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 Arguments
Applicant's arguments filed 09/01/26 have been fully considered but they are not persuasive.
On pages 18-19 regarding drawing objections Applicant argues reference number 102 shows “outer arms” and argues the other elements that item 102 names in the specification are actually the same thing.
The Examiner suggests amending the specification as is necessary to indicate that these elements are the same thing in order to overcome the objection of record.
On page 19 Applicant argues that there are no “lines that lead to nothing”.
The Examiner respectfully disagrees, noting on the bottom left of figures 6-7 there are solid, s-shaped, dark lines which do not appear to be a part of the invention and are not connected to any reference number.
On pages 20-22 Applicant argues the elements which the Examiner identified that are not shown in the figures are actually shown at various points. However, while Applicant argues the “first electrically conductive contact portion” from claims 1, 15 is seen in Figure 4a item 404 and figure 6 above item 602, and figure 8c above item 809. However, the specification identifies these elements as a “second electrically conductive contact portion” (404, 602), and a “contacting surface” (809). There isn’t anything in the specification that identifies this “first electrically conductive contact portion” as Applicant suggests. Similarly, while Applicant suggests item 401, 801, 803, and 806 all represent the “one or more flexible portions”, the specification has identified these as the “switching member” (401), “straight beam/switching member” (801), a hairpin turn switching member 803, and a hairpin loop section 806. None of these identify “one or more flexible portions”. The remainder of the explanations are likewise unclear. The Examiner suggests amending the specification and figures as is required to ensure all the claimed subject matter is able to be identified in the figures in order to overcome the drawing objections of record.
On pages 22-23 regarding 112 rejections Applicant argues 112 rejections are overcome by amendments to the claims.
The Examiner respectfully agrees and withdraws 112 rejections.
On pages 24-30 Applicant argues amendments overcome the prior art rejections.
The Examiner respectfully refers to the rejection below regarding amended claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore,
the first electrically conductive contact portion (claims 1, 15),
the more than one flexible portions (claim 5),
curved portion of the switching member (claim 6),
the part of the one or more flexible portions (claim 6),
the one or more flexible portions being located at a curved portion of the first electrically conductive portion (claim 6),
the curved portion of the lever comprises a curve of from about 45-135 degrees (claim 7, 10, 22),
the one or more flexible portions comprising multiple of the listed group of portions (claim 8),
the more than one flexible portions in the lever, and the more than one flexible portions comprising multiples from the listed group, and the multiple flexible portions being located at the curve (claim 9),
a first part of the tissue contact portion, a second part of the tissue contact portion, the remaining part of the switching member, a surface area of the first part being configured to make contact with tissue is greater than the cross-sectional area of the second part (claim 14, 30),
the switch (claim 15),
the hairpin turns are located at the first electrically conductive portion (claim 21),
a part of the one or more flexible portions is located at a curved portion of the lever (claim 21),
two or more implant portions (claim 26),
each implant portion being electrically connected to a different interface device (claim 27),
an electrically conductive actuating line for moving the tissue grasping member (claim 28),
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because item 102 refers to “outer arms”, “pairs”, and “members”.
Further, figures 6-7 appears to have lines which leads to nothing
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 25-26 are objected to because of the following informalities:
Claim 25 is objected to for referring to “a respective interface of the one or more interface devices” when there are no previously referenced interface devices, and it is unclear what this is referring to.
Claim 26 is objected to since it is unknown how the more than two implant portions would fit into the system.
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: “interface devices” in claim 25 and 27.
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. These are accordingly understood to be “any type of device that humans can interact with or receive feedback from, such as a computer, microprocessor, oscilloscope, LCD screen, light-emitting diode, or speaker.”
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-11, 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb et al. (US 20100022823 A1) hereinafter known as Goldfarb in view of Dixon et al. (US 20210145571 A1) hereinafter known as Dixon.
Regarding claims 1 and 13 Goldfarb discloses an implant comprising:
a tissue grasping member for grasping bodily tissue (Figure 28 item 14; Abstract) comprising a switching member (Figure 28 item 16) at a first side of the tissue grasping member (Annotated Figure 28), which comprises a tissue contact portion (Figure 41a-f item 281) and a first electrically conductive contact portion ([0134] if the circuit is formed when deflectable elements 281 contact surface 50 of connecting member 18, it is considered inherent that the connecting member 18 and tissue contacting portion are both made of conductive material), the tissue contact portion (281) extending through the first side and a second side of the grasping member (see annotated figure 28 and figures 41a-f which shows the tissue contact portion 281 extending through the first top side to the second side) to make contact with the bodily tissue at the second side of the grasping member (Figures 41a-f), the first and second sides of the grasping member being reverse sides of each other (Annotated Figure 28), and
a connecting member (Figure 28 item 18) comprising a second electrically conductive contact portion ([0134] if the circuit is formed when deflectable elements 281 contact surface 50 of connecting member 18, it is considered inherent that the connecting member 18 and tissue contacting portion are both made of conductive material) at the first side of the grasping member (Annotated Figure 28),
wherein the first and second contact portions are each configured to be electrically connected to each other at the first side of the grasping member ([0134]),
wherein the first and second contact portions form a switch having a closed position when the contact portions are in contact with one another (Figure 41a, left side) and an open position where the contact portions are not in contact with one another (Figure 41a, left side), and
but is silent with regards to whether the switch is biased.
