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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/31/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 12/31/2025. As directed by the amendment: claims 1 have been amended and claims 3-13 and 15-16 have been cancelled. Thus, claims 1-2 and 14 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 12/31/2025, with respect to the USC 112b rejections have been fully considered and are persuasive. The applicant’s amendment to the claim overcomes the issue of clarity within the claims. The USC 112b rejection the claims have been withdrawn.
Applicant's arguments, see pages 7-20, filed 12/31/2025, with respect to the rejections of claim 1 under 35 U.S.C. 103 as being unpatentable over Perszyk et al (US 20210236138 A1), herein referenced to as “Perszyk” in view of Coyle et al (US 20190046170 A1), herein referenced to as “Coyle” and Onorato et al (US 20220346869 A1), herein referenced to as “Onorato” have been fully considered but they are not persuasive.
The applicant argues that the limitation “The stent consisting of only a left disc, a right disc, and a waist” is not met by Perszyk. They argue that the existence of “eyelets of the marker bands of 206” is additional structure that is thereby excluded by the limitation. The examiner respectfully disagrees and notes that this limitation exists in the body of the applicant’s claim, rather than immediately following the preamble.
Hence, the MPEP notes in 2111.03 II:
When the phrase "consisting of" appears in a clause of the body of a claim, rather than immediately following the preamble, there is an "exceptionally strong presumption that a claim term set off with ‘consisting of’ is closed to unrecited elements." Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350, 1359, 119 USPQ2d 1773, 1781 (Fed. Cir. 2016) (a layer "selected from the group consisting of" specific resins is closed to resins other than those listed). However, the "consisting of" phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole. Mannesmann Demag Corp. v. Engineered Metal Products Co., 793 F.2d 1279, 230 USPQ 45 (Fed. Cir. 1986). See also In re Crish, 393 F.3d 1253, 73 USPQ2d 1364 (Fed. Cir. 2004) (The claims at issue "related to purified DNA molecules having promoter activity for the human involucrin gene (hINV)." Id., 73 USPQ2d at 1365. In determining the scope of applicant’s claims directed to "a purified oligonucleotide comprising at least a portion of the nucleotide sequence of SEQ ID NO:1 wherein said portion consists of the nucleotide sequence from … to 2473 of SEQ ID NO:1, and wherein said portion of the nucleotide sequence of SEQ ID NO:1 has promoter activity," the court stated that the use of "consists" in the body of the claims did not limit the open-ended "comprising" language in the claims (emphases added). Id. at 1257, 73 USPQ2d at 1367. The court held that the claimed promoter sequence designated as SEQ ID NO:1 was obtained by sequencing the same prior art plasmid and was therefore anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. Id. at 1256 and 1259, 73 USPQ2d at 1366 and 1369. The court affirmed the Board’s interpretation that the transition phrase "consists" did not limit the claims to only the recited numbered nucleotide sequences of SEQ ID NO:1 and that "the transition language ‘comprising’ allowed the claims to cover the entire involucrin gene plus other portions of the plasmid, as long as the gene contained the specific portions of SEQ ID NO:1 recited by the claim[s]." Id. at 1256, 73 USPQ2d at 1366.).
Hence the transitional phrase “consisting of” applies only to the clause immediately after it, and the claim follows with “the occluder further comprising a central through hole that penetrates the left disc…”. Hence, the claim does not exclude structure surrounding the stent and the eyelets of the marker bands are not considered to be part of the stent itself but of the occluder.
The applicant argues that the combination of references does not teach “A membrane comprising four layers sewn within the central through hole to block the hole from the inside while remaining puncturable”.
The applicant argues that the combination of references does not teach this limitation as Onorato which teaches a three-layer member that is sewn onto the metallic braided mesh that makes up the disc and the waist does not teach a four layer membrane stack located entirely within a single large central through hole and that examiner’s rationale of “mere duplication of the essential working parts of a device involves only routine skill” impermissibly abstracts away the geometry, location, and function of the claimed membrane.
The examiner respectfully disagrees.
In response to applicant's argument that the location of the extra layers and the geometry, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Furthermore, Perszyk discloses there can be more than one layer (see [0042], patch closure(s)) so that one ordinary skill of the art would know how to duplicate the layer to up to four layers, this is further supported with Onorato having three layers.
