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
In the present application, claims 1-20 are currently pending. Claims 3-9 and 13-17 are currently amended. Claims 18-20 are newly added.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Claim 1 and 2 line 5 lacks punctuation. It is suggested to a colon ‘:’ after the word “having.”
Claim 2 states the limitation “…an output configuration to correspond an opening….” The limitation should be amended to state, “…an output configuration to correspond with an opening….”
Appropriate correction is required.
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, 2, 3, 8, 16, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the air/water or suction valve ports" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the air/water and suction valve cylinder ports.” Examiner will be interpreting the limitation as such. Appropriate correction is required.
Claim 1 recites the limitation "the air/water or suction valve cylinder ports" in lines 6-7, and 8-9. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the air/water and suction valve cylinder ports.” Examiner will be interpreting the limitation as such. Appropriate correction is required.
Claim 2 recites the limitation "the air/water or suction valve ports" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the air/water and suction valve cylinder ports.” Examiner will be interpreting the limitation as such. Appropriate correction is required.
Claim 2 recites the limitation "the air/water or suction valve cylinder ports" in lines 6-7, and 8-9. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the limitation to state, “the air/water and suction valve cylinder ports.” Examiner will be interpreting the limitation as such. Appropriate correction is required.
Claim 3 recites the limitation "the guide channel" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the claim to amend from claim 2 or amend the limitation to state, “a guide channel.” Appropriate correction is required.
Claim 8 recites the limitation "the guide channel" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the claim to amend from claim 2 or amend the limitation to state, “a guide channel.” Appropriate correction is required.
Claim 16 recites the limitation "the guide channel" twice in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the claim to depend from claim 2 or amend the first limitation in line 2 of claim 16 to state, “a guide channel.” Appropriate correction is required.
Claim 17 recites the limitation "the guide channel" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend the claim to amend from claim 2 or amend the limitation to state, “a guide channel.” Appropriate correction is required.
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.
(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.
Claims 1-5, 7, 9-11, 14-15, and 18-19 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Suriano et al. (US2020/0178783) hereinafter Suriano.
Regarding Claim 1, Suriano discloses a positioning aid (Fig. 1 apparatus 100) attachable to a handle of an endoscope control handle (Fig. 2 near valve ports 220, 22) having air/water and suction valve cylinder ports (Fig. 2 valve ports 220, 22) having at least one channel (Figs. 2-3 cavities 220a, 222a) and operable to guide a tool ([0027-0029]) into at least one channel (Figs. 2-3 cavities 220a, 222a) of the air/water or suction valve ports (Fig. 2 valve ports 220, 22) the positioning aid comprising:
a body (Fig. 3 body 102) for coupling to the endoscope control handle (Fig. 2 near valve ports 220, 22), the body (Fig. 3 body 102) including at least one guide port (Fig. 1a first guide port 108, second guide port 110, conduit 112,guide 106) having
an input port (Fig. 1a first guide port 108) for receiving an instrument to be inserted into the at least one channel in the air/water or suction valve cylinder ports ([0031] “The first guide port 108 can receive the cleaning implement while the body 102 can be received by the valve port of the medical device to be cleaned.”),
an output port (Fig. 1a second guide port 110) configured to correspond with an opening to the at least one channel in the air/water or suction valve cylinder ports ([0031] “The conduit 112 may extend through the body 102 from the first guide port 108 to a second guide port 110. The second guide port 110 may be disposed at a second position 104 b on the surface 104 of the body 102 that can be different from the first position 104 a. The second position 104 b can be configured to align the second guide port 110 with a lumen of the medical device. The second guide port 110 can be configured to receive the cleaning implement. The position, orientation, and shape of the second guide port 110 can be configured to enable movement of the cleaning implement into and through the second guide port 110 and into a lumen of a medical device. For example, the second guide port 110 can be suitable to align with a lumen of a medical device.”) , and
a guide pathway (Fig. 1a conduit 112) coupled between the input port (Fig. 1a first guide port 108) and the output port (Fig. 1a second guide port 110), wherein a transition of the guide pathway (Fig. 1a conduit 112) between the input port (Fig. 1a first guide port 108) and the output port (Fig. 1a second guide port 110) exhibits curvature (Fig. 1a) in more than one plane (Fig. 1a).
