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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites “coupled to track.” This should be “coupled to the track.”
Appropriate correction is required.
Claim Interpretation
The claim 1 and 16 limitation “configured to be coupled to…another medical device” is considered met by a device capable of being coupled to another medical device, but the medical device is not a positively recited part of these claims so is not explicitly required.
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: “control elements coupling the primary actuator to the movable portion of the end cap” in claims 1, 16, and 19, interpreted as “a coil, a tube, a sheath, a rod,” [Par. 0036] and “actuation element” in claim 1, interpreted as “a wire, a coil, a tube, a rod” [Par. 0036].
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 § 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) 1-4, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whelehan et al. [US 2022/0265968 A1, hereinafter “Whelehan”].
Re. claim 1, Whelehan discloses a medical device [Fig. 2A], comprising:
a handle [113, see Fig. 1A, 123, and 110, together], wherein the handle includes a primary actuator [123] and a secondary actuator [305];
an end cap [117 and 115, together] configured to be coupled to a distal end of another medical device [the cap is capable of such use; see Claim Interpretation, above], wherein the end cap includes a stationary portion [115] and a movable portion [117];
a patch [160], wherein the patch is coupled to the movable portion of the end cap [via 210, Fig. 2A];
one or more control elements [tube 120] coupling the primary actuator to the movable portion of the end cap; and
an actuation element [wire 210], wherein the actuation element extends distally from the secondary actuator and the actuation element is configured to be coupled to the patch [Fig. 2A], wherein movement of the primary actuator moves the movable portion of the end cap relative to the stationary portion of the end cap [Fig. 2A, described for the first embodiment in Par. 0021-22], and
wherein movement of the secondary actuator at least partially deploys the patch from the movable portion of the end cap [Par. 0031].
Re. claim 2, Whelehan discloses: The medical device of claim 1, wherein the handle includes a handle body [110 and 113, together], and wherein both the primary actuator and the secondary actuator are movable relative to the handle body [123 is movable relative to 110/113, see Fig. 2A, Par. 0021-22, and 305 is a knob or switch and movable (by turning or switching) relative to 110/113] to control the movement of the one or more control elements and the actuation element [Pars. 0021-22, 0031].
Re. claim 3, Whelehan discloses: The medical device of claim 2, wherein the handle body includes a track [110] and the primary actuator is movably coupled to track [Par. 0022], and wherein the primary actuator is configured to translate along the track in a first direction [backwards in Fig. 2A] and an opposite second direction [forwards in Fig. 2A].
Re. claim 4, Whelehan discloses: a translation of the primary actuator in the first direction is configured to translate the movable portion of the end cap distally relative to the stationary portion [Fig. 2A, Par. 0022], and wherein a translation of the primary actuator in the second direction is configured to translate the movable portion of the end cap proximally relative to the stationary portion [just as a backward motion moves the end cap distally, moving handle 123 in a forward direction would bring elements 117 and 115 closer together].
Re. claim 15, Whelehan discloses a sheath [124] configured to at least partially cover the patch and the end cap [see Figs. 1A-B], and wherein the sheath is retractable and/or the movable portion is extendable to expose the patch and at least the movable portion of the end cap [Figs. 1A-B].
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.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Whelehan in view of Taheri [US 6120524 A].
Re. claim 12 and 13, Whelehan discloses: the medical device of claim 1, but fails to teach the patch comprising one or more wires which bias the patch into a shape. However, Taheri teaches, in a medical device, a patch [16, Figs. 2-7] comprises one or more wires [wire loop 28”], wherein
Claim 12: each of the one or more wires extend throughout a length of the patch [Fig. 4], and wherein the one or more wires bias the patch into a shape [Col 2 lines 32-40].
Claim 13: the one or more wires are biased
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Whelehan to add a wire biased to a circular shape to bias the patch into a shape, as taught by Taheri, in order to allow the patch to be delivered in a folded, compact shape through a catheter and deployed into an unfolded, desired shape [Taheri Col. 2 lines 32-54].
Allowable Subject Matter
Claims 16-20 are allowed.
Claims 5-11 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of record fails to teach or suggest the opposite edges including channels, the stationary portion of the end cap having through-hole(s) with the control elements and actuation elements extending through the through-holes or the patch having channels configured to receive a first and second strand of the actuation element.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-Th 9 am to 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACKIE HO can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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