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 .
Claim Objections
Claim 24 is objected to because of the following informalities:
Regarding claim 24, the claim should be amended to recite “a plurality of first teeth” in line 2 to correct for grammar.
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 21-40 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.
Regarding claims 21 and 37, the claim recites “an exterior surface of the hub body” in lines 8 and 4, respectively, and later recites “over a portion of an exterior surface of the hub body”. It is unclear if this second recitation of “an exterior surface” is the same exterior surface of the hub body or a different exterior surface. Further, the claim later recites “the exterior surface of the hub body” in the last line of the claims. it is unclear if this exterior surface is in reference to the first exterior surface or the second exterior surface. For examination purposes, the exterior surfaces are considered the same surface.
Claims 22-36 and 38-40 are also rejected by virtue of being dependent on claims 21 or 37.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21-23, 26, 27, 30-34, 36, and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hruska (US 20110313403).
Regarding claim 21, Hruska discloses a drainage catheter (catheter 10 in fig. 1), comprising:
an elongated tubular member (tubular member 13 in fig. 1) having a proximal end (proximal end 19 in fig. 2), a distal end (distal end 11 in fig. 1), and a tubular member passageway extending longitudinally through the tubular member (passageway 16 in fig. 1);
a catheter hub attached to the proximal end of the tubular member (locking mechanism 15 in fig. 1A), the catheter hub including a hub body (main body portion 20 and tip portion 30 form the “hub body” in fig. 2) and a locking arm connected to the hub body (locking arm 50 in fig. 1A), the locking arm having an opening therethrough (opening 59 in fig. 3), the hub body defining a hub body passageway in fluid communication with the tubular member passageway (passage formed by passageway 20 and passageway 32 in fig. 1A) and an aperture extending between the hub body passageway and an exterior surface of the hub body (passageway 34 in fig. 2; fig. 2 shows the passageway 34 connects the exterior surface of hub body below), the catheter hub also including a seal element received in the aperture (plug 60 in fig. 2; paragraph 39 discloses the plug fills the passageway 34); and
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a tension member (tension member 14 in fig. 1) attached to the distal end of the tubular member (fig. 3 shows a portion of the tension member 14 attached to port 18) and extending proximally through the tubular member passageway (fig. 2 shows a portion of tension member 14 extending through passageway 16), through the hub body passageway (fig. 2), through the seal element (fig. 2), over a portion of an exterior surface of the hub body aligned with and under the opening of the locking arm (see below), and through a clamping region of the catheter hub configured to clamp the tension member between an interior surface of the locking arm and the exterior surface of the hub body (see below).
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Regarding claim 22, Hruska discloses the locking aim is rotatable relative to the hub body (paragraph 40 discloses that member 56 is pivotable).
Regarding claim 23, Hruska discloses an angle of rotation for the locking arm relative to a longitudinal axis of the hub body is restricted from 0 degrees in a locked position in which the tension member is clamped in the clamping region to about 30 degrees in an unlocked position in which the tension member is not clamped in the clamping region (the examiner notes that the angle would be measured against a plane or structure and such plane/structure not defined in the claim; as such, the angle of rotation defined by Hruska can be considered to be between 0-30 degrees).
Regarding claim 26, Hruska discloses the hub body includes a post (ring 36 in fig. 1A) and the locking arm includes a hole sized to receive the post therein to connect the locking arm to the hub body (see below).
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Regarding claim 27, Hruska discloses the exterior surface of the hub body includes a centering tab configured to align the tension member along a longitudinal axis of the hub body(ledge 23 in fig. 2 aligns the tension member 14 by guiding the tension member out from the seal).
Regarding claim 30, Hruska discloses the opening of the locking arm is defined in a distal portion of the locking arm (the examiner notes that the “distal portion” is not further defined, the port 59 is considered to be on a distal portion of the locking arm absent any other limitations limiting the distal portion).
Regarding claim 31, Hruska discloses the seal element is made of silicone, thermoplastic, or polyisoprene material, or a combination of these materials (paragraph 39 discloses the plug 60 is made from silicone).