Regarding Claim 2, Suriano discloses a positioning aid (Fig. 1 apparatus 100) attachable to a handle of an endoscope control handle (Fig. 2 near valve ports 220, 22) having air/water and suction valve cylinder ports (Fig. 2 valve ports 220, 22) having at least one channel (Figs. 2-3 cavities 220a, 222a) and operable to guide a tool ([0027-0029]) into at least one channel (Figs. 2-3 cavities 220a, 222a) of the air/water or suction valve ports (Fig. 2 valve ports 220, 22) the positioning aid comprising:
a body (Fig. 3 body 102) for coupling to the endoscope control handle (Fig. 2 near valve ports 220, 22), the body (Fig. 3 body 102) including at least one guide port (Fig. 1a first guide port 108, second guide port 110, conduit 112,guide 106) having
an input port (Fig. 1a first guide port 108) for receiving an instrument to be inserted into the at least one channel in the air/water or suction valve cylinder ports ([0031] “The first guide port 108 can receive the cleaning implement while the body 102 can be received by the valve port of the medical device to be cleaned.”),
an output port (Fig. 1a second guide port 110) configured to correspond with an opening to the at least one channel in the air/water or suction valve cylinder ports ([0031] “The conduit 112 may extend through the body 102 from the first guide port 108 to a second guide port 110. The second guide port 110 may be disposed at a second position 104 b on the surface 104 of the body 102 that can be different from the first position 104 a. The second position 104 b can be configured to align the second guide port 110 with a lumen of the medical device. The second guide port 110 can be configured to receive the cleaning implement. The position, orientation, and shape of the second guide port 110 can be configured to enable movement of the cleaning implement into and through the second guide port 110 and into a lumen of a medical device. For example, the second guide port 110 can be suitable to align with a lumen of a medical device.”) , and
a guide channel (Fig. 1a conduit 112) coupled between the input port (Fig. 1a first guide port 108) and the output port (Fig. 1a second guide port 110), wherein at least one of an angle of incidence (see annotated Fig. 1a) of the guide channel (Fig. 1a conduit 112) at the interface with the input port (Fig. 1a first guide port 108) or an angle of incidence of the guide channel at the interface with the output port is less than 20 degrees (see annotated Fig. 1a).
PNG
media_image1.png
802
720
media_image1.png
Greyscale
Regarding Claim 3, Suriano discloses the positioning aid according to claim 1,wherein an angle between a channel opening (Figs. 2-3 near cavities 220a, 222a, see annotated Fig. 4) of a valve cylinder port (Fig. 2 valve ports 220, 22) and a straight portion of a segment (see annotated Fig. 1a) of the guide channel (Fig. 1a conduit 112) corresponding to the channel opening (Figs. 2-3 near cavities 220a, 222a, see annotated Fig. 4) as the straight portion of the segment (see annotated Fig. 1a) approaches the channel opening (Figs. 2-3 near cavities 220a, 222a, see annotated Fig. 4) is between 0 degrees and 30 degrees (see Fig. 4).
PNG
media_image2.png
620
1230
media_image2.png
Greyscale
Regarding Claim 4, Suriano discloses the positioning aid according to claim 1,wherein a bend radius of a curved section (Fig. 1a section 112a) that joins a first straight portion of a first guide channel segment (see annotated Fig. 1a) of the guide channel (Fig. 1a conduit 112) and a second straight portion of a second guide channel segment (see annotated Fig. 1a) of the guide channel (Fig. 1a conduit 112) and is greater than 0.1 inches (see Fig. 1a).
PNG
media_image3.png
802
720
media_image3.png
Greyscale
Regarding Claim 5, Suriano discloses the positioning aid according to claim 4, wherein an angle (Fig. 1a angle of section 112a) between the first and second straight portions (see annotated Fig. 1a) at a connection point (Fig. 1a section 112a) at respective ends of the curved section (Fig. 1a angle of section 112a) is greater than 100 degrees (see Fig. 1a).
PNG
media_image3.png
802
720
media_image3.png
Greyscale
Regarding Claim 7, Suriano discloses the positioning aid according to claim 1,wherein the at least one guide port Fig. 1a first guide port 108, second guide port 110, conduit 112,guide 106) is formed entirely (Fig. 1a second guide port 110) within the body (Fig. 3 body 102).
Regarding Claim 9, Suriano discloses the positioning aid according to claim 1,wherein the input port (Fig. 1a first guide port 108) comprises flexible tubing (Fig. 6 tubing of cleaning implement 630) extending out from the body (Fig. 3 body 102).
