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 at least one inflation channel within the wall of the sheath, the balloon coupled to the distal end portion of the sheath and positioned in fluid communication with the at least one inflation channel of the sheath of claim 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 1, 3, 14, 19, and 187 are objected to because of the following informalities:
Claim 1 line 1 “the left atrial appendage” is suggested to read “a left atrial appendage” for better antecedent basis.
Claim 3 lines 3 “the occlude portion” is suggested to read “the occluder portion” for better claim language consistency.
Claim 3 lines 3-4 “the occlude-deployed state” is suggested to read “the occluder-deployed state” for better claim language consistency.
Claim 14 line 3 “the interior space of the balloon” is suggested to read “an interior space of the balloon” for better antecedent basis.
Claim 19 line 1 “the LAA” is suggested to expand the acronym prior to using the acronym and should recite “the left atrial appendage (LAA)”.
Claim 19 line 1 should include a colon after “comprising” for better claim language structure.
Claim 19 line 20 “the internal volume” is suggested to read “an internal volume” for better antecedent basis.
Claim 187 line 1 “the left atrial appendage” is suggested to read “a left atrial appendage” for better antecedent basis.
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: “mixing component” in claim 17.
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.
Claims 9-10, 13-14 and 18 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 9 recites the limitation "the injection channel" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant meant to recite the injection lumen as introduced in claim 1, or to introduce an injection channel. For the purposes of examination, the Office will interpret the claim to mean the injection lumen. Claim 10 is rejected due to its dependency on claim 9.
Claim 13 recites “wherein the sheath further comprises: at least one inflation channel within the wall of the sheath; and a balloon coupled to the distal end portion of the sheath and positioned in fluid communication with the at least one inflation channel of the sheath, the balloon enclosing an interior space” and is unclear as to how the inflation of the balloon is to occur since claim 14 recites “wherein the wall of the delivery catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the balloon.” It is unclear if the fluid communication is to occur between the sheath and the balloon, or the catheter body and the balloon, in order to inflate the balloon. For the purposes of examination, the Office will interpret the sheath to mean the delivery catheter body. Claim 14 is rejected due to its dependency on claim 13.
Claim 18 recites the limitation "the second lumen" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant meant to recite the injection lumen, the auxiliary lumen, or to introduce the second lumen. For the purposes of examination, the Office will interpret the second lumen to mean the injection lumen.
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.
Claims 1-7, 11-12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Edmiston et al. (US PGPub 2014/0364941) in view of Siegel et al. (US PGPub 2016/0089151), hereinafter known as “Edmiston” and “Siegel,” respectively.
With regards to claim 1, Edmiston discloses (Figures 18-20) a method of occluding the left atrial appendage (LAA) of a patient, wherein the LAA extends from a left atrium of the patient's heart and has an internal volume and an ostium at its juncture with the left atrium (paragraph 8), the method comprising:
positioning an occlusion device 300 within the ostium of the LAA (paragraph 113),
wherein the occlusion device 300 comprises an occluder portion 306 comprising a proximal end and a distal end, the proximal end coupled to a hub 312 having an injection lumen 310 passing axially therethrough (paragraphs 113-114 and 121; figures 19-20); and an anchor portion 308 operably coupled to the occluder portion 306 (paragraph 113); and
wherein when the occlusion device 300 is positioned within the ostium of the LAA, the anchor portion 308 extends into the internal volume of the LAA (paragraph 114).
Edmiston further discloses injecting a contrast fluid 304 into the LAA of the patient through the injection lumen 310 (figure 19; paragraphs 113-114 and 121).
Edmiston is silent to injecting a fluid biomaterial into the LAA of the patient through the injection lumen, wherein the fluid biomaterial exhibits a cure time following injection during which it remains flowable but after which it solidifies to form a biocompatible polymeric matrix that fills and occupies the internal volume of the LAA; and
retaining the occlusion device within the ostium of the LAA until the cure time has elapsed and the fluid biomaterial has solidified to form the biocompatible polymeric matrix.
