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 .
Claim Rejections - 35 USC § 102
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.
(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.
Claims 1, 2, 5 – 9, 11, 16, and 18 – 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morin et al (US 2022/0280166 A1).
Regarding claim 1, Morin discloses, a medical device (medical device 10 / medical device of annotated Fig. 32A) for occluding a left atrial appendage (“LAA”) (abstract, paragraphs [0005], [0050], [0053 – 0055], and Figs. 25A, 28A, 32A), the medical device comprising:
a proximal disk (designated in the first iteration of annotated Fig. 32A) configured to cover an ostium of the LAA in an implanted condition of the medical device (Examiner’s note: the designated structure is capable of performing the function claimed, therefore, it is said that the designated structure is configured as claimed);
a distal lobe (designated in the first iteration of annotated Fig. 32A) configured to be received within a cavity of the LAA in the implanted condition of the medical device (Examiner’s note: the designated structure is capable of performing the function claimed, therefore, it is said that the designated structure is configured as claimed);
a connecting member (designated in the first iteration of annotated Fig. 32A) connecting the proximal disk to the distal lobe (see the first iteration of annotated Fig. 32A);
a first group of stabilizing members (some of the stabilizing members 200, designated in the first iteration of annotated Fig. 32A), each stabilizing member in the first group having a first engagement feature (tip of each designated stabilizing members) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (paragraphs [0044], [0047 – 0048], [0053], [0055], [0063], and [0088]); and
a second group of stabilizing members (some of the stabilizing members 200, designated in the first iteration of annotated Fig. 32A), each stabilizing member in the second group having a second engagement feature (tip of each designated stabilizing members) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (paragraphs [0044], [0047 – 0048], [0053], [0055], [0063], and [0088]),
wherein in an unbiased condition (condition shown in Fig. 32A) of the medical device, the distal lobe has an axial length (total length of the dotted line – extending parallel with the medical device – shown in the first iteration of annotated Fig. 32A) extending between a proximal face and a distal face of the distal lobe (see the first iteration of annotated Fig. 32A), the second engagement features of the stabilizing members in the second group being positioned at least 33% of the axial length beyond the proximal face of the distal lobe (Examiner’s note: as shown in the first iteration of annotated Fig. 32A, the length of the distal lobe is 12 ‘dashes’ long, and is divided equally into thirds; further, each of the second engagement features (i.e., the tips of the designated second stabilizers) is at least positioned between about 33% and 50% of the length from the proximal face),
the first engagement features of the stabilizing members in the first group being positioned distal to the second engagement features of the stabilizing members in the second group (see the first iteration of annotated Fig. 32A).
Annotated Figure 32A of Morin
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Regarding claim 2, Morin discloses wherein the second engagement features (tips of the designated second stabilizers) of the stabilizing members in the second group are positioned between about 33% and about 55% of the axial length beyond the proximal face of the distal lobe (Examiner’s note: as shown in the first iteration of annotated Fig. 32A, the length of the distal lobe is 12 ‘dashes’ long, and is divided equally into thirds; further, each of the second engagement features (i.e., the tips of the designated second stabilizers) is at least positioned between about 33% and 50% of the length from the proximal face).
Regarding claim 5, Morin discloses wherein each stabilizing member in the first group is positioned between a pair of stabilizing members in the second group (see the first iteration of annotated Fig. 32A) (Examiner’s note: each of the designated stabilizing members in first group is between the designated stabilizing members in the second group radially about the circumference).
Regarding claim 6, Morin discloses wherein each stabilizing member in the first group is substantially identical in structure to each stabilizing member in the second group (see the first iteration of annotated Fig. 32A).
Regarding claim 7, Morin discloses wherein each stabilizing member in the first group has an axial length that is equal to or longer than an axial length of each stabilizing member in the second group (Examiner’s note: the axial length of each stabilizing member is equal).
Regarding claim 8, Morin discloses wherein a total number of the stabilizing members in the first group is equal to a total number of stabilizing members in the second group (see the first iteration of annotated Fig. 32A).
