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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2025 has been entered.
Response to Amendment
The amendment filed 09/15/2025 has been entered. Claims 1-11 and 13-19 remain pending in the application, and claim 12 is cancelled. Applicant’s amendments to the claims have overcome the Drawing and Specification objections, however has not overcome the interpretation of the rejection previously set forth in the Final Office Action mailed 07/15/2025. However, a more relevant prior art (Inouye et al.) is applied as a teaching reference to better represent the first and second sensors located in their respective first and second housing member (see rejection below), as opposed to the previous prior art rejection in view of Najafi.
Response to Arguments
Applicant's arguments filed 04/09/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
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 13-19 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 13 recites the limitation "the second sensor housing" in line 10. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the Applicant is referring to the second sensor housing member as introduced in line 8, or if Applicant meant to introduce a new second sensor housing. For the purposes of examination, the Office will interpret the claim to mean “the second sensor housing member.” Claims 14-19 are rejected due to their dependency to claim 13.
Claim 16 recites the limitation "the first sensor housing" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the Applicant is referring to the first sensor housing member as introduced in claim 13, or if Applicant meant to introduce a new first sensor housing. For the purposes of examination, the Office will interpret the claim to mean “the first sensor housing member.”
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 1-11 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US PGPub 2019/0374229) in view of Richardson (US PGPub 2013/0110106), in view of Carlson et al. (US PGPub 2013/0165965), and further in view of Inouye et al. (US PGPub 2019/0336135), hereinafter known as “Anderson,” “Richardson,” “Carlson,” and “Inouye,” respectively.
With regards to claim 1, Anderson discloses (Figures 8-9) an occlusive implant 610 (paragraph 91), comprising:
an expandable framework 612 configured to shift between a collapsed configuration and an expanded configuration (figures 8-9, paragraph 91);
an occlusive member 614 disposed along at least a portion of the expandable framework 612 (paragraph 91);
a housing 625 coupled to the expandable framework 612 and occlusive member 614 (paragraphs 94-95); the housing having a first end (adjacent the expandable framework 612) and a second end opposite the first end (figures 8-9); and
Anderson is silent to a collar attached to the expandable framework;
the housing coupled to the collar; and
However, in the field of expansion devices, Richardson teaches (Figures 3A-3B) a collar 114 attached to the expandable framework 118 (attached via spring 120 and collar 116);
a housing 106 coupled to the collar 114 (figures 3A-3B)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of attaching the spring to the collar of Richardson to the spring of Anderson because it would yield the predictable result of an axially reciprocating collar/spring system to radially expand and contract an expandable device by way of having one end of the spring attached to a fixed collar, and the other end attached to a movable collar (MPEP 2143 I.A). Furthermore, as Anderson discloses coupling, but is silent to the means for coupling, it would have been particular obvious to look to the art of expansion devices and to use known coupling means, including that disclosed by Richardson.
Anderson/Richardson are silent to the housing being a sensor housing, the sensor housing including a first sensor housing member and a second housing member threadedly engaged with the first sensor housing member; and
a first sensor disposed in the first sensor housing member.
However, in a similar field of endeavor of occlusion devices, Carlson teaches (Figures 1-5) a sensor housing 65, the sensor housing 65 including a first sensor housing member 65 and a second housing member 30 threadedly engaged with the first sensor housing member 65 (paragraphs 22 and 28); and
a first sensor 35 disposed in the first sensor housing member 65 (paragraph 26; figure 4 shows sensor 35 placed in housing 65).
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 occlusive implant of Anderson/Richardson to include a first sensor disposed in the first sensor housing member as taught by Carlson for the purpose of sensing the pressure of the blood occupying the heart chamber and surrounding the sensor (paragraph 26 of Carlson).
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 occlusive implant of Anderson/Richardson to include a second housing threadedly engaged with the first sensor housing member as taught by Carlson for the purpose of threadedly attaching the first housing member to the second housing member and equipping the expandable framework and occlusive member with a pressure sensor that will allow the left atrial pressure to be measured and reported for the duration of the plug 90 being implanted in the left atrial appendage (paragraph 30 of Carlson).
Anderson/Richardson/Carlson are further silent to a second sensor disposed in the second sensor housing member.
