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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 17, 2025, has been entered.
Claims 1-5 and 7-15 are pending.
Drawings
The drawing objection from the Office Action dated August 21, 2025, is removed in light of the amendments to the claims.
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.
Claims 1, 5, 7, 9, 10, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2014/0275763) in view of Siegmund (US 4,919,112).
Regarding Claim 1, King discloses:
An endoscope device comprising:
a disposable unit (102 and 104 make up the disposable unit) comprising:
an endoscopic insertion tube (104);
an interface unit (see Fig. 13 where the asterisk shows the electrical coupling portion of 130); and
a housing (102) defining a confined space and a rear opening (see Figs. 4 and 13 showing the handle housing with a rear opening for receiving 112); and
a reusable unit (112) configured to be disposed and secured inside the housing of the disposable unit (see Figs. 4 and 13 showing how the reusable unit is inserted into the handle housing 102), the reusable unit comprising a receiver to receive, via the interface unit, image data of the imaged distal object (see Paragraph 0134 indicating that pins are used to pass data to and from the imaging device at the tip),
wherein the reusable unit is configured to be slidably fitted, via the rear opening, into the confined space of the housing (shown in Fig. 13, for example, discussed throughout the disclosure), to be sealingly accommodated and within the housing of the disposable unit (Paragraph 0089 indicating that the device is hermetically sealed), with a front outside surface, adjacent to the endoscopic insertion tube and lateral surfaces of the reusable unit encased by the housing (shown in Fig. 13 with the front and sides covered by the housing),
wherein the opening of the housing is configured to be covered by a rear cover (114) when the reusable unit is inside the housing (hinged cap 114 closes the housing).
King does not explicitly disclose an optical guide, having a proximal end and a distal end, for imaging a distal object. Siegmund teaches using an optical guide (22) for transmitting an image from the distal end to the proximal end of a multi-component device with a disposable shaft. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify King’s device to include Siegmund’s optical guide. Such a modification provides a low-cost means for transmitting an image from the distal end to the proximal end of an endoscopic device. Furthermore, this modification uses well-known components (optical fibers) in a well-known manner (within the shaft of an endoscope) to perform a well-known function (transmit images).
Regarding Claim 5, King does not explicitly disclose wherein the disposable unit further comprises a navigation mechanism comprising a navigation lever connected to a disk that is connected to navigation wires for manipulating a distal tip of the insertion tube (although King clearly shows a mechanism with wires for steering the distal tip; see Figs. 5A-12B). Siegmund teaches such an endoscope with the navigation mechanism (wires 28/29) as is known in the art. The Examiner also notes that Applicant’s disclosure indicates that the navigation mechanism is known for several types of endoscopes (see Paragraph 0056). This configuration is a well-known means for deflecting the distal tip such that it would be obvious to use such a means with King. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify King’s device to include Siegmund’s wires. Such a modification provides a means for deflecting the distal tip as is known in the art.
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Regarding Claim 7, King as modified further discloses a light source (LEDs, Paragraph 0063).
Regarding Claim 9, King as modified further discloses wherein the light source is disposed at the distal end of the insertion tube (202 at the distal end 110 may be one or more LEDs).
Regarding Claim 10, King as modified further discloses wherein the optical guide comprises a multicore fiber (Siegmund teaches using a fiber optic bundle (see 18 in Fig. 5 showing the plurality of cores)).
Regarding Claim 12, King as modified further discloses an aligning device for aligning of the proximal end of the optical guide with an optical axis of the receiver (King teaches using registration features 160; when combined with Siegmund, these alignment features are used to align the optical guide with the corresponding receiver).
Regarding Claim 15, King as modified further discloses wherein when the reusable unit is situated inside the housing, wherein the opening of the housing is sealingly covered by a rear cover of the disposable unit (cap 114 covers the opening of the housing).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2014/0275763) and Siegmund (US 4,919,112), as applied to claim 1 above, and further in view of Birnkrant et al. (US 2008/0249355).
King and Siegmund disclose the invention substantially as claimed as stated above.
Regarding Claim 2, King and Siegmund do not explicitly disclose wherein the interface unit comprises an optical coupler. Birnkrant teaches using an optical coupler (see Paragraph 0057 indicating that the coupler 218 may couple optical cables/channels). With the combination of Siegmund’s optical guide, an optical coupler would be obvious to enable optical transmission from one component to another. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify King and Siegmund’s device to include Birnkrant’s optical coupler. Such a modification provides a means for optical data to go from the distal end of the device to the proximal end.
