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 .
Election/Restrictions
Applicant’s election of Invention II in the reply filed on 12/5/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant canceled claims directed to the unelected invention thus claims 1, 5-6, 14-16 and 26-43 are now pending.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 recites “A bioimplant for insertion a vessel” which should recite “A bioimplant for insertion into a vessel” for grammatical accuracy.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “delivery device” in claim 5 and “activating mechanism” in claim 27.
Claim 5 recites the limitation of a “delivery device”. The term “device” is used as a substitute for “means” and is modified by functional language “delivery”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “delivery device” is “a catheter dimensioned for intravascular application” (Page 20) or equivalents thereof.
Claim 27 recites the limitation of a “activating mechanism”. The term “mechanism” is used as a substitute for “means” and is modified by functional language “applying a force on the at least one wire to rotate the delivery catheter”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “activating mechanism” is “any structure or mechanism suitable for the intended purpose of applying the axial force to the pull wires …rotating wheels, pulley systems, ratchet mechanism, levers, or the like” (Page 63) or equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 42 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 42 recites the language “wherein the imaging is processed via an automated computer assisted modality to guide the configuration of the implant during its creation”, which is written as a method step, however the claim is an apparatus claim, rendering the scope of the claim indefinite.
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) 1, 5-6, and 14-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Connor (US 20190365472 A1) (noted on IDS).
Regarding claim 16, Connor discloses a bioimplant for insertion a vessel, comprising: an implant member configured and dimensioned to correspond to a particular anomaly in the vessel (Paragraph 0086), the implant member defining at least one of a size or shape determined at least in part on imaging data obtained of the anomaly (Paragraph 0086; 0099).
Regarding claim 1, Connor further discloses wherein the implant is formed based on a model of a bioimplant based on the imaging data (Paragraph 0086); and the bioimplant generally corresponds in dimension to the anomaly in the vessel (Paragraph 0086).
Regarding claim 5, Connor further discloses the bioimplant according to claim 16 in combination with at least one delivery device (catheter) (Paragraph 0040). (As indicated above, the limitation “delivery device” invokes 112(f). The corresponding structure in Connor is a catheter, which is equivalent to a catheter, as disclosed in the present disclosure.)
Regarding claim 6, Connor further discloses wherein the at least one delivery device includes a catheter dimensioned for intravascular application (Paragraph 0040).
Regarding claim 14, Connor further discloses wherein the bioimplant is, at least in part, self-expandable (Paragraph 0103).
Regarding claim 15, Connor further discloses wherein the bioimplant comprises a hydrogel coating (Paragraph 0018; 0089).
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) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor in view of McFann et al. (US 20020032391 A1).
Regarding claim 26, Connor discloses a bioimplant system comprising: the bioimplant of claim 16 (see rejection of claim 16 above); and a delivery system including: a delivery catheter (catheter) (Paragraph 0040). Connor fails to explicitly disclose at least one wire including a spiral configuration extending along at least a segment of the delivery catheter.
However, McFann is directed to a catheter device and teaches a guide wire (10) including a spiral configuration (100) extending along at least a segment of the catheter (200) (Figure 1; Paragraph 0009; 0035; 0037).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Connor such that the delivery system includes at least one wire including a spiral configuration extending along at least a segment of the delivery catheter, as taught by McFann, as both references and the claimed invention are directed to catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Connor with the teachings of McFann by incorporating at least one wire including a spiral configuration extending along at least a segment of the delivery catheter in order to apply outward radial force to position the catheter as desired (McFann Paragraph 00009), as Connor is silent to details of the delivery catheter.
Claim(s) 27-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor in view of McFann and further in view of Cragg et al. (US 5795331 A).
Regarding claim 27, Connor as modified by McFann teaches the bioimplant system of claim 26, but fails to explicitly disclose an activating mechanism capable of applying a force on the at least one wire to rotate the delivery catheter.
However, Cragg is directed to an occluder delivery system and teaches a guide wire (70), which as a result of applied force via an activating mechanism (coupling of distal segment of guide wire 70), rotates the catheter (Col 5, line 37-43; Col 15, line 24-30). (As indicated above, the limitation “activating mechanism” invokes 112(f). The corresponding structure in Cragg is a coupling of a guide wire to the lumen, which can be manually actuated by the user to rotate the catheter, which is equivalent to any structure or mechanism suitable for the intended purpose of applying the axial force to the pull wires, as disclosed in the present disclosure.)
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Connor as modified by McFann to include an activating mechanism capable of applying a force on the at least one wire to rotate the delivery catheter, as taught by Cragg, as both references and the claimed invention are directed to catheters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Connor as modified by McFann with the teachings of Cragg by incorporating an activating mechanism capable of applying a force on the at least one wire to rotate the delivery catheter in order to rotate the catheter to position it for delivery (Cragg Col 5, lines 37-43). Further, Connor recites the use of a plurality of directional/rotational actuators (Paragraph 0106), thus the modification is suggested by Connor.
Regarding claim 28, Connor as modified by McFann and Cragg teaches wherein the delivery catheter is configured such that rotation of the delivery catheter alters an orientation of the bioimplant during delivery (the bioimplant is located inside the catheter during delivery, thus rotation of the catheter would result in rotation of the bioimplant).
Regarding claim 29, Connor further discloses at least one orientation marker (fiducial markers) (Paragraph 0104).
Regarding claim 30, Connor further discloses wherein the at least one orientation marker is included on the bioimplant (Paragraph 0104).
