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 .
This Office Action is in response to the amendments dated October 21, 2025.
Claims 1-6, 8, and 12-26 are pending.
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, “a scope tube defined in the elongate tube opposite the rotating tube”, as claimed in Claim 15, must be shown or the feature(s) canceled from the claim(s). FIG. 1A shows a scope tube 24 and a telescope 26 (having an elongate tube – see paragraph [0090]. It is unclear in the figures how the scope tube 24 is defined in the telescope 26. Rather, FIG. 1A appears to depicts the telescope 26 disposed within the scope tube 24. 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 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.
Independent Claims 1, 8, and 15, and their respective dependent Claims 2-6, 12-14, and 16-26 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.
More specifically, Claims 1, 8, and 15 claim “the rotating tube is in rotational communication with the scope tube”. Examiner is unable to identify the term “rotational communication” as a term well known to those skilled in the art, and the term is not defined in the present specification. For purposes of examination, Examiner interprets the phrase “the rotating tube is in rotational communication with the scope tube” as one tube/passage rotating within or relative to another tube/passage.
Furthermore, Claim 15 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.
More specifically, Claim 15 claims “a scope tube defined in the elongate tube opposite the rotating tube”. FIG. 1A shows a scope tube 24, a telescope 26 (having an elongate tube – see paragraph [0090], and a rotating tube 20. It is unclear in the figures how the scope tube 24 is defined in the telescope 26. For purposes of examination “a scope tube defined in the elongate tube opposite the rotating tube” is interpreted as “a scope tube defined in the rotating tube”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6, 8, 12-18, 20, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Dejima et al. (US PGPUB 2018/0296073 – “Dejima”) in view of Jorgensen (US PGPUB 2015/0066033 – “Jorgensen”) and Surti et al. (US PGPUB 2013/0131450 – “Surti”).
Regarding Claim 1, Dejima discloses:
An endoscopic device (Dejima FIG. 1, surgery system 10) comprising:
a) a substantially rigid sheath (Dejima FIG. 1, outer sheath 500) comprising a lumen and having a distal sheath end and proximal sheath end (Dejima paragraph [0068], “outer sheath 500 is formed in a tubular shape, and has a distal end opening 500a and a proximal end opening 500b, and an insertion passage (not illustrated) through which the overtube 300 is rotatably inserted”);
b) a rotating tube (Dejima FIG. 1, overtube 300; Dejima paragraph [0006], “the overtube is rotated…to change the protruding position of the treatment tool”) comprising a distal rotating tube end and a proximal rotating tube end (Dejima FIG. 1, showing distal and proximal ends of overtube 300);
c) a scope tube (Dejima FIG. 2, endoscope insertion passage 306), the scope tube comprising a distal scope tube end and a proximal scope tube end (Dejima FIG. 2, distal end and proximal end of endoscope insertion passage 306; and
wherein:
the rotating tube is in rotational communication with the scope tube and is configured for the introduction of a surgical tool (Dejima FIG. 1, treatment tool 200) and/or suction to the distal rotating tube end for colocalization with a telescope (Dejima FIG. 1, endoscope 100; Dejima FIG.12, image pick-up element 118 in distal end of endoscope 100) introduced through the scope tube (Dejima FIG. 1, showing endoscope 100 inserted into scope tube; (Dejima paragraph [0068], “outer sheath 500 is formed in a tubular shape, and has a distal end opening 500a and a proximal end opening 500b, and an insertion passage (not illustrated) through which the overtube 300 is rotatably inserted”).
Dejima does not explicitly disclose d) a flexion cartridge disposed within the rotating tube, and the flexion cartridge is configured to have three degrees of freedom: i) advancement and retraction, ii) rotation, and iii) flexion.
Jorgensen teaches a flexion cartridge disposed within the rotating tube (Jorgensen FIG. 5, flexible distal end segment 414; absent any conflicting definition of a “flexion cartridge” in the present specification, Examiner interprets this term as any flexible tube component), and the flexion cartridge is configured to have three degrees of freedom: i) advancement and retraction, ii) rotation, and iii) flexion (Jorgensen paragraph [0040], “The present invention can articulate in any combination of the following five degrees of freedom, which are described in more detail herein: (i) translation along the axis of the tubular outer body member, resulting from the surgeon inserting or withdrawing the device from the body, (ii) curvilinear bending of a distal portion of the surgical instrument, (iii) rotation about the linear axis of the outer tube resulting from the surgeon rotating his/her wrist and hand, (iv) rotation of the outer cutting window member of the operable tip relative to the outer tube, and (v) rotation of the inner cutting member of the operable tip relative to the outer cutting window member.”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Jorgensen’s flexible distal end with the endoscope disclosed by Dejima. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope capable of having flexible access to a patient body part, such as a joint (see Jorgensen paragraph [0011].
