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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 07/07/2026.
Status of the claims:
Claims 1 – 7 and 9 – 12 are pending in the application.
Claims 1, 4 – 7, and 11 are amended.
Drawings
The drawings were received on 07/07/2026. These drawings are accepted.
Specification
The objections to specification in the previous action dated 04/09/2026 have been withdrawn in light of the Applicant’s amendments filed 07/07/2026. Specifically, the objection to the specification, regarding the phrase “delivery catheter 1040”, has been withdrawn as the appropriate corrections have been made.
Claim Objections
The objections to claims 5 and 6 in the previous action dated 04/09/2026 have been withdrawn in light of the Applicant’s amendments filed 07/07/2026. Specifically, the objection to claim 5, regarding the phrase “the first or second longitudinal directions”, and the objection to claim 6, regarding the phrase “the operating handle”, have all been withdrawn as the appropriate corrections have been made.
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:
the generic placeholder is “a valve retention mechanism” in claims 1 and 11, which is coupled to the functional language “[configured to] retain a valve”. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “valve retention mechanism” in claim 1 will be read as a suture ring or a florets, sutures, tabs, tethers, loops, (which is the disclosed corresponding structure, as described in paragraphs [0045] and [0057] of the instant specification) or an equivalent structure (which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way).
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
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.
The rejection of claims 4 – 7, 9, 11, and 12 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 04/09/2026 have been withdrawn in light of the Applicant’s amendments filed 07/07/2026. Specifically, the rejection of claims 4, 6, 7, and 9, regarding the lack of clarity in the phrase “the brace”, the rejection of claim 9, regarding the lack of clarity in the phrase "the first diameter at the proximal end of the brace", and the rejection of claims 5 and 6 for being dependent on an indefinite claim have been withdrawn as the appropriate corrections have been made. However, the rejection of claims 11 and 12 the rejection of claims 11 and 12, regarding the lack of clarity in the phrase "wherein the valve retention mechanism", has been maintained as the appropriate corrections have not been made.
Claims 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 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.
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, 9, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gianotti (US 6,068,635 A1) (previously recited).
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);
wherein the flange (stop ring 181) has a proximal-facing surface extending in a plane oriented substantially perpendicular to the longitudinal axis (Fig. 6);
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 assembly (nose section 165) defines a funnel (funnel-shaped recess 165') having a first diameter (diameter at annular groove 174’) at a proximal end of a brace (nose section 165) of the brace assembly (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) of the brace assembly, the first diameter being greater than the second diameter (Figs. 6 and 7).
Regarding claim 9, Gianotti discloses wherein the flange (stop ring 181) is positioned at the proximal end of the brace (nose section 165) of the brace assembly (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) of the brace assembly (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 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) (previously cited).
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);
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);
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 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 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), wherein the valve retention mechanism (connecting ring 34) is configured to threadedly connect to the inner catheter (suture catheter 72) (paragraph [0077]); 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);
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);
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 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]).
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 (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 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.
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 2 and 4 – 6 are rejected under 35 U.S.C. 103 as being unpatentable over von Oepen et al (US 2018/0092744 A1) (previously cited) as applied to claim 1 above, and further in view of Cully et al (US 6,702,845 B1).
Regarding claim 2, as discussed above, von Oepen discloses the loading device of claim 1. Additionally, von Oepen discloses wherein the brace assembly (funnel portion 92) includes a brace (funnel portion 92) (paragraph [0075] and Figs. 13 – 15 and 18).
However, von Oepen is silent regarding (i) the brace assembly including a plurality of brace arms.
As to the above, Cully teaches a loading device (funnel 42) configured to radially compress an expandable medical implant (implantable device 30) comprising a brace (funnel 52; which equates to the funnel portion 92 of von Oepen) and a plurality of brace arms (longitudinal ribs / flutes 52) for the purpose of aiding in compacting of the implant and reducing the forces required to compact the device (abstract, col. 7 lines 14 – 34, col. 8 lines 21 – 32, and Fig. 4) (Examiner’s note: an “arm” is defined as a slender structure that projections from a main body; and the longitudinal ribs / flutes 52 extend radially inward from the main body of the funnel).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the brace assembly (funnel portion 92) of von Oepen to incorporate a plurality of brace arms, based on the teachings of Cully, for the purpose of aiding in compacting of the implant and reducing the forces required to compact the device (col. 8 lines 21 – 32 – Cully)
Regarding claim 4, as discussed above, the combination of von Oepen and Cully makes obvious the loading device of claim 2. Additionally, 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, as discussed above, the combination of von Oepen and Cully makes obvious the loading device of claim 2. Additionally, 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 a first or second longitudinal directions (paragraph [0073]) and to apply the force upon an inner catheter (suture catheter 72) during loading (paragraphs [0075 – 0076]).
Regarding claim 4, (alternate interpretation – changes are italicized) as discussed above, the combination of von Oepen and Cully makes obvious the loading device of claim 2. Additionally, 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) as discussed above, the combination of von Oepen and Cully makes obvious the loading device of claim 2. Additionally, 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 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).
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, wherein at least one of the arms is configured to be removed. 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.
Response to Arguments
Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive. More specifically:
With respect to Applicant’s argument that “The Action has provided no citation in Gianotti demonstrating that the inner shaft is capable of coupling to a valve retention mechanism. In fact, such a configuration would disrupt the principle of operation of Gianotti”, it should be understood that the limitation as currently written only requires that the structure of the prior art be capable of being coupled to a “valve retention mechanism”, and the inner shaft 125 is capable of coupling to a valve retention mechanism. Furthermore, Applicant has not provided any structure to further define the “valve retention mechanism”, therefore, the “valve retention mechanism” is any structure that is configured to retain a valve. Moreover, the claim does not require the implant to be coupled to the “valve retention mechanism”, and therefore, does not require the coupling of the inner catheter to the implant via the “valve retention mechanism”. Additionally, the Examiner’s notes that a “valve retention mechanism” coupled on the inner shaft 125 could be attached to the implant *after* the valve has been loaded onto the delivery system, such that the valve is retained in the delivery position during delivery thereof. Lastly, there is no evidence that suggests the coupling of a valve retention mechanism to the inner shaft 125 would disrupt the principle operation of Gianotti, the Applicant has not provided any evidence to prove the modified device would not operate as intended. Merely, saying that the such structure would result in the inoperability of the device is not sufficient to show inoperability of the device. Furthermore, the examiner notes that the arguments of the attorney can not take place of evidence. See In Re Schulze, 346, F.2d 600,602, 145 USPQ 716, 718 (CCPA 1965).
With respect to Applicant’s argument that “the Action did not allege anticipation of claim 8 by von Oepen, Applicant believes the rejection to be moot.”, although the Examiner erred in not listing claim 8 in the header for the rejection of all of the claims rejected under von Oepen, the Examiner did reject claim 8, which can be found on page 14 of the previous rejection.
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.
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.
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, 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
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