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 .
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 4 is 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.
In re claim 4, the limitation “wherein a portion of the second fixation mechanism extends approximately perpendicularly to a portion of the lever” promotes a clarity concern. Specifically, the term “approximately perpendicularly” is a relative term which renders the claim indefinite. The term “approximately perpendicularly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. For examination purposes the limitation will be interpreted as requiring a portion of the second fixation mechanism to extend perpendicularly to a portion of the lever.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 12,011,147. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant Application
Reference (US 12,011,147)
Claim 1. An actuation device comprising:
Claim 1. An actuation device comprising:
a device body that comprises a first fixation mechanism configured to affix a proximal end of a first member of a medical device to the device body, and
a device body that comprises a first fixation mechanism configured to affix a proximal end of a first member of an accessory device to the device body; and
an actuator comprising an operable mechanism and a second fixation mechanism configured to affix a proximal end of a second member of the medical device to the actuator,
an actuator comprising an operable mechanism, a second fixation mechanism configured to affix a proximal end of a second member of the accessory device to the actuator,
wherein movement of the operable mechanism from a first position to a second position is configured to move the second member proximally relative to the first member, and
wherein…movement of the operable mechanism from the second position to the first position is configured to move the second member proximally relative to the first member,
wherein movement of the operable mechanism from the second position to the first position is configured to move the second member distally relative to the first member,
wherein… movement of the operable mechanism from a first position to a second position is configured to move the second member distally relative to the first member,
wherein at least one of the first member or the second member of the medical device is configured to be removably affixed to the device body or the actuator, respectively.
…a first fixation mechanism configured to affix a proximal end of a first member of an accessory device to the device body;
…a second fixation mechanism configured to affix a proximal end of a second member of the accessory device to the actuator
Claim 7. wherein the first fixation mechanism comprises a set screw or clamp…wherein the second fixation mechanism comprises a set screw or clamp.
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 –
(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 1, 3-6, 9-13 and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yee et al. (US 2017/0143195).
In re claim 1, Yee discloses an actuation device (Fig. 1A-1B: 100) comprising:
a device body (110) that comprises
a first fixation mechanism (110p) configured to affix a proximal end [0028] of a first member (132o) of a medical device (132; [0028]: “catheter”) to the device body, and
an actuator (122) comprising
an operable mechanism (122a) and
a second fixation mechanism (122p) configured to affix a proximal end [0028] of a second member (132i) of the medical device to the actuator [0028],
wherein movement of the operable mechanism from a first position (Fig. 1B) to a second position (Fig. 1A) is configured to move the second member proximally relative to the first member ([0033]: “pushing the lever 122a away from endoscope 200 as shown in Fig. 1A causes the inner elongate member 121i to retract proximally relative to the outer elongate member 132o”), and
wherein movement of the operable mechanism from the second position (Fig. 1A) to the first position (Fig. 1B) is configured to move the second member distally relative to the first member ([0033]: “pulling lever 122a toward endoscope as shown in Fig. 1B causes the inner elongate member 132i to advance distally relative to the outer elongate member 132o”),
wherein at least one of the first member or the second member of the medical device is configured to be removably affixed to the device body or the actuator, respectively ([0028]: “outer elongate member 132o” is “fixed to the body” via “a fixation member (e.g. screw, clamp)”; [0029]: “inner elongate member 132i” is “fixed” to the actuator via a “fixation member (e.g., a set screw, clamp)”).
In re claim 3, Yee discloses,
wherein the actuator is pivotally mounted relative to the device body ([0029]; Figs. 1A-1B show pivot point 126)
wherein the actuator comprises a lever (122a) that can move the actuator around a pivot (126).
In re claim 4, Yee discloses, wherein a portion of the second fixation mechanism extends approximately perpendicularly to a portion of the lever (Figs. 1A-1B; Examiner notes that under the broadest reasonable interpretation “a portion” can be defined as any region/section, therefore it is apparent that at least “a portion” of the second fixation mechanism would extend perpendicularly to “a portion of the lever”; Regarding the limitation “approximately perpendicularly” see above section Claim Rejections § 112).
In re claim 5, Yee discloses, wherein the device body is removably fixable to an endoscope handle ([0032]; “device body” is attached “at a point adjacent to a handle of the endoscope” via “fastener 112”)
In re claim 6, Yee discloses, further comprising a biasing member ([0037]: “spring or another mechanism”) configured to bias the actuator in the first position or the second position [0037].
In re claim 9, Yee discloses, wherein
the actuation device is configured to removably affix to an endoscope handle [0032] and
*the endoscope handle comprises a female mating member and
the device body comprises a corresponding male mating member (112) for removably coupling the device body to the endoscope handle [0032].
*Regarding the limitation “the endoscope handle comprises a female mating remember”, Examiner notes that “an endoscope handle” is not positively required by claim 9. Therefore, the claim only requires that the actuation device be configured to removable affix to “an endoscope handle”. It is apparent that the “actuation device” of Yee would be able to mate with a suitably dimensioned “endoscope handle” as claimed.
In re claim 10, Yee discloses, wherein the male mating member is formed of a flexible material ([0032]: “examples of fasteners for this purpose include…(e.g., elastic straps, VELCRO hook-and-loop fastener straps, etc.)”).
