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 .
Benefit
The application, filed 30 January 2005, claims benefit to US Provisional 63/627,173 filed 31 January 2024.
Formal Matters
Claims 1-20 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 30 January 2025 and 21 July 2025 have considered by the examiner. Signed copies are attached.
Claim Interpretation
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.
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 1-7, 12-17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clements et al., US 20180064426 (8 March 2018).
Regarding independent claim 1, Clements teaches a medical device (FIG 1, multiple core biopsy device MCB; ¶46) comprising:
a receiving portion (FIGs 14A-C), the receiving portion comprising:
a vessel (FIGs 14A-C, specimen chamber 120, ¶88), the vessel including an opening (FIGs 14A-C),
a blade (FIGs 14A-C, moveable blade 122; ¶88) the blade including a first sharp edge on a first side (FIGs 14A-C, moveable pivotable blade 122; ¶88) and a second sharp edge on a second side opposite to the first side (FIGs 14A, fixed edge portion 125; ¶93);
wherein the receiving portion (FIGs 14A-C) includes a first configuration (FIG 14A, stowed position; ¶88) and a second configuration (FIG 14C, deployed position; ¶89);
wherein, when the receiving portion (FIGs 14A-C) is in the first configuration (FIG 14A, stowed position; ¶88), the first sharp edge extends from one side of the opening (FIG 14A; ¶88);
wherein, when the receiving portion (FIGs 14A-C) is in the second configuration (FIG 14C, deployed position; ¶89); the second sharp edge extends from another side of the opening (FIG 14C; ¶89).
Regarding claim 2, Clements teaches the medical device of claim 1, as set forth above, wherein the blade (122) is pivotable (¶88) about a proximal most point of the opening and a distalmost point of the opening (FIGs 14A-C).
Regarding claim 3, Clements teaches the medical device of claim 2, as set forth above, wherein the blade (122) is operably connected to an actuator (control wire 37; ¶89), wherein actuating the actuator transitions the receiving portion from the first configuration to the second configuration (FIGs 14A-C; ¶89).
Regarding claim 4, Clements teaches the medical device of claim 3, as set forth above, wherein the blade (122) travels along an interior surface (FIG 14A) of the vessel (120) while the receiving portion (FIGs 14A-C) transitions from the first configuration (FIG 14A, stowed position; ¶88) to the second configuration (FIG 14C, deployed position; ¶89).
Regarding claim 5, Clements teaches the medical device of claim 1, as set forth above, wherein, when in the first configuration (FIG 14A, stowed position; ¶88), the blade (122) is configured to cut a portion of a marker into a treatment site (¶89).
Additionally, Clements teaches that “[d]eployment of depth stops 18 limit the plunge depth of the forward facing cutting edge of the specimen chamber” (FIGs 14A-C; ¶65). Accordingly, Clements teaches that the depth of the cut portion can be limited by an end-user by adjusting the depth stops 18. The term “marker” is broadly interpreted as encompassing a cut (Specification ¶9): “the blade may be configured to cut a portion of a marker into a treatment site. When in the second configuration, the blade may be configured to cut another portion of the marker into the treatment site. The marker may include a circular shape or an elliptical shape.”
Regarding claim 6, Clements teaches the medical device of claim 5, as set forth above, wherein, when in the second configuration (FIG 14C, deployed position; ¶89), the blade (122) is configured to cut another portion of the marker into the treatment site (¶89).
Additionally, “[d]eployment of depth stops 18 limit the plunge depth of the forward facing cutting edge of the specimen chamber” (FIGs 14A-C; ¶65).
Regarding claim 7, Clements teaches the medical device of claim 6, as set forth above, wherein the marker includes a circular shape or an elliptical shape (¶49).
Regarding claim 12, Clements teaches the medical device of claim 1, as set forth above, wherein the vessel (120) includes a semi-spherical shape or semi-ellipsoidal shape (FIGs 14A-C; ¶49).
Regarding claim 13, Clements teaches the medical device of claim 12, as set forth above, wherein the opening (FIGs 14A-C) includes a circular or elliptical shape (¶49).
Regarding claim 14, Clements teaches the medical device of claim 12, as set forth above, wherein the blade (122) includes an arcuate shape (FIGs 14A-C, arched cutting blade 122, ¶89).
Regarding claim 15, Clements teaches the medical device of claim 14, as set forth above, wherein a first longitudinal end of the blade (122) is pivotally connected (pivot 22) to a proximal most point of the opening and a second longitudinal end of the blade is pivotally connected (pivot 22) to a distalmost point of the opening (FIGs 14B; ¶¶88-89).
