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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 09/03/2025.
Status of the claims:
Claims 1, 4, 5, 7, 8, 17 – 21, 86, 92 – 99, and 101 – 102 are pending in the application.
Claims 1, 4, 5, 7, 8, 18, 20, 86, 92, 94 – 99, and 101 are amended.
Claim 102 is new.
Priority
The Instant Application, filed on 05/19/2022, which claims priority to PCT US2020/061368 claims priority to Provisional Application 63/039,510, filed on 06/16/2020, and Provisional Application 62/937,508, filed on 11/19/2019. Claims 4, 5, 7, 8, 92, 97, and 98 of the Instant Application are directed to subject matter that was introduced for the first time in the Provisional Application 63/039,510, filed on 06/16/2020. The earlier Provisional Application 62/937,508 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for “a rod / push-pull rod configured to transition an engagement member from the retracted position to the engagement position” (claims 92 and 98), and an engagement member having “a trumpet shape”, “a mass that varies from a base towards a terminal outer edge”, and/or “flexible wire mesh” (claims 4, 5, and 7 & 97). Accordingly, claims 4, 5, 7, 8, 92, 97, and 98 are not entitled to the benefit of the earliest Provisional Application because of the limitations recited therein in the Instant Application. The earliest disclosure for the subject matter of claims 4, 5, 7, 8, 92, 97, and 98 and thus the effective filing date for the subject matter of claims 4, 5, 7, 8, 92, 97, and 98 is 06/16/2020.
Drawings
The objections to the drawings in the previous action dated 06/03/2025 have been withdrawn in light of the Applicant’s amendments filed 09/03/2025. Specifically, the objection to the drawings, regarding the drawings not showing both of the first and second engagement members having the substantially trumpet shape, varying mass, comprising a mesh, and on a push rod, has been withdrawn as the claims no longer require two engagement members.
Claim Objections
The objections to claims 1, 7, 8, 94, 98, and 100 in the previous action dated 06/03/2025 have been withdrawn in light of the Applicant’s amendments filed 09/03/2025. Specifically, the objection to claims 1, 17, and 18, regarding the phrase “the engagement end”, the objection to claims 7 and 8, regarding the phrase “The catheter system”, the objection to claim 8, regarding the phrase “wherein the flexible mesh comprised of nitinol”, the objection to claim 94, regarding the phrase “the first and second engagement member”, and the objection to claim 100 have all been withdrawn as the appropriate corrections have been made. However, the objections to claims 18, 21, 92, and 98 have been maintained, and repeated below, as the appropriate corrections were not made. New objections to the claims have been set forth below in light of Applicant’s amendments.
Claims 1, 18, 20, 21, 92, and 94 – 98 are objected to because of the following informalities:
Claim 1 recites “and engagement end” in line 7 and “in radial direction” in line 14, however these is not grammatically correct as there are no articles (a/an/the) before the nouns; thus the Examiner suggests the lines be amended to read “an engagement end” and “a radial direction”;
Claims 1 and 95 recites “bout 2.0 mm” in line 17 and line 5, respectively, however this appears to be a typographical error, and the Examiner suggests the line be amended to read “about 2.0 mm”;
Claims 18 and 94 recite “its distal end” in lines 4 – 5 and 25 – 26, respectively, and although the line is understood by the Examiner to mean “the distal end of the inner catheter” as the term “its” is understood to mean “the distal end of the inner catheter”, the Examiner suggests the line be amended to read “the distal end of the inner catheter” for the purpose of maintaining consistent language throughout the claims;
Claim 18 recites “when in the engagement configuration” in line 6, although the line is understood by the Examiner to mean “when the at least one engagement member is in the engagement configuration” as the at least one engagement member has the engagement configuration not the inner catheter, the Examiner suggests the line be amended to read “when the at least one engagement member is in the engagement configuration” for the purpose of maintaining consistent language throughout the claims;
Claim 20 recites “to cause transition” in line 2, however this is not grammatically correct as there is no article (a/an/the) before the noun, thus the Examiner suggests the line be amended to read “to cause a transition”;
Claim 21 recites “The system according to claim 1 further comprising at least one marker configured to permit identification of its position” in lines 1 – 3, although “its position” is understood by the Examiner to mean “the system’s position”, the Examiner suggests the line be amended to read “The system according to claim 1 further comprising at least one marker configured to permit identification of the position of the system” for the purpose of maintaining consistent language throughout the claims;
