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 .
DETAILED ACTION
Status of Claims
This office action is responsive to the arguments filed on 08/07/2026. As directed by the amendment: claims 18-20 are withdrawn. Thus, claims 1-17 and newly added claims 21-22 are presently pending in this application.
Response to Arguments
Applicant's arguments with respect to claims 1-17 have been fully considered but are not found to be persuasive. On page 6 of the response, it is argued that Fulkerson fails to disclose “the projections are formed of a soluble material configured to dissolve” since it’s the drug 408 that dissolves when in interacts with tissue/fluid. Furthermore, it is argued that no structural element of the stent or the drug delivery feature itself is dissolvable. This is not found to be persuasive because claim 1 broadly requires “at least a portion of the projections are formed of a soluble material configured to dissolve”. Fulkerson discloses the projections or drug delivery features 404 comprise the drug 408 where the drug 408 makes up at least a portion of the projection or drug delivery feature 404. Furthermore, par. 0022 of Fulkerson discloses the projections or drug delivery features that include 112 and 404 are made of bioresorbable/biodegradable materials which are fully capable of dissolving to release the drug 408 from drug depots 406, as required by claim 1. Therefore, Marin in view of Paul and Fulkerson discloses the claimed invention of claim 1 including the projections are formed of a soluble material configured to dissolve.
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.
Claims 1-4, 6, 7, 9-12 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Marin et al. (5397355) “Marin” in view of Paul JR. et al. (2012/0035708) “Paul” further in view of Fulkerson et al. (2017/0100266) “Fulkerson”.
Regarding claims 1 and 21-22, Marin discloses a stent 10 (Fig. 1) for treating tissue within tubular structures of a subject (abstract), the stent comprising: a tubular body (col. 2, lin. 39-40 discloses tubular) extending along a central axis and configured to move between a retracted position and an elongated position (Fig. 3 discloses unexpanded/retracted position and Fig. 4 discloses the expanded/elongated stent; col, 3. Lin. 3-11); and a plurality of projections 18 (Figs. 3-4) formed into the tubular body (rib 14 of tubular body of stent; Fig. 3), each projection 18 forming a cutting edge to pierce a tissue within a tubular structure of the subject (Figs. 3-4 and col. 3, lin. 11-15 disclose the projections 18 having a cutting triangular edge which penetrate the inner lining of the blood vessel), wherein each projection among the plurality of projections is configured to change orientation relative to the central axis when the tubular body moves between the retracted position and the elongated position; further comprising hinges between the tubular body and the plurality of projections (Figs. 1-4 and col. 3, lin. 8-11 disclose the projections move radially outwardly from the stent surface like hinges as the stent expands). Marin is silent regarding each projection including drug depots that, when the cutting edge pierces the tissue, are configured to be injected into the tissue and wherein at least a portion of the projections are formed of a soluble material configured to dissolve and release one or more therapeutic agents from the drug depots; plastic hinges; and wherein the plurality of projections fully dissolve.
However, Paul teaches a similar stent 120 (Fig. 7B) comprising projections 14’ (Fig. 8A) including drug depots 43 (par. 0052 discloses barbs 14 have tips 43 with pores that allow for drug delivery). The combination of the drug storing pores in Paul with the tissue piercing projections 18 (col. 3, lin. 11-15) of Marin arrive at the intended use that when the cutting edge pierces the tissue, the drug depots are configured to be injected into the tissue. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent in Marin to include each projection including drug depots that, when the cutting edge pierces the tissue, are configured to be injected into the tissue, as taught and suggested by Paul, for providing therapeutic drug delivery at the site of implantation (par. 0052).
Furthermore, Fulkerson teaches a similar stent 400 (Fig. 4) comprising a soluble material configured to dissolve and release one or more therapeutic agents from the drug depots 406 (par. 0037 and Fig. 4 discloses drug delivery feature 404 which dissolves to release drug 408 from reservoir/depot 406); plastic plurality of projections (par. 0022 discloses projections 112 made of plastic material); and wherein the plurality of projections 112/404 fully dissolve (par. 0022 discloses bioresorbable/biodegradable polymeric material which is dissolvable). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent projections and hinges in Marin in view of Paul to include a soluble material configured to dissolve and release one or more therapeutic agents from the drug depots; plastic hinges; and wherein the plurality of projections fully dissolve, as taught and suggested by Fulkerson, for providing a drug delivery mechanism with an effective means for selectively delivering a drug to a desired location, while reducing inadvertent loss or release of drugs (par. 0037).
