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 .
Election/Restrictions
Applicant’s election without traverse of Species B from Group 1, claims 1-20 and Species A from Group 2, claims 17-20 in the reply filed on 03/03/2026 is acknowledged.
Examiner has withdrawn claims 4 and 5 as being drawn to a non-elected species from Group 1.
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.
Claims 1, 6 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.
Claim 1 recites the limitation “a protection sheath externally inserted into the inner sheath” which is confusing and unclear because the applicant’s disclosure discloses the inner sheath as being inserted into the protection sheath and not vice versa, this claim language implies the opposite which makes the claim indefinite.
Claim 6, once again, recites the limitation “the protection sheath is externally inserted into the inner sheath” which has already been established as indefinite; claim 6 further recites “in a state in which rotation of the protection sheath is locked with respect to the inner sheath by engaging the engaged part and the engaging part with each other” it is difficult to interpret the intended structure/ functions invoked by the limitation since the invention as claimed has not disclosed any functions of the protective or inner sheaths relating to rotation up until this point, so discerning the requirements for “a state in which rotation… is locked” is ambiguous and open to interpretation, as this could mean the engaged part and engaging part are simply connected to one another in any way as long as there is no intentional design to purposefully bring about rotation of the parts.
Examiner’s Comments
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Honda et al. (US 20110004060 A1, hereinafter Honda).
Regarding Claim 1, Honda discloses
A medical instrument guide device (medical tube 11, FIG. 1) having an insertion passage (depicted in FIG. 1) for guiding a medical instrument (cholangioscope 1, FIG. 1) into a body (par. 3 disclose medical instrument inserted into a body cavity),
the medical instrument guide device comprising:
a long tube main body (tube main body 13, FIG. 1) to be inserted into the body (par. 3 disclose medical tube inserted into a body cavity); and
a handle part provided on a proximal end side of the tube main body (FIG. 1, 13-14, par. 109 disclose user’s hand side/ proximal end side of tube main body),
wherein the handle part includes an inner sheath (conduit 13a, FIG. 2B, 3B) to which a proximal end part of the tube main body is connected (depicted in FIG. 1) and
a protection sheath (fixing section 12, FIG. 1) externally inserted into the inner sheath (depicted in FIG. 1), and
the inner sheath includes a port part (air lumen 31a, FIG. 34A) for supplying and discharging a fluid to and from the tube main body (par. 151 discloses air lumen extends through tube main body, i.e. via conduit, and communicates with an external device to allow supply and discharge of air, i.e. fluid).
Regarding Claim 2, Honda discloses
The medical instrument guide device according to claim 1, wherein the tube main body includes a hardness change part (hardness changing chamber 31 + hardness changing portion 51, FIG. 36A) that is arranged along a longitudinal direction (major axis Lm, FIG. 3A) of the tube main body and of which hardness is changed due to the fluid supplied and discharged from the port part (par. 154 discloses air, i.e. fluid, is supplied to the hardness changing chamber via the air lumen which causes the rigidity to change).
Regarding Claim 3, Honda discloses
The medical instrument guide device according to claim 1,
wherein a stress relaxation ring (stopper ring 26, FIGS. 13-14) that surrounds an outer periphery of a connection portion (conduit 26a, FIGS. 13-14) between the inner sheath and the tube main body in a loosely fitted state is arranged (par. 92 discloses conduits 25a and 26a communicate with inner conduit 13a between tube main body), and
the inner sheath and the protection sheath are coupled and fixed to the stress relaxation ring (par. 92 discloses conduit 26a sheathed over inner conduit and is part of, i.e. fixed to, the fixing section).
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones et al. (US 20090287049 A1, hereinafter Jones).
