DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of GROUP I, Species A in the reply filed on 10/24/2025 is acknowledged. Claims 13, 16, and 19-20 have been withdrawn from further consideration and claims 1-12, 14, 15, 17, and 18 are pending.
Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement is still deemed proper and is therefore made FINAL.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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.
Claim(s) 1, 5-7, 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US PGPub 2020/0038005) in view of Nakao (US Patent 5,336,227).
Regarding Claim 1, Smith teaches a medical device, comprising:
a handle (Paragraph 0042 discloses a mechanism for controlling inner cap 254 via a mechanical lever or an electronic switch and thus is considered a handle by the Examiner);
an end cap (distal end of delivery instrument 250 and shown in Figures 2A-2C), the end cap comprising an inner cap (254; Figures 2B-2C; Paragraph 0041) and an outer cap (206; Figure 2B; Paragraph 0041) wherein the inner cap (254) is movable such that the inner cap (254) extends relative to the outer cap (206; as seen in Figures 2B and 2C); and
a patch (800) disposed between the inner cap (254) and the outer cap (206) such that movement of the inner cap (254) relative to the outer cap (206) at least partially deploys the patch (800; see Figures 2A-2C).
Smith fails explicitly to disclose:
a handle, wherein the handle includes a movable body and a stationary body;
wherein the inner cap is coupled to the movable body by a control element such that movement of the movable body relative to the stationary body extends the inner cap relative to the outer cap.
Nakao teaches a medical device (Figure 1A) configured to be deployed through an endoscope (42; see Figures 2A-2C; Column 7, Lines 14-16), the medical device (Figure 1A) comprises an inner member (24; analogous to the inner cap of Smith; the examiner notes that Column 5 discloses that element 24 deployed a flexible sheet/web 26, see also Column 7 Lines 4-7) and an outer member (22; analogous to the outer cap of Smith), the medical device having:
a handle (20; Figure 1A), wherein the handle (20) includes a movable body (32) and a stationary body (28);
wherein the inner member/cap (24) is coupled to the movable body (32) by a control element (36; Figure 1A) such that movement of the movable body (32) relative to the stationary body (28) extends the inner member/cap (24) relative to the outer member/cap (22; Column 6, Lines 55-65 and Column 7, Lines 25-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the medical device taught by Smith to include a handle with a movable and stationary body to control relative movement between an inner and outer member via a control element, as taught by Nakao for the advantage of providing a control mechanism that can be controlled by one hand.
Furthermore/Alternatively, it is the Examiner’s position that it would have been obvious to one of ordinary skill before the effective filing date of the invention to substitute the control mechanism taught by Smith with the control mechanism as taught by Nakao since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the control mechanism taught by Nakao would be sufficient to provide deployment of the patch to the user.
Regarding Claim 5, the combination of references disclosed above teaches the medical device of claim 1, wherein both Smith and Nakao individually teach the control element (36; as taught by Nakao in Claim 1) is moveably disposed within a lumen of a sheath (wherein the sheath is the endoscope; see element 42; Figure 2A-2C wherein the sheath is element 42 in Nakao; see Figure 1, endoscope 104; Paragraph 0040 in Smith).
Regarding Claim 6, the combination of references disclosed above teaches the medical device of claim 5, wherein Smith and Nakao, individually, teach the sheath (the endoscope) is coupled to the outer cap (254; as taught by Smith; the Examiner notes that the outer cap is slidably coupled to the endoscope so that the medical device can be disposed within the endoscope).
Regarding Claim 7, the combination of references disclosed above teaches the medical device of claim 1, wherein Smith teaches the end cap (254; as well as the entire medical device) is removably coupled to an endoscope (104; Figure 1) by one or more fasteners (110), adhesives, or friction fit (Paragraph 0040; Figure 1).
Regarding Claim 9, the combination of references disclosed above teaches the medical device of claim 1, wherein Smith teaches the patch (800) includes an adhesive on a side of the patch facing away from inner cap (254) (Paragraph 0034).
Regarding Claim 10, the combination of references disclosed above teaches the medical device of claim 1, wherein Smith teaches the patch (800) includes a hemostatic agent (Paragraph 0035).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US PGPub 2020/0038005) in view of Nakao (US Patent 5,336,227) as applied to claim 1 above, and further in view of Whelehan (US PGPub 2022/02655968).
Regarding Claim 2, the combination of references disclosed above teaches the medical device of claim 1, wherein Smith teaches wherein distal movement of the inner cap (556; Figures 5B-5D) relative to the outer cap (506; Figures 5A, but see also Figures 5B-5D) allows the inner cap (556) to expand to deploy the patch (Figure 5D; Paragraph 0056).
Smith fails to disclose:
a support structure (556) partially surrounding a portion of the inner cap, and wherein distal movement of the inner cap relative to the outer cap results in the support structure expanding.