However, in a similar field of endeavor of occlusion devices, Inouye teaches (Figure 5) a second sensor housing 23; and a second sensor 32 disposed in the second sensor housing 23 (paragraphs 71-73). Inouye also teaches in paragraph 73 “the arrangement of the first sensor 30 and the second sensor 32 shown in FIG. 5 (or any of the figures herein) is merely exemplary and not intended to be limiting. Rather, it is contemplated that the first sensor 30 and/or the second sensor 32 may be positioned and/or arranged along other portions of the core wire 18, the central hub 23, the framework 12 and/or the occlusive member 14.” Therefore, multiple sensors can be arranged at multiple locations within the same, or different, housing members.
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 occlusive implant of Anderson/Richardson/Carlson to include a second sensor disposed in the second sensor housing member as taught by Inouye for the purpose of being designed to sense, measure, collect, record, etc. one or more parameters related to the flow of fluid (e.g., blood) adjacent to the occlusive implant and/or the left atrial appendage (paragraph 74 of Inouye).
The combination of Anderson/Richardson/Carlson/Inouye would result in an expandable framework 612 of Anderson, an occlusive member 614 of Anderson, a first sensor housing member 65 of Carlson, a second sensor housing member 30 of Carlson; a first collar 114 and second slidable collar 116 of Richardson that would be disposed over the first sensor housing member 65 of Carlson and/or the second sensor housing member 30 of Carlson and attach on either ends to the spring 623 of Anderson; the first sensor 35 of Carlson that would be disposed in the first sensor housing 65 of Carlson; and the second sensor 32 of Inouye that would be disposed in the second sensor housing member 30 of Carlson.
With regards to claim 2, Anderson/Richardson/Carlson/Inouye disclose wherein the collar (114 of Richardson) includes an aperture (through hole where 106 traverses in figures 3A-3B of Richardson), and wherein the first sensor housing member (65 of Carlson) extends within the aperture of the collar (114 of Richardson). The first sensor housing member 65 of Carlson would extend through the aperture of the collar 114 of Richardson in order for the collar to be seen as disposed around the first sensor housing member).
With regards to claim 3, Anderson/Richardson/Carlson/Inouye disclose wherein the collar (114 of Richardson) extends circumferentially around an outer surface of the first sensor housing member (65 of Carlson). See figures 3A-3B of Richardson for the collar 114 extending circumferentially around the catheter shaft 106, would similarly apply to the first sensor housing member 65 of Carlson).
With regards to claim 4, Anderson/Richardson/Carlson/Inouye disclose wherein the collar (114 of Richardson) includes an aperture (through hole where 106 traverses in figures 3A-3B of Richardson), and wherein the second sensor housing member (30 of Carlson) extends within the aperture of the collar (114 of Richardson). The second sensor housing member 30 of Carlson would extend through the aperture of the collar 114 of Richardson in order for the collar to be seen as disposed around the second sensor housing member).
With regards to claim 5, Anderson/Richardson/Carlson/Inouye disclose wherein the collar (114 of Richardson) extends circumferentially around the second sensor housing member (30 of Carlson). See figures 3A-3B of Richardson for the collar 114 extending circumferentially around the catheter shaft 106, would similarly apply to the second sensor housing member 30 of Carlson).
With regards to claim 6, Anderson further discloses wherein anchor members and the expandable framework are formed from a monolithic sheet of material (paragraphs 58 and 74). Anderson/Richardson/Carlson/Inouye are silent wherein the collar and expandable framework are formed from a monolithic sheet of material.
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 occlusive implant of Anderson/Richardson/Carlson/Inouye to include the collar and expandable framework to be formed of a monolithic sheet of material as taught by the anchor members and expandable framework being formed of a monolithic sheet of material of Anderson for the purpose of ease of manufacturing and low costs.
With regards to claim 7, Anderson/Richardson/Carlson/Inouye disclose wherein the expandable framework (612 of Anderson) further includes a plurality of struts (see annotated figure 8 of Anderson below) attached to the collar (114 of Richardson).
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With regards to claim 8, Anderson/Richardson/Carlson/Inouye disclose wherein the expandable framework (612 of Anderson) further includes a plurality of struts (see annotated figure 8 of Anderson above) attached to the first sensor housing member (Carlson: 65, as seen in Anderson’s figures 8-9, plurality of struts are attached to the housing 625 and would similarly attach to the sensor housing members 65/30 of Carlson).
