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 .
Response to Amendment
Claims 1-21 and 23-30 are pending. No new matter has been entered.
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.
Claims 1-5, 14-18, 20-22, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sharkey et al. (US 20030181964, henceforth Sharkey) in view of Saal et al. (US 20090259126, henceforth Saal) and Cunningham (US 20160339206, henceforth Cunningham).
Regarding claim 1, Sharkey discloses a minimally invasive device (Device shown in fig. 3a) for delivering a therapeutic agent percutaneously to a target tissue of an intervertebral disc (See [0085] and [0087] regarding collagen fluid, which is a therapeutic agent), the device comprising: a rigid introducer needle (Introducer 12, fig. 3a) including an elongated cannula (Lumen 13, fig. 3a) having a proximal end (End closer to handle 11, see fig. 3a) and a distal end (End closer to tip 29, see fig. 3a), the proximal and distal ends forming openings (Openings are where catheter 14 passes through introducer 12 – proximal portion 15 and intradiscal portion 16 in fig. 3a are understood to go through openings) and being in communication along the cannula (The openings must be in communication to allow for the catheter to pass through), and a stylet (Obturator of [0058]) extending through the cannula (Obturator is understood to be inserted into lumen 13 as in [0058]) and having a tip (The obturator is understood to have a tip as they are elongated members and thus must have a tip) that closes the opening at the distal end of the cannula (Since the obturator prevents clogging as in [0058], it is understood to close the opening at the distal end of the cannula), the cannula and stylet configured to allow insertion of the needle percutaneously into tissue (Insertion is allowed though skin when the devices are inserted as a combination as in [0058]); and a delivery catheter (Catheter 14, figs. 3a and 4) that fits coaxially through the introducer needle (See [0059] and figs. 3a and 3b, catheter 14 is inside of introducer 12) when the stylet is removed (Obturator is removed in [0058] leaving a hollow needle introducer behind; this is understood to be when the catheter is inserted; See also sequential insertions of [0057]), the delivery catheter being longer than the introducer needle (See fig. 4; catheter 14 extends beyond introducer 12) and including an elongated hollow shaft (Intradiscal portion 16, figs. 3a and 4) that has a preset bend (Tip 28 of intradiscal section 16 is bent as shown in fig. 3A and [0065]), the delivery catheter having a proximal end (Proximal portion 15, fig. 3A) and a distal end (End of intradiscal section closer to tip 28 is the distal end), the proximal and distal ends each forming an opening (See [0087] – the opening disclosed would have to be present at both ends for delivery of a fluid to be possible, see also discussion of hollow lumen 36 in [0085] and fig. 5A) and being in communication along the hollow shaft (See [0085], [0087] as above), the distal end of the delivery catheter including a blunt tip (Tip 29 is blunt, see [0071]), the delivery catheter being extendable from the distal end of the introducer needle and into a target tissue of an intervertebral disc (See fig. 4), the combination of the blunt tip and preset bend allowing the delivery catheter to advance through but not out of an annulus fibrosus of the intervertebral disc (See [0061] and fig. 4; the blunt tip and preset bend are what allow catheter 14 to advance along the annulus).
Sharkey does not disclose the preset bend providing a pre-shaped curved portion along a length of the delivery catheter. Cunningham teaches a delivery catheter (delivery cannula 300, fig. 10C) to be used inside of an introducer needle (guide cannula 200, fig. 10C) which has a preset bend (270° curve shown in fig. 10C of delivery cannula 300) which provides a pre-shaped curved portion (the portion of delivery cannula 300 extending beyond the distal end of guide cannula 200 in fig. 10C is a pre-shaped curved portion; see also Cunningham [0074] and figs. 14A and 14B) along a length of the delivery catheter (see figs. 14B and 10C; the delivery cannula 300 is not curved for its entire length as shown in the top of fig. 14B but is curved at the distal end where it has a predetermined shape 305, as is further shown as being curved where it extends beyond guide cannula 200 in fig. 10C). Cunningham additionally teaches that the characteristics of the shaping of the delivery catheter can be chosen depending on the exact target area and delivery profile ([0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have given the delivery catheter of Sharkey a pre-shaped curve at its distal end for a length of the delivery catheter for the benefit of providing therapeutics to multiple areas around a target (Cunningham [0074]) or having the delivery catheter travel along a predetermined desired path around a specific predetermined structure to deliver a therapeutic agent into the structure (Cunningham [0074]) such as the annulus fibrosus in intervertebral discs as in Sharkey.
