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 .
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “the tissue” in line 2,3, although the line is understood by the Examiner to mean “the heart tissue” as previously defined, the Examiner suggests the line be amended to read “the heart tissue” for the purpose of maintaining consistent language throughout the claims;
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 “a fastener” in claims 1 and 11, which is coupled to the functional language “configured to attach to the occlusion device [therapeutic device]”. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “fastener” in claims 1 and 11 will be read as a hook, suture, staple, adhesive, threaded connection, interlocking structures (which is the disclosed corresponding structure, as described in paragraphs [0055] and [0062] of the instant specification) or an equivalent structure (which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 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.
Regarding claim 20, the phrase "wherein the occlusion device is positioned within a left atrial appendage (LAA)" renders the claim indefinite because it is unclear whether Applicant is intending to positively recite “the occlusion device” or is intending for the “occlusion device” to only be functionally required by the claim. Additionally, the Examiner notes that if Applicant is intending for the “occlusion device” to be positively recited, the claim limitation above would comprise a 101 issue for encompassing a human organism as the “occlusion device” is required to be within the left atrial appendage, thereby requiring the left atrial appendage to be present. For the purpose of examination, the Examiner will interpret the claim under BRI such that the “therapeutic device” which comprises the “occlusion device” is only functionally required, thereby making the “occlusion device” only functionally required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 – 7, 9 – 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inouye (US 2019/0247053 A1).
Regarding claim 1, Inouye discloses an apparatus (occlusive member 210) (abstract, paragraphs [0003], [0097 – 0098], and Figs. 11 – 12) (Examiner’s note: paragraph [0097] recites wherein the occlusive member 210 is similar in form and function to the occlusive member 10; therefore, although the Examiner is relying on the embodiment of occlusive member 210, recitations relied upon by the Examiner directed to the form and function of the occlusive member 10 apply to the embodiment of occlusive member 210), comprising:
an implantable device (occlusive member 210) configured to:
contact heart tissue proximate to a left atrial appendage (LAA) with an occlusion device, cover a non-circular gap between the occlusion device and a wall of the LAA, and prevent blood flow into or out of the LAA (Examiner’s note: the preceding limitations are intended use limitations which require only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the occlusive member 210 is capable of functioning in the manner claimed),
wherein the implantable device (occlusive member 210) comprises:
a frame (expandable frame 212) forming an umbrella-like shape comprising a bottom (proximal end region 211) and sides curving upwards from the bottom (paragraph [0097] and Fig. 11);
a mesh (occlusive member 214) disposed over the bottom and at least a portion of the sides of the frame (paragraphs [0071], [0097], and Fig. 11) (Examiner’s note: as stated in paragraph [0071] the occlusive member 14/214 is made up of braided material which equates to being a mesh); and
a fastener (hub member 232) extending downward from the bottom (proximal end region 211) of the frame and configured to attach to the occlusion device (occlusive disk 256) (paragraph [0097] and Figs. 11, 12).
Regarding claim 2, Inouye discloses wherein the frame (expandable frame 212) comprises a plurality of wires (paragraph [0100] and Fig. 1).
Regarding claim 3, Inouye discloses wherein the frame (expandable frame 212) is collapsable such that: in a first configuration, the frame comprises a first diameter (Fig. 5), and in a second configuration, the frame comprises a second diameter (Fig. 3) that is larger than the first diameter (abstract, paragraph [0065], and Figs. 3 – 5).
Regarding claim 4, Inouye discloses wherein the mesh (occlusive member 214) is collapsable with the frame (expandable frame 212) between the second configuration and the first configuration (Examiner’s note: as stated in paragraph [0065] the implant is collapsable, and the occlusive member 214 is a part of the implant; therefore, the occlusive member 214 is also collapsable in the manner claimed).
Regarding claim 5, Inouye discloses further comprising a delivery catheter (delivery catheter 24) comprising a lumen configured to receive the implantable device before the implantable device contacts the tissue (paragraph [0063] and Fig. 1).
Regarding claim 6, Inouye discloses further comprising an actuator (wire 18) positioned within the lumen and configured to provide distal motion to the implantable device to move the implantable device outside of the lumen (paragraph [0064] and Fig. 1).
Regarding claim 7, Inouye discloses wherein: when the implantable device (occlusive device 212) is positioned within the lumen, the frame (expandable frame 212) is in the first configuration and when the implantable device is moved outside the lumen, the frame (expandable frame 212) is in the second configuration (paragraph [0065]).
Regarding claims 9 and 10, Inouye discloses wherein the mesh (occlusive member 214) is disposed on a convex outer portion of the frame and disposed over an entirety of the convex outer portion of the frame (paragraph [0070] and Figs. 11, 12).
