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 .
Response to Amendment
The amendment filed on 05/26/2026 has been entered. Claims 1, 2, 6, 9-13, 15, and 16 have been amended. Claims 4, 5, 7, 8, and 17-20 are in the original/previously presented form. Claims 3 and 14 are cancelled. Claims 21-25 are newly presented. Thus, claims 1, 2, 4-13, and 15-25 remain pending in the application.
Claim Objections
Claims 1, 2, 4, 6, 16, 21-25 are objected to because of the following informalities: The applicant refers to the “inner core” in multiple ways, such as “stiff inner core”, “stiff core”, and “inner core”. The examiner recognizes all these terms refer to the same part, however for continuity purposes, the examiner suggest modifying the multiple different names to be under the same name. 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.
Claims 1, 6, 21, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims 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.
Regarding claims 1, 6 and 22, the claims have been amended to describe the proximal end of the stiff inner core as “free”. The examiner considers this to be new matter. There is no reference in the specification made to the proximal end of the stiff inner core being “free”, or defining what “free” means. On pg. 12 lines 3-18 of the specification, the specification states “the inner core 134 can extend beyond the proximal end 130 of the catheter 107 in the direction of the proximal end 102 of the retrieval probe 100 a length 190…By extending the inner core 134 in the proximal direction beyond the proximal end 130 of the catheter 107, the present inventors have found that the stiffness of the catheter 107 can be maintained adjacent to the handle 108 for improved control of the retrieval probe 100 during an insertion procedure.”. Yet, this information does not reasonably convey the meaning of “free”. As for the drawings, FIG. 2 shows the stiff inner tube within the housing, yet the farthest proximal end of the stiff inner tube appears to be in contact with some surface of the housing, indicated by two lines extending from the farthest proximal end of the housing. The examiner remains confused as to how the applicant defines the proximal end of the stiff inner core as “free”, and suggests providing more context within the specification or clarity within the drawings.
Regarding claims 6 and 21, the claims have been amended to recite “an annular recess”, which is formed between the outer surface of the inner core at the proximal end and an internal wall defining the handle lumen. The examiner considers this to be new matter. There is no reference in the specification made describing an annular recess. On pg. 12 lines 2-3 of the specification, the specification states “a length 188 of the inner core 134 can extend within the handle 108”. Yet, this information does not reasonably convey there to be “an annular recess” existing between the inner core and handle lumen. As for the drawings, FIG. 2 shows the stiff inner tube within the housing, yet the farthest proximal end of the stiff inner tube appears to be in contact with some surface of the housing, indicated by two lines extending from the farthest proximal end of the housing. The examiner remains confused as to where the “annular recess” is supposed to be as well as the benefits of having said component, and suggests providing more context within the specification or clarity within the drawings.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-9, and 15-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkpatrick et al. (United States Patent Application Publication No. US 2014/0196723 A1; herein, Kirkpatrick), and further in view of Wakeford et al. (United States Patent Application Publication No. US 2009/00627772 A1; herein, Wakeford) and Carlyon et al. (United States Patent Application Publication No. US 2008/0082082 A1; herein, Carlyon).
Regarding claim 1, Kirkpatrick discloses a retrieval probe (FIG. 2-4B, delivery probe 200) for insertion of a bridle (bridle 104) into a nasal passageway of a patient (last sentence of [0047]), the retrieval probe comprising: a proximal end (proximal end 204) defining a handle (FIG. 2 and FIG. 4A, housing 210 has gripping members 414), and a distal end (distal end 206), the handle having an internal wall defining a handle lumen (Annotated on FIG. 4B below); a catheter (elongated member 202) between the proximal end and the distal end (FIG. 2), the catheter having a proximal end coupled to the handle (FIG. 4B, [0050], elongated member 202 is seated in the connection portion 412), the catheter defining a catheter lumen and a catheter lumen inner diameter (FIG. 3); a stiff inner core (stylet 302) positioned within the catheter lumen ([0049]) from the proximal end along a portion of a length of the catheter (FIG. 3 and FIG. 4B), the stiff inner core having an outer surface that is sized and shaped corresponding to the catheter lumen (the stylet 302, specifically the outer surface of the stylet 302, fits within the catheter lumen; therefore, it reads on being “sized and shaped corresponding to the catheter lumen” as seen in FIG.3), the stiff core comprising a proximal end (Annotated on FIG. 4B below) positioned within the handle (FIG. 4B) and a distal end (Annotated on FIG. 3 below) positioned within the catheter (FIG. 3), the proximal end terminating within the handle (FIG. 4B, where stylet 302 appears to end within the handle); and a magnetic tip (magnetic portion 102) disposed at the distal end (FIG. 3); wherein the catheter comprises a hollow section (Annotated on FIG. 3 below) disposed between the magnetic tip (magnetic portion 102) and the distal end of the stiff inner core (Annotated on FIG. 3 below).
