DETAILED ACTIONNotice 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 .
Examiner’s note
The Examiner held an interview with Applicant’s representative on 4/1/2026 for the purpose of suggesting a possible Examiner’s Amendment to pull the limitations of claim 3 (and the limitations of any intervening claims) into the independent claim as claim 3 has been found to be allowable over the prior art. Applicant’s representative wished to have the Non-Final Rejection sent out.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1041” has been used to designate what appears to be the “inner catheter”, the “retention mechanism”, and what appears to be the “heart valve” (See Fig. 10C). 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1046” has been used to designate both the “larger diameter portion of the brace” and what appears to be struts of the “heart valve” (See Fig. 10C). 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. 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.
Specification
The disclosure is objected to because of the following informalities:
Line 2 of paragraph [0059] on page 15 of the Specification recites “delivery catheter 1040” however, based on previous recitations throughout the disclosure it appears that the line should read “delivery catheter 1016”.
Appropriate correction is required.
Claim Objections
Claims 5 and 6 are objected to because of the following informalities:
Claim 5 recites “the first or second longitudinal directions” in line 5, although the line is understood by the Examiner to mean “a first or second longitudinal direction” as the “first or second longitudinal directions” were not previously defined, the Examiner suggests the line be amended to read “a first or second longitudinal direction” for the purpose of having proper antecedent basis for the claimed terms;
Claim 6 recites “the operating handle” in line 2, although the line is understood by the Examiner to mean “the handle” as previously defined, the Examiner suggests the line be amended to read “the handle” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 4 – 7, 9, 11, and 12 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.
Regarding claims 4, 6, 7, and 9, the phrase “the brace” in various lines in each of the claims, renders the claims indefinite because it is unclear if Applicant is intending for “the brace” to refer to “the brace assembly” defined in claim 1 or if Applicant is intending for “the brace” to refer to “the brace” (of the brace assembly) defined in claim 2. If Applicant is intending the former, the Examiner suggests the lines be amended to read “the brace assembly”. If Applicant is intending the latter, the Examiner notes that the phrase lacks antecedent basis in each of the claims above; and that the phrase further renders the claims indefinite as it is unclear if Applicant is intending for the above claims to be dependent on claim 2 which would provide the antecedent basis for the phrase or if Applicant is intending for the claims listed above to maintain their current dependency and to provide the antecedent basis for the phrase therein. For the purpose of examination and under BRI the Examiner will read “the brace” as “the brace assembly”.
Claim 9 recites the limitation "the first diameter at the proximal end of the brace" in lines 2 – 3. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the phrase renders the claim indefinite because it is unclear if Applicant is intending for claim 9 to be dependent on claim 7 which provides antecedent basis for the above claimed term, or if Applicant is intending for claim 9 to be dependent on claim 8, as it is currently, and for claim 9 to provide the antecedent basis for the above claimed term. For the purpose of examination, the Examiner will read the claim as the latter.
Regarding claims 11 and 12, the phrase "wherein the valve retention mechanism" renders the claim indefinite because it is unclear whether Applicant is intending to further narrow the claims by positively reciting the “valve retention mechanism” or if Applicant is intending for the claims to only functionally require the “valve retention mechanism”. For the purpose of examination the Examiner will read the claims such that the valve retention mechanism and any corresponding structure is/are functionally recited.
Claims 5 and 6 are rejected as being indefinite for being dependent on an indefinite claim.
Claim Rejections - 35 USC § 102
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.
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, 2, 4, 7 – 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gianotti (US 6,068,635 A1).
Regarding claims 1 and 2, Gianotti discloses a loading device (device 150) configured to radially collapse an expandable medical implant (endoprosthesis 101) (abstract, col. 6 lines 34 – col. 7 line 33, and Fig. 6), the loading device comprising:
a handle (grip element 187/187’) having an opening (opening through grip element 187/187’) therein extending along a longitudinal axis thereof (col. 6 lines 60 – 65 and Fig. 6);
a delivery system (catheter 110), including i) an inner catheter (inner shaft 125) (col. 7 lines 54 – 62 and Fig. 6) configured to couple to a valve retention mechanism of the expandable medical implant (Examiner’s note: it should be understood that the preceding limitation is an intended use and only requires that the structure of the prior art be capable of functioning in the manner claimed; with that said, the inner shaft 125 is capable of coupling to a valve retention mechanism. Therefore, the inner shaft is configured to function as claimed); and ii) a delivery catheter (outer catheter 115) configured to receive the collapsed expandable medical implant (col. 7 lines 54 – 62, col. 8 lines 11 – 26, and Fig. 6);
