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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 12, 2025 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application Nos. 15/932,911, 15/732,953, and 16/869,982, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed applications do not disclose an impeller. Additionally, 15/932,911 and 15/732,953 do not disclose energy emitting elements.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: energy emitting element in claims 21 and 28-30.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 55 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 55 recites a single balloon proximal of the at least one side hole. The balloon referred to in the claim appears to be balloon 50 shown in Fig. 5 as this is the only Figure which depicts a balloon in this location. However, balloon 50 appears to be secured 60 as opposed to the elongated member. For purposes of the rejection the claim is interpreted as the balloon is secured to the overall apparatus and thereby secured to the elongated member.
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.
Claim(s) 21-23, 48, 51-53, 56, 59, and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael (US 5,460,610) in view of Evans et al. (US 2002/0188276 A1), Schwartz et al. (US 5,163,910) and Schmaltz (US 2010/0234842).
With regard to claims 21-23, and 48, Don Michael teaches a surgical apparatus for treating a blood vessel blockage in a patient, the surgical apparatus comprising: an elongated member including: a proximalmost end including a proximal hole (the lumens extend to the proximal end creating a proximal end hole, Col. 4 lines 46-55, Col. 5 lines 15-18); a distalmost end including a distal exit hole, wherein the elongated member defines a generally uniform transverse cross-sectional dimension between the proximalmost end and the distalmost end (Fig. 1 distal outlet of lumen 4, at least lumen 4 has a uniform transverse cross-sectional dimension); at least one side hole (Fig. 1 hole 18); a side opening for injection of medication (Fig. 1 hole 24); an outer wall defining a lumen (Fig. 1 catheter 2). Don Michael does not disclose a plurality of side openings. However, Evans et al. teach a plurality of side openings may be used between balloons for delivering a thrombolytic agent in a uniform release (Fig. 8 members 104, [0030]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a plurality of openings in Don Michael as Evans et al. teach this is effective for delivering a thrombolytic in a uniform manner and would yield the same predictable result of delivery. Don Michael does not disclose a motor driven impeller. However, Schwartz et al. disclose a catheter for treatment of an occluded vessel where blood flow between holes 32 and 30 with a motor driven impeller within the lumen to aid in pumping the blood through the catheter past the occlusion and allows for bidirectional flow and variable flow rates regardless of pressure in the vessel (Figs. 1, 2, and 6, motor 50 impeller 52, Col. 3 lines 65-67, Col. 4 lines 12-14). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an impeller in Don Michael as Schwartz et al. teach this is beneficial for bidirectional flow and variable flow rates regardless of pressure in the vessel. Placing the impeller of Schwartz as shown in Fig. 2 in an equivalent location of Don Michael would place it between the at least one side hole and distal hole, the proximal end of the impeller would be distal of the at least one side hole, and the distal end of the impeller would be proximal of the plurality of side openings.
Don Michael teaches ultrasound may be additionally used to disrupt the plaque of the clot but does not disclose energy emitting elements as claimed (Col. 8 lines 15-20). However, Schmaltz teaches using a plurality of electrodes on either side of a blockage to emit ultrasound to aid in breaking up the clot for removal (Fig. 6 210a and 210b, [0048], [00543], [0054]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use longitudinally spaced ultrasound emitting electrodes in Don Michael as Don Michael teaches ultrasound may be used in conjunction with the catheter for clot removal and Schmaltz teaches using electrodes on either side of a blockage as effective for treating a clot. Schmaltz teaches the members 210 are controlled via a generator ([0054]) and shows wires for electrical connection (see Fig. 1 exemplary wires 112). As Schmalz teaches placing the electrodes on either side of the blockage this would be in the area between the balloons of Don Michael as this is where the opening which delivers the agent to the clot is provided.
With regard to claims 51 and 52, see at least lumen 20 connected to hole 24 between holes 18 and the hole connected to the distal outlet of 4 (Fig. 1, one of the plurality of holes as combined is taken as at least one secondary distal end hole).
With regard to claims 54, and 56, balloon 14 is distal of 18 (Fig. 1, 14 is a single balloon).