Regarding Claim 1, Jones discloses
A medical instrument guide device (access system 10, FIG. 1) having an insertion passage (lumen 25, FIG. 1) for guiding a medical instrument (endoscope 50, FIG. 3) into a body (patient 53, FIG. 3),
the medical instrument guide device comprising:
a long tube main body (structurally modifiable port body 12, FIG. 1) to be inserted into the body (par. 18 discloses port body can be secured to gastric wall inside body); and
a handle part (proximal handle 14, FIG. 1) provided on a proximal end side of the tube main body (depicted in FIG. 1),
wherein the handle part includes an inner sheath (channel 32, FIG. 1) to which a proximal end part of the tube main body is connected (FIG. 1, par. 22 disclose channel can be a separate tubular construct that connects to the port body) and
a protection sheath (gastric wall securing system 16, FIG. 1) externally inserted into the inner sheath (depicted in FIG. 1), and
the inner sheath includes a port part (valved injection ports 26, 28, 34, FIG. 1) for supplying and discharging a fluid to and from the tube main body (par. 19, 22 disclose ports allow for fluid flow through port body).
Regarding Claim 2, Jones discloses
The medical instrument guide device according to claim 1, wherein the tube main body includes a hardness change part (inflatable cuffs 22, 24, FIGS. 1-2) that is arranged along a longitudinal direction of the tube main body and of which hardness is changed due to the fluid supplied and discharged from the port part (FIGS. 1-2, par. 19, 22 disclose cuffs are in fluid communication with ports to alter rigidity of cuffs/ port body).
Claim(s) 1, 6-10, 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelly et al. (US 20200353205 A1, hereinafter Kelly).
Regarding Claim 1, Kelly discloses
A medical instrument guide device (catheter 100, FIG. 17A) having an insertion passage (inner hollow lumen 130, FIG. 1) for guiding a medical instrument into a body (par. 113 discloses medical devices can go through inner lumen; par. 3 discloses catheters entering body of patient),
the medical instrument guide device comprising:
a long tube main body (elongated tubular member 110, FIGS. 1, 17A) to be inserted into the body (par. 3 discloses catheters entering body of patient); and
a handle part (proximal luer 700, FIG. 17A) provided on a proximal end side of the tube main body (depicted in FIG. 17A),
wherein the handle part includes an inner sheath (inflation lumen 200, FIG. 1, 17A) to which a proximal end part of the tube main body is connected (FIG. 17A, par. 102, 109 disclose inflation lumen(s) extending between proximal luer and distal end of tubular member) and
a protection sheath (inner core 140 + tie-layer 240 + tubular jacket 250, FIGS. 2A, 15A) externally inserted into the inner sheath (depicted in FIGS. 1-2A, 15A), and
the inner sheath includes a port part (inflation lumen ports 702, 704, FIG. 17A) for supplying and discharging a fluid to and from the tube main body (par. 111 discloses ports can be used to provide and suction fluid to and from the tubular member).
Regarding Claim 6, Kelly discloses
The medical instrument guide device according to claim 1,
wherein an engaging part (skive or cut-away 212, FIG. 15A) is provided to protrude on an outer peripheral surface of the inner sheath (depicted in FIG. 15A),
the protection sheath includes a slit-shaped engaged part (openings 252, FIG. 15A) open toward a tube main body side (depicted in FIG. 15A), and
the protection sheath is externally inserted into the inner sheath in a state in which rotation of the protection sheath is locked with respect to the inner sheath by engaging the engaged part and the engaging part with each other (FIG. 15A, par. 98-100 disclose inflation lumen and jacket can respectively include openings/ cut-aways to allow for communication and engagement between them and the balloon).
Regarding Claim 7, Kelly discloses
The medical instrument guide device according to claim 6, wherein the port part is provided in the engaging part (FIGS. 15B, 18A, par. 102, 113 disclose skive/ cut-away of inflation lumen extends to ports).
