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 30-47 are currently pending. Claims 1-29 are currently cancelled. Claims 20 and 42 are currently amended. No new subject matter added.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/29/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim 30-47 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claims 30-47 are now rejected under 103 in view of Shaffer et al. (US 20180353194 A1) and Jordan (US 8366694 B1).
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. p
Claims 30-35 and 38-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaffer et al. (US 20180353194 A1), hereinafter referred to as “Shaffer” in view of Jordan (US 8366694 B1).
Regarding Claim 30, Shaffer teaches a system for treating clot material in the vasculature of a patient (see Abstract; Figure 1), the system comprising:
a catheter defining a lumen and having a distal end portion, wherein the catheter is configured to be intravascularly advanced through the vasculature of the patient such that the distal end portion of the catheter is positioned proximate to the clot material (the vacuum systems can find use with any thrombectomy, embolectomy, atherectomy, or other catheter or probe system where blood and clot are withdrawn wholly or partially by application of a vacuum to the proximal end of any reperfusion catheter, aspiration catheter or probe for the purpose of clot extraction, see Paragraph [0011]);
an aspiration source (vacuum console 42 having a pump 68);
a canister defining a volume (collection canister 44, see Figure 4) and having an aspiration port (connector 110), a vacuum port (a vacuum port 102 extends upwardly through a much larger lumen or tube and terminates in an open aperture 108 at its upper end, see Paragraph [0039]), and
wherein the aspiration port and the vacuum port each define a fluid path from the volume to outside the volume (aperture 108 and connector 110 will be exposed to the interior of the canister 44 but will be maintained well above the mid-section and bottom where the clot and blood are collecting, see Paragraph [0039]; Figure 4);
the aspiration port is configured to fluidly coupled the catheter to the volume (a connector 110 which is attached to a proximal end of the catheter see Paragraph [0040]),
the vacuum port is configured to fluidly coupled the aspiration source to the volume (the clot and blood are drawn into the interior of the main body 78 by the vacuum which is drawn through the vacuum port 102 by the vacuum console 42, see Paragraph [0040]),
the aspiration source is positioned outside the volume (vacuum console 42 being located outside of canister 44, see Figure 2) and configured to generate vacuum pressure in the volume via the vacuum port to aspirate at least a portion of the clot material and blood into the volume through the lumen of the catheter and the aspiration port (the clot and blood are drawn into the interior of the main body 78 by the vacuum which is drawn through the vacuum port 102 by the vacuum console 42, as previously described, see Paragraph [0040]);
a filter positioned within the canister (filter plate 86 within canister 44, see Figure 4), wherein the filter is configured to filter the blood from the portion of the clot material (the clot collects on the upper surface of the filter plate 86 while the blood flows through the perforations in the plate and collects in the bottom of the canister, see Paragraph [0040]).
However Shaffer does not explicitly disclose a filter port, wherein the filter port each define a fluid path from the volume to outside the volume; and a pressure source configured to be releasably fluidly coupled to the filter port and activated to draw the blood through the filter and through the filter port into the pressure source.
Jordan teaches a device for use in a system or method of collecting and processing aspirated tissue received from a harvesting device (see Abstract; Figures 1) is provided by a canister body (22) having a volume (see Figure 2), the system comprising: a vacuum port (24), a filter port (30); wherein the filter port each define a fluid path from the volume to outside the volume (tissue retrieval port 30 is defined outside of the canister body 22, see Figure 2); and a pressure source (collection syringe 54) configured to be releasably fluidly coupled to a filter port (syringe 54 has an entry channel 168 on one end that may attach to a canula (not shown) for enabling re-injection of the collected tissue into a patient site or another syringe body, see Col. 10 lines 18-20) and activated to draw the blood through the filter and through the filter port into the pressure source (syringe 54 is an conventional aspiration syringe that can create suction within the canister body 22).
Shaffer and Jordan are analogous art because both teach a collection canister with a tissue material filter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the collection canister of Shaffer and further include a filter port wherein a pressure source is configured to be releasably fluidly coupled to the filter port to draw fluid through the collection canister, as taught by Jordan. Jordan teaches the releasable pressure source is beneficial if more than one syringe is needed, the primary syringe may be uncoupled and additional syringes as needed may be coupled to the tubing end and the collection process repeated to load one or more syringes with irrigated, separated fatty tissue for re-injection (Col. 16 lines 46-51).
Regarding Claim 31, Shaffer and Jordan teach all of the limitations as discussed above in claim 30. However, Shaffer and Jordan do not explicitly disclose wherein the pressure source is further configured to be releasably fluidly coupled to a reinfusion catheter intravascularly positioned in the vasculature of a patient and activated to drive the blood through the reinfusion catheter into the vasculature of the patient.
