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
This application contains claims directed to the following patentably distinct species:
Endoscope Delivery System 1 (Figs. 1- 12, 20)
Endoscope Delivery System 1A (Figs. 13- 15)
Endoscope Delivery System 2 (Figs. 16A- 17B)
Endoscope Delivery System 2A (Figs. 18A-18B)
Endoscope Delivery System 2B (Figs. 19A- 19B)
The species are independent or distinct because as disclosed the different species have mutually exclusive characteristics for each identified species including, but not limited to, a different type of restriction portion near the distal end of the device, a fixing member disposed in the operation portion at the proximal end side instead of being disposed in the sheath, a fixing member that is an elastic member or a spring, or wherein the slider and the fixing member contact each other to restrict the forward movement of the slider and operation wire. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter and/or the species or groupings of patentably indistinct species require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Joel Gotkin on August 27th, 2026 a provisional election was made with traverse to prosecute the invention of Endoscope Delivery System 2B, claims 1- 20. Affirmation of this election must be made by applicant in replying to this Office action.
Claim Objections
Claims 12- 20 are objected to because of the following informalities:
Claim 12, Line 10 states “clip transition”, it is suggested to change this to “clip transitions”.
Claim 12, Line 13 states “clip transition”, it is suggested to change this to “clip transitions”.
Claims 13- 20 are objected to from being dependent on or from objected claim 12.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 7- 13, 15- 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayashi et al. (JP 2013085859A English Machine Translation).
Regarding claim 1, Hayashi (Hayashi et al.) teaches a clip apparatus (medical device 10)(Figs. 1- 4, 10A and 10B)(In Paragraph 0095, Hayashi teaches that the third embodiment, which is herein relied upon, is the same as the first embodiment shown in Fig. 1, except that the configuration of the temporary restricting portion is different, therefore the third embodiment shown in Figure 10 would have the same structure as demonstrated within Figure 1 of the clip protrusion and the proximal opening being located distally relative to the operation body.) for use with an endoscope (Paragraph 0015), comprising:
A clip (20)(Paragraph 0020);
A wire (440) configured to receive an operation force to transition the clip between an open configuration and a closed configuration (Paragraphs 0013 and 0023);
A slider (drive unit 540) connected to the wire (Paragraph 0013), the slider including a first surface (see annotated Fig. 10A below);
An operation body (temporary restricting unit 60) configured to move relative to the slider (Paragraph 0097), the operation body including a second surface (see annotated Fig. 10A below),
Wherein in the closed configuration, when the operation force is smaller than a value, the first surface contacts the second surface to maintain the clip in the closed configuration (Paragraphs 0013, 0018 and 0098), and when the operation force is equal to or larger than the value, the first surface moves over the second surface to transition the clip from the closed configuration to the open configuration (Paragraphs 0029, 0103 and 0104).
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Regarding claim 2, Hayashi teaches the clip apparatus as discussed above.
Regarding wherein in the closed configuration, when the operation force is applied proximally, the first surface moves proximally away from the second surface, as Hayashi teaches that the slider is able to move proximally away during operation (Paragraphs 0067 and 0071), then when the slider moves proximally, the first surface moves proximally away from the second surface.
Regarding claim 7, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein in the open configuration, when the operation force is equal to or larger than the predetermined value, the first surface moves over the second surface to transition the clip from the open configuration to the closed configuration (Paragraphs 0029 and 0103).
Regarding claim 8, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein in the open configuration, the first surface is located distally relative to the second surface (see annotated Fig. 10A below), and in the closed configuration, the first surface is located proximally relative to the second surface (Paragraphs 0099- 0103).