Regarding claims 2 and 10, Marin discloses wherein when the tubular body is in the retracted position, the plurality of projections form a cylindrical outer surface of the tubular body, and wherein when the tubular body is in the elongated position, the plurality of projections extends radially outward from the tubular body into a deployed position to pierce the tissue proximate to the tubular body (col, 3, lin. 1-15 disclose the projections lie flat in the surface of the tubular member in the retracted position and when the stent expands, the projections extend radially outward and penetrate the inner lining).
Regarding claims 3 and 11, Marin discloses wherein the projections 18 define a needle angle between about 1 degree and about 90 degrees relative to the central axis when the projections are in a deployed position (Fig. 4 discloses the projections 18 when they extend radially outward, the angle between the base and the projection tip is less than 90).
Regarding claims 4 and 12, Marin discloses wherein the projections are triangular-shaped, with a first edge and a second edge defining the cutting edge (as shown in Fig. 3), and a base 14 of the triangular-shaped projections defining an uncut portion of the tubular body (as shown in Fig. 3, rib 14 is attached to the tubular body).
Regarding claim 6, Marin discloses the plurality of projections 18 are formed by a pattern of interconnected cuts into the tubular body (col. 2, lin. 42-44 disclose laser cutting the stent at openings 12 to form barbs 18).
Regarding claim 7, Marin discloses wherein the plurality of projections 18 are circumferentially arranged around the tubular body (as shown in. Figs. 1-2).
Regarding claim 9, Marin discloses a stent system 10 (Fig. 1) for treating a tissue of a subject (abstract), the system comprising: a tubular body (col. 2, lin. 39-40 discloses tubular) extending along a central axis to form a lumen within the tubular body, an actuator (col. 2, lin. 26-29 and 55-57 disclose balloon deployment) received within the lumen and configured to move the tubular body between a retracted position and an elongated position (col. 2, lin. 26-29 and 55-57); and a pattern of a plurality of cuts 12 (Fig. 3) formed along the tubular body and extending through the tubular body to the lumen (col. 2, lin. 42-44 disclose laser cutting the stent at openings 12 to form barbs 18), wherein the pattern of the plurality of cuts deploy into a plurality of interconnected projections 18 that are configured to extend radially away from the tubular body relative to the central axis to engage a tissue within a tubular structure of a subject when the tubular body is moved towards the elongated position (col, 3, lin. 1-15 disclose the projections lie flat in the surface of the tubular member in the retracted position and when the stent expands, the projections extend radially outward and penetrate the inner lining).
Marin is silent regarding the projections include drug depots configured to inject the drug depots into the tissue when the plurality of cuts engage the tissue within the tubular structure of the subject and wherein at least a portion of the projections are formed of a soluble material configured to dissolve and release one or more therapeutic agents from the drug depots. However, Paul teaches a similar stent 120 (Fig. 7B) comprising projections 14’ (Fig. 8A) including drug depots 43 (par. 0052 discloses barbs 14 have tips 43 with pores that allow for drug delivery). The combination of the drug depots in Paul with the tissue piercing projections 18 (col. 3, lin. 11-15) of Marin arrive at the intended use of being configured to inject the drug depots into the tissue when the plurality of cuts engage the tissue within the tubular structure of the subject. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent in Marin to include the projections include drug deposits configured to inject the drug depots into the tissue when the plurality of cuts engage the tissue within the tubular structure of the subject, as taught and suggested by Paul, for providing therapeutic drug delivery at the site of implantation (par. 0052).
Furthermore, Fulkerson teaches a similar stent 400 (Fig. 4) comprising a soluble material configured to dissolve and release one or more therapeutic agents from the drug depots 406 (par. 0037 and Fig. 4 discloses drug delivery feature 404 which dissolves to release drug 408 from reservoir/depot 406). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent projections in Marin in view of Paul to include a soluble material configured to dissolve and release one or more therapeutic agents from the drug depots, as taught and suggested by Fulkerson, for providing a drug delivery mechanism with an effective means for selectively delivering a drug to a desired location, while reducing inadvertent loss or release of drugs (par. 0037).
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Marin et al. (5397355) “Marin” in view of Paul JR. et al. (2012/0035708) “Paul” further in view of Fulkerson et al. (2017/0100266) “Fulkerson” further in view of Ischinger (2009/0005857).
