DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/449556, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. PLEASE NOTE: the application data sheet lists priority to provisional application 61/449556; however, this appears to be a typo instead should list provisional application 61/449566 (which is the provisional application listed in first paragraph of the specification). However, neither of the aforementioned provisional applications provide support for a medical device system comprising: and introducer sheath with a peripheral opening and a flexible tipped catheter (with a puncture wire therethrough) which is configured to go thru the introducer sheath and thru the peripheral opening (as required by claim 1). As such, claim(s) 1 (and 2-7 which depend therefrom) are awarded a priority date of June 23, 2011 (the filing date of 13/167502).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
The flange extending in a direction parallel to a longitudinal axis of the coronary sinus (as required by claim 5, lines 4-5) (as can be seen in figs. 58-59 of Applicant’s drawings the plurality of substantially triangular struts, making up the flange, appear to be extend radially outward around a “short portion”, in which case some of the plurality of substantially triangular struts would extend at angles not parallel to any single longitudinal axis)
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Within claim 5, lines 1-4: Applicant claims, “wherein the medical device comprises a cylindrical portion […] wherein the cylindrical potion is adapted to be placed at least partially in the coronary sinus of the patient”; it is unclear, and therefore indefinite, if this is the same (and therefore a redefining thereof) as OR different from the proximal portion which is adapted to be at least partially disposed in the coronary sinus (as required by claim 1, lines 13-14). Claim(s) 6-7, which depend from claim 5, inherit all the problems associated with claim 5.
Within claim 5, lines 4-5: Applicant claims, “a flange extending from the cylindrical portion in a direction parallel to a longitudinal axis of the coronary sinus”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the directionality of the flange is claimed in relation to the human body - extending in a direction parallel to a longitudinal axis of the coronary sinus, which is associated with a method of positioned the device; however, the scope of the claim (determined by the preamble) is directed to the device alone - which is merely intended to be positioned at least partially in the coronary sinus. As such, it is unclear, if a product would need to be implanted at least partially within the coronary sinus such that the flange would be in a direction parallel to a longitudinal axis of the coronary sinus OR if a product merely needs to have a structure such that the flange would be capable of extending in a direction parallel to a longitudinal axis of the coronary sinus. Additionally, it is unclear, and therefore indefinite, how the flange, which includes a plurality of substantially triangular struts can extend parallel to a single longitudinal axis. For figs. 58-59 of Applicant’s drawings the plurality of substantially triangular struts appear to be extend radially outward around a “short portion”, in which case some of the plurality of substantially triangular struts would extend at angles not parallel to any single longitudinal axis.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the “short portion”, the figures and the description only describe an embodiment with a “flange” within figures 58-59; however, the flange does not directly connect to the cylindrical portion/ longer portion of the stent (41, 42), as described in paragraphs [0361-0362] fig. 57; instead the structure includes a shorter portion (43) between the cylindrical portion/ longer portion and the flange to account for the thickness of the heart wall.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 3-4 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Makower et al. (US 6283983 B1).
