensions or relationships to one another. The figures, for example, Fig. 4A-4C do not clearly establish the width of the connecting portion is greater than the width of the first or second clamping portion, as the depicted widths are sufficiently similar that the claimed relationship cannot be reliably ascertained from the figures. Further, the specification indicates the relative dimensional relationships may differ from those illustrated in the drawings. Accordingly, there is not sufficient support or explicit relationships for those dimensions or written description for the subject matter.
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, 3-12, 14, 16, 18, 21, 24, 26 and 56-60 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 limitation "deployed configuration" in line 19. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites wherein the second clamping portion and the first clamping portion are not connected to one another at opposite second end of the occlusion device. This language is unclear as Claim 1 was amended to include “wherein the second end of the first clamping portion and a second end of the second clamping portion are not coupled”. This language appears to be the same second or opposite second end of the occlusion device are not coupled and not connected.
Claim 58 discloses “distal ends of the first and second clamping portions are not coupled”. This language is unclear as to whether the distal ends are the same or different from the second ends of the first and second clamping members which are not coupled as disclosed in claim 1.
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, 3-12, 14, 16, 18, 21, 24, 26, 56, 58, 59 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michler et al. US 2007/0149988 in view of Glithero et al. US 2008/0208324.
Regarding claim 1, 4-7 and 11, Michler et al. teaches an occlusion device 30 for occluding a left atrial appendage extending from a lateral wall of a left atrium of a heart (paragraph 0011), the occlusion device comprising:
a first clamping portion 32 configured for positioning along a first side of the left atrial appendage (figures 8, 9, paragraph 0033); and
a second clamping portion 34 movably connected to the first clamping portion and configured for positioning along an opposite second side of the left atrial appendage while the first clamping portion is positioned along the first side (figures 8, 9; paragraph 0033);
wherein the first clamping portion 32 and the second clamping portion 34 each comprise:
an inner surface which faces toward the left atrial appendage when the occlusion device is in a deployed configuration (see annotated figure 8 and 9 below);
an outer surface disposed opposite the inner surface and configured to face away from the left atrial appendage when the occlusion device is deployed (see annotated figures 8 and 9 below);
a concave surface extending between the inner surface and the outer surface and configured to face away from the lateral wall when the occlusion device is deployed (see annotated figure 9 below);
and a convex surface extending between the inner surface and the outer surface and disposed opposite the concave surface and configured to face toward the lateral wall when the occlusion device is deployed (see annotated figure 9 below),
wherein the concave and convex surfaces are complementary (figure 9), and each extend in along a curved longitudinal axis of a respective one of the first and second clamping portions (see annotated figure 9 below); and
a connecting portion (hinge 16, figure 8) movably connecting a first end of the first clamping portion 32 and a first end of the second clamping portion 34 at a first end of the occlusion device (see annotated figure 8), wherein the second end of the first clamping portion and a second end of the second clamping portion are not coupled (figure 8), and wherein the connecting portion has an outer surface that continuously and smoothly connects a proximal end of the outer surface of each of the first and second clamping portions to connecting portion and an inner surface that continuously and smoothly connects a proximal end of the inner surface of each of the first and second clamping portions to the connecting portion (see annotated figure 8 below, Examiner notes the continuously and smoothly does not mean there are not tapered portion, but can mean a gradual taper or a smooth connection as they are seamless or not uninterrupted), wherein the occlusion device is configured to transition between an open configuration and a closed configuration (open configuration figure 8, closed configuration figure 9, open and closed with hinge 16, paragraph 0028), the connecting portion comprises a hinge 16 (figure 8, paragraph 0028).
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Michler et al. fails to explicitly disclose wherein at least the connecting portion biases movement of the first and second clamping portions towards one another or bias the occlusion device toward the closed configuration.
