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
The objection to the claims are withdrawn in light of Applicant’s amendments.
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.
The rejection of Claims 22-27, and 29-31 is withdrawn in light of Applicant’s amendments.
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.
Claims 21-35 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (US 2017/0238965 A1—previously cited) in view of Kreidler et al. (US 20040220610 A1).
Regarding claim 21, Murphy discloses a catheter system (paras. [0025]-[0044]) comprising: a catheter 146 including a first proximal end (as shown at the proximal end of Fig 8), a first distal end (i.e., connecting to 142), and a first elongate body extending between the first proximal end and the first distal end (Fig. 8; i.e., the first elongate body under BRI is the body of the catheter); an expandable pump 142 coupled to the first distal end (Fig. 8); and an outer sheath 100 including a second proximal end (i.e., shown in Fig. 8 at proximal end), a second distal end (i.e., as shown in Fig. 8 which 102 is inserted), and a second elongate body extending between the second proximal end and the second distal end (Fig. 8); wherein, in a first configuration having a tubular form, a first sheath portion 102 is extendable over the first elongate body (Fig. 8) and the expandable pump (para. [0048]) for a percutaneous advancement of the expandable pump and catheter through a patient's vasculature to a desired location to perform a medical procedure while the pump is expanded (para. [0043]-[0044]), wherein the first sheath portion maintains the expandable pump in a stored configuration during advancement of the expandable pump and catheter through the patient’s vasculature to the desired location (i.e., during advancement into the blood vessel, the pump goes through hub assembly 100 such that advancement of the expandable pump, the expandable pump is in a stored position until reaching the desired location (see also para. [0029]); wherein, while the expandable pump remains in the desired location to perform the medical procedure (para. [0030]), a second sheath portion 110 is withdrawn from the patient’s vasculature to eliminate a corresponding obstruction of blood flow in the patient’s vasculature by the second sheath portion (para. [0029] i.e., and similarly as described related to hub 50 as disclosed in para. [0028], [0030]); and wherein, once withdrawn from the patient’s vasculature, the second sheath portion 100 is configured to divide in a controlled manner into a second configuration having a non-tubular form for removal from the first elongate body (para. [0030], [0042]-[0044]).
The device of Murphy is fully capable of the second sheath portion being retractable over the first sheath portion while withdrawing, and once withdrawn from the patient’s vasculature, the second sheath portion is configured to divide in a controlled manner into a second configuration having a non-tubular form for removal from the first elongate body if one desired to do so (i.e., see Fig. 8 which shows it would be capable to retract 102 out of the blood vessel prior to splitting the sheath for removal at least to ensure easy removal of sheath 102 through 150 since 150 is dimensioned to accommodate 102 (i.e., see para. [0043]) such that removal of sheath 102 prior to splitting would make removal easier)- note that the limitations of claim 21 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Murphy doesn’t directly disclose a second sheath separate from the outer sheath, the second sheath being advanceable within the patient’s vasculature and over the first elongate body of the catheter after the second sheath portion has been divided.
In the same field of endeavor of delivery devices (and more specifically peel-away sheaths), Kreidler et al. discloses a similar device to Murphy including an implant 304 and a peel-away sheath (i.e., outer sheath) 512.
Murphy also discloses a second sheath 514 separate from the outer sheath (para. [0208]), the second sheath being advanceable within the patient’s vasculature (para. [0208] discloses that the recapture sheath is advanced distally) and over the first elongate body of the catheter 540 (see para. [0185]; Fig. 23) after the second sheath portion has been divided (para. [0208]).
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 device of Murphy to have a second sheath separate from the outer sheath, the second sheath being advanceable within the patient’s vasculature and over the first elongate body of the catheter after the second sheath portion has been divided as disclosed by Kreidler for purposes of collapsing and recapturing the expandable implant (para. [0206]).
Regarding claim 22, Murphy and Kreidler disclose the catheter system of Claim 21. Murphy also discloses wherein the second elongate body includes at least one longitudinally-extending separation zone 14, 122 for at least a portion of the second elongate body for removal from the first elongate body at a location exterior to the patient’s vasculature (para. [0025]-[0028], [0030]).
Regarding claim 23, Murphy and Kreidler disclose the catheter system of Claim 22. Murphy also discloses the at least one longitudinally-extending separation zone extends entirely from the second proximal end to the second distal end (i.e., para. [0034] discloses that the sheath 102 may be torn along the longitudinal scoring 122 to remove the assembly including the longitudinal sheath 102 such that removal of the elongate sheath would require the scoring to extend the entire length of the sheath).