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Regarding claim 9, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein the clip is configured to transition from the closed configuration to a locked configuration (Paragraphs 0060, 0061, and 0072)(In Paragraph 0095, Hayashi teaches that the third embodiment, which is herein relied upon, is the same as the first embodiment shown in Fig. 1, except that the configuration of the temporary restricting portion is different, therefore the third embodiment shown in Figure 10 would have the same structure as demonstrated within Figure 1 of the clip protrusion and the proximal opening being located distally relative to the operation body.), the clip includes a clip arm (260)(Paragraph 0050) including a clip protrusion (clamp receiving portion 26)(Paragraph 0058); and a clip tube (tightening portion 24) including a proximal opening, the clip tube inserting the clip arm (see annotated Fig. 4 below)(Paragraphs 0053), in the locked configuration, the clip protrusion and the proximal opening are engaged each other to prohibit the clip from transition from the locked configuration to the open configuration (Paragraphs 0060, 0061, and 0072).
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Regarding claim 10, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein the clip protrusion and the proximal opening are located distally relative to the operation body (see annotated Fig. 1 below)(In Paragraph 0095, Hayashi teaches that the third embodiment, which is herein relied upon, is the same as the first embodiment shown in Fig. 1, except that the configuration of the temporary restricting portion is different, therefore the third embodiment shown in Figure 10 would have the same structure as demonstrated within Figure 1 of the clip protrusion and the proximal opening being located distally relative to the operation body.).
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Regarding claim 11, Hayashi teaches the clip apparatus as discussed above.
Regarding wherein the clip is configured to transition from the closed configuration to a locked configuration, in the locked configuration, the first surface and the second surface are spaced apart from each other, as Hayashi teaches that the slider is able to move more proximally away during operation in order to lock the device (Paragraphs 0067 and 0071), then when the slider moves proximally, the first surface moves proximally away from the second surface and is spaced apart from the second surface.
Regarding claim 12, Hayashi teaches a clip apparatus (medical device 10)(Figs. 1, 10A and 10B)(In Paragraph 0095, Hayashi teaches that the third embodiment, which is herein relied upon, is the same as the first embodiment shown in Fig. 1, except that the configuration of the temporary restricting portion is different, therefore the third embodiment shown in Figure 10 would have the same structure as demonstrated within Figure 1 of the clip protrusion and the proximal opening being located distally relative to the operation body.) for use with an endoscope (Paragraph 0015), comprising:
A clip (20)(Paragraph 0020);
A wire (440) configured to receive an operation force to transition the clip between an open configuration and a closed configuration (Paragraphs 0013);
A restriction portion (see annotated Fig. 10A below) configured to restrict transition of the clip between the open configuration and the closed configuration (Paragraphs 0013, 0018 and 0098),
Wherein in the open configuration, when the wire moves proximal by receiving the operation force, the clip transitions to the closed configuration (Paragraphs 0013, 0018 and 0098), and
In the closed configuration, when the wire moves distally by receiving the operation force, the clip transitions to the open configuration (Paragraphs 0103 and 0104).
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Regarding claim 13, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein the restriction portion includes a first portion and a second portion (see annotated Fig. 10A below), wherein in the open configuration, the first portion is located distally relative to the second portion, and the first portion is configured to move over the second portion to transition the closed configuration (Paragraph 0103), wherein in the closed configuration, the first portion is located proximally relative to the second portion (Paragraph 0098), and the first portion is configured to move over the second portion to transition the open configuration (Paragraphs 0013, 0018, 0098, 0103, and 0104).
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Regarding claim 15, Hayashi teaches the clip apparatus as discussed above.
Regarding when the operation force is applied proximally, the first surface moves proximally away from the second surface, as Hayashi teaches that the slider is able to move proximally away during operation (Paragraphs 0067 and 0071), then when the slider moves proximally, the first surface moves proximally away from the second surface.
Regarding claim 16, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein the wire is configured to be tensioned distally by the clip (Paragraphs 0013, 0021, and 0023), and in the open configuration, when the operation force is equal to or larger than the value, the restriction portion transitions the clip from the open configuration to the closed configuration (Paragraphs 0029 and 0103).
Regarding claim 17, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein the wire is configured to be tensioned distally by the clip, and in the closed configuration, when the operation force is smaller than the value, the restriction portion maintains the clip in the closed configuration (Paragraphs 0013, 0018 and 0098), and when the operation force is equal to or larger than the value, the restriction portion transitions the clip from the closed configuration to the open configuration (Paragraphs 0029, 0103 and 0104).
