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 .
Status of Claims
Claims 1-20 are pending, claims 10-12 have been withdrawn from consideration, and claims 1-9 and 13-20 are currently under consideration for patentability under 37 CFR 1.104. Previous drawing objection has been withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 and 13-20 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.
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive (regarding USC 112(f) interpretation of “control unit” in claim 4).
Regarding Applicant’s argument that “the challenged terms, namely…“control unit”, are not nonce terms devoid of structural meaning, but instead refer to well-understood classes of structural components in the medical device and electronics arts….rather recognized structural groupings of components” (pg. 6-7 of Remarks), the Examiner respectfully disagrees. The feature of “control unit” is interpreted under 35 USC 112f, where “unit” is the generic placeholder and “control” is the function. The term “control unit” does not denote structure, specifically an art-recognized structure, as prior art has used the term in various ways (i.e., buttons, actuation/steering mechanism, the grip/handle of an endoscope, a separate processor, etc. | see MPEP 2181, Subsection I, Part C).
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: “a control unit” in claim 4.
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 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 8 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.
Regarding claim 8, the limitation “a central core” is unclear. The term was previously recited in claim 1. It is unclear if a separate or the same central core is being referred to.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-9, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US 2018/0136456), in view of Watanabe (US 2023/0346209, hereinafter referred to as “Watanabe 2023”).
Regarding claim 1, Watanabe discloses an interventional medical device (2, figure 1) comprising: an insertion tube (6, figure 1) extending between a proximal end and a distal end (see the ends of 6, figure 1), the distal end configured to be inserted into internal tissues of a patient during a medical procedure (figure 1), the insertion tube having a dielectric waveguide (41, figure 2 | dielectric material [0078]) extending between the proximal end and the distal end; and a transmitter (23 and 27, figure 2) coupled to the dielectric waveguide at the distal end, the transmitter transmitting a radio frequency signal along the dielectric waveguide from the distal end to the proximal end (transmission…radio waves [0071]). Watanabe further discloses a round dielectric material waveguide may be employed ([0081]). Watanabe is silent regarding the dielectric waveguide including at least one dielectric layer at a central core of dielectric material.
Watanabe 2023 teaches an endoscope system (1, figure 2) with a waveguide (26, figure 2) to propagate millimeter/submillimeter waves from the transmitter circuit (2113, figure 2) to the control device (5, figure 2). The waveguide includes a core made of a rod-shaped dielectric that is extended in a longitudinal direction of the waveguide ([0047]).
It would have been obvious to modify the dielectric waveguide to have a core made of a rod-shaped dielectric as taught by Watanabe 2023 ([0047]). Doing so would provide a constant permittivity in a longitudinal direction of the waveguide ([0047]). The modified device would have the dielectric waveguide including at least one dielectric layer at a central core of dielectric material (core…rod-shaped dielectric [0047]; Watanabe 2023).
Regarding claim 2, Watanabe further discloses a receiver (34, figure 2) coupled to the dielectric waveguide at the proximal end, the receiver receiving the radio frequency signal from the dielectric waveguide (millimeter waves…received by 34 [0102] | millimeter/submillimeter radio waves [0100]).
Regarding claim 4, Watanabe further discloses an imaging module (22 and driver IC 23, figure 2) at the distal end and a control unit (this element is interpreted under 35 USC 112f as a receiver, processor, and integrated circuit | 31, 33, and 34, figure 2; MMIC monolithic microwave integrated circuit [0067]) at the proximal end operably coupled to the imaging module, the transmitter allowing data communication from the imaging module to the control unit via the dielectric waveguide (see 41, figure 2).
Regarding claim 5, Watanabe further discloses the imaging module includes a camera (22, figure 2) and an integrated circuit (23, figure 2) receiving signals from the camera (see arrows, figure 2), the transmitter including a transmit antenna (27, figure 2) coupled to the integrated circuit transmitting the radio frequency signal, the control unit including an integrated circuit (MMIC monolithic microwave integrated circuit [0067]) having a receive antenna (34, figure 2) configured to receive the radio frequency signal from the dielectric waveguide and convert the radio frequency signal to a digital signal (millimeter/submillimeter radio waves [0100]; extracted from the millimeter waves…projected on the display apparatus [0103]-[0104]), the control unit including a data processor processing the digital signal (31, figure 2).
Regarding claim 6, Watanabe further discloses the transmitter includes an integrated circuit (driver IC 23, figure 2) receiving a digital signal (A/D conversion [0099]), the transmitter including an antenna (27, figure 2) coupled to the integrated circuit converting the digital signal to the radio frequency signal (sends…radio waves [0100]).