Regarding claims 11 – 18 and 20, Inouye discloses a system (delivery system 20 and occlusive member 210) for treating leakage between a therapeutic device and heart tissue of a patient an apparatus (abstract, paragraphs [0003], [0063 – 0065], [0097 – 0098], and Figs. 1, 11 – 12) (Examiner’s note: paragraph [0097] recites wherein the occlusive member 210 is similar in form and function to the occlusive member 10; therefore, although the Examiner is relying on the embodiment of occlusive member 210, recitations relied upon by the Examiner directed to the form and function of the occlusive member 10 apply to the embodiment of occlusive member 210), comprising:
a catheter (delivery catheter 24) comprising a tube defining a lumen and a distal opening at a distal end of the tube (paragraphs [0063 – 0065] and Fig. 1);
an expandable implant (occlusive member 210) disposed in the lumen before the implant is implanted in the patient (paragraphs [0063 – 0065], [0097 – 0098], and Figs. 1, 11 – 12), wherein the implant comprises:
a frame (expandable frame 212) comprising a plurality of wires forming a bottom with sides curving upwards from the bottom such that the frame comprises [claim 13] a umbrella-shaped or bowl-shaped having a convex outer portion and a concave inner portion (paragraphs [0097 – 0100] and Figs. 1, 11, 12);
a mesh (occlusive member 214) [claim 12] disposed over the bottom and at least a portion of the sides of the frame (paragraphs [0070], [0097 – 0098], and Figs. 1, 11 – 12); and
a fastener (hub member 232) extending downward from the bottom (proximal end region 211) of the frame and configured to attach to the therapeutic device (occlusive disk 256) (paragraph [0097] and Fig. 11), [claim 20] wherein the therapeutic device is an occlusive device (occlusive disk 256) configured to be placed in the LAA (paragraphs [0097 – 0098] and Figs. 11, 12);
[claim 14] an actuator (wire 18) disposed within the lumen of the catheter (catheter 24) and configured to move the implant (occlusive member 210) distally within the lumen such that the implant exits the catheter via the distal opening (paragraphs [0063 – 0065]);
[claims 15 and 16] wherein the implant (occlusive member 210) comprises: a first, constrained configuration (shown in Fig. 5) when the implant is disposed within the lumen of the catheter (catheter 24) and a second, unconstrained configuration (shown in Fig. 3) when the implant (occlusive member 210) exits the distal end of the catheter (catheter 24) wherein the implant is biased to expand from the first configuration to the second configuration (paragraphs [0063 – 0065]);
[claim 17] wherein the plurality of wires of the frame are closer to each other in the first configuration than in the second configuration (Examiner’s note: as shown in Fig. 5 (i.e., the first configuration) the wires of the frame are closer to each other than in Fig. 3 (i.e., the second configuration));
wherein the mesh (occlusive member 214) is flexible such that it is moveable with the frame between the first configuration and the second configuration (Examiner’s note: as stated in paragraph [0065] the implant is collapsable, and the occlusive member 214 is a part of the implant; therefore, the occlusive member 214 is also collapsable / flexible in the manner claimed).
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 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable Inouye (US 2019/0247053 A1) as applied to claims 1 and 11 above, and further in view of Bergheim et al (US 2016/0089255 A1).
Regarding claims 8 and 19, as discussed above, Inouye discloses the apparatus and system of claims 1 and 11, respectively.
However, Inouye is silent regarding (i) [claims 8 and 19] wherein the fastener is a hook with a bendable wire.
As to the above, Bergheim teaches, in the same field of endeavor, an occlusive device (occlusive device 100) comprising a frame (body 101) with a fastener (hook 106) extending from a bottom of the frame (body 101), wherein the fastener (hook 106) comprises a bendable wire (abstract, paragraphs [0042 – 0044], and Fig. 1B) (Examiner’s note: as stated in paragraph [0044] the hook 106 is a flexible nitinol hook; flexible equates to bendable and a wire is a thin metal strip. Therefore, the flexible nitinol hook is a bendable wire).
It should be understood that Inouye and Bergheim are known references in the art that teach an occlusive device comprising a fastener for connecting to other devices (abstract, paragraphs [0003], [0063 – 0065], [0097 – 0098], and Figs. 1, 11 – 12 – Inouye ; abstract, paragraphs [0042 – 0044], and Fig. 1B – Bergheim); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one fastener for another, and the results of the substitution would have been predictable and resulted in the modified fastener of Inouye being able to function as intended to properly couple the frame to the occlusive disk 256. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Corcoran et al (US 10,441,258 B2), Lee (US 11,369,355 B2), and Chu (US 2019/0299011 A1) teach occlusive / implant devices configured to be placed in the LAA.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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