Regarding claim 24, Murphy and Kreidler disclose the catheter system of Claim 21. Murphy also discloses the second elongate body includes at least one seam 122, the at least one seam defining a line of weakness to divide a portion of the second elongate body (para. [0030]).
Regarding claim 25, Murphy and Kreidler disclose the catheter system of Claim 24. Murphy also discloses the at least one seam is a linear seam (para. [0030]).
Regarding claim 26, Murphy and Kreidler disclose the catheter system of Claim 21. Murphy also discloses the outer sheath further includes a first handle 118a and a second handle 118b disposed at the second proximal end (Fig. 2), wherein the first handle and the second handle allow the second elongate body to be retracted relative to the first elongate body and facilitate a dividing of the second elongate body via respective applications of opposing force (para. [0044]).
Regarding claim 27, Murphy and Kreidler disclose the catheter system of Claim 21. Murphy also discloses the second elongate body includes first 118a and second 118b separation features opposing one another, and wherein the first and second separation features are operable to divide the second elongate body into a first piece and a second piece (para. [0044]).
Regarding claim 28, Murphy and Kreidler disclose the catheter system of Claim 21. Murphy also discloses the first proximal end has an outer diameter between 8 Fr and 10 Fr (para. [0029] i.e., such that it would be accommodated through the second proximal end), and wherein the second proximal end has an outer diameter between 10 Fr and 12 Fr (para. [0029]).
Regarding claims 29-31, Murphy and Kreidler discloses the catheter system of claim 21. Kreidler also discloses wherein the second sheath comprises a recovery sheath 514 separately provided from the outer sheath (para. [0184]-[0185]), wherein the recovery sheath is extendable around the first elongate body after the second elongate body is separated from the first elongate catheter body (para. [0208]); wherein the recovery sheath is percutaneously advanceable over the first elongate body in the patient’s vasculature after the outer sheath has been removed from the patient’s vasculature (para. [0208]-[0209] i.e., by being advanced distally); wherein the recovery sheath includes an outer diameter and an inner diameter (Fig. 23), the inner diameter defining a lumen for receiving the expandable pump therein (para. [0210] i.e., the implant being the pump as disclosed by Murphy), the outer diameter sealing an incision site previously occupied by the second elongate body (para. [0208] discloses the recapture sheath 514 does not allow air past the valve 532 seal).
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 device of Murphy to have a recovery sheath for purposes of collapsing and recapturing the expandable implant (paras. [0182], [0206]).
Regarding claim 32, Murphy and Kreidler disclose the catheter system of Claim 21. Murphy also discloses the expandable pump is a radially expandable axial flow pump (para. [0043] discloses any suitable pump including intravascular heart pump, a heart pump driven by a flexible shaft and a motor positioned external to the patient's body, a heart pump including an implantable motor, a heart pump having an expandable pump rotor, or any other suitable pump, which would include an axial flow pump).
Regarding claim 33, Murphy and Kreidler disclose the catheter system of Claim 32. Murphy also discloses the radially expandable axial flow pump includes a collapsible and expandable impeller (para. [0043] discloses an expandable pump rotor).
Regarding claim 34, Murphy and Kreidler disclose the catheter system of Claim 32. Murphy also discloses the desired location is a left ventricle of the patient’s heart (i.e., para. [0028] discloses a heart pump which would include a heart pump for a left ventricle).
The limitation “the desired location is a left ventricle of the patient’s heart” is being interpreted as an intended use limitation. As seen in MPEP section 2114 section 2, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647. Thus, it’s seen if the prior art has the claimed structure of the invention, it is able to perform the function. As seen here since the structure is provided such that the device may be intended to be used in the heart, the device is capable of being used in the left ventricle.
Regarding claim 35, Murphy and Kreidler disclose the catheter system of Claim 34. The limitation “the medical procedure relates to a cardiogenic shock condition” is being interpreted as an intended use limitation. As seen in MPEP section 2114 section 2, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647. Thus, it’s seen if the prior art has the claimed structure of the invention, it is able to perform the function. As seen here, because Murphy discloses all of the structure of the claim, the intended use is also met.
Regarding claim 36, Murphy and Kreidler disclose the catheter system of Claim 21. Murphy also discloses wherein the first sheath portion and second sheath portion are integrally formed with each other (i.e., 50 and 102 are not easily separable and separating one in turn separates the other (Fig. 2).
Regarding claim 37, Murphy and Kreidler disclose the catheter system of Claim 21. Murphy also discloses wherein first sheath portion and second sheath portion are separate components (Fig. 2, Fig. 8; the separate components are still integrally formed and are separable through splitting).
Response to Arguments
Applicant’s arguments with respect to claims 21-37 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771