Claims 92 and 98 recite “transition at least one engagement member” in line 2, however this is not grammatically correct as there are no articles (a/an/the) before the noun, therefore, the Examiner suggests the line be amended to read “transition the at least one engagement member”;
Claim 94 recites “where at least one engagement member” in lines 17 – 18, however this is not grammatically correct as there are no articles (a/an/the) before the noun, therefore, the Examiner suggests the line be amended to read “the at least one engagement member”;
Claim 94 recites “the inner channels of the elongated member and the at least one engagement member” in lines 24 – 25, although the line is understood by the Examiner to mean “the inner channel of the elongated member and the internal channel of the at least one engagement member”, as the previously defined, the Examiner suggests the line be amended to read “the inner channel of the elongated member and the internal channel of the at least one engagement member” for the purpose of maintaining consistent language throughout the claims;
Claim 96 recites “the channel” in line 3, although the line is understood by the Examiner to mean “the channel of the steerable catheter” as the other “channels” are defined as “internal channels”, the Examiner suggests the line be amended to “the channel of the steerable catheter” for the purpose of better differentiating the location of the at least one engagement member;
Claim 97 recites “is comprise” in line 2, however this is not grammatically correct, therefore the Examiner suggests the line be amended to read either “is comprised of” or “comprises”;
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:
the generic placeholder is “at least one engagement member” in claims 1 and 94, which is coupled to the functional language “to engage the portion of the heart valve”. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “engagement member” in claims 1 and 94 will be read as a balloon, expandable foam, deflectable hooks, trumpet anchor, and/or flexible wire mesh (which is the disclosed corresponding structure, as described in paragraphs [0055], [0057 – 0058], and [0070 – 0071] 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
The rejection of claims 1, 4, 5, 7, 8, 17 – 21, and 85 – 93 under U.S.C 35 101 for being directed to or encompassing a human organism, recited in the previous action dated 06/03/2025 have been withdrawn in light of the Applicant’s amendments filed 09/03/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 4, 5, 7, 8, 92, 97, and 98 under U.S.C 35 112(a) for failing to comply with the written description requirement, recited in the previous action dated 06/03/2025 have been withdrawn in light of the Applicant’s amendments filed 09/03/2025. Specifically, the rejection of claim 4, regarding the phrase “each of the first and second engagement members have a generally circular cross-sectional trumpet shape in the engagement configuration”, the rejection of claim 5, regarding the phrase “wherein a mass of [each of the first and second] engagement members vary from the base toward the terminal outer edge”, the rejection of claims 7 and 97, regarding the phrase “the engagement member[s] is a flexible wire mesh”, and the rejection of claims 92 and 98, regarding the phrase “a rod configured to transition engagement member from the retracted configuration into the engagement configuration”, and the rejection of claim 8 for being dependent on claim 7 have all has been withdrawn. However, a new rejection for claims 92 and 98 have been set forth below in light of Applicant’s amendments.
Claims 92 and 98 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 94 recite “a catheter” / “a steerable catheter” and “an elongate member”, claims 92 and 98, which depend from claims 1 and 94, respectively, recite “a push-pull rod configured to transition the at least one engagement member from the retracted configuration into the engagement configuration”. Although Applicant’s disclosure has support for a system comprising “a catheter” / “a steerable catheter” (designated with reference character 412 in Figs. 35 – 36) and “an elongate member” (designated with reference character 442) extending through the “catheter” / “steerable catheter” and, wherein the “elongate member” functions as a push-pull rod (see Specification paragraph [0076]), and, separately, has support for using a push-pull rod to control the “catheter” / “steerable catheter” (see Specification paragraph [0085]), Applicant’s disclosure does not have support for a system comprising “a catheter” / “a steerable catheter”, “an elongate member”, in addition to “a push-pull rod configured to transition the at least one engagement member from the retracted configuration into the engagement configuration”. Additionally, because Applicant’s Specification paragraph [0076] recites “the elongated member442 and hub 480 can function as a push-pull rod” it appears that Applicant is equating the elongate member to be the claimed push-pull rod that is configured to transition the at least one engagement member from the retracted configuration into the engagement configuration. Based on the above, claims 92 and 98 are seen as failing to comply with the written description requirement.