With regard to claim 53, Don Michael teaches a surgical apparatus for treating a blood vessel blockage in a patient, the surgical apparatus comprising: an elongated member including: a proximalmost end including a primary proximal end hole (the lumens extend to the proximal end creating a proximal end hole, Col. 4 lines 46-55, Col. 5 lines 15-18); a distalmost end including a distal end hole, wherein the elongated member defines a generally uniform transverse cross-sectional dimension between the proximalmost end and the distalmost end (Fig. 1 distal outlet of lumen 4, at least lumen 4 has a uniform transverse cross-sectional dimension); an outer wall defining a lumen (Fig. 1 catheter); a circumferential wall defining a primary lumen (Fig. 1 wall around lumen 4); a side opening located on one side of the circumferential wall of the elongated member for injection of medication (Fig. 1 hole 24); at least one side hole extending thorugh the circumferential wall and into communication with the primary lumen, wherein the at least one side hole is positioned between the primary proximal end hole and the distal end hole and axially aligned with the plurality of side hole openings (Fig. 1 hole 18 is along the same central axis through 2 as hole 24). Don Michael does not disclose a plurality of side openings. However, Evans et al. teach a plurality of side openings may be used between balloons for delivering a thrombolytic agent in a uniform release (Fig. 8 members 104, [0030]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a plurality of openings in Don Michael as Evans et al. teach this is effective for delivering a thrombolytic in a uniform manner and would yield the same predictable result of delivery. Don Michael does not disclose a motor driven impeller. However, Schwartz et al. disclose a catheter for treatment of an occluded vessel where blood flow between holes 32 and 30 with a motor driven impeller within the lumen to aid in pumping the blood through the catheter past the occlusion and allows for bidirectional flow and variable flow rates regardless of pressure in the vessel (Figs. 1, 2, and 6, motor 50 impeller 52, Col. 3 lines 65-67, Col. 4 lines 12-14). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an impeller in Don Michael as Schwartz et al. teach this is beneficial for bidirectional flow and variable flow rates regardless of pressure in the vessel. Don Michael teaches ultrasound may be additionally used to disrupt the plaque of the clot but does not disclose energy emitting elements as claimed (Col. 8 lines 15-20). However, Schmaltz teaches using a plurality of electrodes on either side of a blockage to emit ultrasound to aid in breaking up the clot for removal (Fig. 6 210a and 210b, [0048], [00543], [0054]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use longitudinally spaced ultrasound emitting electrodes in Don Michael as Don Michael teaches ultrasound may be used in conjunction with the catheter for clot removal and Schmaltz teaches using electrodes on either side of a blockage as effective for treating a clot. Schmaltz teaches the members 210 are controlled via a generator ([0054]) and shows wires for electrical connection (see Fig. 1 exemplary wires 112). As Schmalz teaches placing the electrodes on either side of the blockage this would be in the area between the balloons of Don Michael as this is where the opening which delivers the agent to the clot is provided.
With regard to claims 59 and 60, see at least lumen 20 connected to hole 24 between holes 18 and the hole connected to the distal outlet of 4 (Fig. 1, the lumens extend to the proximal end creating a proximal end hole, Col. 4 lines 46-55, Col. 5 lines 15-18).
Claim(s) 24-27, 31, 41, 42, 45, 46, and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael (US 5,460,610) in view of Evans et al. (US 2002/0188276 A1) and Schwartz et al. (US 5,163,910).
With regard to claims 31, 24, 25, and 50, Don Michael teaches a surgical apparatus for treating a blood vessel blockage in a patient, the surgical apparatus comprising: an elongated member including (Fig. 1 catheter 2): a proximalmost end including a proximal end hole (the lumens extend to the proximal end creating a proximal end hole, Col. 4 lines 46-55, Col. 5 lines 15-18); a distalmost end including a distal end hole, wherein the elongated member defines a generally uniform transverse cross-sectional dimension between the proximalmost end and the distalmost end (Fig. 1 distal outlet of lumen 4, at least lumen 4 has a uniform transverse cross-sectional dimension); and at least one side hole positioned between the proximal end hole and the distal end hole (Fig. 1 hole 18, Col. 5 lines 9-15 connects to the distal end hole for blood flow); a side opening for injection of medication (Fig. 1 hole 24). Don Michael does not disclose a plurality of side openings. However, Evans et al. teach a plurality of side openings may be used between balloons for delivering a thrombolytic agent in a uniform release (Fig. 8 members 104, [0030]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a plurality of openings in Don Michael as Evans et al. teach this is effective for delivering a thrombolytic in a uniform manner and would yield the same predictable result of delivery. Don Michael does not disclose a motor driven impeller. However, Schwartz et al. disclose a catheter for treatment of an occluded vessel where blood flow between holes 32 and 30 with a motor driven impeller within the lumen to aid in pumping the blood through the catheter past the occlusion and allows for bidirectional flow and variable flow rates regardless of pressure in the vessel (Figs. 1, 2, and 6, motor 50 impeller 52, Col. 3 lines 65-67, Col. 4 lines 12-14). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an impeller in Don Michael as Schwartz et al. teach this is beneficial for bidirectional flow and variable flow rates regardless of pressure in the vessel. As combined see the impeller of Schwartz et al. which extends along the blood flow lumen and has portions which are positioned distal and proximal to holes 30 and between 30 and 32 which would extend it between and on either side of opening 24, placing it between the distal end hole and side hole 18 and the side hole and the opening of Don Michael.
With regard to claims 26 and 27, see Fig. 1 hole 24 which would be a plurality as combined with Evans et al.
With regard to claims 41 and 42, as combined above Schwartz et al. teach it is beneficial to be able to change the direction and flow rate, further see Schwartz et al. Col. 6 lines 36-61.
With regard to claim 45, the device is capable of connection to an aspiration source.
