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 .
Election/Restrictions
Applicant’s election without traverse of Group VI species (abrasion feature comprising at least one strand), claims 1-18, 22-24, 27-32, 34, and 40-48 in the reply filed on 09/03/2025 is acknowledged.
Response to Amendment
The amendment filed 09/10/2025 has been entered. Claims 1, 7-17, 22-23, 28-30, 32, 34, and 40-48 remain pending in the application, claims 2-6, 18-21, 24-27, 31, 33, and 35-39 are cancelled, and claims 49-68 have been added. Applicant’s amendments to the claims have overcome the prior art rejection previously set forth in the Non-Final Office Action mailed 11/19/2024, however a new rejection is made in view of Wyzgala et al. (see rejection below).
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
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 such as “removal means” in claim 1, 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: “control mechanism” in claims 1, 66, 68.
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 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 42 is 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.
The term “about 2 mm to about 25 mm” in claim 42 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The Office will interpret the claim to mean “2 mm to 25 mm.”
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 66 and 68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wyzgala et al. (US PGPub 2004/0158270), hereinafter known as “Wyzgala.”
With regards to claim 66, Wyzgala discloses (Figures 4A-4B) a tissue treatment device 80 for detaching and enabling removal of mucus producing cells from an airway wall of a lung of a patient (functional limitation – paragraphs 72-74 – ablation burr 80 is capable of being inserted into an airway wall of a lung of a patient to remove mucus producing cells), comprising:
an elongate member 84;
an expandable abrasion feature 82 disposed on the elongate member 84, wherein the expandable abrasion feature 82 comprises at least one strand (paragraphs 72-74 – combination of 82 and the abrasive plated on the outer surface of the spring coils is the expandable abrasion feature), and wherein the at least one strand 82 comprises a member selected from the group consisting of a fiber (paragraph 72 - coiled wire spring 82 is interpreted as a fiber);
a control mechanism (motor disclosed in paragraph 48 is combination with 24/94; see Note below; paragraph 74; although the motor is not disclosed explicitly with regards to the figures 4A-4B embodiment, figure 1A and paragraph 48 discloses a similar drive shaft 24 coupled to an electric motor) in operative association with the elongate member 84, wherein the control mechanism (motor/24/94) is configured to expand the expandable abrasion feature 82 until it makes contact with the airway wall of the lung, the airway wall comprising a basement membrane, a smooth muscle layer, and a cartilage layer (functional limitation – paragraphs 72-74 – expandable abrasion feature 82 expands and is capable of contacting the airway wall of the lung); and
wherein the at least one strand 82 of the expandable abrasion feature 82, when the expandable abrasion feature 82 is expanded by the control mechanism (motor/24/94), is configured to detach a number of mucus producing cells from the airway wall of the lung of the patient, without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall (functional limitation – paragraphs 72-74 – the at least one strand of the expandable abrasion feature 82 is capable of detaching the number of mucus producing cells from the airway wall of the lung of the patient, without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall by manual movement of the user), and
wherein the at least one strand 82 of the expandable abrasion feature, upon withdrawal from the patient, is configured to remove a first portion of the number of detached mucus producing cells from the lung while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall (functional limitation – paragraphs 72-74 - the at least one strand of the expandable abrasion feature 82 is capable of removing a first portion of the number of detached mucus producing cells by manual movement of the user).
Note – 112(f) interpretation – Applicant’s control mechanism is a motor assembly, a motion driving handpiece, handpiece, or the like that cause the catheter to rotate and/or translate in an oscillatory or vibrational manner (spec. [00203]); Wyzgala’s control mechanism is a motor that rotates and axially translates the drive shaft to control the maximum diameter of the spring 82 (paragraphs 48 and 74); therefore both control mechanisms are equivalent in rotating/translating a catheter/shaft.
