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 1-11) and species 3 (figures 12-33) in the reply filed on 12/16/25 is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/25.
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 threaded drive screw including one or more retaining elements at its proximal end, wherein the grooves of the helical threaded portion of the drive screw are connected to the corresponding retaining elements 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
Claims 9-10 are objected to because of the following informalities:
Claim 9 is objected to for claiming the double start threads are formed by “two grooves” when it is unclear how, if at all, these two grooves are linked to the previously claimed “one or more grooves”.
Claim 10 is objected to for the last phrase “at a distal end portion of the delivery apparatus” since it is unclear what is/what is happening “at a distal end portion”. It is unclear if the handle portion’s steering mechanism is intended to be located at a distal end portion, or whether the rotation of the housing occurs at the distal end portion, or whether the shaft’s adjustment of curvature occurs at the distal end portion.
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: “retaining element” in claim 4. The specification [0130]-[0131] indicates that the retaining element is a “protruding member (also referred to as a detent) 460, a first linear thread portion 462 arranged on a first side of the protruding member 460 and a second linear thread portion 464 arranged on a second side of the protruding member 460)”, and “a tab 485 arranged inward (in the distal, axial direction) of the protruding member 460”.
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 § 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 1-3, 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landon et al. (US 20190008639 A1) hereinafter known as Landon in view of Bradway et al. (US 20190269540 A1) hereinafter known as Bradway, further in view of Beard et al. (US 20150282965 A1) hereinafter known as Beard.
Regarding claim 1 Landon discloses a delivery apparatus for an expandable implantable medical device (This is stated as an “intended use” of the claimed delivery apparatus. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Landon was considered capable of performing the cited intended use. See, for example [0004].), comprising:
a handle portion (14) including a release mechanism configured to adjust a linear position relative to a central longitudinal apparatus of the delivery apparatus, of a component of the delivery apparatus ([0155] and Figure 22; the inner shaft 18 linearly translates using knob 212), the release mechanism comprising:
a threaded drive screw (Figure 22 item 204) including a helical threaded portion having a lead (Figure 22 item 204 shows a helical thread; having a lead is inherent), wherein the helical threaded portion includes one or more grooves extending around the drive screw (Figure 22 item 204), wherein the drive screw is coupled to the component ([0153] the housing 204 and inner shaft 18 are connected together),
and a rotatable knob surrounding and coaxial with the drive screw (Figure 22 item 212 ), the knob including one or more teeth, each tooth of the one or more teeth being configured to interface with a corresponding groove of the one or more grooves of the drive screw ([0155] the knob 212 rotates in order to engage the grooves of 204 to move it proximally or distally. The Examiner understands there to inherently be teeth which engage with the groove in order to achieve this rotation),
but is silent with regards to the drive screw having a lead of at least one inch,
and the teeth being arranged at the proximal end of the knob and extends only a portion of the total distance between the proximal/distal ends, towards a distal end of the knob.
However, regarding claim 1 Bradway teaches that a handle portion of a delivery apparatus ([0002]) can have a threaded drive screw (Figure 24 item 172) with a lead of at least one inch ([0084] a pitch of 1-40 mm includes 24.5 mm (1 inch=24.5 mm), and [0084] describes how the screw lead can be a dual start thread, indicating the lead = pitchx2, or lead =1mm to 40mm (x2)= 2mm to 80 mm, which includes a lead amount over 24.5 mm). Landon and Bradway are involved in the same field of endeavor, namely delivery apparatus handles. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the delivery apparatus of Landon so that the lead was any length, including over one inch as is taught by Bradway since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would find it obvious to try any length for the lead, which might render the delivery of the medical device successful.
Further, regarding claim 1 Beard teaches that a tooth (Figure 12 item 363) for engaging a threaded screw (Figure 9a item 364) can be located at a proximal end of a knob (Figure 12 item 360) and extend a portion of a total distance between the proximal/distal end towards a distal end of the knob (Figure 12 shows the tooth extending only inward, which occupies a small space between the proximal and distal ends of the knob). Landon and Beard are involved in the same field of endeavor, namely delivery apparatus handles. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the delivery apparatus of Landon so that the teeth are on the proximal end of the handle as is taught by Beard so that they are located in the appropriate place to engage the grooves thereunder, and so they will function as is disclosed by Landon.
Regarding claims 2-3 the Landon Bradway Beard Combination teaches the delivery apparatus of claim 1 substantially as is claimed,
wherein Beard further teaches the portion of the total distance between the proximal end and distal end is less than ¼ the total distance or (clm 3 - Less than 1/10 the total distance (Figure 12 shows how at least 10 tooth 363 would be able to fit between the proximal and distal ends of the knob 360 indicating the tooth takes up less than 1/10 the distance therebetween).
Regarding claim 7 the Landon Bradway Beard Combination teaches the delivery apparatus of claim 1 substantially as is claimed,
wherein the Combination further teaches the component of the delivery apparatus which the release mechanism is configured to adjust the linear position of, includes one or more release members removably coupled to the implantable medical device (this does not appear to materially change the structure of the claimed delivery apparatus).
Regarding claim 8 the Landon Bradway Beard Combination teaches the delivery apparatus of claim 7 substantially as is claimed,
wherein Beard further discloses an inner shaft (Figure 9a-d the shaft proximally coupled to sheath item 200) including a proximal end fixedly coupled to a cap of the release mechanism (see Figures 9a-d which shows how the shaft connected to the distally extending sheath 200 is attached to the back of 340, which serves as a cap. See Figures 2-8 show how the shaft is fixedly coupled to the rear cover 340, as it does not displace during rotation).
Regarding claim 9 the Landon Bradway Beard Combination teaches the delivery apparatus of claim 1 substantially as is claimed,
wherein Bradway further teaches threads formed by the grooves of the helical threaded portion are double start threads formed by two grooves ([0084]).
Regarding claim 10 the Landon Bradway Beard Combination teaches the delivery apparatus of claim 1 substantially as is claimed,
wherein Beard further teaches the handle portion further comprises a steering mechanism ([0031] steering mechanism) including a steering knob ([0033]) configured to rotate relative to a housing of the handle portion and adjust a curvature of one or more shafts of the delivery apparatus, at a distal end portion of the delivery apparatus (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the apparatus of the Combination (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0031]).
Regarding claim 11 the Landon Bradway Beard Combination teaches the delivery apparatus of claim 1 substantially as is claimed,
wherein the Combination further teaches the implantable medical device is a prosthetic heart valve (this does not appear to materially change the structure of the claimed delivery apparatus. See also Landon Abstract).
Regarding claim 4 the prior art fails to teach one or more retaining elements that comprise a protruding member (also referred to as a detent), a first linear thread portion arranged on a first side of the protruding member and a second linear thread portion arranged on a second side of the protruding member”, and “a tab arranged inward (in the distal, axial direction) of the protruding member”, which is arranged at a proximal end of the drive screw, so the one or more grooves of the helical threaded portion are each connected to a corresponding retaining element of the one or more retaining elements.
Claim 5-6 depend from claim 4 and so is also not rejected with prior art.
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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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 01/09/25