Regarding independent claim 16, Clements teaches a medical device (FIG 1, multiple core biopsy device MCB; ¶46) comprising:
a container (FIGs 14A-C, ¶88), the container including a chamber (specimen chamber 120; ¶88) and an opening at a distal end of the chamber (FIGs 14A-C), the opening including a rim extending along a perimeter of the opening (FIGs 14A-C); and
a shaft (cannula 14), wherein a distal end of the shaft is connected to a proximal end of the container (FIG 1); wherein the rim (FIGs 14A-C, including fixed blade 125) is configured to apply a material or deliver energy (cutting action, ¶88) to form a marker on a treatment site surrounding a target (blade (122) is configured to cut into a treatment site (¶89)).
The term “marker” is broadly interpreted as encompassing a cut (Specification ¶9): “the blade may be configured to cut a portion of a marker into a treatment site. When in the second configuration, the blade may be configured to cut another portion of the marker into the treatment site. The marker may include a circular shape or an elliptical shape.”
Regarding claim 17, Clements teaches the medical device of claim 16, as set forth above, wherein the medical device is configured to be coupled to a suction source (¶48), wherein the shaft (cannula 14) includes an internal lumen (suction channel 86) that fluidly connects the suction source (“V”, syringe, suction pump, or house suction source; ¶70) to the chamber of the container (FIG 1, ¶48), and wherein the suction source is configured to create negative pressure within the chamber of the container (FIG 4, specimen chamber 120; ¶70) .
Regarding independent claim 20, Clements teaches a medical system (FIG 1; system for multiple core biopsy (MCB); ¶62) comprising:
an insertion device (FIG 1; ¶65), wherein the insertion device includes:
a handle (50), the handle including a port (68); and
a shaft (cannula 14), the shaft extending from a proximal end of the handle (50), the shaft including a working channel (FIG 1, biopsy channel; ¶65); and
a medical device (FIG 1, multiple core biopsy device (MCB) 10; ¶46),
wherein the medical device includes an actuator (wire 37; ¶67) positioned at a proximal end of the medical device (FIGs 9) and an end effector (FIGs 14A-C) positioned at a distal end of the medical device (FIG 1),
the end effector (FIGs 14A-C) being receivable within the working channel (¶56),
the end effector (FIGs 14A-C) comprising:
a vessel (FIGs 14A-C, specimen chamber 120, ¶88), the vessel including an opening (FIGs 14A-C, ¶88), and a blade (FIGs 14A-C, moveable blade 122; ¶88) the blade including a first sharp edge on a first side (FIGs 14A-C, moveable pivotable blade 122; ¶88) and a second sharp edge on a second side opposite to the first side (FIGs 14A, fixed edge portion 125; ¶93);
wherein the end effector (FIGs 14A-C) includes a first configuration (FIG 14A, stowed position; ¶88) and a second configuration (FIG 14C, deployed position; ¶89) different from the first configuration (FIGs 14A-C);
wherein, when the end effector is in the first configuration (FIG 14A, stowed position; ¶88), the first sharp edge extends from one side of the opening (FIG 14A; ¶88);
wherein, when the receiving portion (FIGs 14A-C) is in the second configuration (FIG 14C, deployed position; ¶89); the second sharp edge extends from another side of the opening (FIG 14C; ¶89);
wherein actuating the actuator (wire 37) of the medical device transitions the end effector from the first configuration to the second configuration (FIGs 14A-C).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Clements et al., US 20180064426 (8 March 2018) in view of Anderhub et al., US 20050113867 (26 May 2005).
Regarding claim 8, Clements teaches the medical device of claim 1, as set forth above, wherein the medical device includes an articulation portion comprising: a pivot (FIGs 14A-C, pivot 22; ¶88).
Clements does not teach an arm; wherein a proximal end of the arm is pivotally connected to the pivot, and wherein a distal end of the arm is connected to a proximal end of the vessel.
Anderhub teaches biopsy collector assemblies comprising end effector assembly 11 (FIG 1, ¶31) comprising an arm (clevis 17), pivotally connected (pivot pin 19) to the proximal end of a vessel (pouch 16, ¶31).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Clements and Anderhub, given that the prior art included each element claimed, although not necessarily in a single reference. Clements and Anderhub teach in the same field of endeavor, medical biopsy and specimen collection.
