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Claims 1-11, 13-19, 21-24, 26-33, 35-37, and 39-44 are pending, claims 13, 22-23, 33, 36-37, and 41-44 have been withdrawn from consideration, claims 12, 20, 25, 34, and 38 have been cancelled, and claims 1-11, 14-19, 21, 24, 26-32, 35, and 39-40 are currently under consideration for patentability under 37 CFR 1.104. Previous claim objections and 35 USC 112 Rejections are partially withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-12, 14-21, 24, 26-32, 34-35, and 38-40 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.
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.
Specification
The spacing of the lines of the specification (specifically pg. 43 in the specification filed on 05/05/2022) is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
A substitute specification not including the claims is required pursuant to 37 CFR 1.125(a) because of the line spacing on pg. 43 of the specification.
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
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 “handle and the image processor include wireless connection means to communicate image data from the imaging sensor to the image processor” (in claim 17) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. In claim 16, the image processor is recited to be in the handle. The drawings, as well as Applicant’s arguments (05/22/2025), does not specify wireless connection means between an imaging sensor and the image processor in the handle (as is discussed in pg. 20 of Applicant’s arguments).
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
Claims 1, 14, and 26-27 are objected to because of the following informalities:
In claim 1, on line 15, the limitation “the image correction means” should recite “image correction means”.
In claim 1, on line 22, the limitation “image correction means” should recite “the image correction means”.
In claim 14, on line 18, the limitation “the image correction means” should recite “image correction means”.
In claim 26, on line 17, the limitation “the image correction means” should recite “image correction means”.
In claim 27, on line 2, the limitation “image correction means” should recite “the image correction means”.
Appropriate correction is required.
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 17 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. The limitation “the handle and the image processor include wireless connection means to communicate image data from the imaging sensor to the image processor” is not disclosed in the specification. The specification discloses wireless communication between the PCB and the image processor, however the image processor is not within the handle (see 11, figure 1). Yet, claim 16 recites the handle to include the image processor. In the Remarks on 05/22/2025, PCB is included inside the handle performed preliminary image processing to prepare image data from the sensor for transfer (pg. 20). Again, the specification does not disclose wireless communication means to communicate image data from the imaging sensor to an image processor in the handle.
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 1-11 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 1, the limitation “the camera” (on line 26) is not previously recited. It is not clear if this feature is the same as the previously recited imaging sensor. Claims 2-11 are rejected due to their dependency on claim 1.
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) 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Lord (US 2020/0345218), in view of Kienzle (US 2019/0321077) and Savvouras (US 2017/0042573) and Haggerty (US 2017/0078583).
Regarding claim 1, Lord discloses a medical endoscope system (figure 1a) for visualization of a patient's interior tissues or cavity in real time (image sensors…; abstract), comprising: an endoscope device (100, figure 1a), a handle (112 and 114, figure 2a), an imaging sensor (image sensor [0021]) being connected to the handle for transmission of digital image data to a connected image processor remote from the endoscope device (processor…[0082] | computer [0083] and [0085]), the image processor including image correction means (this element is interpreted under 35 USC 112f as part of an image processor | rotation orientation…”right” the image [0074]) for maintaining an upright consistent image orientation of video images when displayed despite rotation ([0074]), and a video monitor (video display screen [0074]) connected to the image processor to display video images of the patient's tissue or cavity from the camera in real time. Lord is silent regarding having a needle with a distal end for insertion into tissue and a proximal end with the handle; the distal end having the imaging sensor and imaging optic for producing digital video images, the needle being rotatable along a longitudinal axis with respect to a base part of the handle, a rotation transducer operable between the handle and the needle, the transducer comprising a potentiometer monitoring rotational position of the needle relative to the handle and producing a signal sent to the image correction means, a fluid delivery cannula fitted over the needle, with a luer port connected to the cannula for receiving a fluid and delivering the fluid through the cannula to exit the cannula essentially at the distal end of the needle, the luer port being rotatable about a longitudinal axis independently of the cannula and the needle, maintaining an upright consistent image orientation of video images when displayed despite rotation of the needle, the video images being corrected for rotational orientation and displaying consistent image orientation during use of the endoscope device with rotation of the needle.
