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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/09/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 06/09/2025. As directed by the amendment: Claims 1, 4, 6, 11, and 16 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-20 are presently pending in the application.
Applicant’s amendments to the claims have overcome the previous objection previously set forth in the Final Office Action mailed 12/10/2024.
Response to Arguments
Applicant argues, lines 1-14 on page 7 and lines 1-4 on page 8, that Kirkpatrick does not appear to disclose the amendments to claims 1 and 16 and that the stylet 514 in Kirkpatrick extends over only a portion of the area/cross-sectional area of the lumen of the elongated member 502 and stylet 302 does not disclose a stiff inner core “sized and shaped corresponding to the catheter lumen”. Examiner disagrees, the claims do not disclose that the stiff inner core extends along all the portion of the area/cross-sectional area of the lumen. The claims recite that the inner core needs to fit within the catheter lumen. Stylets/inner core 302 and 514 fit within the catheter lumen as seen in Figs.3 and 5B.
Applicant argues, lines 14-16 on page 7, that the stylet 514 of Kirkpatrick does not have a “solid construction having a solid cylindrical cross-sectional shape” as recited in amended claim 6. Examiner disagrees, the stylet of Kirkpatrick is formed from a solid construction (wire) having a solid cylindrical cross-sectional shape (cross-section in Fig.3) (lines 7-9 in parag. [0049]).
Applicant argues, lines 5-18 on page 8 and page 9, that the magnetic holding tip 108 of Kirkpatrick does not disclose the magnetic holding tip and connection member as amended in claim 11. Examiner disagrees, the catheter connection section extends proximally from the exposed section of the connection member 106 toward the proximal end of the magnetic holding tip wherein the catheter connection section includes a constant diameter (see annotated figure below).
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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.
Claims 1-3, 5-11, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkpatrick (US 2014/0196723); in view of Wakeford (US 20090062772).
Regarding Claim 1, Kirkpatrick discloses a retrieval probe (200; Figs.2-4B) for insertion of a bridle (104) into a nasal passageway of a patient (last sentence in parag. [0047]), the retrieval probe comprising: a proximal end (204) and a distal end (206); a catheter (202) between the proximal end (204) and the distal end (206) (Fig.2), the catheter defining a catheter lumen and a catheter lumen inner diameter (Fig.3); a stiff inner core (302) positioned with the catheter lumen (parag. [0049]) from the proximal end (204) along a portion of a length of the catheter (Figs.3 and 4B), the stiff inner core (302) sized and shaped corresponding to the catheter lumen (the stiff inner core/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); a magnetic tip (102) disposed at the distal end (206) (Fig.3); wherein the catheter comprises a hollow section (see annotated figures below) disposed between the magnetic tip (102) and a distal end of the stiff inner core (see annotated figure below).
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Kirkpatrick does not appear to disclose a stiff inner core formed from a material having a higher stiffness than a catheter.
Wakeford teaches it was known in the art to have a stylet/stiff inner core formed from a material that is stiffer/more rigid than the catheter material (first sentence in parag. [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirkpatrick to incorporate the teachings of Wakeford to have a stiff inner core formed from a material having a higher stiffness than a catheter in order to facilitate guidance of the catheter during placement (last sentence in parag. [0048]).
Regarding Claim 2, Kirkpatrick as modified discloses the retrieval probe of claim 1, and further discloses wherein the catheter comprises a first material and the inner core comprises a second material (the catheter 202 is made of a material more flexible than the material of the stiff inner core/stylet 302; therefore, the catheter 202 and the inner core are made of different materials) (lines 5-7 in parag. [0048] and lines 4-9 in parag. [0049]).
Regarding Claim 3, Kirkpatrick as modified discloses the retrieval probe of claim 2, and further discloses wherein the first material and the second material are dissimilar (the catheter 202 is made of a material more flexible than the material of the stiff inner core/stylet 302; therefore, the catheter 202 and the inner core are made of different materials) (lines 5-7 in parag. [0048] and lines 4-9 in parag. [0049]).
Regarding Claim 5, Kirkpatrick discloses the retrieval probe of claim 2, and further discloses wherein the first material is a thermoplastic elastomer (lines 7-11 in parag. [0048]) and the second material is nylon.
Kirkpatrick does not appear to disclose a second material is nylon.
Wakeford teaches it was known in the art to have a nylon stiff inner core/stylet 30 (parag. [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirkpatrick to incorporate the teachings of Wakeford to have a second material is nylon in order to provide column strength to facilitate guidance of the catheter during placement (parag. [0048]).
Regarding Claim 6, Kirkpatrick as modified discloses the retrieval probe of claim 1, and further discloses wherein the stiff inner core (302) is formed from a solid construction (wire).
Kirkpatrick does not explicitly disclose a stiff inner core having a solid cylindrical cross-sectional shape.
Wakeford teaches it was known in the art to have a stylet/stiff inner core having a solid cylindrical cross-sectional shape as see in Figs.1-2B.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirkpatrick to incorporate the teachings of Wakeford to have a stiff inner core having a solid cylindrical cross-sectional shape in order to provide sufficient rigidity to the catheter.
Regarding Claim 7, Kirkpatrick as modified discloses the retrieval probe of claim 1, and further discloses wherein the hollow section (see annotated figure under above) is configured to bend at an angle of about 180 degrees without kinking (the hollow section (section between end/distal end of the stylet/stiff inner core 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) (lines 4-7 in parag. [0049] and lines 36-40 in parag. [0051]).
Regarding Claim 8, Kirkpatrick as modified discloses the retrieval probe of claim 1, and further discloses wherein the hollow section comprises a length in a range from about 1.5 cm to about 2.5 cm (hollow section (see annotated figure above) 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 Figs.2-3).
