DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 03/30/2026. As directed by the amendment: claims 1 and 18 have been amended, claim 7 has been cancelled, and claims 11-17 remain withdrawn. Thus, claims 1-6 and 8-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 03/30/2026, with respect to the rejection(s) of claim(s) 1 and 18 under 35 U.S.C. 103 as being unpatentable over Frazier et al (US 20040044361 A1), herein referenced to as “Frazier”, in view of O’Halloran et al (US 20210369283 A1), herein referenced to as “O’Halloran”, Kermode et al (US 20110098525 A1), herein referenced to as “Kermode”, Anderson et al (US 20110184439 A1), herein referenced to as “Anderson”, and Ulmer (US 20170312398 A1), herein referenced to as “Ulmer” have been fully considered and are persuasive.
The applicant amended claims 1 and 18 to further recite “wherein the biological tissue is a pericardium membrane”.
The applicant further argues that Anderson which teaches a biological tissue is a pericardium membrane does not teach that the tissue is “at least partially covering” as it is tissue components.
The examiner agrees.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Frazier in view of O’Halloran, Kermode, Theobald et al (US 20130035712 A1), and Ulmer.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 19 recites “characterized in that the biological tissue is a pericardium membrane”, however claim 18 which claim 19 is dependent on recite “wherein the biological tissue is a pericardium membrane”. As such claim 19 fails to further limit the subject matter of claim 18.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-6, 8-10, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Frazier et al (US 20040044361 A1), herein referenced to as “Frazier”, in view of O’Halloran et al (US 20210369283 A1), herein referenced to as “O’Halloran”, Kermode et al (US 20110098525 A1), herein referenced to as “Kermode”, Theobald et al (US 20130035712 A1), herein referenced to as “Theobald”, and Ulmer (US 20170312398 A1), herein referenced to as “Ulmer”.
Claim 1
Frazier discloses: Occluder 10 (see Figs. 7-8, and 10, [0076]-[0077]) for closing the left atrial appendage (see [0079]) of a patient, comprising a proximal end 192 (see Figs. 7-8 and 10, [0077]) and a distal end 190 (see Figs. 7-8, [0077]), and comprising a self-expandable frame 228 (see Figs. 7-8, [0077] and [0081], biased towards the enlarged orientation), characterized in that, in an expanded state enlarged state (see Figs. 7-8), the frame 228 has a substantially spherical outer contour (see Fig. 7A), in that, in an insertion position low profile orientation (see [0081]), the occluder 10 has, by comparison with the expanded state enlarged state, an elongate outer contour tubular/tube stock extend generally parallel to the longitudinal axis (see [0080]-[0081]) in which the proximal end is displaced in a proximal direction 192 and the distal end 190 is displaced in a distal direction (see [0080]-[0081]), in that the frame 228 comprises a tubular end portion 222 (see Figs. 7-8, [0077]) at its proximal end 192, in that on the outside of a proximal hemisphere 216 (see Fig. 10, [0085]) of the frame 228, at least partially covering membrane 15 (see Fig. 10, [0085]) is arranged.
Frazier does not explicitly disclose: least partially covering biological tissue is arranged, wherein the biological tissue comprises animal membrane and wherein the biological tissue is a pericardium membrane, in that the biological tissue has an opening, so that an insertion catheter can be inserted into the frame through the opening and then through the tubular end portion, in that a plurality of X-ray markers are arranged on the frame along the circumference of the occluder, wherein the X-ray markers are of positioned along a parting plane delineating the proximal hemisphere and a distal hemisphere of the frame, and wherein the biological tissue covers the X-ray markers, and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried.
