CTFR 18/063,910 CTFR 86485 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-37 AIA Applicant's arguments filed 05/18/26 have been fully considered but they are not persuasive. On page 8 regarding drawing objections, Applicant argues the specification [0130] describes the “one or more retaining elements arranged at a proximal end of the drive screw, wherein each groove of the one or more grooves of the helical threaded portion is connected to a corresponding retaining element”, and states this is shown in Figures 26-27, 30-31, and 16. The Examiner respectfully disagrees, noting that the figures fail to show the retaining element 458 connected to a groove 452. The explanation provided in [0130] is unclear, since the retaining element 458 does not appear to include either elements 462 or 464 as the specification states. The annotated figure provided likewise does not show element 464 as being connected to 458. This objection is maintained. On page 9 regarding claim objections Applicant argues amendments overcome the objections of record. The Examiner respectfully agrees and withdraws objections. On page 11 regarding prior art rejections Applicant argues Beard’s tooth 363 does not engage the threaded screw 364. The Examiner respectfully notes that it appears Applicant is viewing Beard alone as opposed to the rejection of record, which relies upon Landon in view of other references, including Beard. The Examiner also acknowledges the typographical error in the rejection, which inadvertently labeled the incorrect screw number. The Examiner has corrected the rejection below using both the screws and both the threads. On page 12 Applicant argues further that even if Landon could be modified to include one or both pins of Beard, the combination would be missing the knob including teeth at the proximal end of the knob, each tooth to interface with a groove of the drive screw. The Examiner respectfully disagrees, noting only one tooth is required by the independent claim. On pages 12-13 Applicant argues the amendments overcome the rejection of record. The Examiner respectfully refers to the rejection below regarding amended claims . Drawings 06-36 AIA 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. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA 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. 07-30-05 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 § 112 07-30-02 AIA 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. 07-34-01 Claim 7-8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 7 is indefinite for claiming the “delivery apparatus” comprises “one or more release members coupled to the drive screw”. The originally filed disclosure appears to state that the “release members” are coupled to the delivery apparatus (e.g. see [0108]) as opposed to being a part of the delivery apparatus. The originally filed invention also appeared to indicate that the “release members” were part of the “component” the delivery apparatus is configured to adjust a linear position of (see the originally filed claims 1 and 7. It is accordingly unclear if this is now simply new matter for claiming the release member is a part of the delivery apparatus, or whether this might be drawn towards an embodiment which was not originally filed, or something else. The Examiner is accordingly unclear on how to examine this claim. Remaining claims are rejected for depending on an indefinite claim. 07-34-23 Claim limitation “ release member ” ( claim 7 ) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification refers to the element a few times, but does not actually state anywhere what the member actually is. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. Claim Rejections - 35 USC § 103 07-103 AIA The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. 07-21-aia AIA Claim s 1-3, 7-8, 10-11, 21-22 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 (Figures 12-13 items 363, 352) for engaging a thread (Figure 9a item 364, Figures 12-13 item 368) 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 (Figures 12-13 show 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 and 21 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 (Figures 12-13 show how at least 10 tooth 363, 352 would be able to fit between the proximal and distal ends of the knob 360 indicating the tooth takes up less than 1/4 the distance therebetween), but is silent with regards to the shape of the tooth. However, regarding claims 2 and 21 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 the Combination so that the shape of the tooth occupied any shape, including that which is claimed, 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 the Combination. The Examiner also notes no cited benefit or reason for this particular tooth shape, meaning any shape would have been obvious to try. Regarding claim 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 1/10 the total distance (Figures 12-13 show how at least 10 tooth 363, 352 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, 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. See the 112 rejections above relating to this claim). 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 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 a distal end portion of one or more shafts 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). with prior art. Regarding claim 22 the Landon Bradway Beard Combination teaches the delivery apparatus of claim 1 substantially as is claimed, wherein Landon further discloses the drive screw is axially moveable between a first position and a second position, wherein in the first position, the drive screw is retracted within the knob with the helical threaded portion of the drive screw contained within an interior of the knob and wherein in the second position the drive screw extends outward from the proximal end of the knob with a majority of the drive screw disposed outside of the knob ([0150], [0155], and Figure 22 rotating allows the screw to slide in and out of the knob 212) . 07-21-aia AIA Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landon, Bradway, and Beard as is applied above, further in view of Cioanta et al. (US 20070156224 A1) hereinafter known as Cioanta . 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]), but is silent with regards to there being two grooves and two teeth. However, regarding claim 9 Cioanta teaches that threadingly engaged parts of a catheter can include two grooves and two teeth which interfaces with a corresponding groove, so terminal ends of the teeth are diametrically opposed ([0010], [0041], Figure 3) Landon and Cioanta are involved in the same field of endeavor, namely catheters. 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 the Combination so that there are at least two grooves and at least two teeth as is taught by Cioanta in order to more evenly distribute the forces around the circumference of the catheter as compared to having fewer starts ([0041]) . Conclusion 07-39 AIA 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Jacqueline Woznicki/Primary Examiner, Art Unit 3774 06/01/26 Application/Control Number: 18/063,910 Page 2 Art Unit: 3774 Application/Control Number: 18/063,910 Page 3 Art Unit: 3774 Application/Control Number: 18/063,910 Page 4 Art Unit: 3774 Application/Control Number: 18/063,910 Page 5 Art Unit: 3774 Application/Control Number: 18/063,910 Page 6 Art Unit: 3774 Application/Control Number: 18/063,910 Page 7 Art Unit: 3774 Application/Control Number: 18/063,910 Page 8 Art Unit: 3774 Application/Control Number: 18/063,910 Page 9 Art Unit: 3774 Application/Control Number: 18/063,910 Page 10 Art Unit: 3774 Application/Control Number: 18/063,910 Page 11 Art Unit: 3774 Application/Control Number: 18/063,910 Page 12 Art Unit: 3774 Application/Control Number: 18/063,910 Page 13 Art Unit: 3774 Application/Control Number: 18/063,910 Page 14 Art Unit: 3774 Application/Control Number: 18/063,910 Page 15 Art Unit: 3774 Application/Control Number: 18/063,910 Page 16 Art Unit: 3774 Application/Control Number: 18/063,910 Page 17 Art Unit: 3774 Application/Control Number: 18/063,910 Page 18 Art Unit: 3774
Prosecution Insights