Regarding claim 7, Watanabe further discloses a sensor (22, figure 2; CMOS [0061]) at the distal end, the transmitter receiving signals from the sensor (see arrows to 23, figure 2) and converting the signals to the radio frequency signal for transmission to the proximal end through the dielectric waveguide (A/D conversion [0099] | sends…radio waves [0100]).
Regarding claim 8, Watanabe and Watanabe 2023 further disclose the dielectric waveguide includes a central core (see 112b Rejection above | see 501, figure 16; Watanabe | core…rod-shaped dielectric [0047]; Watanabe 2023) and a cladding (502-503, figure 16; Watanabe) surrounding the core, the radio frequency signal being transmitted along the central core (radio waves are enclosed in the waveguide tube [0110]).
Regarding claim 9, Watanabe further discloses the insertion tube includes an electrical conductor (power wire 42, ground wire 43…[0068]) extending between the proximal end and the distal end.
Regarding claim 13, Watanabe further discloses the dielectric waveguide is flexible (dielectric material…sufficiently flexible [0226]; see figure 6).
Regarding claim 14, Watanabe further discloses the radio frequency signal is at a frequency of at least 30 GHz (radio waves having a frequency of approximately 30-600 GHz [0071]).
Regarding claim 15, Watanabe further discloses the radio frequency signal is between 30 GHz and 300 GHz (radio waves having a frequency of approximately 30-600 GHz [0071]).
Regarding claim 16, Watanabe discloses an interventional medical device (2, figure 1) comprising: an insertion tube (6, figure 1) extending between a proximal end and a distal end (see the ends of 6, figure 1), the distal end configured to be inserted into internal tissues of a patient during a medical procedure (figure 1), the insertion tube having a dielectric waveguide (41, figure 2 | dielectric material [0078]) extending between the proximal end and the distal end; an imaging module (22 and driver IC 23, figure 2) at the distal end of the insertion tube (see figure 2), the imaging module imaging the internal tissues of the patient during the medical procedure (see figures 1-2), the imaging device generating an image signal (see arrows, figure 2); and a transmitter (23 and 27, figure 2) coupled to the dielectric waveguide at the distal end (see figure 2), the transmitter transmitting a radio frequency signal along the dielectric waveguide from the distal end to the proximal end (millimeter waves…received by 34 [0102] | millimeter/submillimeter radio waves [0100]), the radio frequency signal corresponding to the image signal from the imaging device ([0100]-[0102]).
Watanabe further discloses a round dielectric material waveguide may be employed ([0081]). Watanabe is silent regarding the dielectric waveguide including at least one dielectric layer at a central core of dielectric material; the transmitter transmitting the radio frequency signal along the at least one dielectric layer at the central core of the dielectric waveguide.
Watanabe 2023 teaches an endoscope system (1, figure 2) with a waveguide (26, figure 2) to propagate millimeter/submillimeter waves from the transmitter circuit (2113, figure 2) to the control device (5, figure 2). The waveguide includes a core made of a rod-shaped dielectric that is extended in a longitudinal direction of the waveguide ([0047]).
It would have been obvious to modify the dielectric waveguide to have a core made of a rod-shaped dielectric as taught by Watanabe 2023 ([0047]). Doing so would provide a constant permittivity in a longitudinal direction of the waveguide ([0047]). The modified device would have the dielectric waveguide including at least one dielectric layer at a central core of dielectric material (core…rod-shaped dielectric [0047]; Watanabe 2023); the transmitter transmitting the radio frequency signal along the at least one dielectric layer at the central core (propagated by the waveguide [0037]; core…rod-shaped dielectric [0047]; Watanabe 2023) of the dielectric waveguide (millimeter waves…received by 34 [0102] | millimeter/submillimeter radio waves [0100]; Watanabe).
Regarding claim 17, Watanabe further discloses the imaging module includes a camera (22, figure 2) and an integrated circuit (driver IC 23, figure 2) receiving signals from the camera, the transmitter including a transmit antenna (27, figure 2) coupled to the integrated circuit transmitting the radio frequency signal.
Regarding claim 18, Watanabe discloses an interventional medical device (2, figure 1) comprising: an insertion tube (6, figure 1) extending between a proximal end and a distal end (see the ends of 6, figure 1), the distal end configured to be inserted into internal tissues of a patient during a medical procedure (figure 1), the insertion tube having a dielectric waveguide (41, figure 2 | dielectric material [0078]) extending between the proximal end and the distal end, the insertion tube including a lumen (treatment instrument channel…[0202]) extending between the proximal end and the distal end; a transmitter (23 and 27, figure 2) coupled to the dielectric waveguide at the distal end, the transmitter transmitting a radio frequency signal along the dielectric waveguide from the distal end to the proximal end (transmission…radio waves [0071]); and a tool received in the lumen (insertion of a treatment instrument…[0202]), the tool configured to interact with the patient during the medical procedure (instrument for treatment…[0202]). Watanabe further discloses a round dielectric material waveguide may be employed ([0081]). Watanabe is silent regarding the dielectric waveguide including at least one dielectric layer at a central core of dielectric material; the transmitter transmitting the radio frequency signal along the at least one dielectric layer at the central core of the dielectric waveguide.