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Kirkpatrick does not disclose the stiff inner core formed from a material having a higher stiffness than the catheter, the proximal end of the stiff core being free, and the outer surface of the proximal free end being spaced from the internal wall of the handle.
However, Wakeford teaches the stiff inner core formed from a material having a higher stiffness than the catheter (first sentence of [0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval probe disclosed by Kirkpatrick to have a stiff inner core formed from a material having a higher stiffness than a catheter as taught by Wakeford in order to facilitate guidance of the catheter during placement ([0048]).
Kirkpatrick in view of Wakeford still does not disclose the proximal end of the stiff core being free, and the outer surface of the proximal free end being spaced from the internal wall of the handle.
However, Carlyon teaches the proximal end of the stiff core being free (FIG. 1 shows the proximal end of access cannula 104 being free from other parts of the device within the catheter hub 106; [0046], “access cannula 104 may be replaced with a solid stylet”), and the outer surface of the proximal free end being spaced from the internal wall of the handle (FIG. 1, access cannula 104 is spaced a distance from the catheter hub 106 in all directions at the proximal end). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval probe disclosed by Kirkpatrick to have the proximal end of the stiff core free and spaced from the internal wall of the handle as taught by Carlyon in order to facilitate access to the body ([0046]).
Regarding claim 2, in the modified device of Kirkpatrick, Kirkpatrick discloses the catheter comprises a first material and the inner core comprises a second material ([0048], [0049], the elongated member 202 is made of a material more flexible than the material of the stylet 302, as well as the example materials given for the elongated member 202 do not overlap with those given for the stylet 302; therefore, the elongated member 202 and the stylet 302 are made of different materials), wherein the first material and the second material are dissimilar ([0048], [0049], the example materials given for the elongated member 202 do not overlap with those given for the stylet; therefore, the elongated member 202 and the stylet 302 are made of dissimilar materials).
Regarding claim 4, in the modified device of Kirkpatrick, Kirkpatrick discloses the first material has a first durometer and the second material has a second durometer ([0049], the stylet 302 increases rigidity when inserted within the elongated member 202, so the stylet and elongated member are made of different durometers). Kirkpatrick does not explicitly disclose the catheter is formed from a material having a durometer that ranges from 15 to 35, an inner core is formed from a material having a durometer that ranges from 60 to 90, and a ratio of the first durometer to the second durometer is in a range from about 1:2 to about 1:4. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the ranges in Kirkpatrick to have a catheter material having a durometer that ranges from 15 to 35, an inner core material having a durometer that ranges from 60 to 90, and a ratio of the first durometer to the second durometer is in a range from about 1:2 to about 1:4, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the ranges of Kirkpatrick would not operate differently with the claimed ranges. Further applicant places no criticality on the ranges claimed, indicating simply that the material of the catheter “can have” (specification; page 7, lines 15-17), the material of the inner core “can have” (specification, page 8, lines 9-11), and the length “can be” been within the claimed ranges (specification; page 8, lines 11-13).
Regarding claim 5, in the modified device of Kirkpatrick, Kirkpatrick discloses the first material is a thermoplastic elastomer ([0048], "a flexible materials which includes…thermoplastic).
Kirkpatrick does not disclose the second material is nylon. However, Wakeford teaches the second material is nylon ([0048], "Suitable materials include…nylon 6/6"). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval probe disclosed by Kirkpatrick to have a second material as nylon as taught by Wakeford in order to provide column strength to facilitate guidance of the catheter during placement ([0048]).
Regarding claim 6, in the modified device of Kirkpatrick, Kirkpatrick discloses the stiff inner core is formed from a solid construction ([0049], “The stylet 302 may be provided as a wire”).
Kirkpatrick does not disclose the inner core having a solid cylindrical cross- sectional shape, an annular recess is formed between the outer surface of the inner core at the proximal free end and the internal wall defining the handle lumen.