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 7, 8, 92, and 98 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 06/03/2025 have been withdrawn in light of the Applicant’s amendments filed 09/03/2025. Specifically, the rejection of claims 7, 92, and 98, regarding the lack of clarity in the phrase "engagement member", and the rejection of claim 8 for being dependent on an indefinite claim have been withdrawn.
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 1, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Arevalos et al (US 2020/0289196 A1) (previously cited) (priority date of 06/06/2019 via WO 2019/109013 A1 which teaches the same subject matter of the US publication – see attached PDF of WO doc.).
Regarding claim 1, Arevalos discloses a system (transcatheter device 2808) (abstract, paragraph [0174], and Figs. 28A-K) capable of engaging a portion of a heart valve (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88), comprising:
a catheter (delivery catheter 2801) having a proximal end, a distal end opposite the proximal end along a central axis a channel that extends from the proximal end to the distal end, a first terminal edge (distal most face of catheter 2801) defined by the distal end on a first plane that is perpendicular to and intersects the central axis (paragraph [0174] and Fig. 28B);
an elongated member (catheter 2805) that extends along the central axis (paragraph [0174] and Fig. 28A/B), the elongated member (catheter 2805) having a proximal end and an engagement end (entire end portion shown in Fig. 28B); and
at least one engagement member (tissue stabilizer 2804) on the engagement end of the elongated member (paragraphs [0174], and Fig. 28D - K), wherein the at least one engagement member (tissue stabilizer 2804) has a retracted configuration (configuration shown in Fig. 28A), where at least one engagement member (tissue stabilizer 2804) is inside the channel (Figs. 28A-D) and collapsed toward the central axis (Figs. 28A-D), and an engagement configuration (configuration shown in Fig. 28F–I), where the at least one engagement member (tissue stabilizer 2804) A) is outside the channel (Fig. 28F) and is expanded in a radial direction outwardly with respect to the central axis (Fig. 28F – I), and B) defines a terminal outer edge (distal most face of the tissue stabilizer 2804 with ring 2804) on a second plane parallel to the first plane.
However, Arevalos is silent regarding (i) wherein a distance between the first plane and the second plane is between about 0.25 mm and bout 2.0 mm.
There is no evidence of record that establishes that changing the distance between the terminal outer edge of the at least one expandable member and the terminal edge of the catheter would result in a difference in function of the Arevalos device. Further, a person having ordinary skill in the art, being faced with modifying the distance, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be within the claimed range, and offering other acceptable ranges (e.g., “or more than 2.0mm as needed”, specification at paras. [0082 – 0083]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify he distance between the terminal outer edge of the at least one expandable member and the terminal edge of the catheter to be within the claimed range as an obvious matter of design choice within the skill of the art.
Regarding claim 4, as discussed above, Arevalos teaches the device of claim 1. Additionally, Arevalos discloses wherein at least one engagement member (tissue stabilizer 2804) has a generally tubular shape in the retracted configuration (shown in Fig. 28A) and a generally circular cross-sectional trumpet shape in the engagement configuration (shown in Fig. 28F – I).
Regarding claim 5, as discussed above, Arevalos teaches the device of claim 1. Additionally, Arevalos discloses wherein at least one engagement member (tissue stabilizer 2804) has a base (portion directly attached to the catheter 2805) disposed at the elongated member and the terminal outer edge (end with stabilizing ring 2804b for tissue stabilizer 2804), wherein a mass of the engagement members vary from the base toward the terminal outer edge (Examiner’s note: because the terminal end of tissue stabilizer 2804 (i.e., the at least one engagement member) has the stabilizing ring 2804b on the terminal end, the mass at the terminal end of the above will be different from the mass at the base end; and therefore, the mass varies from the base towards the terminal outer edge).
Claims 1, 7, 8, 17, 20, 86, and 92 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al (US 2019/0142587 A1) (previously cited).