Whelehan teaches a device medical device with comprises an endcap having an outer endcap (220) and an inner endcap (210) and further comprising a support structure (270; stent; Paragraph 0037) partially surrounding a portion of the inner cap (210), wherein distal movement of the inner cap (210) relative to the outer cap (220) results in the support structure expanding (Paragraph 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the expanding end cap teachings of the Smith be a stent disposed about the end cap, as taught by Smith for the advantage of providing a self-expanding support structure for deploying the patch, thus reducing the need for inflation media to inflate a balloon (Paragraph 0039; Whelehan).
Regarding Claim 3, the combination of references disclosed above teaches the medical device of claim 2, wherein the support structure includes a woven shape-memory material (Paragraph 0037).
Claim(s) 4 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US PGPub 2020/0038005) in view of Nakao (US Patent 5,336,227) as applied to claim 1 above, and further in view of Carrillo (US PGPub 2017/0172602).
Regarding Claim 4, the combination of references disclosed above teaches the medical device of claim 1, wherein Smith teaches the inner cap (254; Figure 3B-2C) includes a proximal wall (256) extending radially outward from the inner cap, and a distal wall (the distal face of inner cap 254), wherein in a first configuration (Figure 2A) the outer edge of the proximal wall (256) is proximal to the inner edge of the outer cap (206; Figure 2A) wherein, in a second configuration (Figure 2B-2C), the outer edge of the proximal wall (256) and the distal end of the inner cap (254) is distal to the inner edge of the outer cap (206; see Figures 2B-2C).
Smith fails to disclose:
the distal wall extends radially outward from the inner cap
wherein, in a first configuration, an outer edge of the distal wall of the inner cap abuts an inner edge of the outer cap, and
wherein, in a second configuration, the outer edge of the distal wall of the inner cap is distal to the inner edge of the outer cap.
Carrillo a medical device (abstract) comprising a endcap (142; Paragraph 0034) having an inner cap (132; Figure 1A) and an outer cap (162; Figure 1A), wherein the inner cap (132) is movable relative to the outer cap (162; Paragraph 0035), wherein the inner cap comprises proximal wall (136) extending radially outwards from the inner cap (132) and a distal wall (134; Figure 3A which is comparable to the Smith base reference and see element 134’ in Figure 10, which the Examiner is relying upon):
the distal wall (134’) extends radially outward from the inner cap (132; see Figure 10; Paragraph 0052)
wherein, in a first configuration (Figure 10), an outer edge of the distal wall (134’) of the inner cap (132) abuts an inner edge of the outer cap (162), and
wherein, in a second configuration, the outer edge of the distal wall (134’) of the inner cap (132) is distal to the inner edge of the outer cap (162) (as described in Paragraph 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal wall of the inner cap to extend radially outward to contact the outer cap, as taught by Carrillo, for the advantage of preventing the patch of Smith from sliding out the distal end of the outer cap before deployment.
Regarding Claim 11, the combination of references disclosed above teaches the medical device of claim 1, wherein in a separate embodiment of Smith, a cap disposed on the endoscope is transparent (Paragraph 0050; Smith) but in the embodiment of Figures 2A-2B, Smith fails to explicitly teach wherein at least a portion of the end cap is transparent.
Carrillo a medical device (abstract) comprising a endcap (142; Paragraph 0034) having an inner cap (132; Figure 1A) and an outer cap (162; Figure 1A), wherein the inner cap (132) is movable relative to the outer cap (162; Paragraph 0035), wherein at least a portion of the end cap (142) is transparent (Paragraph 0036).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end cap of the combination of prior art references disclosed above to be transparent, as taught by Carrillo for the advantage of providing a clear view for an imaging and/or an illumination device (Paragraph 0036; Carrillo).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US PGPub 2020/0038005) in view of Nakao (US Patent 5,336,227) as applied to claim 1 above, and further in view of Satar (US PGPub 2009/0264919).
Regarding Claim 8, the combination of references disclosed above teaches the medical device of claim 1, but Smith fails to disclose wherein the inner cap includes a lumen extending from a proximal end to a distal end.
Satar teaches a puncture closure medical device (Abstract) comprising an endcap having an inner cap (18 or 22) and an outer cap (16) (see Figures 7-8) for the purpose of deploying a patch (34; Paragraph 0034; Figures 7-8) wherein the inner cap (either 18 or 22) includes a lumen extending from a proximal end to a distal end (as seen in Figures 7-8 for housing the guidewire).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inner cap taught by Smith to include a lumen, as taught by Satar for the advantage of advancing the medical device over a guidewire to the target area (Paragraph 0005).
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US PGPub 2020/0038005) in view of Whelehan (US PGPub 2022/02655968).
Regarding Claim 12, Smith teaches a medical device, comprising:
an end cap (distal end of delivery instrument 250 and shown in Figures 2A-2C), the end cap comprising an inner cap (254; Figures 2B-2C; Paragraph 0041; see also 556; Figure 5D) and an outer cap (206; Figure 2B; Paragraph 0041)
an expandable structure (556; balloon) positioned at the inner cap (Paragraph 0054; Figures 5A-5D); and
a patch (860) positioned around the expandable structure (556) (Figures 5B-5D; Paragraph 0054-0055);
wherein, in a first configuration (Figures 5A-5B), the inner cap (556) is disposed within the outer cap (506) and the patch (860) is disposed between a portion of the inner cap (556) and a portion of the outer cap (506; Figures 5A-5B), and, in a second configuration (Figures 5C-5D), at least a portion of the inner cap (556) is distal to the outer cap (506) and the patch (860) is released (Figure 5D; Paragraph 0056).