With regards to claim 68, Wyzgala discloses (Figures 4A-4B) a tissue treatment device 80 for detaching and enabling removal of mucus producing cells from an airway wall of a lung of a patient (functional limitation – paragraphs 72-74 – ablation burr 80 is capable of being inserted into an airway wall of a lung of a patient to remove mucus producing cells), comprising:
an elongate member 84;
an expandable abrasion feature 82 disposed on the elongate member 84, wherein the expandable abrasion feature 82 comprises at least one strand (paragraphs 72-74 – combination of 82 and the abrasive plated on the outer surface of the spring coils is the expandable abrasion feature), and wherein the at least one strand 82 comprises a member selected from the group consisting of a fiber (paragraph 72 - coiled wire spring 82 is interpreted as a fiber);
a control mechanism (motor disclosed in paragraph 48 in combination with 24/94; see Note below; paragraph 74; although the motor is not disclosed explicitly with regards to the figures 4A-4B embodiment, figure 1A and paragraph 48 discloses a similar drive shaft 24 coupled to an electric motor) in operative association with the elongate member 84, wherein the control mechanism (motor/24/94) is configured to enable expansion of the expandable abrasion feature 82 until it makes contact with the airway wall of the lung, the airway wall comprising a basement membrane, a smooth muscle layer, and a cartilage layer (functional limitation – paragraphs 72-74 – expandable abrasion feature 82 expands and is capable of contacting the airway wall of the lung); and
wherein the at least one strand 82 of the expandable abrasion feature 82, when the expandable abrasion feature 82 is expanded to make contact with the airway wall of the lung, is configured to detach a number of mucus producing cells from the airway wall of the lung of the patient, without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall, and wherein the number of detached mucus producing cells are removable from the lung while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall (functional limitation – paragraphs 72-74 – the at least one strand of the expandable abrasion feature 82 is capable of detaching and removing the number of mucus producing cells from the airway wall of the lung of the patient, without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall by manual movement of the user).
Note – 112(f) interpretation – Applicant’s control mechanism is a motor assembly, a motion driving handpiece, handpiece, or the like that cause the catheter to rotate and/or translate in an oscillatory or vibrational manner (spec. [00203]); Wyzgala’s control mechanism is a motor that rotates and axially translates the drive shaft to control the maximum diameter of the spring 82 (paragraphs 48 and 74); therefore both control mechanisms are equivalent in rotating/translating a catheter/shaft.
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, 7-17, 22-23, 28-30, 32, 34, 40-44, 50-51, 55-65, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Wyzgala.
With regards to claim 1, Wyzgala discloses (Figures 4A-4B) a tissue treatment device 80 for detaching and removing a number of mucus producing cells from an airway wall of a lung of a patient (functional limitation – paragraphs 72-74 – ablation burr 80 is capable of being inserted into an airway wall of a lung of a patient to remove mucus producing cells), comprising:
an elongate member 84;
an expandable abrasion feature 82 disposed on the elongate member 84, wherein the expandable abrasion feature 82 comprises at least one strand (paragraphs 72-74 – combination of 82 and the abrasive plated on the outer surface of the spring coils is the expandable abrasion feature), and wherein the at least one strand 82 comprises a member selected from the group consisting of a metallic wire (paragraph 72 – coiled wire spring; although metal is not explicitly disclosed, paragraph 57 discloses materials used for a burr which includes metal);
a control mechanism (motor disclosed in paragraph 48 in combination with 24/94; see Note below; paragraph 74; although the motor is not disclosed explicitly with regards to the figures 4A-4B embodiment, figure 1A and paragraph 48 discloses a similar drive shaft 24 coupled to an electric motor) in operative association with the elongate member 84, wherein the control mechanism (motor/24/94) is configured to expand the expandable abrasion feature 82 until it makes contact with the airway wall of the lung, the airway wall comprising a basement membrane, a smooth muscle layer, and a cartilage layer (functional limitation – paragraphs 72-74 – expandable abrasion feature 82 expands and is capable of contacting the airway wall of the lung); and
wherein the at least one strand 82 of the expandable abrasion feature 82, when the expandable abrasion feature 82 is expanded by the control mechanism (motor/24/94), is configured to detach the number of mucus producing cells from the airway wall of the lung of the patient, without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall (functional limitation – paragraphs 72-74 – the at least one strand of the expandable abrasion feature 82 is capable of detaching the number of mucus producing cells from the airway wall of the lung of the patient, without separating the smooth muscle layer of the airway wall from the cartilage layer of the airway wall by manual movement of the user).
Note – 112(f) interpretation – Applicant’s control mechanism is a motor assembly, a motion driving handpiece, handpiece, or the like that cause the catheter to rotate and/or translate in an oscillatory or vibrational manner (spec. [00203]); Wyzgala’s control mechanism is a motor that rotates and axially translates the drive shaft to control the maximum diameter of the spring 82 (paragraphs 48 and 74); therefore both control mechanisms are equivalent in rotating/translating a catheter/shaft.