Dejima in view of Jorgensen does not explicitly teach the flexion cartridge comprising a plurality of triangular flexion units configured to articulate the flexion cartridge.
Surti teaches the flexion cartridge comprising a plurality of triangular flexion units (Surti FIG. 2, triangular notches 108 and 110 in overtube 102) configured to articulate the flexion cartridge (Surti FIG. 2, steering wires 114; Surti paragraph [0033], “overtube 102 is equipped with steering means, such as two-way steering wires 114. Steering wires 114 are disposed within the luminal wall of overtube 102 to…provide a means for two-way deflection of overtube 102”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Surti’s triangular slotted vertebrae for Jorgensen’s circular slotted vertebrae in the endoscope taught by Dejima in view of Jorgensen. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a flexible insertion portion having limited bending motion in a particular direction due to the difference in spacing created by the triangular notching.
Regarding Claim 2, Dejima in view of Jorgensen and Surti teaches the features of Claim 1, as described above.
Dejima further discloses wherein the rotating tube is configured to accommodate a laser (Dejima paragraph [0066], “treatment tool 200 …may be…a laser probe”).
Regarding Claim 3, Dejima in view of Jorgensen and Surti teaches the features of Claim 2, as described above.
Dejima further discloses wherein the rotating tube is in rotational communication with the scope tube (Dejima FIG. 1, in which the rotating tube rotates around the scope tube as described Dejima paragraphs [0009] – [0010]).
Regarding Claim 4, Dejima in view of Jorgensen and Surti teaches the features of Claim 2, as described above.
Jorgensen teaches wherein the rotating tube comprises a flexion cartridge (Jorgensen FIG. 5, flexible distal end segment 414; absent any conflicting definition of a “flexion cartridge” in the present specification, Examiner interprets this term as any flexible tube component) disposed therein.
Regarding Claim 5, Dejima in view of Jorgensen and Surti teaches the features of Claim 4, as described above.
Jorgensen further teaches wherein the flexion cartridge comprises a plurality of flexion units (Jorgensen FIG. 6A, vertebrae 422) configured to articulate the cartridge.
Regarding Claim 6, Dejima in view of Jorgensen and Surti teaches the features of Claim 4, as described above.
Dejima further discloses wherein the flexion cartridge is configured to be capable of advancement beyond the distal end of the rotating tube (Dejima FIG. 1, showing the distal end of endoscope insertion part 102 advancing beyond the distal end of overtube 300).
Regarding Claim 8, Dejima discloses:
An endoscopic device (Dejima FIG. 1, surgery system 10) comprising:
a) a substantially rigid sheath (Dejima Fig. 2, overtube 300) comprising a lumen (Dejima FIG. 2, endoscope insertion passage 306) and having a distal sheath end and proximal sheath end (Dejima FIG. 2 showing distal end and proximal end of overtube 300);
b) a rotating tube defined in the lumen (Dejima FIG. 1, overtube 300; Dejima paragraph [0006], “the overtube is rotated…to change the protruding position of the treatment tool”), the rotating tube comprising a distal rotating tube end and a proximal rotating tube end (Dejima FIG. 1, showing distal and proximal ends of overtube 300);
c) a scope tube (Dejima FIG. 2, endoscope insertion passage 306), the scope tube comprising a distal scope tube end and a proximal scope tube end (Dejima FIG. 2, distal end and proximal end of endoscope insertion passage 306);
wherein the rotating tube is in rotational communication with the scope tube (Dejima FIG. 1, in which the rotating tube rotates around the scope tube as described Dejima paragraphs [0009] – [0010]).
Dejima does not explicitly disclose d) a flexion cartridge disposed within the rotating tube; and the flexion cartridge is configured to have three degrees of freedom: i) advancement and retraction, ii) rotation, and iii) flexion.
