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 .
Note to Applicant
Applicant should note that the current Examiner is different than the previous Examiner who authored the previous office action(s); the current Examiner has inherited the instant application.
MPEP 706.04:
Full faith and credit should be given to the search and action of a previous examiner unless there is a clear error in the previous action or knowledge of other prior art. In general, an examiner should not take an entirely new approach or attempt to reorient the point of view of a previous examiner, or make a new search in the mere hope of finding something. Amgen, Inc. v. Hoechst Marion Roussel, Inc., 126 F. Supp. 2d 69, 139, 57 USPQ2d 1449, 1499-50 (D. Mass. 2001).
Information Disclosure Statement
Applicant should note that the large number of references in the attached information disclosure statement have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b).
Election/Restrictions
Claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/17/2026.
Applicant’s election without traverse of group I, claims 1-12 in the reply filed on 6/17/2026 is acknowledged.
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, 6, 8-10, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vidlund (US 20070055303 A1; 3/8/2008).
Regarding claim 1, Vidlund teaches a device for placing an anchor in a heart (Fig. 5-6; [0022]), the device comprising:
a tube (Fig. 5-6; [0065] “catheter 100”; [0066] “lumen”);
a needle formed on a distal end of the tube, the needle configured to pierce from an endocardium layer of the heart through an epicardium layer of the heart (Fig. 5-6; [0066] “piercing needle”; [0067] “needle”);
an inflatable balloon in proximity to the distal end of the tube, the inflatable balloon configured to inflate and form an anchor located outside the epicardium layer (Fig. 5-6; Fig. 19-20; Fig. 26; [0020] “balloon”; [0043]; [0066]; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The prior art is capable of meeting the instant limitation(s).); and
a control plate located proximally from the inflatable balloon, the control plate configured to abut against the endocardium layer and reduce movement of the tube while the inflatable balloon is inflated (Fig. 5-6; Fig. 19-20; Fig. 26; [0020] “balloon”; [0043]; [0066]; the proximal balloon reads on the recited “control plate” since it is proximal to the distal balloon and the two features sandwich the heart layer; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The prior art is capable of meeting the instant limitation(s).).
Regarding claim 6, Vidlund teaches a catheter configured to contain the tube ([0066] “catheter 100”);
wherein the control plate is attached to an external surface of the catheter, the control plate configured to hold the catheter steady while the tube and inflatable balloon are moved to a target location (Fig. 5-6; Fig. 19-20; Fig. 26; [0020] “balloon”; [0043]; [0066]; the proximal balloon reads on the recited “control plate” since it is proximal to the distal balloon and the two features sandwich the heart layer; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The prior art is capable of meeting the instant limitation(s).).
Regarding claim 8, Vidlund teaches wherein the inflatable balloon is configured to form a generally disk shape (Fig. 16; Fig. 19). Also see alternative 103 rejection below.
Regarding claim 9, Vidlund teaches wherein the inflatable balloon is configured to form a generally cylindrical shape (Fig. 16; Fig. 19; Fig. 25, 403). Also see alternative 103 rejection below.
Regarding claim 10, Vidlund teaches wherein the inflatable balloon is configured to form a generally saucer shape (Fig. 5-6; Fig. 19-21). Also see alternative 103 rejection below.
Regarding claim 12, Vidlund teaches wherein the inflatable balloon is further configured to detach from the tube ([0112] “detachable”).
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) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund as applied to claim 1 above, in view of Hardert (US 20080033480 A1; 2/7/2008).
Regarding claim 2, Vidlund does not teach a conduit in the tube for releasing curable adhesive into the inflatable balloon, the curable adhesive configured to inflate the inflatable balloon. However, Hardert teaches in the same field of endeavor (Abstract; Fig. 1) a conduit in the tube for releasing curable adhesive into the inflatable balloon, the curable adhesive configured to inflate the inflatable balloon (Fig. 1; Fig. 7; [0008]; [0029]; [0040]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vidlund to include these features as taught by Hardert because this enables using solidified material to create a more permanent placement of balloon (Fig. 7; Fig. 6a-6d; [0040]).
Regarding claim 3, in the combination of Vidlund and Hardert, Hardert teaches a fiber optic cable configured to emit ultraviolet (UV) light, the UV light configured to cure the curable adhesive in the inflatable balloon and permanently leave the inflatable balloon in its inflated configuration (Fig. 7; Fig. 6a-6d; [0040]). ]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vidlund to include these features as taught by Hardert because this enables using solidified material to create a more permanent placement of balloon (Fig. 7; Fig. 6a-6d; [0040]).