However, Wakeford teaches the inner core having a solid cylindrical cross- sectional shape (FIG. 1-2B shown stylet 30 having a cylindrical shape). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified retrieval probe disclosed by Kirkpatrick to have a cylindrical stiff inner core as taught by Wakeford in order to provide column strength and facilitate guidance of the catheter during placement ([0048]).
Kirkpatrick in view of Wakeford still does not disclose an annular recess is formed between the outer surface of the inner core at the proximal free end and the internal wall defining the handle lumen. However, Carlyon teaches an annular recess is formed between the outer surface of the inner core at the proximal free end and the internal wall defining the handle lumen (FIG. 1, annular recess is formed between the outer surface of access cannula 104 and inner wall of catheter hub 106). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval probe disclosed by Kirkpatrick to have the proximal end of the stiff core spaced from the internal wall of the handle as taught by Carlyon in order to have more control over the inner core when facilitating access to the body ([0046]).
Regarding claim 7, in the modified device of Kirkpatrick, Kirkpatrick discloses the hollow section is configured to bend at an angle of about 180 degrees without kinking ([0049], [0051], the hollow section (section between the distal end of the stylet 302 and connection point 110) can undergo a pronounced curvature to couple magnetic portions 102 and 508 near the rear of the vomer bone through the nostril; therefore, the hollow section is fully capable of being bent up to 180 degrees).
Regarding claim 8, in the modified device of Kirkpatrick, Kirkpatrick discloses the hollow section comprises a length in a range from about 1.5 cm to about 2.5 cm (hollow section is located within the distal end 206 as seen in FIG. 3 wherein the distal end has a length from 1-2 cm as seen in FIG. 2; therefore, the range of the hollow section is within the range 1.5 to 2.5 cm as seen in FIG. 2-3).
Regarding claim 9, in the modified device of Kirkpatrick, Kirkpatrick discloses the magnetic tip comprises a magnetic holding tip body (Annotated on FIG. 3 below) having a catheter connecting section at a proximal end (Annotated on FIG. 3 below), a protruding section distal to the catheter connection section (Annotated on FIG. 3 below) and a shoulder between the catheter connection section and the protruding section (Annotated on FIG. 3 below).
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Regarding claim 15, in the modified device of Kirkpatrick, Kirkpatrick discloses the connection member (magnet 106) comprises a permanent magnet and/or a magnetically connective material ([0047]).
Regarding claim 16, Kirkpatrick discloses a system for securing a nasal tube comprising: a bridle (bridle 104); a magnetic connection portion attached to the bridle (magnetic portion 102); and a retrieval probe (retrieval probe 500), the retrieval probe comprising: a proximal end (proximal end 504) and a distal end (distal end 506); a catheter (elongated member 502) between the proximal end and the distal end (FIG. 5A), the catheter defining a catheter lumen (FIG. 5B, central lumen of catheter seen in cross-sectional view) having a circumferential inner surface defining a catheter lumen inner diameter (FIG. 5B); an inner core (stylet 514) positioned within the catheter lumen (FIG. 5B) from the proximal end (proximal end 504) along a portion of a length of the catheter (FIG. 5B, [0053]), the inner core having a circumferential outer surface that is sized and shaped corresponding to the catheter lumen (the stylet 514, specifically the outer surface of the stylet 514, fits within the elongated member 502 lumen; therefore, it reads on being “sized and shaped corresponding to the catheter lumen” as seen in FIG. 5B); a magnetic tip (magnetic portion 508) disposed at the distal end (FIG. 5A); wherein the catheter comprises a hollow section (region 516) disposed between the magnetic tip and a distal end of the inner core (FIG. 5B); wherein the magnetic connection portion attached to the bridle and the magnetic tip of the retrieval probe are configured to magnetically couple during a procedure for inserting the bridle in a nasal passageway of a patient ([0057]).
Kirkpatrick does not disclose the inner core being sized to substantially fill the catheter lumen inner diameter, and the inner core formed from a material having a higher stiffness than the catheter.
