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 .
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.
Response to Amendment
The amendment filed 11/20/2025 has been entered. Claims 1-14 and 28-39 remain
pending. Claim 15 has been cancelled.
Response to Arguments
Applicant’s arguments with respect to claims 1, 28, and 34 have been considered but are moot because the new ground of rejection does not rely on any teaching or matter specifically challenged in the argument.
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 limitations use 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 limitations are: “attachment mechanism” (claims 4, 6, and 34).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification discloses that the “attachment mechanism” (claims 4, 6, and 34) can include a tab, hook, loop, notch, peg, magnet, strap, pin, hole, socket, and/or other mechanism configured to join separate portions of the implant (see paragraph [0072] of the Instant Application).
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recites sufficient structure to perform the claimed function so as to avoid 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
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.
Claims 1, 7-8, and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170105839 A1 (hereafter -- Subramanian--).
Regarding Claim 1, Subramanian discloses a method comprising: providing a medical implant forming an elongate body and one or more anchors extending from the elongate body (see annotated elongate body and anchors in Figures 50-51 below), the elongate body and the one or more anchors having a continuous structure (see annotated elongate body and anchors in Figures 50-51 below); rolling the elongate body and the one or more anchors (see Figures 50-51 below, see also paragraph [0193]), inserting the medical implant into a catheter (see annotated catheter 360 in Figures 50-51 below, see also paragraph [0193])); delivering the catheter to a treatment location within a human body (see paragraph [0193]); and removing the medical implant from the catheter (see paragraph [0193]).
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Regarding Claim 7, Subramanian discloses the method of claim 1, wherein removing the medical implant from the catheter causes unrolling of the medical implant to an expanded profile, and a width of the medical implant in the expanded profile exceeds a width of the catheter (see paragraph [0193]).
Regarding Claim 8, Subramanian discloses the method of claim 1, and further comprising unrolling the medical implant to an expanded profile, wherein a width of the medical implant in the expanded profile exceeds a width of the catheter (see paragraph [0193]).
Regarding Claim 11, Subramanian discloses the method of claim 1, wherein the medical implant naturally assumes a generally flat form (see paragraph [0193], see also flat form in Figures 51A and 51B above).
Regarding Claim 12, Subramanian discloses the method of claim 1, wherein the medical implant is at least partially composed of Nitinol (see paragraph [0197]).
Regarding Claim 13, Subramanian discloses the method of claim 1, wherein the one or more anchors are anchoring arms (see annotated anchoring arms in Figure 51A above).
Regarding Claim 14, Subramanian discloses the method of claim 1, wherein the one or more anchors are shape-set to extend perpendicularly from the elongate body (see annotated anchoring arms in Figure 51A above).
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.
Claims 2-6, 9-10, and 28-39 are rejected under 35 U.S.C. 103 as being unpatentable over US 20170105839 A1 (hereafter -- Subramanian--), as applied to claim 1 above, in further view of US 20090143713 A1 (hereafter --Van Dam--).
Regarding Claim 2, Subramanian discloses the method of claim 1, wherein the medical implant comprises a first end and a second end (see annotated first and second end in Figures 50-51 above).
Subramanian fails to disclose the method further comprising detaching the first end of the medical implant from the second end of the medical implant prior to rolling the medical implant.
Van Dam discloses a method comprising: rolling a medical implant to reduce a profile of the medical implant (see Figure 12A below, see also paragraph [0074]), the medical implant comprising a first end and a second end (see annotated second and first end in Figure 12A below); inserting the medical implant into a catheter (see paragraphs [0023] and [0084]); delivering the catheter to a treatment location within a human body (see paragraph [0085]); and removing the medical implant from the catheter (see paragraph [0085]). Van Dam teaches the method further comprising detaching the first end of the medical implant from the second end of the medical implant prior to rolling the medical implant (see paragraph [0074] denoting that the preparation of the implant may include cutting the tube wall, rolling up the implant, then rejoining the edges to form a larger diameter).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the method further comprising detaching the first end of the medical implant from the second end of the medical implant prior to rolling the medical implant, since applying the known technique taught by Van Dam of starting with a tubular structure of an implant and detaching two ends to then rolling it back up to deliver to the method of delivering the implant of Subramanian would have yielded predicable results, namely, a tubular implant that is then cut to form a flat implant with two ends.
