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 .
Disposition of Claims
Claims 1-20 are pending and rejected.
Claim Objections
Claim 18 is objected to because of the following informality:
Regarding Claim 18, Claim 18 recites the limitation “a proximal portion configured to cover the first actuator [emphasis added]” on Lines 2-3. In light of Applicant’s specification (see Para. [0026]) and the prosecution history of Application 17/487,632 now U.S. Patent 12,178,404, the parent application/patent of this instant application (see Claim 15 of ‘404), this appears to be a clear drafting error and should read “a proximal portion configured to cover the second actuator [emphasis added]” and appropriate correction is required.
NOTE: For the sake of compact prosecution, brevity and to avoid any unnecessary delays, the limitation of Claim 18 is being interpreted as “a proximal portion configured to cover the second actuator” with regards to art and double patenting rejections and has not been rejected under 35 U.S.C. § 112(a) for lacking written support. If this is not a drafting error, however, Claim 18 will be rejected under § 112(a) in the subsequent office action.
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.
Claims 16 & 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Uchida et al.(hereinafter "Uchida") (US 2021/0063723).
Regarding Claim 16, Uchida discloses an endoscope system (Fig. 2A, an endoscopic system comprising 1 and 10; [0060] & [0081]) comprising:
an endoscope (Fig. 1, 1; [0060]) including a handle (Fig. 1, 3; [0060]); and
a controller (Fig. 2A, 10; [0081]) configured to be coupled to the handle ([0083]), and uncoupled from the handle ([0083]), the controller comprising:
a body (Fig. 2A, a housing assembly comprising 11 and 12; [0083]), wherein the body comprises:
a first actuator (Fig. 4A, 41; [0102]) configured to mate with a second actuator of the handle (Fig. 1, 3g; [0069]) such that rotation of the first actuator causes rotation of the second actuator ([0106]);
a third actuator (Fig. 2D, 62; [0136]), wherein actuation of the third actuator is configured to initiate rotation of the first actuator and the second actuator ([0149]); and
a first recess (Fig. 4B, 25; [0096]) configured to receive a first locking actuator of the endoscope (Fig. 1, 3h; [0069]) and prevent rotation of the first locking actuator when the body is coupled to the endoscope ([0078] & [0096]).
Regarding Claim 18, Uchida discloses the endoscope system of Claim 16. Uchida further discloses wherein the body includes a distal portion (Fig. 2A, 12; [0083]) configured to wrap around the handle ([0088]) and a proximal portion (Fig. 2A, 11; [0083]) configured to cover the second actuator ([0088]).
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neumann (DE 202010009234 U1).
Regarding Claim 19, Neumann, as best understood, a controller (Fig. 4, 1; [0044]) configured for use with a medical device (Fig. 4, 2; [0037]), comprising:
a body (Figs. 3 & 4, a device body comprising 13 & 15; [0045] & [0052]) configured to removably couple to the medical device ([0015]), wherein the body comprises:
a first body (Fig. 3, 13; [0045]) configured to mate with a first actuator of the medical device (Fig. 1, 5; [0041]); and
a second body (Fig. 4, 15; [0052]) including:
a second actuator (Fig. 4, 12; [0050]), wherein actuation of the second actuator is configured to wirelessly initiate movement of the first actuator ([0051] & [0069]);
wherein the second body is configured to (i) directly couple to the medical device (see Fig. 4) and (ii) wirelessly connect to the first body to initiate movement of the first actuator (Fig. 4, 11 of 15 is connected via Bluetooth to 10 of 13; [0050] & [0069]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 10-11 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Uchida et al. (hereinafter "Uchida") (US 2021/0063723) in view of Gumbs et al. (hereinafter "Gumbs") (US 2014/0296633).
Regarding Claim 1, Uchida discloses a controller (Fig. 2A, 10; [0081]) configured for use with a medical device (Fig. 1, 1; [0060]), comprising:
a body (Fig. 2D, a housing assembly comprising 11 and 60; [0083] & [0089]) configured to removably couple to the medical device ([0083]), wherein the body comprises:
a first body (Fig. 2A, 11; [0083]) configured to mate with a first actuator of the medical device (Fig. 1, 3g; [0069]); and
a second body (Fig. 2D, 60; [0089]) including:
a second actuator (Fig. 2D, 62; [0136]), wherein actuation of the second actuator is configured to initiate movement of the first actuator ([0149]);
wherein the second body is U-shaped (Fig. 5A, 61 of 60 is substantially U-shaped defined by 64; [0136]) and configured to
(i) directly couple to and abut a handle of the medical device ([0190] & see Figs. 2D & 7C) and
(ii) connect to the first body to initiate movement of the first actuator (Figs. 4C & 6A, 71 of 60 sends signals to 32 of 11 rotate 3g via 41; [0132] & [0151] – [0152]).