Regarding claim 9, Morin discloses wherein a spacing between each adjacent pair of stabilizing members is substantially equal (Examiner’s note: the term “substantially” is a broad term and nonspecific to the exact spacing between each adjacent pair of stabilizing members. With that said, the adjacent pairs of the designated stabilizing members in the first iteration of annotated Fig. 32A are considered to be substantially equally spaced).
Regarding claim 11, Morin discloses a medical device (medical device 10 / medical device of annotated Fig. 32A) for occluding a left atrial appendage (“LAA”) (abstract, paragraphs [0005], [0050], [0053 – 0055], and Figs. 25A, 28A, 32A), the medical device comprising:
a proximal disk (designated in the second iteration of annotated Fig. 32A) configured to cover an ostium of the LAA in an implanted condition of the medical device (Examiner’s note: the designated structure is capable of performing the function claimed, therefore, it is said that the designated structure is configured as claimed);
a distal lobe (designated in the second iteration of annotated Fig. 32A) configured to be received within a cavity of the LAA in the implanted condition of the medical device (Examiner’s note: the designated structure is capable of performing the function claimed, therefore, it is said that the designated structure is configured as claimed);
a connecting member (designated in the second iteration of annotated Fig. 32A) connecting the proximal disk to the distal lobe (see the second iteration of annotated Fig. 32A);
a first group of stabilizing members (group of stabilizers 200 as designated in the second iteration of annotated Fig. 32A), each stabilizing member in the first group having a first engagement feature (distal tip of each stabilizing member) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (paragraphs [0044], [0047 – 0048], [0053], [0055], [0063], and [0088]); and
a second group of stabilizing members (group of stabilizers 200 as designated in the second iteration of annotated Fig. 32A), each stabilizing member in the second group having a second engagement feature (distal tip of each stabilizing member) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (paragraphs [0044], [0047 – 0048], [0053], [0055], [0063], and [0088]); and
a third group of stabilizing members (group of stabilizers 200 as designated in the second iteration of annotated Fig. 32A), each stabilizing member in the third group having a third engagement feature (distal tip of each stabilizing member) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (paragraphs [0044], [0047 – 0048], [0053], [0055], [0063], and [0088]),
wherein in an unbiased condition of the medical device, the distal lobe has an axial length (designated in the second iteration of annotated Fig. 32A) extending between a proximal face and a distal face of the distal lobe (see the second iteration of annotated Fig. 32A), the first engagement features are positioned at a first distance along the axial length, the second engagement features are positioned at a second distance along the axial length, and the third engagement features are positioned at a third distance along the axial length, the first distance being different than the second distance, the second distance being different than the third distance, the third distance being different than the first distance (Examiner’s note: as shown in the second iteration of annotated Fig. 32A each of the groups is positioned at a different length from the proximal face in the axial direction).
Annotated Figure 32A of Morin
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Regarding claim 16, Morin discloses wherein the medical device includes a total number of stabilizing members (four) in the first group that is twice as many as a total number of stabilizing members (two) in the second group and that is twice as many as a total number of stabilizing members (two) in the third group (see second iteration of annotated Fig. 32A).
Regarding claim 18, Morin discloses wherein each stabilizing member is separate from the other stabilizing members, wherein each group of stabilizing members comprises more than one stabilizing member, and wherein each stabilizing member is connected to the distal lobe (see second iteration of annotated Fig. 32A).
Regarding claim 19, Morin discloses wherein each stabilizing member in the first, second, and third groups is either (i) formed of a wire (paragraph [0048] and [0057]) or (ii) cut from a sheet of material (paragraph [0060]).
Regarding claim 20, Morin discloses wherein each first engagement feature, each second engagement feature, and each third engagement feature is a hook (paragraph [0063] and Fig. 32A).
Claims 1, 2, 5 – 9, 11, 16 – 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al (CN 116077125 A) (translated PDF version attached).
