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 .
Detailed Action
This is in response to the amendment filed 02/06/2025.
Allowable Subject Matter
Claims 4, 5, 12, 13, 18, 20 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.
The following is a statement of reasons for the indication of allowable subject matter: Claim 4 recites an annular seal having a seal lumen aligned with the cap lumen, wherein the seal lumen has a circular profile. Claim 12 recites a tool cap mounted on the tool body and having a cap lumen, wherein the cap lumen has a non-circular profile. Claim 13 recites a locking tab extending radially outward from the tool body. Claim 18 recites wherein the ledge includes a groove face having a dimple. Claim 20 recites wherein the introducer seal includes a cross-slit providing a passage from a proximal side of the introducer seal to a distal side of the introducer seal.
The Office agrees the art of record fails to teach or suggest these features.
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, 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 15 of U.S. Patent No. 11,364,364
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 7, 15 of the patent generally recites a valve bypass tool, with a bypass sheath, and tool body, wherein the tool body is form from a different material than the bypass sheath, a push tab (tab 40a, see paragraph [0053]) extending radially outward from the tool body, which is not patentably distinct from what is recited in claims 1, 10 of the current application.
It is clear that all the elements of claims 1, 10 are to be found in claims 7, 15 of the patent. The difference between claims 1,10 of the application and claims 7, 15 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims 7, 15 of the patent is in effect a “species” of the “generic” invention of claims 1, 10 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,226,593
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 of the patent generally recites a valve bypass tool, with a bypass sheath, and tool body, wherein the tool body is form from a different material than the bypass sheath, a push tab extending radially outward from the tool body, which is not patentably distinct from what is recited in claims 1-13 of the current application.
It is clear that all the elements of claims 1-14 are to be found in claims 1-13 of the patent. The difference between claims 1-14 of the application and claims 1-13 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims 1-13 of the patent is in effect a “species” of the “generic” invention of claims 1-14 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 102
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) 15, 16, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticapted by U.S. Patent Publication Number 2004/0254534 (Bjorkman et al.)
Regarding claims 15, 16, 19 Bjorkman et al. discloses as shown in Figure 2, an access introducer, comprising: an introducer body (assembly 2, see paragraph [0042]) having an introducer port; an elongated tubular member (cannula portion 14) extending distally from the introducer body and having an internal lumen; and an introducer cap (cap 8, see paragraph [0042]) having a locking coupling (sealing neck 30, see paragraph [0046]), wherein the introducer cap includes a profile having one or more tab slots (opening in first narrowed portion 34), wherein the locking coupling includes a female coupling (opening in sealing neck) having a locking groove distal to a ledge, an introducer seal (sealing lips 44, see paragraph [0050]) disposed between the introducer body and the introducer cap.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0054330 (Kurth et al.) in view of U.S. Patent Publication Number 2006/0030849 (Mirizzi et al.), U.S. Patent Publication Number 2001/0049499 (Lui)
Regarding claims 1, 2, 9 Kurth et al. discloses as shown in Figures 1, 9, 10 a valve bypass tool, comprising: a bypass sheath (introducer 12, see paragraph [0047]) having a solid tubular wall around a bypass lumen,; and a tool body (first and second portions 38, 40, see paragraphs [0014], [0053]) mounted on an outer surface of the solid tubular wall, wherein the tool body has a body lumen aligned with the bypass lumen, a push tab (tab 40a, see paragraph [0053]) extending radially outward from the tool body, wherein the push tab includes a flange, wherein the push tab extends radially outward from the tool body to an outer tab face, and wherein a radial dimension between the tool body and the outer tab face is greater than a longitudinal dimension of the outer tab face. See paragraph [0081].
Kurth is silent about the bypass sheath having a solid tubular wall, made of rigid metal and the tool body being formed from a polymer.
Lui, from the same field of endeavor teaches a similar valve bypass tool as shown in Figure 1, where it is known to form the tool body in the form of silicone. See paragraph [0007].
Mirizzi et al., from the same field of endeavor teaches a similar bypass sheath as shown in Figure 1, where it is known to form a bypass sheath having a solid tubular wall, made of rigid metal. See paragraph [0048].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify valve bypass tool disclosed by Kurth et al. by substituting the material of the tool body disclosed by Kurth for the material of the tool body disclosed by Lui and substituting the material of the bypass sheath disclosed by Kurth for the material of the bypass sheath disclosed by Mirizzi et al. because it would only require the simple substitution of one known alternative material for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 6, Kurth in view of Mirizzi, and Lui discloses wherein the tool body is overmolded onto the tubular wall. See paragraph [0061] of Kurth.