However, in a similar field of endeavor of occluders, Siegel teaches (Figures 7-14) injecting a fluid biomaterial 112 into the LAA of the patient through the injection lumen 172 (paragraph 54), wherein the fluid biomaterial 112 exhibits a cure time following injection during which it remains flowable but after which it solidifies to form a biocompatible polymeric matrix that fills and occupies the internal volume of the LAA (paragraph 36; figure 10); and
retaining the occlusion device 140 within the ostium of the LAA until the cure time has elapsed and the fluid biomaterial 112 has solidified to form the biocompatible polymeric matrix (paragraph 83).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Edmiston to include injecting a fluid biomaterial into the LAA of the patient through the injection lumen, wherein the fluid biomaterial exhibits a cure time following injection during which it remains flowable but after which it solidifies to form a biocompatible polymeric matrix that fills and occupies the internal volume of the LAA; and
retaining the occlusion device within the ostium of the LAA until the cure time has elapsed and the fluid biomaterial has solidified to form the biocompatible polymeric matrix as taught by Siegel for the purpose of eliminating/reducing the volume of the LAA and minimizing the flow of blood into the LAA (paragraphs 13 and 53 of Siegel).
With regards to claim 2, Edmiston further discloses wherein the occluder portion 306 is configured to move between an occluder-deployed state and an occluder-nondeployed state (paragraph 79), and
wherein the anchor portion 308 is configured to move between an anchor-deployed state and an anchor-nondeployed state (paragraph 84; although directed to a different embodiment, paragraph 116 discloses that “the medical device delivery system 302… is similar to that described and depicted relative to fig. 4 herein (as well as other embodiments herein)”).
With regards to claim 3, Edmiston further discloses wherein the anchor portion 308 comprises a plurality of anchor segments, wherein each of the plurality of anchor segments extend distally beyond the occluder portion 306 when the occlude portion 306 is in the occlude-deployed state and the anchor portion 308 is in the anchor-deployed state (figure 19 – strut segments that make up the anchor portion 308 extend past the occluder portion 306).
With regards to claim 4, Edmiston further discloses wherein each of the anchor segments 308 comprises a barb portion 86 (paragraph 87; figure 3A – although directed to a different embodiment, paragraph 113 discloses “In this embodiment, the structural components and functionality of the medical device 300 and the medical device delivery system 302 may be substantially similar to any one of the embodiments previously described. For example, the medical device 300 may include an occluder portion 306 and an anchor portion 308, similar to that described above”).
With regards to claim 5, Edmiston further discloses wherein the anchor portion 308 is coupled to the occluder portion 306 by way of the hub 312 (paragraph 17).
With regards to claim 6, Edmiston further discloses wherein the occluder portion 306 comprises a tissue growth member extending between the proximal end and the distal end of the occluder portion 306 (paragraphs 114-115).
With regards to claim 7, Edmiston further discloses wherein the tissue growth member comprises a layer formed from an expanded polytetrafluoroethylene (ePTFE) (paragraphs 114-115).
With regards to claim 11, Edmiston further discloses wherein the occlusion device 300 is positioned within the ostium of the LAA using a delivery system 302 (paragraph 113), wherein the delivery system 302 comprises:
a delivery catheter 318, wherein the delivery catheter 318 comprises:
a delivery catheter body 318 extending between a proximal end and a distal end, the catheter body 318 comprising a wall structure that defines at least one injection channel 322 extending from the proximal end to the distal end and terminating in an outlet opening (paragraph 116; figures 18 and 20 – outlet opening of 322 is in communication with the injection lumen 310);
a handle 320 coupled to the proximal end of the delivery catheter body 318 (figure 18; paragraph 116), and
the occlusion device 300 operatively coupled to the handle 320 and coupled to the distal end of the delivery catheter body 318 (figure 18; paragraph 116),
wherein the outlet opening of the at least one injection channel 322 is fluidly connected to the injection lumen 310 of the occlusion device 300 (figures 18 and 20; paragraphs 116 and 121).