Glithero et al. teaches a method for occluding a left atrial appendage (paragraph 0002) comprising an occlusion device (for example, 800 or 1000), comprising a first clamping portion (820 or 1010), a second clamping portion (830 or 1020), and a connecting portion (810 or 1020) movably connecting the first and second clamping portion wherein the first and second clamping portions are configured to transition between an open configuration (figures 11, 13 or 16) and the closed configuration (figures 12, 14 or 15), wherein distal ends of the first and second clamping portions at the second end of the occlusion device are not coupled in either the open or closed configuration (paragraph 0088, 0089; spring force is applied, no latch required to secure tissue between the clamping members). Examiner notes the clamping members may be biased toward one another with a lip or latch 824 (figure 11) or alternatively may be biased toward one another by a spring configured to urge the device into the closed configuration (figure 15, paragraphs 0088, 0089), the clamping portions remaining not coupled as the members don’t require a latch to connect, but only biased together to hold the tissue therebetween, wherein the occlusion device is configured to transition between an open configuration and a closed configuration (open configuration figure 16, closed configuration figure 15, open and biased to the closed configuration), wherein the connecting portion is configured to bias the occlusion device or first and second clamping members toward each other (paragraphs 0088, 0089, with spring hinge 1030 moving the first and second clamping members toward each other), wherein the second clamping portion and the first clamping portion are configured to pivot relative to one another as the occlusion device is transitioned between the open configuration and the closed configuration (paragraph 0088, 0089, with hinge).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Michler et al. with a spring hinge to bias the first and second clamping members towards one another without a coupling latch, as taught by Glithero et al. as a known substitute for biasing a device clamping members into a closed configuration with a spring hinge.
Regarding claim 3, Michler et al. in combination discloses wherein the second clamping portion 34 and the first clamping portion 32 are not connected to one another at an opposite second end of the occlusion device (figure 8, open at side with end latch 14a).
Regarding claim 8, Michler et al. discloses the connecting portion defines a first connecting portion 16 connected to the first clamping portion 32 and the second clamping portion 34 (figure 8); and a second connecting portion 14a connected to the first clamping portion and the second clamping portion and positioned at an opposite second end of the occlusion device (figure 8, connected when latch 14a is closed); wherein the second clamping portion is movably connected to the first clamping portion via the first connecting portion and the second connecting portion (pivot from an open to closed position, paragraph 0028).
Regarding claim 9, Michler et al. discloses wherein the first clamping portion 32, the second clamping portion 34, the first connecting portion 16, and the second connecting portion form an enclosed loop defining an opening configured to receive the left atrial appendage therethrough (figure 9, when latch 14a is in the closed position around LAA 2).
Regarding claim 10, Michler et al. discloses wherein the occlusion device is configured to transition between an open configuration and a closed configuration (paragraph 0028, open configuration figure 8, closed configuration figure 9).
Regarding claim 12, Michler et al. discloses wherein the first connecting portion 16 and the second connecting portion 14a each have a curved shape (see annotated figure 8 below).
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Regarding claim 14, 16, 18, 21 and 60, Michler et al. discloses wherein the inner surfaces and outer surfaces are each planar and has a linear profile viewed from a top side or a bottom side of the occlusion device (figure 8), wherein the concave surface and the convex surfaces are each smooth, continuous surfaces (Examiner notes the continuously and smoothly does not mean there are not tapered portion, but can mean a gradual taper or a smooth connection as they are seamless or not uninterrupted) having concave and convex profiles, respectively (figure 9) viewed from a lateral side of the occlusion device (figure 9).
Regarding claim 24, Michler et al. discloses a fabric covering 18 extending over at least a portion of each of the first clamping portion and the second clamping portion (paragraphs 0013, 0031, flexible cover 18).
