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
Claims 1-6, 8, 9, 11, 20-27, 29, 32, 36, 39, 42, 43, 46, and 48-50 are pending and currently under consideration for patentability.
Claims 7, 10, 12-19, 28, 30, 31, 33-38, 40, 41, 44, 45, and 47 are cancelled.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Response to Arguments
Applicant's arguments filed 8/4/2025 have been fully considered but they are not persuasive.
The applicant has failed to cite evidence or prove that the 112(b) rejection should be withdrawn.
In response to the applicants argument that Herscu fails to teach “a catheter extraction tool teach wherein cutting the first filament portion at the cutting notch when the locking arm is in the locked position releases the distal region of the catheter tube from the secured anchoring profile” In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case Herscu is not teaching the entire device, however is providing motivation to add the cutting notch to Neoh.
In response to the applicant’s argument that does not teach cutting notch, based on the claim language, the notch in question must only be capable of providing a cut. There is no strict criteria of the claim other than a notch able to create a cut.
Applicant’s arguments, see page, filed 8/4/2025, with respect to the 112(b) rejection have been fully considered and are persuasive. The 112b of claims 1-6, 8, 9, 11, 20-27, 29, 32, 36, 39, 42, 43, 46, and 48-50 has been withdrawn.
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.
Claim(s) 1-6, 8-9, 11, 20-27, 29, 32-33, 39, 42, 46 and 48-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neoh (US 20170232231 A1) in view of Herscu (US 20170056067 A1).
Regarding Claim 1, Neoh teaches a catheter (paragraph [0018])(figures 1-6), comprising:
a catheter tube (106) defining a catheter lumen, the catheter tube having a distal region (figure 1);
a hub (100) attached to the catheter tube (106), the hub including a hub body (102) and a locking arm (108) connected to the hub body (102), the locking arm (108) having an outer surface (160) defining a cutting notch (annotated figure 4) having a cutting notch bottom wall (See annotated figure 4);
a filament (110) for securing the distal region of the catheter tube (106) in secured anchoring profile (paragraph [0023]), the filament (110) extending from the distal region (112) of the catheter tube to the hub (102) (figures 4), the filament (110) including a proximal filament (110) segment external of the hub body (102) (figure 4), wherein the proximal filament (110) segment is position able to a filament path providing a first filament portion extending over the cutting notch bottom wall (Below cutting notch) of the locking arm outer surface(108) and a second filament portion extending between the locking arm and the hub body (See annotated figure 4) (paragraph [0034]);
the locking arm (108) movable relative to the hub body (100) between an unlocked position (figure 3) in which the second filament portion (release of tension member, paragraph [0069]) is not positionally fixed by compression between the locking arm (108) and the hub body (100) and a locked position (figure 4) in which the second filament portion is positionally fixed by compression between the loc7king arm and the hub body (100) for securing the distal region of the catheter tube (106) in the secured anchoring profile (paragraph [0033-0034]); and
Neoh fails to explicitly teach wherein cutting the first filament portion at the cutting notch when the locking arm is in the locked position releases the distal region of the catheter tube from the secured anchoring profile. However Herscu teaches a catheter extraction tool teach wherein cutting the first filament portion at the cutting notch when the locking arm is in the locked position releases the distal region of the catheter tube from the secured anchoring profile (paragraph [0080]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify cutting arm of Neoh so the cutting the first filament portion at the cutting notch when the locking arm is in the locked position releases the distal region of the catheter tube from the secured anchoring profile so that the cut portion may separate from the rest of the body and may be discarded.
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Regarding Claim 2, Neoh in view of Herscu teaches the catheter of claim 1, wherein:
the hub body (102) defines a hub lumen (184) in fluid communication with the catheter lumen (106) and a seal seat passage fluidly communicating with the hub lumen (184) and having a seal seat passage (132) opening at a location on an outer surface of the hub body(102) (figure 1) (paragraph [0036]);
a sealing element (136) is at least partially positioned in the seal seat passage (132); and
the filament (110) passes from the catheter lumen (106) into the hub lumen (184), through the seal seat passage and sealing element (136) , and out of the seal seat passage opening (paragraph [0023 and 0036] and figure 4).
Regarding Claim 3, Neoh in view of Herscu teaches the catheter of claim 1, wherein the locking arm has an inner surface facing the outer surface of the hub body (102), with the inner surface of the locking arm (108) having a filament fixing (150, figure 3) region cooperable with a filament fixing region (156) of the outer surface of the hub body to compress and thereby positionally fix the second filament portion when the locking arm is in the locked position ([0023] an (figure 4).