Although, Clements discloses the claimed base medical device (receiving portion, vessel, blade, and an articulation portion comprising a pivot), Clements does not teach an arm; wherein a proximal end of the arm is pivotally connected to the pivot, and wherein a distal end of the arm is connected to a proximal end of the vessel.
Anderhub specifically addresses the device comprising an end effector assembly comprising an arm that is pivotally connected to the proximal end of a vessel. Because Clements includes an articulation portion comprising a pivot, a person of ordinary skill in the art, seeking more precise control of articulation and articulation angles of the end effector vessel in Clements' architecture would reasonably consult Anderhub’s pivotable clevis solution. Anderhub’s pivotable clevis solution can be incorporated alongside Clements' distal articulation assembly (same general location and interaction with the collection mechanism) using known assembly methods without redesigning Clements' receiving portion, vessel, blade or their use in biopsy/sample collection.
Because the references address the same engineering problem (biopsy/sample collection in lumens) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding an arm and clevis to the articulation portion comprising a pivot), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 9, Clements modified by Anderhub teaches the medical device of claim 8, as set forth above, for the reasons set forth above.
Anderhub teaches wherein the pivot (19) is operably connected to a first actuator (FIG 1 pull wire 14; ¶31), wherein actuating the first actuator pivots the arm along a horizontal plane (FIG 1; ¶31).
Regarding claim 10, Clements modified by Anderhub teaches the medical device of claim 9, as set forth above, for the reasons set forth above.
Anderhub wherein the pivot (19; ¶35) is operably connected to a second actuator (FIG 2A, tang 152; ¶35), wherein actuating the second actuator pivots the arm along a vertical plane (¶35).
Regarding claim 11, Clements modified by Anderhub teaches the medical device of claim 10, as set forth above, for the reasons set forth above.
Anderhub teaches wherein the receiving portion (FIGs 1, 2A) is operably connected to a third actuator (FIG 2A, central bridging portion 154), wherein actuating the third actuator transitions the receiving portion from the first configuration to the second configuration (¶35), wherein deactuating the third actuator transitions the receiving portion from the second configuration to the first configuration (¶¶35, 47).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Clements et al., US 20180064426 (8 March 2018) in view of Nakao, US 5,741,271 (21 April 1998).
Regarding claim 18, Clements teaches the medical device of claim 17, as set forth above.
Clements does not teach wherein the rim is coated in a dye or marker pigment, and wherein the marker is formed by the dye or marker pigment.
Nakao teaches use of a dye or marker pigment, and wherein the marker is formed by the dye or marker pigment (FIGs 12-15; col 11, line 64 to col 12, line 30).
Nakao does not expressly each wherein the rim is coated in the dye or marker pigment. However, the application of the dye to a particular area is a results-effective variable that is under the control of the end-user/surgeon/clinician, and which can be optimized. One of skill in the art would clearly recognize that the application of markers and dye can be optimized depending on the end effect desired for the use case. This is shown by FIGs 12-15 of Nakao. One of ordinary skill in the art would have had a reasonable expectation of success in applying the dye via the pressurized dye supply taught by Nakao at FIGs 12 and 13 or the Colored-Fluid source of FIG 14. The application of the dye is a results-effective variable that can be optimized by a person of ordinary skill in the art without undue experimentation based on the availability of the dye in the apparatus, as taught by Nakao. As such, applying the dye to the rim of a vessel in order to form a marker using the dye would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Clements and Nakao, given that the prior art included each element claimed, although not necessarily in a single reference. Clements and Nakao teach in the same field of endeavor, medical biopsy and specimen collection.
Although, Clements discloses the claimed base medical device (receiving portion, vessel, blade, and an articulation portion comprising a pivot), Clements does not teach wherein the rim is coated in a dye or marker pigment, and wherein the marker is formed by the dye or marker pigment.
Nakao specifically addresses teaches use of a dye or marker pigment, and wherein the marker is formed by the dye or marker pigment (FIGs 12-15; col 11, line 64 to col 12, line 30). Nakao does not expressly each wherein the rim is coated in the dye or marker pigment. However, the application of the dye to a particular area is a results-effective variable that is under the control of the end-user/surgeon/clinician, and which can be optimized. One of skill in the art would clearly recognize that the application of markers and dye can be optimized depending on the end effect desired for the use case. This is shown by FIGs 12-15 of Nakao. One of ordinary skill in the art would have had a reasonable expectation of success in applying the dye via the pressurized dye supply taught by Nakao at FIGs 12 and 13 or the colored-fluid source of FIG 14.