Regarding claim 1, Wang discloses a medical device for occluding a left atrial appendage (“LAA”) (abstract, page 2, and Figs. 1, 2), the medical device comprising:
a proximal disk (cover member 300 and designated in the first iteration of annotated Fig. 1) configured to cover an ostium of the LAA in an implanted condition of the medical device (Fig. 2);
a distal lobe (anchoring piece 100 and designated in the first iteration of annotated Fig. 1) configured to be received within a cavity of the LAA in the implanted condition of the medical device (Fig. 2);
a connecting member (adjusting member 200 and designated in the first iteration of annotated Fig. 1) connecting the proximal disk to the distal lobe;
a first group of stabilizing members (some of the barbs 100 designated in the first iteration of annotated Fig. 1), each stabilizing member in the first group having a first engagement feature (tip of the barb) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (page 5 and Fig. 2); and
a second group of stabilizing members (some of the barbs 100 designated in the first iteration of annotated Fig. 1), each stabilizing member in the second group having a second engagement feature (tips of the barbs) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (page 5 and Fig. 2),
wherein in an unbiased condition of the medical device (configuration shown in Fig. 1), the distal lobe has an axial length extending between a proximal face and a distal face of the distal lobe (see the first iteration of annotated Fig. 1), the second engagement features of the stabilizing members in the second group being positioned at least 33% of the axial length beyond the proximal face of the distal lobe (Examiner’s note: as shown in the first iteration of annotated Fig. 1 the second group of stabilizing members are positioned at near 50% of the axial length), the first engagement features of the stabilizing members in the first group being positioned distal to the second engagement features of the stabilizing members in the second group (see the first iteration of annotated Fig. 1).
Annotated Figure 1 of Wang
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Regarding claim 2, Wang discloses wherein the second engagement features of the stabilizing members in the second group are positioned between about 33% and about 55% of the axial length beyond the proximal face of the distal lobe (Examiner’s note: as shown in the first iteration of annotated Fig. 1, the second group of stabilizing members, and their engagement features, are positioned at about 50% of the length, therefore, they are within the claimed range).
Regarding claim 5, Wang discloses wherein each stabilizing member in the first group is positioned between a pair of stabilizing members in the second group (see the first iteration of annotated Fig. 1).
Regarding claim 6, Wang discloses wherein each stabilizing member in the first group is substantially identical in structure to each stabilizing member in the second group (see the first iteration of annotated Fig. 1).
Regarding claim 7, Wang discloses wherein each stabilizing member in the first group has an axial length that is equal to or longer than an axial length of each stabilizing member in the second group (see the first iteration of annotated Fig. 1).
Regarding claim 8, Wang discloses wherein a total number of the stabilizing members (two) in the first group is equal to a total number of stabilizing members (two) in the second group (see the first iteration of annotated Fig. 1).
Regarding claim 9, Wang discloses wherein a spacing between each adjacent pair of stabilizing members is substantially equal (see the first iteration of annotated Fig. 1).
Regarding claim 11, Wang discloses a medical device for occluding a left atrial appendage (“LAA”) (abstract, page 2, and Figs. 1, 2), the medical device comprising:
a proximal disk (cover member 300 and designated in the second iteration of annotated Fig. 1) configured to cover an ostium of the LAA in an implanted condition of the medical device (Fig. 2);
a distal lobe (anchoring piece 100 and designated in the second iteration of annotated Fig. 1) configured to be received within a cavity of the LAA in the implanted condition of the medical device (Fig. 2);
a connecting member (adjusting member 200 and designated in the second iteration of annotated Fig. 1) connecting the proximal disk to the distal lobe;
a first group of stabilizing members (every other barb 101 in the bottom row, such that there are a total of 4, designated in the second iteration of annotated Fig. 1), each stabilizing member in the first group having a first engagement feature (tip of the barb) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (page 5 and Fig. 2); and
a second group of stabilizing members (two of the barbs 101 designated in the second iteration of annotated Fig. 1), each stabilizing member in the second group having a second engagement feature (tips of the barbs) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (page 5 and Fig. 2); and
a third group of stabilizing members (two of the barbs 101 designated in the second iteration of annotated Fig. 1), each stabilizing member in the third group having a third engagement feature (tips of the barbs) configured to engage tissue surrounding the LAA in the implanted condition of the medical device (page 5 and Fig. 2),
wherein in an unbiased condition of the medical device (configuration shown in Fig. 1), the distal lobe has an axial length extending between a proximal face and a distal face of the distal lobe (see the first iteration of annotated Fig. 1), the first engagement features are positioned at a first distance along the axial length, the second engagement features are positioned at a second distance along the axial length, and the third engagement features are positioned at a third distance along the axial length, the first distance being different than the second distance, the second distance being different than the third distance, the third distance being different than the first distance (Examiner’s note: as shown in the second iteration of annotated Fig. 1 each of the groups of stabilizing members are at a different length from the proximal face).