However, O’Halloran in a similar field of invention teaches an occluder (see Figs. 1A-1F) for closing the left atrial appendage (see [0006]) with self-expandable frame 3 (see Figs. 1A-1F, [0025], [0100], and [0120]) that in the expanded state has a substantially spherical outer contour (see [0100], spheroid) with a proximal hemisphere proximal end of the cage (see Figs. 1-1F) with at least partially covering membrane 7 (see Figs. 1A-1F, [0120]) and a tubular end portion (see annotated Fig. 1B below)). O’Halloran further teaches: least partially covering biological tissue 7 (see [0103], biological material) is arranged, in that the biological tissue 7 has an opening 8 (see Figs. 1A-1F, [0120] and [0121], the flap is formed on the cover), so that an insertion catheter 10 + 12 (see Fig-s. 1A-1F, [0120]) can be inserted into the frame 3 through the opening 8 (see Fig. 1B) and then through the tubular end portion (see annotated Fig. 1B below, [0120] the 10 is abutting a mouth of the recessed socket 5, which is within the tubular end portion).
PNG
media_image1.png
472
582
media_image1.png
Greyscale
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 Frazier to incorporate the teachings of O’Halloran and have the occluder with the covering membrane be a biological tissue and in that the biological tissue has an opening, so that an insertion catheter can be inserted into the frame through the opening and then through the tubular end portion. Motivation for such can be found in O’Halloran as this re-closable aperture is to allow access to the recessed socket from the left atrium when the modular active element is being removed and replaced, and at other times fluidically isolate the recessed socket from the left atrium.
The combination of Frazier and O’Halloran does not explicitly teach: wherein the biological tissue comprises animal membrane and wherein the biological tissue is a pericardium membrane; in that a plurality of X-ray markers are arranged on the frame along the circumference of the occluder, wherein the X-ray markers are of positioned along a parting plane delineating the proximal hemisphere and a distal hemisphere of the frame, and wherein the biological tissue covers the X-ray markers, and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried.
However, Kermode in a similar field of invention teaches an occlusive device (see Figs. 26A-26B) with a self-expandable frame 2601 (see Figs. 26A-26B, [0115], nitinol tube, expand outwards) with a proximal hemisphere (see annotated Fig. 26B below), a distal hemisphere (see annotated Fig. 26B below), and a circumference (see annotated Fig. 26B below). Kermode further teaches: in that a plurality of X-ray markers 2605 (see Figs. 26A and annotated Fig. 26B, [0115]) are arranged on the frame 2601 (the bands/markers are part of the nitinol frame tube, see [0115]) along the circumference (see annotated Fig. 26B below) of the occluder, wherein the X-ray markers 2605 are of positioned along a parting plane (see annotated Fig. 26B below, the parting plane is on the circumference of the sphere) delineating the proximal hemisphere (see annotated Fig. 26B below) and a distal hemisphere (see annotated Fig. 26B below) of the frame 2601.
PNG
media_image2.png
644
662
media_image2.png
Greyscale
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 occluder of Frazier to incorporate the teachings of Kermode and teach an occluder with a plurality of X-ray markers are arranged on the frame along the circumference of the occluder, wherein the X-ray markers are of positioned along a parting plane delineating the proximal hemisphere and a distal hemisphere of the frame. Motivation for such can be found in Kermode as the radiographic markers can assist the user which markers contact tissue within the desired landing zone for the device and also detect the presence of any structure that would impede proper deployment of the implant (see [0115]).
The combination of Frazier, O’Halloran, and Kermode further teaches: wherein an occlusive membrane covers the X-ray markers (as combined, Frazier incorporates the X-ray markers onto the nitinol frame/as part of the Nitinol frame, and Frazier and O’Halloran discloses that the occlusive membrane overlays the frame, see Fig. 10 of Frazier and Figs. 1C-1D of O’Halloran).
The combination of Frazier, O’Halloran, and Kermode does not explicitly teach: wherein the biological tissue comprises animal membrane and wherein the biological tissue is a pericardium membrane; and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried.
