DETAILED ACTION
Election/Restrictions
Claims 5 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/15/2026.
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.
Claims 1-4, 6-7 and 9-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, the limitation “for insertion into tissue” renders the claim indefinite because it is unclear which aspect(s) of the inner hollow needle are for insertion into the tissue (the needle, the tip, the distal end?). For purposes of examination the indefinite limitation has been deemed to claim that the tip is for insertion into tissue.
Regarding claim 1, the limitation “the expanding cutting portion” lacks proper antecedent basis. For purposes of examination the indefinite limitation has been deemed to claim that “the expanding cutting potion” is the same element as the “expandable flexible cutting element”. This issue also occurs in several dependent claims.
Regarding Claim 1, the limitation “assumes… configuration” renders the claim indefinite as it is unclear what limitation “assumes” imparts on the claims. It is not known if this is a static configuration or if it is a moving configuration to “assume”. For purposes of examination the indefinite limitation has been deemed to claim that the cutting element/portion can be at any point one of the claimed shapes.
Regarding Claim 1, the limitation “the outer needle” lacks proper antecedent basis. For purposes of examination the indefinite limitation has been deemed to claim that the outer needle is the same element as the sheath.
Regarding Claim 1, the limitation “wherein when the needle (301) is inserted into the target tissue, the sheath or outer needle (305) deployed in the open position, and the needle (301) rotated via the rotation mechanism, the cutting mechanism (304) cuts the tissue and directs said cut tissue into the aperture (302) and further into the lumen (306)” renders the claim definite. It is unclear if this sentence is a list of conditions that occur to allow the cutting mechanism to cut, or if the claim is intended to recite that the insertion of the needle into target tissue renders the sheath deployed in the open position. For purposes of examination the indefinite limitation has been deemed to claim “wherein when the needle (301) is inserted into the target tissue, and the sheath or outer needle (305) deployed in the open position, and the needle (301) rotated via the rotation mechanism, the cutting mechanism (304) cuts the tissue and directs said cut tissue into the aperture (302) and further into the lumen (306)”
Regarding Claim 2, the claim is nonsensical. At an angle of 10 to about 90 degrees or less appear to include angles less than 10 degrees. The limitations in parenthesis make it unclear if the limitations inside are included or excluded claim langauge. “The long axis of the inner needle” lacks proper antecedent basis. The train of “or” statements make it impossible for the Examiner to determine what is excluded or included in the claim and what angles or relative positions are being claimed. For purposes of examination the indefinite limitation has been deemed to claim that the cutting portion has an angle.
Regarding Claim 3, the claim is nonsensical. The limitations in parenthesis make it unclear if the limitations inside are included or excluded claim language. The train of “or” statements make it impossible for the Examiner to determine what is excluded or included in the claim. For purposes of examination the indefinite limitation has been deemed to claim that the cutting portion protrudes at least some % degree relative to the diameter of the needle.
Regarding Claim 4, the limitation “the long axis of the needle” lacks proper antecedent basis.
Regarding Claim 6, once again the train of “or” statements make it impossible for the Examiner to determine what is included or excluded from the claim. “The surface” lacks proper antecedent basis, is this the exterior surface as set forth in Claim 1? The train of “or” statements make it impossible for the Examiner to determine what is excluded or included in the claim. As currently claimed it appears the cutting edge can be at an position relative to the surface because all possible positions are claimed.
Regarding Claim 7, the limitations “the width”, “the inner diameter”, and “the long axis” lack proper antecedent basis. The train of “or” statements also render the claim indefinite.
Regarding Claim 9, the citation of FIG. 37C is expressly prohibited in US practice and renders the claim indefinite, as it is unclear if the applicant is attempting to claim a figure in the claim.
Regarding Claim 10, the limitation “the cut solid tissue sample component” lacks proper antecedent basis.
Regarding Claim 11, the “e.g.” limitations render the claim indefinite, because it appears the claim is using those part numbers as an example. Furthermore, the limitation “thereof” renders the claim indefinite because it is unclear what the capsule is part of. For purposes of examination the indefinite limitation has been deemed to claim that the capsule is part of the collection chamber.
Regarding Claim 12, the limitation “thereunto” renders the claim indefinite, because it is unclear what the window is “unto”. For purposes of examination the indefinite limitation has been deemed to claim that the window is part of the collection chamber.