Annotated Figure 1 of Wang
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Regarding claim 16, Wang discloses, wherein the medical device includes a total number of stabilizing members (four) in the first group that is twice as many as a total number of stabilizing members (two) in the second group and that is twice as many as a total number of stabilizing members (two) in the third group (see the second iteration of annotated Fig. 1).
Regarding claim 17, Wang discloses wherein a single stabilizing member in either the second group or the third group is positioned between each circumferentially adjacent pair of stabilizing members in the first group (Examiner’s note: each of the stabilizing members in the second and third group are circumferentially between adjacent pairs in the first group as shown in the second iteration of annotated Fig. 1).
Regarding claim 18, Wang discloses wherein each stabilizing member is separate from the other stabilizing members, wherein each group of stabilizing members comprises more than one stabilizing member, and wherein each stabilizing member is connected to the distal lobe (see the second iteration of annotated Fig. 1).
Regarding claim 20, Wang discloses wherein each first engagement feature, each second engagement feature, and each third engagement feature is a hook (Examiner’s note: the barbs 101 / the designated stabilizing members form hooks).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 3, 4, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Morin et al (US 2022/0280166 A1) as applied to claims 1 and 11 above, and further in view of Melanson et al (US 2021/0393271 A1).
Regarding claims 3, 4, and 12, as discussed above, Morin discloses the second engagement features of the stabilizing members being placed within 33% and 55% of the axial length of the distal lobe from the proximal face of the distal lobe (as shown in the first iteration of annotated Fig. 32A).
However, Morin is silent regarding (i) the axial length being [claim 3] about 7.5 mm wherein the second engagement features are positioned between 3.0 mm to 4.0 mm beyond the proximal face of the distal lobe or [claims 4 and 12] about 10mm wherein the second engagement features are positioned between 3.75 mm to 5.25 mm beyond the proximal face of the distal lobe.
As to the above, Melanson teaches, in the same field of endeavor, a medical device (medical device 10 – Fig. 35) for occluding a left atrial appendage (abstract) comprising a distal lobe (medical device 10; which equates to the distal lobe of Morin) has a diameter of 5 to 50 mm and an axial length equal to the diameter, such that the axial length is between 5 to 50 mm (paragraph [0159]). Melanson teaches overlapping ranges encompassing the claimed range. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
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 axial length of the distal lobe of the device of Morin to encompass the claimed range, based on the teachings of Melonson, as the claimed length range is a known length for a left atrial appendage occluder, as one of ordinary skill in the art would have a reasonable expectation of success in choosing an axial length of 7.5mm and/or 10mm, and the modification would be predictable and would result in the device being operable as intended.
Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the axial length of the distal lobe of Morin to be 7.5 mm and, alternatively, 10mm 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 Morin would not operate differently with the claimed diameter and since distal lobe is intended to reside within the left atrial appendage the device would function appropriately having the claimed length(s).