Wyzgala is silent in the figures 4A-4B embodiment to a removal means;
wherein the removal means is configured to remove the number of detached mucus producing cells from the lung of the of the patient while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall.
However, Wyzgala teaches in the figures 19A-19D embodiment a removal means 574 (see Note below; paragraphs 152 and 156);
wherein the removal means 574 is configured to remove the number of detached mucus producing cells from the lung of the of the patient while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall (functional limitation – paragraphs 152 and 156 – removal means/aspiration sheath 574 is capable of removing the number of detached mucus producing cells from the lung of the of the patient while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall by applying a vacuum).
Note – 112(f) interpretation – Applicant’s removal means is a vacuum operated to remove abraded tissue from the lumen of the patient (spec. [00129]); Wyzgala’s removal means is an aspiration sheath that applies a slight vacuum to remove tissue from the vessel (paragraph 152); therefore both removal means are equivalent in applying vacuum to remove tissue.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the figures 4A-4B embodiment of Wyzgala to include a removal means as taught by the figures 19A-19D embodiment of Wyzgala for the purpose of reversing the flow of the fluid and loose particulate so that it may be removed from the vessel (paragraph 152 of Wyzgala).
With regards to claim 7, Wyzgala discloses wherein the removal means 574 comprises a vacuum source that operates to draw the airway wall toward the expandable abrasion feature 82 (functional limitation – paragraphs 152 and 156 – aspiration sheath 574 uses slight vacuum pressure and thus is capable of drawing the airway wall toward the expandable abrasion feature).
With regards to claim 8, Wyzgala discloses wherein the vacuum source 574 operates to remove the number of detached mucus producing cells from the lung (functional limitation – paragraphs 152 and 156 – aspiration sheath 574 uses slight vacuum pressure and thus is capable of removing the number of detached mucus producing cells).
With regards to claim 9, Wyzgala discloses wherein the expandable abrasion feature 82 comprises an abrasive media selected from the group consisting of diamond (paragraph 72 discloses the abrasive plated to the outer surface of the individual spring coils, paragraph 54 discloses the small diamond chips as an abrasive).
With regards to claim 10, Wyzgala discloses wherein the abrasive media has a grit size within a range from about 2 microns in average particle diameter to 3000 microns in average particle diameter (paragraph 54).
With regards to claim 11, Wyzgala discloses wherein the elongate member 84 comprises an expandable mechanism 22, and the expandable abrasion feature (abrasive on the spring 82) is disposed on the expandable mechanism 22 (figure 4A).
With regards to claim 12, Wyzgala discloses wherein the control mechanism (motor/24/94) is configured to produce linear motion in the expandable abrasion feature 82 (paragraph 74 – 94 is axially moved to control the maximum diameter of the spring 82, thus is capable of producing linear and radial motion of the expandable abrasion feature 82).
With regards to claim 13, Wyzgala discloses wherein the removal means 574 further comprises a filter trap configured to receive the number of detached mucus producing cells (paragraphs 152 and 154 – aspiration pump/filter; functional limitation – the aspiration filter is capable of filtering through the detached mucus producing cells).
With regards to claim 14, Wyzgala discloses further comprising a guidewire, wherein the expandable abrasion feature 82 is mounted on the guidewire (paragraph 73 – “Although not shown in FIGS. 4A and 4B, the drive tube 84 and nose cone 86 preferably include a lumen extending therethrough for passage of a guide wire” – expandable abrasion feature is mounted on the guidewire by way of being mounted on the drive tube 84).
With regards to claim 15, Wyzgala discloses wherein the guidewire comprises a blunt distal tip (although the guidewire is disclosed in paragraph 73 but not shown in figures 4A-4B, the guidewire is shown in another embodiment of figures 1A-1B as element 26 that has a rounded flat surface at the distal end).
With regards to claim 16, Wyzgala discloses wherein the guidewire comprises a wire cable (although the guidewire is disclosed in paragraph 73 but not shown in figures 4A-4B, the guidewire is shown in another embodiment of figures 1A-1B as element 26 that is a wire cable).