Evans teaches a system for treating clot material in the vasculature of a patient (see Abstract; Figure 1), the system comprising: a pressure source (infusion reservoir 21) configured to be releasably fluidly coupled to the filter port (fluidly coupled to three-way valve 22, see Figure 1) and activated to draw the blood through the filter and through the filter port into the pressure source (infusion reservoir 21 is a syringe that can be used to aspirate, see Paragraph [0038]);
wherein the pressure source is further configured to be releasably fluidly coupled (via three way valve 22) to a reinfusion catheter (infusion tubing 16) intravascularly positioned in the vasculature of a patient and activated to drive the blood through the reinfusion catheter into the vasculature of the patient (the blood product can be infused directly back through the infusion tubing 16 and into the infusion port 12 of the treatment catheter 10 and back into the treated area, see Paragraph [0035]).
Shaffer, Jordan, and Evans are analogous art because both teach a filtering device for human tissue.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the pressure source of of Modified Shaffer and further include wherein the pressure source is further configured to be releasably fluidly coupled to a reinfusion catheter intravascularly positioned in the vasculature of a patient and activated to drive the blood through the reinfusion catheter into the vasculature of the patient, as taught by Evans. Evans teaches the filter system allows for 1) the controlled aspiration of body fluid such as blood and clot material from a blood vessel, 2) the filtration of such material to remove any unwanted blood clot particles, and 3) the reinfusion of the filtered material back into the patient to minimize the amount of blood product lost during the procedure (see Paragraph [0014]).
Regarding, Claim 32, Modified Shaffer teaches all of the limitations as discussed above in claim 31 and Evans further teaches the reinfusion catheter (infusion tubing 16).
Regarding, Claim 33, Modified Shaffer teaches all of the limitations as discussed above in claim 30 and Jordan further teaches wherein the pressure source is a syringe (collection syringe 54).
Regarding, Claim 34, Modified Shaffer teaches all of the limitations as discussed above in claim 33 and Jordan further teaches wherein activating the syringe comprises withdrawing a plunger of the syringe (syringe 54 is an conventional aspiration syringe that can create suction by retracting plunger 170).
Regarding, Claim 35, Modified Shaffer teaches all of the limitations as discussed above in claim 30 and Shaffer further teaches wherein the aspiration source is an electric pump (the pump is plugged into an outlet via a power cord that is supplied with the pump, see Paragraph 0035]).
Regarding, Claim 38, Modified Shaffer teaches all of the limitations as discussed above in claim 30 and Shaffer further teaches wherein the filter is removably positioned within the canister (filter 86 is removably mounted on post 90, see Figure 6).
Regarding, Claim 39, Modified Shaffer teaches all of the limitations as discussed above in claim 30 and Shaffer further teaches wherein the filter is coupled to a cap configured to be releasably coupled to the canister (lid 80 removably coupled to the canister, see Paragraph [0037]).
However, Modified Shaffer does not explicitly disclose wherein the filter is coupled to the cap.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to try wherein the filter is coupled to the cap since it has been held "a person of ordinary skill has good reason to pursue the known options (the filter being coupled to the canister or to the cap) within his or her technical grasp. If this leads to the anticipated success (wherein the cap and filter can be removable together), it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Regarding, Claim 40, Modified Shaffer teaches all of the limitations as discussed above in claim 30. However, Modified Shaffer does not explicitly disclose wherein the cap is rotatable to release the cap and the filter from the canister.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to try wherein the cap is rotatable to release the cap and the filter from the canister since it has been held "a person of ordinary skill has good reason to pursue the known options (the filter being coupled to the canister or to a rotatable cap) within his or her technical grasp. If this leads to the anticipated success (wherein the cap and filter can be easily removable together), it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Regarding, Claim 41, Modified Shaffer teaches all of the limitations as discussed above in claim 30 and Shaffer further teaches wherein the canister (44) has a first end portion (top of canister 44) and a second end portion opposite the first end portion (bottom of canister 44), wherein the aspiration port (110) and the vacuum port (108) are positioned proximate to the first end portion (see Figure 4). Jordan further teaches wherein the filter port is positioned proximate to the second end portion (port 30 located at the bottom of the canister 22, see Figure 2).
Regarding Claim 42, Shaffer teaches a blood filtering system (see Abstract; Figure 1), comprising:
a canister defining a volume (collection canister 44, see Figure 4);
an aspiration port (connector 110) defining a fluid path from the volume to outside the volume (see Figure 4) and configured to fluidly couple the volume to an aspiration catheter (a connector 110 which is attached to a proximal end of the catheter, see Paragraph [0040]);
a vacuum port (a vacuum port 102 extends upwardly through a much larger lumen or tube and terminates in an open aperture 108 at its upper end, see Paragraph [0039]) defining a fluid path from the volume to outside the volume (aperture 108 will be exposed to the interior of the canister 44 but will be maintained well above the mid-section and bottom where the clot and blood are collecting, see Paragraph [0039]; Figure 4) and configured to fluidly couple the volume to an aspiration source positioned outside the volume (the clot and blood are drawn into the interior of the main body 78 by the vacuum which is drawn through the vacuum port 102 by the vacuum console 42, see Paragraph [0040]); and
a filter assembly releasably coupled to the canister (filter plate 86 within canister 44 that is removably coupled to post 90, see Figure 4 and 6), wherein the filter assembly includes (a) a filter configured to filter blood from clot material within the volume (A filter plate 86, shown as a perforated screen, see Paragraph [0040]).
