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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 196. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 7 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 7 improperly depends from itself, resulting in uncertainty as to the scope of the claim, because it is unclear what prior claim provides the base limitations for the angle in claim 7. For the purposes of examination, claim 7 will be examined as if dependent on claim 1.
Claim Rejections - 35 USC § 102
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 –
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Walters et al. (US 2020/0391014 A1).
With regard to claim 1, Walters et al. discloses an attachment device configured for coupling with a hub of a sheath for delivery of a medical device (Fig. 1 sheath seal 200 coupled with hub 406), the attachment device comprising:
a base (Fig. 2 seal housing 220) having a proximal end (Fig. 2 end closer to 240),
a distal end opposite the proximal end (Fig 2. end closer to 260), and
a lumen (Fig. 2 lumen 280) extending along a longitudinal axis between the proximal end
(240) and the distal end (260);
a first extension (Fig. 2 suture pads 224) coupled with the base (220),
the first extension (224) having a leg portion (see ‘Modified FIG. 2’ below, where the initial
portion of the first extension makes up the leg portion) and a base portion (see
‘Modified FIG. 2’ below, where the second portion of the first extension makes up the base portion),
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the base portion comprising at least one opening (see the openings as shown in ‘Modified FIG.
2’ above, and [0069] the description of a suture pad configuration permitting the passage of a suture therethrough);
a second extension (224) coupled with the base (220),
the second extension (224) having a leg portion and a base portion (as shown in ‘Modified FIG.
2’ above, which is the same as what is seen in the first extension), the base portion
comprising at least one opening (as shown in ‘Modified FIG. 2’ above, which is the same as what is seen in the first extension and [0069]);
wherein the leg portion of the first extension and the leg portion of the second portion are each
angled relative to the longitudinal axis of the base (see ‘Modified FIG. 2’ above, where there is relative angling to the longitudinal axis of the base at angle α), and
wherein the base is composed of an elastomeric material (see [0095] the elastomeric material is
formed of rubber) such that the attachment device is configured to provide strain relief at both the proximal end (240) and the distal end (260) when the attachment device (200) is coupled with the hub (406).
With regard to claim 2, Walters discloses the elastomeric material is composed of silicone or rubber (see [0095] the elastomeric material is formed of rubber).
With regard to claim 3, Walters discloses the base comprises a narrowed portion and a cylindrical portion (see ‘Modified FIG. 3A’ below, where the base (220) has a narrowed portion and a cylindrical portion).
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With regard to claim 4, Walters discloses the narrowed portion is defined by a length and the cylindrical portion is defined by a length, wherein the length of the narrowed portion is less than the length of the cylindrical portion (see ‘Modified FIG. 3A’ above, where the shorter narrowed portion is less than the length of the cylindrical portion).
With regard to claim 5, Walters discloses the narrowed portion is defined by a length and the cylindrical portion is defined by a length, wherein the length of the narrowed portion is approximately equal to the length of the cylindrical portion (see ‘Modified FIG. 3A’ above, where the narrowed portion defined by a length is approximately equal to the length of the cylindrical portion defined by a length).
With regard to claim 6, Walters discloses the angle at which the leg portion of the first extension extends and the angle at which the leg portion of the second extension are approximately equal (see ‘Modified FIG. 2’ above, where the angle α at which the leg portion of the first extension extends is approximately equal to the angle at which the leg portion of the second extension extends).
With regard to claim 7, Walters discloses the angle has a value between approximately 30 and approximately 90 (see ‘Modified FIG. 2’ above, where the angle α has a value between approximately 30 and approximately 90).
With regard to claim 9, Walters discloses the at least one opening of each base portion includes two openings (see [0069] and the openings in the extension base portions shown in ‘Modified FIG. 2’ above).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2020/0391014 A1) in view of Corbett et al. (US 2017/0049947 A1).
With regard to claim 8, Walters does not disclose at least a portion of the hub is received within the lumen of the attachment device. However, Corbett et al. discloses at least a portion of the hub (Corbett et al., Fig. 2 hub 126) is received within the lumen (Corbett et al., Fig. 2 lumen 116) of the attachment device. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the hub and attachment device of Walters et al. so at least a portion of the hub is received within the lumen of the attachment device, as taught by Corbett et al., as at least a portion of the hub is received within the lumen of the attachment device can be one of the connections known in the art (known in the art of Corbett et al.) that Walters et al. mentions is allowed between the hub and attachment device as described in Walters et al., p. 7, col 1, [0107], lines 1-6, in non-limiting embodiments or aspects, y-connection 408 includes an angularly extending or curved main section 412 and an elongated section 414. Proximal end(s) of the main section 412 and/or elongated section 414 can include connections as are known in the art, for example, and without limitation, luer connections (male or female).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2020/0391014 A1) in view of Radomski et al. (CA 2652277 A1).
