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 .
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 “expandable cage annulus positioner” of claims 27 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Figures 1-5B are objected to because the use of shading in the drawings fails to aid in understanding of the invention and it reduces legibility. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. See 37 CFR 1.84 (m) and (I).
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 10, 18-21, and 30-32 are objected to because of the following informalities:
In claim 10, “coupled to the of the” should be changed to “coupled to one of the” or similar change to correct the grammatical error.
In claims 18-21, there is insufficient antecedent basis for “the anchoring means”.
In claim 30, there is insufficient antecedent basis for “the step of shielding patient’s tissue from the anchoring means”.
In claim 31, there is insufficient antecedent basis for “the step of shielding patient’s tissue from the arms of the delivery device”.
In claim 32, there is insufficient antecedent basis for “the step of adjusting the anchoring angle”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 9, 16, 18, 21, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “an arm of the delivery system” in line 2. There is insufficient antecedent basis for “the delivery system”. It is unclear if this limitation is referring to the “device for delivery” set forth in claim 1 or an additional delivery system. Further, it is unclear if “an arm” refers to one of the plurality of arms of claim 1 or is setting forth an additional arm.
Claim 9 recites “the shield” in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the claim is intending to set forth a shield or should depend from claim 8 which recites a shield.
Claim 16 recites “each crest” in line 2. It is unclear if “each crest” is referring to each of the plurality of crests set forth in line 4 of claim 14, each of the crests of the attachment portions set forth in line 6, or all of the crests. As best understood by the examiner in view of the specification, each crest comprising an anchoring means is only disclosed to include each crest of the attachment portions.
Claims 18, 21, and 22 recite “the crest”. It is unclear which crest is being referred to because claim 14 sets forth a plurality of crests and one or more attachment portions consisting of a crest.
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.
Limitations of the claims which invoke interpretation under 35 USC 112(f) include:
“First means for coupling” in claims 1. [0104] of the specification discloses a paddle and recess is the structure capable of performing the coupling.
“Second means for releasing” in claims 1. [0025, 0028] of the specification discloses cover or a paddle configured as a cover is the structure capable of performing the releasing.
“Anchoring means” in claims 8, 15-18, 21-22, 30, and 32. [0057] of the specification discloses a pin is the structure capable of performing the anchoring.
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.
Claim(s) 1-25 and 28-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lashinski et al. (US 2016/0015515).
Regarding claim 1, Lashinski et al. discloses a device (Delivery catheter 301 having connector arms 401, FIG 3, 4, 5A, 7) for the delivery and securing of an intracorporeal device (400) to a target site in a patient (Mitral valve 104, FIG 5A-5B, [0077-0078]), wherein the delivery device comprises a shaft (catheter 301) and a plurality of arms coupled to said shaft (Connector arms 401, FIG 7, also described in embodiments of [0088-0091] and FIGs 16-22) and configured to expand radially outwards relative to said shaft (FIG 4), wherein each arm comprises first means for coupling with the intracorporeal device (In FIG 16 for example, the means for coupling to intracorporeal device 1605 is 1607 and 1602, [01290130) and second means for releasing the intracorporeal device (The means for releasing is 1610, see FIGs 16A-16B which show retraction of 1610 releases 1602/1607 from engagement with device 1605).
Regarding claim 2, Lashinski et al. discloses first means for coupling with the intracorporeal device comprises a paddle having at least one recess (The rod comprising cog 107 is interpreted as a paddle and has a recess in the form of the cut out of cog 107) configured to receive an attachment portion of the intracorporeal device (Wherein the nut 1601 of the intracorporeal device is an attachment portion and is received within the cog, [0129]).
Regarding claim 3, Lashinski et al. discloses the recess is configured to couple with the intracorporeal device by friction (See proximal end of 1605 that is sized and shaped to fit within the recess of 1607, thereby forming a frictional coupling).
Regarding claim 4, Lashinski et al. discloses first means for coupling with the intracorporeal device and/or second means for releasing the intracorporeal device comprises a cover configured to cover the recess (The second means 1610 is interpreted as a cover which covers the recess as shown in the top FIG of 16A).
Regarding claim 5, Lashinski et al. discloses the cover is slidable or pivotable relative to the paddle (1610 is slidable, see arrows in FIG 16A).
