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 .
Response to Arguments
Applicant's arguments filed 04/27/26 have been fully considered but they are not persuasive.
On pages 7-10 Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
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 pairs of first and second posts, the first post, the second post, the first link, second link, third link, fourth link, the first end portion and second end portion of each link, the first, second, third, fourth, fifth, and sixth compliant joints, 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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to for referring to ‘pairs of adjacent first and second posts” when it is unclear how, if at all, these posts relate to the previously claimed “plurality of posts”.
Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the pairs of adjacent first and second posts, first link, second link, third link, fourth link, first end portion and second end portion of each link, first, second third fourth, fifth, and sixth compliant joints.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 9-13, 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is rejected for having new matter for claiming there are “exactly” four links and exactly one interconnect”. The term “exactly” indicates a precise number, meaning no more or no less than that given number. This effectively excludes all other numbers of links and all other numbers of interconnects. However, MPEP 2173.05(i) states that “[a]ny negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). The mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement.”. Accordingly, the limitation which excludes other numbers of links and interconnects is not supported by the originally filed specification.
Remaining claims are rejected for depending on a claim with new matter.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 9, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over 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),
wherein pairs of adjacent first and second posts are interconnected to each other by four links and exactly one interconnect positioned axially between the inflow and outflow end of the frame, wherein the four links include a first, second, third, and fourth link (see Annotated Figure 204, below),
wherein the first link has a first end portion coupled to the first post at the inflow end of the frame by a first compliant joint and a second end portion coupled to the interconnect by a second compliant joint, wherein the second link has a first end portion coupled to the first post at the outflow end by a third compliant joint and a second end portion coupled to the interconnect by a fourth compliant joint, the third link has a first end portion coupled to the second post at the inflow end of the frame by a fifth compliant joint and a second end portion coupled to the interconnect by the second compliant joint, the fourth link has a first end portion coupled to the second post at the outflow end of the frame by a sixth compliant joint and a second end portion coupled to the interconnect by the fourth compliant joint (Annotated Figure 204),
the interconnect comprises a hub (Annotated Figure 204; “hub” is defined by Merriam-Webster as “a center of activity; focal point”. The interconnect is considered a center of activity or focal point for the links to connect to), and the second an fourth compliant joints are on opposite sides of the hub (Annotated Figure 204),
wherein as the frame moves from the radially compressed state to the fully radially expanded state, the plurality of compliant joints deflect circumferentially ([0287]),
but is silent with regards to there being exactly four links.
However, regarding claim 1 it would have been obvious to one of ordinary skill in the art at the time the invention was filed to include any number of links, including exactly four, since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Cartledge. In this case, the Applicant has not disclosed that the number of links is critical or essential in any way, is done for any particular purpose, or indicated that having more than four links would be detrimental or undesirable in any way, making the change obvious.
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Regarding claim 9 Cartledge teaches the device of claim 1 substantially as is claimed,
wherein Cartledge further discloses the interconnect pivotally couples four of the links (Annotated Figure 204; [0287]).
Regarding claim 11 Cartledge teaches 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 teaches 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).
Claims 2-5, 10, 22 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 teaches the device of claim 1 substantially as is claimed,
but is silent with regards to the first, third, fifth, and sixth joints including a flexible neck portion comprising a cutout region 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 comprising a cutout region 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 cutout/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 cutout region/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 teaches the device of claim 1 substantially as is claimed,
but is silent with regards the neck portion of each of the first, third, fifth, and sixth 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).
Regarding claim 10 Cartledge 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.
Regarding claim 22 the Cartledge Shanley Combination teaches the device of claim 2 substantially as is claimed,
wherein the Combination further teaches the cutout region is C-shaped (Figures 4a-b show how the thicker struts 29, 31 connect at a hinge joint which forms a c-shaped cutout/gap (at neck parts 45, 47).
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 teaches 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 05/06/26
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