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 Arguments
Applicant’s arguments, filed 23 June 2025, with respect to the rejection(s) of claim(s) 1-2, 4-5, 7-12 under 35 USC 103 have been fully considered and are persuasive. Specifically, Applicant has amended the claims to further recite further features of the opening spacing. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lanciano, Mathis and Mody as presented below.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2, 4-5, and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lanciano (US 4740195) in view of Mathis (US 2006/0167416) further in view of Mody (US 6454740).
Regarding claim 1, Lanciano discloses a drainage catheter device (10) comprising an outer drainage catheter (12, figure 1) having a proximal end (proximal end near element 28 as depicted in figure 2), a distal end (tip formed adjacent 22, figure 1) at which the outer drainage catheter terminates, and a distal portion (figure 1, distal end opposite proximal end) adjacent the distal end, wherein the distal portion comprises a self-deformable material that biases the distal portion into a plurality of loops (col 3, lines 32-40, loops formed when rod is removed), wherein the distal portion extends straight in a first configuration when a hollow stylet metal rod (32) is disposed within the distal portion and conforms into the plurality of loops of a second configuration in response to the removal of the hollow stylet metal rod from the distal portion (col 3, lines 32-40), and a surface of the distal portion that faces radially inward in the second configuration defines a plurality of openings (14, figure 1), wherein the distal end defines an opening (22) that is coaxial with a central longitudinal axis of the outer drainage catheter (col 3, lines 49-51).
Lanciano does not disclose the hollow stylet is a metal needle and wherein the plurality of openings defined on the radially inward surface of the plurality of loops are spaced apart by a quarter turn of each loop.
Mathis discloses catheter relatively pertinent to problem posed by Applicant of moving material via catheter. Mathis teaches hollow stylet metal needle (720) that is disposable within the outer drainage catheter (710, figure 10A-10B, [0121]).
Mathis provides the needle among many introducer alternatives in order to allow the device to be introduced as desired in the body ([0004], [0121]). It would be obvious to one of ordinary skill in the art at the time of the invention to modify Lanciano with the needle of Mathis via simple substitution, to include a hollow stylet metal needle that is disposable within the outer drainage catheter to allow the device to be introduced as desired. The stylet needle appears to be an alternative to the rod disclosed in Lanciano and the device would work similarly as a substitute.
Mathis and Lanciano do not disclose wherein the plurality of openings defined on the radially inward surface of the plurality of loops comprises circumferentially adjacent openings that are spaced apart from each other by a quarter turn of each loop.
Mody discloses the drainage catheter teaches wherein the outer drainage catheter (14) comprises plurality of openings (40, figure 3) defined on the radially inward surface of the plurality of loops are spaced apart by a quarter turn of each loop (see annotated figure below).
Mody provides openings spaced as desired on the tubing to allow for desirable fluid movement characteristics (col 4, lines 32-37). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Mathis and Lanciano to allow desired spacing such as quarter turn spacing to achieve desirable fluid characteristics.
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The prior art does not teach that each circumferentially adjacent opening are spaced apart from each other by a quarter turn of each loop.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the prior art device to have desired spacing of a quarter turn of each loop since it has been held that “where the only difference between the prior art and the claims was a 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 Mody would not operate differently with the claimed opening spacing and since the device of Mody already has more openings between the quarter turns to adequately drain the device, the prior art device would function appropriately having the claimed spacing of openings. Further, applicant places no criticality on the range claimed, indicating simply that the openings be in some implementations (specification “Brief Summary”).
Regarding claim 2, Lanciano does not disclose the hollow stylet metal needle is extendable through the opening defined by the distal end.
Mathis discloses catheter relatively pertinent to problem posed by Applicant of moving material via catheter. Mathis teaches hollow stylet metal needle (720) that is disposable within the outer drainage catheter (710, figure 10A-10B, [0121]) and extendable through the distal end opening (figure 10B).
Mathis provides the needle among many introducer alternatives in order to allow the device to be introduced as desired in the body ([0004], [0121]). It would be obvious to one of ordinary skill in the art at the time of the invention to modify Lanciano with the needle of Mathis via simple substitution, to include a hollow stylet metal needle that is disposable within the outer drainage catheter to allow the device to be introduced as desired. The stylet needle appears to be an alternative to the rod disclosed in Lanciano and the device would work similarly as a substitute.
Regarding claim 4, Lanciano discloses multiple loops (figure 1) does not disclose the loops comprise at least 2.5 loops.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Lanciano to have at least 2.5 loops since it has been held that “where the only difference between the prior art and the claims was a 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 device of Lanciano would not operate differently with the claimed number of loops and since the loops are dependent on the length of the catheter. The more loops would accommodate more openings an allow efficient drainage. Further, applicant places no criticality on the range claimed, indicating simply that the loops “in some implementations” (page 1).
Regarding claim 5 and 7, Lanciano discloses the openings (14) defined on the radially inward surface of the loops are evenly spaced apart (figure 1, openings evenly spaced)(claim 5) and wherein an area of the radially inward surface of the loops that defines the openings has a first end and a second end, the first end being spaced apart distally from a proximal end of the distal portion by a half loop, and the second end being spaced apart proximally from the distal end of the outer drainage catheter by a half loop (Figure 1 shows a half loop spaced apart distally from a proximal end of the distal portion and another half loop spaced apart proximally from the distal end)(claim 7).
Regarding claim 8, Lanciano discloses the length of approximately about 7.85cm (7.5cm is about 7.85cm col 3, lines 12-16).
Regarding claim 9, Lanciano discloses a length of the outer drainage catheter between proximal end and distal end in the first configuration is about 14-18cm (col 3, lines 55-58).
Regarding claim 10, Lanciano discloses a hub (28) coupled to the proximal end of the catheter (figure 1).
Regarding claim 11, Lanciano does not discloses the loops have a diameter of about 1cm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the loops of Lanciano to have about 1cm diameter since it has been held that “where the only difference between the prior art and the claims was a 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 device of Lanciano would not operate differently with the claimed diameter since the diameter would allow the device to properly drainage anatomy. Further, applicant places no criticality on the range claimed, indicating simply that the loops be “about” 1cm (page 3).
Regarding claim 12, Lanciano and Mathis do not disclose the material being plastic.
Mody discloses the drainage catheter teaches wherein the outer drainage catheter (14) comprises a plastic material (tubular member (drainage catheter) is made of a flexible polymeric material, such as Ultrathane™ (plastic material); column 3, lines 47-50).
Mody provides plastic material to comply with necessary regulations for medical devices (col 3, lines 47-52). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lanciano with the material selection of Mody in order to have the device comply with medical device regulations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached on M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/ Primary Examiner, Art Unit 3781