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 .
Notice of Amendment
In response to the amendment filed February 23, 2026, amended claims 1-3, 7-9; canceled claims 3-4 and 10-11; and new claims 14-15 are acknowledged. The following new grounds of rejection are set forth:
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “112”, "304" and "306" have both been used to designate a “flexible inner tube” and reference characters “124” and "706" " have both been used to designate a “suction port”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
Specification
The disclosure is objected to because of the following informalities:
Reference characters "128" and "129" have both been used to designate “the slot”. See paras 0032/0038 and 0039.
Reference character “306” has been used to designate both “flexible inner” and “short rigid tube”. See paras 0038 and 0042. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
GROUND 1: Claim 1-3, 6-9 and 12-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 7 recite, in part, an endoscopy device and method for manufacturing an endoscopy device, respectively, wherein “the switching mechanism comprises a pulley to retract or extend the inner tube outwardly through the outer tube, and a protrusion attached to the pulley, and wherein the housing portion comprises a slot to slidingly translate the protrusion to retract or extend the inner tube” which is not supported by the specification and/or drawings. The claims require a protrusion 120, attached to a pulley 302, which translate the pulley along housing 106 and results in the extension and/or retraction of inner tube 112/304/306. Figs 3a-b illustrate the extension and retraction of inner tube 304/306, however it is unclear how pulley 302 is configured to enable either action, particularly extension of flexible inner tube 306. Figure 4 and para 0039 illustrate and discuss the switching mechanism 300, but fail to explain how a pulley 302, which consists of a wheel 404, bearing 406 and a housing 408 are configured to extend the “flexible inner tube” shown in Figure 3b. Para 0039 states:
[0039] FIG. 4 shows an exploded view of the switching mechanism 300 of FIG. 3A, according to an alternative embodiment. The switching mechanism 300 may follow the principles of a sliding pulley system, which can be made from three-dimensional printing and may include ball bearings and bolts 402 for assembly. The pulley 302 may be assembled with three-dimensional printed parts consisting of a wheel 404 having a grooved rim with a bearing 406 fitted in its inner circumference, a wheel housing 408, bolts 402 and nuts 410. The inner tube 112 is then inserted through the pulley 302, in the space between the wheel 404 and the housing 408. The switching mechanism 300 is then housed within a rectangular sliding compartment (as shown in FIG. 1B) and the pulley 302 can be manoeuvred (sic) externally via the protrusion 120 by sliding along the slot 129 of the housing portion 106.
(emphasis added)
As emphasized above, “The inner tube 112 is then inserted through the pulley 302, in the space between the wheel 404 and the housing 408”. As such, if the flexible inner tube merely passes through the housing 408, and around wheel 404, it is unclear how any tension would be applied to the flexible inner tube via the pulley and result in extension thereof. For example, when the pulley is moved to the proximal/right side of the housing (as seen in Figure 3b), the flexible inner tube would presumably be pulled around wheel 404, to retract into housing 106. However, once fully retracted, it is unclear how movement of pulley 302 back to the distal/left side of the housing (as seen in Fig 3a) would result in extension of the flexible inner tube 304 as shown. Figure 3b, clearly illustrates the flexible slack of the inner tube 304 within housing 106, which then extends round the wheel 404 of the pulley out towards control button 116a. How would the flexible slack of inner tube 306 then be pushed by the pulley to extend outwardly from outer tube 110 as claimed? The pulley is claimed to comprises a wheel 404 and ball bearing 406, which allows the wheel to spin freely. As such, the flexibility of the tube would prevent the inner tube from being fed through the housing 408 and around free spinning wheel 404, as well as being pushed outwardly. At best, assuming the flexible inner tube was somehow capable of being proximally fed around the pulley/wheel, it appears that distal movement of the pulley would somehow pull the proximal end of the tube connected at pulley 602/control button 116a (as seen in Fig 6a) towards the distal/left side of the housing. Although unclear, this particular movement is supported by para 0038 which discloses, in part:
….For example, starting from FIG. 3A, when the pulley 302 is pulled further towards the right of the slot 128 to the position as shown in FIG. 3B. the inner tube 304 is shortened and vice versa.
(emphasis added)
In other words, one would understand the citations to mean that “when the pulley 302 is pulled further towards the left of the slot 128 to the position as shown in FIG. 3a. the inner tube 304 is shortened” from the opposite end of the inner tube, in the same manner the inner tube can be retracted into outer tube 110. Yet, this movement would appear to destroy the device, assuming the inner tube and guide wires 606 are fixedly attached to actuator/pulley604 (See Fig. 6a and para 0043). Ultimately, there is no support that the switch mechanism as shown and disclosed, comprises a pulley that extends the inner tube from the outer tube upon translational movement thereof. Appropriate clarification and correction is required.
Claims 2-3, 6 and 8-9 and 12-15 are rejected as being necessarily dependent upon claims 1 and 7.
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.
GROUND 2: Claims 1-3, 69 and 12-15 are 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.
As discussed above, Claims 1 and 7 recite, in part, an endoscopy device and method for manufacturing an endoscopy device, respectively, wherein “the switching mechanism comprises a pulley to retract or extend the inner tube outwardly through the outer tube, and a protrusion attached to the pulley, and wherein the housing portion comprises a slot to slidingly translate the protrusion to retract or extend the inner tube”. It is unclear what the Applicant is attempting to claim with regard to the switching mechanism comprising a pulley which is configured to retract or extend the flexible inner tube outwardly through the outer tube, as this extension of the inner tube via the pulley/protrusion does not appear to be physically possible. Appropriate clarification and correction is required.