Regarding claim 32, Hruska discloses the tension member has a portion extending proximal of the clamping region (fig. 2).
Regarding claim 33, Hruska discloses the distal end of the tubular member is lockable in a restraining shape on application of tension to the tension member and clamping the tension member in the clamping region (fig. 1 and paragraph 27 discloses the tubular member being lockable in a loop shape when the pivotable member 56 is in a locked position).
Regarding claim 34, Hruska discloses the restraining shape is a curled shape (fig. 1).
Regarding claim 36, Hruska discloses a kit, comprising:
a drainage catheter according to claim 21 (see discussion above);and
at least one of (i) a cannula configured for passage into the elongate tubular member of the drainage catheter and (ii) a guidewire (paragraph 43 discloses a “wire guide”).
Regarding claim 37, Hruska discloses a catheter hub for a drainage catheter (locking mechanism 15 in fig. 1A), comprising:
a hub body (body defined by body portion 20, tip portion 30 in fig. 1A, and body portion 52 in fig. 10) defining a longitudinally extending hub body passageway (passageway formed by 22 and 32 in fig. 2) and an aperture extending between the hub body passageway and an exterior surface of the hub body (passageway 34 in fig. 2; fig. 2 shows the passageway 34 connects the exterior surface of hub body below);
a seal element received in the aperture (plug 60 in fig. 2);
a locking arm connected to the hub body (pivotable element 56 in fig. 2), the locking arm having an opening therethrough (opening 59 in fig. 2); and
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a tension member configured to apply tension to a distal end of a tubular member of the drainage catheter (tension member 14 in fig. 2), the tension member extending proximally through the through the hub body passageway (fig. 2), through the seal element (fig. 2), over a portion of an exterior surface of the hub body aligned with and under the opening of the locking arm (see below), and through a clamping region configured to clamp the tension member between an interior surface of the locking arm and the exterior surface of the hub body (see 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.
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) 24, 25, and 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hruska, as applied to claims 21 and 37 above, and further in view of Ovcharchyn (US 8177773).
Regarding claim 24, Hruska discloses all of the claimed limitations set forth in claim 21, as discussed above, but does not teach or disclose the clamping region comprises plurality of first teeth on the hub body and a plurality of second teeth on the locking arm.
Ovcharchyn teaches a similar device (fig. 5) comprising a clamping region located at a distal-most end of the locking arm which comprises a first plurality of first teeth on the hub body (teeth 115 in fig. 11) and a plurality of second teeth on the locking arm (teeth 113 in fig. 11). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the clamping region of Hruska to include a plurality of first teeth on the hub body and a plurality of second teeth on the locking arm, as taught by Ovcharchyn, in order to better fix the tension member in place (6:57-61).
Regarding claim 25, in the modified catheter of Hruska, Ovcharchyn discloses the first teeth and the second teeth have a triangular, rectangular, circular, curved, or polygonal shape (fig. 11 shows a triangular shape).
Regarding claim 38, Hruska discloses all of the claimed limitations set forth in claim 37, as discussed above, and further discloses the locking arm is rotatable relative to the hub body (paragraph 40 discloses that member 56 is pivotable). However, Hruska does not teach or disclose the clamping region comprises a plurality of first teeth on the hub body and a plurality of second teeth on the locking arm.
Ovcharchyn teaches a similar device (fig. 5) comprising a clamping region located at a distal-most end of the locking arm which comprises a first plurality of first teeth on the hub body (teeth 115 in fig. 11) and a plurality of second teeth on the locking arm (teeth 113 in fig. 11). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the clamping region of Hruska to include a plurality of first teeth on the hub body and a plurality of second teeth on the locking arm, as taught by Ovcharchyn, in order to better fix the tension member in place (6:57-61).
Regarding claim 39, in the modified hub of Hruska, Ovcharchyn discloses the first teeth and the second teeth have a triangular, rectangular, circular, curved, or polygonal shape (fig. 11 shows a triangular shape).