Regarding Claim 4, Neoh in view of Herscu teaches the catheter of claim 3, wherein the filament fixing region of the outer surface (156) of the hub body (102) includes a protrusion for cooperating with a recess of the filament fixing region of the inner surface of the locking arm (150) and/or wherein the filament fixing region of the inner surface (150) of the locking arm includes a protrusion (openings on the interior surface of the locking arm on either side of material bridge underneath cutting notch 179, figure 4) for cooperating with a recess (146) of the filament fixing region (156) of the outer surface of the hub body (102).
Regarding Claim 5, Neoh in view of Herscu teaches the catheter of claim 4, wherein the filament fixing region (156) of the outer surface of the hub body (102) includes a plurality of protrusions for cooperating with a plurality of recesses (openings on the interior surface of the locking arm on either side of material bridge underneath cutting notch 179, figure 4) of the filament fixing region (156) of the inner surface of the locking arm (108).
Regarding Claim 6, Neoh in view of Herscu teaches the catheter of claim 4, wherein the filament fixing region of the inner surface of the locking arm includes a plurality of protrusions (179)(figure 3) for cooperating with a plurality of recesses (146) of the filament fixing region of the outer surface of the hub body (156) (figure 3).
Regarding Claim 8, Neoh in view of Herscu teaches the catheter of claim 3, wherein when the locking arm is in the locked position in a relaxed condition (figure 2: open arm is relaxed), at least a portion of the filament fixing region of the inner surface of the locking arm is spaced a distance from the filament fixing region of the outer surface of the hub body (when the filament is attached to the lever arm when extended in figure 2, the filament would be spaced away from the hub).
Regarding Claim 9, Neoh in view of Herscu teaches the catheter of claim 8. Neoh fails to teach wherein the second filament portion has a diameter, and wherein the ratio of said diameter to said distance is about 1.2:1 or greater, or in the range of about 1.2:1 to about 3:1. Neoh teaches this value to be optimizable based on design preferences of the user(paragraph 0031). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the second filament portion diameter so the ratio of said diameter to said distance is about 1.2:1 or greater, or in the range of about 1.2:1 to about 3:1 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding Claim 11, Neoh in view of Herscu teaches the catheter of claim 1 wherein: the locking arm (150) defines a first opening (179; and
the filament (110) path exits the hub body (102) and passes through the first opening (179) to the outer surface of the locking arm (150), through the cutting notch, into a compression zone between the fixing region of the inner surface of the locking arm and the fixing region of the outer surface of the hub body (paragraph [0031]). The primary embodiment of Neoh fails to teach a second opening. However alternative embodiment teaches first opening (286) and a second opening (288); Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Neoh so the filament may be more securely locked into place for cutting.
Regarding Claim 20, Neoh teaches a catheter (paragraph [0018])(figures 1-6), comprising:
a catheter tube (106) defining a catheter lumen, the catheter tube having a distal region (figure 4);
a hub (100) attached to the catheter tube (106), the hub including a hub body (102) and a locking arm (108) connected to the hub body (100;
the locking arm (108) movable relative to the hub body (100) between an unlocked position (figure 3) for allowing travel of a filament portion between the locking arm and the hub body and a locked position in which the filament portion is positionally fixed by compression between a filament fixing surface region (150) of the locking arm and a filament fixing surface region (156) of the hub body for securing the distal region of the catheter tube in an anchoring profile (paragraph [0033-0034]) (figures 1-4), wherein when the locking arm is in the locked position in a relaxed condition (figure 2), at least a portion of the filament fixing surface region of the locking arm is spaced a distance from the filament fixing surface region of the hub body (when the filament is attached to the lever arm when extended in figure 2, the filament would be spaced away from the hub);
a filament (110) for securing the distal region of the catheter tube (106) in an anchoring profile (paragraph [0028]), the filament (110) extending from the distal region of the catheter tube (106) to the hub (100) (figures 1-6), the filament (110) including a proximal filament (110) segment external of the hub body (102) (figure 4).