With regards to claim 12, Edmiston further discloses wherein the delivery system 302 further comprises a sheath 316 having a proximal end portion, a distal end portion having a distal tip, and a wall circumferentially enclosing a sheath lumen 317 extending along an entire length of the sheath 316 (figures 18 and 18B; paragraphs 116-118);
wherein the delivery catheter 318 is sized to be received and selectively advanceable within the sheath lumen 317 such that the occlusion device 300 can be passed through the sheath lumen 317 to a position distal of the distal tip (figure 18; paragraphs 15, 23, 116-118).
With regards to claim 19, Edmiston discloses (Figures 18-20) a method of occluding the LAA of a patient (paragraph 8) comprising
(a) advancing a delivery system 302 percutaneously through the patient's vasculature to reach the patient's right atrium (paragraph 113), the delivery system 302 comprising:
a delivery catheter 318, wherein the delivery catheter 318 comprises:
a delivery catheter body 318 extending between a proximal end and a distal end, the catheter body 318 comprising a wall structure that defines at least one injection channel 322 extending from the proximal end to the distal end and terminating in an outlet opening (paragraph 116; figures 18 and 20 – outlet opening of 322 is in communication with the injection lumen 310);
a handle 320 coupled to the proximal end of the delivery catheter body 318 (paragraph 116), and
an occlusion device 300 operatively coupled to the handle 302 and coupled to the distal end of the delivery catheter body 318 (paragraph 116), wherein the occlusion device 300 comprises an occluder portion 306 comprising a proximal end and a distal end, the proximal end coupled to a hub 312 having an injection lumen 310 passing axially therethrough; and an anchor portion 308 operably coupled to the occluder portion 306 (paragraphs 113-114 and 121; figures 19-20);
wherein the outlet opening of the at least one injection channel 322 is fluidly connected to the injection lumen 310 of the occlusion device 300 (paragraph 121; figure 20);
(b) advancing the delivery system 302 through an opening in the interatrial septum to reach the patient's left atrium (paragraph 15 and 23 – “advancing a medical device coupled to a distal end of a delivery catheter through a sheath positioned in the vasculature and into the LAA of the heart”); and
(c) deploying the occlusion device 300 within the ostium of the LAA such that the anchor portion 308 extends into the internal volume of the LAA (paragraph 114).
Edmiston further discloses injecting a contrast fluid 304 into the LAA through the injection channel 322 of the delivery catheter body 318 and the injection lumen 310 of the occlusion device 300 (figure 19; paragraphs 113-114 and 121).
Edmiston is silent to (d) injecting a fluid biomaterial into the LAA through the injection channel of the delivery catheter body and the injection lumen of the occlusion device, wherein the fluid biomaterial exhibits a cure time following injection during which it remains flowable but after which it solidifies to form a biocompatible polymeric matrix that fills and occupies the internal volume of the LAA; and (e) retaining the occlusion device within the ostium of the LAA until the cure time has elapsed and the fluid biomaterial has solidified to form the biocompatible polymeric matrix.
However, in a similar field of endeavor of occluders, Siegel teaches (Figures 7-14) (d) injecting a fluid biomaterial 112 into the LAA through the injection lumen 172 of the delivery catheter body (paragraph 54), wherein the fluid biomaterial 112 exhibits a cure time following injection during which it remains flowable but after which it solidifies to form a biocompatible polymeric matrix that fills and occupies the internal volume of the LAA (paragraph 36; figure 10); and
(e) retaining the occlusion device 140 within the ostium of the LAA until the cure time has elapsed and the fluid biomaterial 112 has solidified to form the biocompatible polymeric matrix (paragraph 83).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Edmiston to include injecting a fluid biomaterial into the LAA through the injection channel of the delivery catheter body and the injection lumen of the occlusion device, wherein the fluid biomaterial exhibits a cure time following injection during which it remains flowable but after which it solidifies to form a biocompatible polymeric matrix that fills and occupies the internal volume of the LAA; and retaining the occlusion device within the ostium of the LAA until the cure time has elapsed and the fluid biomaterial has solidified to form the biocompatible polymeric matrix as taught by Siegel for the purpose of eliminating/reducing the volume of the LAA and minimizing the flow of blood into the LAA (paragraphs 13 and 53 of Siegel).