Kienzle teaches a tissue visualization device (1100, figure 2a) with an elongated body (1102, figure 2a) and a handpiece (1104, figure 2a). The elongated body has an outer tubular body (1126, figure 3a) that may be a needle with a sharpened tip ([0122]). The elongated body is able to be independently rotated about its longitudinal axis ([0097]).
Savvouras teaches a visualization stylet (7, figure 2) with a videoscope (8, figure 2). The visualizations stylet can be moved through a veress needle (12, figure 2). The veress needle is connected to a rotating male luer lock (41, figure 2) of a Y-connector (20, figure 2) to provide gas input (figure 2).
Haggerty teaches an endoscope (10, figure 3a) with a handle (12, figure 3a). The handle can have separate parts that are coupled together through any suitable means, such as snap-fit ([0105]). Haggerty further teaches a rotation sensing assembly (150, figure 8) with an attached potentiometer (122, figure 8), where the electrical resistance of the potentiometer will vary proportionately based on the amount of rotation of a sensor gear shaft (120, figure 8; [0136]). A controller receives the electrical resistance values from the potentiometers to compute the degree of rotation of the sensor shaft with a desired accuracy through 360 degrees of rotation, thus helping to eliminate computation “blind spots” in measuring the rotation of the components at the distal shaft of the endoscope ([0138]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the endoscope system, specifically the shaft (110, figure 2a; Lord) to have an outer tubular body that is a needle (see 1126, figure 3a) with a sharpened tip ([0122]) as taught by Kienzle. Doing so would provide a tip that is sharpened to penetrate a tissue site of interest ([0121]). Additionally, it would have been obvious to modify the system to have a veress needle with a rotating male luer lock and Y-connector (41 and 20, figure 2) as taught by Savvouras. Doing so would provide gas input to the distal end of the endoscope (see figure 2 of Savvouras). Further, it would have been obvious to have a rotation sensing assembly (150, figure 8) as taught by Haggerty to monitor the rotation of the needle. Doing so would provide the degree of rotation of the sensor shaft (and ultimately of components at the distal end of the endoscope) with a desired accuracy through 360 degrees of rotation, thus helping to eliminate computation “blind spots” in measuring the rotation of the components at the distal shaft of the endoscope ([0138]). The modified system would have a needle (1126, figure 3a; Kienzle) with a distal end for insertion into tissue (penetrate a tissue [0121]; Kienzle) and a proximal end with the handle (120, figure 2a; Lord); the distal end having the imaging sensor (the modified distal end would have the image sensor [0021]; Lord) and imaging optic (interpreted as an optic of the camera [0030]; Lord) for producing digital video images, the needle being rotatable along a longitudinal axis with respect to a base part of the handle (rotate…insertion shaft 110…locked to rotate with each other [0022]; Lord), a rotation transducer (potentiometer(s) 122, figure 8; Haggerty) operable between the handle and the needle (degree of rotation…components at the distal end of the endoscope [0138]; Haggerty), the transducer comprising a potentiometer monitoring rotational position of the needle relative to the handle and producing a signal sent to the image correction means (potentiometers…determine the amount of rotation…[0136]; Haggerty | compute a rotational orientation…[0074]; Lord), a fluid delivery cannula (12, figure 2; Savvouras) fitted over the needle, with a luer port (43, figure 2; Savvouras) connected to the cannula for receiving a fluid and delivering the fluid through the cannula to exit the cannula essentially at the distal end of the needle (gas input, figure 2; Savvouras), the luer port being rotatable about a longitudinal axis independently of the cannula and the needle (rotating…female luer lock sideport [0081]; Savvouras), maintaining an upright consistent image orientation of video images when displayed despite rotation of the needle ([0074]; Lord | 1126, figure 3a; Kienzle), the video images being corrected for rotational orientation and displaying consistent image orientation during use of the endoscope device with rotation of the needle (rotational orientation…“right” the image [0074]; Lord).