Uchida fails to explicitly disclose wherein actuation of the second actuator is configured to wirelessly initiate the movement of the first actuator; and wherein the second body is configured to wirelessly connect to the first body.
However, Gumbs teaches a controller (Fig. 1, a remote endoscope handle manipulation; [0039]) configured for use with a medical device (Fig. 1, 60; [0042]), comprising:
a body (Fig. 1, a control system comprising 10 and 20; [0042]) configured to removably couple to the medical device (Fig. 1, 10 of the control system is configured to removably attach to 60; [0046]), wherein the body comprises:
a first body (Fig. 1, 10; [0042]) configured to mate with a first actuator of the medical device (Fig. 1, 70A; [0047]); and
a second body (Fig. 1, 20; [0042]) including:
a second actuator (Fig. 1, 22; [0042]), wherein actuation of the second actuator is configured to wirelessly initiate movement of the first actuator ([0042] & [0047]); and
wherein the second body is configured to wirelessly connect to the first body to initiate movement of the first actuator (Figs. 1 & 5, 22 of 20 communicates with 16A of 10 via wireless communication; [0042] & [0047]).
The advantage of the wireless communication is to permit an operator to control the endoscope without manipulating the first actuator (Gumbs; [0048]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the second actuator of the second body as disclosed by Uchida, to permit wireless communication with the first body so to wirelessly initiate movement of the first actuator as taught by Gumbs, to permit an operator to control the endoscope without manipulating the first actuator (Gumbs; [0048]).
Regarding Claim 2, Uchida, as previously modified by Gumbs, teaches the controller of Claim 1. Uchida further discloses wherein the body further comprises a motor (Fig. 4B, 32; [0099]) communicatively coupleable with the second actuator ([0151]), and the motor is configured to cause movement of the first actuator ([0132]).
Regarding Claim 4, Uchida, as previously modified by Gumbs, teaches the controller of Claim 1. Uchida further discloses wherein the first actuator is a knob configured to articulate a distal portion of the medical device (Fig. 1, 2b2; [0077]).
Regarding Claim 10, Uchida, as previously modified by Gumbs, teaches the controller of Claim 1. Uchida further discloses wherein the second body is configured to couple to a distal portion of the first body (see Fig. 2D).
Regarding Claim 11, Uchida, as previously modified by Gumbs, discloses the controller of Claim 1. Gumbs further teaches a circuit board (a processor; [0042]) electrically coupled to the second actuator ([0042]).
Regarding Claim 15, Uchida, as previously modified by Gumbs, teaches the controller of Claim 1. Uchida further discloses wherein the second actuator is configured to be positioned proximate to an umbilicus of the medical device when the controller is coupled to a handle of the medical device (Fig. 2D, 60 is disposed proximal to 4 of 1; [0086]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Neumann (DE 202010009234 U1) in view of Masaki et al. (hereinafter "Masaki") (US 2012/0277534).
Regarding Claim 20, Neumann, as best understood, discloses the controller of Claim 19. Neumann further discloses wherein the second actuator is a joystick (Fig. 4, 12 is a joystick; [0051]). Neumann fails to explicitly disclose wherein the second actuator includes at least four buttons, and wherein at least two of the at least four buttons are configured to control actuation of the first actuator.
However, Masaki teaches a medical device (Fig. 8, 1; [0053]), comprising:
a first body (Fig. 8, 10; [0051]) having a first actuator (Fig. 8, 29; [0057]);
a second body (Fig. 8, 11B; [0051]) having a second actuator (Fig. 7, 18B; [0051]) and configured to removably couple to the first body ([0052] & see Fig. 7);
wherein actuation of the second actuator is configured to initiate movement of the first actuator ([0057]);
wherein the second actuator includes at least four buttons (Fig. 7, 43A-43D; [0053]); and
wherein at least two of the at least four buttons are configured to control actuation of the first actuator (Fig. 7, 43A-43D are buttons; [0053]).
The advantage of the optical-control-button type actuator is to contactlessly control the first actuator of the medical device thereby reducing physical wear and tear (Masaki; [0056]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to replace the joystick-type second actuator as disclosed by Neumann, with the optical-control-button type second actuator as taught by Masaki, to contactlessly control the first actuator of the medical device thereby reducing physical wear and tear (Masaki; [0056]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 15 of U.S. Patent No. 12,178,404.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application limit a broader version of ‘404 and thus are anticipated by ‘404.
