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 .
Election/Restrictions
Applicant’s election without traverse of Species 1-A in the reply filed on September 9, 2025, is acknowledged.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 9, 2025.
Claims 14 and 16-20 are also withdrawn as being directed to non-elected species. Claim 14 is directed to a collar shown in Figs. 20-22, Species E. Claims 16-17 are directed to Fig. 35, Species H. Claims 18-20 include a rotary input member and linear output member shown in Figs. 29A-33, Species 2. These species were not elected, so the claims are being withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “illuminating element” in claims 1 and 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 5 is 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. Claim 5 requires “the light intensity of each illuminating element being independently adjustable by a processor using an artificial intelligence program.” At no point does Applicant explain how this program is integrated into the device or how it adjusts the illuminating element. This generic recitation does not establish that Applicant was in possession of such a program. Without some discussion as the artificial intelligence model or what the model even does, the Examiner asserts that a person having ordinary skill in the art would not consider Applicant to be in possession of the claimed invention. For example, the disclosure does not indicate under what conditions the light intensity would be increased or how does the system know which illuminating element should be adjusted. Such a bare assertion can only be made if this feature is so well-known, a person having ordinary skill in the art would need no further instruction. Assuming that is the case, then the Examiner does not see how this could be a patentable distinction over the prior art. In any case, for now, the Examiner does not see a sufficient explanation in the original disclosure to establish Applicant’s possession of the claimed invention.
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 1-3, 8, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. (US 2012/0232345) in view of Konstorum (US 2014/0012075).
Regarding Claim 1, Levy discloses:
An apparatus, comprising:
(a) a shaft assembly (850) including a distal portion having an open distal end (see opening 854 in Fig. 3A) with a first outer diameter sized and configured to fit in a patient (the device is intended to be used in the body), the shaft assembly defining a working channel sized and configured to enable advancement of a working element distally past the distal end of the shaft assembly (854 is a working channel through a tool can be inserted); and
(b) a distal endoscope cap (500) configured to attach to the distal end of the shaft assembly (see Fig. 5A), the distal endoscope cap having a second outer diameter, the second outer diameter being larger than the first outer diameter (see Fig. 5A), the distal endoscope cap including:
(i) a body (502) having at least one coupling member (ring portion of 502 shown in Fig. 5A) for attaching the distal endoscope cap to the distal end of the shaft assembly (see Fig. 5A),
(ii) at least one image sensor (516A) secured to the body for visualizing an anatomical structure, and
(iii) at least one illuminating element (518A) secured to the body for illuminating a field of view of the at least one image sensor.
Levy does not explicitly disclose a rigid proximal portion and a flexible distal portion, wherein the device is sized and configured to fit in an anatomical passageway in an ear, nose, or throat of a patient, and the flexible distal portion being configured to enable lateral deflection of the distal end away from or toward a longitudinal axis defined by the rigid proximal portion.
Konstorum teaches having a rigid proximal portion (26) and a deflectable distal portion (28) that is sized to fit in a sinus (see Title, Abstract, and throughout the disclosure). 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 Levy’s shaft to have Konstorum’s rigidity and flexibility and sizing. Such a configuration is common in the art wherein the rigid proximal portion provides stability during insertion, and the flexible distal portion can be deflected to change the field of view or angle of the tip of the device. Re-sizing the device allows it to fit into a particular anatomical region as is known and standard in the art where a person having ordinary skill in the art would have a reasonable expectation of success because the mere change in size does not change the function of the device.
Regarding Claim 2, Levy as modified further discloses the at least one image sensor including a pair of image sensors (516A/516B).
Regarding Claim 3, Levy as modified further discloses the at least one illuminating element including a pair of illuminating elements (see Figs. 5A showing two illuminators 518A and Fig. 5B showing a pair of illuminators 518).
Regarding Claim 8, Levy as modified further discloses the distal endoscope cap further including a bore extending longitudinally through the body for axial alignment with the working channel of the shaft assembly to enable advancement of the working element from the working channel through the bore (see Fig. 5A showing the bore of the cap aligned with the opening of the working channel such that tools can exit the working channel).
Regarding Claim 11, Levy as modified further discloses the distal endoscope cap being operable to apply energy to tissue (Levy’s cap applies light energy via the illuminators).
Regarding Claim 15, Levy as modified further discloses the distal endoscope cap being removably attached to the distal end of the shaft assembly (the ring shape allows the cap to be removed and the cap is intended to be added to existing endoscopes).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. (US 2012/0232345) and Konstorum (US 2014/0012075), as applied to claim 1 above, and further in view of Ganapati et al. (US 2018/0028047).