However, Theobald in a similar field of invention teaches an occlusive device 10 (see 1A-2) with a self-expandable frame 20 (see Figs. 1A-2) and on the outside (Figs. 1A-2, [0031], outer surface of the frame 20) proximal hemisphere 10 is a hemisphere that is proximally directed (see Figs. 1A-2 and Figs 7-9) at least partially covering biological tissue 60 (see Figs. 1A-2, [0051]-[0052], bioremodable sheet material as a cover, tissue layers formed into a sheet, hence a sheet of pericardium, see [0052]). Theobald further teaches: wherein the biological tissue 60 comprises animal membrane (see Figs.1A-2, [0051]-[0052], a sheet of pericardium) and wherein the biological tissue is a pericardium membrane(see Figs.1A-2, [0051]-[0052], a sheet of pericardium).
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 Frazier and O’Halloran to incorporate the teachings of Theobald and teach an occluder for closing the left atrial appendage of a patient with the biological tissue comprises animal membrane and wherein the biological tissue is a pericardium membrane. Motivation for such can be found in Theobald as bioremodable materials include naturally derived tissues with ECMs possessing biotropic properties and include naturally-derived collagenous tissue materials retaining native matrix configurations and bioactive agents, such as growth factors, which serve to facilitate tissue remodeling, such that a tissue from the pericardium would be suitable for implantation in the left atrial appendage (see [0052]).
The combination of Frazier, O’Halloran, Kermode, and Theobald does not explicitly teach: and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried.
The claimed phrase “by means of a reticulation method” is being treated as a product by process limitation; that is the process of stabilizing biological tissue. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Ulmer in a similar field of invention teaches a method of manufacture for materials for medical implants and medical implants (see [0001]) such as a heart valve prosthesis 30 (see Fig. 2) with a proximal frame 34 (see Fig. 2). Ulmer further teaches: that on the outside of a proximal part of the frame (see [0058]-[0059], covers the stent structure), at least partially covering biological tissue (see [0058], biological materials such as cellulose or pericard tissue) is arranged, in that the biological tissue has an opening the proximal opening of the tissue as the tissue is tubular in shape (see Fig. 2) and in that the biological tissue is stabilized by means of a reticulation method (see [0044]-[0045]; [0055]-[0057]) and, in order to make it durable, is either wetted with a liquid medium (alcohol [0044]; [0056] rehydrated) or dried (see [0074], dried). Thus, the structure of the biological tissue of Ulmer is found to be equivalent to the “stabilized” biological tissue as claimed.
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 combination of Frazier, O’Halloran, and Theobald to incorporate the teachings of Ulmer and have an occlusive device in that on the outside of the proximal hemisphere of the frame, at least partially covering biological tissue is arranged and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried. Motivation for such can be found in Ulmer as, biological tissues are known for use in implants, and can have reduced swelling capacity, which one of ordinary skill of the art would know would reduce pressure in the enclosed space of the LAA or an aneurysm (see [0058] and [0062]).
Claim 2
The combination of Frazier, O’Halloran, Kermode, Theobald, and Ulmer teaches: Occluder according to claim 1, see 103 rejection above. Ulmer further teaches: characterized in that the reticulation method (see [0055]-[0057]) comprises a crosslinking process (see [0062], glutaraldehyde is used in crosslinking processes) using glutaraldehyde (not being examined due to being an optional limitation) and/or alcohol (see [0044]-[0045]).
Claim 3
The combination of Frazier, O’Halloran, Kermode, Theobald, and Ulmer teaches: Occluder according to claim 1, see 103 rejection above. Ulmer further teaches: characterized in that the liquid medium with which the biological tissue is wetted is glutaraldehyde (not being examineded due to being an optional limitation) and/or alcohol (see [0044]-[0045]).
Claim 4
The combination of Frazier, O’Halloran, Kermode, Theobald, and Ulmer teaches: Occluder according to claim 1, see 103 rejection above. Ulmer further teaches: characterized in that the biological tissue is initially wetted with glycerol (see [0044], glycerol) and/or with a mono- to trihydric alcohol ([0044], isopropyl alcohol) and is then dried (see [0045], then is dried).