However, Wakeford teaches the inner core being sized to substantially fill the catheter lumen inner diameter ([0053]), and the inner core formed from a material having a higher stiffness than the catheter (first sentence of [0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval probe disclosed by Kirkpatrick to have the inner core substantially fill the catheter lumen and be formed from a material having a higher stiffness than a catheter as taught by Wakeford in order to move the inner core can easily slide into and out of the catheter ([0053]) and to facilitate guidance of the catheter during placement ([0048]).
Regarding claim 17, in the modified system of Kirkpatrick, Kirkpatrick discloses either the magnetic connection portion of the bridle or the magnetic tip of the retrieval probe comprises a permanent magnet ([0052], "the magnetic portion 508 would be permanently attached to the distal end 506 of the elongated member 502").
Regarding claim 18, in the modified system of Kirkpatrick, Kirkpatrick discloses the other of the magnetic connection portion (magnetic portion 102) of the bridle or the magnetic tip (magnetic portion 508) of the retrieval probe comprises a magnetically connective material that is not a permanent magnet ([0052], "the releasable magnetic portion 102").
Regarding claim 19, in the modified system of Kirkpatrick, Kirkpatrick discloses the magnetic connection portion (magnetic portion 102) of the bridle and the magnetic tip of the retrieval probe each comprises a permanent magnet ([0047], [0052]).
Regarding claim 20, in the modified system of Kirkpatrick, Kirkpatrick discloses the hollow section of the retrieval probe is configured to bend up to about 180 degrees to enable coupling of the magnetic connection portion of the bridle and the magnetic tip of the retrieval probe during the procedure for inserting the bridle ([0057], region 516 is fully capable of being bent up to 180 degrees to couple the magnetic portion 508 of the retrieval probe 500 and the magnet 106 of bridle, since the retrieval probe 500 moves towards the rear vomer bone through the second nostril).
Regarding claim 21, in the modified system of Kirkpatrick, Kirkpatrick discloses a handle (FIG. 5A and 5B, handle portion 510) is coupled to a proximal end of the catheter at a catheter transition section (FIG. 5B, elongated member 502 is positioned within handle portion 510), the handle having an internal wall defining a handle lumen (Annotated on FIG. 5B below), the circumferential outer surface of the inner core engages the catheter lumen at the catheter transition section (Annotated on FIG. 5B below), the inner core is formed from a solid construction ([0049], “The stylet 302 may be provided as a wire”), and the inner core extends beyond the proximal end of the catheter such that the inner core extends within a handle lumen (FIG. 5B).
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Kirkpatrick does not disclose the inner core having a solid cylindrical cross- sectional shape, and an annular recess is formed between the circumferential outer surface of the inner core and an internal wall defining the handle lumen.
However, Wakeford teaches the inner core having a solid cylindrical cross- sectional shape (FIG. 1-2B shown stylet 30 having a cylindrical shape). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified retrieval probe disclosed by Kirkpatrick to have a cylindrical stiff inner core as taught by Wakeford in order to provide column strength and facilitate guidance of the catheter during placement ([0048]).
Kirkpatrick in view of Wakeford still does not disclose an annular recess is formed between the circumferential outer surface of the inner core at the proximal free end and the internal wall defining the handle lumen. However, Carlyon teaches an annular recess is formed between the circumferential outer surface of the inner core at the proximal free end and the internal wall defining the handle lumen (FIG. 1, annular recess is formed between the outer surface of access cannula 104 and inner wall of catheter hub 106). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval probe disclosed by Kirkpatrick to have the proximal end of the stiff core spaced from the internal wall of the handle as taught by Carlyon in order to have more control over the inner core when facilitating access to the body ([0046]).
Regarding claim 22, in the modified system of Kirkpatrick, Kirkpatrick discloses the stiff core comprises a proximal end (Annotated of FIG. 5B above) positioned within the handle (FIG. 5B) and a distal end positioned within the catheter (Annotated on FIG. 5B above), the proximal end terminating within the handle (FIG. 5B).
Kirkpatrick does not disclose teaches the proximal end of the stiff core being free. However, Carlyon teaches the proximal end of the stiff core being free (FIG. 1 shows the proximal end of access cannula 104 being free from other parts of the device within the catheter hub 106; [0046], “access cannula 104 may be replaced with a solid stylet”), and the outer surface of the proximal free end being spaced from the internal wall of the handle (FIG. 1, access cannula 104 is spaced a distance from the catheter hub 106 in all directions at the proximal end). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified retrieval probe disclosed by Kirkpatrick to have the proximal end of the stiff core free and spaced from the internal wall of the handle as taught by Carlyon in order to facilitate access to the body ([0046]).