Because Clements includes a device comprising a rim and Nakao teaches another instrument comprising a pressurized supply of biocompatible dye (col 12, lines 5-19) which is taught as being applied to the surface of a polyp or polyp neck, a person of ordinary skill in the art, desiring to pre-mark targets prior to cutting tissue using the end effector vessel in Clements’ architecture would reasonably consult Nakao’s fluidic dye marking solution. Nakao’s fluidic dye marking solution is taught as being fully compatible with endoscopic assemblies to mark organic tissues inside patients (col 12, lines 12-19) and the solution can be incorporated alongside Clements’ distal articulation assembly (same general location and interaction with the collection mechanism) using known assembly methods without redesigning Clements’ biopsy/sample collection device.
Because the references address the same engineering problem (biopsy/sample collection in lumens) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding another endoscope assembly compatible pressurized fluidic dye marking device), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 19, Clements teaches the medical device of claim 16, as set forth above.
Clement does not teach wherein the medical device includes an electrical conduit that is electrically connected to the rim, wherein the electrical conduit is configured to be coupled to an energy source, and wherein the rim is configured to be energized by energy delivered by the electrical conduit.
Nakao teaches endoscopy-based snare cauterization assemblies for using during polyp removal operations (col 16, line 61) wherein the medical device includes an electrical conduit (FIG 25, electrically conductive wire 954; col 16, lines 41-67) that is electrically connected to the rim (expandable and contractable loop 952, col 16, lines 41-45), wherein the electrical conduit (954) is configured to be coupled to an energy source, and wherein the rim (FIG 25, loop 952) is configured to be energized by energy delivered by the electrical conduit (col 17, lines 39-43).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Clements and Nakao, given that the prior art included each element claimed, although not necessarily in a single reference. Clements and Nakao teach in the same field of endeavor, medical biopsy and specimen collection.
Although, Clements discloses the claimed base medical device (receiving portion, vessel, blade, and an articulation portion comprising a pivot), Clements does not teach wherein the medical device includes an electrical conduit that is electrically connected to the rim, wherein the electrical conduit is configured to be coupled to an energy source, and wherein the rim is configured to be energized by energy delivered by the electrical conduit.
Nakao specifically addresses endoscopy-based snare cauterization assemblies for biopsies and polyp removal operations (col 16, line 61) where cauterization snare includes an electrical conduit (FIG 25, electrically conductive wire 954; col 16, lines 41-67) that is electrically connected to the rim (expandable and contractable loop 952, col 16, lines 41-45) of the snare, wherein the electrical conduit (954) is configured to be coupled to an energy source, and wherein the rim (FIG 25, loop 952) is configured to be energized by energy delivered by the electrical conduit (col 17, lines 39-43).
Because Clements includes a biopsy sample/collection device comprising a rim and Nakao teaches electrified snare cauterization devices used in polyp removal and biopsy endoscopic procedures, a person of ordinary skill in the art, desiring to cauterize targets to reduce complications related to blood loss in addition to or in conjunction with the tissue cutting end effector and vessel assembly in Clements’ architecture, would reasonably consult Nakao’s snare cauterization assemblies. One of ordinary skill in the art would be able to use Clements’ architecture for large polyp masses or biopsy samples and Nakao’s snare cauterization for polyp necks or in cases where the sample might be particularly bloody, require a deep biopsy, or if the desired sample/lesion is close to a vessel, given that both Clements’ assembly and Nakao’s solutions are taught as being fully compatible with endoscopic assemblies and Nakao’s solution can be incorporated alongside Clements’ device (same general location and interaction with the collection mechanism) using known assembly methods without redesigning Clements’ biopsy/sample collection device.
Because the references address the same engineering problem (biopsy/sample collection in lumens) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding another endoscope assembly comprising an snare cauterization assembly), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Smith et al., US 20130172918 (4 July 2013) teaches a tissue resection bander and related methods of use.
Purohit et al., US 20240041312 (8 February 2024) teaches endoscopic patch delivery.
Nakao, US 20070016225 (18 January 2007) teaches endoscope retrieval instrument assembly.
Nakao US 5,997,547 (7 December 1999) teaches a surgical retrieval assembly and associated method.
Nguyen et al., US 20130110109 (2 May 2013) teaches a mucosal resection device and related methods of use.
Grace, US 5651781 (29 July 1997) teaches a surgical cutting instrument.
Saadat et al., US 20050203500 (15 September 2005) teaches apparatus and methods for mapping out endoluminal gastrointestinal surgery.
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/CHERIE M POLAND/Examiner, Art Unit 3771
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