CTNF 18/987,281 CTNF 93875 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-29-03 AIA The claims are objected to because the lines are crowded too closely together , making reading difficult (see Claims 14 and 15) . Substitute claims with lines one and one-half or double spaced on good quality paper are required. See 37 CFR 1.52(b). 07-29-01 AIA Claim s 15 – 19 are objected to because of the following informalities: Claims 15 – 19 recite one of “a piece of expandable foam” and “the piece of expandable foam” in various lines, although the lines do not rise to the level of being indefinite as the lines are understood by the Examiner to mean “a first piece of expandable foam” and “the first piece of expandable foam”, as the claims further include a “second piece of expandable foam” , the Examiner suggests the lines be amended to read “a first piece of expandable foam” and “the first piece of expandable foam”, respectively, for the purpose of maintaining consistent language throughout the claims; Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 14 and 20 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. Regarding claim 14, the phrase "the piece of expandable foam is not directly attachable to the occlusive implant" renders the claim indefinite because it is unclear if Applicant is intending to further narrow the claims to positively require the occlusive implant or if Applicant is intending to only functionally recite the occlusive implant. For the purpose of examination, the Examiner will read the claim to mean the latter such that the claim is read as “wherein the piece of expandable foam is configured to not directly attachable to the occlusive implant”. Regarding claim 30, the phrase "the kit of claim 30" renders the claim indefinite because the claim set does not comprise claim 30 and it is unclear which claim Applicant is intending for claim 20 to be dependent on due to the lack of claim 30. For the purpose of examination, the Examiner will read the claim to be dependent on independent claim 15. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1, 4 – 8, and 10 – 14 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Dakin et al (US 2019/0201190 A1) . Regarding claim 1 , Dakin discloses gap sealing system (occluder device) (occluder 800A) (abstract, paragraphs [0045], [0061], [0078 – 0079], and Figs. 3A – 4E) capable of being used with an occlusive implant disposed within a left atrial appendage of a patient (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. With that said, because the system of Dakin is used for sealing gaps between implants and the adjacent tissue walls within the heart, the system of Dakin is capable of being used to seal a gap with an implant within the LAA), comprising: a piece of expandable foam (occluder 800A with body 810A) (Examiner’s note: as stated in paragraph [0062] body 810A is made up of a shape-memory foam; and a shape-memory foam is expandable) configured to expand from a delivery configuration to an expanded configuration in vivo (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of prior art be capable of functioning in the manner claimed. With that said, because the shape memory foam occluder 800A is a shape-memory foam it is capable of being compressed in a delivery configuration and then expanding back to its original shape in an expanded configuration); and an anchoring element (fastener / hook 320) extending from the piece of expandable foam (paragraphs [0045] and [0061]) (Examiner’s note: as stated in paragraph [0061] the occluder 800A comprises any features from previously discussed embodiments, which includes the occluder 300 with the fastener 320 / hook 320; therefore, Dakin discloses occluder 800A with the fastener / hook 320 (i.e., the anchoring element) extending from the body of the occluder 800A / body 810A made of foam). Regarding claim 4 , Dakin discloses wherein the anchoring element (fastener / hook 320) is integrally formed with the piece of expandable foam (occluder 800A with body 810A) (Examiner’s note: the fastener / hook 320 and the occluder 800A form a single unit, and thus are integrally formed). Regarding claims 5 and 6 , Dakin discloses wherein the anchoring element (fastener / hook 320) is formed from a metallic material, wherein the material is different material than the piece of expandable foam (occluder 800A with body 810A) (Examiner’s note: as stated in paragraph [0045] the fastener / hook 320 is formed of a metallic filament; and as stated in paragraph [0062] the shape memory foam is made up of polyethylene terephthalate). Regarding claim 7 , Dakin discloses further comprising a tubular member (outer sheath 410) (paragraph [0050]) (Examiner’s note: as stated in paragraph [0061] the occluder 800A comprise any features from previously discussed embodiments, which includes delivery system there of; therefore, Dakin discloses using the outer sheath 410 to deliver the occluder 800A (i.e., the expandable foam piece)) sized and configured to deliver the piece of expandable foam to the left atrial appendage (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the outer sheath is capable of delivering the occluder 800A to the LAA). Regarding claim 8 , Dakin discloses wherein the anchoring element (fastener / hook 320) is configured to engage with the occlusive implant (paragraph [0045]). Regarding claim 10 , Dakin discloses