In re claim 11, Yee discloses,
wherein the medical device is a first medical device (132; [0028]: “catheter”), and
wherein the actuation device is integrally formed (Figs. 1A-1B) with a handle of a second medical device (200; [0032]: “a handle of the endoscope”).
In re claim 12, Yee discloses,
wherein the medical device is a first medical device (132; [0028]: “catheter”), and
wherein the actuation device is removably fixable [0032] to a handle of a second medical device (200; [0032]).
In re claim 13, Yee discloses, wherein
the first member is a sheath ([0028]: “hollow outer elongate member 132o (e.g. a catheter)”) and
the second member is a pull wire ([0029]: “The inner elongate member 123i may be solid (e.g. in the form of a wire”).
In re claim 15, Yee discloses,
wherein the medical device is a first medical device (132; [0028]: “catheter”),
wherein the first fixation mechanism is configured to fix the first member of the first medical device relative to a handle of a second medical device (200, [0032]: “a handle of endoscope”; Figs. 1A-1B), and
wherein the second fixation mechanism is movable with respect to the first fixation mechanism, such that the second member of the first medical device is movable with respect to the first member of the first medical device and the handle of the second medical device [0029].
In re claim 16, see above (In re claim 1).
Yee further discloses a medical device system (Figs. 1A-1B) comprising:
a first medical device (200) having a first handle ([0032]: “a handle of endoscope”);
a second medical device (132; [0047]: “…accessory device 132 in the form of a cutting knife”)
wherein the actuation device is operable from the handle of the first medical device (Fig. 3, Fig. 4).
In re claim 17, Yee discloses, further comprising a third medical device ([0050]: “an accessory device 132 that comprises an articulating hook or grasper”)
wherein a first member (132o of “accessory device 132 that comprises an articulating hook or grasper”; [0050]) of the third medical device is removably affixable to the first fixation member [0028], and
wherein a second member (132i of “accessory device 132 that comprises an articulating hook or grasper”; [0050]) of the third medical device is affixable to the second fixation member [0029].
In re claim 18, Yee discloses, wherein
the second medical device is one of a tome, a snare, a balloon, a basket, a knife, a needle, a ligation device, a clip, forceps, graspers, a stapler, a suturing device, a stent, a cautery device, or a biopsy collection device ([0047]: “…accessory device 132 in the form of a cutting knife”), and
the third medical device is another of a tome, a snare, a balloon, a basket, a knife, a needle, a ligation device, a clip, forceps, graspers, a stapler, a suturing device, a stent, a cautery device, or a biopsy collection device ([0050]: “accessory device 132 that comprises an articulating hook or grasper”), different from the second medical device (Examiner notes that an “articulating hook or grasper” is different from “a cutting knife”).
In re claim 19, see above (In re claim 1 and In re claim 3).
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.
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 2, 8, 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yee et al. (US 2017/0143195), in view of Jogasaki et al. (US 2017/0156711).
In re claim 2, Yee does not disclose, wherein:
the first fixation mechanism comprises a first arm and a second arm, and
the first member is configured to extend between the first arm and the second arm.
Jogasaki discloses a fixation mechanism (FIG. 1: 11, shown in greater detail in FIG. 5A), that like the first fixation mechanism disclosed by Yee, functions to secure a guidewire (2) to an actuation device (components to the right of element 19). As shown in FIG. 5A, the fixation mechanism includes a pair of arms (11a) that attach to a protruding component (2a) of the guidewire.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to: 1) modify the first fixation mechanism of Yee to comprise a first arm and a second arm and 2) modify the first member to include at least one protrusion, as taught by Jogasaki. One would have been motivated to make this modification to make it easier for an operator to remove the guide wire from the actuation device (Jogasaki, [0056]). Accordingly, such a modification would yield wherein “the first member is configured to extend between the first arm and the second arm”.
In re claim 8, for substantially the same reasons as described above (In re claim 2), it would have been obvious to one of ordinary skill in the art to 1) modify the second fixation mechanism to comprise a pair of arms, each arm comprising a curved portion and 2) modify the second member to include at least one protrusion, as taught by Jogasaki.
In re claim 14, see above (In re claim 2 and In re claim 8).
In re claim 20, see above (In re claim 2 and In re claim 8).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yee et al. (US 2017/0143195), in view of Pradhan et al. (US 2026/0137450).
In re claim 7, Yee discloses wherein the biasing member is a spring [0037].
Yee does not disclose the biasing member being a torsion spring
Pradhan, like Yee, discloses a medical device system (FIGURE 2) with an actuation device (102) attached to an endoscope (204). The actuation device comprises a body (202) and a trigger lever (FIGURE 4a: 314) attached to the body. As disclosed by Pradhan, the trigger lever also includes a torsion spring, to help return the trigger lever to its original position [0039].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spring disclosed by Yee to be a torsion spring, as taught by Pradhan. One would have been motivated to make this modification because the spring of Yee and torsion spring of Pradhan are functionally equivalent, that is, they both function to bias an actuator towards its original position. Moreover, one of ordinary skill in the art would have the ability to choose a type of spring that would best meet their needs.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Carrillo (US 2004/0162465) discloses a hook like fixation mechanism (FIG. 11: 210) for securing a guidewire (38) to an endoscope (Examiner notes 190 is “an access port” of endoscope; [0040]).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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