Regarding Claim 8, Kelly discloses
The medical instrument guide device according to claim 7,
wherein the tube main body includes a hardness change part (balloon 210, FIGS. 2A-2B, 17A) that is arranged along a longitudinal direction of the tube main body (FIGS. 2A-2B, 17A) and of which hardness is changed due to the fluid supplied and discharged from the port part (par. 110-113 disclose balloon is inflated or deflated from fluid flushed and suctioned from the ports), and
the port part includes a fluid port (inflation lumen port 702, FIG. 17A) for supplying and discharging the fluid to and from the tube main body (par. 111 discloses inflation lumen ports provide fluid and suction for inflating and deflating balloon, i.e. through elongated tubular member), and
a liquid port (proximal opening 712, FIG. 17A) for supplying a liquid to an inner peripheral surface of the insertion passage (par. 111 discloses ports provide fluid, i.e. liquid, through elongated tubular member; par. 113 discloses proximal opening can accept any device, i.e. fluid/ liquid source same as the other ports, and deliver the device through the inner hollow lumen).
Regarding Claim 9, Kelly discloses
The medical instrument guide device according to claim 8, wherein the fluid port and the liquid port are installed adjacent to each other along an axial direction of the inner sheath (depicted in FIG. 18A).
Regarding Claim 10, Kelly discloses
The medical instrument guide device according to claim 9, wherein the liquid port is arranged on a side opposite to a side of the inner sheath to which the tube main body is connected, with respect to the fluid port (depicted in FIG. 18A).
Regarding Claim 13, Kelly discloses
The medical instrument guide device according to claim 1,
wherein the protection sheath includes a first sleeve part (jacket 250 + inner core 140 + distal tie-layer 240, FIGS. 2A, 15A) arranged on a tube main body side (depicted in FIG. 15A), and
a second sleeve part (proximal tie-layer 240, FIG 6A) arranged on a side opposite to the tube main body side with respect to the first sleeve part and having a larger outer diameter than the first sleeve part (depicted in FIG. 6A).
Regarding Claim 14, Kelly discloses
The medical instrument guide device according to claim 13,
wherein the first sleeve part includes a sleeve body large-diameter part (Section B-B, FIG. 6A) arranged on the tube main body side, and
a sleeve body small-diameter part (Section C-C, FIG. 6A) arranged on a side opposite to the tube main body side with respect to the sleeve body large-diameter part and having a smaller outer diameter than the sleeve body large-diameter part (depicted in FIG. 6A).
Regarding Claim 15, Kelly discloses
The medical instrument guide device according to claim 14, wherein an axial length of the sleeve body small-diameter part is longer than an axial length of the second sleeve part (depicted in FIG. 6A).
Regarding Claim 16, Kelly discloses
The medical instrument guide device according to claim 14, wherein the sleeve body small-diameter part is arranged on a side opposite to the tube main body side with respect to the port part (depicted in FIGS. 2A, 6A, 17A).
Claim(s) 1, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inoue et al. (US 20140024897 A1, hereinafter Inoue).
Regarding Claim 1, Inoue discloses
A medical instrument guide device (insertion assisting tool 60, FIG. 1) having an insertion passage (passage 66, FIGS. 1, 4) for guiding a medical instrument (endoscope 10, FIG. 1) into a body (human body parts 100 + 104 + 106, FIGS. 8-9),
the medical instrument guide device comprising:
a long tube main body (tube main body 64, FIG. 1) to be inserted into the body (depicted in FIGS. 8-9); and
a handle part (grasping part 62, FIG. 1) provided on a proximal end side of the tube main body (depicted in FIG. 1),
wherein the handle part includes an inner sheath (fluid channel 98, FIG. 4) to which a proximal end part of the tube main body is connected (par. 65 discloses fluid channel extends to proximal end side of tube main body) and
a protection sheath (sidewall portion 65, FIG. 4) externally inserted into the inner sheath (FIG. 4, par. 65 disclose fluid channel extend along axial direction in the sidewall portion), and
the inner sheath includes a port part (tube 74, FIG. 1) for supplying and discharging a fluid to and from the tube main body (par. 66 discloses tube supplies and sucks out fluid to/ from the tube main body).
