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 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.
Claims 10-16 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.
Claim 10 recites “an occlusion device” in each of lines 2 and 3 which renders the scope of the claim indefinite since it is unclear if the second recitation of “an occlusion device” is introducing a new element or is a reference to the previously recited occlusion device. As best understood from the specification and figures, the first and second links are components of a singular occlusion device. Therefore, for examination purposes, each recitation of an occlusion device has been interpreted as referring to the same occlusion device.
It is recommended that claim 10, line 3 is amended to recite “placing a second link of [[an]] the occlusion device…” to alleviate the clarity issues.
Claims 11-16 are similarly rejected by virtue of their dependency from claim 10.
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.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hughett et al. (US 9,282,973 B2)
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Regarding claim 1, Hughett discloses a minimally invasive surgical assembly (100, see Fig. 1) comprising: an occlusion device for occluding a left atrial appendage of a patient (see col. 6, lines 23-25), the occlusion device comprising: an elongated first link (1112, see Fig. 40) comprising a first end and a second end; and an elongated second link (1114) comprising a first end and a second end, wherein the first end of the second link is pivotably coupled to the first end of the first link (the clamping portions 1112 and 1114 are pivotably coupled to each other by urging members 1108, see Fig. 40); and a delivery device, the delivery device comprising a rigid frame (deployment device 118, see Fig. 1, 34) having a receiving aperture (see receiving aperture in annotated Fig. 32 above) that extends through a first portion of the rigid frame, the receiving aperture adapted to receive at least a portion of the left atrial appendage of the patient, the receiving aperture being at least partially defined by a first aperture edge and a second aperture edge (see second aperture edge in annotated Fig. 32 above; the first aperture edge is the edge opposite the second aperture edge), wherein the first link of the occlusion device is configured to be removably coupled to a second portion of the rigid frame that is at or adjacent to the first aperture edge, and the second link of the occlusion device is configured to be removably coupled to a third portion of the rigid frame that is at or adjacent to the second aperture edge (the first and second links are removably coupled to all portions of the rigid frame since the occlusion clip 1160 is removably coupled to the deployment device 118, see col. 10, lines 38-41).
Regarding claim 2, Hughett discloses the minimally invasive surgical assembly occlusion device of claim 1, wherein a fourth portion of the rigid frame that entirely surrounds the receiving aperture is planar (the fourth portion forming the inner surface of the deployment device 118 entirely surrounds the receiving aperture and is planar, see Fig. 32 and col. 15, lines 3-6).
Regarding claim 3, Hughett discloses the minimally invasive surgical assembly occlusion device of claim 1, wherein the rigid frame is planar (the frame of deployment device 118 is considered planar since it is made up of smooth surfaces, see Fig. 32).
Regarding claim 4, Hughett discloses the minimally invasive surgical assembly occlusion device of claim 1, wherein the first aperture edge is substantially linear (the first edge opposite the second in annotated Fig. 32 is linear), and the first link is configured to be parallel to the first aperture edge (the first link formed by clamping portion 1112, see Fig. 40, is configured to be parallel to the first aperture edge when loaded into the device as shown in Fig. 29-30).
Regarding claim 5, Hughett discloses the minimally invasive surgical assembly occlusion device of claim 4, wherein the second aperture edge is substantially linear (see second aperture edge in annotated Fig. 32), and the second link is configured to be parallel to the second aperture edge (the second link formed by clamping portion 1114, see Fig. 40 is configured to be parallel to the second aperture edge when loaded into the device as shown in Fig. 29-30).
Regarding claim 6, Hughett discloses the minimally invasive surgical assembly occlusion device of claim 1, wherein the receiving aperture is at least partially defined by the first aperture edge, the second aperture edge, and a third aperture edge (see annotated Fig. 32).
Regarding claim 7, Hughett discloses the minimally invasive surgical assembly occlusion device of claim 6, wherein the third aperture edge is substantially linear (see third aperture edge in annotated Fig. 32).
Regarding claim 8, Hughett discloses the minimally invasive surgical assembly occlusion device of claim 2, wherein the fourth portion of the rigid frame is at least partially defined by a first perimeter edge that is parallel to the first aperture edge and a second perimeter edge that is parallel to the second aperture edge (the fourth portion of the frame forming the inner surface of deployment device 118 is partially defined by perimeter edges that are parallel to the first and second aperture edges as shown in annotated Fig. 32).