It should be understood that with the axial length being 7.5 mm, because the second engagement features of Morin are disclosed as being between 33% and 55% of the axial length (shown in the first iteration of annotated Fig. 32A), the modified device would encompass or, in the alternative, make obvious wherein the second engagement features are located at a position between 33% of 7.5 mm = 2.475 mm and 55% of 7.5 mm = 4.125 mm; and 2.475 mm is about 3 mm and 4.125 is about 4.0 mm. In addition to the above, it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed range from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05. Therefore, the combination encompasses or, in the alternative, makes obvious the distal lobe having the claimed axial length with the second engagement features being placed within the claimed axial position ranges.
Furthermore, it should be understood that with the axial length being 10 mm, because the second engagement features of Morin are disclosed as being between 33% and 55% of the axial length (shown in the first iteration of annotated Fig. 32A), the modified device would encompass or, in the alternative, make obvious wherein the second engagement features are located at a position between 33% of 10 mm = 3.3 mm and 55% of 10 mm = 5.5 mm; and 3.3 mm is about 3.75 mm and 5.5 is about 5.25 mm. In addition to the above, it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed range from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05. Therefore, the combination encompasses or, in the alternative, makes obvious the distal lobe having the claimed axial length with the second engagement features being placed within the claimed axial position ranges.
Annotated Figure 32A of Morin
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Claims 3, 4, and 12 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (CN 116077125 A) (translated PDF version attached) as applied to claims 1 and 11 above, and further in view of Melanson et al (US 2021/0393271 A1).
Regarding claims 3 and 4, as discussed above, Wang discloses the second engagement features of the stabilizing members being placed at about 50% of the axial length of the distal lobe from the proximal face of the distal lobe (as shown in the first iteration of annotated Fig. 1).
However, Wang is silent regarding (i) the axial length being [claim 3] about 7.5 mm wherein the second engagement features are positioned between 3.0 mm to 4.0 mm beyond the proximal face of the distal lobe or [claim 4] about 10mm wherein the second engagement features are positioned between 3.75 mm to 5.25 mm beyond the proximal face of the distal lobe.
As to the above, Melanson teaches, in the same field of endeavor, a medical device (medical device 10 – Fig. 35) for occluding a left atrial appendage (abstract) comprising a distal lobe (medical device 10; which equates to the distal lobe of Wang) has a diameter of 5 to 50 mm and an axial length equal to the diameter, such that the axial length is between 5 to 50 mm (paragraph [0159]). Melanson teaches overlapping ranges encompassing the claimed range. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
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 axial length of the distal lobe of the device of Wang to encompass the claimed range, based on the teachings of Wang, as the claimed length range is a known length for a left atrial appendage occluder, as one of ordinary skill in the art would have a reasonable expectation of success in choosing an axial length of 7.5mm and/or 10mm, and the modification would be predictable and would result in the device being operable as intended.
Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the axial length of the distal lobe of Wang to be 7.5 mm and, alternatively, 10mm 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 Wang would not operate differently with the claimed diameter and since distal lobe is intended to reside within the left atrial appendage the device would function appropriately having the claimed length(s).
It should be understood that with the axial length being 7.5 mm, because the second engagement features of Wang are disclosed as being at about 50% of the axial length of the distal lobe (shown in the first iteration of annotated Fig. 1), as shown in the first iteration of the annotated Fig. 1, the modified device would encompass or, in the alternative, make obvious wherein the second engagement features are located at a position of about 50% of 7.5 mm = about 3.75 mm; and a position of about 3.75 mm is within the claimed range.
Furthermore, it should be understood that with the axial length being 10 mm, because the second engagement features of Wang are disclosed as being at about 50% of the axial length of the distal lobe (shown in the first iteration of annotated Fig. 1), as shown in the first iteration of the annotated Fig. 1, the modified device would encompass or, in the alternative, make obvious wherein the second engagement features are located at a position of about 50% of 10 mm = about 5 mm; and a position of about 5 mm is within the claimed range. Therefore, the combination encompasses or, in the alternative, makes obvious the distal lobe having the claimed axial length with the second engagement features being placed within the claimed axial position ranges.