Jorgensen teaches d) a flexion cartridge disposed within the rotating tube (Jorgensen FIG. 5, flexible distal end segment 414; absent any conflicting definition of a “flexion cartridge” in the present specification, Examiner interprets this term as any flexible tube component); ; and the flexion cartridge is configured to have three degrees of freedom: i) advancement and retraction, ii) rotation, and iii) flexion (Jorgensen paragraph [0040], “The present invention can articulate in any combination of the following five degrees of freedom, which are described in more detail herein: (i) translation along the axis of the tubular outer body member, resulting from the surgeon inserting or withdrawing the device from the body, (ii) curvilinear bending of a distal portion of the surgical instrument, (iii) rotation about the linear axis of the outer tube resulting from the surgeon rotating his/her wrist and hand, (iv) rotation of the outer cutting window member of the operable tip relative to the outer tube, and (v) rotation of the inner cutting member of the operable tip relative to the outer cutting window member.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Jorgensen’s flexible distal end with the endoscope disclosed by Dejima. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope capable of having flexible access to a patient body part, such as a joint (see Jorgensen paragraph [0011].
Dejima in view of Jorgensen does not explicitly teach the flexion cartridge comprising a plurality of triangular flexion units configured to articulate the flexion cartridge.
Surti teaches the flexion cartridge comprising a plurality of triangular flexion units (Surti FIG. 2, triangular notches 108 and 110 in overtube 102) configured to articulate the flexion cartridge (Surti FIG. 2, steering wires 114; Surti paragraph [0033], “overtube 102 is equipped with steering means, such as two-way steering wires 114. Steering wires 114 are disposed within the luminal wall of overtube 102 to…provide a means for two-way deflection of overtube 102”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Surti’s triangular slotted vertebrae for Jorgensen’s circular slotted vertebrae in the endoscope taught by Dejima in view of Jorgensen. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a flexible insertion portion having limited bending motion in a particular direction due to the difference in spacing created by the triangular notching.
Regarding Claim 12, Dejima in view of Jorgensen and Surti teaches the features of Claim 8, as described above.
Jorgensen further teaches wherein the flexion cartridge is in operational communication with at least one actuator button (Jorgensen paragraph [0038], “A second actuation mechanism can comprise a bending control mechanism which comprises a trigger, ring, or one or more actuating buttons on the handle.”).
Regarding Claim 13, Dejima in view of Jorgensen and Surti teaches the features of Claim 8, as described above.
Jorgensen further teaches wherein the flexion cartridge is in operational communication with at least one cable (Jorgensen FIG. 5, flexible distal end segment 414; Jorgensen FIG. 6A, tensioning members 421; Jorgensen paragraph [0111], “bending of flexible distal end segment 414…is achieved by the actuation of two diametrically-opposed tensioning members 421”).
Regarding Claim 14, Dejima in view of Jorgensen and Surti teaches the features of Claim 8, as described above.
Dejima further discloses a locking mechanism (Dejima paragraph [0023], “the movable body has an endoscope locking part to which the endoscope holding part is locked, and a treatment tool locking part to which the treatment tool holding part is locked.”).
Regarding Claim 15, Dejima discloses:
An endoscopic device (Dejima FIG. 1, surgery system 10) comprising:
a) a substantially rigid sheath (Dejima FIG. 1, outer sheath 500) comprising a lumen and having a distal sheath end and proximal sheath end (Dejima paragraph [0068], “outer sheath 500 is formed in a tubular shape, and has a distal end opening 500a and a proximal end opening 500b, and an insertion passage (not illustrated) through which the overtube 300 is rotatably inserted”);
b) a rotating tube (Dejima FIG. 1, overtube 300; Dejima paragraph [0006], “the overtube is rotated…to change the protruding position of the treatment tool”) defined in the lumen, the rotating tube comprising a distal rotating tube end and a proximal rotating tube end (Dejima FIG. 1, showing distal and proximal ends of overtube 300);
c) a scope tube (Dejima FIG. 2, endoscope insertion passage 306) defined in the rotating tube (Dejima FIG. 2, showing endoscope insertion passage 306 within the overtube 300) , the scope tube comprising a distal scope tube end and a proximal scope tube end;
and
e) at least one locking mechanism (Dejima paragraph [0023], “the movable body has an endoscope locking part to which the endoscope holding part is locked, and a treatment tool locking part to which the treatment tool holding part is locked.”); and
wherein: the rotating tube is in rotational communication with the scope tube and is configured for the introduction of a surgical tool (Dejima FIG. 1, treatment tool 200) and/or suction to the distal rotating tube end for colocalization with a telescope (Dejima FIG. 1, endoscope 100; Dejima FIG.12, image pick-up element 118 in distal end of endoscope 100) introduced through the scope tube (Dejima FIG. 1, showing endoscope 100 inserted into scope tube; (Dejima paragraph [0068], “outer sheath 500 is formed in a tubular shape, and has a distal end opening 500a and a proximal end opening 500b, and an insertion passage (not illustrated) through which the overtube 300 is rotatably inserted”).
