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 .
Status of Claims
Claims 1-10 and 37 are pending and examined on the merits.
Claim 1 is currently amended.
Claim 37 is new.
Claims 13-14, 16-18, 21-22, 24, and 27-28 are withdrawn for being drawn to non-elected inventions.
Claims 11-12, 15, 19-20, 23, 25-26, and 29-36 are cancelled.
Response to Amendment
Applicant amendments filed 09/11/2025 have been fully considered.
Response to Arguments
Applicant's arguments filed 09/11/2025 have been fully considered but they are not persuasive. Regarding Applicant’s argument that “O’Mahony fails to teach of suggest the subject matter of amended claim 1” (see page 5 of Remarks filed 09/11/2025), Examiner respectfully disagrees. Specifically, as explained in more detail below, under broadest reasonable interpretation (BRI), the main body is considered to be hub 203 and dual lumen section 312, the first position is located on a first side at hub 203 while the second position is located on a second side at dual lumen second 312 (adjacent 314), which is located opposite the first side (see Fig. 22 and Image 1).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Mahony (U.S. Pre Grant Pub. No. 2005/0119597 A1).
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Regarding claim 1, O’Mahony, with reference to Image 1 above, teaches: A bi-directional perfusion cannula (see at least Abstract and catheter 200 in Fig. 13 and para. [0108]) for use in peripheral veno- arterial extracorporeal membrane oxygenation of a patient (see at least Figs. 1-4), the cannula comprising:
a cannula main body (see catheter tube 204 in Fig. 23 and para. [0110]; as broadly recited, the main body includes hub 203 and dual lumen section 312) having a primary lumen (see withdrawal lumen 212 in Fig. 23), the primary lumen leading to a distal end of the cannula main body (see for example Figs. 8 and 23), wherein
the main body further comprises a passage (see infusion lumen 214 in Fig. 23) for passing a second cannula therethrough (at least inherent since cannula 214 is integral with the passage), the passage being oriented such that when a second cannula (a second cannula is considered to be inserted into the main body passage at least because the cannula is integral with infusion lumen 214) is inserted into the passage the second cannula is arranged for providing anterograde blood perfusion (see arrows in Fig. 23), and
wherein the passage enters the main body at a first position on a first side of a side wall (as described above, cannula 214 is integral with the passage and the main body; as shown in Fig. 22, the main body is considered to be hub 203 and dual lumen section 312; therefore, since the passage is integral with the main body, the passage enters the main body at dual lumen section 312 adjacent second 314) of the main body (as shown in Fig. 22 and Image 1, for example, lumens 212 and 214 each originate at hub 203; as broadly recited, the main body comprises hub 203 and dual lumen section 312 and, therefore, lumens 212 and 214 each enter from the side wall of the main body; as broadly recited, sidewall does not necessarily have to be an exterior surface; the hub 203 and dual lumen section 312 of Fig. 22 are considered to be part of the main body and part of the sidewall; therefore, lumen 214 is attached to a side portion of the sidewall of the main body at least because the sidewall does not necessarily have to be an outer wall; as shown in Fig. 22, lumens 212 and 214 initiate at an offset of a centerline and are therefore considered to be attached to a side portion of the sidewall) and leaves the main body at a second position on a second side of the side wall of the main body located opposite the first side (as shown in Fig. 23, lumen 214 exits the main body at port 222 which is located opposite the first side),
the first position and the second position being angularly offset from one another about a projected cross section of the main body (as shown in Figs. 22-23, the lumens 212, 214 directly adjacent hub 203 are angularly offset from port 222 in Fig. 23).
Regarding claim 2, O’Mahony teaches the invention as discussed above in claim 1. However, while O’Mahony fails to explicitly teaches wherein the passage is a preformed channel having a sidewall which leads from the first position to the second position, claim 2 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a passage with a channel having a sidewall which leads from the first position to the second position. Manufacturing steps such as forming a solution, exposing to specific temperatures, solvent casting, cutting, are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
Regarding claim 3, O’Mahony teaches the invention as discussed above in claim 2. Additionally, O’Mahony teaches wherein the preformed channel is attached to the sidewall of the main body along a portion thereof (as shown in Figs. 22-23 and Image 1, lumen 214 extends from hub 203 to port 222 and therefore is attached to the sidewall along a portion of the main body).