Regarding Claim 3, Subramanian as modified discloses the method of claim 2, wherein detaching the first end from the second end involves cutting the medical implant (see claim 2 rejection above).
Regarding Claim 4, Subramanian as modified discloses the method of claim 2, wherein detaching the first end from the second end involves disengaging an attachment mechanism at the first end (see claim 2 rejection above, the attachment mechanism being the physical connection between the two sends prior to cutting the wall of the implant, the attachment mechanism being interpreted under 112f, in which this mechanism can be interpreted as “other mechanism configured to join separate portions of the implant”).
Regarding Claim 5, Subramanian as modified discloses the method of claim 2.
Subramanian fails to disclose further comprising attaching the first end to the second end after removing the medical implant from the catheter.
Van Dam teaches further comprising attaching the first end to the second end after removing the medical implant from the catheter (see paragraph [0074], see also Figure 12A(2) denoting the two ends being connected again after delivery and expanding to bigger diameter “D”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the method further comprising attaching the first end to the second end after removing the medical implant from the catheter, as doing so would form a complete and sealed tubular structure at deployment (see paragraph [0074]).
Regarding Claim 6, Subramanian as modified discloses the method of claim 5, wherein attaching the first end to the second end involves engaging an attachment mechanism at the first end (see claim 5 above, the attachment mechanism being interpreted under 112f, in which this mechanism can be interpreted as “other mechanism configured to join separate portions of the implant).
Regarding Claim 9, Subramanian as modified discloses the method of claim 2, wherein rolling the elongate body and the one or more anchors causes at least some overlap between the first end and the second end (see Figure 50 above, in which the two ends do not directly overlap or touch, but do overlap in the sense that they “occupy the same area in part” (see Merriam Webster online)).
Regarding Claim 10, Subramanian as modified discloses the method of claim 2, wherein rolling the elongate body and the one or more anchors causes no overlap between the first end and the second end (see Figure 50 above, in which they do not directly touch and therefore do not “extend over or past and cover a part of” (see Merriam Webster online)).
Regarding Claim 28, Subramanian discloses a method comprising: providing a medical implant forming an elongate body and one or more anchors extending from the elongate body (see annotated elongate body and anchors in Figures 50-51 below), the elongate body and the one or more anchors having a continuous structure (see annotated elongate body and anchors in Figures 50-51 below); rolling the elongate body and the one or more anchors (see Figures 50-51 below, see also paragraph [0193]), inserting the medical implant into a catheter (see annotated catheter 360 in Figures 50-51 below, see also paragraph [0193])); delivering the catheter to a treatment location within a human body (see paragraph [0193]); and removing the medical implant from the catheter (see paragraph [0193]).
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Subramanian fails to disclose detaching a first end of a medical implant from a second end of the medical implant.
Van Dam teaches the method further comprising detaching the first end of the medical implant from the second end of the medical implant prior to rolling the medical implant (see paragraph [0074] denoting that the preparation of the implant may include cutting the tube wall, rolling up the implant, then rejoining the edges to form a larger diameter).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the method further comprising detaching the first end of the medical implant from the second end of the medical implant prior to rolling the medical implant, since applying the known technique taught by Van Dam of starting with a tubular structure of an implant and detaching two ends to then rolling it back up to deliver to the method of delivering the implant of Subramanian would have yielded predicable results, namely, a tubular implant that is then cut to form a flat implant with two ends.
Regarding Claim 29, Subramanian as modified discloses the method of claim 28.
Subramanian fails to disclose further comprising attaching the first end to the second end after removing the medical implant from the catheter.
Van Dam teaches further comprising attaching the first end to the second end after removing the medical implant from the catheter (see paragraph [0074], see also Figure 12A(2) denoting the two ends being connected again after delivery and expanding to bigger diameter “D”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the method further comprising attaching the first end to the second end after removing the medical implant from the catheter, as doing so would form a complete and sealed tubular structure at deployment (see paragraph [0074]).
Regarding Claim 30, Subramanian as modified discloses the method of claim 28, wherein the one or more anchors are shape-set to extend perpendicularly from the elongate body (see annotated anchoring arms in Figure 51A above).
