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
In response to the amendment filed on 02/24/2025, Claims 20-45 have been cancelled, and Claims 1-19 are pending.
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.
Claim(s) 1-5, 8-10, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vale (US PGPub 2021/0275197) in view of Fuller (US PGPub 2017/0252043)
Regarding Claim 1, Vale teaches a medical device (100; Figures and Figure 9A-9B), comprising:
an elongate shaft comprising a distal end (115; Figure 5 and Figure 9B; Paragraph 0077); and
an expandable funnel (200; Figure 5 and Figure 9B) disposed at or near the distal end (Figure 5 and Figure 9B; Paragraph 0077), the funnel (200) comprising a compliant material (118 cover; Paragraph 0084; Figure 5 and 9B) and at least one imaging marker (68) disposed on the compliant material (118; Paragraph 0107) .
Vale fails to teach that the imaging marker is disposed or encapsulated within the compliant material.
Fuller teaches a guide extension catheter comprising an elongate shaft (16; Figure 3) and an expandable tip (26; Figure 3), the expandable tip (26) comprising a compliant material (30; Paragraph 0074), wherein the compliant material (30) can be loaded with a radiopaque material (Paragraph 0074; thus would be encapsulated within the compliant material) and Fuller clearly teaches that the radiopaque marker (35; Figure 3) can be embedded in the body portion (30; Paragraph 0075).
It would have been obvious to one of ordinary skill in the art to modify the placement of the imaging marker of Vale, to be embedded within the compliant material, as taught by Fuller, for the advantage of avoiding catching the metallic radiopaque marker on tissue that the funnel portion has expanded upon. Furthermore, embedding the radiopaque marker allows for a smooth surface on the outer surface of the funnel portion.
Regarding Claim 2, the combination of references disclosed above teaches the medical device of claim 1, wherein Vale teaches further comprising a funnel frame (112; Figure 9B) disposed within the compliant material (118; Figure 9B; Paragraph 0084).
Regarding Claim 3, the combination of references disclosed above teaches the medical device of claim 1, wherein Fuller teaches the at least one imaging marker (35) is supported only by the compliant material (30; Figure 3; Paragraph 0074-0075).
Regarding Claim 4, the combination of references disclosed above teaches the medical device of claim 2, wherein Fuller teaches the at least one imaging marker (35) is supported only by the compliant material (30) and not by the frame (35) (Figure 3; Paragraph 0074-0075). The examiner notes that the combination would make it so that the imaging marker is not on the funnel frame of Vale.)
Regarding Claim 5, the combination of references disclosed above teaches the device of claim 1, wherein Vale teaches the at least one imaging marker (68; Figure 9B) comprises a radiopaque material (Paragraph 0107).
Regarding Claim 8, the combination of references disclosed above teaches the device of claim 1, wherein Vale teaches the funnel frame (112) comprises a shape memory material (Paragraph 0092).
Regarding Claim 9, the combination of references disclosed above teaches the device of claim 1, wherein Vale teaches the funnel frame (112) includes a distal end arranged in a chevron pattern (at element 215 is V shaped like the chevron pattern; Figure 9C).
Regarding Claim 10, the combination of references disclosed above teaches the device of claim 9, wherein Vale teaches the at least one imaging marker (68) is disposed around at least one segment of the chevron pattern (near element 215; Figure 9C; see also Figure 8).
Regarding Claim 12, the combination of references disclosed above teaches the device of claim 2, wherein Fuller teaches the at least one imaging marker (35) comprises a plurality of imaging markers (Paragraph 0075) embedded in the compliant material (30) at least partially distal to the funnel frame (30) (Paragraph 0075).
Regarding Claim 13, the combination of references disclosed above teaches the device of claim 1, wherein Vale teaches the at least one imaging marker (68) is arranged generally along a longitudinal axis of the medical device (Figure 9B).
Claim(s) 6 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vale (US PGPub 2021/0275197) in view of Fuller (US PGPub 2017/0252043) as applied to claim 1 above, and further in view of Mintz (US PGPub 2022/0175404).
Regarding Claim 6, the combination of references disclosed above teaches the device of claim 1, but fails to disclose wherein the at least one imaging marker comprises platinum iridium.
Mintz teaches a catheter with a radiopaque expandable member (Figure 2) which has a radiopaque marker (21; Figure 2) which is formed of platinum-iridium.
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the materials of the imaging markers of the combination of references using the materials as taught by Mintz, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 19, the combination of references disclosed above teaches the device of claim 1, wherein the one or more imaging markers are flat sheets (Figure 9B; Paragraph 0107) but fails to disclose wherein the one or more imaging markers are formed from a flat sheet of a Pt-Ir material.