Regarding claim 26, Michler et al. discloses a method for occluding a left atrial appendage 2 extending from a lateral wall of a left atrium of a heart 1 (figure 9), the method comprising:
causing an occlusion device to transition from a closed configuration (for example, figures 3, 9) to an open configuration (for example, figures 2, 8), wherein the occlusion device comprises: a first clamping portion 32 and a second clamping portion 34 movably connected to the first clamping portion (with hinge 16);
wherein the first clamping portion and the second clamping portion each comprise:
an inner surface (see annotated figure 8 below);
an outer surface disposed opposite the inner side (see annotated figure 8 below);
a concave surface (see annotated figure 9 below); and
a convex surface extending between the inner surface and the outer surface and disposed opposite the concave surface (see annotated figure 9 below), wherein a connecting movably connecting a first end of the first clamping portion and a first end of the second clamping portion at a first end of the occlusion device (see annotated figure 8 below), wherein a second end of the first clamping portion and a second end of the second clamping portion are not coupled (figure 8), and wherein an outer surface of the connecting portion continuously and smoothly connects proximal ends of the outer surface of each of the first and second clamping portions to the connecting portion and an inner surface of the connecting portion that continuously and smoothly connects proximal ends of the inner surface of each of the first and second clamping portions to the connecting portion (see annotated figure 8 below, Examiner notes the continuously and smoothly does not mean there are not tapered portion, but can mean a gradual taper or a smooth connection as they are seamless or not uninterrupted),
positioning the occlusion device relative to the left atrial appendage such that the first clamping portion is positioned along a first side of the left atrial appendage (for example, figures 5, 9) and the second clamping portion is positioned along an opposite second side of the left atrial appendage (for example, figures 5, 9); causing the occlusion device to transition from the open configuration (figures 2, 8) to a deployed configuration in which the occlusion device occludes the left atrial appendage (figures 5, 9) wherein, when the occlusion device is in the deployed configuration, the inner surfaces of the first clamping portion and the second clamping portion each face toward the left atrial appendage (figures 5, 9), the outer surfaces of the first clamping portion and the second clamping portion each face away from the left atrial appendage (figures 5, 9), the concave surfaces of the first clamping portion and the second clamping portion each face away from the lateral wall 1 (see annotated figure 9 below), and the convex surfaces of the first clamping portion and the second clamping portion each face toward the lateral wall 1 (see annotated figure 9 below).
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Michler et al. fails to explicitly disclose wherein at least the connecting portion biases movement of the first and second clamping portions towards one another or bias the occlusion device toward the closed configuration.
Glithero et al. teaches a method for occluding a left atrial appendage (paragraph 0002) comprising an occlusion device (for example, 800 or 1000), comprising a first clamping portion (820 or 1010), a second clamping portion (830 or 1020), and a connecting portion (810 or 1020) movably connecting the first and second clamping portion wherein the first and second clamping portions are configured to transition between an open configuration (figures 11, 13 or 16) and the closed configuration (figures 12, 14 or 15), wherein distal ends of the first and second clamping portions at the second end of the occlusion device are not coupled in either the open or closed configuration (paragraph 0088, 0089; spring force is applied, no latch required to secure tissue between the clamping members). Examiner notes the clamping members may be biased toward one another with a lip or latch 824 (figure 11) or alternatively may be biased toward one another by a spring configured to urge the device into the closed configuration (figure 15, paragraphs 0088, 0089), the clamping portions remaining not coupled as the members don’t require a latch to connect, but only biased together to hold the tissue therebetween, wherein the occlusion device is configured to transition between an open configuration and a closed configuration (open configuration figure 16, closed configuration figure 15, open and biased to the closed configuration), wherein the connecting portion is configured to bias the occlusion device or first and second clamping members toward each other (paragraphs 0088, 0089, with spring hinge 1030 moving the first and second clamping members toward each other), wherein the second clamping portion and the first clamping portion are configured to pivot relative to one another as the occlusion device is transitioned between the open configuration and the closed configuration (paragraph 0088, 0089, with hinge).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Michler et al. with a spring hinge to bias the first and second clamping members towards one another without a coupling latch, as taught by Glithero et al. as a known substitute for biasing a device clamping members into a closed configuration with a spring hinge.
Regarding claim 56, Michler et al. discloses wherein the outer surface of the connecting portion is not tapered relative to the inner surface of the first and second clamping portions (Examiner notes the continuous arcuate surface may be considered to not be tapered, but instead may be considered a bent or non-linear surface extending to the inner side of the proximal end).
