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Claims 1-20 are pending, claims 10-12 have been withdrawn from consideration, and claims 1-9 and 13-20 are currently under consideration for patentability under 37 CFR 1.104.
Election/Restrictions
Applicant's election with traverse of Species 2 and Species I, readable on claims 1-9 and 13-20, in the reply filed on 11/25/2025 is acknowledged. The traversal is on the ground(s) that “Species election must be determined based on the claims and the claimed subject matter…the claims recite related subject matter” (pg. 7 of Remarks) and “the Restriction Requirement fails to establish…because the reasons and/or examples provided to support the conclusions are inadequate…the Restriction Requirement does not provide adequate support for establishing that the species are independent or distinct” (pg. 7-8 of Remarks).
This is not found persuasive because election may be required prior to a search on the merits (A) in applications containing claims to a plurality of species with no generic claims, and (B) in applications containing both species claims and generic or Markush claims (see MPEP 808.01(a)). Election of species should not be required between claimed species that are considered clearly unpatentable (obvious) over each other (see MPEP 808.01(a)). The Species as listed in the Requirement for Restriction filed on 08/27/2025 are not unpatentable (or not obvious) over each other due to the differences in features among the species that are not obvious over each other (i.e., tool in a lumen, concentric dielectric layers, conductors arranged in the waveguide, etc.). Further, these species are mutually exclusive as one claim recites limitations disclosed for a first species but not a second, while a second claim recites limitations disclosed only for the second species and not the first (see MPEP 806.04(f)).
Regarding Applicant’s argument that “The Restriction Requirement merely provides the conclusory statement in support of the perceived search burden…does not provide adequate support for establishing a serious burden on the examiner under the second prong of the analysis, so the Restriction Requirement is improper” (pg. 8-9 in Remarks), the Examiner respectfully disagrees. In order to demonstrate a serious search burden, the examiner must show by appropriate explanation one of the following: (A) separate classification thereof, (B) a separate status in the art when they are classifiable together, (C) a different field of search (see MPEP 808.02). As recited in the Requirement for Restriction filed on 11/25/2025, the species require a different field of search due to the different features among them (see pg. 3). Different search queries and CPC classifications (i.e., text search focusing on instruments, conductors, etc.) may be used to search for these different features for the species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-12 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species 1 and 3-4 and Species II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/25/2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “an imaging module at the proximal end of the insertion tube” (in claim 16) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Objections
Claim 3 is objected to because of the following informalities: change “a medical procedure” to “the medical procedure” (i.e., previously recited in claim 1). Appropriate correction is required.
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: “an imaging module” and “a control unit” in claim 4; “an imaging module” in claim 16; “a control unit” in claim 19.
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.
Claims 16-17 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. In claim 16, the limitation “an imaging module at the proximal end of the insertion tube” is not disclosed in the specification. Although the specification recites an imaging module at the proximal end ([0006]), the paragraph also recites “a transmitter coupled to the dielectric waveguide at the distal end…correspond to the image signal from the imaging device”. Throughout the specification, the imaging module is disclosed to be provided at the distal end ([0025]). Therefore, the subject matter of claim 16 fails to comply with the written description requirement. Claim 17 is rejected due to its dependency on claim 16.
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.
Claims 16-17 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.
Regarding claim 16, the limitation “an imaging module at the proximal end of the insertion tube” is unclear when considering the limitation “a transmitter coupled to the dielectric waveguide at the distal end…corresponding to the image signal from the imaging device”. It is unclear where the imaging module is located in the device. Claim 17 is rejected due to its dependency on claim 16.
Regarding claim 16, the limitation “the imaging device” on lines 6 and 10-11 lack antecedent basis. This feature has not been previously recited, and it is unclear if this feature is the same feature as the imaging module.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 4-9, and 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watanabe (US 2018/0136456).
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/or 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]).
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 (this element is interpreted under 35 USC 112f as a camera and integrated circuit | 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 further discloses the dielectric waveguide includes a central core (see 501, figure 16) and a cladding (502-503, figure 16) 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 (this element is interpreted under 35 USC 112f as a camera and integrated circuit | 22 and driver IC 23, figure 2) at the proximal end of the insertion tube (see 112a and b rejection above | for examination purposes, interpreted the imaging module as being at the distal end; 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/or 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 (see 112a and b rejection above | for examination purposes, interpreted the imaging module as being at the distal end; [0100]-[0102]).
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/or 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]).
Regarding claim 19, Watanabe further discloses an imaging module (22 and 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), 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 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) 3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (US 2018/0136456) as applied to claims 1 and 18 above, and further in view of Vayser (US 2016/0287348).
Regarding claim 3, Watanabe discloses all of the features in the current invention as shown above in claim 1. Watanabe is 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 a 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 a medical procedure (catheters…[0034]).
Regarding claim 20, Watanabe discloses all of the features in the current invention as shown above in claim 18. Watanabe is 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Deyanov (US 2022/0104692) and Rezaie (US 2020/0015792).
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
January 8, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795