Mintz teaches a catheter with a radiopaque expandable member (Figure 2) which has a radiopaque marker (21; Figure 2) which is formed of a sheet of platinum-iridium.
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the materials of the imaging markers of the combination of references using the materials as taught by Mintz, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Claim(s) 7 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vale (US PGPub 2021/0275197) in view of Fuller (US PGPub 2017/0252043) as applied to claim 1 and 2 above, and further in view of Butaric (US PGPub 2002/0058984)
Regarding Claim 7, the combination of references disclosed above teaches the device of claim 2, but fails to disclose wherein the at least one imaging marker comprises a coil, wherein the coil is wound around at least a portion of the funnel frame.
Butaric teaches a medical device (10) having a frame (12; Paragraph 0084; Figure 2), and at least one imaging marker (15; Figure 2; Paragraph 0084) comprises a coil (15; Figure 2), wherein the coil is wound around at least a portion of the frame (12; Figure 2; Paragraph 0084).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the imaging markers taught by the combination of references disclosed above with the coiled radiopaque markers taught by Butaric since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the coil markers of Butaric would be sufficient to visualize the distal end of the funnel frame of the combination of references.
Regarding Claim 11, the combination of references disclosed above teaches the device of claim 1, but fails to disclose wherein the at least one imaging marker comprises a circumferential coil disposed near a distal end of the funnel.
Butaric teaches a medical device (10) having a frame (12; Paragraph 0084; Figure 2), and at least one imaging marker (15; Figure 2; Paragraph 0084) comprises a circumferential coil (15; Figure 2), wherein the coil is wound at least partially circumferentially around a portion of the frame (12; Figure 2; Paragraph 0084).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the imaging markers taught by the combination of references disclosed above with the coiled radiopaque markers taught by Butaric since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the coil markers of Butaric would be sufficient to visualize the distal end of the funnel frame of the combination of references.
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vale (US PGPub 2021/0275197) in view of Fuller (US PGPub 2017/0252043) as applied to claim 1 above, and further in view of Bishara (US PGPub 2020/0046422).
Regarding Claim 14, the combination of references disclosed above teaches the device of claim 1, wherein the at least one imaging marker includes one or more axial flexibility features configured to improve or increase an axial flexibility of the at least one imaging marker.
Bishara teaches a medical device comprising imaging markers (231b; Figure 8) which includes one or more axial flexibility features configured to improve or increase an axial flexibility of the at least one imaging marker (Paragraph 0402 discloses serpentine configurations which allow for increased flexiblilty; see Figure 8 provided below).
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Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the imaging markers taught by the combination of references disclosed above with the coiled radiopaque markers taught by Bishara since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the serpentine markers of Bishara would be sufficient to visualize the distal end of the funnel frame of the combination of references and would provide the added advantage of making the markers have increased flexibility (Paragraph 0402; Bishara)
Regarding Claim 15, the combination of references disclosed above teaches the device of claim 14, wherein Bishara teaches the one or more axial flexibility features (231C) comprises a slit or cutout that is orthogonal to a longitudinal axis of the medical device (the slits are the empty portions of the serpentine sections; see Figure 8 and Paragraph 0402; furthermore the examine notes that a slit or cutout may be treated as a product by process claim in which the final product still has a space that is considered the cutout/slit).
Regarding Claim 16, the combination of references disclosed above teaches the device of claim 1, but fails to disclose wherein the one or more imaging markers comprise a serpentine pattern.
Bishara teaches a medical device comprising imaging markers (231a-231j; Figure 8) comprise a serpentine pattern (Paragraph 0402 discloses serpentine configurations which allow for increased flexibility; see Figure 8 provided below).
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Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute the imaging markers taught by the combination of references disclosed above with the coiled radiopaque markers taught by Bishara since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the serpentine markers of Bishara would be sufficient to visualize the distal end of the funnel frame of the combination of references and would provide the added advantage of making the markers have increased flexibility (Paragraph 0402; Bishara)
Regarding Claim 17, the combination of references disclosed above teaches the device of claim 16, wherein Bishara teaches the serpentine pattern (231a a-c) includes gaps between the serpentine pattern than are generally orthogonal to a longitudinal axis of the one or more imaging markers (231a-c; Figure 8; Paragraph 0402).
Regarding Claim 18, the combination of references disclosed above teaches the device of claim 16, wherein Bishara teaches the serpentine pattern (231c) does not include any free ends (furthermore, it appears from Applicants on Figure 8D that there are free ends 28. The Examiner suggests amending this limitation to recite that the ends of the serpentine pattern form two eyelets or any other language that is supported by the specification).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