With regard to claim 46, as the catheter is made of a single tubular structure the sidewall is taken to encompass the entire outer surface which forms the “side” of the catheter and includes the distal end surface though which the first hole extends as well as the radial surface in which 18 is present. The claims do not recite any particular location or extent of the side.
Claim 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael (US 5,460,610), Evans et al. (US 2002/0188276 A1), and Schwartz et al. (US 5,163,910) as applied to claim 31 above, and further in view of Nahon et al. (US 2007/0185445 A1).
With regard to claim 43, Don Michael teaches a device substantially as claimed. Don Michael does not disclose an outer support sheath as recited. However, Nahon et al. teach a slideable outer sheath 28 which is used to cover and uncover a side port 26 used for blood perfusion to control flow ([0019], [0021]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an outer sheath in Don Michael as in Nahon et al. as this is beneficial for controlling flow. The device of Don Michael as combined with the impeller can redirect flow in conjunction with the sheath, additionally flow which is impeded by the sheath may push back from the wall in various directions.
Claim 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael (US 5,460,610), Evans et al. (US 2002/0188276 A1), and Schwartz et al. (US 5,163,910), as applied to claim 31 above, and further in view of Boehm JR. et al. (US 2017/0000493 Al).
With regard to claim 44, Don Michael teaches a device substantially as claimed. Don Michael does not disclose a valve. However, Boehm Jr. et al. teach using a valve to prevent backflow through the catheter (Fig. 8 member 23, [0045]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a valve in Don Michael as Boehm Jr. et al. teach this is beneficial to prevent backflow through the catheter.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael (US 5,460,610), Evans et al. (US 2002/0188276 A1), Schwartz et al. (US 5,163,910), and Schmaltz (US 2010/0234842) as applied to claim 21 above, and further in view of Brinkmann et al. (US 2021/0169517 A1).
With regard to claim 47, Don Michael and Schwartz et al. teach a device substantially as claimed. Don Michael and Schwartz et al. do not disclose the motor within the elongated member. However, Brinkmann et al. teach a motor within a catheter for rotating an impeller to remove occlusive material (Fig. 2, member 40 coupled to the motor or the motor is within 120 which is considered as part of the elongated member, [0044], [0046]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to connect the impeller to a motor within a handle which extends from the catheter and is considered as part of the elongated member in Don Michael and Schwartz et al. as Brinkmann et al. teach this to be an art effective means for providing power and would yield the same predictable result.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael (US 5,460,610), Evans et al. (US 2002/0188276 A1), and Schwartz et al. (US 5,163,910) as applied to claim 31 above, and further in view of Brinkmann et al. (US 2021/0169517 A1).
With regard to claim 49, Don Michael and Schwartz et al. teach a device substantially as claimed. Don Michael and Schwartz et al. do not disclose the motor within the elongated member. However, Brinkmann et al. teach a motor within a catheter for rotating an impeller to remove occlusive material (Fig. 2, member 40 coupled to the motor or the motor is within 120 which is considered as part of the elongated member, [0044], [0046]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to connect the impeller to a motor within a handle which extends from the catheter and is considered as part of the elongated member in Don Michael and Schwartz et al. as Brinkmann et al. teach this to be an art effective means for providing power and would yield the same predictable result.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Don Michael (US 5,460,610), Evans et al. (US 2002/0188276 A1), Schwartz et al. (US 5,163,910) and Schmaltz (US 2010/0234842) as applied to claim 54 above, and further in view of Nahon et al. (US 2007/0185445 A1) and Yassinzadeh (US 2012/0029436 A1).
With regard to claim 55, Don Michael teaches a device substantially as claimed. Don Michael does not disclose a balloon proximal of the side hole. However, Nahon et al. teach a slideable outer sheath 28 which is used to cover and uncover a side port 26 used for blood perfusion to control flow ([0019], [0021]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use an outer sheath in Don Michael as in Nahon et al. as this is beneficial for controlling flow. Further, Yassinzadeh teaches the delivery sheath to have a balloon to divert fluid as necessary during delivery (Figs. 1 and 5 member 30, [0023], [0029]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a balloon on the sheath in Don Michael as combined with Nahon et al. as Yassinzadeh teaches this is beneficial to divert flow. As combined the balloon would necessarily connect to a third lumen in the sheath for inflation and as the balloon is on the sheath it may be placed proximally of the side hole when covering and uncovering.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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. Previous rejections under 35 U.S.C. 112 are withdrawn. Generally regarding Applicant’s remarks to the new limitation of a generally uniform cross-sectional dimension, other than being transverse the claim does not describe where the cross section is taken. Further, even if the outer surface were considered, the claim says “generally uniform” the Examiner finds the slight curvature at the distal dip of Don Michael would still allow the device to be considered generally uniform. Regarding Schmalz, no explicit arguments are provided as to why Applicant does not find the electrodes to be in the locations as rejected. As explained in the rejection, to emit energy to the clot as in Schmaltz, the electrodes would be placed between the balloons placing them in a position as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783