Claim 5
The combination of Frazier, O’Halloran, Kermode, Theobald, and Ulmer teaches: Occluder according to claim 1, see 103 rejection above. Ulmer further teaches: characterized in that the biological tissue is vacuum-dried (not examined here, due to being an optional claim limitation) or air-dried (see [0045], air-dried).
Claim 6
The combination of Frazier, O’Halloran, Kermode, Theobald, and Ulmer teaches: Occluder according to claim 1, see 103 rejection above. Ulmer further teaches: characterized in that the dried biological tissue is sterilized (see [0055], sterilized) with ethylene oxide.
The combination of Frazier, O’Halloran, Theobald, and Ulmer doesn’t explicitly teach: with ethylene oxide.
The claimed phrase “is sterilized with ethylene oxide” is being treated as a product by process limitation; that is, that the dried biological tissue is sterilized with ethylene oxide. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though the combination of Frazier, O’Halloran, and Ulmer is silent as to the process used to sterilize the dried biological tissue, it appears that the biological tissue in Frazier, O’Halloran, Theobald, and Ulmer would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of an animal membrane (see instant spec, [0012] and [0013]).
Claim 8
The combination of Frazier, O’Halloran, Kermode, Theobald, and Ulmer teaches: Occluder according to claim 1, see 103 rejection above. Frazier further discloses: wherein, in order to insert the occluder into the patient, the frame 228 can be transferred into the insertion position low profile orientation in which the occluder has a substantially tubular outer contour (see [0080]-[0081], advanced from a low profile orientation).
Claim 9
The combination of Frazier, O’Halloran, Kermode, Theobald, and Ulmer teaches: Occluder according to claim 1, see 103 rejection above. Frazier further discloses: wherein the frame 228 comprises a pot- shaped end portion (a pot-shaped object is a rounded object, which the distal end of 228 is rounded) at its distal end 190.
Claim 10
The combination of Frazier, O’Halloran, Kermode, Theobald, and Ulmer teaches: Occluder according to claim 1, see 103 rejection above. Frazier further discloses: wherein the proximal hemisphere has first anchoring means (will not be examined due to being an optional claim limitation indicated as an alternative embodiment by the conjunction “/or”, and/or wherein a distal hemisphere distal hemi-sphere opposite of 216 (see Fig. 1) of the frame 228 has second anchoring means 195 (see Fig. 10, [0079]).
Claim 18
Frazier discloses: Occluder 10 (see Figs. 7-8, and 10, [0076]-[0077]) for closing the left atrial appendage (see [0079]) of a patient, comprising a self-expandable frame 228 (see Figs. 7-8, [0077] and [0081], biased towards the enlarged orientation), wherein, in an expanded state enlarged state (see Figs. 7-8), the frame 228 has a substantially spherical outer contour (see Fig. 7A) that includes a proximal hemisphere 216 (see Fig. 10, [0085]) and a distal hemisphere distal hemisphere opposite of 216 (see Fig. 10), wherein the frame 228 comprises a tubular end portion 222 (see Figs. 7-8, [0077]) at its proximal end 192, wherein a covering membrane 15 (see Fig. 10, [0085]) is arranged on the frame 228 that at least partially covers the proximal hemisphere 216 (see Fig. 10) of the outside of the frame 228 (see Fig. 10).
Frazier does not explicitly disclose: wherein the biological tissue comprising animal membrane and wherein the biological tissue is a pericardium membrane, wherein the biological tissue has an opening, so that an insertion catheter can be inserted into the frame through the opening and then through the tubular end portion, in that a plurality of X-ray markers are arranged on the frame along the circumference of the occluder, wherein the X-ray markers are of positioned along a parting plane delineating the proximal hemisphere and a distal hemisphere of the frame, and wherein the biological tissue covers the X-ray markers, and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried.