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However, regarding claim 1 Dixon teaches an implant comprising a tissue grasping member (Figures 48-66 item 4400) comprising a switching member (Figures 48-66 item 4450) which comprises a tissue contact portion (Figures 48-66, see the distal barbed end near item 4456),
and a connecting member (Figures 48-66 item 4410),
wherein the device functions as a switch with a closed position (e.g. Figures 51-58) and an open position (e.g. Figures 48-50),
wherein the switch is biased to the closed position (clm 13) ([0285]) and is configured to be opened by contact between the tissue contact portion and bodily tissue ([0284]). Goldfarb and Dixon are involved in the same field of endeavor, namely leaflet grasping apparatuses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of Goldfarb so that the switch is biased to closed position such as is taught by Dixon, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would have found it obvious for the implant of Goldfarb to have any default position, so that movement therefrom would indicate to the cardiac interventionalist whether the leaflet is properly grasped.
Regarding claim 2 the Goldfarb Dixon Combination teaches the implant of claim 1 substantially as is claimed,
wherein Goldfarb further discloses the tissue grasping member is a leaflet grasping member for grasping a valve leaflet (Abstract; Figure 28).
Regarding claim 3 the Goldfarb Dixon Combination teaches the implant of claim 1 substantially as is claimed,
wherein Dixon further teaches the switching member is integrally formed with the tissue grasping member (Figures 48-66; [0026]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of the Combination so the switching member and tissue grasping member are integrally formed as is taught by Dixon since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). It would have been equally obvious to one of ordinary skill to attempt having the switching member and tissue grasping member be either integrally formed or separately formed.
Regarding claim 4 the Goldfarb Dixon Combination teaches the implant of claim 1 substantially as is claimed,
wherein Dixon further teaches the switching member is a lever (Figures 48-66).
Regarding claim 5 the Goldfarb Dixon Combination teaches the implant of claim 4 substantially as is claimed,
wherein Dixon further teaches the lever comprises a flexible portion (Figures 48-66 item 4460).
Regarding claim 6 the Goldfarb Dixon Combination teaches the implant of claim 5 substantially as is claimed,
wherein Dixon further teaches a part of the flexible portion is located at a curved portion of the switching member (see for example, Figure 51, 53-54, etc.).
Regarding claim 7 the Goldfarb Dixon Combination teaches the implant of claim 6 substantially as is claimed,
wherein Dixon further teaches the curved portion of the lever comprises a curve of from 45-135° (see at least Figures 48-66; at least one of the embodiments shows a curved portion which falls within the range of about 45-135 degrees. While the figures are not understood to be drawn to scale, the Examiner understands that a person of ordinary skill would find it obvious to modify the Combination based on the figures of Dixon to have the curved portion have a curve that falls within the illustrated range.).
Regarding claim 8 the Goldfarb Dixon Combination teaches the implant of claim 5 substantially as is claimed,
wherein Dixon further teaches the flexible portion comprises hairpin turns (Figures 48-66 item 4424).
Regarding claim 9 the Goldfarb Dixon Combination teaches the implant of claim 1 substantially as is claimed,
wherein Dixon further teaches the switching member is a lever (Figures 48-66) with a flexible portion (Figures 48-66 item 4460),
wherein the flexible portion comprises hairpin turns (Figures 48-66 item 4424),
a part of the flexible portion is located at a curved portion of the lever (see for example, Figure 51, 53-54, etc.).
Regarding claim 10 the Goldfarb Dixon Combination teaches the implant of claim 9 substantially as is claimed,
wherein Dixon further teaches the curved portion of the lever comprises a curve of from 45-135° (see at least Figures 48-66; at least one of the embodiments shows a curved portion which falls within the range of about 45-135 degrees. While the figures are not understood to be drawn to scale, the Examiner understands that a person of ordinary skill would find it obvious to modify the Combination based on the figures of Dixon to have the curved portion have a curve that falls within the illustrated range).