Regarding claim 5, Marin in view of Paul and Fulkerson discloses the claimed invention of claims 1; except for wherein the elongated position of the tubular body defines an elongated length that is between about 1% and about 100% greater than an initial length of the tubular body in the retracted position. However, Ischinger teaches a similar stent comprising an elongated position of a tubular body defines an elongated length that is between about 1% and about 100% greater than an initial length of the tubular body in the retracted position (Fig. 9e and par. 0087 disclose the axial length of the stent increases after expansion due to the longitudinal and circumferential elements expanding).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent in Marin in view of Paul and Fulkerson to include the elongated position of the tubular body defines an elongated length that is between about 1% and about 100% greater than an initial length of the tubular body in the retracted position, as taught and suggested by Ischinger, for allowing the stent to cover a larger axial portion of the blood vessel.
Regarding claim 13, Marin in view of Paul and Fulkerson discloses the claimed invention of claim 9; except for wherein the actuator is configured to elongate the tubular body to an elongated length that is between about 1% and about 100% greater than an initial length of the tubular body in the retracted position. However, Ischinger teaches a similar balloon activated stent (abstract) comprising the actuator is configured to elongate the tubular body to an elongated length that is between about 1% and about 100% greater than an initial length of the tubular body in the retracted position (Fig. 9e and par. 0087 disclose the axial length of the stent increases after expansion due to the longitudinal and circumferential elements expanding).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent and actuator in Marin in view of Paul and Fulkerson to include the actuator is configured to elongate the tubular body to an elongated length that is between about 1% and about 100% greater than an initial length of the tubular body in the retracted position., as taught and suggested by Ischinger, for allowing the stent to cover a larger axial portion of the blood vessel.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Marin et al. (5397355) “Marin” in view of Paul JR. et al. (2012/0035708) “Paul” further in view of Fulkerson et al. (2017/0100266) “Fulkerson” further in view of White et al. (2002/0123790) “White”.
Marin in view of Paul and Fulkerson discloses the claimed invention of claim 1; except for at least a portion of the stent is coated with a therapeutic agent. However, White teaches a similar stent comprising t least a portion of the stent is coated with a therapeutic agent (par. 0030 discloses cell growth coating). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent in Marin in view of Paul and Fulkerson to include at least a portion of the stent is coated with a therapeutic agent, as taught and suggested by White, for promoting cell growth (par. 0030 of White).
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Marin et al. (5397355) “Marin” in view of Paul JR. et al. (2012/0035708) “Paul” further in view of Fulkerson et al. (2017/0100266) “Fulkerson” further in view of Campbell et al. (2008/0033477) “Campbell”.
Marin in view of Paul and Fulkerson discloses the claimed invention of claim 9; except for the actuator is a pneumatic actuator including an actuator body having an interior cavity and an inlet port, wherein the inlet port is configured to be in fluid communication with a pressurized fluid source to provide pressurized fluid to the interior cavity; wherein the pneumatic actuator comprises an elastomeric material; wherein the actuator body includes a fiber reinforcement extending along at least a portion of the length of the actuator body and wherein the fiber reinforcement includes strands of fibers arranged in a helical pattern.
However, Campbell teaches a similar stent actuating system comprising a pneumatic actuator (balloon and sheath portion 28; par. 0021 and Fig. 1; par. 0046 discloses the actuator is inflating with a fluid) including an actuator body 28 having an interior cavity and an inlet port 34 (Fig. 1), wherein the inlet port is configured to be in fluid communication with a pressurized fluid source to provide pressurized fluid to the interior cavity (par. 0046 discloses the inflating fluid injected into the introducer inflation port using inflation pressure); wherein the pneumatic actuator comprises an elastomeric material (elastomer sheath 28; pars. 0021 and 0046); wherein the actuator body includes a fiber reinforcement 39 (Fig. 1) extending along at least a portion of the length of the actuator body and wherein the fiber reinforcement includes strands of fibers arranged in a helical pattern (par. 0024 disclose the fiber reinforced balloon is wrapped in a spiral configuration 52 with the reinforced fiber).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator in Marin in view of Paul and Fulkerson to include a pneumatic actuator including an actuator body having an interior cavity and an inlet port, wherein the inlet port is configured to be in fluid communication with a pressurized fluid source to provide pressurized fluid to the interior cavity; wherein the pneumatic actuator comprises an elastomeric material; wherein the actuator body includes a fiber reinforcement extending along at least a portion of the length of the actuator body and wherein the fiber reinforcement includes strands of fibers arranged in a helical pattern, as taught and suggested by Campbell, for allowing a uniform distribution of force when expanding the stent whilst keeping a compact profile (par. 0007 of Campbell).
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 extension fee 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 comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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