Claims 3, 4, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2014/0275763), Siegmund (US 4,919,112), and Birnkrant et al. (US 2008/0249355), as applied to claims 1 and 2 above, and further in view of L’Helgoual’ch (US 2015/0011825).
King, Siegmund, and Birnkrant disclose the invention substantially as claimed as stated above.
Regarding Claim 3, they do not explicitly disclose wherein receiver is adapted to receive an optical image from the optical guide via the optical coupler and to convert it to digital image data. L’Helgoual’ch teaches a focal-distance adapting optical system (34) with a CMOS that converts the light rays to electrical signals (Paragraphs 0087-0088) as is known in the art. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify King’s device to include L’Helgoual’ch’s sensor. Such a modification incorporates well-known technology (CMOS or CCD sensors) to convert light rays to electrical signals to provide a digital image that can then be displayed on a digital screen. Looking at Siegmund, the reference uses old technology of simply looking at the image from the distal end. L’Helgoual’ch provides the more modern approach of obtaining a digital image that can then be displayed on a monitor, allowing viewing by multiple surgeons, digital manipulation of the image, storage of the images, etc.
Regarding Claim 4, King as modified further discloses wherein the receiver comprises an optical sensor (L’Helgoual’ch’s sensor is CCD/CMOS, see Paragraph 0087).
Regarding Claim 8, King, Siegmund, and Birnkrant do not explicitly disclose wherein the light source is disposed within the reusable unit, and wherein the insertion tube further comprises an illumination guide to guide light from the illumination source to the distal end of the insertion tube (although Siegmund does disclose a proximal light source with an illumination guide extending from the proximal end to the distal end of the insertion tube; see Fig. 3). L’Helgoual’ch teaches using a housing for holding an illuminating lamp that supplies light to the light fiber 24 that extends the length of the insertion tube (Paragraph 0094). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify King’s device to include L’Helgoual’ch’s illumination source. Such a modification provides a self-contained unit that does not need a light supply cable.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2014/0275763) and Siegmund (US 4,919,112), as applied to claim 1 above, and further in view of Yarush et al. (US 6,692,432).
King and Siegmund disclose the invention substantially as claimed as stated above.
Regarding Claim 11, they do not explicitly disclose a focusing unit for enabling focusing the image by means of controlling the distance between the proximal end of the optical guide and the receiver, the focusing unit comprising: a springy element for applying a continuous force to push an optical element towards a rear end of the reusable unit, and an adjustment knob for moving a threaded housing in which the optical element is placed. Yarush teaches using a spring (642) to press a light source against a fiber bunder for retaining the source. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify King’s device to include Yarush’s spring. Such a modification helps retain the light source against the fiber bundle for consistent light application.
Yarush also teaches using a focus wheel (knob) that engages threads of lens train to control the focus the lens train (see Col 7 Lines 64-67). The Examiner also notes that using knobs and threaded elements to control focus is standard in the art. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify King’s device to include Yarush’s knob and threads. Such a modification provides the user with a means to control easily the focus of the device by moving the lens as is known in the art.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2014/0275763) and Siegmund (US 4,919,112), as applied to claim 1 above, and further in view of Adair (US 5,402,768).
King and Siegmund disclose the invention substantially as claimed as stated above.
Regarding Claim 13, they do not explicitly disclose an extendable sterilization protecting flexible sleeve configured to be rolled off an aft end of the disposable unit and enclose a cable leading from the reusable unit to a control unit. Adair teaches one such sleeve (156) for extending over a proximal cable for protection. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify King’s device to include Adair’s sleeve. Such a modification protects the cable from contamination as is known in the art.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2014/0275763) and Siegmund (US 4,919,112), as applied to claim 1 above, and further in view of Pacey et al. (US 2010/0261967).
King and Siegmund disclose the invention substantially as claimed as stated above.
Regarding Claim 14, they do not explicitly disclose wherein when the reusable unit is situated inside the housing, wherein the opening of the housing is sealingly covered by a rear cover of the reusable unit. Pacey teaches several embodiments where the reusable unit is inserted into a single use housing with the proximal end of the reusable unit locking into the housing creating a seal with therewith (see Fig. 10, in particular, showing the proximal flange of the reusable unit being secured to the housing creating a seal). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify King’s device to have Pacey’s sealing configuration. Such a modification is an alternative means of securing the reusable unit to the single use housing that is secure and easy to use.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and its dependents 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.
Newly cited reference King addresses Applicant’s amendments, and the Examiner considers King to be concerned with the same issue as Applicant (preventing contamination of a reusable component), and solves the problem in the same way by sealing the reusable component inside a housing. Therefore, the claims are not in condition for allowance at this time.
Conclusion
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795