Regarding claim 11 the Goldfarb Dixon Combination teaches the implant of claim 1 substantially as is claimed,
wherein Dixon further teaches the tissue contact portion is integrally formed with the switching member (Figures 48-66; [0026]).
Regarding claim 14 the Goldfarb Dixon Combination teaches the implant of claim 1 substantially as is claimed,
wherein Dixon further teaches the tissue contact portion comprises a first part configured to make contact with the tissue and a second part that connects a first part to a remaining part of the switching member (see Figures 48-66; [0282]-[0283]),
but is silent with regards to a surface area of the first part and a cross-sectional area of the second part.
However, regarding claim 14 it would have been obvious to one of ordinary skill at the time the invention was filed to modify the implant of the Combination so that the surface area of the first part is greater than the cross-sectional area of the second part since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art.
Claims 12, 15-23, 25-27, 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb and Dixon as is applied above, further in view of Abnussar et al. (US 20220296248 A1) hereinafter known as Abnussar.
Regarding claim 12 the Goldfarb Dixon Combination teaches the implant of claim 1 substantially as is claimed,
but is silent with regards to the connecting member comprising an electrically insulating surface configured to be in contact with a surface of the tissue grasping member.
However, regarding claim 12 Abunassar teaches a tissue/implant indicator system that has a connecting member (Figure 28 item 18) that comprises an electrically insulating surface ([0075] polymer) configured to be in contact with a surface of the grasping member (Figure 28). Goldfarb and Abunassar are involved in the same field of endeavor, namely leaflet grasping systems. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of the Combination so that there is an electrically insulating surface on the connecting member that is configured to be in contact with the tissue grasping member as is taught by Abunassar it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, the use of any biologically compatible material is considered obvious to use.
Regarding claims 15 and 29 Goldfarb discloses a system for implant-tissue contact sensing comprising:
one implant portion comprising: a tissue grasping member for grasping bodily tissue (Figure 28 item 14; Abstract) comprising a switching member (Figure 28 item 16) at a first side of the grasping member (Anntoated Figure 28), the switching member comprising a tissue contact portion (Figure 41a-f item 281) and a first electrically conductive contact portion ([0134] if the circuit is formed when deflectable elements 281 contact surface 50 of connecting member 18, it is considered inherent that the connecting member 18 and tissue contacting portion are both made of conductive material), (see annotated figure 28 and figures 41a-f which shows the tissue contact portion 281 extending through the first top side to the second side) to make contact with the bodily tissue at the second side of the grasping member (Figures 41a-f), the first and second sides of the grasping member being reverse sides of each other (Annotated Figure 28), and
a connecting member (Figure 28 item 18) comprising a second electrically conductive contact portion ([0134] if the circuit is formed when deflectable elements 281 contact surface 50 of connecting member 18, it is considered inherent that the connecting member 18 and tissue contacting portion are both made of conductive material) at the first side of the grasping member (Annotated Figure 28), and
wherein the first and second electrically conductive contact portions are each configured to be electrically connected to each other at the first side of the grasping member (Annotated Figure 28 along with Figures 41a-f), and the first and second contact portions together form a switch having a closed position when the portions are in contact (Figure 41a, left side) and an open position when the contact portions are not in contact (Figure 41a, left side), and
but is silent with regards to whether the switch is biased,
and whether there is an electrical signal source.
However, regarding claims 15 and 29 Dixon teaches an implant comprising a tissue grasping member (Figures 48-66 item 4400) comprising a switching member (Figures 48-66 item 4450) which comprises a tissue contact portion (Figures 48-66, see the distal barbed end near item 4456),
and a connecting member (Figures 48-66 item 4410),
wherein the device functions as a switch with a closed position (e.g. Figures 51-58) and an open position (e.g. Figures 48-50),
wherein the switch is biased to the closed position (clm 29) ([0285]) and is configured to be opened by contact between the tissue contact portion and bodily tissue ([0284]). Goldfarb and Dixon are involved in the same field of endeavor, namely leaflet grasping apparatuses. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of Goldfarb so that the switch is biased to closed position such as is taught by Dixon, since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would have found it obvious for the implant of Goldfarb to have any default position, so that movement therefrom would indicate to the cardiac interventionalist whether the leaflet is properly grasped.