With regards to claim 17, Wyzgala discloses the device as claimed in claim 14. Wyzgala is silent wherein the guidewire has a diameter within a range of 0.005 inches to 0.100 inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wyzgala to have wherein the guidewire has a diameter within a range of 0.005 inches to 0.100 inches since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Wyzgala would not operate differently with the claimed diameter and since the guidewire is intended to reside within the elongate member 84, the method would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter is “preferably” be within the claimed ranges (specification pp. [00240]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameter of the guidewire of Wyzgala to range from 0.005 inches to 0.100 inches as an obvious matter of design choice within the skill of the art.
With regards to claim 22, Wyzgala discloses wherein the removal means 574 comprises a catheter, a suction source, and a filter trap, and wherein the suction source is configured to produce suction that draws the number of detached mucus producing cells through the catheter into the filter trap (paragraphs 152, 154, and 156 – aspiration sheath 574 is a catheter that is connected to an aspiration pump/filter, the aspiration pump produces suction and is capable of drawing the number of detached mucus producing cells through the catheter and into the filter trap).
With regards to claim 23, Wyzgala discloses further comprising a catheter 22, wherein the expandable abrasion feature 82 is coupled with the catheter 22 (figures 4A-4B; paragraph 72).
With regards to claim 28, Wyzgala discloses wherein the at least one strand 82 comprises the metallic wire (paragraph 72 – coiled wire spring; although metal is not explicitly disclosed, paragraph 57 discloses materials used for a burr which includes metal).
With regards to claim 29, Wyzgala discloses wherein the at least one strand 82 comprises a cross-section selected from the group consisting of a round cross-section (figures 4A-4B – coiled wire spring is round).
With regards to claim 30, Wyzgala discloses wherein the at least one strand 82 comprises a shape selected from the group consisting of a helical shape (paragraph 72 – coiled wire spring).
With regards to claim 32, Wyzgala discloses wherein the at least one strand 82 comprises multiple strands (paragraph 72 – individual spring coils).
With regards to claim 34, 40, and 58-59, Wyzgala discloses the device as claimed in claim 1. The combination of embodiments of Wyzgala is silent wherein the at least one strand comprises nitinol (claim 34); wherein the expandable abrasion feature comprises a shape memory material (claim 40); wherein the at least one strand comprises the metallic wire, and the metallic wire comprises a member selected from the group consisting of stainless steel, titanium, and a nickel based alloy (claim 58); and wherein the metallic wire comprises the nickel based alloy, and wherein the nickel based alloy comprises nitinol (claim 59).
However, Wyzgala further teaches in the figures 19A-19D embodiment of a spring metal mesh 612 made of Nitinol (paragraph 153).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one strand of the figures 4A-4B embodiment of Wyzgala to include wherein the at least one strand comprises nitinol; and wherein the expandable abrasion feature comprises a shape memory material as taught by the figures 19A-19D embodiment of Wyzgala for the purpose of utilizing the shape memory effect during expansion of the at least one strand.
With regards to claim 41, Wyzgala discloses wherein the expandable abrasion feature 82 is operable to expand and press against the wall of the lung airway (paragraphs 48 and 72-74 – expandable abrasion feature expands by way of the control mechanism (motor/24/94) and is capable of pressing up against the wall of the lung airway.
With regards to claim 42, Wyzgala discloses wherein the expandable abrasion feature 82 is operable to expand and press against the wall of the lung airway, and wherein the lung airway has a diameter within a range from about 2 mm to about 25 mm (functional limitation – paragraphs 48 and 72-74 - expandable abrasion feature 82 expands by way of the control mechanism (motor/24/94) and is capable of pressing up against the wall of the lung airway that has a diameter within a range from about 2 mm to about 25 mm).
With regards to claim 43, Wyzgala discloses wherein the expandable abrasion feature 82 is operable to change diameter from a first value to a second value that are within a range from 0.01 mm to 28 mm (functional limitation – paragraph 75 discloses the several diameters that can be used, thus the expandable abrasion feature is capable of changing diameters from a first value to a second value that are within a range from 0.01 mm to 28 mm).
With regards to claim 44, Wyzgala discloses wherein the expandable abrasion feature 82 is operable to expand by actuation of the control mechanism (motor/24/94; paragraphs 48 and 74).
With regards to claim 50, Wyzgala further discloses wherein the expandable abrasion feature 82 is operable to expand by actuation of a handle (motor) of the control mechanism (motor/24/94; paragraphs 48 and 74 – motor is interpreted as the handle as being on the proximal end of the device).