Claims 8-10 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Edmiston in view of Siegel, and further in view of Otero et al. (US PGPub 2014/0277070), hereinafter known as “Otero.”
With regards to claims 8-10, Edmiston/Siegel disclose the method as claimed in claim 7. Edmiston further discloses wherein the injection lumen 310 (see 112(b) rejection above) terminates distally at an injection outlet 332 (figure 19; paragraphs 119 and 121). The combination is silent wherein the hub further comprises a second lumen passing axially therethrough, wherein the second lumen is fluidly isolated from the injection lumen (claim 7); wherein the second lumen terminates distally at a fluid inlet (claim 8); and wherein the injection outlet is separated from and distal to the fluid inlet (claim 10).
However, in a similar field of endeavor of occluders, Otero teaches (Figure 2) wherein the hub 224 further comprises a second lumen 216 passing axially therethrough, wherein the second lumen 216 is fluidly isolated from the injection lumen 212 (figure 2; paragraph 75);
wherein the second lumen 216 terminates distally at a fluid inlet (figure 2); and
wherein the injection outlet is separated from the fluid inlet (figure 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Edmiston/Siegel to include the second lumen as taught by Otero for the purpose of removing blood that is present in the LAA following sealing of the LAA (paragraph 80 of Otero).
Although the resulting combination does not explicitly disclose that the injection outlet is distal to the fluid inlet, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the injection outlet of Edmiston to be distal to the fluid inlet of Otero since In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice. The operation of the injection lumen 310 of Edmiston and the second lumen 216 of Otero would not modify the operation of the device, as both lumens are fluidly isolated from another.
With regards to claims 15-17, Edmiston/Siegel disclose the method as claimed in claim 11. The combination is silent wherein the at least one injection channel of the delivery catheter body comprises a plurality of injection channels (claim 15); wherein the at least one injection channel of the delivery catheter body comprises first and second injection channels, and wherein the wall structure of the delivery catheter body comprises an outer wall and an inner wall that extends between opposing portions of the outer wall to define the first and second injection channels (claim 16); and further comprising a mixing component positioned between first and second injection channels and the outlet opening (claim 17).
However, in a similar field of endeavor of occluders, Otero teaches (Figure 2) wherein the at least one injection channel of the delivery catheter body 200 comprises a plurality of injection channels 210/212 (figure 2; paragraphs 72-73);
wherein the at least one injection channel of the delivery catheter body comprises first 210 and second 212 injection channels, and wherein the wall structure of the delivery catheter body 200 comprises an outer wall and an inner wall that extends between opposing portions of the outer wall to define the first 210 and second 212 injection channels (figure 2; paragraphs 72-73 – catheter body 200 defines the first 210 and second 212 injection channels as the channels extend through the body of the catheter 200 opposite one another); and
further comprising a mixing component 217/222 (see Note below) positioned between first 210 and second 212 injection channels and the outlet opening (figure 2; paragraphs 72-74).
Note – 112(f) interpretation – Applicant’s mixing component is a static mixing component that does not require any particular structural arrangement, can have a central receiving channel that provides for a variable flow pathway (page 53 line 26 – page 54 line 3); Otero’s mixer is a channel that mixes solutions from the first and second lumens (paragraphs 73-74); therefore both mixing components are equal in providing a flow pathway by way of being a channel.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Edmiston/Siegel to include the second lumen and the mixing component as taught by Otero for the purpose of forming a homogenous solution or suspension to be injected into the LAA (paragraphs 73-74 of Otero).
With regards to claim 18, Edmiston/Siegel disclose the method as claimed in claim 11. The combination is silent wherein the delivery catheter further comprises an auxiliary lumen fluidly isolated from the at least one injection channel and extending from the proximal end to the distal end and terminating in an auxiliary opening, and wherein the auxiliary opening of the auxiliary lumen is fluidly connected to the second lumen of the occlusion device.