However, O’Halloran in a similar field of invention teaches an occluder (see Figs. 1A-1F) for closing the left atrial appendage (see [0006]) with self-expandable frame 3 (see Figs. 1A-1F, [0025], [0100], and [0120]) that in the expanded state has a substantially spherical outer contour (see [0100], spheroid) with a proximal hemisphere proximal end of the cage (see Figs. 1-1F) with at least partially covering membrane 7 (see Figs. 1A-1F, [0120]) and a tubular end portion (see annotated Fig. 1B below)). O’Halloran further teaches: the covering membrane is a biological tissue 7 (see [0103], biological material), wherein the biological tissue 7 has an opening 8 (see Figs. 1A-1F, [0120] and [0121], the flap is formed on the cover), so that an insertion catheter 10 + 12 (see Fig-s. 1A-1F, [0120]) can be inserted into the frame 3 through the opening 8 (see Fig. 1B) and then through the tubular end portion (see annotated Fig. 1B below, [0120] the 10 is abutting a mouth of the recessed socket 5, which is within the tubular end portion).
PNG
media_image1.png
472
582
media_image1.png
Greyscale
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 Frazier to incorporate the teachings of O’Halloran and have the occluder with the covering membrane be a biological tissue and in that the biological tissue has an opening, so that an insertion catheter can be inserted into the frame through the opening and then through the tubular end portion. Motivation for such can be found in O’Halloran as this re-closable aperture is to allow access to the recessed socket from the left atrium when the modular active element is being removed and replaced, and at other times fluidically isolate the recessed socket from the left atrium.
The combination of Frazier and O’Halloran does not explicitly teach: wherein the biological tissue comprising animal membrane and wherein the biological tissue is a pericardium membrane, in that a plurality of X-ray markers are arranged on the frame along the circumference of the occluder, wherein the X-ray markers are of positioned along a parting plane delineating the proximal hemisphere and a distal hemisphere of the frame, and wherein the biological tissue covers the X-ray markers, and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried.
However, Kermode in a similar field of invention teaches an occlusive device (see Figs. 26A-26B) with a self-expandable frame 2601 (see Figs. 26A-26B, [0115], nitinol tube, expand outwards) with a proximal hemisphere (see annotated Fig. 26B below), a distal hemisphere (see annotated Fig. 26B below), and a circumference (see annotated Fig. 26B below). Kermode further teaches: in that a plurality of X-ray markers 2605 (see Figs. 26A and annotated Fig. 26B, [0115]) are arranged on the frame 2601 (the bands/markers are part of the nitinol frame tube, see [0115]) along the circumference (see annotated Fig. 26B below) of the occluder, wherein the X-ray markers 2605 are of positioned along a parting plane (see annotated Fig. 26B below, the parting plane is on the circumference of the sphere) delineating the proximal hemisphere (see annotated Fig. 26B below) and a distal hemisphere (see annotated Fig. 26B below) of the frame 2601.
PNG
media_image2.png
644
662
media_image2.png
Greyscale
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 occluder of Frazier to incorporate the teachings of Kermode and teach an occluder with a plurality of X-ray markers are arranged on the frame along the circumference of the occluder, wherein the X-ray markers are of positioned along a parting plane delineating the proximal hemisphere and a distal hemisphere of the frame. Motivation for such can be found in Kermode as the radiographic markers can assist the user which markers contact tissue within the desired landing zone for the device and also detect the presence of any structure that would impede proper deployment of the implant (see [0115]).
The combination of Frazier, O’Halloran, and Kermode further teaches: wherein an occlusive membrane covers the X-ray markers (as combined, Frazier incorporates the X-ray markers onto the nitinol frame/as part of the Nitinol frame, and Frazier and O’Halloran discloses that the occlusive membrane overlays the frame, see Fig. 10 of Frazier and Figs. 1C-1D of O’Halloran).
The combination of Frazier, O’Halloran, and Kermode does not explicitly teach: wherein the biological tissue comprising animal membrane and wherein the biological tissue is a pericardium membrane; and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried.
