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 .
Detailed Action
This is in response to the amendment filed 01/26/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1- 20 rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling.
The disclosure does not enable one of ordinary skill in the art to practice the invention without constriction of the inlet tubing 120 disclosed on paragraph [0030], which is/are critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). Claims 1 and 11 have both been amended to recite “approximately 95% of the positive pressure is applied to the distal end of the aspiration catheter, and approximately 5% of the positive pressure is applied to the dual pressure generator receptacle and approximately 95% of the vacuum pressure is pulled from the distal end of the aspiration catheter, and approximately 5% of the vacuum pressure is pulled from the dual pressure generator receptacle” The specification makes clear that the only structure responsible for this described function is constriction of the inlet tubing 120 disclosed on paragraph [0030] which is/are critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0034986 (Chou et al.) in view of U.S. Patent Number 4,191,204 (Nehring)
Regarding claims 1, 2, 10 Chou et al. discloses as shown in Figures 18, 43 a cyclic aspiration system capable of producing a cyclic aspiration pressure waveform of intermittent cycles of vacuum pressure below atmospheric pressure and positive pressure higher than vacuum pressure, the cyclic aspiration system comprising: an aspiration catheter (device 110, see paragraph [0127]) having a proximal end and an opposite distal end; and a dual pressure generator receptacle (syringe 1120, see paragraphs [0185]) disposed proximally of and connected in fluid communication with the aspiration catheter; the dual pressure generator receptacle capable of receiving a collectable fluid therein that is intermittently cyclically subjectable to application or withdraw of a compressible force via a linear displacement mechanism (plunger of syringe); the positive pressure being capable of being generated while the collectable fluid in the dual pressure generator receptacle is subject to the compressive force and the vacuum pressure being generatable while the collectable fluid in the dual pressure generator receptacle is not subject to the compressive force; wherein the cyclic aspiration pressure waveform is capable of being produced via the dual pressure generator receptacle without a separate vacuum pump, further comprising inlet tubing (line 615, shunt 120 see paragraphs [0131], [0151]) disposed proximally of a proximal hub (shown in figure 18) arranged at the proximal end of the aspiration catheter; and the dual pressure generator receptacle and a separate collection vessel (filter 1145, see paragraph [0186]) is connected in fluid communication with the inlet tubing, wherein the linear displacement mechanism is external of the dual pressure generator receptacle, not contaminatable with blood, and reusable; while the dual pressure generator receptacle is contaminatable with blood and discardable after a single use.
Chou et al. fails to disclose approximately 95% of the positive pressure is applied to the distal end of the aspiration catheter, and approximately 5% of the positive pressure is applied to the dual pressure generator receptacle, and approximately 95% of the vacuum pressure is pulled from the distal end of the
aspiration catheter, and approximately 5% of the vacuum pressure is pulled from the dual pressure generator receptacle.
Nehring, from the same field of endeavor teaches a similar system as shown in Figure 1, where a percentage of the positive pressure is applied to a dual pressure generator receptacle and a percentage of the vacuum pressure is pulled from the dual pressure generator receptacle is a recognized result effective variable for the purpose of compensating for increasing differential pressure across the flow restriction and improving energy efficiency in the system. see col. 4, lines 27-36.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Chou such that approximately 95% of the positive pressure is applied to the distal end of the aspiration catheter, and approximately 5% of the positive pressure is applied to the dual pressure generator receptacle, and approximately 95% of the vacuum pressure is pulled from the distal end of the aspiration catheter, and approximately 5% of the vacuum pressure is pulled from the dual pressure generator receptacle in order to compensate for increasing differential pressure across the flow restriction and improve energy efficiency in the system because it would only require optimizing a result effective variable and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 11, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0019310 (Hogendijk et al.) in view of U.S. Patent Number 4,191,204 (Nehring)
Regarding claims 11, 20 Hogendijk discloses as shown in Figures 1, 2 a method for using a cyclic aspiration system for producing a cyclic aspiration pressure waveform of intermittent cycles of vacuum pressure below atmospheric pressure and positive pressure higher than vacuum pressure; the cyclic aspiration system comprising: an aspiration catheter (catheter 21, see paragraph [0034]) having a proximal end and an opposite distal end; and a dual pressure generator receptacle (pump 60, see paragraphs [0041]) disposed proximally of and connected in fluid communication with the aspiration catheter; wherein the method comprises the steps of: delivery of the aspiration catheter through a vessel to a target site on a proximal side of a clot; see paragraphs [0003]. [0032] and producing the cyclic aspiration pressure waveform using the dual pressure generator receptacle by intermittently cyclically subjecting a collectable fluid receivable therein to application or withdraw of a compressible force via a linear displacement mechanism; the positive pressure being generated while the collectable fluid in the dual pressure generator receptacle is subject to the compressive force and the vacuum pressure being generated while the collectable fluid in the dual pressure generator receptacle is not subject to the compressive force; wherein the cyclic aspiration pressure waveform is producible via the dual pressure generator receptacle without a separate vacuum pump.
Hogendijk et al. fails to disclose approximately 95% of the positive pressure is applied to the distal end of the aspiration catheter, and approximately 5% of the positive pressure is applied to the dual pressure generator receptacle, and approximately 95% of the vacuum pressure is pulled from the distal end of the
aspiration catheter, and approximately 5% of the vacuum pressure is pulled from the dual pressure generator receptacle.