Claims 10 and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hughett et al. (US 2012/0035631 A1).
Regarding claim 10, Hughett ‘631 discloses a method of occluding tissue (see Fig. 2 and [0036]), comprising: placing a first link (20) of an occlusion device(10) laterally at a base of tissue (the base of the LAA, see Fig. 2); placing a second link (30) of the occlusion device on an opposing side of the base of tissue, substantially parallel with the first link (beam members 20,30 are parallel to each other, see Fig. 2); and securing the first link and the second link to fully occlude the base of tissue (the occlusion device is closed around the LAA, see [0036]).
Regarding claim 12, Hughett ‘631 discloses the method of occluding tissue of claim 10, further comprising snaring filament (48) held within the first link and the second link (band 48 is held within a portion of the beam members 20 and 30, see Fig. 2 and 10 and [0041]).
Regarding claim 13, Hughett ‘631 discloses the method of occluding tissue of claim 10, further comprising securing the first link of the occlusion device and the second link of the occlusion device with a first mechanical fastener (band 48 is connected to beam member 20 by a first pin 28e which can be considered a first mechanical fastener, see Fig. 2 and [0041]).
Regarding claim 14, Hughett ‘631 discloses the method of occluding tissue of claim 13, further comprising securing the first link of the occlusion device and the second link of the occlusion device with a second mechanical fastener (band 48 is connected to beam member 30 by a second pin 38e which can be considered a second mechanical fastener, see Fig. 2 and [0041]).
Regarding claim 15, Hughett ‘631 discloses the method of occluding tissue of claim 10, wherein placing the first link of an occlusion device laterally at a base of tissue further comprises using a delivery frame (jaws 142 and 242 form a rigid frame, see Fig. 3).
Regarding claim 16, Hughett ‘631 discloses the method of occluding tissue of claim 10, wherein placing the first link of an occlusion device laterally at a base of tissue further comprises using an introducer device (deployment device 110 is used to place the first link and the second link at the base of the LAA, see Fig. 3 and [0036]).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hughett ‘973, as applied to claim 1 above, and further in view of Bardsley et al. (US 2008/0294175).
Regarding claim 9, Hughett ‘973 teaches the minimally invasive surgical assembly occlusion device of claim 1, but fails to teach the rigid frame is translucent or transparent.
Bardsley, in the same field of art, teaches a delivery device (see Fig. 2) with a frame (13) comprised of transparent material to create a field of view during a surgical procedure (see [0056]).
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 Hughett ‘973 such that the delivery frame is comprised of a transparent material, as taught by Bardsley, since doing so would improve the field of vision when the device is used in a surgical procedure. The transparent material would also be translucent.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hughett ‘631, as applied to claim 10 above, and further in view of Francischelli et al. (US 2008/0033457 A1).
Regarding claim 11, Hughett ‘631 discloses the method of occluding tissue of claim 10, further comprising: positioning the first and second links of an occlusion device (10) so that the LAA may be passed through the occlusion device while the occlusion device is held by a delivery frame (110, see Fig. 3 and [0036]). Hughett further teaches releasing the first link and the second link from the delivery frame (see [0036]).
Hughett ‘631 fails to expressly teach grasping a portion of the LAA and pulling it through the delivery frame.
Francischelli, in the same field of art, teaches a related method of occluding tissue including the step of grasping a portion of the tissue and pulling a portion of the tissue through an occlusion device while it is held by a delivery frame to aid in placement of the occlusion device around the tissue (see [0149]).
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 method of Hughett ‘631 to include the step of grasping tissue and pulling it through the occlusion device while it is held by the delivery frame, as taught by Francischelli, since doing so would have aided in placement of the occlusion device around the tissue.
The combination of Hughett ‘631 and Francischelli teaches the step of pulling a portion of the tissue through the delivery frame since the delivery frame 110 of Hughett ‘631 is structured such that any tissue passing through the occlusion device while it is held by the jaws of the delivery frame would also pass through the delivery frame (see Fig. 3 of Hughett ‘631).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims (1,2,8), 3, (4,5), (6,7), and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (1), 2, (3), (4), and 5, respectively, of U.S. Patent No. 12,364,483. Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited above, where Applicant has once been granted a patent containing a claim for the specific or narrower invention, Applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
The limitations of the present application are recited in the corresponding ‘483 patent claims as mapped below:
Present Claims 19/253,163
U.S. Patent No. 12,364,483
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