Levy and Konstorum disclose the invention substantially as claimed as stated above.
Regarding Claim 4, they do not explicitly disclose each illuminating element of the pair of illuminating elements having a light intensity, the light intensity of each illuminating element being independently adjustable. Ganapati teaches using control logic to independently change the emission intensity of each light emitter (see Paragraph 0018). 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 Levy and Konstorum’s illuminating elements to be independently controlled as taught by Ganapati. Such a modification allows for customization of the lighting profile as desired for the particular application.
Regarding Claim 5, Levy, Konstorum, and Ganapati do not explicitly disclose the light intensity of each illuminating element being independently adjustable by a processor using an artificial intelligence program. Ganapati discloses using control logic as part of a processor (see Paragraph 0018), and the Examiner asserts that using AI is well-known in the art such that optimizing the output of the computer would be obvious. 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 Levy and Ganapati’s system to use artificial intelligence to control the lighting. Such a modification incorporates old and well-known programming techniques to automate and optimize an already existing system.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. (US 2012/0232345) and Konstorum (US 2014/0012075), as applied to claim 1 above, and further in view of Yasui et al. (US 5,725,477).
Levy and Konstorum disclose the invention substantially as claimed as stated above; however, they do not explicitly disclose the distal endoscope cap further including an irrigation lumen configured to direct liquid toward the at least one image sensor. Yasui teaches using a nozzle on the cap to direct fluid toward the image sensor to clean away debris (see Fig. 2, for example, and nozzle 14, with the lumen shown in Fig. 3). 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 Levy’s cap to include Yasui’s irrigation lumen. Such a modification provides a well-known means of clearing debris from the imager as is known in the art.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. (US 2012/0232345) and Konstorum (US 2014/0012075), as applied to claim 1 above, and further in view of Beeckler et al. (US 2020/0107704).
Levy and Konstorum disclose the invention substantially as claimed as stated above; however, they do not explicitly disclose the distal endoscope cap further including at least one navigation sensor secured to the body, the at least one navigation sensor being configured to generate signals indicative of a position of the distal endoscope cap in three-dimensional space. Beeckler teaches placing a sensor in the distal tip of a medical instrument to determine the location and orientation of the tip (see Paragraphs 0042 and 0061). Such sensors are well-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 Levy’s cap to include Beeckler’s navigation sensor. Such a modification provides information related to the instrument’s location and orientation as is known in the art.
Claim 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. (US 2012/0232345) and Konstorum (US 2014/0012075), as applied to claim 1 above, and further in view of Lu et al. (US 2019/0246884).
Levy and Konstorum disclose the invention substantially as claimed as stated above.
Regarding Claim 10, they do not explicitly disclose the at least one image sensor being configured to distally extend and proximally retract relative to the body. Lu teaches an extendable and retractable image sensor as part of a cap (see Fig. 11A and Paragraph 0060) to change the angle of the camera. 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 Levy and Konstorum’s image sensor to include Lu’s sliding feature. Such a modification provides a means for slightly changing the angle of the imager during use without having to deflect the entire tip.
Regarding Claim 12, they do not explicitly disclose the body including a distal end, the at least one image sensor being proximally recessed relative to the distal end. Lu teaches an extendable and retractable image sensor as part of a cap (see Fig. 11A and Paragraph 0060) to change the angle of the camera where the sensor is recessed in the retracted position. 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 Levy and Konstorum’s image sensor to include Lu’s sliding feature. Such a modification provides a means for slightly changing the angle of the imager during use without having to deflect the entire tip.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Levy et al. (US 2012/0232345) and Konstorum (US 2014/0012075), as applied to claim 1 above, and further in view of Bayer et al. (US 2008/0021274).
Levy and Konstorum disclose the invention substantially as claimed as stated above; however, they do not explicitly disclose the at least one coupling member including a pair of laterally-opposed wings configured to frictionally engage the distal end of the shaft assembly for attaching the distal endoscope cap to the distal end of the shaft assembly. Bayer teaches using pairs of wings for attaching a cap to a distal end of an endoscope (see Figs. 7-8, wings 128). The Examiner also notes that tabs and slots are common ways of connecting tubular members. 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 Levy’s coupling member to include Bayer’s wings. Such a modification provides a secure, releasable means for removably attaching the cap to the scope.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795