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 .
Drawings
The drawings are objected to because of the use of heavy shading. Note that solid black shading areas are not permitted, except when used to represent bar graphs or color. 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.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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 “rinse basins that are releasably coupled with the second tray” in claim 10, 17 and “multiple separate rinse basins are nested together within the second tray” in claim 19 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. It is noted that the drawings show the rinse basin coupled with the first tray and not to second tray.
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 § 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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 9 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US 2018/0110578 to Gallagher.
Regarding claim 1, Gallagher discloses a medical device system (100) comprising an implantable device delivery system comprising a handle device (112) and one or more catheters (114) coupled to and extending from the handle device, a packaging system configured to contain the device delivery system, the system comprising a first tray (102) and a second tray (106) releasably coupled with the handle device (112), the second tray slidably coupled with the first tray (Fig 1).
Regarding claim 9, Gallagher further discloses second tray (106) configured to releasably receive the handle device and is slidable along longitudinal axis of the first tray (102) since it has the structure as recited.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US 2018/0177977 to De Soto.
Regarding claim 11, De Soto discloses a medical device system (Fig 4) comprising an implantable device delivery system comprising a handle device and one or more catheters coupled to and extending from the handle device (€0042, 50), packaging system configured to container the delivery system, the packaging system comprising a first tray (10) and a catheter support member (80) that is releasably coupleable with the catheter , the catheter support member upwardly movable to an elevated orientation in relation to first tray to elevate the catheters relative to first tray (€0051).
Regarding claim 12, De Soto further discloses a latch mechanism (52) by which the support member (80) is detained in elevated orientation.
Claim(s) 17 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US 2023/0014376 to Colgan et al. (Colgan).
Regarding claim 17, Colgan discloses a medical device system (Fig 1) comprising an implantable device delivery system comprising a handle device (16) and one or more catheters (18) coupled to and extending from the handle device, a packaging system configured to contain the device delivery system, the packaging system comprising a first tray (12), a second tray (60), multiple separate rinse basins (42) releasably coupled with the first or second tray.
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.
Claim(s) 2, 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher in view of US 2012/0085720 to Bettenhausen et al. (Bettenhausen).
Regarding claim 2, Gallagher teaches the system of claim 1 but does not teach a catheter support member movably coupled to first tray. However, Bettenhausen discloses a system (Fig 1) and in particular discloses support members (41, 42) movably coupled to tray (30) for holding medical instruments. One of ordinary skill in the art would have found it obvious to incorporate support members to Gallagher as suggested by Bettenhausen in order to facilitate support for the medical instrument.
Regarding claim 6, the modified Gallagher further teaches support member (41, 42, Bettenhausen) defining a groove (70, Fig 2, Bettenhausen) to support catheters.
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher in view of Bettenhausen and US 2010/0286670 to Doyle et al. (Doyle).
Regarding claim 3, the modified Gallagher teaches the system of claim 2 but does not teach the support member movable between first and second positions as recited. However, Doyle discloses a system (Fig 1) and in particular discloses a tray (102) with support members (110, 112) movable between a first position in which the support member is laying down parallel to tray (Fig 1) and second position in which support member is extending transversely upward out of and away from the tray (Fig 2). One of ordinary skill in the art would have found it obvious to have the modified Gallagher support member movable between two positions as suggested by Doyle in order to facilitate storage of the support member when not in use.
Regarding claim 4, the modified Gallagher further teaches the support member (41, 42, Bettenhausen) latching in second position (Fig 4, Bettenhausen).
Regarding claim 5, the modified Gallagher teaches the support member coupled to the first tray but does not teach it pivotally coupled. However, Doyle discloses a tray (102) with support members (110, 112) pivotally coupled. One of ordinary skill in the art would have found it obvious to have the support members pivotally coupled to the tray as suggested by Doyle in order to facilitate storage and handling.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher in view of US 2014/0346072 to Jacobson.