With regard to claim 10, Walters et al. teach an attachment device configured for coupling with a hub of a sheath for delivery of a medical device (Fig. 1 sheath seal 200 coupled with hub 406), the attachment device comprising:
a base (Fig. 2 seal housing 220) having a proximal end (Fig. 2 end closer to 240),
a distal end opposite the proximal end (Fig 2. end closer to 260), and
a lumen (Fig. 2 lumen 280) extending along a longitudinal axis between the proximal
end (240) and the distal end (260);
the base having a cylindrical portion and a narrowed portion see ‘Modified FIG. 3A’ above,
where the base (220) has a narrowed portion and a cylindrical portion;
a first suture pad (224) coupled with the base (220) having at least one opening (see the
openings as shown in ‘Modified FIG. 2’ above, and [0069] the description of a suture pad configuration permitting the passage of a suture therethrough);
a second suture pad (224) coupled with the base (220) having at least one opening (see the
openings as shown in ‘Modified FIG. 2’ above, and [0069] the description of a suture pad configuration permitting the passage of a suture therethrough);
wherein each of the first suture pad and the second suture pad are angled relative to the
longitudinal axis of the base with an angle of between approximately 30 degrees and approximately 90 degrees (see ‘Modified FIG. 2’ above, where there is relative angling to the longitudinal axis of the base at angle α, and angle α has a value between approximately 30 and approximately 90).
Walters et al. teach a cylindrical portion and narrowed portion of the base but do not disclose the details that the cylindrical portion has a length of approximately 10 mm and the narrowed portion has a length of approximately 12 mm.
However, Radomski et al. teach a base (Fig. 4 inserter head 12) for an attachment device (Fig. 3 catheter insertion apparatus 10) wherein the cylindrical portion (Fig. 4 proximal end portion 12b) has a length of approximately 10mm (p. 21) and the narrowed portion (Fig 4. distal connecting means 12c) has a length of approximately 12mm (p. 21). It would have been obvious to a person having ordinary skill in the art before the effective filing to modify the length of the cylindrical portion and the narrowed portion of Walters et al. to be approximately 10mm and 12mm, respectively, as taught by Radomski, as varying the length of the cylindrical and narrowed portion of an attachment device has existing a finite number of identified, predictable lengths, with a reasonable expectation of success of accommodating medical devices of different sizes and types.
With regard to claims 11, the modified device of Walters et al. discloses the base is composed of an elastomeric material (see Walters et al, [0095], the elastomeric material is formed of rubber) such that the attachment device is configured to provide strain relief at both the proximal end (Walters et al, 240) and the distal end (Walters et al, 260) when the attachment device (Walters et al, 200) is coupled with the hub (Walters et al, 406).
With regard to claim 12, the modified device of Walters et al. discloses the elastomeric material is silicone or rubber (Walters et al, [0095]).
With regard to claim 13, the modified device of Walters et al. discloses the first suture pad and the second suture pad each includes at least two openings (see Walters et al., ‘Modified FIG. 2’ above, openings as also described in Walters et al., [0069]).
With regard to claim 14, the modified device of Walters et al. discloses the first suture pad (see Walters et al., Modified FIG. 2 above, first extension) and the second suture pad (see Walters et al., Modified FIG. 2 above, second extension) each includes a leg portion (see Walters et al., Modified FIG. 2 above, extension leg portion) extending from the base (see Walters et al., Modified FIG. 2 above, attachment device base 220) and attached to a base portion (see Walters et al., Modified FIG. 2 above, extension base portion) of the first suture pad (see Walters et al., Modified FIG. 2 above, first extension) and the second suture pad (see Walters et al., Modified FIG. 2 above, second extension).
Claim(s) 15, 16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2020/0391014 A1) in view of Shiels et al. (US 2022/0032037 A1).