Regarding claim 2, Lord further discloses the imaging sensor and imaging optic are angled at an acute angle from the longitudinal axis so as to produce side view video images when the needle is rotated (see figure 3b; Lord). When the needle is rotated, the imaging sensor and imaging optic will also be rotated (rotate…insertion shaft 110…locked to rotate with each other [0022]; Lord).
Regarding claim 3, Lord further discloses the needle forms a part of a disposable component which includes a needle base permanently secured to a proximal end of the needle and releasably connectable to the handle (he modified needle with needle base, see 120, figure 2d of Lord, can be disposable; [0021] in Overview | disposable cap 120 and shaft 110 may be disposable [0025]; Lord).
Regarding claim 4, Lord further discloses the handle includes a distal end piece (112, figure 2d; Lord) which is rotatable (rotation collar 112 [0024]) with respect to a proximal body portion (114, figure 2d) of the handle that forms a part of the base part, with a manually engageable radial projection (surface features…[0022]) on the rotatable piece for rotation of the needle during use of the endoscope system, the disposable component being releasably connectable to the distal end piece of the handle (disposable cap 120 and rotation collar 112 may be separable from each other [0025]).
Regarding claim 5, Lord further discloses the handle comprises a distal end piece (see 112, figure 2d; Lord), a body (114, figure 2d) proximal of the distal end piece and a back cap as a proximal component (proximal handle…components…connections to external sources…[0073]). Lord, Kienzle, Savvouras, and Haggerty are silent regarding the distal end piece being secured in a snap- together connection with the body and the body being secured in a snap-together connection with the back cap, without screws.
Haggerty teaches an endoscope (10, figure 3a) with a handle (12, figure 3a). The handle can have separate parts that are coupled together through any suitable means, such as snap-fit ([0105]).
It would have been obvious to modify the system to use any suitable means, such as a snap-fit, to couple separate parts of a handle together ([0105]) as taught by Haggerty. Doing so would provide an endoscope design whose manufacturing and assembly are cost effective ([0007]). The modified system would have the distal end piece being secured in a snap- together connection ([0105]; Haggerty) with the body and the body being secured in a snap-together connection with the back cap, without screws ([0105]).
Regarding claim 6, Lord further discloses the distal end piece is a rotatable part of the handle (rotation collar 112, figure 1a; [0024]; Lord).
Regarding claim 7, Lord further discloses the imaging sensor is connected to the image processor by wireless connection (image data…processing [0046] | data…computer, a processor…[0083] | processing…wireless…[0085]; Lord).
Regarding claim 8, Lord further discloses the distal end of the needle includes an illumination device comprising a distal end of an optical fiber carrying light from a light source proximal in the endoscope device (optical fiber may carry illumination to the tip [0038]; Lord).
Regarding claim 9, Lord further discloses the light source is an LED positioned in a needle base secured to the needle (LED may be recessed from the tip…somewhere in the shaft [0038]; Lord | interpreted the LED may be in the proximal end of the shaft/needle base).
Regarding claim 11, Lord further discloses the distal end of the needle includes an illumination device comprising one or more LEDs (LED may be placed in the tip [0038]).
Claim(s) 14-19, 21, 26-32, 35, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Lord (US 2020/0345218), in view of Kienzle (US 2019/0321077) and Haggerty (US 2017/0078583).
Regarding claim 14, Lord discloses a medical endoscope system (figure 1a) for visualization of a patient's interior tissues or cavity in real time (image sensors…; abstract), comprising: an endoscope device (100, figure 1a), a handle (112 and 114, figure 1a), an imaging sensor (image sensor [0021]) being connected for transmission of digital image data to a connected image processor (processing board [0028] | processor…[0082] | computer [0083] and [0085]), a fixed element (120, figure 1a), the fixed element being removably attached to the handle (disposable cap 120 and rotation collar 112 may be separable from each other [0025]), and a video monitor (display system [0028]; [0074]) connected to the image processor to display video images of the patient's tissue or cavity from the image sensor in real time (computer, a processor…[0083]). Lord is silent regarding a needle with a distal end for insertion into tissue and a proximal end with the handle, the distal end having the imaging sensor and imaging optic for producing digital video images, the needle being rotatable along a longitudinal axis with respect to the handle, and including a needle base or scope cavity permanently secured to the needle, the needle base being rotatably connected to the fixed element, a rotation transducer operable between the handle and the needle, the transducer comprising a potentiometer monitoring rotational position of the needle relative to the handle and producing a signal sent to the image correction means.