The applicant argues that the combination of references does not explicitly teach or render obvious “A connecting wire integrally woven with the wire material forming the outer layer of the right disc during braiding”. They further assert that this limitation is opposite of what Perszyk teaches with the post-forming attachment of connecting wires as separate hardware elements.
However, this limitation “a connecting wire integrally woven with the wire material forming the outer layer of the right disc during braiding” is being treated as a product by process limitation; that is, that the connecting wires are made by being woven with the wire material forming the outer layer of the right disc during braiding. 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. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Perszyk is silent as to the process used to weave the connecting wires, it appears that the connecting wire in Perszyk be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a memory alloy material (such as nitinol) (see instant spec at [0007]).
The applicant argues that there is no rationale for modifying Perszyk using Coyle and Onorato. The examiner respectfully disagrees.
For Perszyk and Coyle: Therefore, it would have been obvious to try, by one of ordinary skill in the art before effective filing date of the invention, to have the right disc and the left disc be the same diameter as seen in Coyle and to incorporate it into the occluder of Perszyk since there are a finite number of identified, predictable potential solutions (i.e., the diameters of the discs being different vs being the same) to the recognized need (the diameters of the discs of an atrial septum occluder) and one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success (choosing the alternates being having the discs be different diameters or the same diameter).
In this case there are a limited number of alternatives between two discs with different diameters or the same diameters (the two discs are the same, the left is larger than the right, the right is larger than the left), in this case being three different possibilities and it would be obvious to try the different alternatives.
For Perszyk and Onorato the motivation is two-fold:
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 Perszyk to incorporate the teachings of Onorato and teach a puncturable atrial septal occluder with the membrane having three layers and wherein the membrane is attached along the entire circumference of the central through hole, and is configured to be puncturable by a sheath canal for a subsequent atrial septal puncture interventional operation. The motivation for such can be found in Onorato as this assists in sealing by creating a layer between both of sides of the atria instantly and providing a surface for better endothelization (see [0073]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have four layers of a membrane instead of three layers of a membrane, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 (VI-B).
The applicant argues that Coyle with destroy the functionality of Perszyk.
In response to applicant's argument that since Coyle’s teaching has a context of a different sealing and delivery architecture that importing it’s teaching into Perszyk’s would require altering Perszyk’s geometry and load distribution without any explanation of how Perszyk’s attachment, scheme, delivery mechanics, and central-passage behavior would remain operable, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The applicant argues that Onorato would destroy the functionality of Perszyk.
In response to applicant's argument that Perszyk’s core functionality depends on a large central through hole that remains reliably accessible after implantion, with a patch structure designed to avoid bulging, deformation, or loss of patency during subsequent puncture and sheath passage. Onorato, however, is directed to a fundamentally different problem and solution: sealing potential fenestrations on disc surfaces using polymeric patches sewn onto braided mesh, with layers distributed across different structural regions… modifying Perszyk to incoprate Onorator’s multi-layer disc-surface patching would obstruct or materially alter Perszyk’s central passage…, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Furthermore, Onorato’s patch is within the central through hole, not on the discs themselves. Additionally, Perszyk’s own patch (see Fig. 14) has a plurality of fenestrations as well.
The applicant argues that Coyle would change the principle of operation of Perszyk. The applicant argues since the two different occluders have different designs that the there would be substantial reconstruction of Perszyk.
The examiner respectfully disagrees. Both devices have the principle of operation of sealing atrial septal defects.
The applicant argues that Onorato would change the principle of operation of Perszyk. The applicant argues that Onorato’s patch architecture would cause their to be membrane on the discs.
The examiner respectfully disagrees as it can be seen clearly in Figure 4, that this is within the central through hole, surrounded by the disc material. Furthermore, Perszyk’s own patch (see Fig. 14) has a plurality of fenestrations as well.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The applicant argues that Perszyk teaches away from the claimed invention of the application. The applicant cites different elements that exist in Perszyk such as the patch or closure element and marker bands as teaching away from the pending application’s claims. The examiner respectfully disagrees.
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Perszyk et al (US 20210236138 A1), herein referenced to as “Perszyk” in view of Coyle et al (US 20190046170 A1), herein referenced to as “Coyle” and Onorato et al (US 20220346869 A1), herein referenced to as “Onorato”.
