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 .
Administrative
MPEP 608.01(i) includes the requirements of 37 CFR 1.75, with part (i) stating, “Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation.” While the term “should” does not absolutely require the claims to follow this format it does help in establishing the metes and bounds of the claim by clearly indicating which structural elements are required. The examiner suggests amending Claim 11 to follow 37 CFR 1.75(i) for providing clarification on the intended interpretation of the claimed inventions.
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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 1, usage of “therethrough” in line 4 is unclear as it is not apparent what component “therethrough” refers to (e.g. the opposite distal end, the outer wall, the catheter, etc…).
As to claim 1, usage of “thereof” in line 6 is unclear as it is not apparent what component “thereof” refers to (e.g. the proximal section, the proximal section of the passageway, etc…).
As to claim 1, usage of “therethrough” in line 8 is unclear as it is not apparent what component “therethrough” refers to (e.g. the distal section, the passageway, the catheter, etc…).
Claim 1 recites the limitation "the distal end of the catheter" in three instances. While the claim did previously refer to a distal end of an outer wall, a distal end of an outer wall is not necessarily always synonymous with a distal of a catheter, and therefore it is not apparent whether “the distal end of the catheter” is intended to be read as the part as the distal end of the outer wall or if “the distal end of the catheter” is intended to refer to a different part. The examiner notes that claims 6 and 8 also refer to “the distal end of the catheter”.
Claims 2-10 are rejected as they depend from a rejected claim.
As to claim 11, usage of “therethrough” in line 3 is unclear as it is not apparent what component “therethrough” refers to (e.g. the opposite distal end, the outer wall, the catheter, etc…).
As to claim 11, usage of “thereof” in line 5 is unclear as it is not apparent what component “thereof” refers to (e.g. the proximal section, the proximal section of the passageway, etc…).
As to claim 11, usage of “therethrough” in line 7 is unclear as it is not apparent what component “therethrough” refers to (e.g. the distal section, the passageway, the catheter, etc…).
Claim 11 recites the limitation "the distal end of the catheter" in three instances. While the claim did previously refer to a distal end of an outer wall, a distal end of an outer wall is not necessarily always synonymous with a distal of a catheter, and therefore it is not apparent whether “the distal end of the catheter” is intended to be read as the same part as the distal end of the outer wall or if “the distal end of the catheter” is intended to refer to a different part. The examiner notes that claims 12 and 14 also refer to “the distal end of the catheter”.
Claims 12-20 are rejected as they depend from a rejected claim.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
As to claim 1, the closest prior art appears to be Grey et al. (WO 2014151209 A1, provided by applicant on 6/27/24 and hereafter “Grey”).
Grey discloses a pulsatile aspiration system (see Figs. 2A-3C) comprising: a catheter (206) comprising: an outer wall extending in a longitudinal direction from a proximal end (end attached to 212a) to an opposite distal end (end near 202) defining a passageway therethrough (not numbered, however clear from at least pages 6-7 that a lumen extends through catheter 206); a proximal section with an associated proximal section of the passageway; a distal section disposed distally thereof with an associated distal section of the passageway (see Fig. 2A; both “sections” can be interpreted arbitrarily). Grey also teaches supplying a dynamic pressure waveform at a distal end of the catheter by using a pump system (208) (see page 9, Figs. 2C-3C discussing method steps and example waveforms, also see para beginning line 16 col. 11).
However, Grey is silent to an internal wall extending in the longitudinal direction therethrough and dividing the proximal section of the passageway into (i) a central main lumen defined radially inward relative to the internal wall and (ii) an auxiliary lumen at least partially defined by the internal wall and internal to the outer wall, the central main lumen, through which a first fluid is receivable, being configured to produce one of negative fluid pressure or positive fluid pressure therein, the auxiliary lumen, through which a second fluid is receivable, being configured to produce the other of the positive fluid pressure or the negative fluid pressure therein, and a distal portion of the central main lumen and a distal portion of the auxiliary lumen are in fluid communication with one another where the negative fluid pressure and the positive fluid pressure combine as a resulting pressure in the distal section of the passageway; and a pump system in fluid communication with the catheter and independently controlling the negative fluid pressure and the positive fluid pressure in the central main lumen and the auxiliary lumen so as to produce at the distal end of the catheter a pulsatile aspiration waveform variable between a maximum aspiration pressure and a maximum positive pressure, the maximum aspiration pressure being producible at the distal end of the catheter when the resulting pressure is exclusively negative fluid pressure, and the maximum positive pressure being producible at the distal end of the catheter when the positive fluid pressure counterbalances that of the negative fluid pressure.
Yurek (US 2021/0121188 A1) discloses a catheter (102) comprising an internal wall extending in a longitudinal direction and dividing a proximal section of a passageway into (i) a central main lumen defined radially inward relative to the internal wall and (ii) an auxiliary lumen at least partially defined by the internal wall and internal to the outer wall, the central main lumen, through which a first fluid is receivable (see Fig. 1 and Figs. 5A-6A depicting various embodiments, also see para 0082-0085). However Yurik does not teach the pump system or the limitations above regarding a pulsatile aspiration waveform variable between a maximum aspiration pressure and a maximum positive pressure, the maximum aspiration pressure being producible at the distal end of the catheter when the resulting pressure is exclusively negative fluid pressure, and the maximum positive pressure being producible at the distal end of the catheter when the positive fluid pressure counterbalances that of the negative fluid pressure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. 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, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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