Regarding claim 1, Duffy discloses a system (delivery system / catheter based system 200) (abstract, paragraph [0053], and Figs. 2 – 12B) capable of engaging a portion of a heart valve (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88), comprising:
a catheter (outer sheath 208) having a proximal end (proximal end 216), a distal end (distal end 218) opposite the proximal end along a central axis a channel (passage 220) that extends from the proximal end to the distal end, a first terminal edge (distal most face of catheter 208 – shown in Fig. 3E) defined by the distal end on a first plane that is perpendicular to and intersects the central axis (paragraph [0054] and Figs. 1 – 3E);
an elongated member (inner shaft 210E) that extends along a central axis (paragraphs [0054] and [0065] and Figs. 3D and 3F), the elongated member (inner shaft 210 and flanged device 204E) having a proximal end (proximal end 228) and an engagement end (distal end 230E – shown in Fig. 3E); and
at least one engagement member (proximal anchor 234) on the engagement end of the elongated member (paragraphs [0062], [0063], [0070], and Fig. 3D, 3F, 3G), wherein at least one engagement member (proximal anchor 234) has a retracted configuration (configuration shown in Fig. 3F), where the at least one engagement member (proximal anchor 234) is inside the channel and collapsed toward the central axis (Fig. 3F), and an engagement configuration (configuration shown in Fig. 3G), wherein the at least one engagement member (proximal anchor 234) A) is outside the channel and is expanded in a radially direction outwardly with respect to the central axis (Fig. 3G) and B) defines a terminal outer edge (distal most face of the proximal anchor 234) on a second plane parallel to the first plane (Fig. 3G).
However, Duffy is silent regarding (i) wherein a distance between the first plane and the second plane is between about 0.25 mm and bout 2.0 mm.
There is no evidence of record that establishes that changing the distance between the terminal outer edge of the at least one expandable member and the terminal edge of the catheter would result in a difference in function of the Duffy device. Further, a person having ordinary skill in the art, being faced with modifying the distance, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be within the claimed range, and offering other acceptable ranges (e.g., “or more than 2.0mm as needed”, specification at paras. [0082 – 0083]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify he distance between the terminal outer edge of the at least one expandable member and the terminal edge of the catheter to be within the claimed range as an obvious matter of design choice within the skill of the art.
Regarding claims 7 and 8, as discussed above, Duffy teaches the system of claim 1. Additionally, Duffy discloses wherein the at least one engagement member (proximal anchor 234) is a flexible, Nitinol, wire mesh (Examiner’s note: as stated in paragraph [0069] the proximal frame of the proximal anchor is a braided, nitinol, mesh).
Regarding claim 17, as discussed above, Duffy teaches the system of claim 1. Additionally, Duffy discloses wherein the elongated member (inner shaft 210) has an inner channel (channel 226 through inner shaft 210) that extends along the central axis from the proximal end toward the engagement end (paragraph [0077] and Figs. 2B, 3E, and 10).
Regarding claim 20, as discussed above, Duffy teaches the system of claim 1. Additionally, Duffy discloses further comprising an actuator (actuator that causes outer sheath 208 to retract) configured to cause transition of the at least one engagement member (proximal anchor 234) from the retracted configuration into the engagement configuration (paragraph [0074]).
Regarding claim 86, as discussed above, Duffy teaches the system of claim 1. Additionally, Duffy discloses wherein the distal end of the catheter (outer sheath 208) is flexible or rigid (Examiner’s note: the distal end of outer sheath 208 is either flexible or rigid, there is no other option; additionally, paragraph [0056] discloses that the outer sheath 208 can be made from relatively flexible and relatively rigid materials).
Regarding claim 1, (alternate interpretation – changes italicized) Duffy discloses a system (delivery system / catheter based system 200) (abstract, paragraph [0053], and Figs. 2 – 12B) capable of engaging a portion of a heart valve (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88), comprising:
a catheter (guide catheter) having a proximal end, a distal end opposite the proximal end along a central axis a channel (passage through the guide catheter through which the outer sheath 208 and inner catheter 210 extend – Fig. 3) that extends from the proximal end to the distal end, a first terminal edge (distal most face of the guide catheter) defined by the distal end on a first plane that is perpendicular to and intersects the central axis (paragraph [0085] and Figs. 3 – 10);
an elongated member (inner shaft 210) that extends along a central axis (paragraphs [0054] and [0065] and Figs. 3D and 3F), the elongated member (inner shaft 210 and flanged device 204) having a proximal end (proximal end 228) and an engagement end (distal end 230 – shown in Fig. 3E); and
at least one engagement member (proximal anchor 234) on the engagement end of the elongated member (paragraphs [0062], [0063], [0070], and Fig. 3D, 3F, 3G), wherein at least one engagement member (proximal anchor 234) has a retracted configuration (configuration shown in Fig. 3F), where the at least one engagement member (proximal anchor 234) is inside the channel and collapsed toward the central axis (Fig. 3F) (Examiner’s note: when the outer sheath 208 and inner catheter 210, which hold the proximal anchor 234 in the collapsed configuration, pass through the guide catheter passage, the proximal anchor will be collapsed in the collapsed configuration shown in Fig. 3F), and an engagement configuration (configuration shown in Fig. 3G), wherein the at least one engagement member (proximal anchor 234) A) is outside the channel and is expanded in a radially direction outwardly with respect to the central axis (Figs. 3G and 8) and B) defines a terminal outer edge (distal most face of the proximal anchor 234) on a second plane parallel to the first plane (Figs. 3G and 8).