Regarding claim 6, Lashinski et al. discloses first means for coupling with the intracorporeal device comprises a first paddle having at least one recess (The rod comprising cog 107 is interpreted as a paddle and has a recess in the form of the cut out of cog 107) configured to receive an attachment portion of the intracorporeal device (Wherein the nut 1601 of the intracorporeal device is an attachment portion and is received within the cog, [0129]), and wherein first means for coupling with the intracorporeal device and/or second means for releasing the intracorporeal device comprises a second paddle configured to cover the recess (The second means 1610 is interpreted as a paddle which covers the recess as shown in the top FIG of 16A).
Regarding claim 7, Lashinski et al. discloses the first and/or second paddles are pivotably or slidably coupled to an arm of the delivery system (Both elements are pivotable relative to the remainder of the delivery system because they can articulate as shown in FIG 18A and FIG 7).
Regarding claim 8, Lashinski et al. discloses one or more arms further comprise a shield (1001, FIG 10) configured to shield patient's tissues from the anchoring means of the intracorporeal device ([0115-0116]; cover 1001 protects the tissue from the anchor 1002).
Regarding claim 9, Lashinski et al. discloses the shield is slidable relative to the arm (FIG 10 shows shield 1001 slidable relative to arm 1003).
Regarding claim 10, Lashinski et al. discloses the shield is coupled to the of the paddle, cover or arm (FIG 10, 1001 is coupled to arm 1003).
Regarding claim 11, Lashinski et al. discloses the arm(s) comprise one or more articulations (FIG 7 shows the tilt adjuster 702 which provides articulation to the arms [0110]).
Regarding claim 12, Lashinski et al. discloses the delivery device comprises a cover (308, FIG 3) configured to surround the arms of the delivery device ([0064 and 0066]).
Regarding claim 13, Lashinski et al. discloses the arm cover is slidably coupled to the shaft (FIG 3-4, [0066], 308 is slidable relative to 301 in order to unsheath the implant).
Regarding claim 14, Lashinski et al. discloses an intracorporeal implant device (600, FIG 6A, [0084]) for restoring an anatomical annulus from a dysfunctional configuration to a working configuration (reshaping the mitral valve), the intracorporeal implant device comprising: a continuous band forming a central section (FIG 6B shows 600 is a continuous band, wherein the central opening is interpreted as a central section) and a plurality of crests (601) extending radially from said central section; one or more attachment portions consisting of a crest (See annotated FIG 6A below).
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Regarding claim 15, Lashinski et al. discloses the one or more attachment portions consist of a crest (as annotated above) and of an anchoring means (604, 605, [0084]).
Regarding claim 16, Lashinski et al. discloses each crest comprises an anchoring means (For at least every attachment portion, each crest comprises an anchoring means in the form of anchor 604, 605).
Regarding claim 17, Lashinski et al. discloses one or more crests are devoid of an anchoring means (Crests 601 are devoid of an anchor, FIG 6A).
Regarding claim 18, Lashinski et al. discloses the anchoring means extend inside or below the crest (604 extends below the crest of the attachment portion, FIG 6A).
Regarding claim 19, Lashinski et al. discloses the anchoring means comprises or consists of a substantially straight pin (Anchors 604, 605 are interpreted as substantially straight pins).
Regarding claim 20, Lashinski et al. discloses the anchoring means comprises or consists of a curved pin (603 are interpreted as curved pins, [0086] used for anchoring).
Regarding claim 21, Lashinski et al. discloses the anchoring means extends within the plane formed by the crest (As shown in FIG 6A).
Regarding claim 22, Lashinski et al. discloses the anchoring means extends at an angle from the plane formed by the crest (anchoring means 603 can extend at an angle from the crest, [0086] discloses “Receiver holes may be in any number of orientations, including vertically positioned as in FIG. 6A, horizontal, angled, etc. with respect to the long axis of the implant”).
Regarding claim 23, Lashinski et al. discloses a system (System of FIGs 3-5B) for the delivery and securing of an intracorporeal device to a target site in a patient (FIG 5B), wherein the system comprises a delivery device according to claim 1 (As set forth above) and an intracorporeal implant device (400).
