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 the Claims
The amendment filed 12/18/2025 has been entered. Claims 1-8 and 10-20 are pending and under consideration.
Response to Arguments
In response to the applicant’s argument with respect 35 USC 102 and 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
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: a drive system for controlling the progressive cavity pump of claim 14.
In an effort to compact prosecution, the drive system is interpreted as an electrical system illustrated in [0117] or a manual system illustrated in [0119].
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 § 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.
Claims 1-7, 11, 12, 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al (US 20010004700 A1) in view of Summers et al (US 5112349 A)
Regarding claim 1, Honeycutt teaches substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A method of removing an occlusive material within a blood lumen of a patient ([0010]), said method comprising:
positioning a material-removal device (figures 1-2 and [0010] positioning surgical instrument 10 having distal end 16 in contact with occlusive material in blood vessel) proximate to or in contact with said occlusive material within said blood lumen, said material-removal device comprising:
a catheter (figure 2, tubular body 12) comprising a catheter lumen (figure 2, central lumen 20) and a progressive cavity pump (figure 2, cutter 22 with cutter housing 21) located at a distal portion (figure 2, distal end 16) of said catheter, said progressive cavity pump in fluid communication with said catheter lumen and said blood lumen ([0010]), wherein said progressive cavity pump comprises a stator and a rotor; and
actuating said progressive cavity pump to ingest at least a portion of said occlusive material from said blood lumen into said catheter lumen, wherein said actuating the progressive cavity pump comprises forming at least one cavity between the stator and the rotor that is fluidically sealed when closed.
Honeycutt does not teach the catheter comprising a progressive cavity pump, wherein said progressive cavity pump comprises a stator and a rotor; and
actuating said progressive cavity pump to ingest at least a portion of said occlusive material from said blood lumen into said catheter lumen, wherein said actuating the progressive cavity pump comprises forming at least one cavity between the stator and the rotor that is fluidically sealed when closed.
In the same field of endeavor, namely a progressive cavity pump, Summers a catheter (figures 1, catheter 16) comprising a progressive cavity pump (figure 1, pump 14 further illustrated in figure 5) located at a distal portion of said catheter, wherein said progressive cavity pump comprises a stator and a rotor (figure 5, stator 102 and rotor 104); and
actuating said progressive cavity pump to ingest at least a portion of said occlusive material from said blood lumen into said catheter lumen (col 5 lines 30-56, rotating rotor along axis of shaft 110 ingests occlusive material through intake port 106), wherein said actuating the progressive cavity pump comprises forming at least one cavity (figure 5 and col 5 lines 30-56, the outer surface of rotor abuts the inner surface of stator and forms at least one fluidically sealed one cavity 101) between the stator and the rotor that is fluidically sealed when closed.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honeycutt, to incorporate the teachings of Summers, and provide the progressive cavity pump as claimed for the purpose of providing non-turbulence suction with low surge and a low-pulsation which is ideal for shear sensitive materials, as taught by Summers (col 6 lines 25-45).
Regarding claim 2, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches wherein said occlusive material partially or completely occludes the blood lumen, and further wherein the blood lumen comprises at least one of a blood vessel and an artificial vascular graft (Honeycutt; [0003], [0010] and [0125] method comprising removing obstructive material at least partially blocks blood vessel lumen).
Regarding claim 3, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches wherein said occlusive material comprises at least one of clotted blood, thrombus and plaque (Honeycutt; [0041] [0051] calcified plaque or thrombus).
Regarding claim 4, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches comprising depositing said at least a portion of said occlusive material from a proximal portion of said catheter lumen into a container located externally to the patient (Honeycutt; figure 8 and [0110] the removed material continues flow from tubular body lumen 20 to tissue collection/fluid separation container through vacuum tubing 88)
Regarding claim 5, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches wherein said forming at least one cavity (Summers; figure 5, at least one cavity 101) between the stator and the rotor comprises (i) when said at least one cavity is distally open, said at least a portion of said occlusive material is ingested into the at least one cavity (Summers; figure 5 and col 5 lines 30-56, As rotor 104 rotates about the drive shaft 110, its outer surface, specifically proximate to port 106, intermittently engages and disengage with the inner surface of stator 102, upon disengaging, the at least one cavity opened and occlusive material is ingested through intake port 106), (ii) when said at least one cavity is closed, said at least a portion of said occlusive material is then translated proximally through said progressive cavity pump (Summers; figure 5 and col 5 lines 30-56, upon the surfaces engage, the at least one cavity closed, and sealed and transport the occlusive material in proximal direction through the pump), and (iii) when said at least one cavity re-opens proximally, said at least a portion of said occlusive material is transferred from said progressive cavity pump into said catheter lumen (Summers; figure 5 and col 5 lines 30-56, as the surfaces intermittently engages and disengages, the occlusive material is transferred from the pump 100 to suction tubing 16 as shown figure 1).
Regarding claim 6, Honeycutt, as modified by Summers, teaches the method of claim 5.