With regard to claim 15, Walters et al. discloses a delivery system for at least one medical device into a blood vessel (Walters et al., [0002]), the delivery system comprising:
a sheath (Walters et al., [0004]) having a proximal end and a distal end and configured for insertion through the blood vessel (Walters et al discloses a sheath but does not explicitly specify a proximal end and a distal end and configured for insertion through the blood vessel);
a hemostasis valve hub coupled with the proximal end of the sheath, the hemostasis valve
coupled with an attachment device at the distal end of the hemostasis valve hub (Walters et al. mentions the use of a hub and valve (Walters et al., [0106]) coupled with the delivery system (Walters et al., [0107]), but does not explicitly state the use of a hemostasis valve hub and hemostasis valve),
the attachment device (Walters et al., 200) comprising:
a base (Walters et al., 220) having a proximal end (Walters et al., 240),
a distal end opposite the proximal end (Walters et al., 260), and
a lumen (Walters et al., 280) extending along a longitudinal axis between the proximal end
(Walters et al., 240) and the distal end (Walters et al., 260);
a first extension (Walters et al., 224) coupled with the base (Walters et al., 220),
the first extension (Walters et al., 224) having a leg portion (see Walters et al., ‘Modified FIG.
2’ above, where the initial portion of the first extension makes up the leg portion) and a base portion (see Walters et al., ‘Modified FIG. 2’ above, where the second portion of the first extension makes up the base portion),
the base portion comprising at least one opening (see the openings as shown in Walters et al.
‘Modified FIG. 2’ above, and [0069] the description of a suture pad configuration permitting the passage of a suture therethrough);
a second extension (Walters et al., 224) coupled with the base (Walters et al., 220),
the second extension (Walters et al., 224) having a leg portion and a base portion (as shown in
Walters et al., ‘Modified FIG. 2’ above, which is the same as what is seen in the first extension), the base portion comprising at least one opening (as shown in Walters et al., ‘Modified FIG. 2’ above, which is the same as what is seen in the first extension and Walters et al., [0069]);
wherein the leg portion of the first extension and the leg portion of the second portion are each
angled relative to the longitudinal axis of the base (see Walters et al., ‘Modified FIG. 2’ above, where there is relative angling to the longitudinal axis of the base at angle α), and
wherein the base is composed of an elastomeric material (see Walters et al., [0095] the
elastomeric material is formed of rubber) such that the attachment device is configured to provide strain relief at both the proximal end (Walters et al., 240) and the distal end (Walters et al., 260) when coupled with the hemostasis valve hub (Walters et al. discloses a “hub” as shown in Fig. 1 hub 406 that is not explicitly disclosed as a hemostasis valve hub)
Walters et al. does not explicitly show a sheath’s proximal and distal end configured for insertion through the blood vessel. However, Shiels et al. teaches the delivery system comprising: a sheath (Shiels et al., Fig. 1 repositioning sheath assembly 126) having a proximal end (Shiels et al., Fig. 1 proximal end 128) and a distal end (Shiels et al., Fig. 1 distal end 124) and configured for insertion through the blood vessel (Shiels et al., [0025]). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of Shiels et al. of specifying a proximal and distal end to the sheath component of the system with the disclosure of the sheath in the system of Walters et al. without specifying a proximal and distal end to the sheath component of the system to disclose a sheath with specifying a proximal and distal end to the sheath component of the system, as Walters et al. already discloses a sheath configured for insertion through the blood vessel as described in [0004], and discloses the specifying of a proximal and distal end to other components in the system. One of the components in the system of Walters et al. that has specified for it a proximal and distal end includes a housing 220, as described in p. 5, col 2, [0095], lines 2-5, with reference to FIGS. 2, 3A, and 3B, sheath seal 200 includes a housing 220 having a proximal end 240, a distal end 260. Another one of the components in the system of Walters et al. that has specified for it a proximal and distal end includes lumen 280, as described in p. 5, col 2, [0095], lines 5-6, a lumen 280 arranged between the proximal end 240 and the distal end 260.
Walters et al. mentions the use of a hub and valve (Walters et al., [0106]) coupled with the delivery system (Walters et al., [0107]), but does not explicitly state the use of a hemostasis valve hub and hemostasis valve. However, Shiels et al. teaches a hemostasis valve (Shiels et al., Fig 3. hemostasis valve 131) hub (Shiels et al., hub 154) coupled with the proximal end of the sheath (Shiels et al., 128) (Shiels et al., [0028]-[0030]),
the hemostasis valve (Shiels et al., 131) coupled with an attachment device (Shiels et al., Fig. 1
butterfly 130) at the distal end of the hemostasis valve (Shiels et al., 131) hub (Shiels et al., 154) (Shiels et al., [0030]),
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add a hemostasis valve as taught by Shiels et al. to the hub of Walters et al., as a hemostasis valve added with a hub would meet the need for a valve for heart-assist treatment as described in p. 7, col 1, [0106], lines 1-6, with reference to FIGS. 1 and 3A, assembly 1000 includes, in non-limiting embodiments or aspects, one or more valves 302 within sheath seal 200. Such valves, which may constitute fixed impingement devices, allow for multiple devices to be used and secured during treatment, such as heart-assist treatment).