Regarding claim 4, in the combination of Vidlund and Hardert, Hardert teaches wherein the fiber optic cable runs longitudinally along a surface of the tube ([0008]; [0029]; [0032]; second lumen holding fiber runs longitudinally along surface of first lumen which reads on recited “tube”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vidlund to include these features as taught by Hardert because this enables using solidified material to create a more permanent placement of balloon (Fig. 7; Fig. 6a-6d; [0040]).
Regarding claim 5, in the combination of Vidlund and Hardert, Hardert teaches wherein the fiber optic cable and the conduit are in separate lumens in the tube ([0008]; [0029]; [0032]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vidlund to include these features as taught by Hardert because this enables using solidified material to create a more permanent placement of balloon (Fig. 7; Fig. 6a-6d; [0040]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund as applied to claim 1 above, in view of Milo (US 20140148786 A1; 5/29/2014).
Regarding claim 7, Vidlund does not teach wherein the control plate is attached to the tube at a fixed distance from the needle, the control plate configured to prevent the needle from passing further than the fixed distance from the endocardium layer. However, Milo teaches in the same field of endeavor (Abstract) wherein the control plate is attached to the tube at a fixed distance from the needle, the control plate configured to prevent the needle from passing further than the fixed distance from the endocardium layer (Fig. 2, 31b; [0044] “stop 31b”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vidlund to include these features as taught by Milo because this enables stable positioning ([0044]).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund as applied to claim 1 above.
Regarding claim 8, Vidlund teaches wherein the inflatable balloon is configured to form a generally disk shape (Fig. 16; Fig. 19). Alternatively, this would be an obvious change in shape to use an appropriate shape for the anatomy; MPEP 2144.04.
Regarding claim 9, Vidlund teaches wherein the inflatable balloon is configured to form a generally cylindrical shape (Fig. 16; Fig. 19; Fig. 25, 403). Alternatively, this would be an obvious change in shape to use an appropriate shape for the anatomy; MPEP 2144.04.
Regarding claim 10, Vidlund teaches wherein the inflatable balloon is configured to form a generally saucer shape (Fig. 5-6; Fig. 19-21). Alternatively, this would be an obvious change in shape to use an appropriate shape for the anatomy; MPEP 2144.04.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund as applied to claim 1 above, in view of Lashinski (US 20060020334 A1; 1/26/2006).
Regarding claim 11, Vidlund does not teach further comprising a suture attached to the inflatable balloon. However, Lashinski teaches in the same field of endeavor (Abstract; [0248]) further comprising a suture attached to the inflatable balloon ([0446] “Alternatively the balloon may be attached to the implant with sutures designed to break as the balloon is inflated”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vidlund to include these features as taught by Lashinski because this enables attaching balloon to other implants as needed ([0446]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vidlund (US 20070055303 A1; 3/8/2008) in view of Milo (US 20140148786 A1; 5/29/2014).
Regarding claim 21, Vidlund teaches a device for placing an anchor in a heart (Fig. 5-6; [0022]), the device comprising:
a tube (Fig. 5-6; [0065] “catheter 100”; [0066] “lumen”);
a catheter disposed over the tube ([0066] “catheter 100”);
a needle formed on a distal end of the tube, the needle configured to pierce from an endocardium layer of the heart through an epicardium layer of the heart (Fig. 5-6; [0066] “piercing needle”; [0067] “needle”);
an inflatable balloon in proximity to the distal end of the tube, the inflatable balloon configured to inflate and form an anchor located outside the epicardium layer (Fig. 5-6; Fig. 19-20; Fig. 26; [0020] “balloon”; [0043]; [0066]; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The prior art is capable of meeting the instant limitation(s).);
a control plate coupled to an outer surface of the catheter and configured to mitigate movement of the catheter (Fig. 5-6; Fig. 19-20; Fig. 26; [0020] “balloon”; [0043]; [0066]; the proximal balloon reads on the recited “control plate” since it is proximal to the distal balloon and the two features sandwich the heart layer; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The prior art is capable of meeting the instant limitation(s).).
Vidlund does not teach a spring structure disposed distal to the control plate and configured to further anchor the control plate to the heart wall. However, Milo teaches in the same field of endeavor (Abstract) a spring structure disposed distal to the control plate and configured to further anchor the control plate to the heart wall (Fig. 2, 31b reads on control plate, 21 reads on spring; [0044] “stop 31b”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vidlund to include these features as taught by Milo because this enables stable positioning ([0044]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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