However, Duffy is silent regarding (i) wherein a distance between the first plane and the second plane is between about 0.25 mm and bout 2.0 mm.
There is no evidence of record that establishes that changing the distance between the terminal outer edge of the at least one expandable member and the terminal edge of the catheter would result in a difference in function of the Duffy device. Further, a person having ordinary skill in the art, being faced with modifying the distance, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be within the claimed range, and offering other acceptable ranges (e.g., “or more than 2.0mm as needed”, specification at paras. [0082 – 0083]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify he distance between the terminal outer edge of the at least one expandable member and the terminal edge of the catheter to be within the claimed range as an obvious matter of design choice within the skill of the art.
Regarding claim 92, (alternate interpretation) as discussed above, Duffy teaches the system of claim 1. Additionally, Duffy discloses further comprising a rod (outer catheter 208) configured to transition the at least one engagement member (proximal anchor 234) from the retracted configuration into the engagement configuration (paragraph [0074]) (Examiner’s note: Applicant’s disclosure, paragraph [0076], describes the elongated member 442 as a tube with a lumen that functions as a rod, thereby defining a “rod” as hollow tube. Therefore, the outer catheter 208 is considered a rod as defined by Applicant).
Claims 18, 19, 93 – 99, and 101 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al (US 2019/0142587 A1) (previously cited), as applied to claim 1 above, and further in view of Zhang (US 2010/0249918 A1).
Regarding claim 18, as discussed above, Duffy teaches the system of claim 1. Additionally, Duffy discloses an inner catheter (auxiliary device 900) having a proximal end, a distal end, and an internal channel (Examiner’s note: as stated in paragraph [0077] the medical device 900 delivers a radially compressed heart valve, and as shown in Fig. 10 the heart valve is not on the outside of the medical device 900, thus the medical device 900 must have an internal channel where the heart valve is compressed), and wherein the inner catheter is configured to slide through the inner channel of the elongated member and an internal channel of the at least one engagement member so that its distal end is extendable past the at least one engagement member when in the engagement configuration (paragraphs [0077 – 0078] and Fig. 10).
However, Duffy is silent regarding (i) wherein the internal channel extends from the proximal end to the distal end of the inner catheter.
As to the above, Zhang teaches a device (delivery device 100) for delivering a prosthetic heart valve (which equates to the medical device 900 of Duffy) wherein the delivery device is hollow (i.e., has an internal channel that extends from the proximal end to the distal end of the inner catheter) to allow insertion of a guidewire 110 along which the delivery device may be advanced for delivery of the valve prosthesis (abstract, paragraph [0215], and Fig. 25I).
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 medical device 900 (i.e., the inner catheter) of Duffy to be hollow / have the internal channel extend along the entire length thereof, based on the teachings of Zhang, for the purpose of allowing insertion of a guidewire 110 along which the delivery device may be advanced for delivery of the valve prosthesis (paragraph [0215] – Zhang).
Regarding claim 19, as discussed above, the combination of Duffy and Zhang teaches the device of claim 18. Additionally, Duffy discloses wherein the elongated member (inner catheter 210) has a first length, and the inner catheter has a second length that is greater than the first length (Examiner’s note: as shown in Fig. 10 the auxiliary device 900 (i.e., the inner catheter) extends distally past the inner catheter 210 (i.e., the elongate member); and in order for the auxiliary device 900 (i.e., the inner catheter) to extend distally past the inner catheter 210 (i.e., the elongated member) the length of the auxiliary device 900 (i.e., the inner catheter) must be greater than that of the inner catheter 210 (i.e., the elongated member).
