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 .
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.
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Claims 1, 2, 6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, and 6 of U.S. Patent No. 12,029,910 (now referred to as Pat ‘910). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Claim 1, Claim 1 of Pat ‘910 discloses a biostimulator (leadless pace maker; Column 20, Line 52), comprising:
a body having a fixing end and a docking end on a longitudinal axis (Column 20, Line 53-54);
a helical anchor at the fixing end to attach to tissue (Column 20, Line 56); and
a docking projection extending in a proximal direction from the docking end and having three or more side keys notched in an end surface (proximalmost surface) (Column 20, Line 57-61).
Regarding Present Claim 2, Claim 4 of Pat ‘910 discloses the biostimulator of claim 1, wherein the end surface has a curved profile (Column 21, Lines 3-4), and wherein each side key extends over the curved profile (Claim 1, Lines 61-62).
Regarding Present Claim 6, Claim 3 of Pat ‘910 discloses the biostimulator of claim 1, wherein the three or more side keys are rotationally symmetric about the longitudinal axis.
Regarding Present Claim 8, Claim 6 of Pat ‘910 discloses the biostimulator of claim 1, wherein the docking projection includes a neck radially inward from the end surface.
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, 2, 7-10, 12 , 13, 16, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelly (US PGPub 2016/0269423).
Regarding Claim 1, Kelly teaches a biostimulator (Figure 3), comprising:
a body having (26; Figure 3) a fixing end (near element 28) and a docking end (near element 29) on a longitudinal axis (Figure 3; Paragraph 0030, 0032, 0049);
a helical anchor (28; Figure 3) at the fixing end to attach to tissue (38; Figure 3); and
a docking projection (29; Figure 3) extending in a proximal direction from the docking end and having three or more side keys notched in an end surface (Paragraph 0113 discloses docking cap (370; Figure 17A) is configured to mate with longitudinal ridges of the docking cap with smooth surface of the docking projection (proximal structure) of the biostimulator (Paragraph 0113; Figure 17A) and thus the docking projection (which is not shown) will have corresponding side keys notched in an end surface of the docking projection to mate with the longitudinal ridges (378a) of the docking cap (370; Figure 17A)
Regarding Claim 2, Kelly teaches the biostimulator of claim 1, wherein the end surface has a curved profile (Figure 3), and wherein each side key extends over the curved profile (Paragraph 0113).
Regarding Claim 7, Kelly teaches the biostimulator of claim 1, wherein the three or more side keys include dimples in the end surface (Paragraph 0113; wherein the side keys on the end surface are depressions and thus dimples in order to mate with the longitudinal ridges on the docking cap).
Regarding Claim 8, Kelly teaches the biostimulator of claim 1, wherein the docking projection includes a neck radially inward from the end surface (See Figure 3 for the neck between docking projection 29 and body 26).
Regarding Claim 9, Kelly teaches a catheter system (12; Figure 2), comprising:
a torque shaft (22/24; Figure 3) having a longitudinal axis (Paragraph 0033); and
a docking cap (36) coupled to the torque shaft (24), wherein the docking cap (36) has a cap surface defining a chamber(best seen in Figures 17B-17C) to receive a docking projection (29; Figure 3; Paragraph 0113), and wherein the docking cap (370; Figure 17A-17C) includes three or more cap keys (378B) extending over the cap surface (see Figure 17C; Paragraph 0114).
Regarding Claim 10, Kelly teaches the catheter system of claim 9, wherein the cap surface has a curved profile (Figure 17A and Figure 17C).
Regarding Claim 12, Kelly teaches a biostimulator system (Figure 3), comprising:
a biostimulator (Figure 3), comprising:
a body having (26; Figure 3) a fixing end (near element 28) and a docking end (near element 29) on a longitudinal axis (Figure 3; Paragraph 0030, 0032, 0049);
a helical anchor (28; Figure 3) at the fixing end to attach to tissue (38; Figure 3); and
a docking projection (29; Figure 3) extending in a proximal direction from the docking end and having three or more side keys notched in an end surface (Paragraph 0113 discloses docking cap (370; Figure 17A) is configured to mate with longitudinal ridges of the docking cap with smooth surface of the docking projection (proximal structure) of the biostimulator (Paragraph 0113; Figure 17A) and thus the docking projection (which is not shown) will have corresponding side keys notched in an end surface of the docking projection to mate with the longitudinal ridges (378a) of the docking cap (370; Figure 17A)
a catheter system (12; Figure 2), comprising:
a torque shaft (22/24; Figure 3) having a longitudinal axis (Paragraph 0033); and
a docking cap (36) coupled to the torque shaft (24), wherein the docking cap (36) has a cap surface defining a chamber(best seen in Figures 17B-17C) to receive a docking projection (29; Figure 3; Paragraph 0113), and wherein the docking cap (370; Figure 17A-17C) includes three or more cap keys (378B) extending over the cap surface (see Figure 17C; Paragraph 0114).