wherein the piece of expandable foam (occluder 800A with body 810A) is formed from a shape memory polymer (polyethylene terephthalate) (paragraph [0062]). Regarding claim 11 , Dakin discloses wherein the piece of expandable foam (occluder 800A with body 810A) is configured to be disposed alongside the occlusive implant to occlude a gap between the occlusive implant and a side wall of the left atrial appendage (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, as stated in paragraph [0077] Dakin states the occluder can be utilized anywhere where it is desirable to create a seal between the periphery of the device and the adjacent body tissue, thus the expandable foam of Dakin is capable of being used in the LAA in the manner claimed). Regarding claims 12 – 14 , Dakin discloses a gap sealing system (occluder 800A) (abstract, paragraphs [0045], [0061], [0078 – 0079], and Figs. 3A – 4E) capable of being used with an occlusive implant disposed within a left atrial appendage of a patient (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. With that said, because the system of Dakin is used for sealing gaps between implants and the adjacent tissue walls within the heart, the system of Dakin is capable of being used to seal a gap with an implant within the LAA), comprising: a piece of expandable foam (occluder 800A with body 810A) (Examiner’s note: as stated in paragraph [0062] body 810A is made up of a shape-memory foam; and a shape-memory foam is expandable) configured to expand from a delivery configuration to an expanded configuration in vivo (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of prior art be capable of functioning in the manner claimed. With that said, because the shape memory foam occluder 800A is a shape-memory foam it is capable of being compressed in a delivery configuration and then expanding back to its original shape in an expanded configuration); and an anchoring element (fastener / hook 320) comprising at least one arm (fastener / hook 320 – Fig. 3A) extending distally from the piece of expandable foam in the expanded configuration foam (paragraphs [0045], [0061], and Figs. 3A – 4E) (Examiner’s note: as stated in paragraph [0061] the occluder 800A comprises any features from previously discussed embodiments, which includes the occluder 300 with the fastener 320 / hook 320; therefore, Dakin discloses occluder 800A with the fastener / hook 320 (i.e., the anchoring element) extending from the body of the occluder 800A / body 810A made of foam), wherein the at least one arm (fastener / hook 320 – Fig. 3A) comprises a longitudinally extending portion (straight portion extending from the occluder – looking at Fig. 3A) and a laterally extending portion (curved portion at the distal end of straight portion extending from the occluder – looking at Fig. 3A); wherein the piece of expandable foam (occluder 800A with body 810A) is configured to be disposed proximal of the occlusive implant to occlude an ostium of the left atrial appendage (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of prior art be capable of functioning in the manner claimed. With that said, because the occluder 800A is a shape-memory foam it is compressible and thus capable of being placed proximal of an occlusive implant to occlude an ostium in the LAA); wherein the laterally extending portion (curved portion of fastener / hook 320) of the at least one arm (fastener / hook 320) is configured to extend into an interior of the occlusive implant in vivo to anchor the piece of expandable foam to the occlusive implant (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of prior art be capable of functioning in the manner claimed. With that said, because the fastener / hook 320 is a separate element and is bendable, it is capable of extending as claimed); [claim 13] wherein the laterally extending portion (curved portion at the distal end of fastener / hook 320) extends laterally from a distal end of the longitudinally extending portion (straight portion extending from the occluder) (Fig. 3A); [claim 14] wherein the piece of expandable foam (occluder 800A with body 810A) is not directly attachable to the occlusive implant (Examiner’s note: it should be understood that the Examiner is considering the “occlusive implant” to not be positively recited as discussed in the 112(b) rejection above. With that said, as discussed in paragraph [0045] and shown in Figs. 4A – 4E the occluder 300 (which equates to the occluder 800A) attaches to the implant via the fastener / hook 320, and thus is not directly attachable to the occlusive implant) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim s 2, 3, 9, 15 – 17, and 19 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dakin et al (US 2019/0201190 A1) . Regarding claims 2 and 3 , as discussed above, the embodiment of occluder 800A of Dakin discloses the system of claim 1. However, the embodiment above is silent regarding (i) [claim 2] a radiopaque marker coupled to the piece of expandable foam and (ii) [claim 3] wherein the anchoring element is fixedly attached to the radiopaque marker. As to the above , Dakin further teaches a radiopaque marker coupled to the fastener / hook 320 (i.e., the anchoring element) which is coupled to the piece of expandable foam (occluder body 310; which equates to the occluder body 810A) for the purpose of aiding in guiding and placement of said occluder (paragraph [0077]). