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 without traverse of invention I (claims 1-13), species 1a (hinge embodiment is a c-shaped gap seen in figures 3-7), species 2a (the frame is unitary), and species 3a (the locking mechanism includes two rails and a toothed central member (seen in figures 3-8a) in the reply filed on 10/30/25 is acknowledged.
Claims 14-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/25.
Further, the Examiner withdraws claims 6-8 for being drawn towards non-elected species 1b-1d, respectively.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 is objected to for claiming there is a plurality of interconnects between each pair of adjacent posts of the plurality of posts, when the figures and specification appear to only indicate one interconnect between two posts. See for example, Figure 3. While interconnects are not labeled, it can be seen there is only one location of connection between two posts.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the plurality of interconnects between each pair of posts must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 2-4 are 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 pre-AIA the applicant regards as the invention.
Claim 2 is indefinite for claiming the compliant joints comprise a flexible neck portion defining a gap between the posts and links. This is indefinite, since claim 1, from which this claim depends, has already stated that the compliant joint couples the links to the posts. It is unclear how there can be both a joint connecting the two structures, as well as a gap (which indicates space). As best the Examiner can understand, the two structures are either connected, or they are not.
Remaining claims are rejected for depending on a rejected claim.
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: “expansion and locking mechanism” in claim 12.
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. In this case, the “expansion and locking mechanism” is understood to comprise one of the structures defined in the specification in: [022]-[027], [0136]-[0137], [0140], [0165]-[0166], [0171], [0182], [0187]-[0189], [0193]-[0195], [0204]-[0205], etc.
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 § 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 11-12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cartledge et al. (US 20130166017 A1) hereinafter known as Cartledge.
Regarding claim 1 Cartledge discloses a prosthetic device comprising:
a frame (Figure 204 (with reference to Figure 5 item 110)) that is radially expandable and compressible between a radially compressed state (Figure 2) and a fully radially expanded state (Figure 9), the frame comprising:
a plurality of posts (Figure 204 items 20412/14320/20414 together) extending axially from an inflow end to an outflow end (Figure 204 shows the posts extending the entire length of the frame),
a plurality of links that extend circumferentially between adjacent posts of the plurality of posts (Figure 204 (with reference to Figure 1 items 112, 114)), and
a plurality of compliant joints that each pivotably couples one of the plurality of links to one of the plurality of posts (considered to be the locations where the links join to the posts), and
wherein as the frame moves from the radially compressed state to the fully radially expanded state, the plurality of compliant joints deflect circumferentially ([0287]).
Regarding claim 11 Cartledge discloses the device of claim 1 substantially as is claimed,
wherein Cartledge further discloses each post comprises a commissure window extending through a thickness of the post (Figure 208 item 18810; [0395] the commissure connector with windows can be attached to the proximal jack).
Regarding claim 12 Cartledge discloses the device of claim 1 substantially as is claimed,
wherein Cartledge further discloses one of the posts is configured as an expansion and locking mechanism (Figure 204 shows an axially extending first member 14320, an axially extending second member 20414, and a cap 14330), and comprises an inner member (Figure 204 item 14320) and one or more outer members (Figure 204 item 20614 and 20612).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge as is applied above in view of Shanley et al. (US 8545545 B2) hereinafter known as Shanley.
Regarding claim 2 Cartledge discloses the device of claim 1 substantially as is claimed,
but is silent with regards to each joint including a flexible neck portion defining a gap between one of the posts and one of the links.
However, regarding claim 2 Shanley teaches that compliant joints (Figure 4a-b item 37) within prosthetic devices can comprise a flexible neck portion defining a gap between two connecting parts (Figures 4a-b show how the thicker struts 29, 31 connect at a hinge joint which forms a c-shaped gap (at neck parts 45, 47)). Cartledge and Shanley are involved in the same field of endeavor, namely endovascular prosthetic devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Cartledge so that the joints include a neck portion and gap as is taught by Shanley in order to provide a weak point within the stent frame which concentrates the location of deformation during expansion so that the location of deformation is predictable and does not affect the structural integrity of the links, thus ensuring uniform and consistent expansion of the device, and which facilitates retaining the device in its expanded condition.
Regarding claim 3 the Cartledge Shanley Combination teaches the device of claim 2 substantially as is claimed,
wherein the Combination further teaches the gap widens as the frame moves from the radially compressed state (Shanley Figure 4a) to the fully radially expanded state (Shanley Figure 4b).