The combination further teaches wherein said stator comprises a first helical portion (Summers; figure 5, inner surface of stator 102) and said rotor comprises a second helical portion (Summers; figure 5, outer surface of rotor 104), and wherein said actuating the progressive cavity pump comprises rotating the second helical portion within said first helical portion so as to open and close said at least one cavity (Summers; figure 5 and col 5 lines 30-56, rotating rotor 104 about the drive shaft 110, its outer surface intermittently engages and disengage with the inner surface of stator 102 opening and closing at least one cavity 101).
Regarding claim 7, Honeycutt, as modified by Summers, teaches the method of claim 6.
The combination further teaches wherein said actuating the progressive cavity pump comprises (i) rotating the second helical portion within said first helical portion so as to form a plurality of cavities within said progressive cavity pump, and (ii) ingesting a plurality of portions of said occlusive material into said plurality of cavities within the progressive cavity pump (Summers; figure 5 and col 5 lines 30-56, as rotor rotates, the surfaces between stator 102 and rotor 104 forms plurality of cavities that intermittently opened and closed creating pumping action, which ingest occlusive material through intake port 106).
Regarding claim 11, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches wherein said progressive cavity pump is located either partially or entirely within, or is operatively coupled to, said distal portion of said catheter (Honeycutt; figure 2, the cutter 22 and cutter housing 21 operatively coupled to distal portion of said catheter 16).
Regarding claim 12, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches wherein the progressive cavity pump is operatively coupled to and extends distally from said distal portion of said catheter (Honeycutt; figure 6, the cutter 22 and cutter housing 21 operatively coupled to distal portion of the catheter 16, and at least cutter extends distally from the distal portion of the catheter).
Regarding Claim 14, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches wherein said material-removal device further comprising a handle assembly (Honeycutt; figure 8, control assembly 18) coupled to a proximal end of the catheter (Honeycutt; [0027] proximal end 14 of the tubular body 12 is coupled to control device 18), wherein said handle assembly comprises a drive system for controlling the progressive cavity pump (Honeycutt; figures 8-10 and [0107]-[0116], a drive system comprising at least a hub 84, fastener 102, motor face plate 100, motor 90, electrical switch 130, motor controller 134 and electronic circuitry illustrated in figure 10).
Regarding Claim 15, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches wherein said material-removal device further comprises a torque member (Summers; figure 5, drive shaft 110 coupled to rotor) operatively coupled to said progressive cavity pump and wherein said actuating said progressive cavity pump comprises rotating said torque member to rotate a rotor portion of said progressive cavity pump (Summers; figure 5 and col 5 lines 30-56)
Regarding Claim 16, Honeycutt, as modified by Summers, teaches the method of claim 15.
The combination further teaches wherein said rotating said torque member comprising rotating said torque member either manually by a user or by a user actuating a motor operatively coupled to said torque member (Summers; col 3 lines 30-50, the drive shaft is driven by a motor 31).
Regarding Claim 17, Honeycutt, as modified by Summers, teaches the method of claim 15.
The combination further teaches wherein said material-removal device further comprises a motor (Summers; figure 2 and col 3 lines 30-50 motor 31 coupled to the drive shaft) operatively coupled to said torque member for rotating said torque member to actuate said progressive cavity pump, said method further comprising varying a speed of rotation of said torque member during said actuating of said progressive cavity pump (Honeycutt; [0118] motor provide variable speed control of flexible drive shaft 24).
Regarding Claim 18, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches said method further comprising infusing at least one of saline, contrast and a therapeutic agent into the blood lumen during said method of treating said occlusive material (Honeycutt; [0077] and [0092] the device allows saline solution during treating occlusive material).
Regarding claim 19, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination further teaches where said progressive cavity pump is positioned or is positionable at an angle relative to a longitudinal axis of said catheter lumen (Summers; figures 1-2, the pump 14 can be positionable at an angle relative to a longitudinal axis of the catheter 16), and wherein said actuating said progressive cavity pump further comprises rotating said progressive cavity pump within said blood lumen to treat a second portion of said occlusive material in said blood lumen (Summers; col 3 lines 30-50, the rotor 104 continuously rotates thereby ingest occlusive material including second portion).
Regarding claim 20, Honeycutt teaches a method of treating an occlusive material within a blood lumen of a patient ([0010]), said method comprising:
positioning a material-removal device (figures 1-2 and [0010], positioning surgical instrument 10 having distal end 16 in contact with occlusive material in blood vessel) proximate to or in contact with said occlusive material within said blood lumen, said material-removal device comprising:
a catheter (figure 2, tubular body 12) comprising a catheter lumen (figure 2, central lumen 20 ), and a pump (figure 2, cutter 22 with cutter housing 21) located at a distal portion of said catheter, said pump in fluid communication with said catheter lumen and said blood lumen ([0010]), wherein said pump comprises a stator comprising a first helical portion and a rotor comprising a second helical portion, and wherein rotation of said second helical portion of said rotor within said first helical portion of said rotor opens and closes at least one cavity formed between said stator and said rotor within said pump, and actuating said pump to open and close said at least one cavity to ingest at least a portion of said occlusive material from the blood lumen into said at least one cavity and move said at least a portion of said occlusive material through the pump and into the catheter lumen, wherein said actuating the pump comprises forming the at least one cavity between the stator and the rotor that is fluidically sealed when closed.
