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 .
Election/Restrictions
Applicant’s election without traverse of Group I: claims 1-12 in the reply filed on 09/14/26 is acknowledged.
Claims 13-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/14/26.
Specification
The disclosure is objected to because of the following informalities:
It appears that in at least [0003] of the current Application’s PGPUB, “bicompatable” is misspelled and should likely read “biocompatible” instead. Applicant is encouraged to check the entirety of the specification for other instances of “biocompatable” instead of “biocompatible.”
Appropriate correction is required.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 line 2 reads “biocompatable material” and should likely read “[[biocompatable]] biocompatible material” as there appears to be a typo in the spelling of biocompatible
Appropriate correction is required.
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.
Claims 1-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Huntoon (U.S. PGPUB No. 2012/0323219) in view of Nguyen et al. (U.S. PGPUB No. 2011/0112576), hereinafter Nguyen.
Regarding claim 1, Huntoon discloses a medical device, comprising:
a flexible tubular body (710, see FIG. 7B) having a wall extending a length from a proximal end to a distal end forming a main lumen with an inner diameter (see [0067]: catheter 710 with guidewire extending through), a portion of the wall of flexible tubular body being fenestrated at the distal end (see openings 750 for providing drug therethrough such as in [0067]);
a cord (730, see [0007]) secured to the flexible tubular body (see [0007]) and extending from the distal end of the flexible tubular body (as seen in FIG.7B); and
an anchor (720) suitable for fixation to bone (see [0007] & [0066]), the anchor (720) comprising an anchor body (see ‘Modified FIG. 7B’ below), and
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wherein the cord (730) is received to detachably connect the distal end of the flexible tubular body to the anchor (see [0007]: guidewire releasably attached to anchor and [0072]: detachable from anchor. Therefore, distal end of tubular body also detachably connected to anchor by way of cord 730).
Huntoon discloses several coupling mechanisms between the cord and anchor (see [0072]: such as hook/eye couplings).
Huntoon is silent to “an aperture formed in the anchor body” and wherein the cord is received “in the aperture formed in the anchor body” to detachably connect the distal end of the flexible tubular body to the anchor.
However, Nguyen teaches a medical device, comprising: a flexible tubular body (41, see FIG.4) having a wall extending a length from a proximal end to a distal end forming a main lumen with an inner diameter (see [0072]), a cord (44) secured to (see [0073]: via channels 46 in shaft) the flexible tubular body (41) and extending from the distal end of the flexible tubular body (suture 44 extends to distal anchor 20, see [0073]); and an anchor (20, see FIG.5) suitable for fixation to bone (See [0074]), the anchor (20) comprising an anchor body (see body forming structure 20 in FIG.5) and an aperture (25b, see FIG. 5) formed in the anchor body (as seen in FIG.5. see also [0070]: anchor has through hole 25 with opening 25a/25b for housing suture),
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wherein the cord (44) is received in the aperture formed in the anchor body (see [0073]: suture 44 disposed in through hole 25 and see ‘Modified FIG. 5’ above for visual clarity) to detachably connect the distal end of the flexible tubular body to the anchor (see [0073]: “The suture 44 helps to keep anchor 20 coupled to the shaft 41” and [0070]: suture housed on anchor 20 after anchored into bone).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor body of the anchor detachably connected by a coupling mechanism to the cord disclosed in Huntoon to include an aperture in which the cord is received as taught by Nguyen.
A person of ordinary skill in the art could have combined the elements (Huntoon’s fenestrated catheter system comprising an anchor body detachably coupled to a cord combined with an anchor body comprising an aperture to receive and couple to a cord as taught in Nguyen) as claimed by known methods (forming a through hole in the anchor body for coupling a cord to the anchor as taught in Nguyen) with no change to the respective functions (both anchors are suitable for fixing into bone and deployed via flexible shaft systems. both anchors use coupling mechanisms to connect to a cord). Further, the combination would yield nothing more than predictable results (the device of Huntoon having an aperture through the anchor body that forms a coupling mechanism between the anchor and cord as taught in Nguyen) to one of ordinary skill in the art, thus achieving “an aperture formed in the anchor body” and wherein the cord is received “in the aperture formed in the anchor body” to detachably connect the distal end of the flexible tubular body to the anchor.
Regarding claim 2, the modified system of Huntoon teaches the medical device of claim 1, but Huntoon is silent to “wherein the cord is coupled to the wall of flexible tubular body.”
However, Nguyen teaches a medical device, comprising: a flexible tubular body (41, see FIG.4), an anchor (20, see FIG.5), and a cord (44), wherein the cord (44) is coupled to the wall of flexible tubular body (41, see [0073]: ends 44a/44b of suture 44 housed in channels 46 that extend along the shaft 41. As seen in FIG. 4, channels 46 formed in wall of shaft).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the walls of the flexible tubular body disclosed in Huntoon to include channels for housing the cord as taught by Nguyen. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a cord housed and deployed through a central lumen of the catheter disclosed in Huntoon) for another known element (a cord housed and deployed through wall lumens of the catheter as taught in Nguyen) in the art to obtain the predictable result of guiding the cord by way of catheter lumens (see MPEP § 2143.I.B), thus achieving “wherein the cord is coupled to the wall of flexible tubular body”.