a flange (stop ring 181) (col. 7 lines 20 – 25 and Fig. 6) configured to be positioned at a distal end of the delivery system (Examiner’s note: it should be understood that the preceding limitation is an intended use and only requires that the structure of the prior art be capable of functioning in the manner claimed; with that said, the stop ring 181 is capable of being positioned at the distal end of the catheter 110. Therefore, stop ring 181 (i.e., the flange) is configured to function as claimed) and defining an internal radius (inner diameter of stop ring 181 shown in Fig. 6) configured to guide the expandable medical implant into the delivery catheter (Examiner’s note: it should be understood that the preceding limitation is an intended use and only requires that the structure of the prior art be capable of functioning in the manner claimed; with that said, the inner diameter of the stop ring 181 is capable of guiding the expandable medical implant into the catheter 110. Therefore, stop ring 181 (i.e., the flange) is configured to function as claimed);
a control element (handle element 157; which pushes piston unit 155) movable relative to the handle (col. 6 lines 42 – 46 and Fig. 6), the control element (handle element 157; which pushes piston unit 155) being configured to apply a force upon the inner catheter to collapse the expandable medical implant within the delivery catheter (col. 8 lines 27 – 40); and
a brace assembly (nose section 165) comprising [claim 2] a brace (nose section 165) and a plurality of brace arms (joint 145 and projection elements 176/176’) (Figs. 6 – 8) and defining a lumen (funnel-shaped recess 165') extending therethrough in a direction parallel to the longitudinal axis (col. 6 lines 42 – 55, col. 7 lines 34 – 62, and Fig. 6) and being configured to fit over an outer diameter of the delivery catheter (outer catheter 115) (col. 7 lines 54 – 58 and Fig. 6), the brace assembly (nose section 165) being configured to interface with the flange (stop ring 181) (Fig. 6) and to provide resistance to a force applied during loading of the expandable medical implant (Examiner’s note: it should be understood that as the piston unit 155 (i.e., the control element) moves distally, towards the delivery catheter and towards the nose section 165 (i.e., the brace assembly), the nose section 165 (i.e., the brace assembly) being a fixed structure relative to the piston unit 155 will provide some resistance to the pushing force (i.e., the force applied during loading) to some degree).
Regarding claim 4, Gianotti discloses a packing rod (piston rod 155) extending from the handle toward the brace (nose section 165) along the longitudinal axis (col. 6 lines 42 – 46, col. 8 lines 27 – 40, and Fig. 6).
Regarding claim 7, Gianotti discloses wherein the lumen (funnel-shaped recess 165') of the brace (nose section 165) defines a funnel (funnel-shaped recess 165') having a first diameter (diameter at annular groove 174’) at a proximal end of the brace (nose section 165) (Fig. 7) and a second diameter (diameter at annular groove with the annular abutment 113’) (Fig. 7) at a distal end of the brace (nose section 165), the first diameter being greater than the second diameter (Figs. 6 and 7).
Regarding claim 8, Gianotti discloses wherein the flange (stop ring 181) has a proximal-facing surface extending in a plane oriented substantially perpendicular to the longitudinal axis (Fig. 6).
Regarding claim 9, Gianotti discloses wherein the flange (stop ring 181) is positioned at the proximal end of the brace (nose section 165) (Fig. 6), the flange having a through-opening that defines the first diameter (diameter at annular groove 174’) at the proximal end of the brace (nose section 165) (Fig. 6).
Regarding claim 10, Gianotti discloses further comprising a through-lumen (lumen through the opening of gripping element 187/187’) extending through the handle (gripping element 187/187’) (Fig. 6), the through-lumen being configured to be used with a stabilizer or stand that would allow the expandable medical implant to be attached to the loading device directly (Examiner’s note: it should be understood that the preceding limitation is an intended use and only requires that the structure of the prior art be capable of functioning in the manner claimed; with that said, the through-lumen through the handle is capable of allowing the device to be used with a stabilizer that would allow the implant to be attached directly to the loading device).
Regarding claim 12, Gianotti discloses wherein the valve retention mechanism includes or is coupled to one or more sutures configured to couple to the expandable medical implant (Examiner’s note: it should be understood that the retention mechanism is being examined as not being positively recited and therefore, only functionally required by the prior art. With that said, the system of Gianotti is capable of being used with an implant that comprises a valve retention mechanism that includes one or more sutures for coupling to the implant).
Claims 1, 2, 4 – 6, and 10 – 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by von Oepen et al (US 2018/0092744 A1).