However, Shaffer does not explicitly disclose a filter port defining a fluid path from the volume to outside the volume and configured to be releasably coupled to a filtered blood reintroduction device.
Jordan teaches a device for use in a system or method of collecting and processing aspirated tissue received from a harvesting device (see Abstract; Figures 1) is provided by a canister body (22) having a volume (see Figure 2), the system comprising: a vacuum port (24), a filter port (30) defining a fluid path from the volume to outside the volume (tissue retrieval port 30 is defined outside of the canister body 22, see Figure 2) and configured to be releasably coupled to a filtered blood reintroduction device (syringe 54 has an entry channel 168 on one end that may attach to a canula (not shown) for enabling re-injection of the collected tissue into a patient site or another syringe body, see Col. 10 lines 18-20).
Shaffer and Jordan are analogous art because both teach a collection canister with a tissue material filter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the collection canister of Shaffer and further include a filter port defining a fluid path from the volume to outside the volume and configured to be releasably coupled to a filtered blood reintroduction device, as taught by Jordan. Jordan teaches the releasable pressure source is beneficial if more than one syringe is needed, the primary syringe may be uncoupled and additional syringes as needed may be coupled to the tubing end and the collection process repeated to load one or more syringes with irrigated, separated fatty tissue for re-injection (Col. 16 lines 46-51).
Regarding Claim 43, Modified Shaffer teaches all of the limitations as discussed above in claim 42 and Shaffer further teaches wherein the canister (44) has a first end portion (top of canister 44) and a second end portion opposite the first end portion (bottom of canister 44), wherein the aspiration port (110) and the vacuum port (108) are positioned proximate to the first end portion (see Figure 4) and wherein the filter assembly is positioned proximate to the second end portion (filter 86 is located near the bottom of the canister 44, see Figure 4).
Regarding Claim 44, Modified Shaffer teaches all of the limitations as discussed above in claim 42 and Jordan further teaches wherein the pressure source is a syringe (collection syringe 54).
Regarding Claim 45, Modified Shaffer teaches all of the limitations as discussed above in claim 42 and Shaffer further teaches wherein the cap is configured to be releasably coupled to the canister (lid 80 removably coupled to the canister, see Paragraph [0037]).
However, Modified Shaffer do not explicitly disclose wherein the filter assembly includes a cap attached to the filter.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to try wherein the filter is coupled to the cap since it has been held "a person of ordinary skill has good reason to pursue the known options (the filter being coupled to the canister or to the cap) within his or her technical grasp. If this leads to the anticipated success (wherein the cap and filter can be removable together), it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Regarding Claim 46, Modified Shaffer teaches all of the limitations as discussed above in claim 42. However, Modified Shaffer does not explicitly disclose wherein the cap is rotatable to release the filter assembly from the canister.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to try wherein the cap is rotatable to release the cap and the filter from the canister since it has been held "a person of ordinary skill has good reason to pursue the known options (the filter being coupled to the canister or to a rotatable cap) within his or her technical grasp. If this leads to the anticipated success (wherein the cap and filter can be easily removable together), it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Regarding Claim 47, Modified Shaffer teaches all of the limitations as discussed above in claim 42 and Shaffer further teaches wherein the aspiration source is an electric pump (the pump is plugged into an outlet via a power cord that is supplied with the pump, see Paragraph 0035]).
Claims 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Shaffer and Jordan, as applied to claim 30 above, and further in view of Laub (US 20170043066 A1).
Regarding, Claim 36, Modified Shaffer teaches all of the limitations as discussed above in Claim 30. However, Modified Fisher does not explicitly disclose wherein the catheter has a size of 16 French or greater.
Laub teaches a system for removing material from the body of a patient (see Abstract; Figure 1), the system including a catheter (aspiration catheter 200), wherein the catheter has a size of 16 French or greater (aspiration catheter has a French size of at least 20 Fr, see Paragraph [0028]).
Modified Shaffer and Laub are analogous art because all teach an aspiration system for collection canister with a blood filter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter of Modified Shaffer and further include wherein the catheter has a size of 16 French or greater, as taught by Laub. Laub teaches the catheter size is beneficial to allow for aspiration of large thrombi and/or other solid materials from the patient (see Paragraph [0028]).
Regarding, Claim 37, Modified Shaffer teaches all of the limitations as discussed above in Claim 30. However, Modified Shaffer does not explicitly disclose wherein the catheter has a size of 20 French or greater.
Laub teaches a system for removing material from the body of a patient (see Abstract; Figure 1), the system including a catheter (aspiration catheter 200), wherein the catheter has a size of 20 French or greater (aspiration catheter has a French size of at least 20 Fr, see Paragraph [0028]).
Modified Shaffer and Laub are analogous art because all teach an aspiration system for collection canister with a blood filter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter of Modified Shaffer and further include wherein the catheter has a size of 20 French or greater, as taught by Laub. Laub teaches the catheter size is beneficial to allow for aspiration of large thrombi and/or other solid materials from the patient (see Paragraph [0028]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (6/24/2026)
Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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