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 01/02/26 have been fully considered but they are not persuasive.
On page 7 regarding prior art rejections, Applicant argues amendments overcome the rejection of record since Spence Figures 3a-h shows wires 92/94 which are two segments of a wire connected by a curved section 98,meaning the segments are “the same wire” and cannot be translated or moved within the lumen relative to one another. Applicant argues figures 3d-h teach wire segments which are permanently attached or coupled together with cross members 100 meaning no spiral bands are able to translate with respect to one another within a lumen.
The Examiner respectfully disagrees noting the spiral bands are disposed within the lumen as is seen in figures 3b-c and 3g-h, and are slidable with respect to one another in that they can slide towards (Fig 3b, 3g) and away (Fig 3c, 3h) from one another. The rejection is accordingly maintained.
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.
Claim 19-22, 28-29, 42 is 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 19 is indefinite for claiming the anchor is disposed in the lumen of the outer sheath and “maintained in the expanded configuration by radial construction from the outer sheath”, when it is unclear how constriction from the sheath contributes to the anchor being in the expanded configuration. It is unclear if the outer sheath functions in a way to maintain the anchor in an expanded configuration which simply isn’t discussed in the specification, or whether Applicant intended this to read that the sheath being the mechanism that maintains the anchor in the unexpanded configuration, or whether there is some other explanation. Since the specification appears to indicate the sheath’s radial constriction actually maintains the anchor in the unexpanded configuration, this is how the Examiner will interpret the claims, but clarification is required.
Remaining claims are indefinite for depending on an indefinite claim.
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: “locking mechanisms” in claim 10. These are understood to be “a frictional band, a polymer coating, or one or more key and one or more key hole features, a pin on a first spiral band and a correspondingly-shaped hole on a second spiral band, slots on the plurality of spiral bands and a correspondingly-shaped in, a first feature disposed on a first hoop of the anchor and a correspondingly-shaped second feature disposed on a second loop of the anchor”.
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 § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 7, 10-11, 14, 19, 28, 42 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Spence et al. (US 20160199177 A1) hereinafter known as Spence.
Regarding claim 1 Spence discloses a system for treating a native valve in a patient (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Spence was considered capable of performing the cited intended use. See, for example [0002]-[0004]), the system comprising:
a frame (10) having an unexpanded (Figure 7b) and expanded (Figure 7d) configuration;
and an anchor (30/50/70/[92/94/96/98]) comprising a free end (see at least figure 2a which shows two free ends of the anchor, or figures 3a, 3d by item 98) and having a flat spiral shape (Figures 3d-e item 92/94/96/98 show the flat shape; see Figures 1a-b, 2a, 2c, 4a, 4c-, 5a-b, and 5g-14c regarding the spiral.), wherein the anchor comprises a housing (96) and a lumen disposed therein (Figures 3a-h show the housing 96 being hollow to hold band segments 92/94), and a plurality of spiral bands (Figures 3a-h items 92/94) translatably disposed within the lumen (Figures 3b-c, 3g-h; [0101]-[0102], [0105]);
wherein the plurality of spiral bands are slidably disposed within the lumen relative to one another (Figures 3b-c, 3g-h; [0101]-[0102], [0105]),
wherein the frame is configured to be actuated from the unexpanded configuration to the expanded configuration adjacent the native valve (this is likewise stated as an “intended use” of the frame. See the explanation above. See also Figures 7a-d; [0123]); and
wherein the anchor is configured to anchor the frame to the native valve when the frame is expanded (this is likewise stated as an “intended use” of the anchor. See the explanation above. See also Figure 7d; [0125]).
Regarding claim 7 Spence discloses the system of claim 1 substantially as is claimed,
wherein Spence further teaches the anchor comprises the flat spiral shape in the expanded configuration (Figures 3a-h show the flat cross-section and Figures 1a-b, 2a, 2c, 4a, 4c-, 5a-b, and 5g-14c show the spiral.
Regarding claim 10 Spence discloses the system of claim 1 substantially as is claimed,
wherein Spence further discloses the anchor comprises one or more locking mechanisms (a frictional band, a polymer coating, or one or more key and one or more key hole features, a pin on a first spiral band and a correspondingly-shaped hole on a second spiral band, slots on the plurality of spiral bands and a correspondingly-shaped in, a first feature disposed on a first hoop of the anchor and a correspondingly-shaped second feature disposed on a second loop of the anchor) ([0121] high friction coating or fabric; [0132], [0134] fasteners; [0139] barbs; [0136] polymer coating) configured to maintain the anchor in the expanded configuration (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Spence discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0121], [0134], [0139] the adjoining of coils is understood to help maintain the anchor in its expanded position).
Regarding claim 11 Spence discloses the system of claim 10 substantially as is claimed,
wherein Spence further discloses the locking mechanism comprises a frictional band, polymer coating, or a key and key hole feature ([0121] a continuous high friction coating shaped like the flat spiral band of the anchor of Figures 3a-h; [0136] polymer coating).
Regarding claim 14 Spence discloses the system of claim 10 substantially as is claimed,
wherein Spence further discloses the locking mechanism comprises a first feature on a first loop of the anchor ([0134] pin from one coil) and a correspondingly shaped second feature on a second loop ([0134] opening formed by engagement/trapping in the fabric of the adjacent coil), and the first and second features are configured to next with one another when the anchor is in the deployed configuration ([0134] the features allow engagement of adjacent coils).
Regarding claim 19 Spence discloses the system of claim 1 substantially as is claimed,
wherein Spence further discloses a delivery device comprising an outer sheath (Figure 3f item 60),
wherein the anchor is disposed in a lumen of the outer sheath (Figure 3f) and maintained in the [un]expanded configuration by radial constriction by the outer sheath and advancement out of the lumen actuates the anchor to the expanded configuration ([0105]).