Sharkey as modified does not disclose the device where the distal opening is a single side opening to the inside of the preset bend where the distal end of the delivery catheter comprises no openings other than the single side opening to the inside of the present bend. Saal teaches a delivery catheter (injection tubing 110, fig. 2A) having a preset bend (see fig. 2A, a curve which is a preset bend is shown near distal end 120; this is also called out as curved portion 109 in fig. 3 and as in [0075]) and a distal opening (injection port 112, fig. 2A) at a distal end of said delivery catheter (distal end 120, fig. 2A) where the distal opening is a single side opening (see fig. 2A, injection port 112 is shown as being in the side of injection tube 110) to the inside of the preset bend (see fig. 2A, injection port 112 is shown on the interior of the curve of the preset bend as shown; see also [0060], “because the injection port 112 is on the interior curve of the distal portion 114 of the injection tubing 110”) where the distal end of the delivery catheter comprises no openings other than the single side opening to the inside of the present bend (see fig. 2A, no other openings are shown at the distal end of the injection tube; see also fig. 3B which is the same embodiment as fig. 2A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the opening at the side of the delivery catheter on the inside of the preset bend as claimed as in Saal for the benefit of preventing inadvertent damage to the patient ([0060]) and particularly for reducing the likelihood that injected fluid would unintentionally enter a structure which could cause damage ([0060], [0075], [0107]), and further to have arranged the opening on the inside of the preset curve so that the fluid is delivered such that it reduces the likelihood of accidental injections into an artery ([0107]).
Regarding claim 2, Sharkey as modified discloses the device wherein the blunt tip is positioned on the shaft at the distal end of the delivery catheter at an angle that is offset from the center line of the delivery catheter (Shown in fig. 3A; the blunt tip is not on a straight center line from the catheter).
Regarding claim 3, Sharkey as modified discloses the delivery catheter (Catheter 14, figs. 3a and 4) having a blunt tip (Tip 29 is blunt, see [0071]) on the distal end of its hollow shaft (See fig. 3a). Additionally, Sharkey as modified disclose the use of radiographic markers such as stainless steel bands in the tip of its catheter ([0097]) but not all of the shaft being composed of the marker material ([0097]).
Sharkey as modified does not disclose the delivery catheter wherein the blunt tip is welded on the hollow shaft at the distal end of the delivery catheter and made of a material different from the shaft. Cunningham teaches use of a blunt tip ([0063]) which is integrally formed with the tip of an elongated, hollow tubular member (see fig. 4C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the blunt tip of Sharkey as modified with the blunt tip of Cunningham for gently pushing tissue out of its path during penetration to thereby minimize trauma to the subject's tissue (Cunningham [0063]). Such a replacement would have yielded the same, predictable result of the catheter being blunt at the end and presenting an atraumatic, rounded surface to the tissues it impacts during use.
{The applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113. The modification made here of replacing the tip of Sharkey as modified with the integrally formed tip of Cunningham, while not specifically welded, yields the same structure and is thus obvious.}
Regarding claim 4, Sharkey as modified discloses the device wherein the hollow shaft of the delivery catheter is made of nitinol ([0074] discloses the use of superelastic memory material such as a nickel-titanium alloy in a part of the catheter shaft; a superelastic memory material that is a nickel-titanium alloy is what nitinol is). {Additionally, Cunningham [0016] further teaches use of nitinol for catheter shafts under the term “shape memory alloys”, further evidencing the claim.}
Regarding claim 5, Sharkey as modified discloses the device wherein the blunt tip of the delivery catheter is made of stainless steel ([0097], the marker bands in the tip are made of stainless steel).