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the anchoring element of the expandable foam 800A of Dakin to incorporate the radiopaque marker, based on the teachings of paragraph [0077] of Dakin, for the purpose of aiding in guiding and placement of said occluder (paragraph [0077] – Dakin). Regarding claim 9 , as discussed above, the embodiment of occluder 800A of Dakin discloses the system of claim 1. However, the embodiment above is silent regarding (i) wherein the anchoring element is configured to pierce tissue of the left atrial appendage. As to the above, Dakin further teaches in another embodiment an occluder 1200 (which equates to the expandable foam occluder 800A) which comprises a plurality of anchoring elements (hooks 1240; which equate to the fasteners / hooks 320) configured to grab onto the implant and the surrounding tissue for the purpose of preventing movement of occluder (i.e., the expandable foam piece) (paragraph [0070]). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the anchoring elements of the occluder 800A of Dakin to be configured to pierce tissue for the purpose of preventing movement of occluder (i.e., the expandable foam piece) (paragraph [0070] – Dakin). Regarding claims 15 , Dakin discloses a kit (delivery system and occluder 800A) for use in sealing a gap (abstract, paragraphs [0045], [0061], [0078 – 0079], and Figs. 3A – 4E) capable of being used with an occlusive implant disposed within a left atrial appendage of a patient (Examiner’s note: “kit” is defined as a collection of things; and the delivery system and occluder together form “a collection of things”. Furthermore, it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. With that said, because the system of Dakin is used for sealing gaps between implants and the adjacent tissue walls within the heart, the system of Dakin is capable of being used to seal a gap with an implant within the LAA), comprising: a piece of expandable foam (occluder 800A with body 810A) (Examiner’s note: as stated in paragraph [0062] body 810A is made up of a shape-memory foam; and a shape-memory foam is expandable), wherein the piece of expandable foam is configured to expand from a delivery configuration to an expanded configuration in vivo (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of prior art be capable of functioning in the manner claimed. With that said, because the shape memory foam occluder 800A is a shape-memory foam it is capable of being compressed in a delivery configuration and then expanding back to its original shape in an expanded configuration); wherein the piece of expandable foam (occluder 800A with body 810A) has a first overall volume (Examiner’s note: occluder 800A has a volume), a tubular member (outer sheath 410) (paragraph [0050]) (Examiner’s note: as stated in paragraph [0061] the occluder 800A comprise any features from previously discussed embodiments, which includes delivery system thereof; therefore, Dakin discloses using the outer sheath 410 to deliver the occluder 800A (i.e., the expandable foam piece)), wherein the tubular member (outer sheath 410) sized and configured to deliver the piece of expandable foam to the left atrial appendage (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed. With that said, the outer sheath 410 is capable of delivering the occluder 800A (i.e., the first piece of expandable foam) to the LAA as claimed). However, the embodiment of Dakin above is silent regarding [claims 15 and 20] (i) a second and third expandable foam piece configured to expand from a delivery configuration to an expanded configuration in vivo, (ii) wherein the first, second, and third expandable foam pieces have different volumes , and (iii) a second and third tubular member sized and configured to deliver their respective pieces of expandable foam to the left atrial appendage. As to the above , Dakin teaches using multiple occluders of different sizes to accommodate multiple different gap sizes present in between the implant and the tissue wall, and further teaches using a separate delivery system, which comprises an outer sheath (i.e., a tubular member) sized and configured to delivery their respective occluders, for the purpose of simultaneously deploying the occluders. Therefore, It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of the embodiment of the occluder 800A to incorporate a second expandable foam piece (i.e., a second occluder 800A) and a third expandable foam piece (i.e., a third occluder 800A), wherein the first, second, and third expandable foam pieces have different volumes for the purpose of being able to seal different sized gaps that require different volumes of foam to effectively seal said gap. Furthermore, It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the kit of Dakin to further include a second tubular member and a third tubular member to deliver their respective expandable foam pieces, for the purpose of being able to simultaneously deliver the expandable foam pieces. Lastly, the second piece of expandable foam and the third piece of expandable foam are configured to expand from a delivery configuration to an expanded configuration in vivo as they are made from a shape-memory polymer material (the same as the first piece of expandable foam) and thus capable of functioning in the same way as the first piece of expandable