With respect to claim 1:
Makower et al. discloses a medical device system for providing (capable of providing) fluid communication between a coronary sinus and a left atrium, comprising:
an introducer sheath (guide catheter 18) comprising a peripheral opening (side exit port 22) extending through at least a portion of a wall of the sheath (guide catheter 18), wherein the introducer sheath (guide catheter 18) is adapted to be disposed (is capable of being disposed) inside the coronary sinus (column 3, line 66-column 4, line 44);
a catheter (working catheter 26) comprising a flexible distal tip (distal end capable of bending out of lumen 24), wherein the catheter (working catheter 26) is configured to be slidably disposed (is capable of being slidably disposed) within the introducer sheath (guide catheter 18), and wherein the flexible distal tip (distal end capable of bending out of lumen 24) of the catheter (working catheter 26) is configured to extend (is capable of extending) through the peripheral opening (side exit port 22) of the introducer sheath (guide catheter 18) (column 3, line 66-column 4, line 44);
a puncture wire (needle electrode 30) configured to be slidably disposed (is capable of being slidably disposed) within the catheter (working catheter 26) (column 7, lines 8-30), wherein a distal end (distal end) of the puncture wire (needle electrode 30) is configured to extend (is capable of extending) distally through a distal end (end cap 28) of the catheter (working catheter 26) (column 7, lines 8-30), and wherein the puncture wire (needle electrode 30) is adapted to penetrate (is capable of penetrating) a wall between the left atrium and the coronary sinus (column 3, line 66-column 4, line 44); and
an implantable medical device (bifurcated stent), as can be seen in fig. 12, comprising a distal portion (free end of branch 47) and a proximal portion (leg 45), wherein the distal portion (free end of branch 47) of the implantable medical device (bifurcated stent) is adapted to be (is capable of being) at least partially disposed inside the left atrium and the proximal portion (leg 45) of the implantable medical device (bifurcated stent) is adapted to be (is capable of being) at least partially disposed inside the coronary sinus (column 7, lines 31-40).
With respect to claim 3:
Further comprising a guide wire (guide wire 16), wherein the introducer sheath (guide catheter 18) is configured to routed (is capable of being routed) over the guide wire (guide wire 16) (column 3, line 66-column 4, line 44).
With respect to claim 4:
Wherein the puncture wire (needle electrode 30) is configured to conduct a radio frequency energy (column 4, lines 45-57).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Makower et al. (US 6283983 B1) in view of LAROYA et al. (US 2002/0077566 A1).
With respect to claim 2:
Makower et al. discloses the invention substantially as claimed, as discussed above. Additionally, Makower et al. discloses the implantable medical device (bifurcated stent) to be a balloon expandable stent (delivered on a balloon) (column 5, lines 20-30). However, Makower et al. is silent concerning the relationship between the balloon catheter (balloon) and the puncture wire (needle electrode 30) (specifically, the balloon catheter (balloon) is configured to be slidably and at least partially disposed over the puncture wire (needle electrode 30)).
LAROYA et al. teaches a system for providing fluid communication between a coronary artery and a heart chamber. The system comprising a puncture wire (guide wire 120A) adapted to penetrate a wall between the coronary artery and the heart chamber (paragraph [0043]), after the puncture wire (guide wire 120A) has penetrated the wall tissue an implantable medical device (conduit 172) mounted on a balloon catheter (balloon 178) is slid along the puncture wire (guide wire 120A) into the wall of the heart where the implantable medical device is expanded by the balloon catheter and left implanted within the wall to maintain blood flow therethrough (paragraphs [0058, 0064]).
It would have been obvious to one having ordinary skill in the art before the effective date of the claimed invention to use a balloon catheter (balloon 178), as taught by LAROYA et al., to deliver the implantable medical device (bifurcated stent) over the puncture wire (needle electrode 30), as disclosed by Makower et al., as both structures (balloon expandable stents) are used for similar purposes (both create a bypass within heart tissue) and as such the tools/ mood of expansion thereof would be obvious variants to try.
Claim(s) 5-7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Makower et al. (US 6283983 B1) in view of Solem (US 2002/0033180 A1) and McNamara et al. (US 2010/0256753 A1).
With respect to claim 5:
Makower et al. discloses the invention substantially as claimed, as discussed above. Additionally, Makower et al. discloses the implantable medical device (bifurcated stent) comprises a cylindrical portion (leg 45) having an outer surface and an inner lumen extending along a longitudinal axis of the cylindrical portion (leg 45), as can be seen in fig. 12, wherein the cylindrical portion (leg 45) is adapted to be placed (is capable of being placed) at least partially in the coronary sinus of the patient, and wherein the device (bifurcated stent) is configured to provide (is capable of providing) fluid communication between the left atrium and the coronary sinus.
However, Makower et al. does not disclose a flange extending from the cylindrical portion (leg 45) in a direction parallel to a longitudinal axis of the coronary sinus, wherein the flange comprises a plurality of substantially triangular struts.