Neoh fails to teach wherein the second filament portion has a diameter, and wherein the ratio of said diameter to said distance is about 1.2:1 or greater, or in the range of about 1.2:1 to about 3:1. Neoh teaches this value to be optimizable based on design preferences of the user(paragraph 0031). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the second filament portion diameter so the ratio of said diameter to said distance is about 1.2:1 or greater, or in the range of about 1.2:1 to about 3:1 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding Claim 21, Neoh in view of Herscu teaches the catheter of claim 20. Neoh fails to teach wherein the second filament portion has a diameter, and wherein the ratio of said diameter to said distance is in the range of about 1.5:1 to about 2:1. Neoh teaches this value to be optimizable based on design preferences of the user(paragraph 0031). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the second filament portion diameter so the ratio of said diameter to said distance is in the range of about 1.5:1 to about 2:1 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding Claim 22, Neoh in view of Herscu teaches the catheter of claim 20, wherein:
the hub body (102) defines a hub lumen (184) in fluid communication with the catheter lumen (106) and a seal seat passage fluidly communicating with the hub lumen (184) and having a seal seat passage (132) opening at a location on an outer surface of the hub body(102) (figure 1) (paragraph [0036]);
a sealing element (136) is at least partially positioned in the seal seat passage (132); and
the filament (110) passes from the catheter lumen (106) into the hub lumen (184), through the seal seat passage and sealing element(136) , and out of the seal seat passage opening (paragraph [0023 and 0036] an figure 4).
Regarding Claim 23, Neoh in view of Herscu teaches the catheter of claim 20, wherein the filament fixing region of the filament fixing surface region (156) of the hub body (102) includes a protrusion for cooperating with a recess of the filament fixing region of the inner surface of the locking arm (150) and/or wherein the filament fixing region (150) of the locking arm includes a protrusion (openings on the interior surface of the locking arm on either side of material bridge underneath cutting notch 179, figure 4) for cooperating with a recess (146) of the filament fixing region (156) of the hub body (102).
Regarding Claim 24, Neoh in view of Herscu teaches the catheter of claim 20, wherein the filament fixing region (156) of the hub body (102) includes a plurality of protrusions for cooperating with a plurality of recesses (openings on the interior surface of the locking arm on either side of material bridge underneath cutting notch 179, figure 4) of the filament fixing region (156) of the locking arm (108).
Regarding Claim 25, Neoh in view of Herscu teaches the catheter of claim 20, wherein the filament fixing region surface of the locking arm includes a plurality of protrusions (179)(figure 3) for cooperating with a plurality of recesses (146) of the filament fixing surface of the hub body (156) (figure 3).
Regarding Claim 26, Neoh teaches the e catheter of claim 24, wherein the protrusions of the filament fixing surface of the hub body each have an apex surface (figure 4), and wherein the apex surfaces (146) (figure 2) of the protrusions of the filament fixing surface of the hub body are spaced said distance from the filament fixing surface region (150) of the locking arm when the locking arm is in the locked position (figure 1 and 4) .
Regarding Claim 27, Neoh in view of Herscu teaches the catheter of claim 25, wherein the protrusions of the filament fixing surface of the hub body each have an apex surface (figure 4), and wherein the apex surfaces (146) (figure 2) of the protrusions of the filament fixing surface of the hub body are spaced said distance from the filament fixing surface region (150) of the locking arm when the locking arm is in the locked position (figure 1 and 4) .
Regarding Claim 29, Neoh teaches the catheter claim 23, wherein: the proximal filament segment (150) defines a first opening (179) and a second opening (132); and the proximal filament (110) path exits the hub body (102) and passes through the first opening (179) to the outer surface of the locking arm (150), through the cutting notch, and through the second opening (132) and into a compression zone between the fixing region of the inner surface of the locking arm and the fixing region of the outer surface of the hub body (paragraph [0031]).
Regarding Claim 32, Neoh in view of Herscu teaches the catheter of claim 29, wherein: the locking arm (108) defines a third opening (opening under tab, 176); and
the filament path exits the compression zone and passes through the third opening (176) to the outer surface of the locking arm (108)(figure 4).
Regarding Claim 33, Neoh in view of Herscu teaches the catheter of claim 32, wherein the locking arm defines a cinching notch (152) proximal of the third opening (opening under tab, 176), the cinching notch configured to cinch and secure the filament (paragraph [0034])(figure 4).