Regarding Claim 10, Suriano discloses the positioning aid according to claim 9, wherein a terminus of the flexible tubing (Fig. 6 tubing of cleaning implement 630) is fixed to a sidewall of the body (Fig. 3 body 102) at the output port (Fig. 1a second guide port 110).
Regarding Claim 11, Suriano discloses the positioning aid according to claim 10, further comprising a coupler ([0038] “Each guide port may be equipped with a fitting. Thus, the cleaning implements can be quickly aligned with the guide on each guide port utilizing the tubing.”) connecting the flexible tubing (Fig. 6 tubing of cleaning implement 630) to the output port (Fig. 1a second guide port 110).
Regarding Claim 14, Suriano discloses the positioning aid according to claim 1, wherein the body (Fig. 3 body 102) comprises a keyway (Fig. 5B alignment member 116) that cooperates with the handle (Fig. 2 near valve ports 220, 22) to enable attachment of the body (Fig. 3 body 102) in only one orientation with respect to the handle (Fig. 2 near valve ports 220, 22).
Regarding Claim 15, Suriano discloses the positioning aid according to claim 1,wherein the body (Fig. 3 body 102) comprises a stop (Fig. 5B alignment member 116) that limits a depth of insertion of the body (Fig. 3 body 102) into the handle (Fig. 2 near valve ports 220, 22).
Regarding Claim 18, Suriano discloses the positioning aid according to claim 2,wherein an angle between a channel opening (Figs. 2-3 near cavities 220a, 222a, see annotated Fig. 4) of a valve cylinder port (Fig. 2 valve ports 220, 22) and a straight portion of a segment (see annotated Fig. 1a) of the guide channel (Fig. 1a conduit 112) corresponding to the channel opening (Figs. 2-3 near cavities 220a, 222a, see annotated Fig. 4) as the straight portion of the segment (see annotated Fig. 1a) approaches the channel opening (Figs. 2-3 near cavities 220a, 222a, see annotated Fig. 4) is between 0 degrees and 30 degrees (see Fig. 4).
PNG
media_image2.png
620
1230
media_image2.png
Greyscale
Regarding Claim 19, Suriano discloses the positioning aid according to claim 2,wherein a bend radius of a curved section (Fig. 1a section 112a) that joins a first straight portion of a first guide channel segment (see annotated Fig. 1a) of the guide channel (Fig. 1a conduit 112) and a second straight portion of a second guide channel segment (see annotated Fig. 1a) of the guide channel (Fig. 1a conduit 112) and is greater than 0.1 inches (see Fig. 1a).
PNG
media_image3.png
802
720
media_image3.png
Greyscale
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Suriano in view of Marvi et al. (US2022/0143817) hereinafter Marvi.
Regarding Claim 6, Suriano discloses the positioning aid according to claim 1, but is silent wherein the body comprises a three-dimensional printed body.
However Marvi, in the same field of endeavor, teaches wherein the body comprises a three-dimensional printed body ([0105] “Being able to 3D print the foregoing components allows for rapid prototyping of any complex design ….”
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Suriano with the teachings of Marvi to have the body comprises a three-dimensional printed body for the benefit of having the capability of rapid prototyping of parts (Marvi – [0105])
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Suriano in view of Weisenburgh, II et al. (US2009/0234193) hereinafter Weisenburgh.
Regarding Claim 8, Suriano discloses the positioning aid according to claim 1. Suriano illustrates wherein the guide channel is formed with a curve in Fig. 1A but is silent at explicitly disclosing the guide channel has a helical pattern.
However Weisenburgh, in the same field of endeavor, teaches wherein the guide channel is formed with a curve in Fig. 1A but is silent at explicitly disclosing the guide channel has a helical pattern. (Weisenburgh – helical flow path [0030, 0060, 00066, 0067] “In an alternate employment, as seen in figures 18 and 19, the lumen 108 has a substantially helical flow path 110. Flow path 110 is the flow path of the irrigation fluid in lumen 108. In one variation (which can be pictured as having the sheath 112 of FIG. 18 substituted for the sheath 18 of FIG. 7A), this allows the distal lumen end 34 to be substantially tangentially aligned with the annular fluid passageway 58 of the manifold 56 which reduces pressure losses.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Suriano with the teachings of Weisenburgh to have the guide channel has a helical pattern for the benefit of reducing any pressure loss of fluid between the input and the output of the guide channel lumen (Weisenburgh – [0060]).