Regarding claim 31, Connor further discloses wherein the implant member is configured and dimensioned to correspond to a dimension of an outpouching in the vessel, wherein at least one of a size or shape of the implant member is determined at least in part on pre-procedural imaging data obtained at the outpouching (the implant is configured to correspond to an image of a desired area, thus is fully capable of being configured and dimensioned to correspond to a dimension of an outpouching in the vessel, wherein at least one of a size or shape of the implant member is determined at least in part on pre-procedural imaging data obtained at the outpouching).
Regarding claim 32, Connor further discloses one or more markers on the implant member (fiducial markers) (Paragraph 0104), wherein positioning of the one or more markers is based at least in part on pre-procedural image data obtained of physical references associated with the anomaly (Paragraph 0106; 0114).
Regarding claim 33, Connor further discloses wherein the one or more markers are configured to orient the implant during implantation (Paragraph 0104).
Regarding claim 34, Connor further discloses wherein the implant member comprises one of a mesh structure or a pouch (mesh, bag) (Paragraph 0086).
Regarding claim 35, Connor further discloses wherein the Implant member is self-expandable (Paragraph 0103).
Regarding claim 36, Connor further discloses wherein at least one of a size or shape of the implant member determined at least in part on pre-procedural imaging data obtained of the anomaly (Paragraph 0087).
Regarding claim 37, Connor further discloses a pusher (wire, catheter, or other resilient member) in the delivery catheter (Connor discloses deploying the implant via pushing a proximal portion with a wire, catheter, or other resilient member.) (Paragraph 0101).
Claim(s) 38-39 and 41-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor in view of McFann and Cragg as applied to claim 37 above, and further in view of Shrivastava et al. (US 20120041470 A1).
Regarding claim 38, Connor as modified by McFann and Cragg teaches the bioimplant system of claim 37, but fails to explicitly disclose wherein the delivery catheter has an inner lumen with a non-circular cross-sectional shape, and the pusher has a corresponding non-circular outer cross-sectional shape to inhibit relative rotation between the pusher and the delivery catheter, wherein the pusher is axially movable within the delivery catheter.
However, Shrivastava is directed to a delivery catheter and teaches the delivery catheter (216) has an inner lumen with a non-circular cross-sectional shape (Figure 29, 33; Paragraph 0317; 0321-322), and the pusher (226) has a corresponding non-circular outer cross-sectional shape (Figure 29; Paragraph 0324) to inhibit relative rotation between the pusher and the delivery catheter, wherein the pusher is axially movable within the delivery catheter (Paragraph 0322).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Connor as modified by McFann and Cragg such that the delivery catheter has an inner lumen with a non-circular cross-sectional shape, and the pusher has a corresponding non-circular outer cross-sectional shape to inhibit relative rotation between the pusher and the delivery catheter, wherein the pusher is axially movable within the delivery catheter, as taught by Shrivastava, as both references and the claimed invention are directed to Shrivastava. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Connor as modified by McFann and Cragg with the teachings of Shrivastava by incorporating the delivery catheter has an inner lumen with a non-circular cross-sectional shape, and the pusher has a corresponding non-circular outer cross-sectional shape to inhibit relative rotation between the pusher and the delivery catheter, wherein the pusher is axially movable within the delivery catheter in order to reduce lateral motion of the pull wire and prevent premature deployment (Shrivastava Paragraph 0322).
Regarding claim 39, the combination of Connor as modified with Shrivastava teaches wherein rotation of the delivery causes corresponding rotation of the pusher and the bioimplant (the pusher and bioimplant are located within the catheter, thus as the catheter rotates the components inside would rotate as well).
Regarding claim 41, Connor further discloses wherein the implant member is customized to dimensions of the particular anomaly in a particular patient, using pre-procedural imaging to guide the implant member (Paragraph 0087).
Regarding claim 42, as best understood in view of the 112(b) issues above, Connor further discloses wherein the imaging is processed via an automated computer assisted modality to guide the configuration of the implant during its creation (Paragraph 0063).
Regarding claim 43, Connor further discloses wherein the implant member is configured and dimensioned to correspond to a dimension of an aneurysm (Paragraph 0086), wherein at least one of a size or shape of the implant member determined at least in part on pre-procedural imaging data obtained of the aneurysm (Paragraph 0087).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor in view of McFann and Cragg as applied to claim 34 above, and further in view of Balgobin et al. (US 20080269721 A1).
regarding claim 40, Connor as modified by McFann and Cragg teaches the bioimplant system of claim 34, but fails to explicitly disclose wherein the delivery catheter further comprises: at least one orientation marker.
However, Balgobin is directed to a delivery system (10) and teaches wherein the delivery catheter (16) comprises: at least one orientation marker (30) (Paragraph 0004).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Connor as modified by McFann and Cragg such that the delivery catheter comprises: at least one orientation marker, as taught by Balgobin, as both references and the claimed invention are directed to implant delivery systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Connor as modified by McFann and Cragg with the teachings of Balgobin by incorporating the delivery catheter comprises: at least one orientation marker in order to determine the exact location and orientation of the catheter (Balgobin Paragraph 0004).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nair et al. (US 20180092690 A1) discloses a bioimplant for insertion a vessel, comprising: an implant member configured and dimensioned to correspond to a particular anomaly in the vessel (Paragraph 0052), the implant member defining at least one of a size or shape determined at least in part on imaging data obtained of the anomaly (Paragraph 0013-14).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771