Regarding Claim 31, Subramanian as modified discloses the method of claim 28, wherein rolling the elongate body and the one or more anchors causes at least some overlap between the first end and the second end (see Figure 50 above, in which the two ends do not directly overlap or touch, but do overlap in the sense that they “occupy the same area in part” (see Merriam Webster online)).
Regarding Claim 32, Subramanian as modified discloses the method of claim 28, further comprising wherein removing the medical implant from the catheter causes unrolling of the medical implant to an expanded profile, wherein a width of the medical implant in the expanded profile exceeds a width of the catheter (see paragraph [0193]).
Regarding Claim 33, Subramanian as modified discloses the method of claim 28, further comprising unrolling the medical implant to an expanded profile, wherein a width of the medical implant in the expanded profile exceeds a width of the catheter (see paragraph [0193]).
Regarding Claim 34, Subramanian discloses a method comprising: providing a medical implant forming an elongate body and one or more anchors extending from the elongate body (see annotated elongate body and anchors in Figures 50-51 below), the medical implant comprising a first end and a second end (see annotated first and second end in Figures 50-51 below); the elongate body and the one or more anchors having a continuous structure (see annotated elongate body and anchors in Figures 50-51 below); rolling the elongate body and the one or more anchors (see Figures 50-51 below, see also paragraph [0193]), inserting the medical implant into a catheter (see annotated catheter 360 in Figures 50-51 below, see also paragraph [0193])); delivering the catheter to a treatment location within a human body (see paragraph [0193]); and removing the medical implant from the catheter (see paragraph [0193]).
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Subramanian fails to disclose the first end having one or more attachment mechanisms to alternately join with and detach from the second end; and attaching the first end to the second end via the one or more attachment mechanisms.
Van Dam teaches further comprising the first end having one or more attachment mechanisms to alternately join with and detach from the second end; and attaching the first end to the second end via the one or more attachment mechanisms (see paragraph [0074], see also Figure 12A(2) denoting the two ends being connected again after delivery and expanding to bigger diameter “D”, the attachment mechanism being the physical connection between the two sends prior to cutting the wall of the implant, the attachment mechanism being interpreted under 112f, in which this mechanism can be interpreted as “other mechanism configured to join separate portions of the implant”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the method further comprising the first end having one or more attachment mechanisms to alternately join with and detach from the second end; and attaching the first end to the second end via the one or more attachment mechanisms, as doing so would enable the implant to form a complete and sealed tubular structure at deployment (see paragraph [0074]).
Regarding Claim 35, Subramanian as modified discloses the method of claim 34.
Subramanian as modified fails to disclose further comprising detaching the first end of the medical implant from the second end of the medical implant prior to rolling the medical implant.
Van Dam teaches the method further comprising detaching the first end of the medical implant from the second end of the medical implant prior to rolling the medical implant (see paragraph [0074] denoting that the preparation of the implant may include cutting the tube wall, rolling up the implant, then rejoining the edges to form a larger diameter).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the method further comprising detaching the first end of the medical implant from the second end of the medical implant prior to rolling the medical implant, since applying the known technique taught by Van Dam of starting with a tubular structure of an implant and detaching two ends to then rolling it back up to deliver to the method of delivering the implant of Subramanian would have yielded predicable results, namely, a tubular implant that is then cut to form a flat implant with two ends.
Regarding Claim 36, Subramanian as modified discloses the method of claim 34, wherein rolling the elongate body and the one or more anchors causes at least some overlap between the first end and the second end (see Figure 50 above, in which the two ends do not directly overlap or touch, but do overlap in the sense that they “occupy the same area in part” (see Merriam Webster online)).
Regarding Claim 37, Subramanian as modified discloses the method of claim 34, further comprising wherein removing the medical implant from the catheter causes unrolling of the medical implant to an expanded profile, wherein a width of the medical implant in the expanded profile exceeds a width of the catheter (see paragraph [0193]).
Regarding Claim 38, Subramanian as modified discloses the method of claim 34, further comprising unrolling the medical implant to an expanded profile, wherein a width of the medical implant in the expanded profile exceeds a width of the catheter (see paragraph [0193]).
Regarding Claim 39, Subramanian as modified discloses the method of claim 34, wherein the medical implant naturally assumes a generally flat form (see paragraph [0193], see also flat form in Figures 51A and 51B above).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774