Kienzle teaches a tissue visualization device (1100, figure 2a) with an elongated body (1102, figure 2a) and a handpiece (1104, figure 2a). The elongated body has an outer tubular body (1126, figure 3a) that may be a needle with a sharpened tip ([0122]). The elongated body is able to be independently rotated about its longitudinal axis ([0097]).
Haggerty teaches an endoscope (10, figure 3a) with a handle (12, figure 3a). The handle can have separate parts that are coupled together through any suitable means, such as snap-fit ([0105]). Haggerty further teaches a rotation sensing assembly (150, figure 8) with an attached potentiometer (122, figure 8), where the electrical resistance of the potentiometer will vary proportionately based on the amount of rotation of a sensor gear shaft (120, figure 8; [0136]). A controller receives the electrical resistance values from the potentiometers to compute the degree of rotation of the sensor shaft with a desired accuracy through 360 degrees of rotation, thus helping to eliminate computation “blind spots” in measuring the rotation of the components at the distal shaft of the endoscope ([0138]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the endoscope system, specifically the shaft (110, figure 2a; Lord) to have an outer tubular body that is a needle (see 1126, figure 3a) with a sharpened tip ([0122]) as taught by Kienzle. Doing so would provide a tip that is sharpened to penetrate a tissue site of interest ([0121]). Further, it would have been obvious to have a rotation sensing assembly (150, figure 8) as taught by Haggerty to monitor the rotation of the needle. Doing so would provide the degree of rotation of the sensor shaft (and ultimately of components at the distal end of the endoscope) with a desired accuracy through 360 degrees of rotation, thus helping to eliminate computation “blind spots” in measuring the rotation of the components at the distal shaft of the endoscope ([0138]). The modified system would have a needle (1126, figure 3a; Kienzle) with a distal end for insertion into tissue (penetrate a tissue [0121]; Kienzle) and a proximal end with the handle (120, figure 2a; Lord), the distal end having the imaging sensor (the modified distal end would have the image sensor [0021]; Lord) and imaging optic (interpreted as an optic of the camera [0030]; Lord) for producing digital video images, the needle being rotatable along a longitudinal axis with respect to the handle (rotate…insertion shaft 110…locked to rotate with each other [0022]; Lord), and including a needle base or scope cavity (see 120, figure 2a; Lord) permanently secured to the needle (see 120 and 110, figure 1a), the needle base being rotatably connected to the fixed element (rotate…insertion shaft 110…locked to rotate with each other [0022]; Lord), a rotation transducer (potentiometer(s) 122, figure 8; Haggerty) operable between the handle and the needle (degree of rotation…components at the distal end of the endoscope [0138]; Haggerty), the transducer comprising a potentiometer monitoring rotational position of the needle relative to the handle and producing a signal sent to the image correction means (potentiometers…determine the amount of rotation…[0136]; Haggerty | compute a rotational orientation…[0074]; Lord).
Regarding claim 15, Lord further discloses a radially extending lever (fin 304, figure 1a; Lord) on the needle base or scope cavity, positioned to be manually operated when the handle is held, to rotate the needle base and needle relative to the handle ([0063]).
Regarding claim 16, Lord further discloses the handle includes the image processor (processing board in handle [0028]; Lord).
Regarding claim 17, Lord further discloses the handle and the image processor include wireless connection means (this element is interpreted under 35 USC 112f as wifi | interpreted as wireless transmission; [0085]) to communicate image data from the imaging sensor to the image processor (see 112a rejection above | image data…processing [0046] | data…computer, a processor…[0083] | processing…wireless...[0085]; Lord). Lord and Kienzle and Haggerty are silent regarding the handle including a battery for supplying power to the fixed element, the needle base and the needle.
