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 .
Notice of Amendment
In response to the amendment filed on 3/11/2026, amended claims 1, 4, 12, and 17, cancelled claims 2-3, 5-11, 13-16, and 19-20, and new claims 21-35 are acknowledged. Claims 1, 4, 12, 17-18, and 21-35 are currently pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 21, and 23-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Campbell et al. (US Publication No. 2017/0164845 A1).
Regarding claim 1, Campbell et al. discloses a sensor implant device comprising:
a sensor body (36);
a housing (38) coupled to an outer surface of the sensor body (see Figure 4A and [0047] – “The capsule 34 may be formed having two sections 36, 38. In some examples, one section contains and/or supports the sensing element 32 while the other section contains and/or supports components operably connected to the sensing element. For example, section 36 may contain and/or support a pressure sensing diaphragm of sensor 12 and sensor components 42 while section 38 contains the battery 40”);
a sensor component (32); and
a first anchor (30a) and a second anchor (30b) coupled to the housing (at fasteners F1, F2) and sized to anchor within a blood flow pathway or left atrial appendage (see Figure 8), the first anchor comprising multiple ends (68a, 68b) coupled to the housing to form a first loop and the second anchor comprising multiple ends (68c, 68d) coupled to the housing to form a second loop, wherein the first anchor and the second anchor are shape-set to extend away from the housing and from opposite sides of the housing (see Figure 4A and [0054] – “As used herein, free ends 68a-d (collectively, “free ends 68”) of a fixation member 30a, 30b may be the two terminating points of the wire of a respective fixation member 30, 30b which may therein each be connected to the capsule 34. The free ends 68 of each of the fixation members 30a, 30b may be oriented in opposing directions. For example, a first free end 68a, 68c may be oriented downward in relation to the lateral sidewall SW1, SW2, while the other ends 68b, 68d may be oriented upward in relation to the lateral sidewalls SW1, SW2 as shown in FIG. 4A”).
Regarding claim 21, Campbell et al. discloses the first loop increases in width from the housing (see Figures 2A and 4A).
Regarding claim 23, Campbell et al. discloses the housing is disposed adjacent to a distal end of the sensor body, and wherein the first loop and the second loop are shape-set to curve beyond the distal end of the sensor body (see Figures 2A-B and 5).
Regarding claim 24, Campbell et al. discloses the first loop is shape-set to curve away from the second loop and the second loop is shape-set to curve away from the first loop (see Figures 2A-B, 4A-B and 5).
Claim(s) 31 and 35 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Arthur et al. (US Publication No. 2020/0155014 A1).
Regarding claim 31, Arthur et al. discloses a sensor implant system comprising:
a sensor body (219) comprising a first attachment feature (217) (see Figure 2A);
a sensor component (216) (see [0057] – “In FIG. 2A, the device 215 includes a sensor 216 that is coupled to a locking plate 217 via a fixation element (not shown)”);
one or more anchors (220) coupled to the sensor body, the one or more anchors being shape-set to curve away from the sensor body and anchor within a blood flow pathway or left atrial appendage (see [0058] – “FIG. 2B illustrates an exploded view of a device 215 having a coiled attachment element 220. It is to be understood that in other embodiments of the invention, even if not expressly stated, the attachment element 220 may be a hook, spear, or another structure as discussed previously. A coiled attachment element 220 may have any number of turns so that the device 215 is securely embedded in the target location”); and
a delivery shaft (312) comprising a second attachment feature (313a, 313b) sized to detachably mate with the first attachment feature during delivery of the sensor body (see Figure 3 and [0064] – “When the device 215 is attached to the deployment assembly 310, the axial securement tabs 313a, 313b engage with the cutout portion of the locking plate 217 to thereby prevent axial motion of the device 215”).
Regarding claim 35, Arthur et al. teaches the one or more anchors have pointed tips (221) to penetrate tissue (see [0047] – “The helical coil has a sharpened distal-most tip 221 for improved penetration of a vessel wall or tissue. For example, the attachment element may be ground down or cut at the distal-most tip in such a way to create a sharp end or a smaller end”).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al., further in view of Arthur et al.
Regarding claim 4, it is noted Campbell et al. does not specifically teach the first loop and the second loop comprise barbs to penetrate and grip onto surrounding tissue. However, Arthur et al. teaches the first loop and the second loop comprise barbs to penetrate and grip onto surrounding tissue (see [0045] – “The device may further include an attachment element coupled to the base for anchoring the sensor into a vessel lumen or bodily tissue. The attachment element may include a structure such as, e.g., a barb, hook, latch, ring with legs, screw, spear, or tack, or other structure which secures the device in the target location”; see also [0056]-[0057], [0062], and [0085]). 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 Campbell et al. to include the first loop and the second loop comprise barbs to penetrate and grip onto surrounding tissue, as disclosed in Arthur et al., so as to secure the device in the target location (see Arthur et al.: [0045]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al., further in view of Schwartz (US Publication No. 2002/0077555 A1).
Regarding claim 22, it is noted Campbell et al. does not specifically teach the housing is disposed adjacent to a distal end of the sensor body, and wherein the first loop and the second loop are shape-set to curve towards a proximal end of the sensor body. However, Schwartz teaches the housing is disposed adjacent to a distal end of the sensor body, and wherein the first loop and the second loop are shape-set to curve towards a proximal end of the sensor body (see Figures 12A-16G and [0119] – “The ring members 65 are arranged in sets at both the proximal end and distal end of the housing 52 around the longitudinal axis L of the housing 52. Although the ring members 65 are shown as a pair of anchoring members at the proximal end and distal end of the housing 52, any desired number of ring members 65 are contemplated by the present invention”). 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 Campbell et al. to include the housing is disposed adjacent to a distal end of the sensor body, and wherein the first loop and the second loop are shape-set to curve towards a proximal end of the sensor body, as disclosed in Schwartz, so as to anchor the device to a second side of the tissue to complete positioning and anchoring of the sensor and housing between two distinct sides or layers or tissue (see Schwartz: [0131]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al., further in view of Doan et al. (US Publication No. 2014/0213916 A1).