With regards to claim 9, Anderson/Richardson/Carlson/Inouye disclose wherein the collar (114 of Richardson) is configured to remain stationary relative to the first and second sensor housing members (65 and 30 of Carlson) while the expandable framework (612 of Anderson) shifts between the collapsed configuration (figure 9 of Anderson) and the expanded configuration (figure 8 of Anderson). See the collapsed configuration (figure 3A) and expanded configuration (figure 3B) of Richardson where the collar 114 is stationary, would similarly apply to the collapsed and expanded configuration of Anderson.
With regards to claim 10, as rejected above, it would be obvious to modify the implant of Anderson/Richardson/Carlson to include a second sensor disposed in the second sensor housing as taught by Inouye. Inouye further discloses wherein the second sensor 32 is positioned within the expandable framework 12 such that the second sensor 32 faces away from the occlusive member 14 (figure 5 - sensor 32 faces away from the occlusive member 14 by facing a proximal/distal direction as the occlusive member 14 circumferentially surrounds the expandable framework 12). Thus, when incorporating the second sensor in the second sensor housing member as taught by Inouye, the claimed limitation is considered obvious.
With regards to claim 11, Anderson/Richardson/Carlson/Inouye disclose wherein a first portion of the occlusive member (614 of Anderson) is attached to the expandable framework (612 of Anderson) and a second portion of the occlusive member (614 of Anderson) is attached to the collar (114 of Richardson). See annotated figure 8 of Anderson below.
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With regards to claim 13, Anderson discloses (Figures 8-9) an occlusive implant 610 (paragraph 91), comprising:
an expandable framework 612 configured to shift between a collapsed configuration and an expanded configuration (figures 8-9, paragraph 91);
an occlusive member 614 disposed along at least a portion of the expandable framework 612 (paragraph 91); and
a first housing member 625 coupled to the expandable framework 612 and occlusive member 614 (paragraphs 94-95).
Anderson is silent to a collar attached to a proximal portion of the expandable framework;
the first housing member coupled directly to the collar and extending distally therefrom.
However, in the field of expansion devices, Richardson teaches (Figures 3A-3B) a collar 114 attached to a proximal portion of the expandable framework 118 (figures 3A-3B; paragraph 31, attached via spring 120 and collar 116);
a first housing member 106 coupled directly to the collar 114 and extending distally therefrom (figures 3A-3B; paragraph 20 – “The elongate shaft 106 extends from a distal end 108 to a proximal end (not shown) configured to remain outside of a patient's body”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of attaching the spring to the collar of Richardson to the spring of Anderson because it would yield the predictable result of an axially reciprocating collar/spring system to radially expand and contract an expandable device by way of having one end of the spring attached to a fixed collar, and the other end attached to a movable collar (MPEP 2143 I.A). Furthermore, as Anderson discloses coupling, but is silent to the means for coupling, it would have been particular obvious to look to the art of expansion devices and to use known coupling means, including that disclosed by Richardson.
Anderson/Richardson are silent to a second sensor housing member coupled directly to the first housing member and extending proximally therefrom; and
a sensor disposed in the second sensor housing member.
However, in a similar field of endeavor of occlusion devices, Carlson teaches (Figures 1-5) a second sensor housing 65 coupled directly to the first housing member 30 and extending proximally therefore (figure 5); and
a sensor 35 disposed in the second sensor housing member 65 (see 112(b) rejection above; paragraph 26; figure 4 shows sensor 35 placed in housing member 65).
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 occlusive implant of Anderson/Richardson to include a sensor disposed in the second sensor housing member as taught by Carlson for the purpose of sensing the pressure of the blood occupying the heart chamber and surrounding the sensor (paragraph 26 of Carlson).
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 occlusive implant of Anderson/Richardson to include a second housing member as taught by Carlson for the purpose of threadedly attaching the first housing member to the second housing member and equipping the expandable framework and occlusive member with a pressure sensor that will allow the left atrial pressure to be measured and reported for the duration of the plug 90 being implanted in the left atrial appendage (paragraph 30 of Carlson).
Anderson/Richardson/Carlson are further silent to the first housing being a first sensor housing member.