Kienzle further teaches a wireless communication link between the probe and the monitor ([0078]). A battery can be used to power the probe, specifically the wireless communication ([0079]).
It would have been obvious to modify the system of Lord and Kienzle to also have a battery as taught by Kienzle ([0079]). Doing so would allow the endoscope device to be wireless ([0078]-[0079]).
Regarding claim 18, Lord further discloses the needle base or the fixed element includes electronics to receive the digital image data (processing board in handle [0028]; Lord), with a wireless transmitter to send the data wirelessly to the image processor (processing…wireless...[0085]; Lord). Lord and Kienzle and Haggerty are silent regarding the handle includes a battery supplying power to the needle and electronics when the fixed element is attached to the handle.
Kienzle further teaches a wireless communication link between the probe and the monitor ([0078]). A battery can be used to power the probe, specifically the wireless communication ([0079]).
It would have been obvious to modify the system of Lord and Kienzle to also have a battery as taught by Kienzle ([0079]). Doing so would allow the endoscope device to be wireless ([0078]-[0079]).
Regarding claim 19, Lord further discloses the image processor includes image correction means (this element is interpreted under 35 USC 112f as part of an image processor | rotational orientation… “right” the image [0074]) for maintaining an upright consistent image orientation of video images when displayed despite rotation of the needle.
Regarding claim 21, Lord further discloses an LED residing in the handle and optical fibers in the needle (LED may be in the handle…fiber optics [0038]; Lord), the LED optically communicating with the optical fibers of the needle when the fixed element is connected to the handle (optical coupler [0038]).
Regarding claim 26, Lord discloses a medical endoscope system (figure 1a; Lord) for visualization of a patient's interior tissues or cavity in real time (image sensors…; abstract), comprising: an endoscope device (100, figure 1a), a handle (112 and 114, figure 2a), a chip-on-tip imaging sensor (image sensor at tip [0021]) and imaging optic (interpreted as an optic of the image sensor/camera [0030]) for producing digital video images, the imaging sensor being connected for transmission of digital image data to an image processor remote from the endoscope device (image data…processing [0046] | data…computer, a processor…[0083] | processing…wireless...[0085]; Lord), the handle including a rotatable distal end (rotation collar 112 [0024]), rotatably connected to a base part (114, figure 2d) of the handle and having a finger-engaging element (surface features…[0024]) for rotating the handle relative to the base part of the handle using a finger or thumb (fingers…[0063]), the handle being configured to be held and manipulated with a single hand with the base part contacted by a palm or thumb and one or two fingers or a thumb on the finger-engaging element (low-slip grip for a surgeon’s hand [0025]), the base part having a diameter no greater than about 6 cm (shaft 110…10mm or 1 cm; [0034] | the diameter of the shaft is approximately 1/4th the diameter of base part 114, see figures 2; the diameter of the base part is about 4 cm) and the finger-engaging element being about 2 to 10 cm distal of a proximal end of the base part of the handle (the length of 114 is about estimated to be about 2.5 times its diameter, which is about 10 cm | based on figure 2a), and a video monitor (video display screen [0074]) connected to the image processor to display video images of the patient's tissue or cavity from the imaging sensor in real time (computer, a processor…[0083]), the video images being corrected for rotational orientation and displaying consistent image orientation during use of the endoscope device with rotation of the needle (rotational orientation…“right” the image [0074]). Lord is silent regarding a needle with a distal end for insertion into tissue and a proximal end with the handle, the distal end having the chip-on-tip imaging sensor and imaging optic for producing digital video images, the rotatable distal end connected to the needle, a rotation transducer operable between the rotatable distal end of the handle and the base part of the handle, the transducer comprising a potentiometer monitoring rotational position of the needle relative to the handle and producing a signal sent to the image correction means.
Kienzle teaches a tissue visualization device (1100, figure 2a) with an elongated body (1102, figure 2a) and a handpiece (1104, figure 2a). The elongated body has an outer tubular body (1126, figure 3a) that may be a needle with a sharpened tip ([0122]). The elongated body is able to be independently rotated about its longitudinal axis ([0097]).