Regarding claim 14, Sharkey as modified discloses the device wherein the target tissue is a posterior outer third of the annulus fibrosus of the intervertebral disc. {The target tissue is recited functionally in claim 1 (“for delivering a therapeutic agent percutaneously to a target tissue of an intervertebral disc” and “for delivering a therapeutic agent percutaneously to a target tissue of an intervertebral disc”), and thus the device of Sharkey is only required to be capable of delivering to the posterior outer third of the annulus fibrosus of the intervertebral disc. This is further met as shown in fig. 4 where catheter 14 reaches the posterior medial portion 138, and there is no structure present in the modified device of Sharkey which would prevent it from being used in the outermost third of said posterior medial portion 138.}
Regarding claim 15, Sharkey as modified discloses the device wherein the introducer needle is configured to be inserted a pre-determined depth into the annulus fibrosus (See fig. 4, introducer 12 is inserted a predetermined depth into the annulus fibrosus as depicted where it goes into the nucleus pulposus 120; further, the claim limitation is only recited functionally where it reads “configured to be inserted”, meaning that the device of Sharkey is only required to be capable of said insertion) so that the combination of the starting point where the distal end of the delivery catheter exits the distal end of the introducer needle, the length the delivery catheter extends beyond the introducer needle when the catheter is fully extended beyond the distal end of the introducer needle, the preset bend of the delivery catheter, the blunt tip on the end of the delivery catheter, and stiffness or persistence length of the delivery catheter, results in the delivery catheter exiting into and staying within the tissue of the annulus fibrosus (the claimed combination of factors are all present in Sharkey as previously discussed; the result is also the same as shown in fig. 4, as the catheter 14 exits the introducer 12 and goes into and stays within the tissue of the annulus fibrosus).
Regarding claim 16, Sharkey as modified discloses the device wherein the delivery catheter is configured to be retracted from the target tissue in set intervals; at each interval, a portion of the therapeutic agent being introduced into the annulus fibrosus.
{The language of the claim is only functionally recited where it reads “configured to be retracted”, and thus the device only needs to be capable of said function. The device of Sharkey is capable of being retracted from the target tissue in set intervals as it is removed from the annulus fibrosus – while this removal is not explicitly stated, the procedure is not an implantation of the catheter and thus the catheter must be removed – and thus passes the interval locations where it would otherwise be stopped. Additionally, the introduction of therapeutic agent is capable of happening at any time during use in the device of Sharkey since there are no features to prevent this use and it is simply under control of the operator, and thus it is functionally capable of the claimed interval delivery.}
Regarding claim 17, Sharkey as modified discloses the device wherein the therapeutic agent is platelet rich plasma, bone marrow aspirate, bone marrow concentrate, adipose-derived cells, autologous or non-autologous fibrin, medications, contrast dye, or energy delivered over a fiber or probe (See [0050], [0085], and claim 19, fibrin is delivered and can be a part of a fluid; the fibrin of claim 19 must be either autologous or non-autologous because if fibrin is not autologous, it is non-autologous).
Regarding claim 18, Sharkey as modified discloses the device wherein the preset bend of the delivery catheter is such that the catheter upon exiting the introducer needle follows an oval path (See Sharkey fig. 4, catheter 14 is following an oval path – this is in part because of the bend of the tip of catheter 14 because it causes the device to continually deflect inwards and follow along the annulus fibrosus; See also fig. 10C of Cunningham and the modification made in claim 1, as Cunningham shows its curved portion as following an oval path as claimed).
Regarding claim 20, Sharkey as modified discloses the device wherein the length that the delivery catheter is extendable past the distal end of the introducer needle (See [0047] and fig. 4, catheter 14 extends past introducer 12) is sufficient to travel at least 75% of the circumference of a circle (See [0047] and fig. 4, since the distance of extension is in the range of 50%-150% the circumference of the nucleus, and the nucleus is roughly a circle, the distance is sufficient) based on the preset bend of the delivery catheter (The bent distal tip shown at 28 in fig. 3a is a contributing factor which causes catheter 14 to travel in an oval shape when inserted into the annulus fibrosus as shown in fig. 4; see Sharkey [0065]; see also Cunningham [0074]).