With regards to claim 51, Wyzgala discloses wherein the expandable abrasion feature 82 is operable to expand by actuation of a motorized driver of the control mechanism (motor/24/94; paragraphs 48 and 74).
With regards to claim 55, Wyzgala discloses wherein the at least one strand 82 has at least one etched surface (paragraphs 72 and 134).
With regards to claim 56, Wyzgala discloses wherein the control mechanism (motor/24/94) comprises an electrically actuated driver (paragraphs 48 and 74).
With regards to claim 57, Wyzgala discloses wherein the expandable abrasion feature 82 is operable to expand driven by stored strain energy (paragraphs 72-74 - elasticity of the spring 82 that expands).
With regards to claim 60, Wyzgala discloses wherein the at least one strand 82 comprises the fiber, and wherein the fiber is a monofilament fiber or a multifilament fiber (paragraph 72 – coiled wire spring is interpreted as a fiber since the spring is made of wires).
With regards to claims 61-62, Wyzgala discloses the device as claimed in claim 1. The combination of embodiments are silent wherein the at least one strand comprises the fiber, and wherein the fiber comprises a member selected from the group consisting of a polymer, a ceramic, and a glass (claim 61); and wherein the at least one strand comprises the fiber, and wherein the fiber comprises a member selected from the group consisting of a plastic, Kevlar®, a carbon fiber, nylon, polyurethane, and polypropylene (claim 62).
However, Wyzgala further teaches (Figures 9-11) in paragraph 105 of “using an elastic polymeric material for the expansion tube of the burr” and paragraph 108 “The proximal end section 432 of ablation burr 428 is preferably made from a polymeric material such as polyurethane.”
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one strand of the figures 4A-4B embodiment of Wyzgala to include being polyurethane as taught by the figures 9-11 embodiment of Wyzgala for the purpose of utilizing a material with higher flexibility and resistance to abrasion.
With regards to claim 63, Wyzgala discloses wherein the at least one strand 82 is a component of a wire basket (figures 4A-4B – coiled wire spring 82 is interpreted as a component of a wire basket). The combination of embodiments of Wyzgala is silent wherein the at least one strand comprises nitinol.
However, Wyzgala further teaches in the figures 19A-19D embodiment of a spring metal mesh 612 made of Nitinol (paragraph 153).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one strand of the figures 4A-4B embodiment of Wyzgala to include wherein the at least one strand comprises nitinol as taught by the figures 19A-19D embodiment of Wyzgala for the purpose of utilizing the shape memory effect during expansion of the at least one strand.
With regards to claim 64, Wyzgala discloses wherein the at least one strand 82 comprises a member selected from the group consisting of a round section-wire (figures 4A-4B – coiled wire spring is round).
With regards to claim 65, Wyzgala discloses further comprising a connector hub 85 and a distal end 86, wherein the at least one strand 82 is coupled with and positioned between the connector hub 85 and the distal end 86 (figures 4A-4B; paragraph 72).
With regards to claim 67, Wyzgala discloses the device as claimed in claim 66. Wyzgala is silent to further comprising a low pressure source operative to remove a second portion of the number of detached mucus producing cells while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall.
However, Wyzgala teaches in the figures 19A-19D embodiment a low pressure source 574 (paragraphs 152 and 156) operative to remove a second portion of the number of detached mucus producing cells while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall (functional limitation – paragraphs 152 and 156 – aspiration sheath 574 is capable of removing the number of detached mucus producing cells while the smooth muscle layer of the airway wall remains supported by the cartilage layer of the airway wall by applying a vacuum).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the figures 4A-4B embodiment of Wyzgala to include a low pressure source as taught by the figures 19A-19D embodiment of Wyzgala for the purpose of reversing the flow of the fluid and loose particulate so that it may be removed from the vessel (paragraph 152 of Wyzgala).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Wyzgala in view of Laufer et al. (US Patent 6,488,673), hereinafter known as “Laufer.”
With regards to claim 45, Wyzgala discloses the device as claimed in claim 1. Wyzgala is silent wherein the expandable abrasion feature is operable to expand by actuation of a pull wire of the control mechanism.