Solem teaches an implantable medical device (device 8), as can be seen in figs. 3-8 and 14, adapted for use in a patient (paragraphs [0102-0103]), comprising:
a cylindrical portion (second part 10) comprising an outer surface and an inner lumen extending along a longitudinal axis (longitudinal axis) of the cylindrical portion (second part 10) (paragraph [0104]), wherein the cylindrical portion (second part 10) is adapted to be placed (is capable of being placed) at least partially in a coronary sinus of the patient (paragraphs [0102-0104]); and
a flange (subsection of fan part 17 extending toward the top and the bottom of the page in fig. 14), as can be seen in fig. 14, extending from (indirectly connected to) the cylindrical portion (second part 10) in a direction parallel to a longitudinal axis of the coronary sinus (which is along the longitudinal axis (longitudinal axis) of the cylindrical portion (second part 10)) (paragraph [0116]), and wherein the implantable medical device (device 8) is configured to provide (is capable of providing) fluid communication between a left atrium and the coronary sinus (coronary artery) (paragraph [0102]).
McNamara et al. teaches an implantable medical device (vent) comprising a portion (core segment 106) with a flange (flange 103) extending radially outward from the portion (core segment 106) (paragraphs [0169-0170]), wherein the flange (flange 103) comprises a plurality of substantially triangular struts (flange segments 103a-103h) (paragraphs [0169-0170]), as can be seen in fig. 2-2A, and wherein the implantable medical device (vent) is configured to be implanted within a chamber of the heart (abstract).
It would have been obvious to one having ordinary skill in the art before the effective date of the claimed invention to add a flange (subsection of fan part 17 extending toward the top and the bottom of the page in fig. 14), as taught by Solem, on the distal portion (free end of branch 47), as disclosed by Makower et al., in order to better allow the implantable medical device (bifurcated stent), as disclosed by Makower et al., to be used in additional bypass situations (bypass between the coronary sinus and a heart chamber) while preventing the dislodgement (due to the flange (subsection of fan part 17 extending toward the top and the bottom of the page in fig. 14)) therefrom. Additionally, it would have been further obvious to one having ordinary skill in the art before the effective date of the claimed invention to use the flange design (including the plurality of substantially triangular struts (flange segments 103a-103h)), as taught by McNamara et al., for the flange (subsection of fan part 17 extending toward the top and the bottom of the page in fig. 14), as disclosed by Makower et al. as modified by Solem, as the two structures are functional equivalents for each other (both are used within the heart, against a heart wall, to aid in anchoring a structure through the heart wall) and as such are obvious substitutes for each other. (In making the aforementioned combination, Examiner is merely replacing the shape/ structure of the flange (subsection of fan part 17 extending toward the top and the bottom of the page in fig. 14), as disclosed by Solem, on the end of the distal portion (free end of branch 47), as disclosed by Makower et al., with the plurality of substantially triangular struts (flange segments 103a-103h)/ flange (flange 103), as taught by McNamara et al.; in which case, at least two of the triangular struts (flange segments 103a-103h), as taught by McNamara et al., will end up extending a direction parallel to a longitudinal axis of the coronary sinus (which is along the longitudinal axis (longitudinal axis) of the cylindrical portion (leg 45), as disclosed by Makower et al., with the remaining triangular struts (flange segments 103a-103h), as taught by McNamara et al., extending radially outward from the short portion/ end of the distal portion (free end of branch 47)/ opening in the cylindrical portion (leg 45), as disclosed by Makower et al..)
With respect to claim 6:
Wherein the flange (flange segments 103a-103h), as taught by McNamara et al., is adapted to engage (capable of engaging) the atrial wall of the patient (as discussed above with respect to claim 5).
With respect to claim 7:
Wherein the cylindrical portion (leg 45), as disclosed by Makower et al., is configured to transition between a compact state (unexpanded) and a deployed state (after expansion) (Makower et al. column 5, line 19-30).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on (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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/REBECCA S PRESTON/Examiner, Art Unit 3774
Prosecution Insights