Regarding claim 3, the modified system of Huntoon teaches the medical device of claim 1, but Huntoon is silent to “wherein the cord is embedded in the wall of the flexible tubular body.”
However, Nguyen teaches a medical device, comprising: a flexible tubular body (41, see FIG.4), an anchor (20, see FIG.5), and a cord (44), wherein the cord (44) is embedded in the wall of flexible tubular body (41, see [0073]: ends 44a/44b of suture 44 housed in channels 46 that extend along the shaft 41. As seen in FIG. 4, channels 46 formed in wall of shaft).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the walls of the flexible tubular body disclosed in Huntoon to include channels for housing the cord as taught by Nguyen. A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a cord housed and deployed through a central lumen of the catheter disclosed in Huntoon) for another known element (a cord housed and deployed through wall lumens of the catheter as taught in Nguyen) in the art to obtain the predictable result of guiding the cord by way of catheter lumens (see MPEP § 2143.I.B), thus achieving “wherein the cord is embedded in the wall of the flexible tubular body.”
Regarding claim 4, the modified system of Huntoon teaches the medical device of claim 1, and Huntoon further discloses wherein the cord (730, see FIG. 7B) has a cord length greater than the length of the flexible tubular body (cord 730 has a greater length by at least the length shown extending distally from the distal end of the catheter 710 as in FIG.7B. see also [0067]: catheter 710 advanced over 730 and [0006-0009]).
Regarding claim 5, the modified system of Huntoon teaches the medical device of claim 1, but Huntoon is silent to “wherein the cord comprises a suture material.”
However, Nguyen teaches a medical device, comprising: a flexible tubular body (41, see FIG.4), an anchor (20, see FIG.5), and a cord (44), wherein the cord (44) comprises a suture material (see [0092]: suture material such as bioabsorbable polymer, aligning with Applicant disclosure of suture materials in at least [0018] of the current Application’s PGPUB).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cord disclosed in Huntoon to comprise a suture material as taught by Nguyen for the purpose of forming the cord from a bioabsorbable material such that the cord may be left in the patient if required by the surgical process (see [0005]), thus achieving “wherein the cord comprises a suture material.”
Regarding claim 6, the modified system of Huntoon teaches the medical device of claim 1, and Huntoon further discloses wherein the anchor comprises a biocompatable material (see [0049]: such as polylactic acid).
Regarding claim 7, the modified system of Huntoon teaches the medical device of claim 1, and Huntoon further discloses wherein the anchor comprises a suture material (see [0049]: anchor can compose materials such as polylactic acid).
Regarding claim 8, the modified system of Huntoon teaches the medical device of claim 1, and Huntoon further discloses wherein the anchor is threaded (see [0049]: anchor can include threads).
Regarding claim 9, the modified system of Huntoon teaches the medical device of claim 1, and Huntoon further discloses wherein the anchor is self-driving (see [0049]: when anchor is turned, anchor screws into bone).
Regarding claim 12, the modified system of Huntoon teaches the medical device of claim 1, and Huntoon further discloses wherein the proximal end of the flexible tubular body is configured to removably connect to a reservoir suitable to contain a volume of medication in liquid form (see [0067]: drug pumped through catheter and out openings 750. see [0048]: ports provided at proximal end for medication).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Huntoon in view of Nguyen as applied to claim 1 above, and further in view of Rajendran et al. (U.S. Patent No. 10,238,830), hereinafter Raj.
Regarding claim 10, the modified system of Huntoon teaches the medical device of claim 1, and Huntoon further discloses that the flexible tubular body is a catheter (see [0067]).
Modified Huntoon is silent to “wherein the flexible tubular body is a 16 to 20 gauge catheter.”
However, Raj teaches a medical device (see col 11 line 49- col 12 line 5 and col 29 line 48- col 30 line 14) comprising a flexible tubular body (1552, see FIG. 15A), wherein the flexible tubular body is a 16 to 20 gauge catheter (see col 29 line 64- col 30 line 14).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to choose the size of the catheter disclosed in Huntoon to be a 16 to 20 gauge catheter as taught by Raj for the purpose of delivering the catheter to a specific location, such as that required by subarachnoid and epidural regional anesthesia/ pain management procedures (see col 9 lines 43-49), thus achieving “wherein the flexible tubular body is a 16 to 20 gauge catheter.”
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Huntoon in view of Nguyen as applied to claim 1 above, and further in view of Lange et al. (U.S. PGPUB No. 2017/0000974), hereinafter Lange.
Regarding claim 11, the modified system of Huntoon teaches the medical device of claim 1, and Huntoon discloses further comprising a port secured to the proximal end of the flexible tubular body (see [0067]: drug pumped through catheter and out openings 750. see [0048]: ports provided at proximal end for delivering medication).
Modified Huntoon is silent to further comprising “a luer connector” secured to the proximal end of the flexible tubular body.
However, Lange teaches a medical device (see [0001-0002]) comprising a flexible tubular body (1, see FIG. 8A and [0035]) and further comprising a luer connector (17) secured to a proximal end of the flexible tubular body (see [0035]) to enable fluid communication to a medicament reservoir (see [0035]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the port disclosed in Huntoon to be formed as a luer connector as taught by Lange for the purpose of enabling connection to multiple types of medicament reservoirs, such as a syringe or a medication pump (see [0035]), thus achieving further comprising “a luer connector” secured to the proximal end of the flexible tubular body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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