Haggerty teaches an endoscope (10, figure 3a) with a handle (12, figure 3a). The handle can have separate parts that are coupled together through any suitable means, such as snap-fit ([0105]). Haggerty further teaches a rotation sensing assembly (150, figure 8) with an attached potentiometer (122, figure 8), where the electrical resistance of the potentiometer will vary proportionately based on the amount of rotation of a sensor gear shaft (120, figure 8; [0136]). A controller receives the electrical resistance values from the potentiometers to compute the degree of rotation of the sensor shaft with a desired accuracy through 360 degrees of rotation, thus helping to eliminate computation “blind spots” in measuring the rotation of the components at the distal shaft of the endoscope ([0138]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the endoscope system, specifically the shaft (110, figure 2a; Lord) to have an outer tubular body that is a needle (see 1126, figure 3a) with a sharpened tip ([0122]) as taught by Kienzle. Doing so would provide a tip that is sharpened to penetrate a tissue site of interest ([0121]). Further, it would have been obvious to have a rotation sensing assembly (150, figure 8) as taught by Haggerty to monitor the rotation of the needle. Doing so would provide the degree of rotation of the sensor shaft (and ultimately of components at the distal end of the endoscope) with a desired accuracy through 360 degrees of rotation, thus helping to eliminate computation “blind spots” in measuring the rotation of the components at the distal shaft of the endoscope ([0138]). The modified system would have a needle (see 1126, figure 3a; Kienzle) with a distal end for insertion into tissue (penetrate a tissue site [0121]) and a proximal end (120, figure 2a; Lord) with the handle, the distal end having the chip-on-tip imaging sensor (the modified distal end would have the image sensor [0021]; Lord) and imaging optic (interpreted as an optic of the camera [0030]; Lord) for producing digital video images, the rotatable distal end connected to the needle (rotate…insertion shaft 110…locked to rotate with each other [0022]; Lord), a rotation transducer (potentiometer(s) 122, figure 8; Haggerty) operable between the rotatable distal end of the handle and the base part of the handle (see figure 8; degree of rotation…components at the distal end of the endoscope [0138]; Haggerty), the transducer comprising a potentiometer monitoring rotational position of the needle relative to the handle and producing a signal sent to the image correction means (potentiometers…determine the amount of rotation…[0136]; Haggerty | compute a rotational orientation…[0074]; Lord).
Regarding claim 27, Lord further discloses the image processor includes image correction means (this element is interpreted under 35 USC 112f as part of an image processor | rotational orientation… “right” the image [0074]) for maintaining an upright consistent image orientation of video images when displayed despite rotation of the needle.
Regarding claim 28, Lord further discloses the imaging sensor and imaging optic are angled at an acute angle (panning the camera [0073]; Lord) from the longitudinal axis so as to produce side view video images when the needle is rotated (see figure 3b; Lord | rotate…insertion shaft 110…locked to rotate with each other [0024]).
Regarding claim 29, Lord further discloses the handle comprises said distal end (see 112, figure 2d; Lord), a main body piece (114, figure 2d) proximal of the distal end and a back cap as a proximal component (proximal handle…components…connections to external sources…[0073]). Lord, Kienzle, and Haggerty are silent regarding the distal end being secured in a snap-together connection with the main body piece and the main body piece being secured in a snap-together connection with the back cap, without screws or other metal fasteners.
Haggerty teaches an endoscope (10, figure 3a) with a handle (12, figure 3a). The handle can have separate parts that are coupled together through any suitable means, such as snap-fit ([0105]).
It would have been obvious to modify the system to use any suitable means, such as a snap-fit, to couple separate parts of a handle together ([0105]) as taught by Haggerty. Doing so would provide an endoscope design whose manufacturing and assembly are cost effective ([0007]). The modified system would have the distal end being secured in a snap-together connection with the main body piece and the main body piece being secured in a snap-together connection with the back cap ([0105]; Haggerty), without screws or other metal fasteners ([0105]).
Regarding claim 30, Lord further discloses the needle forms a part of a disposable component (disposable shaft 110 and 120 [0036]; Lord) which includes a needle base (see 120, figure 1a) permanently secured to a proximal end of the needle and releasably connectable to the base part of the handle (see figure 1b).