Regarding claim 29, Sharkey as modified discloses the device wherein the single side opening is orientable toward a center of the intervertebral disc for delivering a therapeutic agent to the target tissue (see rejection of claim 1 above; since the opening of Saal is added to the inside of the preset bend which is added from Cunningham, it is considered to be oriented toward the radial center of the intervertebral disc where a substance such as materials discussed in Sharkey [0130], which are pharmaceutical agents for therapy and thus therapeutic agents, can be delivered).
Regarding claim 21, Sharkey discloses a method for minimally invasive delivery of a therapeutic agent percutaneously (Device shown in fig. 3a deliver therapeutic fluids in chosen embodiment; See [0085] and [0087] regarding collagen fluid, which is a therapeutic agent; See also [0058] which discloses that the procedure is through the skin and thus is percutaneous) to target tissue of an intervertebral disc (See fig. 4, the target tissue is an intervertebral disc), through an introducer needle (Introducer 12, figs. 3a and 4) placed in the intervertebral disc (See fig. 4, the needle is in the intervertebral disc), the delivery catheter being longer than the introducer needle (See fig. 4; catheter 14 extends beyond introducer 12 because it is longer than it) and including an elongated hollow shaft (Intradiscal portion 16, figs. 3a and 4) that has a preset bend (Tip 28 of intradiscal section 16 is bent as shown in fig. 3A and [0065]), the delivery catheter having a proximal end (Proximal portion 15, fig. 3A) and a distal end (End of intradiscal section closer to tip 28 is the distal end), the proximal and distal ends each forming an opening (See [0087] – the opening disclosed would have to be present at both ends for delivery of a fluid to be possible, see also discussion of hollow lumen 36 in [0085] and fig. 5A) and being in communication along the delivery catheter (See [0085], [0087] as above), the distal end of the delivery catheter including a blunt tip (Tip 29 is blunt, see [0071]) such that when the distal end of the delivery catheter is extended from the distal end of the introducer needle, the blunt tip allows the delivery catheter to advance through but not out of an annulus fibrosus of the intervertebral disc (See [0061] and fig. 4; the blunt tip and preset bend are what allow catheter 14 to advance along the annulus); and delivering a therapeutic agent through the distal side opening to the target tissue (See [0087]).
Sharkey does not disclose the preset bend providing a pre-shaped curved portion along a length of the delivery catheter. Cunningham teaches a delivery catheter (delivery cannula 300, fig. 10C) to be used inside of an introducer needle (guide cannula 200, fig. 10C) which has a preset bend (270° curve shown in fig. 10C of delivery cannula 300) which provides a pre-shaped curved portion (the portion of delivery cannula 300 extending beyond the distal end of guide cannula 200 in fig. 10C is a pre-shaped curved portion; see also Cunningham [0074] and figs. 14A and 14B) along a length of the delivery catheter (see figs. 14B and 10C; the delivery cannula 300 is not curved for its entire length as shown in the top of fig. 14B but is curved at the distal end where it has a predetermined shape 305, as is further shown as being curved where it extends beyond guide cannula 200 in fig. 10C). Cunningham additionally teaches that the characteristics of the shaping of the delivery catheter can be chosen depending on the exact target area and delivery profile ([0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have given the delivery catheter of Sharkey a pre-shaped curve at its distal end for a length of the delivery catheter for the benefit of providing therapeutics to multiple areas around a target (Cunningham [0074]) or having the delivery catheter travel along a predetermined desired path around a specific predetermined structure to deliver a therapeutic agent into the structure (Cunningham [0074]) such as the annulus fibrosus in intervertebral discs as in Sharkey.