Regarding claim 40, in the modified Hub of Hruska, Hruska discloses the tension member comprises a suture (paragraph 32).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hruska, as applied to claim 21 above, and further in view of Paul (US 5399165).
Regarding claim 29, Hruska discloses all of the claimed limitations set forth in claim 21, as discussed above, but does not teach or disclose the locking arm includes a pair of protrusions configured to engage the hub body and retain the locking arm in a locked position.
Paul is directed towards a similar device (fig. 1) comprising a locking arm (lever 22 in fig. 1) which comprises a pair of protrusions configured to engage the hub body and retain the locking arm in a locked position (projections 40 and 41 in fig. 9; 5:48-52 and 6:3-7). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the locking arm of Hruska to include a pair of protrusions which engage a corresponding pair of recesses in the hub body to retain the locking arm in the locked position, as taught by Paul, as Paul teaches this prevents unintended movement (5:48-52 discloses “maintains” the fixed position).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hruska, as applied to claim 21 above, and further in view of Ahmed (US 20110125135).
Regarding claim 35, Hruska discloses all of the claimed limitations set forth in claim 21, as discussed above, but does not teach or disclose the opening of the locking arm has an elongate oval or slot shape.
Ahmed teaches an opening configured to receive a tension member is an elongate oval (port 38 in fig. 1). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the opening of Hruska to be an elongate oval, as taught by Ahmed, since it appears that the device of Hruska would operate equally well with the claimed shape and since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-27 and 29-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-6 of U.S. Patent No. 10806894 in view of Hruska and the teachings below (see table).
Regarding claim 21, claim 1 of the issued patent claims all of the claimed limitations set forth in instant claim 21 except issued claim 1 does not claim an elongated tubular member having a proximal end, a distal end, and a tubular member passageway extending longitudinally through the tubular member; a tension member attached to the distal end of the tubular member and extending proximally through the tubular member passageway, through the hub body passageway, through the seal element, over a portion of an exterior surface of the hub body aligned with and under the opening of the locking arm, and through a clamping region of the catheter hub configured to clamp the tension member between an interior surface of the locking arm and the exterior surface of the hub body.
Hruska teaches these limitations, as discussed above. It would have been obvious to have modified issued claim 1 to further claim the claimed elongated tubular member and tension member of instant claim 21 since issued claim 1 claims that the hub is “for use” with a catheter and tension member in the preamble. This modification would render the claimed catheter hub useful for its intended purpose.
Regarding claim 37, claim 1 of the issued patent claims all of the claimed limitations set forth in instant claim 37 except issued claim 1 does not claim a tension member configured to apply tension to a distal end of a tubular member of the drainage catheter, the tension member extending proximally through the through the hub body passageway, through the seal element, over a portion of an exterior surface of the hub body aligned with and under the opening of the locking arm, and through a clamping region configured to clamp the tension member between an interior surface of the locking arm and the exterior surface of the hub body.
Hruska teaches this limitation as discussed above. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified issued claim 1 to further claim the claimed tension member of instant claim 37 since issued claim 1 claims that the catheter hub is “for use” with a tension member. This modification would render the claimed catheter hub useful for its intended purpose.
Instant Claims
Issued Claims
Teaching
21
1
see discussion above
22
6
23
Hruska teaches this limitation above since the angle is not defined relative to any other structure or surface. It would have been obvious to have modified the issued claim to allow the arm to rotate about some degree in order to open/close the arm.
24
5
25
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
26
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows the locking arm to attach to the hub.
27
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature assists in guiding the tension member through the locking arm.
29
1
30
1
31
4
32
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature would allow a user to grasp the tension member.
33
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
34
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
35
Ahmed teaches this limitation above. It would have been obvious to have modified the issued claim for the same reasons provided above.
36
Ahmed teaches the claimed guidewire. It would have been obvious to have modified the issued claim to further claim a guidewire for enabling positioning of the drainage catheter.
37
1
see discussion above
38
6
39
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
40
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim to claim the tension member is a suture since Hruska teaches this structure enables manipulation of the catheter.