Regarding claim 4, O’Mahony teaches the invention as discussed above in claim 3. Additionally, O’Mahony teaches wherein the preformed channel is attached to an upper portion of the sidewall of the main body (as shown in Fig. 22, the channel is attached to the hub 203, which is considered an upper portion of the sidewall of the main body) and the second position is located at a lower portion of the sidewall of the main body (as shown in Fig. 23, the second position is located at port 222, which is considered a lower portion of the sidewall).
Regarding claim 5, O’Mahony teaches the invention as discussed above in claim 3. Additionally, O’Mahony teaches wherein the preformed channel is attached to a side portion of the sidewall of the main body (as broadly recited, and as discussed above, the hub 203 of Fig. 22 is considered to be part of the main body and part of the sidewall; therefore, lumen 214 is attached to a side portion of the sidewall of the main body at least because the sidewall does not necessarily have to be an outer wall; as shown in Fig. 22, lumens 212 and 214 initiate at an offset of a centerline and are therefore considered to be attached to a side portion of the sidewall) and the second position is located at a lower portion of the sidewall of the main body (as shown in Fig. 23, the second position is located at port 222, which is considered a lower portion of the sidewall).
Regarding claim 7, O’Mahony teaches the invention as discussed above in claim 1. Additionally, O’Mahony teaches wherein a distal portion of the main body has a generally circular cross section (as shown in Fig. 23, at the distal portion adjacent numeral 116, the main body has a circular cross section) and a second portion of the main body including the passage has a non-circular cross section (as broadly recited, and as shown in Fig. 23, a cross section at port 222 is non-circular; see also Fig. 15) with at least one protrusion providing an increased cross sectional area compared with the distal portion (as shown in Fig. 22, hub 203 is considered to be a protrusion that provides an increased cross sectional area).
Regarding claim 8, O’Mahony teaches the invention as discussed above in claim 1. Additionally, O’Mahony teaches wherein a distal portion of the main body has a generally circular cross section (as shown in Fig. 23, at the distal portion adjacent numeral 116, the main body has a circular cross section) and a second portion of the main body including the passage has a generally circular cross section (see at least Fig. 14) with the second portion having an increased cross sectional area compared with the distal portion (as broadly recited, Fig. 22 shows portion 312 having a greater cross sectional area that portion 314).
Regarding claim 9, O’Mahony teaches the invention as discussed above in claim 1. Additionally, O’Mahony teaches wherein the passage is within a sidewall of the main body (see at least Fig. 23).
Regarding claim 10, O’Mahony teaches the invention as discussed above in claim 1. Additionally, O’Mahony teaches wherein the main body has through holes on either side of the main body (as broadly recited, hub 203 in Fig. 22 is considered to be part of the main body; hub 203 comprises through holes on the proximal and distal sides that are offset from a center line; see Image 1), the through holes each including a seal and providing the passage for the second cannula therethrough (as shown in Fig. 14, septum 210 is considered to be the seal; as shown in Fig. 22, the seal extends through the hub 203; therefore, as broadly recited, the through holes each include a seal and provide passage for the second cannula; see Image 1).
Regarding claim 37, O’Mahony teaches the invention as discussed above in claim 1. Additionally, O’Mahony teaches wherein the first position is located on an external surface of the first side of the side wall of the main body (the claim does not necessarily give direction as to where the external surface is or what it is external of; therefore, the external surface is considered to be a surface that is away from the center of an object; as shown in Fig. 22, the passage originates at a location in the hub 203 that is off-centered, therefore, it is considered to be an external surface).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over O’Mahony (U.S. Pre Grant Pub. No. 2005/0119597 A1) in view of Navia (U.S. Patent No. 6,626,872 B1).
Regarding claim 6, O’Mahony teaches the invention as discussed above in claim 1. However, O’Mahony fails to explicitly teach wherein the passage is terminated by a seal, as required by the claim.
Navia teaches an analogous perfusion cannula (see Abstract) comprising a port 50 at an end of a distal shaft section 14 and a lumen 51 that extends within the distal shaft section 14 (see col. 6, lines 25-47). As broadly recited, the port 50 of Navia is considered to be a seal at least because the port allows lumen 51 to extend through the distal shaft section 14 (see Fig. 9).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Mahony to incorporate the teachings of Navia by terminating the passage by a port that act like a seal at least in order to provide a shunt within a human blood vessel to allow blood or perfusion fluid flow through the distal shaft section 14, as taught by Navia (see col. 6, lines 35-37).
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 JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/SARAH AL HASHIMI/ Supervisory Patent Examiner, Art Unit 3781