Dejima does not explicitly disclose d) a flexion cartridge disposed at the rotating tube distal end, the flexion cartridge is configured to have three degrees of freedom: i) advancement and retraction, ii) rotation, and iii) flexion.
Jorgensen teaches a flexion cartridge disposed at the rotating tube distal end (Jorgensen FIG. 5, flexible distal end segment 414; absent any conflicting definition of a “flexion cartridge” in the present specification, Examiner interprets this term as any flexible tube component); the flexion cartridge is configured to have three degrees of freedom: i) advancement and retraction, ii) rotation, and iii) flexion (Jorgensen paragraph [0040], “The present invention can articulate in any combination of the following five degrees of freedom, which are described in more detail herein: (i) translation along the axis of the tubular outer body member, resulting from the surgeon inserting or withdrawing the device from the body, (ii) curvilinear bending of a distal portion of the surgical instrument, (iii) rotation about the linear axis of the outer tube resulting from the surgeon rotating his/her wrist and hand, (iv) rotation of the outer cutting window member of the operable tip relative to the outer tube, and (v) rotation of the inner cutting member of the operable tip relative to the outer cutting window member.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Jorgensen’s flexible distal end with the endoscope disclosed by Dejima. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope capable of having flexible access to a patient body part, such as a joint (see Jorgensen paragraph [0011].
Dejima in view of Jorgensen does not explicitly teach the flexion cartridge comprising a plurality of triangular flexion units configured to articulate the flexion cartridge.
Surti teaches the flexion cartridge comprising a plurality of triangular flexion units (Surti FIG. 2, triangular notches 108 and 110 in overtube 102) configured to articulate the flexion cartridge (Surti FIG. 2, steering wires 114; Surti paragraph [0033], “overtube 102 is equipped with steering means, such as two-way steering wires 114. Steering wires 114 are disposed within the luminal wall of overtube 102 to…provide a means for two-way deflection of overtube 102”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Surti’s triangular slotted vertebrae for Jorgensen’s circular slotted vertebrae in the endoscope taught by Dejima in view of Jorgensen. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of a flexible insertion portion having limited bending motion in a particular direction due to the difference in spacing created by the triangular notching.
Regarding Claim 16, Dejima in view of Jorgensen and Surti teaches the features of Claim 15, as described above.
Dejima further discloses wherein the rotating tube is configured to rotate around the scope tube (Dejima FIG. 1, in which the rotating tube rotates around the scope tube as described Dejima paragraphs [0009] – [0010]).
Regarding Claim 17, Dejima in view of Jorgensen and Surti teaches the features of Claim 15, as described above.
Dejima in view of Jorgensen further teach wherein the flexion cartridge is configured to extend beyond the distal end of the scope tube (Dejima FIG. 1, showing distal end of insertion part 102 extending beyond the distal end of the scope tube; Jorgensen FIG. 5, showing flexible distal end segment 414 at end of tube 406).
Regarding Claim 18, Dejima in view of Jorgensen and Surti teaches the features of Claim 15, as described above.
Dejima in view of Jorgensen further teach wherein the flexion cartridge is configured to extend beyond the distal end of the rotating tube (Dejima FIG. 1, showing distal end of insertion part 102 extending beyond the distal end of the rotating tube; Jorgensen FIG. 5, showing flexible distal end segment 414 at end of tube 406).
Regarding Claim 20, Dejima in view of Jorgensen and Surti teaches the features of Claim 15, as described above.
Dejima in view of Jorgensen and Surti does not explicitly teach wherein the flexion cartridge comprises a fluidic lumen.
Loeb teaches wherein the flexion cartridge comprises a fluidic lumen (Loeb FIG. 1, port 18 in distal end 16 of cannula 15; Loeb paragraph [0088], “a metal cannula with a bend near its distal end, a conventional guiding catheter or a rigid endoscope, whose distal end may be flexible “; Loeb paragraph [0131], “Luer or other fluid connector fitting 20, which is fixedly attached within and extends through the wall of handpiece 14, is in fluid communication with the longitudinal passageway (not separately shown) in handpiece 14, hollow cannula 15 and port 18”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Loeb’s fluid with the endoscope taught by Dejima in view of Jorgensen and Surti. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope that is capable of irrigating and/or cooling target tissue in a patient (see paragraph [0131] of Loeb).