Watanabe 2023 teaches an endoscope system (1, figure 2) with a waveguide (26, figure 2) to propagate millimeter/submillimeter waves from the transmitter circuit (2113, figure 2) to the control device (5, figure 2). The waveguide includes a core made of a rod-shaped dielectric that is extended in a longitudinal direction of the waveguide ([0047]).
It would have been obvious to modify the dielectric waveguide to have a core made of a rod-shaped dielectric as taught by Watanabe 2023 ([0047]). Doing so would provide a constant permittivity in a longitudinal direction of the waveguide ([0047]). The modified device would have the dielectric waveguide including at least one dielectric layer at a central core of dielectric material (core…rod-shaped dielectric [0047]; Watanabe 2023); the transmitter transmitting the radio frequency signal along the at least one dielectric layer at the central core (propagated by the waveguide [0037]; core…rod-shaped dielectric [0047]; Watanabe 2023) of the dielectric waveguide (millimeter waves…received by 34 [0102] | millimeter/submillimeter radio waves [0100]; Watanabe).
Regarding claim 19, Watanabe further discloses an imaging module (22 and 23, figure 2) at the distal end and a control unit (31, 33, and 34, figure 2; MMIC monolithic microwave integrated circuit [0067]) at the proximal end operably coupled to the imaging module, the transmitter allowing data communication from the imaging module to the control unit via the dielectric waveguide (see 41, figure 2), the imaging module includes a camera (22, figure 2) and an integrated circuit (driver IC 23, figure 2) receiving signals from the camera, the transmitter including a transmit antenna (27, figure 2) coupled to the integrated circuit transmitting the radio frequency signal (radio waves [0100]), the control unit including an integrated circuit (MMIC monolithic microwave integrated circuit [0067]) having a receive antenna (34, figure 2) configured to receive the radio frequency signal from the dielectric waveguide and convert the radio frequency signal to a digital signal (millimeter/submillimeter radio waves [0100]; extracted from the millimeter waves…projected on the display apparatus [0103]-[0104]), the control unit including a data processor processing the digital signal (31, figure 2).
Claim(s) 3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US 2018/0136456) and Watanabe (US 2023/0346209) as applied to claims 1 and 18 above, and further in view of Vayser (US 2016/0287348).
Regarding claim 3, Watanabe and Watanabe 2023 disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the insertion tube includes a lumen concentric with the dielectric waveguide, a tool being received in the lumen, the tool configured to interact with the patient during the medical procedure.
Vayser teaches a malleable waveguide (12, figure 2) in a medical device (10, figures 1). The waveguide may be slidably disposed over the instrument like a glove disposed over a hand ([0034]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the dielectric waveguide to be slidably disposed over an instrument as taught by Vayser ([0034]). Doing so would provide a lower profile instrument ([0036]). The modified device would have the insertion tube includes a lumen concentric with the dielectric waveguide (slidably disposed over an instrument…[0034]), a tool being received in the lumen (instruments include…[0034]), the tool configured to interact with the patient during the medical procedure (catheters…[0034]).
Regarding claim 20, Watanabe and Watanabe 2023 disclose all of the features in the current invention as shown above in claim 18. They are silent regarding the tool is one of a drug delivery tool, a needle, forceps, a balloon, an irrigation device, or a sensor.
Vayser teaches a malleable waveguide (12, figure 2) in a medical device (10, figures 1). The waveguide may be slidably disposed over the instrument like a glove disposed over a hand ([0034]). Exemplary surgical instruments include but are not limited to catheters, laparoscopies instruments, robotically controlled instruments including catheter shafts and laparoscopic instruments ([0034]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the device to use one of the tools as taught by Vayser ([0034]). Doing so would provide a variety of instruments to be used with the waveguide ([0034]). The modified device would have the tool is one of a drug delivery tool, a needle (laparoscopies instruments…[0034]), forceps, a balloon, an irrigation device, or a sensor (catheters [0034]; may have an imaging sensor).
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 PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 571-270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAMELA F. WU
Examiner
Art Unit 3795
July 23, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Prosecution Insights