Regarding claim 14, the phrase "preferably" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "preferably"), thereby rendering the scope of the claim(s) unascertainable.
Regarding Claim 15, the limitation “that allows the system to provide…” renders the claim indefinite, because every element of the claims as recited in the preamble is already drawn to a system, therefore, it is unclear what actual elements are providing the low-energy. For purposes of examination the indefinite limitation has been deemed to claim that the limitation “system” is removed from the body of the claim, and that there is some sort of component in the system that provides low-energy electrocoagulation.
The term “low-energy” in claim 15 is a relative term which renders the claim indefinite. The term “low-energy” 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. For purposes of examination the indefinite limitation has been deemed to claim any energy.
Regarding Claim 16, the claim is indefinite because it is unclear if the limitations in parenthesis are intended to be excluded or included in the claim. And the phrase "for example (e.g.,)" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, it is unclear if the limitation “is chosen” is intended to be a method step. For purposes of examination the indefinite limitation has been deemed to claim that the various limitations are intended to be separated as an “or” statement and that the limitations in parenthesis are optional.
Regarding Claims 18, 19 and 21, the train of “or” statements make it impossible for the Examiner to determine what is excluded and included in the claims. For purposes of examination the indefinite limitation has been deemed to claim that the “or” exists between the very two last limitations as is common in US practice.
Regarding Claim 20, the limitation “the long axis” lacks proper antecedent basis.
Regarding Claims 22 and 23, the claim is indefinite because it is unclear if the limitations in parenthesis are intended to be excluded or included in the claim. For purposes of examination the indefinite limitation has been deemed to claim that the limitations in parenthesis are optional.
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.
Claim(s) 1-4, 6 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticpated by US 20210361267 A1 to Benning et al. (hereinafter, Benning).
Regarding Claim 1, Benning discloses a biopsy system ([0068] “A biopsy device 1900 is shown in FIGS. 22 and 23.”) for harvesting tissue, said system comprising inter alia:
an inner hollow needle (piercing member 1906) having a tip disposed at a distal end of the needle for insertion into tissue ([0068] “Piercing member 1906 may include a piercing tip 1908 having any of the piercing shapes or geometries described above”), wherein a lumen is disposed in the needle (Each expandable member 1910 may be circumferentially adjacent to at least one opening 1909 disposed through the outer surface of the piercing member 1906 and in communication with a lumen extending through the piercing member 1906.);
with a distal aperture (openings 1909) disposed at or near the distal end of the needle ([0069] “piercing member 1906 includes a plurality of expandable members 1910 and a plurality of openings 1909.”), said aperture fluidly connected to the lumen ([0070] “issue has been cut by the expandable members 1910 and guided into openings 1909… move tissue proximally through piercing member 1906, allowing additional tissue to be captured.”);
an expandable flexible cutting (expandable member 1910) element adapted to cut tissue ([0070] “Once expandable members 1910 are in an expanded condition, piercing member 1906 may be rotated to allow expandable members 1910 to cut tissue…”), wherein the expanding cutting portion assumes an omega-shape, semicircular, semispherical, dome, arch, curve, bend(s) or other expanded/curved configuration ([0070] “…expandable members 1910 may be wing-like flaps that slope proximally and radially-inward along an edge 1910a from an outermost distal point 1910b.”);
a sheath slidably disposed around an exterior surface of the inner needle ([0068] “A piercing member 1906 may extend through the lumen of hollow needle 1902, and may be longitudinally slidable relative to hollow needle 1902”) the sheath adapted to move between at least an open position where the aperture and cutting mechanism are exposed (FIG. 23), and a closed position where the aperture and cutting mechanism are covered by the sheath (FIG. 22));
a mechanism for rotating the needle ([0070] “Once expandable members 1910 are in an expanded condition, piercing member 1906 may be rotated…”);
wherein when the needle is inserted into the target tissue, the sheath or outer needle is deployed in the open position, and the needle rotated via the rotation mechanism, the cutting mechanism cuts the tissue and directs said cut tissue into the aperture and further into the lumen ([0070] “Once expandable members 1910 are in an expanded condition, piercing member 1906 may be rotated to allow expandable members 1910 to cut tissue, and guide the cut tissue into respective circumferentially adjacent openings 1909.” “Once the tissue has been cut by the expandable members 1910 and guided into openings 1909, piercing member 1906 and expandable members 1910 may be retracted within the hollow needle 1902. An aspiration source may be coupled to a proximal end of biopsy device 1900 to move tissue proximally through piercing member 1906, allowing additional tissue to be captured.”).