Regarding claim 1, von Oepen discloses a loading device (loading tool 100) configured to radially collapse an expandable medical implant (heart valve assembly 30 / heart valve 10) (abstract, paragraph [0072], and Figs. 17,18), the loading device comprising:
a handle (handle 102) having an opening therein extending along a longitudinal axis thereof (paragraph [0072] and Fig. 17);
a delivery system (delivery member 70), including i) an inner catheter (suture catheter 72) configured to couple to a valve retention mechanism (connecting ring 34) of the expandable medical implant (heart valve assembly 30 / heart valve 10) (paragraphs [0063], [0072 – 0074], and Fig. 14); and ii) a delivery catheter (outer sheath 82) configured to receive the collapsed expandable medical implant (paragraph [0063] and Fig. 14);
a flange (larger / left most perpendicular wall of loading funnel 90 – shown in Fig. 18) configured to be positioned at a distal end of the delivery system and defining an internal radius configured to guide the expandable medical implant into the delivery catheter (Examiner’s note: it should be understood that the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the flange of von Oepen is capable of being positioned at the distal end of the delivery system such that the internal radius guides the medical implant into the delivery catheter);
a control element (thumbwheel 116) movable relative to the handle (handle 102) (paragraphs [0072 – 0075] and Fig. 17), the control element (thumbwheel 116) being configured to apply a force upon the inner catheter (suture catheter 72) to collapse the expandable medical implant within the delivery catheter; and
a brace assembly (funnel portion 92) defining a lumen extending therethrough (Fig. 18) in a direction parallel to the longitudinal axis and being configured to fit over an outer diameter of the delivery catheter (Examiner’s note: as stated in paragraph [0075] the “loading funnel” is placed on the distal end of the loading tool 100; additionally, it should be understood that the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the funnel assembly is capable of fitting over the delivery catheter), the brace assembly (funnel portion 92) being configured to interface with the flange (Examiner’s note: the funnel portion 92 is attached to the perpendicular wall that extends off of the funnel portion 92, therefore, the funnel portion 92 interfaces with the “flange” as claimed) and to provide resistance to a force applied during loading of the expandable medical implant (Examiner’s note: it should be understood that the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the funnel portion is capable of resisting a force applied during loading).
Regarding claim 4, von Oepen discloses a packing rod (smooth portion of shaft 108) extending from the handle toward the brace (funnel portion 92) along the longitudinal axis (paragraphs [0075 – 0076] and Figs. 17 – 18).
Regarding claim 5, von Oepen discloses a threaded rod (threaded portion 110) extending within the opening of the handle (handle 102) parallel to the longitudinal axis and affixed to the packing rod (smooth portion of shaft 108) (paragraph [0072] and Fig. 17), wherein the control element (thumbwheel 116) is an actuation knob (thumbwheel 116) threadedly engaged with the threaded rod (threaded portion 110) (paragraph [0073] and Fig. 17), such that rotational motion of the actuation knob (thumbwheel 116) causes the threaded rod and the packing rod to translate in one of the first or second longitudinal directions (paragraph [0073]) and to apply the force upon an inner catheter during (suture catheter 72) loading (paragraphs [0075 – 0076]).
Regarding claim 4, (alternate interpretation – changes are italicized) von Oepen discloses a packing rod (shaft 108) extending from the handle toward the brace (funnel portion 92) along the longitudinal axis (paragraphs [0075 – 0076] and Figs. 17 – 18).
Regarding claim 6, (alternate interpretation) von Oepen discloses wherein the packing rod (shaft 108) has a first outer diameter (outer diameter of the threads at the threaded portion 1112) at a proximal end of the packing rod within the opening of the operating handle (handle 102) (Figs. 17,18) and a second outer diameter (diameter of the smooth / non-externally threaded portion) at a distal end of the packing rod within the lumen of the brace (funnel portion 92) the first diameter being greater than the second diameter (Figs. 17,18).
Regarding claim 8, von Oepen discloses wherein the flange larger / left most perpendicular wall of loading funnel 90 – shown in Fig. 14) has a proximal-facing surface extending in a plane oriented substantially perpendicular to the longitudinal axis (Examiner’s note: the proximal / right most surface of the larger perpendicular wall portion of the loading funnel 90 extends in a perpendicular plane).
Regarding claim 10, von Oepen further comprising a through-lumen (larger diameter section of lumen handle 102) extending through the handle (Figs. 17,18) the through-lumen being configured (ii) to allow a guidewire or mandrel to remain through the loading device prior to, during, or after loading of the expandable medical implant without interrupting (Examiner’s note: it should be understood that the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the shaft 108 (i.e., a mandrel) is capable of remaining therein prior to, during, or after the loading of the valve).
Regarding claim 11, von Oepen wherein the valve retention mechanism (connecting ring 34) is configured to threadedly connect to the inner catheter (suture catheter 72) (paragraph [0077]).
Regarding claim 12, von Oepen wherein the valve retention mechanism (connecting ring 34) includes or is coupled to one or more sutures (suture loops 36) configured to couple to the expandable medical implant (heart valve assembly 30 / valve 10) (paragraph [0077].
Allowable Subject Matter
Claim 3 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 prior art alone or in combination fails to disclose or make obvious the device of claim 3. Wherein claim 3 includes the device of claim 2 and further comprises wherein the brace has three arms that are each circumferentially spaced apart from each other. The closest prior art, Gianotti discloses the loading device of claim 2 as discussed above. However, Gianotti does not disclose or make obvious wherein the three arms of the brace (each of 71,71’,76, 76’) are all circumferentially spaced from each other. Additionally, it would not be obvious to circumferentially space each one of them from each other as the arms 71 & 71’ and 76 & 76’ of the funnel come together in pairs to form the brace; and spacing out of the arms as claimed would render the funnel inoperable for its intended use as the funnel would not be able to close.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Penner et al (US 5,725,519), Murphy et al (US 9,937,038 B2), and Campbell et al (US 6,090,035) teach loading devices similar to the claimed loading device.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
Prosecution Insights