However, in a similar field of endeavor of occluders, Otero teaches (Figure 2) wherein the delivery catheter 200 further comprises an auxiliary lumen 216 fluidly isolated from the at least one injection channel 210 and extending from the proximal end to the distal end and terminating in an auxiliary opening (distal end of 216 at the distal tip 206).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Edmiston/Siegel to include the auxiliary lumen as taught by Otero for the purpose of removing blood that is present in the LAA following sealing of the LAA (paragraph 80 of Otero).
The combination of Edmiston/Siegel/Otero would result in the auxiliary opening of the auxiliary lumen (216 of Otero) being fluidly connected to the injection lumen (see 112(b) rejection above; 310 of Edmiston) of the occlusion device (300 of Edmiston).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Edmiston in view of Siegel, and further in view of Horton et al. (WO 2019/099686), hereinafter known as “Horton.”
With regards to claims 13-14, Edmiston/Siegel disclose the method as claimed in claim 12. Edmiston further discloses The combination is silent wherein the sheath further comprises:
at least one inflation channel within the wall of the sheath; and
a balloon coupled to the distal end portion of the sheath and positioned in fluid communication with the at least one inflation channel of the sheath, the balloon enclosing an interior space (claim 13); and
wherein the wall of the delivery catheter body defines at least one outlet opening to provide fluid communication between the at least one inflation channel and the interior space of the balloon (claim 14).
However, in a similar field of endeavor of occluders, Horton teaches (Figures 2A-2C) wherein the delivery catheter body 40 (see 112(b) rejection above) further comprises:
at least one inflation channel 54 within the wall of the delivery catheter body 40; and
a balloon 60 coupled to the distal end portion 44 of the delivery catheter body 40 and positioned in fluid communication with the at least one inflation channel 54 of the delivery catheter body 40, the balloon 60 enclosing an interior space 62 (paragraphs 33-34); and
wherein the wall of the delivery catheter body 40 defines at least one outlet opening 50 to provide fluid communication between the at least one inflation channel 54 and the interior space 62 of the balloon 60 (paragraphs 33-34).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Edmiston/Siegel to include the balloon as taught by Horton for the purpose of sealing against an opening or passageway within the body of a subject and holding components of the disclosed catheter assembly in place in a desired location inside of the subject’s body (paragraph 30 of Horton).
Claim 187 is rejected under 35 U.S.C. 103 as being unpatentable over Siegel in view of Gruba et al. (US PGPub 2020/0008870), hereinafter known as “Gruba.”
With regards to claim 187, Siegel discloses a method of occluding the left atrial appendage (LAA) of a patient (paragraph 13) comprising injecting a fluid biomaterial 112 into the LAA of the patient;
wherein the fluid biomaterial 112 solidifies in situ in the LAA to form a biocompatible polymeric matrix that fills and occupies the LAA (paragraphs 36 and 83, figure 10).
Siegel is silent to the fluid biomaterial comprising a silencing agent dissolved or dispersed therein.
However, in a similar field of endeavor of occluders, Gruba teaches (Figures 7-8) a fluid biomaterial comprising a silencing agent dissolved or dispersed therein (paragraph 93 – “As the expandable member 210 is inflated, the liquid may permeate therethrough at the first region 220. The liquid may be saline, a pharmacological agent, an anti-stenotic agent, contrast, or a combination thereof”; paragraph 100 – “The ablation process may be performed simultaneously and concurrently with the delivery of an antimitotic pharmacological agent to the tissue receiving the ablation energy”; paragraph 101 – “In certain instances, the pharmacological agent can have an ionic base so as to optimize the ablative energy's ability to get the agent beyond the endothelium of the tissue. Paclitaxel is an example of one type of antimitotic pharmacological agent that may be used with the apparatuses, systems, and methods discussed herein” – Paclitaxel is apoptotic which is considered as a silencing agent).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Siegel to include the fluid biomaterial comprising a silencing agent dissolved or dispersed therein for the purpose of preventing or reducing the occurrence of fibrosis, stenosis, and neointimal hyperplasia of the tissue undergoing ablation (paragraph 101 of Gruba).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 08/29/2025
/KATHERINE SHI/Primary Examiner, Art Unit 3771