Regarding claim 31, Lord further discloses the rotatable distal end of the handle rotates (rotation collar 112 [0024]; Lord) with respect to a proximal body portion (114, figure 1a) of the handle that forms a part of the base part (see 114, figure 1a), with a manually engageable radial projection (302, figure 1a) on the rotatable piece for rotation of the needle during use of the endoscope system, the disposable component being releasably connectable to the distal end of the handle (see figure 1b).
Regarding claim 32, Lord further discloses the radial projection comprises a finger or thumb- engageable fin (fingers…[0063]; Lord).
Regarding claim 35, Lord further discloses the distal end of the needle includes an illumination device comprising a tip of an optical fiber carrying light from a light source proximal in the endoscope device (optical fiber may carry illumination to the tip [0038]; Lord).
Regarding claim 39, Lord further discloses the needle and a connected needle base are removable from the handle (see figure 1b; Lord) and disposable (disposable shaft [0021]; in Overview), and wherein the handle is reusable (may be reusable [0021]; in Overview).
Regarding claim 40, Lord further discloses the rotatable distal end includes a needle base (see 120, figure 1a; Lord) or scope cavity permanently secured to the needle, the scope cavity being rotatably connected to a fixed element (112, figure 1a), the fixed element being removably connected non-rotatably to the base part of the handle (joint 128, figure 4c | the examiner interpreted the coupling of the fixed element to the base part of the handle to not be a rotatable couple, like threading).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lord (US 2020/0345218) and Kienzle (US 2019/0321077) and Savvouras (US 2017/0042573) and Haggerty (US 2017/0078583) as applied to claim 9 above, and further in view of Hori (US 5,538,497).
Lord, Kienzle, Savvouras, and Haggerty disclose all of the features in the current invention as shown above in claim 9. They are silent regarding a heat sink in contact with the LED for drawing heat from the LED.
Hori teaches an endoscope (30, figure 2) with a handle (32, figure 2). A light source (43, figure 2) is disposed in the handle area. The handle may be fabricated from a thermally conductive material to act as a heat sink to dissipate thermal energy by the light source (Col. 6, lines 40-45).
It would have been obvious to modify the endoscope device, specifically the area of the endoscope device around the light source, to be made from a thermally conductive material as taught by Hori (Col. 6, lines 40-45). Doing so would dissipate thermal energy by the light source (Col. 6, lines 40-45).
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Lord (US 2020/0345218) and Kienzle (US 2019/0321077) and Haggerty (US 2017/0078583) as applied to claim 14 above, and further in view of Savvouras (US 2017/0042573).
Lord, Kienzle, and Haggerty disclose all of the features in the current invention as shown above in claim 14. They are silent regarding in combination with a fluid delivery cannula fitted over the needle, with a luer port connected to the cannula for receiving a fluid and delivering the fluid through the cannula to exit the cannula essentially at the distal end of the needle, the luer port being rotatable about a longitudinal axis independently of the cannula and the needle.
Savvouras teaches a visualization stylet (7, figure 2) with a videoscope (8, figure 2). The visualizations stylet can be moved through a veress needle (12, figure 2). The veress needle is connected to a rotating male luer lock (41, figure 2) of a Y-connector (20, figure 2) to provide gas input (figure 2).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the endoscope system to have a veress needle with a rotating male luer lock and Y-connector (41 and 20, figure 2) as taught by Savvouras. Doing so would provide gas input to the distal end of the endoscope (see figure 2 of Savvouras). The modified system would have a fluid delivery cannula (12, figure 2; Savvouras) fitted over the needle, with a luer port (43, figure 2; Savvouras) connected to the cannula for receiving a fluid and delivering the fluid through the cannula to exit the cannula essentially at the distal end of the needle (gas input, figure 2; Savvouras), the luer port being rotatable about a longitudinal axis independently of the cannula and the needle (rotating…female luer lock sideport [0081]; Savvouras).
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.
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PAMELA F. WU
Examiner
Art Unit 3795
December 11, 2025
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795