Sharkey as modified does not disclose the device where the distal opening is a single side opening to the inside of the preset bend where the distal end of the delivery catheter comprises no openings other than the single side opening to the inside of the present bend. Saal teaches a delivery catheter (injection tubing 110, fig. 2A) having a preset bend (see fig. 2A, a curve which is a preset bend is shown near distal end 120; this is also called out as curved portion 109 in fig. 3 and as in [0075]) and a distal opening (injection port 112, fig. 2A) at a distal end of said delivery catheter (distal end 120, fig. 2A) where the distal opening is a single side opening (see fig. 2A, injection port 112 is shown as being in the side of injection tube 110) to the inside of the preset bend (see fig. 2A, injection port 112 is shown on the interior of the curve of the preset bend as shown; see also [0060], “because the injection port 112 is on the interior curve of the distal portion 114 of the injection tubing 110”) where the distal end of the delivery catheter comprises no openings other than the single side opening to the inside of the present bend (see fig. 2A, no other openings are shown at the distal end of the injection tube; see also fig. 3B which is the same embodiment as fig. 2A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the opening at the side of the delivery catheter on the inside of the preset bend as claimed as in Saal for the benefit of preventing inadvertent damage to the patient ([0060]) and particularly for reducing the likelihood that injected fluid would unintentionally enter a structure which could cause damage ([0060], [0075], [0107]), and further to have arranged the opening on the inside of the preset curve so that the fluid is delivered such that it reduces the likelihood of accidental injections into an artery ([0107]).
Regarding claim 25, Sharkey as modified discloses the method wherein the therapeutic agent is platelet rich plasma, bone marrow aspirate, bone marrow concentrate, adipose-derived cells, autologous or non-autologous fibrin, medications, contrast dye, or energy delivered over a fiber or probe (See [0050], [0085], and claim 19, fibrin is delivered and can be a part of a fluid; the fibrin of claim 19 must be either autologous or non-autologous because if fibrin is not autologous, it is non-autologous).
Regarding claim 26, Sharkey as modified discloses the method further comprising inserting the introducer needle with a stylet (Obturator of [0058]) positioned coaxially within the introducer needle (Obturator is understood to be in lumen 13 as in [0058]) to a pre-determined depth into the annulus fibrosus (See fig. 4 for a depiction of the possible pre-determined depth into the annulus fibrosus), and removing the stylet prior to advancing the delivery catheter (Obturator is removed in [0058] leaving a hollow needle introducer behind; this is understood to be when the catheter is inserted; See also sequential insertion of [0057]).
Regarding claim 30, Sharkey as modified discloses the method further comprising orienting the single side opening toward a center of the intervertebral disc for delivering a therapeutic agent to the target tissue (see rejection of claim 21 above; since the opening of Saal is added to the inside of the preset bend which is added from Cunningham, it is considered to be oriented toward the radial center of the intervertebral disc where a substance such as materials discussed in Sharkey [0130], which are pharmaceutical agents for therapy and thus therapeutic agents, can be delivered).
Claims 6-9, 23, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Sharkey (US 20030181964) in view of Saal et al. (US 20090259126) and Cunningham (US 20160339206, henceforth Cunningham) as applied to claims 1 and 21 above, respectively, and further in view of Podhajsky (US 20090088671, henceforth Podhajsky).
Regarding claim 6, Sharkey as modified discloses the introducer needle (Introducer 12, fig. 3a).
Sharkey as modified does not disclose the device wherein the cannula of the introducer needle has a preset bend at the distal end of the cannula. Podhajsky discloses an introducer needle (Introducer cannula 102, fig. 5) with a cannula (Rigid tubular shaft 108, fig. 5) which has a preset bend (arcuate portion 110, fig. 5) at its distal end (distal end portion 112, fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the introducer needle of Sharkey to have a preset bend at the distal end of the cannula as in Podhajsky for allowing for proper orientation and direction of the delivery catheter upon its insertion (Podhajsky [0037], note that probe 104 referred to in Podhajsky is equivalent to the delivery catheter of Sharkey regarding the azimuthal orientation).
Regarding claims 7 and 28, Sharkey as modified discloses the bent portion of the delivery catheter is pre-bent at about 5-10 mm from the distal tip ([0125]).