Regarding claims 7, 8 Kurth et al. discloses a locking tab (tab 40a, see paragraph [0053]) extending radially outward from the tool body, wherein the locking tab includes a detent (groove 79, see paragraph [0055]) extending from a tab face.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 6,712,791 (Lui et al.) in view of U.S. Patent Publication Number 2006/0030849 (Mirizzi et al.), U.S. Patent Publication Number 2001/0049499 (Lui)
Regarding claims 1, 2 Lui et al. discloses as shown in Figures 23, 34, a valve bypass tool, comprising: a bypass sheath (passageway 120, see col. 10, lines 1-22) having a solid tubular wall around a bypass lumen; and a tool body (introducer sheath 24, see col. 10, lines 1-22) mounted on an outer surface of the solid tubular wall, wherein the tool body has a body lumen aligned with the bypass lumen, a push tab (proximal end 52, see col. 10, lines 1-22) extending radially outward from the tool body, wherein the push tab includes a flange.
Lui et al. is silent about the bypass sheath having a solid tubular wall, made of rigid metal and the tool body being formed from a polymer.
Lui, from the same field of endeavor teaches a similar valve bypass tool as shown in Figure 1, where it is known to form the tool body in the form of silicone. See paragraph [0007].
Mirizzi et al., from the same field of endeavor teaches a similar bypass sheath as shown in Figure 1, where it is known to form a bypass sheath having a solid tubular wall, made of rigid metal. See paragraph [0048].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify valve bypass tool disclosed by Lui et al. by substituting the material of the tool body disclosed by Lui et al. for the material of the tool body disclosed by Lui and substituting the material of the bypass sheath disclosed by Lui et al. for the material of the bypass sheath disclosed by Mirizzi et al. because it would only require the simple substitution of one known alternative material for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 3 Lui et al. discloses a tool cap (wall 47, see col. 6, lines 12-51) mounted on the tool body and having a cap lumen.
Claim(s) 10, 11, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2008/0021532 (Kveen) in view of U.S. Patent Publication Number 2004/0054330 (Kurth et al.), U.S. Patent Publication Number 2006/0030849 (Mirizzi et al.), U.S. Patent Publication Number 2001/0049499 (Lui),
Regarding claims 10, 11, 14 Kveen discloses as shown in Figures 1, 3 a biostimulator transport system, comprising: a handle (handle of trigger device 137, see paragraph [0039]); a catheter (actuation member 160, see paragraph [0039]) extending from the handle; a protective sheath (delivery catheter 130, see paragraph [0029]) slidably mounted on the catheter; and a valve bypass tool (guide sheath 110, see paragraph [0030]) slidably mounted on the protective sheath, wherein the valve bypass tool includes a bypass sheath having a tubular wall around a bypass lumen, a push tab (tab 40a, see paragraph [0053]) extending radially outward from the tool body, wherein the push tab extends radially outward from the tool body to an outer tab face, and wherein a radial dimension between the tool body and the outer tab face is greater than a longitudinal dimension of the outer tab face, wherein the push tab includes a flange. See paragraph [0081].
Kveen fails to disclose the sheath having a solid tubular wall around the bypass lumen, the solid tubular wall formed from a rigid metal, a tool body mounted on an outer surface of the bypass sheath, wherein the tool body has a body lumen aligned with the bypass lumen, and wherein the tool body is formed from a polymer.
Kurth et al., from the same filed of endeavor teaches a similar system as shown in Figures 1, 9, 10 a valve bypass tool, comprising: a bypass sheath (introducer 12, see paragraph [0047]) having a tubular wall around a bypass lumen (lumen defined by valve membrane 72, see paragraph [0053]) ; and a tool body (valve 14, see paragraphs [0014], [0053]) mounted on the bypass sheath, wherein the tool body has a body lumen aligned with the bypass lumen, the purpose of the tool body is to support a valve which provides a fluid tight seal around an opening of the bypass sheath with or without something inserted into it. See paragraph [0014].
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 disclosed by Kveen to include the tool body on the bypass sheath disclosed by Kurth et al. in order to provide a fluid tight seal around an opening of the bypass sheath with or without something inserted into or just to substitute the valve bypass tool disclosed by Kveen for the valve bypass tool disclosed by Kurth et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Lui, from the same field of endeavor teaches a similar valve bypass tool as shown in Figure 1, where it is known to form the tool body in the form of silicone. See paragraph [0007].
Mirizzi et al., from the same field of endeavor teaches a similar bypass sheath as shown in Figure 1, where it is known to form a bypass sheath having a solid tubular wall, made of rigid metal. See paragraph [0048].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify valve bypass tool disclosed by Kurth et al. by substituting the material of the tool body disclosed by Kurth for the material of the tool body disclosed by Lui and substituting the material of the bypass sheath disclosed by Kurth for the material of the bypass sheath disclosed by Mirizzi et al. because it would only require the simple substitution of one known alternative material for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771
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