Smith fails to explicitly teach:
the expandable structure partially surrounding a portion of the inner cap.
Whelehan teaches a device medical device with comprises an endcap having an outer endcap (220) and an inner endcap (210) and further comprising an expandable structure (270; stent; Paragraph 0037) partially surrounding a portion of the inner cap (210), wherein distal movement of the inner cap (210) relative to the outer cap (220) results in the expandable structure expanding (Paragraph 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the expanding end cap teachings of the Smith be a stent disposed about the end cap, as taught by Smith for the advantage of providing a self-expanding structure for deploying the patch, thus reducing the need for inflation media to inflate a balloon (Paragraph 0039; Whelehan).
Regarding Claim 14, the combination of references disclosed above teaches the medical device of claim 12, wherein Whelehan teaches the expandable structure includes a woven shape-memory material (Paragraph 0037).
Claim(s) 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US PGPub 2020/0038005) in view of Whelehan (US PGPub 2022/02655968) as applied to claim 12 above, and further in view of Carrillo (US PGPub 2017/0172602).
Regarding Claim 15, the combination of references disclosed above teaches the medical device of claim 12, wherein Smith teaches the inner cap (254; Figure 3B-2C) includes a proximal wall (256) extending radially outward from the inner cap, and a distal wall (the distal face of inner cap 254), wherein in a first configuration (Figure 2A) the outer edge of the proximal wall (256) is proximal to the inner edge of the outer cap (206; Figure 2A) wherein, in a second configuration (Figure 2B-2C), the outer edge of the proximal wall (256) and the distal end of the inner cap (254) is distal to the inner edge of the outer cap (206; see Figures 2B-2C).
Smith fails to disclose:
the distal wall extends radially outward from the inner cap
wherein, in a first configuration, an outer edge of the distal wall of the inner cap abuts an inner edge of the outer cap, and
wherein, in a second configuration, the outer edge of the distal wall of the inner cap is distal to the inner edge of the outer cap.
Carrillo a medical device (abstract) comprising a endcap (142; Paragraph 0034) having an inner cap (132; Figure 1A) and an outer cap (162; Figure 1A), wherein the inner cap (132) is movable relative to the outer cap (162; Paragraph 0035), wherein the inner cap comprises proximal wall (136) extending radially outwards from the inner cap (132) and a distal wall (134; Figure 3A which is comparable to the Smith base reference and see element 134’ in Figure 10, which the Examiner is relying upon):
the distal wall (134’) extends radially outward from the inner cap (132; see Figure 10; Paragraph 0052)
wherein, in a first configuration (Figure 10), an outer edge of the distal wall (134’) of the inner cap (132) abuts an inner edge of the outer cap (162), and
wherein, in a second configuration, the outer edge of the distal wall (134’) of the inner cap (132) is distal to the inner edge of the outer cap (162) (as described in Paragraph 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal wall of the inner cap to extend radially outward to contact the outer cap, as taught by Carrillo, for the advantage of preventing the patch of Smith from sliding out the distal end of the outer cap before deployment.
Regarding Claim 17, the combination of references disclosed above teaches the medical device of claim 12, wherein in a separate embodiment of Smith, a cap disposed on the endoscope is transparent (Paragraph 0050; Smith) but in the embodiment of Figures 2A-2B, Smith fails to explicitly teach wherein at least a portion of the end cap is transparent.
Carrillo a medical device (abstract) comprising a endcap (142; Paragraph 0034) having an inner cap (132; Figure 1A) and an outer cap (162; Figure 1A), wherein the inner cap (132) is movable relative to the outer cap (162; Paragraph 0035), wherein at least a portion of the end cap (142) is transparent (Paragraph 0036).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end cap of the combination of prior art references disclosed above to be transparent, as taught by Carrillo for the advantage of providing a clear view for an imaging and/or an illumination device (Paragraph 0036; Carrillo).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US PGPub 2020/0038005) in view of Whelehan (US PGPub 2022/02655968) as applied to claim 12 above, and further in view of Satar (US PGPub 2009/0264919).
Regarding Claim 18, the combination of references disclosed above teaches the medical device of claim 12, wherein Smith fails to teach the inner cap includes a lumen extending from a proximal end of the inner cap to a distal end of the inner cap.
Satar teaches a puncture closure medical device (Abstract) comprising an endcap having an inner cap (18 or 22) and an outer cap (16) (see Figures 7-8) for the purpose of deploying a patch (34; Paragraph 0034; Figures 7-8) wherein the inner cap (either 18 or 22) includes a lumen extending from a proximal end to a distal end (as seen in Figures 7-8 for housing the guidewire).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the inner cap taught by Smith to include a lumen, as taught by Satar for the advantage of advancing the medical device over a guidewire to the target area (Paragraph 0005).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771