Sharkey as modified does not explicitly disclose the device wherein the preset bend at the distal end of the cannula is about 3 mm to about 9 mm from the distal tip with an angle between about 4 degrees and about 6 degrees, nor does it explicitly teach the preset bend being about 6.25 mm from the distal tip with an angle of about 5 degrees. Podhajsky teaches that the preset bend may assume a variety of angular orientations depending on the surgical procedure to be performed.
Since Sharkey and Podhajsky teach that the length of a bent portion and angle at which it is bent are needed to achieve the desired surgical characteristics, it would be obvious to alter the length and angle as recited in the claim as it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). One of ordinary skill in the art would have been able to routinely determine the length and angle needed for the desired delivery of the delivery catheter in line with the teachings of Sharkey and Podhajsky and achieved the desired delivery by modifying and using the modified introducer needle of Sharkey.
Regarding claim 8, Sharkey as modified teaches the introducer needle (introducer 12, fig. 3a) with a cannula (lumen 13, fig. 3a) and the stylet (Obturator of [0058]).
Sharkey is silent to the use of handles with respect to the introducer needle and stylet. Podhajsky teaches an introducer needle (cannula 102, fig. 5) which has a two-part handle (handle 116 and hub 150, fig. 45 and [0041], [0044]) with a first part of the handle attached to the cannula (Handle 116, fig. 5 and [0041]) and a second part of the handle attached to the stylet (Proximally positioned hub 150, fig. 5 and [0041]; stylet of Podhajsky is 148 and is equivalent to the obturator of [0058] of Sharkey), each part attached at the proximal end of the introducer needle (See fig. 5 and [0041], they are attached when locked together during insertion), the second part of the handle and stylet being selectively removable from the cannula (See [0051], the stylet is removed), and wherein the first part of the handle defines a passageway (Handle 116 is understood to be a passageway since stylet 148 is going through it removably) in communication with the opening at the distal end of the introducer needle (See fig. 5, the handle is at the other end from cannula tip 114 and is in communication therewith) when the second part of the handle and stylet are removed (See [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the handles of Podhajsky to the proximal ends of the respective equivalent devices in Sharkey for facilitating manipulation of the respective attached members (Podhajsky [0037]).
Regarding claim 9, Sharkey as modified discloses the device wherein the first part of the handle includes a luer hub (Podhajsky [0044]).
Regarding claim 23, Sharkey as modified discloses the method wherein the target tissue is the annulus fibrosus of the intervertebral disc (See fig. 4 where catheter 14 reaches the posterior medial portion 138; this appears to be the outer third of the disc). Further, Sharkey appears to be structurally capable of delivery to the posterior outer third of the annulus fibrosus of the intervertebral disc.
Sharkey does not explicitly teach delivery to a posterior outer third of the annulus fibrosus of the intervertebral disc. Podhajsky teaches delivery of therapeutic treatment to target tissue of the annulus fibrosus of the intervertebral disc which is a posterior outer third of the annulus fibrosus of the intervertebral disc (see fig. 9; this appears to approximately be a posterior outer third of the annulus fibrosus of the intervertebral disc), or more generally, delivery of treatment to an area of the intervertebral disc and annulus fibrosus which has suffered an injury ([0050]-[0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the apparatus of Sharkey as modified to deliver to a posterior outer third of the annulus fibrous of the intervertebral disc if the injured tissue requiring treatment was this area as Sharkey appears to be capable of such a delivery and Podhajsky further teaches such a therapeutic delivery with a similar system to Sharkey (Podhajsky figs. 7-9 and [0050]-[0056]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sharkey (US 20030181964) in view of Saal et al. (US 20090259126) and Cunningham (US 20160339206, henceforth Cunningham) as applied to claim 1 above, and further in view of Talmadge (US 20080027554, henceforth Talmadge).
Regarding claims 10 and 11, Sharkey as modified discloses the delivery catheter (Catheter 14, fig. 4) including a proximal end (Proximal portion 15, fig. 3A).