Claim 1
Perszyk discloses: A puncturable atrial septal occluder (see Figs. 1A-1B, and 3A-3B, [0003] and [0019]), comprising a stent (see Fig. 3A, [0041]) made of a material (see Fig. 3A, wires) with a memory property (see [0041] and [0052], nitinol or a material that needs to return to an expanded form without bulging), the stent consisting of a left disc 205 (see Fig. 3A, [0041], this is a left disc as it is the disc that enters into the left atrium), a right disc 206 (see Fig. 3A, [0041], this is a right disc as it is the disc that remains in the right atrium), wherein both the left disc 205 and the right disc 206 are of a double-layer mesh-shaped structure (see [0012], two layers of braid), and a waist the waist member (see Fig. 3A, [0008] and [0041], a waist has a reduced diameter in comparison to the discs, as the access passage is approximately the size of the waist) that is connected to the left disc 205 and the right disc 206, the occluder (see Figs. 1A-1B and 3A-3B) further comprising a central through hole the hole that allows access through 205 and 206 (see Figs. 3A-3B, [0008] and [0034], unobstructed passageway) that penetrates the left disc 205, the waist the waist member and right disc in sequence (see Figs. 1A-1B and 3A-3B, the hole penetrates through all the listed structures, see also [0060], unobstructed pathway through the braided frame), and a notch the annular ring formed at the center of 205 (see Figs.3A-3B) and a notch the annular ring formed at the center of 206 (see Figs.3A-3B) formed at the centers respective centers of 205 and 206 of the left disc 205 and the right disc 206, after penetration (see response to arguments above, [0008] and [0034], the access passage is formed after penetration of the patch closure, which is the membrane), respectively, wherein the central through hole the hole that allows access through 205 and 206 has a diameter the diameter of the hole that allows access through 205 and 206 close to an inner diameter the inner diameter of the waist which is between 205 and 206, see Fig. 1B for example of a waist member (the diameter of hole is similar to an inner diameter of a waist, therefore is close) of the waist to the greatest extent to ensure that a sheath canal can safely and easily pass through the occluder and enter a left atrium, a membrane patch closure (see [0034] and [0066], see an example of one in Fig. 14, 1402) made of a degradable material (see [0073], the reinforced patch is made with a biodegradable material) is provided inside the central through hole (see [0065], is placed within the access passage through 205 and 206) to block the central through hole the access passage which is the hole that allows access through 205 and 206 from the inside (see [0065]-[0066]) thereof; the layers (see Fig. 14, 1402 has at least one layer, therefore has one to four layers) of the membrane are sewn (see [0072]-[0073], sewn, stitched) in the central through hole (see [0065], is placed within the access passage through 205 and 206) to completely block the central through hole from inside the central through hole, thereby blocking blood from circulating (see [0065], the patch prevents blood from circulating, see [0037], occlusive); the membrane has a sheet shape (see Fig. 14, the patch closure has a circular sheet shape), and has the same cross-sectional shape as the central through hole (see Fig. 14); the central through hole has a circular cross section (see Fig. 14), so the membrane is also circular (see Fig. 14); edges the edge of the annular rings formed at the center of 206 (see Fig. 3A) of the notch the annular rings formed at the center of 206 at the center of the right disc 206 is provided with a plurality of connecting wires the wires that connect to 303 (see Figs. 3A, [0041]) , one end of each of the plurality of connecting wires 200 and each of the wires that connect to 303 (see [0041]) is converged and connected to a delivery component 303 (see Fig. 3A, [0041]), and the other end of each of the plurality of the connecting wires 200 the other end of the wires 303 that connect to the eyelets of the marker bands of 206 is connected to the right disc 206 in a radially extending manner each of the wires extend radially outward from the center point of 303, edges of the notch the circular opening of 205 and the notch the circular opening of 206 at the centers of the left disc 205 and the right disc 206 are both densely woven (the wires of the frames are closely knit as seen in Fig. 3A-3B, hence they are densely woven); a connecting portion 200 (see Fig. 3A-3B, [0041]) of the connecting wire 200 + the wires that lead to 303 with the right disc 206 is an outer layer the outer layer of 206 of the right disc 206 (200 is an outer portion of 206), and the outer layer the outer layer of 206 refers to an outer surface layer the outer layer of 206 in a double-layer structure (see [0012], the discs are made of two layers of braid) of the right disc 206; wherein the delivery component 303 is configured as a wire-clamping steel sleeve 303 is an end screw with wires attached to it and as can be seen in Figs. 3A-3B is a cylindrical tube, hence