Regarding 2, Benning discloses the system of claim 1, wherein the expanding cutting portion protrudes from the inner needle at an angle of at least about 10 degrees to about 90 degrees or less, or (about 100 to about 900) parallel to, or relative to, the long axis of the inner needle, or about 30 degrees to about 60 degrees (FIG. 22 and 23 demonstrate at least the distal portions of the expanding cutting portions are perpendicular, e.g., 90 degrees, with respect the inner cutting needle).
Regarding Claim 3, Benning discloses the system of claim 1, where the flexible expanding cutting portion protruding out from the inner needle (301) at least 1% to no more than 110% of the diameter of the inner needle(301) (The moment the expandable members first exit the inner needle, they are at least 1% the diameter of the inner needle, e.g., they are capable of achieving the claimed 1% position upon moment of first expansion).
Regarding Claim 4, Benning discloses the system of claim 1, wherein the expanding cutting portion has a sharpened or curved surface perpendicular to the long axis of the needle (FIG. 22 and 23 demonstrate at least the distal portions of the expanding cutting portions are perpendicular, e.g., 90 degrees, with respect the inner cutting needle).
Regarding Claim 6, Benning discloses the system of claim 1, where the cutting edge is positioned below the surface of the inner needle (see FIGS. 22 and 23 where the cutting edge (1908) is below the surface of the inner needle (outer surface of 1906)).
Regarding Claim 9, Benning discloses the system of claim 1, wherein said system further comprises a sample collection system (e.g., system 200 in FIG. 37C) that functionally isolates gas from tissue sample via semi-impermeable membrane (209) connected to a negative pressure source (202) ([0070] “An aspiration source may be coupled to a proximal end of biopsy device 1900 to move tissue proximally through piercing member 1906, allowing additional tissue to be captured.”).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning.
Regarding Claim 7, Benning discloses the system of claim 1, except for expressly disclosing wherein the aperture (302) and the cutting element (304) are as narrow as about 50% the width of the inner diameter of the inner needle (301), or up to about 3.5 cm wide along the long axis of the inner needle (304), or about 2.5 cm wide along the long axis of the inner needle (304), or about 1.5 cm wide along the long axis of the inner needle (304),or about 0.5 cm wide along the long axis of the inner needle (304). However, one having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the aperture and cutting elements to such size specifications. As these dimensions directly determine the volume of tissue collected and sizing them to achieve a desired sample size is routine design choice.
Claim(s) 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning in view of US 20120065542 A1 to Hibner et al. (hereinafter, Hibner).
Benning discloses the system of claim 1, except for expressly disclosing (Claim 10) wherein said collection system separates the cut solid tissue sample component from harvested fluid tissue component, (Claim 11) wherein said collection system comprises an inner portion removable as a collection chamber capsule (e.g., 207), a solid tissue sample collection chamber and capsule thereof (e.g., 206) accessible via Luer connection (e.g., 204), and/or a fluid collection chamber (e.g., 210) being accessible via Luer connection, (Claim 12) wherein the fluid collection chamber (210), the solid tissue sample collection chamber (206) and/or a window thereunto (205) is at least 10% translucent to visible light, (Claim 13) wherein the sample collection system comprises a removable or fixed housing (200), and (Claim 14) wherein from 45 degrees to 360 degrees but preferably 180 degrees of the housing is translucent.
However, Hibner teaches a needle biopsy device with a tissue sample holder (Abstract). Hibner teaches (Claim 10) wherein a collection system separates the cut solid tissue sample component from harvested fluid tissue component (via tray 42, see FIGS. 11 and 12), (Claim 11) where said collection system comprises an inner portion removable as a collection chamber capsule (tray 42) or a fluid collection chamber being accessible via a Luer connection (cup 42 is capable of being “accessible via a Luer connection” as it can touch or be in contact with a Luer connection, especially since a “Luer connection” is functionally claimed) (Claim 12) wherein the fluid collection chamber (cup 42) is at least 10% translucent to visible light ([0074] “…all or portions of cup (42) may be made from transparent materials…”), (Claim 13) wherein the sample collection system comprises a removable or fixed housing (outer side 412), and (Claim 14) wherein from 45 degrees to 360 degrees but preferably 180 degrees of the housing is translucent ([0074] “…all or portions of cup (42) may be made from transparent materials…”, e.g., 360 degrees if all portions of the cup are transparent).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the needle biopsy device of Hibner to include the collection system specifics as claimed of Hibner, as Hibner teaches that the fluid collector and tray, all being made of transparent materials, would have allowed a user to visualize collection tissue samples ([0074]).