Sharkey as modified does not disclose the device wherein the delivery catheter includes a luer lock connection at the proximal end of the delivery catheter. Additionally, Sharkey does not teach the device wherein the luer lock enables delivery of the therapeutic agent from a syringe holding the therapeutic agent and being coupled to the luer lock. Talmadge teaches use of a syringe to engage a catheter that has been positioned inside an introducer inside an intervertebral disc ([0031]) and the syringe delivering an agent ([0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery catheter of Sharkey to add a luer lock connection to engage a syringe to deliver therapeutic agent as in Talmadge ([0031]). Such a modification would have to have been done onto the proximal end of the delivery catheter since it is the end of the catheter available to the operator as in figs. 3a and 4 of Sharkey since the distal end of the catheter is inserted into the patient.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Sharkey (US 20030181964) in view of Saal et al. (US 20090259126) and Cunningham (US 20160339206, henceforth Cunningham) as applied to claim 1 above, and further in view of Ayala et al. (US 20050059990, henceforth Ayala).
Regarding claim 12, Sharkey as modified discloses the introducer needle (introducer 12, fig, 3a) inserted into target tissue (See fig. 4).
Sharkey does not teach the device wherein the introducer needle has markings on the outside that allow determining the distance of insertion into the target tissue. Ayala teaches a system of viewable indicators on proximal portions of tubular members ([0016]), including an introducer needle (the catheter of [0016] is analogous to the introducer needle in Sharkey, with the scopes and other elongate medical devices of [0017] and [0018] of Ayala being analogous to the delivery catheter in Sharkey).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added markings to the introducer needle of Sharkey as in Ayala for confirming proper alignment, engagement, and insertions of the introducer needle (Ayala [0016] and [0017]). Such a modification would then render the modified device capable of allowing determining the distance of insertion into the target tissue as is functionally required by the claim.
Regarding claim 13, Sharkey as modified discloses the device wherein the delivery catheter has one or more markings on the proximal end on the outside (Sharkey: Markings 38, fig. 5a and [0095]) that allow determining the distance the delivery catheter is inserted beyond the introducer needle or retracted from the target tissue (See [0095], the markings render the device capable of the functionally claimed limitation, “allow determining the distance”).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sharkey (US 20030181964) in view of Saal et al. (US 20090259126) and Cunningham (US 20160339206, henceforth Cunningham) as applied to claim 18 above, as evidenced by Prokop (US 20080125747, henceforth Prokop).
Regarding claim 19, Sharkey as modified discloses the device wherein the preset bend of the delivery catheter is such that the catheter upon exiting the introducer needle follows a path having an initial diameter between about 1.5 cm and about 3.5 cm (See fig. 4; catheter 14 travels along the interior of the annulus fibrosus in part because of the preset bend of the catheter which influences its travel. The device of Prokop travels in substantially the same area, the curved inner wall of the annulus fibrosus as in [0034] and shown in fig. 1. This curvature has a radius of about 1 to about 5 centimeters, or a diameter of about 2 to about 10 centimeters, as taught in [0034]. This shows that the diameter which the catheter of Sharkey follows is approximately the same, and since the claimed ranges overlap considerably, shows that the range was at least obvious. See MPEP 2144.05(I).).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Sharkey (US 20030181964) in view of Saal et al. (US 20090259126) and Cunningham (US 20160339206, henceforth Cunningham) as applied to claim 21 above, and further in view of Forrest (US 20110071639, henceforth Forrest).
Regarding claim 24, Sharkey as modified discloses the method including delivering a therapeutic agent (See [0087]).
Sharkey as modified does not disclose the device wherein delivering the therapeutic agent includes retracting the delivery catheter from the target tissue in set intervals and, at each interval, delivering a portion of the therapeutic agent to the target tissue. Forrest teaches treatment of intervertebral discs occurring in set intervals as its device is incrementally withdrawn ([0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have delivered the therapeutic agent of Sharkey while retracting the delivery catheter in set intervals for thorough treatment spread out over the desired treatment area (Forrest [0074]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Sharkey (US 20030181964) in view of Saal et al. (US 20090259126) and Cunningham (US 20160339206) as applied to claim 21 above, and further in view of Talmadge (US 20080027554) and Whiting et al. (US 20120035590, henceforth Whiting).