Further, regarding claim 15 Abnussar teaches a tissue/implant indicator system that utilizes an electrical signal source attached to the circuit to indicate the presence of the leaflet ([0144]). Goldfarb and Abnussar are involved in the same field of endeavor, namely systems to indicate the presence of a leaflet within a grasping device. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Goldfarb Dixon Combination so that there is an electrical source connected to the tissue grasping member and connecting member of the Combination as a known alternative to measuring resistance in the circuit. The courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C). Additionally, the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, it would have been obvious to modify the Combination so that any mechanism of alerting the user to the presence of the leaflet, including one which relies on completing a circuit, is used.
Regarding claim 16 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein Goldfarb further discloses the tissue grasping member is a leaflet grasping member for grasping a valve leaflet (Abstract; Figure 28).
Regarding claim 17 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein Dixon further teaches the switching member is integrally formed with the tissue grasping member (Figures 48-66; [0026]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the implant of the Combination so the switching member and tissue grasping member are integrally formed as is taught by Dixon since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). It would have been equally obvious to one of ordinary skill to attempt having the switching member and tissue grasping member be either integrally formed or separately formed.
Regarding claim 18 the Goldfarb Dixon Abnussar Combination teaches the system of claim 16 substantially as is claimed,
wherein Dixon further teaches the switching member is a lever (Figures 48-66).
Regarding claim 19 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein Dixon further teaches the switching member comprises one hairpin turn (Figures 48-66 item 4424).
Regarding claim 20 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein Dixon further teaches the switching member is a lever comprising one hairpin turn (Figures 48-66 item 4424).
Regarding claim 21 the Goldfarb Dixon Abnussar Combination teaches the system of claim 20 substantially as is claimed,
wherein Dixon further teaches the hairpin turn is located at a curved portion of the lever (see for example, Figure 51, 53-54, etc.).
Regarding claim 22 the Goldfarb Dixon Abnussar Combination teaches the system of claim 21 substantially as is claimed,
wherein Dixon further teaches the curved portion of the lever comprises a curve of from 45-135° (see at least Figures 48-66; at least one of the embodiments shows a curved portion which falls within the range of about 45-135 degrees. While the figures are not understood to be drawn to scale, the Examiner understands that a person of ordinary skill would find it obvious to modify the Combination based on the figures of Dixon to have the curved portion have a curve that falls within the illustrated range.).
Regarding claim 23 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein Dixon further teaches the tissue contact portion is integrally formed with the switching member (Figures 48-66; [0026]).
Regarding claim 25 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein Abunassar further teaches an implant-tissue contact system which includes one or more interface devices ([0144] LED), wherein the implant portion is electrically connected to an interface device which is configured to provide an output signal, wherein the interface device is configured to provide a change in output signal when a complete electrical circuit is formed between the electrical signal source, interface device, and implant portion ([0144]).
Regarding claim 26 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein Goldfarb further discloses a second implant portion (Figure 28 shows a left and a right implant portion).
Regarding claim 27 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein the Combination further teaches each implant portion is electrically connected to a different interface device (Figure 50 shows two implant portions which each have multiple electrode pairs 326/328. Figure 51a-c shows multiple LED interface devices 330. While not explicitly discussed, the person of ordinary skill would have found it obvious to ensure the different implant portions with the different electrode pairs to match to distinct LED elements, in order to ensure the user can actually determine which part of the implant device is grasping the leaflet and which part is not. If this were not done, the person would be unable to read the LED lights in any sensical manner.).
Regarding claim 30 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein Dixon further teaches the tissue contact portion comprises a first part configured to make contact with the tissue and a second part that connects a first part to a remaining part of the switching member (see Figures 48-66; [0282]-[0283]),
but is silent with regards to a surface area of the first part and a cross-sectional area of the second part.
However, regarding claim 30 it would have been obvious to one of ordinary skill at the time the invention was filed to modify the implant of the Combination so that the surface area of the first part is greater than the cross-sectional area of the second part since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art.
Claim 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb, Dixon, and Abnussar as is applied above, further in view of Basude et al. (WO 2021195447 A1) hereinafter known as Basude.
Regarding claim 28 the Goldfarb Dixon Abnussar Combination teaches the system of claim 15 substantially as is claimed,
wherein Dixon further teaches a connection connected to the respective connecting member for moving the tissue grasping member ([0020]),
but is silent with regards to that connection being an electrically conductive actuating line.
However, regarding claim 28 Basude teaches a leaflet clip system for a heart valve which allows electric/microprocessor-based actuation of the implant ([0025]). Goldfarb and Basude are involved in the same field of endeavor, namely leaflet clips. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of the Goldfarb Dixon Abnussar Combination so that the connection between the electrical signal source and tissue grasping is an electrically conductive line to move the grasping member, as is made obvious in light of Basude since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known actuation line would have been obvious to try.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/ Primary Examiner, Art Unit 3774