Regarding claim 58, Michler et al. discloses a device essentially as claimed as discussed above, but fails to disclose wherein: the first and second clamping portions are configured to transition between an open configuration and a closed configuration, and distal ends of the first and second clamping portions are not coupled in either the open or closed configuration.
Glithero et al. teaches an occluding device having a first and second clamping portions (clamping portions 1010, 1020) which are connected by an arcuate portion 1030 (figure 15), the first and second clamping portions are configured to transition between an open configuration and a closed configuration (figure 15 closed position, figure 16 open position), and distal ends of the first and second clamping portions are not coupled in either the open or closed configuration (figures 15, 16, clamp portions are only coupled on one end with connecting portion 1030 as they are spring biased to clamp tissue, paragraph 0089) Examiner notes Glithero et al. further teaches a latch at a distal end (for example, figure 17A) as known substitute for clamping tissue.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Michler et al. wherein: distal ends of the first and second clamping portions are not coupled in either the open or closed configuration, as taught by Glithero et al., and known in the art as a known substitute to provide spring loaded clamping portions instead of a latch to clamp and secure tissue between the clamping portions.
Regarding claim 59, Michler et al. discloses a device essentially as claimed as discussed above, but fails to disclose wherein a width of the outer surface of the connecting portion and a width of the first and second clamping portions in a closed configuration is measured when viewed from a top side or a bottom side of the occlusion device, and the width of the outer surface of the connecting portion is greater than a width of the device between the outer sides of the first and second clamping portions in the close configuration.
Glithero et al. teaches an occluding device having a first and second clamping portions (clamping portions 1010, 1020) which are connected by an arcuate portion 1030 (figure 15), the first and second clamping portions are configured to transition between an open configuration and a closed configuration (figure 15 closed position, figure 16 open position), wherein a width of the outer surface of the connecting portion and a width of the first and second clamping portions in a closed configuration is measured when viewed from a top side or a bottom side of the occlusion device, and the width of the outer surface of the connecting portion is greater than a width of the device between the outer sides of the first and second clamping portions in the close configuration (see annotated figure 15 below, Examiner notes the thickness of the arcuate portions and the distal ends of the clamping portions are the same width between the inner and outer surfaces, shown in figure 16, in the closed position the distal ends of the clamping portions are abutting each other while the arcuate portion 1030 has an open space, thereby provide a greater width).
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It would have been an obvious matter of design choice to modify the Michler et al., wherein a width of the outer surface of the connecting portion and a width of the first and second clamping portions in a closed configuration is measured when viewed from a top side or a bottom side of the occlusion device, and the width of the outer surface of the connecting portion is greater than a width of the device between the outer sides of the first and second clamping portions in the close configuration, since applicant has not disclosed that having those particular dimensions solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that wherein a width of the outer surface of the connecting portion and a width of the first and second clamping portions in a closed configuration is measured when viewed from a top side or a bottom side of the occlusion device, and the width of the outer surface of the connecting portion is greater than a width of the device between the outer sides of the first and second clamping portions in the close configuration, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michler et al. US 2007/0149988 in view of Glithero et al. US 2008/0208324 and further in view of Thomas et al. US 2021/0378674.
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Regarding claim 57, Michler et al. discloses a device essentially as claimed as discussed above, but fails to disclose wherein: a first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner surface and the outer surface, and the first width of the connection portion is greater than the second width of the first or second clamping portions.
However, Thomas et al. discloses a similar ligation device comprising a first and second clamping portions (figure 8, 504, 506), wherein: a first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width (see annotated figure 8 below, as the distal end of the clamping portion is tapered forming a second width that is less than the first width).
It would have been an obvious matter of design choice to modify the Michler et al., to have a first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width, the distal end of the clamping portion is tapered forming a second width that is less than the first width, since applicant has not disclosed that having those particular dimensions solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs.
Furthermore, absent a teaching as to criticality that the first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