However, Theobald in a similar field of invention teaches an occlusive device 10 (see 1A-2) with a self-expandable frame 20 (see Figs. 1A-2) and on the outside (Figs. 1A-2, [0031], outer surface of the frame 20) proximal hemisphere 10 is a hemisphere that is proximally directed (see Figs. 1A-2 and Figs 7-9) at least partially covering biological tissue 60 (see Figs. 1A-2, [0051]-[0052], bioremodable sheet material as a cover, tissue layers formed into a sheet, hence a sheet of pericardium, see [0052]). Theobald further teaches: wherein the biological tissue 60 comprises animal membrane (see Figs.1A-2, [0051]-[0052], a sheet of pericardium) and wherein the biological tissue is a pericardium membrane(see Figs.1A-2, [0051]-[0052], a sheet of pericardium).
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 Frazier and O’Halloran to incorporate the teachings of Theobald and teach an occluder for closing the left atrial appendage of a patient with the biological tissue comprises animal membrane and wherein the biological tissue is a pericardium membrane. Motivation for such can be found in Theobald as bioremodable materials include naturally derived tissues with ECMs possessing biotropic properties and include naturally-derived collagenous tissue materials retaining native matrix configurations and bioactive agents, such as growth factors, which serve to facilitate tissue remodeling, such that a tissue from the pericardium would be suitable for implantation in the left atrial appendage (see [0052]).
The combination of Frazier, O’Halloran, Kermode, and Theobald does not explicitly teach: and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried.
The claimed phrase “by means of a reticulation method” is being treated as a product by process limitation; that is the process of stabilizing biological tissue. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Ulmer in a similar field of invention teaches a method of manufacture for materials for medical implants and medical implants (see [0001]) such as a heart valve prosthesis 30 (see Fig. 2) with a proximal frame 34 (see Fig. 2). Ulmer further teaches: that on the outside of a proximal part of the frame (see [0058]-[0059], covers the stent structure), at least partially covering biological tissue (see [0058], biological materials such as cellulose or pericard tissue) is arranged, in that the biological tissue has an opening the proximal opening of the tissue as the tissue is tubular in shape (see Fig. 2) and in that the biological tissue is stabilized by means of a reticulation method (see [0044]-[0045]; [0055]-[0057]) and, in order to make it durable, is either wetted with a liquid medium (alcohol [0044]; [0056] rehydrated) or dried (see [0074], dried). Thus, the structure of the biological tissue of Ulmer is found to be equivalent to the “stabilized” biological tissue as claimed.
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 combination Frazier, O’Halloran, and Theobald to incorporate the teachings of Ulmer and have an occlusive device in that on the outside of the proximal hemisphere of the frame, at least partially covering biological tissue is arranged and in that the biological tissue is stabilized by treatment by means of a reticulation method and, in order to make it durable, is either wetted with a liquid medium or dried. Motivation for such can be found in Ulmer as, biological tissues are known for use in implants, and can have reduced swelling capacity, which one of ordinary skill of the art would know would reduce pressure in the enclosed space of the LAA or an aneurysm (see [0058] and [0062]).
Claim 19
The combination of Frazier, O’Halloran, Kermode, Theobald, and Ulmer teaches: Occluder according to claim 18, see 103 rejection above. Theobald further teaches: characterized in that the biological tissue 60 is a pericardium membrane (see Figs. 1A-2, [0051]-[0052], bioremodable sheet material as a cover, tissue layers formed into a sheet, hence a sheet of pericardium, see [0052]).
Claim 20
The combination of Frazier, O’Halloran, Kermode, Anderson, and Ulmer teaches: Occluder according to claim 18, see 103 rejection above. O’Halloran further teaches: characterized in that the biological tissue 7 is configured to close the left atrial appendage LAA in a fluid-tight manner (see from Figs. 1C-1D, see [0120], fluidically isolate from the left atrium) when the occluder (see Figs. 1A-1F) is in the expanded state (see Figs. 1A-1F).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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, Darwin Erezo can be reached at 571-272-4695. 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.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights