DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/381,770, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Support for the pending claim set could not be found in Application No. 61/381,770. The earliest filing date that appears to provide support is 9/12/2011 for Application No. 13/230,628.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/1/2024 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 31-35 and 38-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallace et al. (US 2003/0195553).
Wallace discloses (see Figs. 3-4) a device for occluding an aneurysm comprising the following claim limitations:
(claim 31) A device (110) for implantation within a cerebral aneurysm (as shown in Fig. 3), the device comprising: a first mesh portion (120) comprising a plurality of braided filaments (as shown in Figs. 3-4; see claims 8, 21, 44 and 56; [0031]-[0033]; [0040]-[0041]), the first mesh portion (120) having a proximal region (i.e., proximal end of mesh structure 120) configured to be positioned over a neck (70) of the aneurysm (40) and a distal region (i.e., distal end of mesh structure 120) configured to be positioned within the aneurysm cavity (40) (as expressly shown in Fig. 3), wherein the first mesh portion (120) has (a) a compressed state for delivery through an elongated shaft (see exemplary Fig. 9a; see claim 36; [0014]; delivery within a catheter expressly disclosed), and (b) an expanded state in which the first mesh portion (120) forms a three-dimensional shape having a concave surface configured to face the aneurysm cavity (40) and a convex surface configured to be positioned over the neck (70) of the aneurysm (40) and face a parent vessel (60) (as expressly shown in Fig. 3), and wherein the first mesh portion (120) is formed of a tubular braid that is folded on itself to form an inner layer and an outer layer that are continuous with one another at a distal end of the three-dimensional shape (as shown in Figs. 3-4; [0040]-[0041]; double (inner and outer) layered bowl 120 expressly disclosed), the inner layer comprising the concave surface (i.e., the upper surface of occluder 120 in Fig. 3) and the outer layer comprising the convex surface (i.e., the lower surface of occluder 120 in Fig. 3); and a second mesh portion (115/130) having a proximal region (i.e., proximal end of tubular portion 115) coupled to the concave surface of the first mesh portion (120) (as expressly shown in Figs. 3-4) and a distal region (i.e., at 130) configured to extend into the aneurysm cavity (40) (as shown in Fig. 3), wherein the second mesh portion (115/130) has (a) a compressed state for delivery through an elongated shaft (see exemplary Fig. 9a; see claim 36; [0014]; delivery within a catheter expressly disclosed), and (b) an expanded state in which the second mesh portion (115) forms a tubular protrusion extending distally from the first mesh portion (120) (as expressly shown in Fig. 3);
(claim 32) wherein, in the expanded state, the first mesh portion (120) is configured to self-expand towards a predetermined shape (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi)) in which a width of the first mesh portion (120) decreases proximally (i.e., proximally narrowing sides of the bowl expressly shown in Fig. 3);
(claim 33) wherein the first (120) and/or second (115/130) mesh portion is configured to conform to the aneurysm wall in the expanded state (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi));
(claim 34) wherein at least some of the filaments comprise a shape-memory alloy (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi));
(claim 35) wherein at least some of the filaments comprise a superelastic material (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi));
(claim 38) wherein the first mesh portion (120) and the second mesh portion (115/130) comprise a unitary structure (as expressly shown in Figs. 3-4; [0014]);
(claim 39) wherein the first (120) and/or second (115/130) mesh portion is configured to self-expand when released from a delivery catheter (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi)); and
(claim 40) wherein the second mesh portion (at 130) comprises a generally parabolic shape in the expanded state (as expressly shown in Fig. 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace et al. (US 2003/0195553) in view of Greenhalgh (US 2005/0277978).
Wallace discloses (see Figs. 3-4) a device for occluding an aneurysm comprising the following claim limitations:
(claim 21) A device (110) for implantation within a cerebral aneurysm (as shown in Fig. 3), the device comprising: a first mesh portion (120) comprising a plurality of braided filaments (as shown in Figs. 3-4; see claims 8, 21, 44 and 56; [0031]-[0033]; [0040]-[0041]), the first mesh portion (120) having a proximal region (i.e., proximal end of mesh structure 120) configured to be positioned over a neck (70) of the aneurysm (40) and a distal region (i.e., distal end of mesh structure 120) configured to be positioned within the aneurysm cavity (40) (as expressly shown in Fig. 3), wherein the first mesh portion (120) has (a) a compressed state for delivery through an elongated shaft (see exemplary Fig. 9a; see claim 36; [0014]; delivery within a catheter expressly disclosed), and (b) an expanded state in which the first mesh portion (120) forms a bowl having an inner layer and an outer layer (as shown in Figs 3-4), the inner and outer layers being continuous with one another at a distal portion of the bowl (as shown in Figs. 3-4; [0040]-[0041]; double (inner and outer) layered bowl 120 expressly disclosed); and a second mesh portion (115) having a proximal region (i.e., proximal end of tubular portion 115) coupled to the inner layer of the bowl of the first mesh portion (120) (as expressly shown in Figs. 3-4), a distal region (i.e., distal end of tubular portion 115), and an intermediate region (i.e., middle region of tubular portion 115) therebetween, the second mesh portion (115) being configured to extend into the aneurysm cavity (40) (as expressly shown in Fig. 3), wherein the second mesh portion (115) has (a) a compressed state for delivery through the elongated shaft (see exemplary Fig. 9a; see claim 36; [0014]; delivery within a catheter expressly disclosed), and (b) an expanded state (as shown in Fig. 3);
(claim 22) wherein, in the expanded state, the first mesh portion (120) is configured to self-expand towards a predetermined shape (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi)) in which a width of the first mesh portion (120) decreases proximally (i.e., proximally narrowing sides of the bowl expressly shown in Fig. 3);
(claim 23) wherein the first (120) and/or second (115) mesh portion is configured to conform to the aneurysm wall in the expanded state (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi));
(claim 24) wherein at least some of the filaments comprise a shape-memory alloy (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi));
(claim 25) wherein at least some of the filaments comprise a superelastic material (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi));
(claim 28) wherein the first mesh portion (120) and the second mesh portion (115) comprise a unitary structure (as expressly shown in Figs. 3-4; [0014]);
(claim 29) wherein the first (120) and/or second (115) mesh portion is configured to self-expand when released from a delivery catheter (see Abstract; [0012]; [0014]; [0033]; use of resilient, self-expanding, shape memory alloys such as Nitinol (i.e., nickel titanium/NiTi));
(claim 30) wherein, when the device is implanted in the aneurysm (40), the bowl (120) has a concave portion facing the aneurysm cavity and a convex portion positioned over the neck (70) of the aneurysm (40) (as expressly shown in Fig. 3).