Nehring, from the same field of endeavor teaches a similar system as shown in Figure 1, where a percentage of the positive pressure is applied to a dual pressure generator receptacle and a percentage of the vacuum pressure is pulled from the dual pressure generator receptacle is a recognized result effective variable for the purpose of compensating for increasing differential pressure across the flow restriction and improving energy efficiency in the system. see col. 4, lines 27-36.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Hogendijk such that approximately 95% of the positive pressure is applied to the distal end of the aspiration catheter, and approximately 5% of the positive pressure is applied to the dual pressure generator receptacle, and approximately 95% of the vacuum pressure is pulled from the distal end of the aspiration catheter, and approximately 5% of the vacuum pressure is pulled from the dual pressure generator receptacle in order to compensate for increasing differential pressure across the flow restriction and improve energy efficiency in the system because it would only require optimizing a result effective variable and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2011/0034986 (Chou et al.) in view of U.S. Patent Number 4,191,204 (Nehring)
as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2002/0198550 (Nash et al.)
Regarding claims 2, 3 under an alternative interpretation, Chou discloses inlet tubing (line 615, see paragraph [0151]) disposed proximally of a proximal hub (shown in figure 18) arranged at the proximal end of the aspiration catheter; and the dual pressure generator receptacle, wherein the dual pressure generator receptacle (syringe 1120, see paragraphs [0185]) is a syringe or a reservoir having a plunger displaceable therein via the linear displaceable mechanism.
Chou fails to disclose a separate collection vessel is connected in fluid communication with the inlet tubing, the collection vessel is a tank or disposable bag in fluid communication therewith via the inlet tubing
Nash, from the same field of endeavor teaches a similar system as shown in Figure 9 where the system includes a separate collection vessel is connected in fluid communication with the inlet tubing, the collection vessel is a tank or disposable bag in fluid communication therewith via the inlet tubing for the purpose of collecting debris taken in from the vessel. See paragraph [0105].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Chou to include the separate collection vessel taught by Nash in order to configure the system to catch and dispose of debris caught by the system.
Regarding claims 4, 5 Chou discloses a first one-way valve (valve 1115, see paragraph [0188]) disposed in the inlet tubing capable of preventing fluid collectable in the system from passing distally therethrough into the aspiration catheter when subject to the positive pressure.
Chou in view of Nash fails to disclose further comprising a second one-way valve preventing fluid collectable in the collection vessel from exiting and controlling the positive pressure to the aspiration catheter.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Chou in view of Nash to include a second one-way valve preventing fluid collectable in the collection vessel from exiting and controlling the positive pressure to the aspiration catheter because it would only require the duplication of parts without changing how the device operates. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0019310 (Hogendijk et al.) in view of U.S. Patent Number 4,191,204 (Nehring) as applied to claim 11 above, and further in view of U.S. Patent Publication Number 2002/0198550 (Nash et al.)
Regarding claims 12, 13 Hogendijk et al. discloses wherein the cyclic aspiration system further comprises inlet tubing (tubing 42, see paragraph [0036]) disposed proximally of a proximal hub arranged at the proximal end of the aspiration catheter; and the dual pressure generator receptacle, wherein the dual pressure generator receptacle is a syringe or a reservoir having a plunger displaceable therein via the linear displaceable mechanism.
Hogendijk fails to disclose a separate collection vessel is connected in fluid communication with the inlet tubing.
Nash, from the same field of endeavor teaches a similar system as shown in Figure 9 where the system includes a separate collection vessel is connected in fluid communication with the inlet tubing, the collection vessel is a tank or disposable bag in fluid communication therewith via the inlet tubing for the purpose of collecting debris taken in from the vessel, and the collection vessel is a tank or disposable bag in fluid communication therewith via the inlet tubing. See paragraph [0105].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Hogendijk to include the separate collection vessel taught by Nash in order to configure the system to catch and dispose of debris caught by the system.
Claim(s) 14, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2004/0019310 (Hogendijk et al.) in view of U.S. Patent Number 4,191,204 (Nehring), U.S. Patent Publication Number 2002/0198550 (Nash et al.) as applied to claim 12 above, and further in view of U.S. Patent Publication Number 2011/0034986 (Chou et al.)
Regarding claims 14, 15 Hogendijk et al. fails to disclose a first one-way valve disposed in the inlet tubing to prevent fluid collectable in the system from passing distally therethrough into the aspiration catheter when subject to the positive pressure, a second one-way valve preventing fluid collectable in the collection vessel from exiting and controlling the positive pressure to the aspiration catheter.
Chou, from, the same filed of endeavor teaches a similar method of using a system as shown in Figures 18, 43, discloses a first one-way valve (valve 1115, see paragraph [0188]) disposed in the inlet tubing capable of preventing fluid collectable in the system from passing distally therethrough into the aspiration catheter when subject to the positive pressure, for the purpose of regulating flow in the inlet tubing.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Hogendijk to include a first one-way valve disposed in the inlet tubing to prevent fluid collectable in the system from passing distally therethrough into the aspiration catheter when subject to the positive pressure taught by Chou in the system disclosed by Hogendijk in order to regulate the flow in the tubing.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Hogendijk in view of Nash and Chou to include a second one-way valve preventing fluid collectable in the collection vessel from exiting and controlling the positive pressure to the aspiration catheter because it would only require the duplication of parts without changing how the device operates. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Response to Arguments
Applicant’s arguments with respect to the rejection of claim(s) 1-20 have been considered but are moot because they do not apply to the the new grounds of rejection.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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