Walters et al. does not explicitly disclose a hemostasis valve hub in the following:
wherein the base is composed of an elastomeric material (see Walters et al., [0095] the
elastomeric material is formed of rubber) such that the attachment device is configured to provide strain relief at both the proximal end (Walters et al., 240) and the distal end (Walters et al., 260) when coupled with the hemostasis valve hub (Walters et al. discloses a “hub” as shown in Fig. 1 hub 406 that is not specific to being a hemostasis valve hub)
However, Shiels et al. discloses a hemostasis valve (Shiels et al., Fig 3. hemostasis valve 131) hub (Shiels et al., hub 154) coupled with an attachment device (Shiels et al., Fig. 1 butterfly 130). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to add a hemostasis valve as taught by Shiels et al. to the hub of Walters et al., as a hemostasis valve added with a hub would meet the need for a valve for heart-assist treatment as described in p. 7, col 1, [0106], lines 1-6, with reference to FIGS. 1 and 3A, assembly 1000 includes, in non-limiting embodiments or aspects, one or more valves 302 within sheath seal 200. Such valves, which may constitute fixed impingement devices, allow for multiple devices to be used and secured during treatment, such as heart-assist treatment).
With regard to claim 16, the modified device of Walters et al. discloses, see Shiels et al., Fig. 3, the hemostasis valve (Shiels et al., 131) hub (Shiels et al., 154) includes a cylindrical portion at the ends of the hemostasis valve (Shiels et al., 131) with a narrow portion at the center of the valve (Shiels et al., 131) and the cylindrical portion is defined by an outer wall, the casing of the valve (Shiels et al., 131) seen in Fig. 2 that gives the hemostasis valve (Shiels et al., 131) hub (Shiels et al., 154) its shape.
With regard to claim 19, the modified device of Walters et al. discloses the elastomeric material of the base is silicone or rubber (see Walters et al., [0095] the elastomeric material is formed of rubber).
With regard to claim 20, the modified device of Walters et al. discloses the angle at which the leg portion of the first extension extends is between approximately 30 degrees and approximately 90 degrees, and the angle at which the leg portion of the second extension extends is between approximately 30 degrees and approximately 90 degrees (see Walters et al., ‘Modified FIG. 2’ above, where there is relative angling to the longitudinal axis of the base at angle α, and angle α has a value between approximately 30 and approximately 90’).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al. (US 2020/0391014 A1) in view of Shiels et al. (US 2022/0032037 A1) as applied to claims 15 and 16 above, and further in view of Mintz et al. (US 10946167 B2).
With regard to claim 17, the modified device of Walters et al. does not explicitly disclose a wall of the lumen of the base comprises a groove extending circumferentially around the lumen. However, Mintz et al. teach a wall of the lumen (Mintz et al., hub lumen 90) of the hub (Mintz et al., 12) base comprises a groove (Mintz et al., Fig. 4 recess 62) extending circumferentially around the lumen (Mintz et al., 90). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Mintz et al. with the teachings of Walters et al. and Shiels et al., regarding the groove in Mintz et al. to achieve the predictable result of allowing for engagement such that the hub and attachment device are able to be properly engaged to enable a medical delivery system to operate correctly.
With regard to claim 18, the modified device of Walters et al. does not explicitly disclose the details of the engagement portion including a groove extending circumferentially around the lumen and a rib extending around a circumference of the outer wall to engage with such groove. However, Mintz et al. teach such groove (Mintz et al., Fig. 4 recess 62) extending circumferentially around the lumen configured for engagement with the rib extending around a circumference of the base (Mintz et al., Fig. 3A-4 flange 104) when the hub (Mintz et al., hub 12) is coupled with the attachment device (Mintz et al., strain relief 14). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use the engagement mechanism in Mintz et al. in the modified device of Walters et al. as this allows for engagement such that the hub and attachment device are still capable of rotation relative to one another as the engagement is retained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISSA J GHANNOUM whose telephone number is (571) 272-8591. The examiner can normally be reached Monday through Friday 8:30 AM to 5:00 PM.
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/ISSA JAMIL GHANNOUM/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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