Wallace, as applied above, discloses a device for occluding an aneurysm comprising all the limitations of the claim except for the second mesh portion forming a tubular loop extending distally from the bowl of the first mesh portion.
However, Greenhalgh teaches (see Figs. 4-5) a similar device for occluding an aneurysm comprising a second mesh portion (40) forming a tubular loop (as expressly shown in the shape of 40 in Figs. 4-5) extending distally from the bowl of the first mesh portion (50) (as shown in Fig. 5) in order to beneficially provide a self-expanding coil structure having great flexibility allowing the self-expanding coil structure to conform to any shape and fill the void space of an aneurysm ([0019]; [0023]-[0027]; [0030]-[0033]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Wallace to have a second mesh portion forming a tubular loop extending distally from the bowl of the first mesh portion in order to beneficially provide a self-expanding coil structure having great flexibility allowing the self-expanding coil structure to conform to any shape and fill the void space of an aneurysm, as taught by Greenhalgh.
Claim(s) 26-27 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace and/or Wallace in view of Greenhalgh as applied to claims 1 and/or 31 above, and further in view of Rosqueta et al. (US 2009/0287294).
Wallace and/or Wallace in view of Greenhalgh, as applied above, discloses a device for occluding an aneurysm comprising all the limitations of the claim except for at least some of the filaments comprising drawn-filled tubes having a platinum core surrounded by an outer layer of Nitinol, and a connector disposed at the proximal region of the first mesh portion to secure the plurality of braided filaments relative to one another.
However, Rosqueta teaches a similar device for occluding an aneurysm comprising a connector disposed at the proximal region of the first mesh portion to secure the plurality of braided filaments relative to one another in order to beneficially retain and secure a plurality of braided filaments together, while also serving as a radiopaque feature, and still further allowing for selective deployment from a detachable pusher/delivery mechanism ([0013]; [0018]-[0019]; [0024]; [0037]; [0043]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Wallace and/or Wallace in view of Greenhalgh to have a connector disposed at the proximal region of the first mesh portion to secure the plurality of braided filaments relative to one another in order to beneficially retain and secure a plurality of braided filaments together, while also serving as a radiopaque feature, and still further allowing for selective deployment from a detachable pusher/delivery mechanism, as taught by Rosqueta.
Additionally, Rosqueta teaches a similar device for occluding an aneurysm comprising at least some of the filaments comprising drawn-filled tubes having a platinum core surrounded by an outer layer of Nitinol ([0013]). Accordingly, Rosqueta teaches that it is known that superelastic wires and platinum core Nitinol DFTs are elements that are functional equivalents for providing an expandable device with resiliency and elasticity wherein the device will return to a pre-set expanded, deployed configuration when no longer constrained during delivery. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the platinum core Nitinol DFTs taught by Rosqueta for the superelastic wires of Amplatz because both elements were known equivalents for providing an expandable device with resiliency and elasticity wherein the device will return to a pre-set expanded, deployed configuration when no longer constrained during delivery within the occlusive device arts. The substitution would have resulted in the predictable results of providing an expandable device with resiliency and elasticity wherein the device will return to a pre-set expanded, deployed configuration when no longer constrained during delivery to the device of Wallace and/or Wallace in view of Greenhalgh.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,446,890 in view of Greenhalgh (US 2005/0277978). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 12,446,890
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1-10
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U.S. Patent No. 12,446,890, as applied above, discloses a device for implantation within an aneurysm comprising all the limitations of the claim except for a second mesh portion distally extending from the first mesh portion and in the form of a tubular loop/protrusion. However, Greenhalgh teaches (see Figs. 4-5) a similar device for implantation within an aneurysm comprising a second mesh portion (40) distally extending from the first mesh portion (50) and in the form of a tubular loop/protrusion (as expressly shown in the shape of 40 in Figs. 4-5) in order to beneficially provide a self-expanding coil structure having great flexibility allowing the structure to conform to any shape and fill the space of an aneurysm ([0019]; [0023]-[0027]; [0030]-[0033]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of U.S. Patent No. 12,446,890 to have a second mesh portion distally extending from the first mesh portion and in the form of a tubular loop/protrusion in order to beneficially provide a self-expanding coil structure having great flexibility allowing the structure to conform to any shape and fill the space of an aneurysm, as taught by Greenhalgh.
Regarding claims 28 and 39, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the first and second meshes as an integral structure, 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. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771