foam discussed above. Regarding claim 16, as discussed above, Dakin encompasses or, in the alternative, makes obvious the kit of claim 15. Additionally, Dakin further discloses wherein the piece of expandable foam and the second piece of expandable foam (first and second occluders 800A) are each configured to be disposed alongside the occlusive implant to fill a gap between the occlusive implant and a side wall of the left atrial appendage (Examiner’s note: the preceding limitation is an intended use limitation and requires only that the structure of the prior art be capable of functioning as claimed. With that said, as stated in paragraphs [0077 – 0078] the occluders (i.e., the first and second expandable foam pieces) are used to fill in gaps between any implanted device and the adjacent tissue wall, therefore, the occluders (i.e., the first and second expandable foam pieces) are capable of functioning as claimed). Regarding claim 17, as discussed above, Dakin encompasses or, in the alternative, makes obvious the kit of claim 15. Additionally, Dakin further discloses wherein the piece of expandable foam (first occluder 800A with body 810A) comprises an anchoring element (fastener / hook 320) extending distally from the piece of expandable foam (paragraphs [0045], [0061], and Fig. 4E) (Examiner’s note: as stated in paragraph [0061] the occluder 800A comprise any features from previously discussed embodiments, which includes the occluder 300 with the fastener 320 / hook 320; therefore, Dakin discloses occluder 800A with the fastener / hook 320 (i.e., the anchoring element) extending from the body of the occluder 800A / body 810A made of foam); and makes obvious wherein the second piece of expandable foam (second occluder 800A with body 810A comprises a second anchoring element (second fastener / hook 320) extending distally from the second piece of expandable foam (Examiner’s note: it would be obvious to one of ordinary skill in the art to modify the second piece of expandable foam of the modified Kit of Dakin to incorporate the second anchor element for the purpose of being able to anchor the occluder to the prosthesis and/or to the tissue wall in order to prevent migration thereof – paragraph [0070] of Dakin). Regarding claim 19, as discussed above, Dakin encompasses or, in the alternative, makes obvious the kit of claim 15. Additionally, Dakin further discloses wherein the anchoring element (fastener / hook 320) is formed from a metallic material (paragraph [0045]) . 07-22-aia AIA Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dakin et al (US 2019/0201190 A1) , as applied to claim 17 above, and further in view of Devellian (US 2005/0070952 A1) . Regarding claim 18 , as discussed above, Dakin makes obvious the kit for use in sealing a gap of claim 17. Additionally, Dakin discloses wherein the anchoring element (fastener / hook 320) is formed of a shape-memory metal (NiTi) (paragraph [0045]). However, Dakin is silent regarding (i) wherein the anchoring element is formed from a shape memory polymer. As to the above , Devellian teaches an anchoring element (anchor 32) for an occlusive implant formed of a shape memory polymer (abstract and paragraph [0037]). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the anchoring element of Dakin to be formed of shape memory polymer, based on the teachings of Devellian, because shape memory polymers are known materials used to form anchoring elements of occlusive elements used within the body; and it is well within the purview of one of ordinary skill in the art to choose form a device out of a material known to be used to form said device, additionally, one of ordinary skill in the art would have a reasonable expectation of success in making such a modification such that the results would be predictable and result in the anchoring element of Dakin being able to couple the occlusion device (i.e., the expandable foam piece) to the prosthesis / implanted device as intended . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : Linder et al (US 2009/0318948 A1), Connor et al (US 2011/0046658 A1), Harrah et al (US 2013/0225918 A1), and Ahlberg et al (US 2014/0114402 A1) teach using an expandable foam piece or pieces to fill in gaps within the body. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Andrew Restaino/Primary Examiner, Art Unit 3771 Application/Control Number: 18/987,281 Page 2 Art Unit: 3771 Application/Control Number: 18/987,281 Page 3 Art Unit: 3771 Application/Control Number: 18/987,281 Page 4 Art Unit: 3771 Application/Control Number: 18/987,281 Page 5 Art Unit: 3771 Application/Control Number: 18/987,281 Page 7 Art Unit: 3771 Application/Control Number: 18/987,281 Page 8 Art Unit: 3771 Application/Control Number: 18/987,281 Page 9 Art Unit: 3771 Application/Control Number: 18/987,281 Page 10 Art Unit: 3771 Application/Control Number: 18/987,281 Page 11 Art Unit: 3771 Application/Control Number: 18/987,281 Page 12 Art Unit: 3771 Application/Control Number: 18/987,281 Page 13 Art Unit: 3771 Application/Control Number: 18/987,281 Page 14 Art Unit: 3771 Application/Control Number: 18/987,281 Page 15 Art Unit: 3771 Application/Control Number: 18/987,281 Page 16 Art Unit: 3771 Application/Control Number: 18/987,281 Page 17 Art Unit: 3771 Application/Control Number: 18/987,281 Page 18 Art Unit: 3771
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