Claims 21-27 and 29-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 12, 15, and 16 of U.S. Patent No. 11969559 in view of Hruska and the teachings below (see table).
Regarding claims 21 and 37, claim 11 of the issued patent claims all of the claimed limitations set forth in instant claims 21 and 37 except issued claim 11 does not claim the tension member extends over a portion of an exterior surface of the hub body aligned with and under the opening of the locking arm, and through a clamping region of the catheter hub configured to clamp the tension member between an interior surface of the locking arm and the exterior surface of the hub body.
Hruska teaches this limitation as discussed above. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified issued claim 11 to further claim that the tension member extends over a portion of an exterior surface of the hub body aligned with and under the opening of the locking arm, and through a clamping region of the catheter hub configured to clamp the tension member between an interior surface of the locking arm and the exterior surface of the hub body, as taught by Hruska, since Hruska teaches this configuration allows the tension member to be releasably secured.
Instant Claims
Issued Claims
Teaching
21
11
teach in last four lines of claim 1
22
16
23
Hruska teaches this limitation above since the angle is not defined relative to any other structure or surface. It would have been obvious to have modified the issued claim to allow the arm to rotate about some degree in order to open/close the arm.
24
12
25
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
26
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows the locking arm to attach to the hub.
27
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature assists in guiding the tension member through the locking arm.
29
Paul teaches this limitation above. It would have been obvious to have modified the issued claim for the same reasons provided above.
30
11
31
15
32
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature would allow a user to grasp the tension member.
33
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
34
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
35
Ahmed teaches this limitation above. It would have been obvious to have modified the issued claim for the same reasons provided above.
36
Ahmed teaches the claimed guidewire. It would have been obvious to have modified the issued claim to further claim a guidewire for enabling positioning of the drainage catheter.
37
11
see discussion above
38
16
Ovcharchyn teaches the claimed pluralities of teeth. It would have been obvious to have modified the issued claim since Ovcharchyn teaches this allows the tension member to be better clamped.
39
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
40
18
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10369330 in view of Hruska and the teachings below (see table).
Regarding claims 21 and 37, claim 1 of the issued claim claims all of the claimed limitations set forth in instant claims 21 and 37 except the issued claim does not claim the locking arm having an opening therethrough and a tension member attached to the distal end of the tubular member and extending proximally through the tubular member passageway, through the hub body passageway, through the seal element, over a portion of an exterior surface of the hub body aligned with and under the opening of the locking arm, and through a clamping region of the catheter hub configured to clamp the tension member between an interior surface of the locking arm and the exterior surface of the hub body.
Hruska teaches these limitations, as discussed above. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to further claim the claimed tension member and the locking arm has an opening therethrough. Since issued claim 1 claims that the catheter is configured to receive a tension member, the modification of the tension member would render the catheter of the issued claim useful for its intended purpose. The modification of the opening through the locking arm would allow excess length of the tension member to be wrapped around the locking arm, as taught by Hruska (fig. 3).
Instant Claims
Issued Claims
Teaching
21
1
teach in tension member and opening through locking arm
22
2
23
3
24
1
25
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
26
4
27
5
28
6
29
Paul teaches this limitation above. It would have been obvious to have modified the issued claim for the same reasons provided above.
30
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since the distal portion is not further defined.
31
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this material is useful in sealing the tension member.
32
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature would allow a user to grasp the tension member.
33
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
34
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
35
Ahmed teaches this limitation above. It would have been obvious to have modified the issued claim for the same reasons provided above.
36
Ahmed teaches the claimed guidewire. It would have been obvious to have modified the issued claim to further claim a guidewire for enabling positioning of the drainage catheter.
37
1
see discussion above
38
2
39
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
40
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim to claim the tension member is a suture since Hruska teaches this structure enables manipulation of the catheter.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11517712 in view of Hruska and the teachings below (see table).