Regarding claim 27, Sharkey discloses the method including advancing the delivery catheter into the target tissue (See fig. 4, catheter 14 is in the intervertebral disc) and use of a stylet (See [0058]).
Sharkey does not disclose the method wherein advancing the delivery catheter into the target tissue includes guiding the delivery catheter with a stylet positioned coaxially within the delivery catheter. Talmadge teaches a method including an introducer needle (Outer needle, see [0029]) through which a delivery catheter is advanced (Inner delivery needle, see [0029], which is the catheter device of [0069]) wherein advancing the delivery catheter into the target tissue includes guiding the delivery catheter with a stylet (Guidewire of [0029]) positioned coaxially within the delivery catheter (See [0069], the catheter device is passed over the guidewire meaning the guidewire is coaxial with the catheter for the chosen embodiment where the catheter has 1 lumen; additionally, the needle is not required to be removed in [0069], meaning that the catheter device can be inserted over the guidewire inside of the needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have advanced the delivery catheter over a stylet as taught in Talmadge for helping to facilitate placement of the delivery catheter (Talmadge [0029]).
Sharkey as modified does not disclose the method wherein the stylet is blunt. Whiting teaches a stylet (guidewire 10) with a blunt distal end (end 34, see [0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stylet of Sharkey used in the order taught by Talmadge to have a blunt tip as in Whiting for reducing the risk of damaging tissue during manipulation of the stylet (Whiting [0067]).
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive.
Applicant first argues that a person of ordinary skill in the art would not have been motivated to combine the references relied upon for the rejection of claims as the different references are drawn to treatment in different spaces within the body. The different references relied on for the rejection are all considered to be relevant to each other where they are each drawn to navigation about structures of or supporting the nervous system, such as the brain, spinal cord, and spinal column. Additionally, regarding the varied rigidities of the different references, the rigidities of different references are not relied upon in the modifications of Sharkey; the different motivations for the respective modifications relied upon would still apply to the device of Sharkey, and thus this is found unpersuasive.
Applicant further argues that the motivation for combining Sharkey and Saal are not relevant to the target tissue of Sharkey because blood vessels, the dura, and other nerve structures are not in the nucleus pulposus. As provided by Applicant, the motivation for combining Sharkey and Saal is “to have arranged the opening at the side of the delivery catheter on the inside of the present bend as claimed as in Saal for the benefit of preventing inadvertent damage to the patient ([0060]) and particularly for reducing the likelihood that injected fluid would unintentionally enter a structure which could cause damage ([0060], [0075], [0107]), and further … so that the fluid is delivered such that it reduces the likelihood of accidental injections into an artery”. This motivation is applicable to the teachings of Sharkey as the annulus fibroses is located near the spinal cord and blood vessels; while the nucleus pulposus may not include those structures, improper delivery of fluid or inadvertent damage to other structures surrounding or near the annulus fibrosus would still preferably be avoided and thus the motivation to combine the references is still valid and Applicant’s argument is found unpersuasive.
Applicant finally argues that the relied upon combination of references does not disclose a delivery catheter that can advance through an annulus fibrosus of the intervertebral disc as claimed. Independent claims 1 and 21 require “the combination of the blunt tip and preset bend allowing the delivery catheter to advance through but not out of an annulus fibrosus of the intervertebral disc” and “the blunt tip allows the delivery catheter to advance through but not out of an annulus fibrosus of the intervertebral disc”, respectively. Sharkey at [0061] teaches “FIG. 4 illustrates the anatomy of an intervertebral disc and shows an apparatus of the invention inserted into a disc.” Fig. 4 (provided below) shows the device of Sharkey inserted into the anterior medial inner annulus 152 of annulus fibrosus 122; this shows that the device is functionally and structurally capable of advancement through the annulus fibrosus as claimed. Further, [0062] of Sharkey further discloses the catheter having sufficient column strength to avoid collapse; one of ordinary skill in the art would recognize that modifications made to the device of Sharkey should maintain this strength to avoid collapse and maintain device functionality.
Thus, each of Applicant’s arguments is respectfully found unpersuasive and Examiner maintains the rejections relied on above.
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Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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