Regarding claim 23, in the modified system of Kirkpatrick, Kirkpatrick does not disclose the outer surface of the stiff inner core engages the entire circumferential inner surface along at least a portion of a length of the catheter. However, Carlyon teaches the outer surface of the stiff inner core engages the entire circumferential inner surface along at least a portion of a length of the catheter (FIG. 1, access cannula 104 engages the entire diameter of elongated member 108). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified retrieval probe disclosed by Kirkpatrick to have at least a portion of the outer surface of the inner core engage with the entire inner surface of the catheter lumen as taught by Carlyon in order to facilitate access to the body ([0046]) and maintain a fluid tight seal between the inner core and catheter ([0047]).
Regarding claim 24, in the modified device of Kirkpatrick, Kirkpatrick discloses the catheter lumen comprises a circumferential inner surface (Fig. 3 and 4B), the outer surface of the stiff inner core is a circumferential outer surface that is sized and shaped corresponding to the circumferential inner surface of the catheter lumen (the stylet 302, specifically the outer surface of the stylet 302, fits within the elongated member 202 lumen; therefore, it reads on being “sized and shaped corresponding to the circumferential inner surface of the catheter lumen” as seen in FIG.3).
Kirkpatrick does not disclose such that the circumferential outer surface of the inner core engages the entire circumferential inner surface of the catheter lumen along at least a portion of a length of the catheter. However, Carlyon teaches such that the circumferential outer surface of the inner core engages the entire circumferential inner surface of the catheter lumen along at least a portion of a length of the catheter (FIG. 1, access cannula 104 engages the entire diameter of elongated member 108). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified retrieval probe disclosed by Kirkpatrick to have at least a portion of the outer surface of the inner core engage with the entire inner surface of the catheter lumen as taught by Carlyon in order to facilitate access to the body ([0046]) and maintain a fluid tight seal between the inner core and catheter ([0047]).
Regarding claim 25, Kirkpatrick discloses a retrieval probe (retrieval probe 500) for insertion of a bridle (bridle 104) into a nasal passageway of a patient, the retrieval probe comprising: a proximal end (proximal end 504) defining a handle (handle portion 510) and a distal end (distal end 506); a catheter (elongated member 502) between the proximal end and the distal end (FIG. 5A), the catheter having a proximal end coupled to the handle at a catheter transition section (FIG. 5B, elongated member 502 is positioned within handle portion 510), the catheter defining a catheter lumen and a catheter lumen inner diameter (FIG. 5B, cross-sectional view displays lumen and inner diameter); a stiff inner core (stylet 514) positioned within the catheter lumen from the proximal end along a portion of a length of the catheter (FIG. 5B, stylet 514 resides within elongated member 502 lumen from handle portion 510 to a point within lumen near the distal end 506), the stiff inner core having an outer surface that is sized and shaped corresponding to the catheter lumen (the stylet 514, specifically the outer surface of the stylet 514, fits within the elongated member 502 lumen; therefore, it reads on being “sized and shaped corresponding to the catheter lumen” as seen in FIG. 5B); and a magnetic tip (magnetic portion 508) disposed at the distal end (FIG. 5A); wherein the catheter comprises a hollow section disposed between the magnetic tip and a distal end of the stiff inner core (FIG. 5B, region 516 provides increased flexibility for elongated member 502).
Kirkpatrick does not disclose the outer surface of the inner core engages the entire catheter lumen along at least a portion of a length of the catheter, the inner core formed from a material having a higher stiffness than the catheter.
However, Carlyon teaches the outer surface of the inner core engages the entire catheter lumen along at least a portion of a length of the catheter (FIG. 1, access cannula 104 engages the entire diameter of elongated member 108). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval probe disclosed by Kirkpatrick to have at least a portion of the outer surface of the inner core engage with the entire inner surface of the catheter lumen as taught by Carlyon in order to facilitate access to the body ([0046]) and maintain a fluid tight seal between the inner core and catheter ([0047]).
Kirkpatrick in view of Carlyon still does not disclose the inner core formed from a material having a higher stiffness than the catheter.
