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 June 1, 2026, amended claims 1 and 7 canceled claims 2-5 and 8-9 are acknowledged. The following new and reiterated grounds of rejection are set forth:
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, 6-7 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, comprising “a flexible inner tube extendable from the outer tube” which is not supported by the specification and/or drawings. The word “extendable”, by definition means “able to be made longer or larger” (see https://dictionary.cambridge.org/dictionary/english/extendable). It is unclear from the specification and drawings how flexible inner tube 112 is capable of being made longer with respect to rigid outer tube 110, through which inner tube is positioned. That is, Figs. 3a-b illustrate the extension (i.e. “extendable”) 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 a 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, or teaching, showing how the flexible inner tube is “extendable from the outer tube” as claimed. Appropriate clarification and correction is required.
Claims 6 and 12-15 are rejected as being necessarily dependent upon claims 1 and 7, respectively.
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, 6-7 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, in part, an endoscopy device and method for manufacturing an endoscopy device, respectively, comprising “a flexible inner tube extendable from the outer tube” which is not supported by the specification and/or drawings and as a result, it is unclear what the Applicant is attempting to claim with regard to the inner tube being “extendable from the outer tube”, in view of the word “extendable”, meaning “able to be made longer or larger”. As discussed above, extension of the inner tube via the pulley/protrusion does not appear to be physically possible and thus it is unclear what the Applicant is attempting to claim with the cited limitations. Appropriate clarification and correction is required.
Claims 6 and 12-15 are rejected as being necessarily dependent upon claims 1 and 7, respectively.
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 3: Claim(s) 1, 6-7 and 12-15 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 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 the inner tube through the outer tube, and a protrusion 351 attached to the pulley (see para 0083) and wherein the housing portion comprises a slot 313 and wherein the protrusion is configured to slide along the slot to retract or the inner tube (See paras 0053-0066). 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 taught by Jenkins et al. and is extremely well known in the art.
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).
Response to Arguments
Applicant's remarks and amendments filed June 1, 2026, have been fully considered and will be addressed as follows with respect to the previously presented claim interpretations and rejections:
Drawings:
The amended drawings filed June 1, 2026 have been reviewed and accepted. The objection to the drawings is withdrawn.
Specification:
The amended specification filed June 1, 2026 has been reviewed and accepted. The objection to the specification is withdrawn.
GROUND 1 (112a rejections):
Amended claims filed June 1, 2026, removed language with regard to the switching mechanism comprising a pulley to “extend the inner tube outwardly though the outer tube”, to seemingly address the rejections made under GROUND 1. However, claims 1 and 7 recite “a flexible inner tube extendable form the outer tube” and thus the rejection of the claims is maintained, as failing to comply with the written description requirement. See GROUND 1 above.
GROUND 2 (112b rejections):
Amended claims filed June 1, 2026, removed language with regard to the switching mechanism comprising a pulley to “extend the inner tube outwardly though the outer tube”, to seemingly address the rejections made under GROUND 2. However, claims 1 and 7 recite “a flexible inner tube extendable form the outer tube” and thus the rejection of the claims is maintained, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. See GROUND 2 above.
GROUND 3 (102 rejections in view of Funk et al.):
In view of the amendments filed June 1, 2026, the rejection of claims 1, 6-7 and 12-15 as being anticipated by U.S. Patent Application Publication No. 2018/0272106 to Funk et al. is withdrawn.
GROUND 4 (102 rejections in view of Harding et al.):
In view of the amendments filed June 1, 2026, the rejection of claims 1, 6-7 and 12-15 as being anticipated by U.S. Patent Application Publication No. 2021/0290905 to Harding et al. is withdrawn.
GROUND 5 (103 rejections in view of Funk et al. and Jenkins et al.):
In the amendments filed June 1, 2026, Applicant incorporated claims 2-3 and 8-9 into claims 1 and 7, respectively. Newly amended claims 1 and 7 stand rejected (see GROUND 3 above) under the same rationale as previously presented for the following reasons:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a handle control button”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims broadly recite “wherein the handle portion comprises a control button to control a distal end of the inner tube”. As seen in Figure 2H, handle portion 233 includes a port/cavity to accommodate torquing device 239 (i.e. “control button”).
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Thus, as broad as claimed, Jenkins et al. teach of a handle portion that comprises a control button to control a distal end of the inner tube. Furthermore, Jenkins et al. disclose guidewire 261 may be fixed at the distal tip of the balloon catheter tool 250 to navigate through the anatomy (see Fig. 3B and para 0079). In the fixed configuration, torquing device 239 would be fixed within the port/cavity of the handle (see Fig. 2h) to enable a user to rotate/torque the guidewire, thereby guiding the device into a desired region of the anatomy. As such, rotation, or torquing, of the guidewire undoubtedly, “controls a distal end of the inner tube” and meets the current limitations of the cited claims.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, 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. 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 with the ability to deflect the distal end thereof, and thus more easily access a desired region within the body as taught by Jenkins et al. and is extremely well known in the art.
Pertinent Art:
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In particular, the following references each illustrate and disclose control buttons on handle portion of the device, which are coupled to guide wires such that activation of the control button results in movement at a distal end of a tube, to which the guide wire is attached. Thus, the subject matter of claims 2-3 and 8-9, which was incorporated into independent claims 1 and 7, respectively, is not considered to be a novel or inventive feature. Rather, a control button with a coupled wire for deflection of an insertion tube, is extremely well known in the art as the following refences show:
US 12390090 – see actuator 14, Figs. 2-4.
US 2024/0260953 – see actuator 120, Figs. 1-2 and 4a.
US 11363944 – see actuator 21, Fig. 1.
US 2018/0303505 – see guidewire actuator 40, Figs. 1-3.
US 9980786 – see actuators 1001, 1003, 1005, Fig. 1A.
US 2015/0038790 – see actuator 17, Fig. 1.
US 7833153 – see actuator 23, Fig. 1.
US 2007/0249899 – see actuator 15. Figs. 4a-b.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, Eileen Lillis can be reached at 571-272-6928. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J KASZTEJNA/ Primary Examiner, Art Unit 3993
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