Claims 2-3, 6 and 8-9 and 12-15 are rejected as being necessarily dependent upon claims 1 and 7.
Claim 1 recites, in part, “…and a protrusion attached to the pulley, and wherein the housing portion comprises a slot to slidingly translate the protrusion to retract or extend the inner tube” which leads to confusion as the slot does not translate the protrusion as claimed, but rather provides a recess, or area, upon which the protrusion may slidingly translate. In other words, the slot cannot translate the protrusion, instead it provides an opening through which the protrusion is configured and capable of being slide along. Appropriate clarification and correction is required.
Claims 2-3, 6 and 13-15 are rejected as being necessarily dependent upon claim 1.
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.
GROUND 3: Claim(s) 1, 6-7 and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2018/0272106 to Funk et al.
In regard to claims 1 and 7, Funk et al. disclose an endoscopy device 300 comprising: a body having a handle portion and a housing portion 310 (See Figs. 5-7 and para 0053, 0068), the housing portion having an outlet 312; a switching mechanism 350 disposed in the housing portion; a rigid outer tube 305 detachably coupled to the housing portion at the outlet (See paras 0023, 0058 ), and a flexible inner tube 330 extendable from the outer tube (See Figs. 5-6), wherein the switching mechanism comprises a pulley 314 to retract or extend the inner tube outwardly through the outer tube, and a protrusion 351 attached to the pulley (see para 0083) and wherein the housing portion comprises a slot 313 to slidingly translate the protrusion to retract or extend the inner tube (See paras 0053-0066).
In regard to claims 6 and 12, Funk et al. disclose an endoscopy device, wherein the handle portion further comprises an inlet 311, and wherein the inlet is configured to receive a medical instrument (See Fig. 5 and paras 0054-0055).
In regard to claim 13, Funk et al. disclose an endoscopy device, wherein the handle portion further comprises an airtight working channel (See Figs. 5-7 and paras 0053-0066).
In regard to claim 14, Funk et al. disclose an endoscopy device, further comprising a suctioning mechanism (i.e. syringe), wherein the suctioning mechanism comprises a pathway and a valve operable to connect the working channel to a suction port (See para 0057).
In regard to claim 15, Funk et al. disclose an endoscopy device, further comprising a suction control button (i.e. syringe plunger), disposed on the handle portion and configured to operate the valve, and wherein the suction port is disposed on the housing portion (See para 0057).
GROUND 4: Claim(s) 1, 6-7 and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2021/0290905 to Harding et al.
In regard to claims 1 and 7, Harding et al. disclose an endoscopy device 800 comprising: a body having a handle portion and a housing portion (See Fig. 8), the housing portion having an outlet; a switching mechanism 850 disposed in the housing portion; a rigid outer tube 100a detachably coupled to the housing portion at the outlet, and a flexible inner tube 853 (i.e. probe/needle, see para 0004) extendable from the outer tube, wherein the switching mechanism comprises a pulley 851b to retract or extend the inner tube outwardly through the outer tube, and a protrusion 851a attached to the pulley and wherein the housing portion comprises a slot 313 to slidingly translate the protrusion to retract or extend the inner tube (See paras 0060-0062).
In regard to claims 6 and 12, Harding et al. disclose an endoscopy device, wherein the handle portion further comprises an inlet 800b, and wherein the inlet is configured to receive a medical instrument (See Fig. 8 and paras 0060-0062).
In regard to claim 13, Harding et al. disclose an endoscopy device, wherein the handle portion further comprises an airtight working channel (See Figs. 5-7 and paras 0053-0066).
In regard to claim 14, Harding et al. disclose an endoscopy device, further comprising a suctioning mechanism (i.e. vacuum tube receiver), wherein the suctioning mechanism comprises a pathway and a valve operable to connect the working channel to a suction port (See Fig. 8 and para 0060).
In regard to claim 15, Harding et al. disclose an endoscopy device, further comprising a suction control button (i.e. vacuum tube receiver) disposed on the handle portion and configured to operate the valve, and wherein the suction port is disposed on the housing portion (See Fig. 8 and para 0060).
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.
GROUND 5: Claim(s) 2-3 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0272106 to Funk et al. in view of U.S. Patent Application Publication No. 2010/0099946 to Jenkins et al.
In regard to claims 1 and 7, Funk et al. disclose an endoscopy device comprising a switching mechanism configured to retract or extend the inner tube outwardly through the outer tube and wherein the housing portion comprises a slot to slidingly translate the protrusion to retract or extend the inner tube (see rejections above). Funk et al. discloses the desirability of providing a deflecting/bending distal catheter end (See paras 0086-0090) but are silent with respect to wherein the handle portion comprises a control button to control a distal end of the inner tube, via a guide wire inserted inside the inner tube and coupled to the control button. Jenkins et al. teach of teach of an analogous endoscopic device wherein a guidewire 238 may be inserted within a balloon catheter 250 via a port on the handle of the device, thus enabling navigation of the balloon catheter through the anatomy via control button 239 (See Figs. 2a-f and para 0074). It would have been obvious to one skilled in the art at the time the invention was filed to provide articulating guidewire through the inside of the of the inner tube of Funk et al. to provide a steerable catheter that is more efficient and effective at accessing a target site within the body as tuaght by Jenkins et al. and is extremely well known in the art.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 6-9 and 12-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW J KASZTEJNA whose telephone number is (571)272-6086. The examiner can normally be reached M-F, 7AM--3PM.
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/MATTHEW J KASZTEJNA/ Primary Examiner, Art Unit 3993