Regarding claim 24, Lashinski et al. discloses the intracorporeal implant device is an intracorporeal implant device for restoring an anatomical annulus from a dysfunctional configuration to a working configuration (For restoring the shape of the mitral valve, abstract, FIG 6A-6K), the intracorporeal implant device comprising: a continuous band (Best shown in FIG 6F wherein a continuous band is formed) forming a central section (Open central region) and a plurality of crests extending radially from said central section (Each bend/change in direction of the band is interpreted as a crest) and one or more attachment portions consisting of a crest (The crest 601, as shown in FIG 6A is the same crest as shown in FIG 16 at 1609 which forms the attachment portion for connecting to the delivery system).
Regarding claim 25, Lashinski et al. discloses the delivery system comprises one or more actuators and/or controllers (Tilt adjuster 702, FIG 7, [0110]), configured: to actuate and/or control the shaft; to actuate and/or control one or more arms (702 is used to control the arms 401, [0110]); to actuate and/or control one or more delivery device cover; to actuate and/or control first means for coupling with the intracorporeal device; to actuate and/or control second means for releasing the intracorporeal device; to actuate and/or control one or more paddles; to actuate and/or control one or more paddle cover; and/or to actuate and/or control the shield(s).
Regarding claim 28, Lashinski et al. discloses a method for restoring an anatomical annulus of a patient from a dysfunctional configuration to a working configuration (Reshaping of a mitral valve, abstract), the method comprising the steps of: delivering an intracorporeal implant device (400) for restoring an anatomical annulus from a dysfunctional configuration to a working configuration using a delivery device according to claim 1 (as described above in claim 1, delivery shown in FIG 3-4); positioning the intracorporal implant device (FIG 4-5A); and releasing the intracorporal implant device (FIG 5B, [0076-0078]).
Regarding claim 29, Lashinski et al. discloses the step of coupling the intracorporeal implant device to the delivery device by means of first means for coupling with the intracorporeal device (As shown in FIG 16A, [0129-0130]).
Regarding claim 30, Lashinski et al. discloses the step of shielding patient's tissues from the anchoring means of the intracorporeal device during delivery, by means of a shield (Via shield 1001, FIG 10, [0115-0116]).
Regarding claim 31, Lashinski et al. discloses the step of shielding patient's tissues from the arms of the delivery device during delivery, by means of a cover (1001) configured to surround the arms of the delivery device (surrounding arm 1003 and shielding therefrom, FIG 10).
Regarding claim 32, Lashinski et al. discloses the step of adjusting the anchoring angle of the anchoring means ([0110]).
Regarding claim 33, Lashinski et al. discloses the step of releasing the intracorporeal implant device from the delivery device by means of second means for releasing the intracorporeal device (By retracting 1610, FIG 16B, [0130]).
Regarding claim 34, Lashinski et al. discloses the incorporeal implant device is an incorporeal implant device for restoring an anatomical annulus from a dysfunctional configuration to a working configuration (For restoring the shape of the mitral valve, abstract, FIG 6A-6K), the intracorporeal implant device comprising: a continuous band (Best shown in FIG 6F wherein a continuous band is formed) forming a central section (Open central region) and a plurality of crests extending radially from said central section (Each bend/change in direction of the band is interpreted as a crest) and one or more attachment portions consisting of a crest (The crest 601, as shown in FIG 6A is the same crest as shown in FIG 16 at 1609 which forms the attachment portion for connecting to the delivery system).
Regarding claim 35, Lashinski et al. discloses the method is a transcatheter method ([0158]).
Regarding claim 36, Lashinski et al. discloses the anatomical annulus is a heart valve annulus (mitral valve 104, [0078]).
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.
Claim(s) 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski et al. (US 2016/0015515) in view of Lv et al. (US 2026/0041549).
Regarding claims 26-27, Lashinski et al. discloses the invention substantially as claimed, as set forth above for claim 23.
Lashinski is silent regarding the system further comprises an annulus positioner comprising an expandable cage.
However, Lv et al. teaches in the same field of endeavor of mitral valve annuloplasty (abstract) a system which first delivers an annulus positioner comprising an expandable cage (21, FIG 5A-5C, shown to be expandable from a deploy configuration to an expanded deploy configuration and used to grasp and position the mitral valve leaflets, [0128-0135]) followed by delivery of an intracorporeal device (1, FIG 5C-5K).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Lashinski to further comprise an annulus positioner comprising an expandable cage, as taught by Lv et al., for the purpose of deploying a mechanism for grasping and positioning the leaflets of the mitral valve to ensure desired placement of the intracorporeal device within the tissue of the annulus upon deployment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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