Honeycutt does not teach wherein said pump comprises a stator comprising a first helical portion and a rotor comprising a second helical portion, and wherein rotation of said second helical portion of said rotor within said first helical portion of said rotor opens and closes at least one cavity formed between said stator and said rotor within said pump, and actuating said pump to open and close said at least one cavity to ingest at least a portion of said occlusive material from the blood lumen into said at least one cavity and move said at least a portion of said occlusive material through the pump and into the catheter lumen, wherein said actuating the pump comprises forming the at least one cavity between the stator and the rotor that is fluidically sealed when closed.
In the same field of endeavor, namely a progressive cavity pump, Summers teaches wherein said pump comprises a stator (figure 5, stator 102) comprising a first helical portion (figure 5, helical inner surface) and a rotor (figure 5, rotor 104) comprising a second helical portion (figure 5, helical exterior surface), and wherein rotation of said second helical portion of said rotor within said first helical portion of said rotor opens and closes at least one cavity formed between said stator and said rotor within said pump (figure 5 and col 5 lines 30-56, As rotor 104 rotates about the drive shaft 110, its outer surface intermittently engages and disengage with the inner surface of stator 102, defining a fluidically sealed cavity 101, and intermittently opens and closes the cavity), and actuating said pump to open and close said at least one cavity to ingest at least a portion of said occlusive material from the blood lumen into said at least one cavity and move said at least a portion of said occlusive material through the pump and into the catheter lumen (col 5 lines 30-56, rotating the rotor ingests occlusive material through intake port 106 into at least one cavity 101), wherein said actuating the pump comprises forming the at least one cavity between the stator and the rotor that is fluidically sealed when closed (figure 5 and col 5 lines 30-56, the outer surface of the rotor 104 engages and the inner surface of stator 102, upon contact, these surfaces defines a fluidically sealed cavity 101).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honeycutt, to incorporate the teachings of Summers and provides the progressive cavity pump as claimed for the purpose of providing non-turbulence suction and a low-pulsation, as taught by Summers without damage shear-sensitive material, such as blood (col 5 line 55- col 6 line 25).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al (US 20010004700 A1) in view of Summers et al (US 5112349 A), and in further view of Samad et al (US 20140369875 A1).
Regarding claim 8, Honeycutt, as modified by Summers, teaches the method of claim 6.
The combination does not expressly teach wherein a first pitch of said first helical portion of said stator is about twice a second pitch of said second helical portion of said rotor.
In the same field of endeavor, namely a progressive cavity pump, Samad teaches wherein a first pitch of said first helical portion of said stator is about twice a second pitch of said second helical portion of said rotor ([0019] rotor pitch equal to one-half of the stator pitch).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honeycutt, as modified by Summers, to incorporate the teachings of Samad and provides the pump as claimed for the purpose of providing effective pumping action as taught by Samad ([0002] [0016])
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al (US 20010004700 A1) in view of Summers et al (US 5112349 A), and in further view of Krampe et al (US 20200124046 A1)
Regarding claim 10, Honeycutt, as modified by Summers, teaches the method of claim 6.
The combination does not expressly teach wherein said at least one cavity, when closed, remains fluidically unsealed.
In the same field of endeavor, namely gap geometry in an eccentric screw pump, Krampe teaches wherein said at least one cavity, when closed, remains fluidically unsealed (figure 3b, cavity 5 remain unsealed due to constriction 7 ).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honeycutt, as modified by Summers, to incorporate the teachings of Krampe and provides the progressive cavity pump as claimed for the purpose of reducing the occurrence of frictional wear and extend the operational life of the components as taught by Krampe ([0009]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al (US 20010004700 A1) in view of Summers et al (US 5112349 A), and in further view of Dance et al (US 5273526 A)
Regarding Claim 13, Honeycutt, as modified by Summers, teaches the method of claim 1.
The combination does not teach wherein said distal portion of said catheter comprises an outer diameter from and including about 6 French to and including about 20 French.
In the same field of endeavor, namely a vascular occlusion removal device and method, Dance teaches wherein said distal portion of said catheter comprises an outer diameter from and including about 6 French to and including about 20 French (col 11 lines 55-68, exemplary sized catheter is about 7.5 French ).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honeycutt, as modified by Summers, to incorporate the teachings of Dance and provides the catheter as claimed for the purpose of providing adequate size for blood vessel occlusion removal procedure as thought by Dance (col 11 lines 55-68)
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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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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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/S.H./Examiner, Art Unit 3781
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781