However, in a similar field of endeavor of abrasion, Laufer teaches (Figures 7 and 43C) wherein the abrasion feature 3038 is operable to expand by actuation of a pull wire 3052 of the control mechanism (Col 28 line 58 – Col 29 line 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the control mechanism of Wyzgala for the control mechanism of Laufer. The difference between the prior art and the claimed invention is that Wyzgala does not teach expansion by actuation of a pull wire. Laufer teaches (see Figs. 43C) a similar control mechanism comprising actuation of a pull wire. Accordingly, the prior art references teach that it is known that the control mechanism of Wyzgala and the control mechanism of Laufer are elements that are functional equivalents for providing expansion of the abrasion feature. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the control mechanism taught by Laufer for the control mechanism of Wyzgala because both elements were known equivalents for providing and would have resulted in the predictable results of providing expansion of the abrasion feature.
Claim 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Wyzgala in view of Springmeyer et al. (US PGPub 2012/0101428), hereinafter known as “Springmeyer.”
With regards to claims 46-48, Wyzgala discloses the device as claimed in claim 1. Wyzgala is silent to further comprising a bronchoscope having a flexible trunk and a working channel exit port, wherein the working channel exit port of the bronchoscope is configured to receive the elongate member, and wherein the bronchoscope is steerable (claim 46); wherein the bronchoscope has a working channel that is 3.2 mm or smaller (claim 47); and wherein the bronchoscope has a working channel that is 2.0 mm or smaller (claim 48).
However, in a similar field of endeavor of tissue treatment devices, Springmeyer teaches (Figures 3-6) a bronchoscope 50 having a flexible trunk (paragraph 25) and a working channel exit port (opening at the distal end of 54), wherein the working channel exit port (opening at the distal end of 54) of the bronchoscope 50 is configured to receive the elongate member 60 (see figure 5), and wherein the bronchoscope 50 is steerable (paragraphs 28 and 30);
wherein the bronchoscope has a working channel 54 that is 2.0 mm or smaller (paragraph 26 — catheter 60 that extends through the working channel 54 has a diameter of about 2 mm, catheter 60 is seen in figure 5 as extending fully within the working channel 54).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Wyzgala to include the bronchoscope as taught by Springmeyer for the purpose of better guiding and visualizing the diseased lung (paragraphs 12 and 25 of Springmeyer).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Wyzgala in view of Springmeyer, and further in view of Rafii-Tari et al. (US PGPub 2019/0183587), hereinafter known as “Rafii-Tari.”
With regards to claim 49, Wyzgala/Springmeyer disclose the device as claimed in claim 46. The combination is silent wherein the bronchoscope is steerable by an electrical driver.
However, in a similar field of endeavor of tissue treatment devices, Rafii-Tari teaches (Figure 1) wherein the bronchoscope 13 is steerable by an electrical driver (paragraphs 55, 59, and 62-63).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bronchoscope of Wyzgala/Springmeyer to be steerable by an electrical driver as taught by Rafii-Tari for the purpose of reducing manual user error.
Claim 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over Wyzgala in view of Bonutti et al. (US PGPub 2013/0253387), hereinafter known as “Bonutti.”
With regards to claims 52-54, Wyzgala discloses the device as claimed in claim 1. Wyzgala is silent wherein the expandable abrasion feature is operable to expand via robot operation of the control mechanism (claim 52); wherein the expandable abrasion feature is operable to move along or within the airway wall via robot operation of the control mechanism (claim 53); and wherein the expandable abrasion feature is operable to expand or move along or within the airway wall via robot motor or magnetic actuator operation of the control mechanism (claim 54).
However, in a similar field of endeavor of tissue treatment devices, Bonutti teaches in paragraph 180 that “Therapeutic substances may be positioned with a guidance device, for example a bronchoscope” and in paragraphs 234-235 that “Embodiments may be configured to utilize any type of energy, for example magnetic energy. Embodiments may include a magnet, electromagnet, and/or magnetizable materials, for example, to position the embodiments herein with a magnetic field… Embodiments may include a robotic arm. The robotic arm may include a robotic mechanism. Embodiments may be configured to position and/or guide any portion of the system, for example effector 110. The robotic arm may be utilized to remove tissue, expand, or if this is open channels to enhance drainage.”
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the movement of the expandable abrasion feature of Wyzgala to be controlled via a robotic/magnetic actuator operation as taught by Bonutti for the purpose of reducing manual user error.
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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/
Examiner, Art Unit 3771
12/12/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771