Regarding Claim 13, Kelly teaches the biostimulator of claim 12, wherein the end surface has a curved profile (Figure 3), and wherein each side key (378B) extends over the curved profile (Paragraph 0113).
Regarding Claim 18, Kelly teaches the biostimulator of claim 12, wherein the three or more side keys include dimples in the end surface (Paragraph 0113; wherein the side keys on the end surface are depressions and thus dimples in order to mate with the longitudinal ridges on the docking cap).
Regarding Claim 19, Kelly teaches the biostimulator of claim 12, wherein the end surface has a curved profile (Figure 3).
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) 4, 5, 6, 11, 15, 16, 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly (US PGPub 2016/0269423) as applied to claim 1, 9, and 12 above, and further in view of Schmidt (US PGPub 2015/0051682).
Regarding Claim 4, Kelly teaches the biostimulator of claim 1, but fails to disclose wherein a circumferential distance between the side keys decreases in the proximal direction.
Schmidt teaches a leadless medical implant/biostimulator (12; Figure 17B) and a catheter delivery (100; Figure 17A and 17B), wherein the catheter delivery system comprises a pusher having a docking cap (112) for torquing the biostimulator (12) into target tissue, the docking cap having three or more cap keys (114) (lugs; 114; in Figure 17a, however the Examiner is relying on the docking cap with triangular cap keys in Figure 18C). The lugs are configured to engage a recess/side keys (82) of the head portion (see specifically Paragraph 0088).
It would have been obvious to one of ordinary skill in the art to modify the side keys in the docking projection taught by Kelly, with a triangular shape, as taught by Schmidt, which would result in a side key that decreases in a proximal direction since the thickest part of the triangle is at the radial most surface, because it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04). Furthermore, Schmidt teaches both linear legs (114; Figure 18B) and triangular lugs (Figure 18C) are alternative configurations (Paragraph 0084; Schmidt)
Regarding Claim 5, Kelly teaches the biostimulator of claim 1, but fails to disclose wherein a width of each side key varies in the proximal direction.
Schmidt teaches a leadless medical implant/biostimulator (12; Figure 17B) and a catheter delivery (100; Figure 17A and 17B), wherein the catheter delivery system comprises a pusher having a docking cap (112) for torquing the biostimulator (12) into target tissue, the docking cap having three or more cap keys (114) (lugs; 114; in Figure 17a, however the Examiner is relying on the docking cap with triangular cap keys in Figure 18C). The lugs are configured to engage a recess/side keys (82) of the head portion (see specifically Paragraph 0088).
It would have been obvious to one of ordinary skill in the art to modify the side keys in the docking projection taught by Kelly, with a triangular shape, as taught by Schmidt, which would result in a side key that has a width which varies in the proximal direction since the thickest part of the triangle is at the radial most surface, because it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04). Furthermore, Schmidt teaches both linear legs (114; Figure 18B) and triangular lugs (Figure 18C) are alternative configurations (Paragraph 0084; Schmidt)
Regarding Claim 6, Kelly teaches the biostimulator of claim 1, but fails to explicitly disclose wherein the three or more side keys are rotationally symmetric about the longitudinal axis.
Schmidt teaches a leadless medical implant/biostimulator (12; Figure 17B) and a catheter delivery (100; Figure 17A and 17B), wherein the catheter delivery system comprises a pusher having a docking cap (112) for torquing the biostimulator (12) into target tissue, the docking cap having three or more cap keys (114) (lugs; 114; in Figure 17a, however the Examiner is relying on the docking cap with triangular cap keys in Figure 18C). The lugs (114) are equally spaced (Paragraph 0086).
It would have been obvious to one of ordinary skill in the art to modify the side keys in the docking projection taught by Kelly, to be equally spaced as taught by Schmidt, for the advantage of equally distributing the axial and torque forces on the docking projection.
Regarding Claim 11, Kelly teaches the catheter system of claim 9, but fails wherein the three or more cap keys are rotationally symmetric about the longitudinal axis.
Schmidt teaches a leadless medical implant/biostimulator (12; Figure 17B) and a catheter delivery (100; Figure 17A and 17B), wherein the catheter delivery system comprises a pusher having a docking cap (112) for torquing the biostimulator (12) into target tissue, the docking cap having three or more cap keys (114) (lugs; 114; in Figure 17a, however the Examiner is relying on the docking cap with triangular cap keys in Figure 18C) that are equally spaced (Paragraph 0086; Figure 18A-C).