a sleeve), one end of the delivery component 303 is connected to the connecting wire the portion closer to 206 is where the connecting wires attached as seen in Fig. 3A, the other end of the delivery component 303 is a free end screw end, and the free end screw end is provided with a connecting port screw end, and connected to a delivery system (see [0041], Amplatzer delivery system) so that the occluder the occluder device can be pulled in or pushed out of the sheath canal as a whole (see Figs. 1A-1B and [0041], all collapse and enter the loader/sheath); wherein a number of the connecting wires 200 + wires that lead up to 303 is at most 12 (there are 12 connecting wires), and at least 3, wherein the connecting wires 200 + wires that lead up to 303 are distributed rotatably and symmetrically (see Fig. 3A, the connecting wires are radially distributed, and there are an equal number distributed radially as well, see also Fig. 4A that the wires can be made to be symmetrical) with respect to a delivery component 303, and a gap gaps between the wires through which a puncture sheathing canal (see [0066], device is puncturable) can pass is provided between the adjacent connecting wires 200 + wires that lead up to 303 through the atrial septal occluder the occluder device and enter the left atrium to finish a puncture (see [0066]); the connecting wire 200 + wires that lead up to 303 and the delivery component 303 are connected to each other to ensure that connection (see [0041]) between the occluder the occluder and a delivery system (see [0041], Amplatzer delivery system) is realized, so that the occluder can be pulled in or retracted into the sheath canal (see Figs. 1A-1B and [0041], all collapse and enter the loader/sheath); and the left disc 205, the right disc 206, and the waist the waist member are of an integral mesh-shaped structure (see Fig. 3A, wires); the integral mesh-shaped structure is made by heat setting after integrally weaving the material with the memory property (see Fig. 3A, see [0041], wires, nitinol); the material with the memory property is a memory alloy material (see [0041] and [0052], nitinol or a material that needs to return to an expanded form without bulging), and is a nickel-titanium alloy material (see [0041] and [0052], nitinol or a material that needs to return to an expanded form without bulging); the memory alloy material has a memory function so that the stent the occluder of the occluder (see Fig. 3A) has a morphological memory (see [0041] and [0052], nitinol or a material that needs to return to an expanded form without bulging), and hence is configured to restore to a working morphology (see [0041] and [0052], nitinol or a material that needs to return to an expanded form without bulging) from delivering morphology (see [0041] and [0052], nitinol or a material that needs to return to an expanded form without bulging, when its compressed within the tube); and a mesh-shaped weaving of the waist the waist member is conducive to strengthening its support force and the restoration of memory morphology (see [0041] and [0052], nitinol or a material that needs to return to an expanded form without bulging).
Perszyk does not explicitly disclose: the waist has a length of 2-8mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Perszyk to have the waist to have a length of 2-8mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Perszyk would not operate differently with the waist to have a length of 2-8mm. Further, applicant places no criticality on the range claimed, (see [0051] of applicant’s specification) as they recite that this is a “in a specific embodiment” feature hence not all embodiments require this range to function.
Perszyk teaches that the occluder comprises using nitinol as the material for the integral mesh-shaped structure, but is silent as to the method of forming. The claimed phrase “the integral mesh-shaped structure is made by heat setting after integrally weaving a wire material” is being treated as a product by process limitation; that is, that the occluder is made by heat setting and weaving. 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. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Perszyk is silent as to the process used to make the integral mesh-shaped structure, it appears that the product in Perszyk would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of memory alloy material (such as nitinol) (see instant spec at [0007]).
However, this limitation “a connecting wire integrally woven with the wire material forming the outer layer of the right disc during braiding” is being treated as a product by process limitation; that is, that the connecting wires are made by being woven with the wire material forming the outer layer of the right disc during braiding. 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. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Perszyk is silent as to the process used to weave the connecting wires, it appears that the connecting wire in Perszyk be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a memory alloy material (such as nitinol) (see instant spec at [0007]).