Regarding claim 93, as discussed above, the combination of Duffy and Zhang teaches the device of claim 18. Additionally, Duffy discloses wherein the distal end of the inner catheter (auxiliary device 900) is steerable or is usable in conjunction with a steerable catheter (Examiner’s note: as shown in Fig. 10 the auxiliary catheter is steered to its position in Fig. 10 via traversing through the inner catheter 210).
Regarding claim 94, Duffy discloses (delivery system / catheter based system 200) (abstract, paragraph [0053], and Figs. 2 – 12B) configured to engage a portion of a heart valve (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88), comprising:
a steerable catheter (outer sheath 208) having a proximal end, a distal end, and a channel (passage 220) that extends from the proximal end (proximal end 216) to the distal end (distal end 218) (paragraph [0056] and Fig. 2B), the distal end of the steerable catheter is positionable proximate the portion of the heart valve (Examiner’s note: as stated in paragraph [0058] the inner catheter 210 is deflectable / bendable, and because the outer sheath 208 is coaxial and travels along the inner catheter 210 the outer sheath 208 will bend and deflect with the inner catheter 210; thus the outer sheath 208 is steerable, via the inner catheter 210 and is a steerable catheter. Additionally, the outer sheath 208 is capable of being positioned proximate a portion of a heart valve; thus the outer sheath 208 is configured to function as claimed);
an elongated member (inner catheter 210) movable in the channel of the steerable catheter (outer sheath 208) (paragraphs [0074 – 0075] and Fig. 8), the elongated member being elongated along a central axis and having a proximal end (proximal end 228), an engagement end (distal end 230), and an inner channel (passageway 226) that extends from the proximal end toward the engagement end along the central axis (paragraph [0057]);
at least one engagement member (proximal anchor 234) on the engagement end of the elongated member (paragraphs [0057], [0062 – 0064], [0070], and Fig. 3 – 10), the at least one engagement member (proximal anchor 234) having an internal channel aligned with the internal channel (passageway 226) of the elongated member (Fig. 3F) and movable in the channel and relative to the steerable catheter between a retracted configuration (configuration shown in Fig. 3F), where the at least one engagement member (proximal anchor 234) is at least partially inside the channel and collapsed toward the central axis (Fig. 3F), and an engagement configuration (configuration shown in Fig. 3G) where the at least one engagement member (proximal anchor 234) is A) outside of the channel (passage 220) (Fig. 3G) and expands outwardly with respect to the central axis (Fig. 3G) and B) configured to engage the portion of the heart valve when the at least one engagement member (proximal anchor 234) is positioned at or near the heart valve (Examiner’s note: it should be understood that the preceding limitation is functional, and requires only that the structure of the prior art be capable of functioning as claimed. With that said, the proximal anchor 234 (i.e., the at least one engagement member) is capable of engaging a portion of a heart valve);
an inner catheter (medical device 900) in the internal channel of the elongated member (inner catheter 210) (Fig. 10) (paragraph [0077] and Figs. 2B, 3E, and 10), the inner catheter having a proximal end, a distal end, and an internal channel (Examiner’s note: as stated in paragraph [0077] the medical device 900 delivers a radially compressed heart valve, and as shown in Fig. 10 the heart valve is not on the outside of the medical device 900, thus the medical device 900 must have an internal channel where the heart valve is compressed), wherein the inner catheter is movable through the inner channels of the elongated member and the at least one engagement member (paragraph [0077] and Figs. 2B, 3E, and 10) such that its distal end is extendable past the at least one engagement member when the at least one engagement member is in the engagement configuration (Fig. 10).
However, Duffy is silent regarding (i) wherein the internal channel extends from the proximal end to the distal end of the inner catheter.
As to the above, Zhang teaches a device (delivery device 100) for delivering a prosthetic heart valve (which equates to the medical device 900 of Duffy) wherein the delivery device is hollow (i.e., has an internal channel that extends from the proximal end to the distal end of the inner catheter) to allow insertion of a guidewire 110 along which the delivery device may be advanced for delivery of the valve prosthesis (abstract, paragraph [0215], and Fig. 25I).
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 medical device 900 (i.e., the inner catheter) of Duffy to be hollow / have the internal channel extend along the entire length thereof, based on the teachings of Zhang, for the purpose of allowing insertion of a guidewire 110 along which the delivery device may be advanced for delivery of the valve prosthesis (paragraph [0215] – Zhang).