Regarding claim 18, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein in the open configuration, when the operation force is equal to or larger than the predetermined value, the restriction portion transitions the clip from the open configuration to the closed configuration (Paragraphs 0029, 0103 and 0104).
Regarding claim 19, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein the clip is configured to transition from the closed configuration to a locked configuration (Paragraphs 0060, 0061, and 0072)(In Paragraph 0095, Hayashi teaches that the third embodiment, which is herein relied upon, is the same as the first embodiment shown in Fig. 1, except that the configuration of the temporary restricting portion is different, therefore the third embodiment shown in Figure 10 would have the same structure as demonstrated within Figure 1 of the clip protrusion and the proximal opening being located distally relative to the operation body.), the clip includes a clip arm (260)(Paragraph 0050) including a clip protrusion (clamp receiving portion 26)(Paragraph 0058); and a clip tube (tightening portion 24) including a proximal opening, the clip tube inserting the clip arm (see annotated Fig. 4 below)(Paragraphs 0053), in the locked configuration, the clip protrusion and the proximal opening are engaged each other to prohibit the clip from transition from the locked configuration to the open configuration (Paragraphs 0060, 0061, and 0072).
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Regarding claim 20, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein the restriction portion includes a first portion and a second portion (see annotated Fig. 10A below), wherein in the open configuration, the first portion is located distally relative to the second portion, and the first portion is configured to move over the second portion to transition the closed configuration (Paragraph 0103), wherein in the closed configuration, the first portion is located proximally relative to the second portion (Paragraph 0098), and the first portion is configured to move over the second portion to transition the open configuration (Paragraphs 0013, 0018, 0098, 0103, and 0104).
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 3- 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayashi (JP 201385859A English Machine Translation).
Regarding claims 3 and 14, Hayashi teaches the clip apparatus as discussed above.
Hayashi further teaches wherein the second surface is configured to move in a radial direction of the wire to transition the clip from the closed configuration to the open configuration (Paragraphs 0097 and 0103).
Hayashi does not teach wherein the first surface is configured to move in a radial direction of the wire to transition the clip from the closed configuration to the open configuration.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first surface and the second surface as taught by Hayashi through reversing the first surface and the second surface, specifically with how the second surface moves due to the spring (Paragraphs 0097 and 0103), since it has been held that mere reversal of parts is an obvious modification of the prior art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). See MPEP 2144.04(VI)(A).
Regarding claims 4- 6, Hayashi teaches the clip apparatus as discussed above.
Hayashi teaches wherein the wire is configured to be tensioned distally by the clip (Paragraphs 0013, 0021, and 0023), and the operation body including an elastic material (spring portion 650), the elastic material configured to: maintain the first surface and the second surface to contact each other (Paragraph 0097), and move with the second surface during the transition from the closed to the open configuration (Paragraph 0103), wherein during the transition between the closed configuration and the open configuration, the elastic material is deformed in a radial direction of the wire and wherein in the closed configuration, the elastic material is configured to generate an elastic force, the first surface and the second surface are configured to generate an engagement force that is larger than the elastic force (Paragraphs 0097, 0098, and 0103)(As Hayashi teaches that the first surface can get over the second surface, and that the spring is connected to the second surface, when a force is applied that overcomes the elastic force, the spring would be compressed and therefore be deformed in a radial direction of the wire.).
Hayashi does not teach wherein the wire is configured to be tensioned distally by the clip, and the slider including an elastic material, the elastic material configured to: maintain the first surface and the second surface to contact each other; and move with the first surface during the transition from the closed configuration to the open configuration, wherein during the transition between the closed configuration and the open configuration, the elastic material is deformed in a radial direction of the wire, or wherein in the closed configuration, the elastic material is configured to generate an elastic force, the first surface and the second surface are configured to generate an engagement force that is larger than the elastic force.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first surface, the second surface and the elastic material as taught by Hayashi to have the elastic material be disposed on the slider and be connected with the first surface, since it has been held that mere reversal of parts is an obvious modification of the prior art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). See MPEP 2144.04(VI)(A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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