However, Wakeford teaches the inner core formed from a material having a higher stiffness than the catheter (first sentence of [0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval probe disclosed by Kirkpatrick to have a stiff inner core formed from a material having a higher stiffness than a catheter as taught by Wakeford in order to facilitate guidance of the catheter during placement ([0048]).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkpatrick in view of Wakeford and Carlyon as applied to claim 9 above, and further in view of Parker et al. (United States Patent Application Publication No. US 2011/0264056 A1; herein, Parker).
Regarding claim 10, in the modified device of Kirkpatrick, Kirkpatrick does not disclose the shoulder has a radius of curvature extending between the catheter connection section and the protruding section to provide a generally smooth transition and a smooth outer surface of the protruding section. However, Parker teaches the shoulder has a radius of curvature extending between the catheter connection section and the protruding section (Annotated on Fig. 2B below) to provide a generally smooth transition and a smooth outer surface of the protruding section ([0063], “distal end being tapered and rounded “forms a smooth transition between the catheter tip 56 and the outer catheter 52”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified retrieval probe disclosed by Kirkpatrick to make the shoulder have a radius of curvature as taught by Parker in order to prevent the protruding section from snagging on tissue or otherwise injuring a patient during use ([0063]).
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Regarding claim 11, in the modified device of Kirkpatrick, Kirkpatrick discloses the catheter connection section is disposed within the distal end of the catheter (Seen in annotated FIG. 3 below, elongated member 202 encompasses catheter connection section) and includes a constant diameter portion (Annotated on FIG. 3 below), the constant diameter portion forming an interference fit with the catheter lumen.
Kirkpatrick does not disclose a tapered portion extending between the constant diameter portion and the proximal end of the magnetic holding tip. However, Patrick teaches a tapered portion extending between the constant diameter portion and the proximal end of the magnetic holding tip (Fig. 2B, flared portion 92 is tapered). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified retrieval probe disclosed by Kirkpatrick to have a tapered portion as taught by Parker in order to prevent the distal end of the probe from snagging on tissue or otherwise injuring a patient during use ([0063]).
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Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkpatrick in view of Wakeford and Carlyon as applied to claim 9 above, and further in view of Berger (United States Patent No. US 6,056,339 A).
Regarding claim 12, in the modified device of Kirkpatrick, Kirkpatrick discloses a connection member (magnet 106) is supported within the protruding section (Seen on annotated FIG. 3 below) and comprises an exposed section extending from a distal end of the magnetic holding tip to a distal end of the connection member (Annotated on FIG. 3 below).
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Kirkpatrick does not disclose the exposed section comprises a length in a range from about 0.75 mm to about 2 mm. However, Berger teaches it was known in the art to have a retrieving device 10 with an extended section of the length of the magnet member 28 to be about 8.89 mm (col. 3 lines 40-50, the length of the magnet member is 0.70 inches (17.78 mm), and the length of the extended section of the magnet is half the length of the magnet member (8.89 mm)). It would have been obvious to one ordinary skill in the art before the effective filling date of the claimed invention to modify the length of the exposed section of modified Kirkpatrick from 8.89 mm to between 0.75 mm to about 2 mm as applicant appears to have placed no criticality on the claimed range (specification, lines 25-26 on page 8, indicating the length “can be” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside the ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir.1990).
Regarding claim 13, in the modified device of Kirkpatrick, Kirkpatrick does not disclose a ratio of a length of the exposed section to a length of the connection member is in a range from about 1:5 to about 1:2. However, Berger teaches a ratio of a length of the exposed section (0.70 inches/2= 0.35 inches) to a length of the connection member (0.70 inches) is in a range from about 1:5 to about 1:2 (0.35/0.70= 0.5 (1:2); col. 3 lines 40-50). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the retrieval probe disclosed by Kirkpatrick to have a ratio of a length of the exposed section to a length of the connection member in a range from about 1:5 to about 1:2 as taught by Berger in order that the device be strong enough to pick up and lift a magnetic article of two and one-half pounds (col. 3 lines 45-47).
Response to Arguments
Applicant’s arguments, see pages 9-15 of Applicant’s Remarks, with respect to claims 1, 6, 9-12, 16, and 21-24, have been considered but are moot because the arguments do not apply in view of the new grounds of rejection. The amended limitation of the catheter and inner core being “circumferential” is interpreted by the examiner as being anticipated by Kirkpatrick.
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 Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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 Tsai can be reached at 571-270-5246. 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.
/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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