However, in a similar field of endeavor of occlusion devices, Inouye teaches (Figure 5) a first sensor housing member 23 (paragraphs 71-73). Inouye also teaches in paragraph 73 “the arrangement of the first sensor 30 and the second sensor 32 shown in FIG. 5 (or any of the figures herein) is merely exemplary and not intended to be limiting. Rather, it is contemplated that the first sensor 30 and/or the second sensor 32 may be positioned and/or arranged along other portions of the core wire 18, the central hub 23, the framework 12 and/or the occlusive member 14.” Therefore, multiple sensors can be arranged at multiple locations within the same, or different, housing members.
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 first housing of Anderson/Richardson/Carlson to be a first sensor housing member as taught by Inouye for the purpose of being designed to sense, measure, collect, record, etc. one or more parameters related to the flow of fluid (e.g., blood) adjacent to the occlusive implant and/or the left atrial appendage (paragraph 74 of Inouye).
The combination of Anderson/Richardson/Carlson/Inouye would result in an expandable framework 612 of Anderson, an occlusive member 614 of Anderson, a first housing member 30 of Carlson that is a first sensor housing member 23 of Inouye, a second sensor housing member 65 of Carlson; a first collar 114 and second slidable collar 116 of Richardson that would be disposed over the first sensor housing member 30 of Carlson and/or the second sensor housing member 65 of Carlson and attach on either ends to the spring 623 of Anderson; and the sensor 35 of Carlson that would be disposed in the second sensor housing member 65 of Carlson.
With regards to claim 14, as rejected above, it would be obvious to modify the implant of Anderson/Richardson/Carlson to include a first sensor housing member as taught by Inouye. Inouye further discloses wherein the first sensor housing member 23 is entirely disposed within the expandable framework 12 (figure 5). Thus, when incorporating the first sensor housing member as taught by Inouye, the claimed limitation is considered obvious.
With regards to claim 15, as rejected above, it would be obvious to modify the implant of Anderson/Richardson to include a second sensor housing member of Carlson. Carlson further discloses wherein the second sensor housing member 65 entirely disposed outside the expandable framework (see figure 5). Thus, when incorporating the second sensor housing member of Carlson, the claimed limitation is considered obvious.
With regards to claim 16, as rejected above, it would be obvious to modify the implant of Anderson/Richardson to include a second sensor housing member coupled directly to the first housing member and extending proximally therefrom of Carlson. Carlson further discloses wherein the second sensor housing member 65 is threadedly connected to the first sensor housing member (see 112(b) rejection above; Carlson: figures 3-5; paragraphs 22 and 30; Carlson’s first housing member 30 that is a sensor housing member 23 as taught by Inouye). Thus, when incorporating the second sensor housing member coupled directly to the first housing member and extending proximally therefrom of Carlson, the claimed limitation is considered obvious.
With regards to claim 17, Anderson further discloses wherein anchor members and the expandable framework are formed from a monolithic sheet of material (paragraphs 58 and 74). Anderson/Richardson/Carlson/Inouye are silent wherein the collar and expandable framework are formed from a monolithic sheet of material.
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 occlusive implant of Anderson/Richardson/Carlson/Inouye to include the collar and expandable framework to be formed of a monolithic sheet of material as taught by the anchor members and expandable framework being formed of a monolithic sheet of material of Anderson for the purpose of ease of manufacturing and low costs.
With regards to claim 18, Anderson/Richardson/Carlson/Inouye disclose wherein the collar (114 of Richardson) is configured to remain stationary relative to the first and second sensor housing members (30 and 65 of Carlson) while the expandable framework (612 of Anderson) shifts between the collapsed configuration (figure 9 of Anderson) and the expanded configuration (figure 8 of Anderson). See the collapsed configuration (figure 3A) and expanded configuration (figure 3B) of Richardson where the collar 114 is stationary, would similarly apply to the collapsed and expanded configuration of Anderson.
With regards to claim 19, Anderson/Richardson/Carlson/Inouye disclose wherein a first portion of the occlusive member (614 of Anderson) is attached to the expandable framework (612 of Anderson) and a second portion of the occlusive member (614 of Anderson) is attached to the collar (114 of Richardson). See annotated figure 8 of Anderson below.
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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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 12/01/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771