Regarding claim 25, it is noted Campbell et al. does not specifically teach the first loop is shape-set to curve towards the second loop and the second loop is shape-set to curve towards the first loop. However, Doan et al. teaches the first loop is shape-set to curve towards the second loop and the second loop is shape-set to curve towards the first loop (see Figure 9B and [0086] – “In an aspect, a biasing mechanism may be provided to provide a force to pull the proximal anchoring elements 902 and the distal anchoring elements 904 together to enhance the anchoring forces provided by the anchoring elements 104. The biasing mechanism may be adapted to press the proximal anchoring elements 902 and/or distal anchoring elements 904 against the walls of the atrial septum 108”). 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 Campbell et al. to include the first loop is shape-set to curve towards the second loop and the second loop is shape-set to curve towards the first loop, as disclosed in Doan et al., so as to enhance the anchoring forces provided by the loops and press the loops against the walls of the atrial septum (see Doan et al.: [0086]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al., further in view of Beasley et al. (US Publication No. 2012/0108986 A1) (previously cited).
Regarding claim 26, it is noted Campbell et al. does not specifically teach the first loop and the second loop comprise a continuous wire. However, Beasley et al. teaches the first loop and the second loop (42, 92) comprise a continuous wire (see Figures 2 and 12 and [0044] – “The fixation member 30 shown includes a pair of longitudinally spaced loops 42 connected by an elongate linear attachment strut 44. The loops 42 are spaced apart sufficiently to receive and embrace the sensor 26 with the sensor extending lengthwise along the attachment strut 44. The sensor 26 is attached to the attachment strut 44 to symmetrically lie along the single common plane 40. The fixation member 30, including the attachment strut 44 may be formed from a sheet of material by laser cutting or electrochemical etching or other fabricating techniques known in the art. The resulting fixation member 30 has a substantially uniform thickness and is formed as a single, integral piece”). 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 Campbell et al. to include the first loop and the second loop comprise a continuous wire, as disclosed in Beasley et al., since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Claim(s) 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arthur et al., further in view of Kaufmann (US Publication No. 2020/0390341 A1) (previously cited).
Regarding claim 32, it is noted Arthur et al. does not specifically teach a leading end coupled to the sensor body and having a conical shape. However, Kaufmann teaches a leading end (31) coupled to the sensor body and having a conical shape (see Figures 4, 6, and 8 and [0053] – “A locking element 31 is accommodated inside the coupling element 30, which can be adjusted with respect to the coupling element 30 so as to release the sensor device 2 from the coupled position according to FIG. 4, and thereby enable a detachment of the sensor device 2 from the coupling device 3, and thus from the catheter device 1, as is illustrated in FIG. 5”). 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 system of Arthur et al. to include a leading end coupled to the sensor body and having a conical shape, as disclosed in Kaufmann, so as to enable attachment and detachment of the sensor body to the delivery shaft (see Kaufmann: [0053]).
Regarding claim 33, Kaufmann teaches the leading end has an at least partially hollow interior (311) (see Figures 4 and 6-7 and [0056] – “The locking element 31 is guided in the coupling element 30 and comprises a body 310, at which engagement grooves 311 are formed on a distal, outwardly directed side, which are arranged in a star-shaped manner with respect to one another and open centrally into an opening 312, as is apparent from FIG. 4 and FIG. 7, for example. In the coupled position, each bracket element 21 of the sensor device 2 engages in one of the engagement grooves 311, wherein each engagement groove 311 is aligned with an assigned engagement section 302 of the coupling element 30, and the bracket element 21 is thereby blocked in the engagement section 302 as a result of the engagement of the respective bracket element 21 in the engagement groove 311, as is apparent, for example, from a combination of FIG. 4 and FIG. 6”).
Regarding claim 34, Kaufmann teaches the one or more anchors (21) are disposed at least partially within the hollow interior of the leading end (see Figures 4 and 6-7 and [0056] – “The locking element 31 is guided in the coupling element 30 and comprises a body 310, at which engagement grooves 311 are formed on a distal, outwardly directed side, which are arranged in a star-shaped manner with respect to one another and open centrally into an opening 312, as is apparent from FIG. 4 and FIG. 7, for example. In the coupled position, each bracket element 21 of the sensor device 2 engages in one of the engagement grooves 311, wherein each engagement groove 311 is aligned with an assigned engagement section 302 of the coupling element 30, and the bracket element 21 is thereby blocked in the engagement section 302 as a result of the engagement of the respective bracket element 21 in the engagement groove 311, as is apparent, for example, from a combination of FIG. 4 and FIG. 6”).
Allowable Subject Matter
Claims 12, 17-18, and 27-30 are allowed.
The following is an examiner’s statement of reasons for allowance:
The claims in this application have been allowed because the prior art of record fails to disclose, either singly or in combination, the claimed method, including, among other features, delivering a sensor implant device in a compressed form to a blood vessel or left atrial appendage via a delivery device, the sensor implant device comprising a sensor body, a sensor component, and a coil coupled to the sensor body and forming an inner lumen, wherein the sensor body is disposed at least partially within the inner lumen, removing the sensor implant device from the delivery device to cause the coil to naturally assume an expanded form; and anchoring the coil within to the blood vessel or left atrial appendage. In particular, nothing in the prior art describes a coil that forms an inner lumen within which the sensor body is placed, as best seen in Applicant’s Figures 18-19 and 21-25.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
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