Claims 1-15 & 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-14 of U.S. Patent No. 12,178,404 in view of Gumbs et al. (hereinafter "Gumbs") (US 2014/0296633) and Masaki et al. (hereinafter "Masaki") (US 2012/0277534).
The claims of ‘404 discloses all the limitations of the instant claims except for wherein actuation of the second actuator is configured to wirelessly initiate the movement of the first actuator; and wherein the second actuator includes at least four buttons, and wherein at least two of the at least four buttons are configured to control actuation of the first actuator.
Regarding Claims 1-15 & 19-20, Gumbs discloses a controller (Fig. 1, a remote endoscope handle manipulation; [0039]) configured for use with a medical device (Fig. 1, 60; [0042]), comprising:
a body (Fig. 1, a control system comprising 10 and 20; [0042]) configured to removably couple to the medical device (Fig. 1, 10 of the control system is configured to removably attach to 60; [0046]), wherein the body comprises:
a first body (Fig. 1, 10; [0042]) configured to mate with a first actuator of the medical device (Fig. 1, 70A; [0047]); and
a second body (Fig. 1, 20; [0042]) including:
a second actuator (Fig. 1, 22; [0042]), wherein actuation of the second actuator is configured to wirelessly initiate movement of the first actuator ([0042] & [0047]); and
wherein the second body is configured to wirelessly connect to the first body to initiate movement of the first actuator (Figs. 1 & 5, 22 of 20 communicates with 16A of 10 via wireless communication; [0042] & [0047]).
The advantage of the wireless communication is to permit an operator to control the endoscope without manipulating the first actuator (Gumbs; [0048]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the second actuator of the second body as disclosed by ‘404, to permit wireless communication with the first body so to wirelessly initiate movement of the first actuator as taught by Gumbs, to permit an operator to control the endoscope without manipulating the first actuator (Gumbs; [0048]).
Regarding Claims 1-15 & 19-20, Masaki discloses a medical device (Fig. 8, 1; [0053]), comprising:
a first body (Fig. 8, 10; [0051]) having a first actuator (Fig. 8, 29; [0057]);
a second body (Fig. 8, 11B; [0051]) having a second actuator (Fig. 7, 18B; [0051]) and configured to removably couple to the first body ([0052] & see Fig. 7);
wherein actuation of the second actuator is configured to initiate movement of the first actuator ([0057]);
wherein the second actuator includes at least four buttons (Fig. 7, 43A-43D; [0053]); and
wherein at least two of the at least four buttons are configured to control actuation of the first actuator (Fig. 7, 43A-43D are buttons; [0053]).
The advantage of the optical-control-button type actuator is to contactlessly control the first actuator of the medical device thereby reducing physical wear and tear (Masaki; [0056]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the second actuator as disclosed by ‘404, to be the optical-control-button type second actuator as taught by Masaki, to contactlessly control the first actuator of the medical device thereby reducing physical wear and tear (Masaki; [0056]).
Allowable Subject Matter
Claims 3, 5-9, 12-14 & 17 would be allowable if rewritten to overcome the double patenting rejections, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding Claim 3, Uchida, as previously modified by Gumbs, discloses the controller of Claim 1. Uchida further discloses wherein the body further includes: a first gear (Fig. 1, 47A; [0047]) configured to mate with the first actuator of the medical device ([0047]).
Uchida, as previously modified by Gumbs, fails to explicitly disclose a second gear configured to mate with a third actuator of the medical device.
Regarding Claim 17, Uchida discloses the endoscope system of Claim 16. Uchida fails to explicitly discloses a second recess configured to receive a second locking actuator of the endoscope and prevent rotation of the second locking actuator when the body is coupled to the endoscope.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Miller et al. (US 2020/0058284) teaches a surgical tool having an integrated microphone.
Yang et al. (US 2019/0125469) teaches a surgical instrument with a terminal steering mechanism.
Pereira et al. (US 2019/0008601) teaches an endoscope with a detachable peripheral device.
Ogawa et al. (US 2016/0193000) teaches an manipulator system with a remote controlling device.
Okamoto et al. (US 2016/0113481) teaches an introducing apparatus with a rotary mechanism.
Oginski et al. (US 2015/0112141) teaches a rotational device for a rotating endoscope.
Foley et al. (US 2012/0078080) teaches a remotely controlled catheter insertion system.
Koyama (US 2010/0268031) teaches an electric bending endoscope with a remote operation portion.
Ueno et al. (US 2007/0238927) teaches a power driven bending endoscope with a detachable insertion portion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN FLOYD LONDON whose telephone number is (571)272-4478. The examiner can normally be reached Monday - Friday: 10:00 am ET - 6:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL CAREY can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHEN FLOYD LONDON/Examiner, Art Unit 3795
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