Regarding Claim 39, Neoh teaches a catheter (paragraph [0018])(figures 1-6)
a catheter tube (106) defining a catheter lumen, the catheter tube having a distal region (figure 4);
a hub (100) attached to the catheter tube (106), the hub including a hub body (102) and a locking arm (108) connected to the hub body (100), the locking arm defining a first opening (179);
a filament (110) for securing the distal region of the catheter tube (106) in an anchoring profile (paragraph [0028]), the filament (110) extending from the distal region of the catheter tube (106) to the hub (100) (figures 1-6), the filament (110) including a proximal filament (110) segment external of the hub body (102) (figure 4), wherein the proximal filament (110) segment is positionable to a filament path that exits the hub body (figure 4) and passes through the first opening (179) to an outer surface of the locking arm (108), and into a compression zone between a fixing region of the inner surface of the locking arm (150) and a fixing region of the outer surface of the hub body (156) (figures 1-6); and
the locking arm (108) movable relative to the hub body (100) between an unlocked position (figure 3) in which a portion of the filament (110) in the compression zone is not positionally fixed by compression between the locking arm (108) and the hub body (102) (figure 2) and a locked position (figure 1) in which the portion of the filament (110) is positionally fixed by compression between the fixing region of the inner surface (150) of the locking arm and the fixing region of the outer surface (146) of the hub body for securing the distal region of the catheter tube in the anchoring profile (figure 4) (paragraph [0033]).
The primary embodiment of Neoh fails to teach a second opening. However alternative embodiment teaches first opening (286) and a second opening (288); Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Neoh so the filament may be more securely locked into place for cutting.
Neoh fails to explicitly teach wherein cutting the first filament portion at the cutting notch when the locking arm is in the locked position releases the distal region of the catheter tube from the secured anchoring profile. However Herscu teaches a catheter extraction tool teach wherein cutting the first filament portion at the cutting notch when the locking arm is in the locked position releases the distal region of the catheter tube from the secured anchoring profile (paragraph [0080]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify cutting arm of Neoh so the cutting the first filament portion at the cutting notch when the locking arm is in the locked position releases the distal region of the catheter tube from the secured anchoring profile so that the cut portion may separate from the rest of the body and may be discarded.
Regarding Claim 42, Neoh in view of Herscu teaches the catheter of claim 39. The primary embodiment fails to teach a third opening in a locking arm. An alternative embodiment further teaches the locking arm (108) defines a third opening (290 )and
the filament path exits the compression zone and passes through the third opening (290) to the outer surface of the locking arm (274)(figure 7).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the arm of Neoh to have a third hole to better secure the filament.
Regarding Claim 46, Neoh in view of Herscu teaches the catheter of claim 39, wherein when the locking arm is in the locked position in a relaxed condition (figure 2: open arm is relaxed), at least a portion of the filament fixing region of the inner surface of the locking arm is spaced a distance from the filament fixing region of the outer surface of the hub body (when the filament is attached to the lever arm when extended in figure 2, the filament would be spaced away from the hub).
Regarding Claim 48, Neoh in view of Herscu teaches the catheter of claim 1. Neoh fails to explicitly teach wherein the cutting notch is configured for insertion of a sharp edge of an instrument into the cutting notch to sever the first filament portion while the locking arm is in the locked position. The notch cited could accept the sharp edge of the instrument as in the end the Neoh, as the device appears to want to cut the filament in the end (Neoh, paragraph [0069]).
Regarding Claim 49, Neoh in view of Herscu teaches the catheter of claim 48. Neoh further teaches wherein the lever arm has an inner surface opposite to the outer surface of the locking arm (108) and facing the outer surface of the hub body (annotated fig. 4), with the inner surface of the locking arm having a filament fixing region cooperable with a filament fixing region (first filament portion, annotated figure 4) of the outer surface of the hub body to compress and thereby positionally fix the second filament portion (second filament portion, figure 4) (paragraph [0034]) when the locking arm is in the locked position; and the proximal filament segment is positioned in the filament path (paragraph [0034]).
Regarding Claim 50, Neoh in view of Herscu teaches the catheter of claim 39, wherein the inner surface of the locking arm is opposite the outer surface of the locking arm (annotated figure 4); the first opening and the second opening each extend from the inner surface of the locking arm to the outer surface of the locking arm (annotated figure 4); and the proximal filament segment is positioned in the filament path (annotated figure 4).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neoh (US 20170232231 A1) in view of Herscu (US 20170056067 A1), as applied to claim 39 above, and further view of Murray (US 20140276655 A1).
Regarding Claim 43, Neoh in view of Herscu teaches the catheter of claim 39. Neoh fails to teach wherein the locking arm defines a cutting notch between the first opening and the second opening, and the filament path extends through the cutting notch. In the same field of endeavor, namely catheters with a cutting tools, Murray teaches a catheter comprising a cutting notch (546), a filament (suture) that is positioned within the opening (538) of the catheter (paragraph [0074]). The cutting member may be used to cut the suture (paragraph 0005). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter of Neoh to include a cutting notch similar to that disclosed by Murray so that the filament may be released while inside the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781