Regarding Claim 9, Kirkpatrick as modified discloses the retrieval probe of claim 1, and further discloses wherein the magnetic tip comprises a magnetic holding tip (see annotated figure below) and a connection member (106).
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Regarding Claim 10, Kirkpatrick as modified discloses the retrieval probe of claim 9, and further discloses wherein a proximal end of the connection member is disposed within the magnetic holding tip and a distal end of the connection member protrudes from the magnetic holding tip (see annotated figure below).
Regarding Claim 11, Kirkpatrick as modified discloses the retrieval probe of claim 10, wherein the connection member (106) comprises an exposed section (114) extending from a distal end (see annotated figure below) of the magnetic holding tip to a distal end of the connection member (see annotated figure below), and a catheter connection section (see annotated figure below) extending proximally from the exposed section toward a proximal end of the magnetic holding tip (see annotated figure below), where the catheter connection section is disposed within the distal end (206) of the catheter (Fig.3) and includes a constant diameter portion and a tapered portion extending between the constant diameter portion and the proximal end of the magnetic holding tip, the constant diameter portion forming an interference fit with the catheter lumen (fits within lumen as seen in Fig.3).
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Regarding Claim 14, Kirkpatrick as modified discloses the retrieval probe of claim 9, and further teaches wherein a proximal end (see annotated figure above) of the magnetic holding tip is disposed within the distal end (206) of the catheter (Fig.3).
Regarding Claim 15, Kirkpatrick as modified discloses the retrieval probe of claim 9, and further discloses wherein the connection member (106) comprises a permanent magnet and/or a magnetically connective material (lines 14-17 in parag. [0047]).
Regarding Claim 16, Kirkpatrick discloses a system for securing a nasal tube comprising: a bridle (104); a magnetic connection portion (102) attached to the bridle (lines 1-4 in parag. [0047]); and a retrieval probe (500), the retrieval probe comprising: a proximal end (504) and a distal end (506); a catheter (502) between the proximal end and the distal end (Fig.5A), the catheter defining a catheter lumen and a catheter lumen inner diameter (Fig.5B); an inner core (514) positioned with the catheter lumen (Fig.5B) from the proximal end (504) along a portion of a length of the catheter (parag. [0053]) (Fig.5B), the inner core (514) sized and shaped corresponding to the catheter lumen (the inner core/stylet 514 fits within the catheter lumen; therefore, it reads on being “sized and shaped corresponding to the catheter lumen” as seen in Fig.5B); a magnetic tip (508) disposed at the distal end (Fig.5A); wherein the catheter comprises a hollow section (516) disposed between the magnetic tip and a distal end of the inner core (Fig.5B); wherein the magnetic connection portion (102) attached to the bridle and the magnetic tip (508) of the retrieval probe are configured to magnetically couple during a procedure for inserting the bridle in a nasal passageway of a patient (parag. [0057]).
Kirkpatrick does not appear to disclose an inner core sized to substantially fill a catheter lumen inner diameter wherein the inner core formed from a material having a higher stiffness than the catheter.
Wakeford teaches it was known in the art to have a stylet/ inner core 30 sized to substantially/for the most part fill a lumen of catheter 20 (parag. [0053]) wherein the stylet/inner core formed from a material that is stiffer/more rigid than the catheter material (first sentence in parag. [0048]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirkpatrick to incorporate the teachings of Wakeford to have an inner core sized to substantially fill a catheter lumen inner diameter in order to move the stylet/inner core can easily slide into and out of the catheter (parag. [0053]) and to have the inner core formed from a material having a higher stiffness than the catheter in order to facilitate guidance of the catheter during placement (last sentence in parag. [0048]).
Regarding Claim 17, Kirkpatrick as modified discloses the system of claim 16, and further discloses wherein either the magnetic connection portion of the bridle or the magnetic tip of the retrieval probe comprises a permanent magnet (lines 16-18 in parag. [0052]).
Regarding Claim 18, Kirkpatrick as modified discloses the system of claim 17, and further discloses wherein the other of the magnetic connection portion (102) of the bridle or the magnetic tip (508) of the retrieval probe comprises a magnetically connective material that is not a permanent magnet (lines 16-18 in parag. [0052]).
Regarding Claim 19, Kirkpatrick as modified discloses the system of claim 16, and further discloses wherein the magnetic connection portion (102) of the bridle and the magnetic tip (508) of the retrieval probe each comprises a permanent magnet (lines 14-18 in parag. [0047] and lines 16-18 in parag. [0052])
Regarding Claim 20, Kirkpatrick as modified discloses the system of claim 16, and further discloses wherein 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 (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) (parag. [0057]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kirkpatrick (US 2014/0196723).
Regarding Claim 4, Kirkpatrick discloses the retrieval probe of claim 2, and further discloses wherein the first material has a first durometer and the second material has a second durometer (the stylet 514 increases rigidity when inserted within the elongated member (502) (parag. [0053], lines 11-14), so the stylet and elongated member are made of different material and different durometers).
Kirkpatrick does not explicitly disclose a 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).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kirkpatrick (US 2014/0196723) in view of Berger (US 6056339).
Regarding Claim 12, Kirkpatrick as modified discloses all the limitations of claim 11 above.
Kirkpatrick does not disclose the exposed section comprises a length in a range from about 0.75 mm to about 2 mm.
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 (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)) (lines 40-50 in column 3).
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, Kirkpatrick as modified discloses the retrieval probe of claim 11, and Berger further teaches wherein 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)) (lines 40-50 in column 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TANIA M ISMAIL whose telephone number is (313)446-6625. The examiner can normally be reached Monday-Thursday 8:00-3:30 pm.
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/T.I./ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783