Regarding claim 28 Spence discloses the system of claim 19 substantially as is claimed,
wherein Spence further discloses the frame structure is detachably coupled to the delivery device in the unexpanded configuration during delivery (this is considered inherent, since the final system does not include the delivery device remaining in situ ([0125] the catheter has been removed).
Regarding claim 42 Spence discloses the system of claim 1 substantially as is claimed,
wherein Spence further discloses the expanded configuration is a tubular expanded shape (Figure 7d).
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 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence as is applied above, in view of Patel et al. (WO 2019164516 A1) hereinafter known as Patel.
Regarding claim 12 Spence discloses the system of claim 10 substantially as is claimed,
wherein Spence further discloses the locking mechanism comprises a pin on a first spiral band ([0134] pin),
but is silent with regards to there being a correspondingly shaped hole on the second spiral band.
However, regarding claim 12 Patel teaches an anchor for a heart valve which includes a locking mechanism comprising a pin on a first spiral and (Figure 18 item 622) and a correspondingly-shaped hole on a second spiral band (Figure 18 item 618). Spence and Patel are involved in the same field of endeavor, namely heart valve repair. 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 Spence by having the locking mechanisms comprise a pin and hole as is taught by Patel since 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).
Regarding claim 13 Spence discloses the system of claim 10 substantially as is claimed,
wherein Spence further discloses the locking mechanism comprises a
pin ([0134] pin),
but is silent with regards to there being a correspondingly shaped plurality of slots.
However, regarding claim 13 Patel teaches an anchor for a heart valve which includes a locking mechanism comprising a plurality of slots (Figure 18 items 618) and a correspondingly-shaped pin (Figure 18 item 622). Spence and Patel are involved in the same field of endeavor, namely heart valve repair. 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 Spence by having the locking mechanisms comprise a pin and slots as is taught by Patel since 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).
Claims 20-22, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence as is applied above, in view of Zhao et al. (CN 110314016 A) hereinafter known as Zhao.
Regarding claim 20 Spence discloses the system of claim 19 substantially as is claimed,
but is silent with regards to the details of the delivery device.
However, regarding claim 20 Zhao teaches a delivery device which includes an inner shaft disposed within a lumen (1011). Spence and Zhao are involved in the same field of endeavor, namely valve repair devices. 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 Spence by having the details of the delivery device of Zhao since 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, the substitution of any known catheter would have been obvious to try.
Regarding claim 21 the Spence Zhao Combination teaches the system of claim 20 substantially as is claimed,
wherein Zhao further teaches a proximal portion of the frame is coupled to a distal portion of the inner shaft (Figure 1 shows the distal portion of the inner shaft 105 coupled to the frame 102 at the frame’s proximal end).
Regarding claim 22 the Spence Zhao Combination teaches the system of claim 20 substantially as is claimed,
wherein Spence further discloses the anchor is actuated into the expanded configuration with removal of the outer sheath ([0105]),
and wherein Zhao further teaches delivery devices for delivering valve repair devices are known to function by having the repair device (102) actuated to expand to an expanded configuration by relative movement of the inner sheath (1011) proximally and the outer sheath (1012) (page 4, 11th paragraph: “said conduit part 101 comprises a middle sheath tube 1011 sleeved on the intermediate sheath 1011 out of the sheath 1012 and is sleeved on the intermediate sheath 1011 in the sheath tube, and the sheath 1012 and the inner sheath tube is capable of sliding relative to the intermediate sheath 1011, the prosthetic heart valve can be loaded on the intermediate sheath 1011, and can be clamped between the intermediate sheath 1011 and the sheath 1012, such that when the sheath 1012 slides relative to the proximal end of the conduit part 101 in the intermediate sheath 1011, the prosthetic heart valve may be exposed from the sheath 1012, and the prosthetic heart valve can be self-expanding and separating said valve delivery device 100, is released to the lesion site of human valve”). It would have accordingly been obvious to the person of ordinary skill at the time the invention was filed to modify the system of the Spence Zhao Combination so that the anchor is also released by relative movement of the outer sheath relative to the anchor, as a well-known technique for releasing expandable implantable valve repair devices. As regards the system’s ability to “advance the inner shaft towards an opening of the lumen of the outer sheath”, the Examiner notes that while Zhao isn’t specific as regards whether the inner shaft 1011 or the outer sheath 1012 is retracted, the person of ordinary skill, in reading Zhao understands the obviousness of either.
Regarding claim 29 Spence discloses the system of claim 19 substantially as is claimed,
but is silent with regards to the mechanism the frame detaches from the delivery device.
However, regarding claim 29 Zhao teaches a valve repair device where expansion of a frame detaches the frame from the delivery device (page 4, 11th paragraph: “said conduit part 101 comprises a middle sheath tube 1011 sleeved on the intermediate sheath 1011 out of the sheath 1012 and is sleeved on the intermediate sheath 1011 in the sheath tube, and the sheath 1012 and the inner sheath tube is capable of sliding relative to the intermediate sheath 1011, the prosthetic heart valve can be loaded on the intermediate sheath 1011, and can be clamped between the intermediate sheath 1011 and the sheath 1012, such that when the sheath 1012 slides relative to the proximal end of the conduit part 101 in the intermediate sheath 1011, the prosthetic heart valve may be exposed from the sheath 1012, and the prosthetic heart valve can be self-expanding and separating said valve delivery device 100, is released to the lesion site of human valve”). Spence and Zhao are involved in the same field of endeavor, namely valve repair systems. 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 Spence to have the frame detach upon expansion as is taught by Zhao 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 situation, attempting to detach the frame from the delivery device via any known method 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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 01/16/26