Regarding Claim 24, Dejima in view of Jorgensen and Surti teaches the features of Claim 15, as described above.
Dejima further discloses wherein the rotating tube is configured to house and rotate a tool in a surgical theater (Dejima FIG. 1 showing rotating tube that rotates treatment tool 200; Examiner interprets a “surgical theater” as being an area of interest being treated by a treatment tool/instrument); see also Dejima FIG. 15, showing treatment tool 200 rotating about a field of view of a surgical site in views 700-702).
Regarding Claim 25, Dejima in view of Jorgensen and Surti teaches the features of Claim 25, as described above.
Dejima further discloses wherein the tool is selected from the group consisting of a plasma tool, a coblation tool, a radiofrequency tool (Dejima paragraph [0066], “the treatment tool 200 is not limited to the forceps, and may be, for example…an ultrasonic device”), a monopolar cautery tool, a bipolar cautery tool and a needle.
Claims 19 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Dejima et al. (US PGPUB 2018/0296073 – “Dejima”) in view of Jorgensen (US PGPUB 2015/0066033 – “Jorgensen”), Surti et al. (US PGPUB 2013/0131450 – “Surti”), and Loeb (US PGPUB 2014/0088571 – “Loeb”).
Regarding Claim 19, Dejima in view of Jorgensen and Surti teaches the features of Claim 15, as described above.
Dejima in view of Jorgensen and Surti does not explicitly teach wherein the flexion cartridge comprises a laser lumen.
Loeb teaches wherein the flexion cartridge comprises a laser lumen (Loeb FIG. 1, port 18 in distal end 16 of cannula 15; Loeb paragraph [0088], “a metal cannula with a bend near its distal end, a conventional guiding catheter or a rigid endoscope, whose distal end may be flexible “; Loeb paragraph [0130], “the emission of laser energy occurs through laser energy emission port 18”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Loeb’s laser with the endoscope taught by Dejima in view of Jorgensen and Surti. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope that is capable of laser treatment of target tissue in a patient (see paragraph [0194] of Loeb).
Regarding Claim 26, Dejima in view of Jorgensen and Surti teaches the features of Claim 8, as described above.
Dejima in view of Jorgensen and Surti does not explicitly teach wherein the flexion cartridge comprises a laser lumen.
Loeb teaches wherein the flexion cartridge comprises a laser lumen (Loeb FIG. 1, port 18 in distal end 16 of cannula 15; Loeb paragraph [0088], “a metal cannula with a bend near its distal end, a conventional guiding catheter or a rigid endoscope, whose distal end may be flexible“; Loeb paragraph [0130], “the emission of laser energy occurs through laser energy emission port 18”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Loeb’s laser with the endoscope taught by Dejima in view of Jorgensen and Surti. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope that is capable of laser treatment of target tissue in a patient (see paragraph [0194] of Loeb).
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Dejima et al. (US PGPUB 2018/0296073 – “Dejima”) in view of Jorgensen (US PGPUB 2015/0066033 – “Jorgensen”), Surti et al. (US PGPUB 2013/0131450 – “Surti”), and Hess et al. (US PGPUB 2017/0056068 – “Hess”).
Regarding Claim 21, Dejima in view of Jorgensen and Surti teaches the features of Claim 15, as described above.
Dejima in view of Jorgensen and Surti does not explicitly teach at least one actuation button configured to advance the flexion cartridge distally beyond the distal end of the scope tube.
Hess teaches at least one actuation button (Hess Fig. 1, button 40) configured to advance the flexion cartridge distally beyond the distal end of the scope tube (Hess paragraph [0046], “an inner shaft actuator 40, such as a button or a slider, can be configured to control proximal/distal movement of the inner shaft…relative the outer shaft”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Hess’s longitudinal movement button with the endoscope taught by Dejima in view of Jorgensen and Surti. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope having control over longitudinal movement of instruments or endoscopes towards a target area inside a patient.
Regarding Claim 22, Dejima in view of Jorgensen and Surti and Hess teaches the features of Claim 21, as described above.