Regarding Claim 20, Suriano discloses the positioning aid according to claim 2. Suriano illustrates wherein the guide channel is formed with a curve in Fig. 1A but is silent at explicitly disclosing the guide channel has a helical pattern.
However Weisenburgh, in the same field of endeavor, teaches wherein the guide channel is formed with a curve in Fig. 1A but is silent at explicitly disclosing the guide channel has a helical pattern. (Weisenburgh – helical flow path [0030, 0060, 00066, 0067] “In an alternate employment, as seen in figures 18 and 19, the lumen 108 has a substantially helical flow path 110. Flow path 110 is the flow path of the irrigation fluid in lumen 108. In one variation (which can be pictured as having the sheath 112 of FIG. 18 substituted for the sheath 18 of FIG. 7A), this allows the distal lumen end 34 to be substantially tangentially aligned with the annular fluid passageway 58 of the manifold 56 which reduces pressure losses.”)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Suriano in view of Jay A. Lenker (US2020/0163694) hereinafter Lenker.
Regarding Claim 12, Suriano discloses the positioning aid according to claim 11, but is silent as to wherein the coupler comprises a brass tube insert.
However Lenker, in the same field of endeavor, teaches wherein the coupler comprises a brass tube insert. (Lenker - [0026] In other embodiments, the steerable transseptal needle can comprise an electrical plug, operably connected to the inner tube, the central stylet or wire, or the outer tube. The electrical plug can be affixed to the hub of the steerable transseptal needle. The plug can be configured for releasable attachment to the cable of a radio frequency (RF) power supply or “Bovie”. The plug can be used to conduct electrical energy to one or more of the tubes or wires of the steerable transseptal needle. The plug can comprise conductive materials such as, but not limited to, stainless steel, cobalt nickel alloy, titanium, brass, copper, nitinol, or the like.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Suriano with the teachings of Lenker to include wherein the coupler comprises a brass tube insert for the benefit of having the capability to conduct electrical energy (Lenker – [ 0026]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Suriano in view of Kent Vilendrer (US5670708) hereinafter Vilendrer.
Regarding Claim 13, Suriano discloses the positioning aid according to claim 6, but is silent wherein the flexible tubing comprises a tube formed from polytetrafluoroethylene.
However Vilendrer, in the same field of endeavor, teaches wherein the flexible tubing comprises a tube formed from polytetrafluoroethylene (Vilendrer – [col 4 lines 36-52] “The manifolds 20 and 22 are preferably constructed from a non-corrosive material such as polypropylene, polytetrafluroethylene, or stainless steel.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Suriano with the teachings of Vilendrer to include wherein the flexible tubing comprises a tube formed from polytetrafluoroethylene for the benefit of having the flexible tubing be constructed from a non-corrosive material (Vilendrer - [col 4 lines 36-52]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Suriano in view of Sungwook Yang (US2019/0076009) hereinafter Yang.
Regarding Claim 16, Suriano discloses the positioning aid according to claim 1, but is silent as to wherein the guide channel is color-coded to identify a size of the guide channel.
However Yang, in the same field of endeavor, teaches wherein the guide channel is color-coded to identify a size of the guide channel (Yang – [0047] “Next, flush lines (30) are attached to respective endoscope openings (226, 228, 228a, 230, 232). Air line (112) is also connected to connector (254). In some versions, flush lines (30) are color coded, and guide located on station (10) provides a reference for the color-coded connections.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Suriano with the teachings of Yang to include the guide channel is color-coded to identify a size of the guide channel for the benefit of “provid[ing] a reference” for the user (Yang – [0047]).
Regarding Claim 17, Suriano discloses the positioning aid according to claim 1, but is silent as to wherein the guide channel is color-coded to identify a port of the endoscope.
However Yang, in the same field of endeavor, teaches wherein the guide channel is color-coded to identify a port of the endoscope. (Yang – [0047] “Next, flush lines (30) are attached to respective endoscope openings (226, 228, 228a, 230, 232). Air line (112) is also connected to connector (254). In some versions, flush lines (30) are color coded, and guide located on station (10) provides a reference for the color-coded connections.”).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Suriano with the teachings of Yang to include wherein the guide channel is color-coded to identify a port of the endoscope for the benefit of “provid[ing] a reference” for the user (Yang – [0047]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
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, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEGAN ELIZABETH MONAHAN/Examiner, Art Unit 3795