Regarding claim 7-8, the modified Gallagher does not teach a third tray covering the second tray. However, Jacobson discloses a system comprising a first tray (100), second tray (210), and a third tray (220), with third tray configured to cover second tray and pivotably coupled with second tray such that the second and third tray are openable like a clamshell (Fig 2). One of ordinary skill in the art would have found it obvious to incorporate a third tray to the Gallagher system as suggested by Jacobson in order to close the second tray.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gallagher in view of US 2016/0030368 to Atkins Jr et al. (Atkins).
Regarding claim 10, Gallagher teaches the system of claim 1 but does not teach multiple separate rinse basins releasably coupled with second tray. However, Atkins discloses a system comprising a medical tray (142) with multiple separate basins (114, 116) releasably coupled with the tray. One of ordinary skill in the art would have found it obvious to incorporate basins to the system of Gallagher as suggested by Atkins in order to hold additional separated contents.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Soto in view of Doyle.
Regarding claim 13, De Soto teaches the system of claim 11 except for the support member pivotally coupled to first tray. However, Doyle discloses a tray (102) with support members (110, 112) pivotally coupled. One of ordinary skill in the art would have found it obvious to have the support members pivotally coupled to the tray as suggested by Doyle in order to facilitate storage and handling.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Soto.
Regarding claim 14, De Soto teaches the system of claim 11 except for a groove in the support member. However, in alternate embodiments (Fig 4), De Soto discloses support member (18) defining a groove (under 50) to releasably support the catheter in elevated orientation. One of ordinary skill in the art would have found it obvious to incorporate a groove to the support of De Soto in order to facilitate holding of the catheter.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Soto in view of Gallagher.
Regarding claim 15, De Soto teaches the system of claim 11 but does not teach a second tray containing the handle device. However, Gallagher discloses a system (Fig 1) and in particular discloses a first tray (102) and a second tray (106) containing handle device (112) of a catheter, the second tray (106) slidable along longitudinal axis of the first tray. One of ordinary skill in the art would have found it obvious to incorporate a second tray to De Soto as suggested by Gallagher in order to support the handle.
Regarding claim 16, De Soto further discloses a third tray (90, Fig 6) that can releasably cover the second tray since the second tray would be located within the first tray.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colgan in view of Gallagher.
Regarding claim 18, Colgan teaches the system of claim 17 but does not teach a second tray containing the handle device and slidable along the first tray. However, Gallagher discloses a system (Fig 1) and in particular discloses a first tray (102) and a second tray (106) containing handle device (112) of a catheter, the second tray (106) slidable along longitudinal axis of the first tray. One of ordinary skill in the art would have found it obvious to incorporate a second tray to De Soto as suggested by Gallagher in order to support the handle.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colgan in view of Atkins.
Regarding claim 19, Colgan teaches the system of claim 17 but does not teach the basins nested together. However, Atkins discloses a system comprising a medical tray (142) with multiple separate basins (114, 116) nested together within the tray. One of ordinary skill in the art would have found it obvious to nest the basins of Colgan as suggested by Atkins in order to facilitate storage.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colgan in view of De Soto.
Regarding claim 20, Colgan teaches the system of claim 17 but does not teach a support member. However, De Soto discloses a medical device system (Fig 4) comprising an implantable device delivery system comprising a handle device and one or more catheters coupled to and extending from the handle device (€0042, 50), packaging system configured to contain the delivery system, the packaging system comprising a first tray (10) and a catheter support member (80) that is upwardly movable to an elevated orientation in relation to first tray to elevate the catheters relative to first tray (€0051). One of ordinary skill in the art would have found it obvious to incorporate a support member to Colgan as suggested by De Soto in order to facilitate support of the catheter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT POON whose telephone number is (571)270-7425. The examiner can normally be reached Monday thru Friday, 8:30 am to 6:00 pm.
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/ROBERT POON/ Examiner, Art Unit 3735