However, Perszyk does not explicitly disclose a weaving density of a reinforced weaving area is 2-5 times as much as that of areas other than the edges to strengthen an ability of the occluder to restore the memory morphology.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Perszyk to have a weaving density of a reinforced weaving area is 2-5 times as much as that of areas other than the edges to strengthen an ability of the occluder to restore the memory morphology since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Perszyk would not operate differently with a weaving density of a reinforced weaving area is 2-5 times as much as that of areas other than the edges to strengthen an ability of the occluder to restore the memory morphology. Further, applicant places no criticality on the range claimed, (see [0016] of applicant’s specification) as they recite that this is a “preferably” feature hence it is not critical but a preference.
Perszyk does not explicitly disclose: the right disc having the same diameter as the left disc.
However, Coyle in a similar field of invention teaches an atrial septal occluder (see Figs. 1-1a) with a right disc 14 or 15 and a left disc 8 (see Figs. 1-1a) and teaches the discs have different diameters in an embodiment. Coyle further teaches in another embodiment: the right disc 15 having the same diameter as the left disc 14 (see Fig. 1, [0029]).
Therefore, it would have been obvious to try, by one of ordinary skill in the art before effective filing date of the invention, to have the right disc and the left disc be the same diameter as seen in Coyle and to incorporate it into the occluder of Perszyk since there are a finite number of identified, predictable potential solutions (i.e., the diameters of the discs being different vs being the same) to the recognized need (the diameters of the discs of an atrial septum occluder) and one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success (choosing the alternates being having the discs be different diameters or the same diameter).
The combination of Perszyk and Coyle does not explicitly teach: the membrane having four layers; wherein the membrane is attached along the entire circumference of the central through hole, and is configured to be puncturable by a sheath canal for a subsequent atrial septal puncture interventional operation.
However, Onorato in a similar field of invention teaches a puncturable atrial septal occluder (see Fig. 4, [0070]) with a puncturable membrane 111 (see Fig. 4, [0018], configured to be perforated) and a central through hole the fenestration through the device (see Fig. 4, [0024]) with a left disc 101 (see Fig. 4) and a right disc 106 (see Fig. 4). Onorato further teaches: the membrane having three layers 111 (see Fig. 4, [0024]); wherein the membrane 111 is attached along the entire circumference (see [0073], the patch is sewn onto the metallic braided mesh that makes up the discs and the waist) of the central through hole (see Fig. 4, 111 is attached along the entire circumference of the through-hole between the discs and the waist), and is configured to be puncturable by a sheath canal for a subsequent atrial septal puncture interventional operation (see [0073]-[0074], sealed when implanted and then puncturable by a physician).
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 Perszyk to incorporate the teachings of Onorato and teach a puncturable atrial septal occluder with the membrane having three layers and wherein the membrane is attached along the entire circumference of the central through hole, and is configured to be puncturable by a sheath canal for a subsequent atrial septal puncture interventional operation. The motivation for such can be found in Onorato as this assists in sealing by creating a layer between both of sides of the atria instantly and providing a surface for better endothelization (see [0073]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have four layers of a membrane instead of three layers of a membrane, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 (VI-B).
Claim 2
The combination of Perszyk, Coyle, and Onorato teaches: The puncturable atrial septal occluder according to claim 1, see 103 rejection above. Perszyk further discloses: wherein the occluder (see Figs. 1A-1B and 3A-3B) has morphological memory (see Fig. 1B, the occluder is compressed in a delivery form and expanded when delivered), with a contraction morphologies (see Fig. 1B, the occluder is compressed in a delivery form and expanded when delivered) and a expansion morphology (see Fig. 3A, delivered state).
Claim 14
The combination of Perszyk, Coyle, and Onorato teaches: The puncturable atrial septal occluder according to claim 1, see 103 rejection above. Perszyk further discloses: the contraction morphology is a strip-shaped morphology (see Figs. 1A-1B and [0041], all collapse and enter the loader/sheath) in which the occluder is compressed into the sheath canal (see Figs. 1A-1B and [0041], all collapse and enter the loader/sheath); the expansion morphology is an “H”-shaped double-disc one-waist morphology after free expansion (see Figs. 1-1a, and Fig. 3A).
Conclusion
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.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771