Hess further teaches wherein the flexion cartridge is advanced by nudge (Hess paragraph [0046], “an inner shaft actuator 40, such as a button or a slider, can be configured to control proximal/distal movement of the inner shaft…relative the outer shaft”; as the term “nudge” is not defined in the present patent application, Examiner interprets a “nudge” as being any longitudinal movement of a tube).
Regarding Claim 23, Dejima in view of Jorgensen and Surti and Hess teaches the features of Claim 21, as described above.
Hess further teaches wherein the flexion cartridge is advanced by slide (Hess paragraph [0046], “an inner shaft actuator 40, such as a button or a slider, can be configured to control proximal/distal movement of the inner shaft…relative the outer shaft”; as the term “slide” is not defined in the present patent application, Examiner interprets a “slide” as being any longitudinal movement of a tube).
Response to Arguments
Applicant’s arguments, see page 7, filed October 21, 2025, with respect to the objection to Claim 17 have been fully considered and are persuasive. The objection to Claim 17 has been withdrawn.
Applicant’s arguments, see pages 7-8, filed October 21, 2025, with respect to the rejections under 35 U.S.C. 112(b) of Claims 7-26 have been fully considered and are persuasive, particularly in view of the amendments to the claims. The rejections under 35 U.S.C. 112(b) of Claims 7-26 have been withdrawn.
Applicant’s arguments, see page 8, filed October 21, 2025, with respect to the rejections under 35 U.S.C. 102(a)(1) of Claims 1-3 have been fully considered and are persuasive, particularly in view of the amendments to the claims. The rejections under 35 U.S.C. 102(a)(1) of Claims 1-3 have been withdrawn. However, Claims 1-3 are now rejected under 35 U.S.C. 103.
Applicant's arguments, see pages 8-16, filed October 21, 2025, with respect the rejections of Claims 1-6, 8, and 1-26- filed have been fully considered but they are not persuasive.
On pages 11-14, Applicant argues that there is no teaching, suggestion, or motivation (TSM) found in the cited prior art to make a combination thereof. Examiner notes that, post-KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007), the TSM test is no longer mandatory. (See MPEP 2141.(III).) Rather, other rationales to support rejections under 35 U.S.C. 103 include, inter alia, (A) Combining prior art elements according to known methods to yield the predictable result; or (B) Simple substitution of one known element for another to obtain the predictable result. Examiner has presented motivation to combine arguments using these constructs in the rejections of Claims 1, 8, 15, etc. under 35 U.S.C. 103 presented above.
On page 12, Applicant argues that Dejima does not teach or suggest “the rotating tube is in rotational communication with the scope tube”. As discussed above in the 35 U.S.C. 112(b) rejection of Claims 1, 8, and 15, Examiner is unable to identify the term “rotational communication” as a term well known to those skilled in the art, and the term is not defined in the present specification. For purposes of examination, Examiner interprets the phrase “the rotating tube is in rotational communication with the scope tube” as one tube/passage rotating within or relative to another tube/passage (e.g., Dejima overtube 300 and Dejima endoscope insertion passage 306), as cited in the rejections under 35 U.S.C. 103 of Claims 1, 8, and 15 above.
On pages 12-14, Applicant argues that a person skilled in the art would not be motivated to combine Dejima’s rotating tube with Jorgensen’s flexible cartridge. As stated above in the rejections under 35 U.S.C. 103 of Claims 1, 8, and 15, Examiner states that t would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Jorgensen’s flexible distal end with the endoscope disclosed by Dejima. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope capable of having flexible access to a patient body part, such as a joint (see Jorgensen paragraph [0011]. Applicant presents no rebuttal to this argument, which stands.
On page 14, Applicant argues that it would be impermissible to combine Dejima with Jorgensen and/or Surti since Dejima’s rigid overtube would no longer be rigid if Jorgensen’s or Surti’s flexible elements. Examiner respectfully disagrees. Jorgensen’s flexible cartridge and Surti’s flexible cartridge are flexible when they exit Dejima’s rigid outer sheath in the device taught by a combination of Dejima and Jorgensen/Surti.
Finally, Examiner argues on page 15 requires impermissible hindsight when combining Dejima with Jorgensen and/or Surti. Examiner provides a rationale in the rejections under 35 U.S.C. 103 of Claims 1, 8 and 15 above, to which Applicant provides no rebuttal.
As such, the rejections under 35 U.S.C. 103 of Claims 1-6, 8, and 12-26 cited above are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
12/31/2025