Annotated Figure 1 of Wang
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Regarding claim 10, as discussed above, Wang discloses the left atrial appendage occluder of claim 1. Additionally, Wang discloses, in Fig. 10, wherein the stabilizing members (in each group) extends fully around the circumference.
However, Wang is silent regarding (i) the number of stabilizing members a single row extending circumferentially around the distal lobe and (ii) wherein a radial spacing between each adjacent pair of stabilizing members is between about 20 degrees and about 65 degrees.
As to the above, Melanson teaches, in the same field of endeavor, a medical device (medical device 3000 – Fig. 85C) for occluding a left atrial appendage (abstract) comprising a distal lobe (medical device 3000; which equates to the distal lobe of Wang) comprising a first group of stabilizing members (anchors 3094; which equate to the barbs of the first group of stabilizing members of Wang) and a second group of stabilizing members (anchors 3090; which equate to the barbs of the second group of stabilizing members of Wang) wherein each group has 14 anchors uniformly spaced around the circumference, such that the radial spacing between adjacent pairs is 3600 / 14 = 25.7 degrees (paragraphs [0322 – 0332]).
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 each of the circumferential rows of barbs of Wang to incorporate 14 barbs, based on the teachings of Melanson, for the purpose of effectively being able to anchor the distal lobe into the ostium.
With respect to (ii), it should be understood that each barb in each row of barbs is evenly spaced 25.7 degrees apart from the adjacent barb; and because the Examiner has designated the stabilizing members in each group to be alternating / every other one, the spacing between the designated adjacent stabilizing member in each group would be 25.7X2 = 51.4 degrees. Therefore, the modification above encompasses limitations as claimed.
Regarding claims 12, 13, 14, and 15, as discussed above, Wang discloses the stabilizing members being placed at the relative axial positions in relation to the axial length of the distal lobe (as shown in the second iteration of annotated Fig. 1).
However, Wang is silent regarding (i) [claim 12] the axial length being about 10 mm, (ii) [claim 13] wherein the first distance is between about 8 mm and about 10 mm, such that the first engagement features are positioned between about 0 mm and about 2 mm proximally of the distal face of the distal lobe, (iii) [claim 14] wherein the second distance is between about 3.3 mm and about 4.3 mm, and (iv) [claim 15] wherein the third distance is between about 4.4 mm and about 5.4 mm.
As to the above, Melanson teaches, in the same field of endeavor, a medical device (medical device 10 – Fig. 35) for occluding a left atrial appendage (abstract) comprising a distal lobe (medical device 10; which equates to the distal lobe of Wang) has a diameter of 5 to 50 mm and an axial length equal to the diameter, such that the axial length is between 5 to 50 mm (paragraph [0159]). Melanson teaches overlapping ranges encompassing the claimed range. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
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 axial length of the distal lobe of the device of Wang to encompass the claimed range, based on the teachings of Wang, as the claimed length range is a known length for a left atrial appendage occluder, as one of ordinary skill in the art would have a reasonable expectation of success in choosing an axial length of 10mm, and the modification would be predictable and would result in the device being operable as intended.
Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the axial length of the distal lobe of Wang to be 10mm 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 Wang would not operate differently with the claimed diameter and since distal lobe is intended to reside within the left atrial appendage the device would function appropriately having the claimed length(s).
It should be understood that with the axial length being 10 mm (as shown in the second iteration of annotated Fig. 1), the first length is within the range of 7.5mm to 10mm (about 8.75mm) from the proximal face such that the first engagement features are positioned between 0mm and 2mm (about 1.25mm) from the distal face, the second length is around 2.5mm which is about 3.4mm and thus is within the claimed range of about 3.3mm to about 4.3mm, and the third length is around 5mm which is in the claimed range of about 4.4mm to about 5.4mm. The term “about” is broad and encompasses a range of surrounding values.
Annotated Figure 1 of Wang
(second iteration)
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Related Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Quick et al (US 2014/0005714 A1) and Amplatz et al (US 2017/0119400 A1) teach LAA occluders with multiple groups of stabilizing members.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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