Regarding claim 4 the Cartledge Shanley Combination teaches the device of claim 2 substantially as is claimed,
wherein the Combination further teaches the flexible neck portion of each joint is thinner or narrower than the links and posts (Shanley Figures 4a-b show the relatively thinner neck portion compared to the struts they connect).
Regarding claim 5 Cartledge discloses the device of claim 1 substantially as is claimed,
but is silent with regards to one of the joints elastically deforming, and subsequently plastically deforming.
However, regarding claim 5 Shanley teaches that joints of prosthetic devices are known to plastically deform when the frame radially expands to a fully expanded state in a “subsequent expansion range” (Column 4 lines 3-4 references US 6241762. The ‘762 patent Column 4 lines 30-37 describes how the thinner cross-sectional area of the hinge-shaped joint allows plastic deformation). As regards the joints elastically deforming as the frame radially expands from the compressed to a partially expanded state during an initial range of expansion of the frame, the Examiner notes that this elastic deformation is inherent, since all materials which exhibit plastic deformation inherently experience elastic deformation before it reaches its yield point (e.g. from the compressed position to a position between that and its fully expanded configuration).
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge as is applied above in view of Maimon et al. (US 20180153689 A1) hereinafter known as Maimon.
Regarding claim 9 Cartledge discloses the device of claim 1 substantially as is claimed,
wherein Cartledge further discloses an interconnect positioned circumferentially between each pair of adjacent posts (Figure 204 (with reference to Figure 2 item 210)), wherein the interconnect pivotally couples four of the links (Figures 2, 5, 204; wherein each of the “links” is understood only from the post 20412/1430/20414 to the interconnect 210, so there are four total links forming one “x” shape),
but is silent with regards to there being a plurality of interconnects.
However, regarding claim 9 Maimon teaches that there can be a plurality of interconnects within a prosthetic device (Figure 14 shows a post member and at least two interconnects connecting four links in an x-shape between posts). Cartledge and Maimon are involved in the same field of endeavor, namely endovascular prosthetic devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Cartledge so that there are more interconnects as is taught by Maimon in order to change the length of the device, thus enabling it to fit within different patients or in different locations throughout the body.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge and Maimon as is applied above, further in view of Shanley as is applied above.
Regarding claim 10 the Cartledge Maimon Combination teaches the device of claim 9 substantially as is claimed,
but is silent with regards to the interconnect elastically and then plastically deforming.
However, regarding claim 10 Shanley teaches that interconnects of prosthetic devices are known to plastically deform when the frame radially expands to a fully expanded state in a “subsequent expansion range” (Column 4 lines 3-4 references US 6241762. The ‘762 patent Column 4 lines 30-37 describes how the thinner cross-sectional area of the hinge-shaped connection allows plastic deformation). As regards the interconnects elastically deforming as the frame radially expands from the compressed to a partially expanded state during an initial range of expansion of the frame, the Examiner notes that this elastic deformation is inherent, since all materials which exhibit plastic deformation inherently experience elastic deformation before it reaches its yield point (e.g. from the compressed position to a position between that and its fully expanded configuration). Cartledge and Shanley are involved in the same field of endeavor, namely endovascular prosthetic devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Cartledge so that the joints include a neck portion and gap (which creates the shape which permits elastic/plastic deformation) as is taught by Shanley in order to provide a weak point within the stent frame which concentrates the location of deformation during expansion so that the location of deformation is predictable and does not affect the structural integrity of the links, thus ensuring uniform and consistent expansion of the device, and which facilitates retaining the device in its expanded condition.
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge as is applied above in view of Mueller (US 5797951 A).
Regarding claim 13 Cartledge discloses the device of claim 12 substantially as is claimed,
but is silent with regards to the inner member comprising a linear rack with teeth, and the outer member comprises a pawl to allow movement in one direction but not an opposite direction.
However, regarding claim 13 Mueller teaches a prosthetic device which includes an expansion and locking mechanism that includes an inner member comprising a linear rack having a plurality of teeth arrayed along a length of the inner member (Figures 1-3 item 16), and at least one outer member comprising a pawl configured to engage the rack (Figures 1-3 item 12) to allow movement of the inner member relative to the outer member in a first direction and prevent movement of the inner member relative to the outer member in a second direction opposite the first direction (Column 4 lines 12-19). Cartledge and Mueller are involved in the same field of endeavor, namely endovascular prosthetic devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Cartledge so substitute the jack struts and inner screw for a linear rack and pawl as is taught by Mueller since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 12/04/25