Regarding claims 21 and 37, claim 1 of the issued claim claims all of the claimed limitations set forth in instant claims 21 and 37 except the issued claim does not claim the locking arm having an opening therethrough and a tension member attached to the distal end of the tubular member and extending proximally through the tubular member passageway, through the hub body passageway, through the seal element, over a portion of an exterior surface of the hub body aligned with and under the opening of the locking arm, and through a clamping region of the catheter hub configured to clamp the tension member between an interior surface of the locking arm and the exterior surface of the hub body.
Hruska teaches these limitations, as discussed above. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to further claim the claimed tension member and the locking arm has an opening therethrough. Since issued claim 1 claims that the catheter is configured to receive a tension member, the modification of the tension member would render the catheter of the issued claim useful for its intended purpose. The modification of the opening through the locking arm would allow excess length of the tension member to be wrapped around the locking arm, as taught by Hruska (fig. 3).
Instant Claims
Issued Claims
Teaching
21
1
teach in tension member and opening through locking arm
22
2
23
3
24
7
25
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
26
4
27
5
28
6
29
Paul teaches this limitation above. It would have been obvious to have modified the issued claim for the same reasons provided above.
30
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since the distal portion is not further defined.
31
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this material is useful in sealing the tension member.
32
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature would allow a user to grasp the tension member.
33
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
34
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
35
Ahmed teaches this limitation above. It would have been obvious to have modified the issued claim for the same reasons provided above.
36
Ahmed teaches the claimed guidewire. It would have been obvious to have modified the issued claim to further claim a guidewire for enabling positioning of the drainage catheter.
37
1
see discussion above
38
2
39
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
40
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim to claim the tension member is a suture since Hruska teaches this structure enables manipulation of the catheter.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-12 of U.S. Patent No. 12070559 in view of Hruska and the teachings below (see table).
Regarding claims 21 and 37, claim 6 of the issued claim claims all of the claimed limitations set forth in instant claims 21 and 37 except the issued claim does not claim the locking arm having an opening therethrough and a tension member attached to the distal end of the tubular member and extending proximally through the tubular member passageway, through the hub body passageway, through the seal element, over a portion of an exterior surface of the hub body aligned with and under the opening of the locking arm, and through a clamping region of the catheter hub configured to clamp the tension member between an interior surface of the locking arm and the exterior surface of the hub body.
Hruska teaches these limitations, as discussed above. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the issued claim to further claim the claimed tension member and the locking arm has an opening therethrough. Since issued claim 6 claims that the catheter is configured to receive a tension member, the modification of the tension member would render the catheter of the issued claim useful for its intended purpose. The modification of the opening through the locking arm would allow excess length of the tension member to be wrapped around the locking arm, as taught by Hruska (fig. 3).
Instant Claims
Issued Claims
Teaching
21
6
teach in tension member and opening through locking arm
22
7
23
8
24
12
25
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
26
9
27
10
28
11
29
Paul teaches this limitation above. It would have been obvious to have modified the issued claim for the same reasons provided above.
30
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since the distal portion is not further defined.
31
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this material is useful in sealing the tension member.
32
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature would allow a user to grasp the tension member.
33
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
34
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim since Hruska teaches this feature allows for the catheter to remain in the body cavity.
35
Ahmed teaches this limitation above. It would have been obvious to have modified the issued claim for the same reasons provided above.
36
Ahmed teaches the claimed guidewire. It would have been obvious to have modified the issued claim to further claim a guidewire for enabling positioning of the drainage catheter.
37
6
see discussion above
38
12
39
Ovcharchyn teaches this limitation above. It would have been obvious to have modified the issued claim since Ovcharchyn teaches teeth having a triangular shape is useful in clamping the tensioning member.
40
Hruska teaches this limitation above. It would have been obvious to have modified the issued claim to claim the tension member is a suture since Hruska teaches this structure enables manipulation of the catheter.
Allowable Subject Matter
Claim 28 would be allowable with the filing of a terminal disclaimer to overcome the double patenting rejection above and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Hruska which does not teach or disclose the centering tab includes a vertical leg that extends from the exterior surface of the hub body to connect to a horizontal leg with a groove therebetween sized to retain the tension member.
Conclusion
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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