Regarding Claim 17, Inoue discloses
The medical instrument guide device according to claim 1,
wherein the tube main body includes a hardness change part (balloon 96, FIG. 1) that is arranged along a longitudinal direction of the tube main body and of which hardness is changed due to the fluid supplied and discharged from the port part (FIG. 1, par. 66 disclose balloon hardness is changed from fluid supplied and discharged from tube),
the port part includes a fluid port (tube 74, FIG. 1) for supplying and discharging the fluid to and from the tube main body (par. 66 discloses tube supplies and sucks out fluid to/ from the tube main body),
a fluid tube (tube 74, FIG. 1) connected to the fluid port is provided (FIG. 1 depicts a tube extending from balloon controlling device 78 to tube 74, i.e. a fluid tube),
a switching unit (balloon controlling device 78, FIG. 1) is provided in a middle of the fluid tube (depicted in FIG. 1), and
the switching unit includes a switching member capable of switching supply and discharge of the fluid for the fluid port (par. 66 discloses balloon controlling device is capable of switching between supply and suction of fluid).
Claim(s) 1, 17-18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsushita (US 20200245847 A1).
Regarding Claim 1, Matsushita discloses
A medical instrument guide device (overtube 10, FIG. 1) having an insertion passage (insertion passage 71, FIG. 5) for guiding a medical instrument (endoscope device 1, FIG. 1) into a body (lumen 160, FIGS. 6A-6H),
the medical instrument guide device comprising:
a long tube main body (overtube body 70, FIG. 1) to be inserted into the body (depicted in FIGS. 6A-6H); and
a handle part (gripping part 76, FIG. 1) provided on a proximal end side (proximal end 74, FIG. 1) of the tube main body (depicted in FIG. 1),
wherein the handle part includes an inner sheath (air supply and discharge pipe line 80, FIG. 5) to which a proximal end part of the tube main body is connected (depicted in FIG. 5) and
a protection sheath (outer circumferential surface 70A, FIG. 4) externally inserted into the inner sheath (FIG. 5, par. 59-60 disclose outer circumferential surface is external protective layer over pipeline), and
the inner sheath includes a port part (balloon air supply port 84, FIG. 1) for supplying and discharging a fluid to and from the tube main body (par. 66 discloses air supply port supplies and sucks out air, i.e. fluid, to/ from the overtube).
Regarding Claim 17, Matsushita discloses
The medical instrument guide device according to claim 1,
wherein the tube main body includes a hardness change part (balloon 78, FIG. 1) that is arranged along a longitudinal direction of the tube main body and of which hardness is changed due to the fluid supplied and discharged from the port part (FIG. 1, par. 66 disclose balloon hardness is changed from air, i.e. fluid, supplied and discharged from air supply port),
the port part includes a fluid port (balloon air supply port 84, FIG. 1) for supplying and discharging the fluid to and from the tube main body (par. 66 discloses air supply port supplies and sucks out air, i.e. fluid, to/ from the overtube),
a fluid tube (tube 106, FIG. 1) connected to the fluid port is provided (FIG. 1, par. 71 disclose tube is an air, i.e. fluid, tube),
a switching unit (balloon control device 100, FIG. 1) is provided in a middle of the fluid tube (depicted in FIG. 1), and
the switching unit includes a switching member (hand switch 102, FIG. 1) capable of switching supply and discharge of the fluid for the fluid port (par. 71 discloses hand switch provides control signals which switch fluid operation from supply to discharge and vice versa).
Regarding Claim 18, Matsushita discloses
The medical instrument guide device according to claim 17, wherein the switching unit includes a fixing part (tube 104, FIG. 1) attachably and detachably fixable to the medical instrument (FIG. 1, par. 71 disclose balloon control device tube is connected to balloon air supply port of endoscope, i.e. attachably and detachably; par. 54 discloses balloon parts are attachable and detachable).
Regarding Claim 20, Matsushita discloses
The medical instrument guide device according to claim 18, wherein the switching member is arranged on a side opposite to a side of the fluid port with respect to the fixing part (depicted in FIG. 1).