It would have been obvious to one of ordinary skill in the art to modify the cap keys in the docking cap taught by Kelly, to be equally spaced as taught by Schmidt, for the advantage of equally distributing the axial and torque forces on the docking projection.
Regarding Claim 15, Kelly teaches the biostimulator system of claim 12, but fails to disclose wherein a circumferential distance between the side keys decreases in the proximal direction.
Schmidt teaches a leadless medical implant/biostimulator (12; Figure 17B) and a catheter delivery (100; Figure 17A and 17B), wherein the catheter delivery system comprises a pusher having a docking cap (112) for torquing the biostimulator (12) into target tissue, the docking cap having three or more cap keys (114) (lugs; 114; in Figure 17a, however the Examiner is relying on the docking cap with triangular cap keys in Figure 18C). The lugs are configured to engage a recess/side keys (82) of the head portion (see specifically Paragraph 0088).
It would have been obvious to one of ordinary skill in the art to modify the side keys in the docking projection taught by Kelly, with a triangular shape, as taught by Schmidt, which would result in a side key that decreases in a proximal direction since the thickest part of the triangle is at the radial most surface, because it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04). Furthermore, Schmidt teaches both linear legs (114; Figure 18B) and triangular lugs (Figure 18C) are alternative configurations (Paragraph 0084; Schmidt)
Regarding Claim 16, Kelly teaches the biostimulator system of claim 12, but fails to explicitly teach wherein a width of each side key (378B) varies in the proximal direction.
Schmidt teaches a leadless medical implant/biostimulator (12; Figure 17B) and a catheter delivery (100; Figure 17A and 17B), wherein the catheter delivery system comprises a pusher having a docking cap (112) for torquing the biostimulator (12) into target tissue, the docking cap having three or more cap keys (114) (lugs; 114; in Figure 17a, however the Examiner is relying on the docking cap with triangular cap keys in Figure 18C). The lugs are configured to engage a recess/side keys (82) of the head portion (see specifically Paragraph 0088).
It would have been obvious to one of ordinary skill in the art to modify the side keys in the docking projection taught by Kelly, with a triangular shape, as taught by Schmidt, which would result in a side key that has a width which varies in the proximal direction since the thickest part of the triangle is at the radial most surface, because it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04). Furthermore, Schmidt teaches both linear legs (114; Figure 18B) and triangular lugs (Figure 18C) are alternative configurations (Paragraph 0084; Schmidt)
Regarding Claim 17, Kelly teaches the biostimulator system of claim 12, but fails to disclose wherein the three or more side keys are rotationally symmetric about the longitudinal axis.
Schmidt teaches a leadless medical implant/biostimulator (12; Figure 17B) and a catheter delivery (100; Figure 17A and 17B), wherein the catheter delivery system comprises a pusher having a docking cap (112) for torquing the biostimulator (12) into target tissue, the docking cap having three or more cap keys (114) (lugs; 114; in Figure 17a, however the Examiner is relying on the docking cap with triangular cap keys in Figure 18C). The lugs (114) are equally spaced (Paragraph 0086).
It would have been obvious to one of ordinary skill in the art to modify the side keys in the docking projection taught by Kelly, to be equally spaced as taught by Schmidt, for the advantage of equally distributing the axial and torque forces on the docking projection.
Regarding Claim 20, Kelly teaches the biostimulator system of claim 12, but fails to disclose wherein the three or more cap keys are rotationally symmetric about the longitudinal axis.
Schmidt teaches a leadless medical implant/biostimulator (12; Figure 17B) and a catheter delivery (100; Figure 17A and 17B), wherein the catheter delivery system comprises a pusher having a docking cap (112) for torquing the biostimulator (12) into target tissue, the docking cap having three or more cap keys (114) (lugs; 114; in Figure 17a, however the Examiner is relying on the docking cap with triangular cap keys in Figure 18C). The lugs (114) are equally spaced (Paragraph 0086). The lugs are configured to engage a recess/side keys (82) of the head portion (see specifically Paragraph 0088).
It would have been obvious to one of ordinary skill in the art to modify the cap keys in the docking projection taught by Kelly, to be equally spaced as taught by Schmidt, for the advantage of equally distributing the axial and torque forces on the docking projection.
Allowable Subject Matter
Claims 3 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim 3 and 14, the prior art of record fails to disclose: wherein a depth of each side key decreases in the proximal direction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771