Regarding claim 95, as discussed above, the combination of Duffy and Zhang teaches the device of claim 18. Additionally, Duffy discloses wherein a distal end of the steerable catheter (guide catheter) defines a first terminal edge (distal most face of the guide catheter) on a first plane that is perpendicular to and intersects the central axis, the at least one engagement member (proximal anchor 234) defines a terminal outer edge (distal most face of the proximal anchor 234) on a second plane parallel to the first plane (Fig. 3G).
However, Duffy is silent regarding (i) wherein a distance between the first plane and the second plane is between about 0.25 mm and bout 2.0 mm.
There is no evidence of record that establishes that changing the distance between the terminal outer edge of the at least one expandable member and the terminal edge of the catheter would result in a difference in function of the Duffy device. Further, a person having ordinary skill in the art, being faced with modifying the distance, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be within the claimed range, and offering other acceptable ranges (e.g., “or more than 2.0mm as needed”, specification at paras. [0082 – 0083]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify he distance between the terminal outer edge of the at least one expandable member and the terminal edge of the catheter to be within the claimed range as an obvious matter of design choice within the skill of the art.
Regarding claim 96, as discussed above, the combination of Duffy and Zhang teaches the device of claim 18. Additionally, Duffy discloses wherein the at least one engagement member (proximal anchor 234) in the expanded configuration is disposed outside of the channel (Figs. 3G and 10) and extends outwardly in a radial direction that is substantially perpendicular to the central axis (Figs. 3G and 10).
Regarding claim 97, as discussed above, the combination of Duffy and Zhang teaches the device of claim 18. Additionally, Duffy discloses wherein the at least one engagement member (proximal anchor 234) comprises an expandable wire mesh, respectively (paragraph [0069]).
Regarding claim 99, as discussed above, the combination of Duffy and Zhang teaches the device of claim 18. Additionally, Duffy discloses further comprising a hub (handle 206) at the proximal end of the elongated member (paragraph [0056] and Fig. 2A/B), and an actuator (actuation mechanism 214), wherein actuation of the actuator causes the at least one engagement member (proximal anchor 234) to transition from the retracted configuration into the engagement configuration (Examiner’s note: as stated in paragraph [0056] the actuation mechanism moves the outer sheath 208 relative to the inner shaft 210 (i.e., the elongate member) ; and as stated in paragraph [0074] the relative movement of the outer sheath 208 actuates the proximal anchor 234 (i.e., the at least one engagement member) from the retracted config. to the engagement config.).
Regarding claim 101, as discussed above, the combination of Duffy and Zhang teaches the device of claim 18. Additionally, Duffy discloses wherein the distal end of the inner catheter (auxiliary device 900) is steerable (Examiner’s note: the auxiliary device 900 is steerable by at least traversing the auxiliary device 900 through the inner catheter 210 (i.e., the elongate member) as discussed in paragraph [0077]).
Regarding claim 94, (alternate interpretation – changes italicized) Duffy discloses (delivery system / catheter based system 200) (abstract, paragraph [0053], and Figs. 2 – 12B) configured to engage a portion of a heart valve (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88), comprising:
a steerable catheter (guide catheter – Figs. 4 – 10) having a proximal end, a distal end, and a channel (passage that sheath 208 and inner catheter 210 extend through) that extends from the proximal end (end opposite the distal end) to the distal end (Fig. 5), the distal end of the steerable catheter is positionable proximate the portion of the heart valve (Examiner’s note: as stated in paragraph [0058] the inner catheter 210 is deflectable / bendable, and because the guide catheter is coaxial and travels along the inner catheter 210 the guide catheter will bend and deflect with the inner catheter 210; thus the guide catheter is steerable, via the inner catheter 210. Additionally, as shown in Fig. 5 the guide catheter is proximate the heart valve);
an elongated member (inner catheter 210) movable in the channel of the steerable catheter (guide catheter) (paragraph [0086] and Fig. 4), the elongated member being elongated along a central axis and having a proximal end (proximal end 228), an engagement end (distal end 230), and an inner channel (passageway 226) that extends from the proximal end toward the engagement end along the central axis (paragraph [0057]);
at least one engagement member (proximal anchor 234) on the engagement end of the elongat