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.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. (US 20200353205 A1, hereinafter Kelly) as applied to claim 10 above, and further in view of Takahashi (US 20210145258 A1).
Regarding Claim 11, Kelly discloses all of the elements of the current invention disclosed in claim 10, however, Kelly does not disclose
a fluid tube connected to the fluid port; and
a liquid tube connected to the liquid port,
wherein a pull-out direction of a proximal end side portion of the fluid tube from the fluid port and a pull-out direction of a proximal end side portion of the liquid tube from the liquid port are the same direction as each other.
Takahashi teaches an analogous medical instrument guide device (overtube 10, FIG. 1) having an endoscope insertion passage (11, FIG. 3) for a medical instrument (endoscope apparatus 1, FIG. 1). The overtube (10) has a gas pipe line (91, FIG. 3, i.e. fluid port) for supplying air (i.e. fluid) and a liquid pipe line (92, FIG. 3, i.e. liquid port) for supplying a liquid such as water [0052-0053]. These pipelines/ ports have respective tubes connected to them, a fluid tube (tube 106, FIG. 1) and a liquid tube (par. 53 discloses a lubricant supply portion such as a syringe, i.e. a liquid tube, is connected to the liquid pipe line).
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the guide device of Kelly with the fluid and liquid tubes of Takahashi in order to provide the fluid and liquid ports with a connection to respective fluid and liquid supply sources [Takahashi – 0053, 0086], which would be beneficial for connecting to the pressurized fluid/ liquid sources of Kelly [Kelly - 0115].
Additionally, upon modifying Kelly to have the fluid tubes in the respective ports (702 & 712), the pull-out directions of a proximal end side portion of each tube will be the same since they will both be facing the proximal direction [Kelly - FIG. 18B].
Regarding Claim 12, Kelly, as previously modified by Takahashi, discloses all of the
elements of the current invention disclosed in claim 15, Takahashi further teaches
wherein the pull-out direction of the proximal end side portion of the fluid tube from the fluid port and the pull-out direction of the proximal end side portion of the liquid tube from the liquid port are directions perpendicular to the axial direction of the inner sheath (first insertion passage 71, FIG. 3 discloses tube-pull out directions of the proximal end side portions of both tubes would be directions perpendicular to the axial direction of the first insertion passage).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsushita (US 20200245847 A1) as applied to claim 18 above, and further in view of Fujikura (US 20050215856 A1).
Regarding Claim 19, Matsushita discloses all of the elements of the current invention disclosed in claim 18, Matsushita further discloses
wherein the medical instrument is an endoscope (endoscope 14, FIG. 1) having an insertion part (insertion part 18, FIG. 1) to be inserted into the body (depicted in FIGS. 6A-6E), and
the fixing part includes a fitting part (balloon air supply port 42, FIG. 1) capable of being fitted into a treatment tool insertion part of the endoscope.
However, Matsushita does not disclose a fitting part capable of being fitted into a treatment tool insertion part of the endoscope.
Fujikura teaches an analogous guide device (insertion aid member 70, FIG. 1) for use with an endoscope (10, FIG. 1) having an insertion portion (12, FIG. 1, i.e. insertion part) to be inserted into a body cavity [FIG. 1, 0023]. The guide (70) has ducts (112a, 112b, 112c, FIGS. 3-4) which carry fluid via connector (110, i.e. fluid port) which connects to an end connector (124, FIG. 4, i.e. fixing part) with a tube (120, i.e. fitting part) which is directly connected to a supply/suction port (44, FIGS. 1, 4, i.e. treatment tool insertion part) of the endoscope [0038-0039, 0045].
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the endoscope of Matsushita with the supply/ suction port of Fujikura in order to allow for direct fluid communication between the guide device and endoscope, allowing for a more interconnected and efficient medical system [Fujikura – FIGS. 1-4, 0034, 0045].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