Claim(s) 15-17, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning in view of Hibner, and further in view of US 20020072688 A1 to Burbank et al. (hereinafter, Burbank).
Benning in view of Hibner teach the system of claim 13, except for expressly disclosing (Claim 15) wherein said sample collection system comprises one or more components that allows the system to provide low-energy electrocoagulation along a needle tract, (Claim 16) wherein said components is chosen from a switch (e.g., battery switch), to enable cauterization/coagulation and/or suction (e.g., from an electric pump, manual pump, syringe, etc.), a voltage or electromotive source (e.g. battery(ies) and a vacuum tube, (Claim 17) wherein said components are arranged such that the electric pump is connected to the vacuum tube which is connected to the solid tissue collection chamber and removable collection capsule, and wherein the pump is in connection to the fluid collection chamberand Luer lock to fluid collection chamber, with semi-permeable vent,
However, Burbank teaches a biopsy device including an RF cutting wire ([0045]). Burbank teaches (Claim 15) wherein said sample collection system comprises one or more components that allows the system to provide low-energy electrocoagulation along a needle tract ([0033] “The cutting element 20 acts as an electrosurgical cutter, energizable by means of RF energy provided by the electrosurgical generator discussed supra.”), (Claim 16) wherein said components is chosen from a switch (e.g., battery switch), to enable cauterization/coagulation and/or suction (e.g., from an electric pump, manual pump, syringe, etc.), a voltage or electromotive source (e.g. battery(ies) and a vacuum tube ([0033] “… energizable by means of RF energy provided by the electrosurgical generator discussed supra.”), (Claim 17) wherein said components are arranged such that the electric pump is connected to the vacuum tube which is connected to the solid tissue collection chamber and removable collection capsule, and wherein the pump is in connection to the fluid collection chamber and Luer lock to fluid collection chamber, with semi-permeable vent (all disclosed by Hibner, above), (Claim 20 and 21) wherein the voltage or electromotive source provides applied voltages span along the long axis of the needle tract the needle created within the tissue for bipolar configuration ([0033] teaches a length of the instrument that is bipolar, while no length is necessarily specifically closed, a skilled artisan would have been motivated to provide e length being from 0.01-15cm, as these would have been one of many chosen lengths a artisan would choose to have a desired length to puncture human tissue).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the sample collection system of Benning in view of Hibner teach the system with the RF energy as set forth in the claims above, as Hibner teaches at [0007] this would have allow isolation of a target lesion and would have provided a sufficient border and clean margin.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning, Hibner and Burbank, and further in view of US 20060173377 A1 to McCullough et al. (hereinafter, McCullough).
Benning, Hibner and Burbank discloses the claimed invention as set forth in Claim 16 except for expressly disclosing wherein the voltage is between 1-30V. However, McCullough teaches at [0054] that common battery voltages are 7.2 V, thus motivating one having an ordinary skill in the art to provide such a common voltage in a battery for powering the device.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning, Hibner and Burbank, and further in view of US 20150265751 A1 to Ivorra Cano et al. (hereinafter, Ivorra),
Benning, Hibner and Burbank discloses the claimed invention as set forth in Claim 16 except for expressly disclosing wherein the voltage or electromotive source has amperages at about 0.01 mA to about 250 mA, or amperages from about 0.1 mA to 250 mA, or amperages from about 1 mA to 50 mA. However, Ivorra teaches at [0042] that limiting amperage between 1-200 mA would have prevented unwanted stimulation, thus motivating one having an ordinary skill in the art to provide such amperage.
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benning, Hibner and Burbank, and further in view of US 20210205015 A1 to Gilliland et al. (Gilliland).
Benning, Hibner and Burbank teach the claimed invention as set forth in Claim 16 except for expressly disclosing wherein the voltage or electromotive source provides an electrical flow at low (about 60Hz or less alternating current) to no frequency (direct current) over the order of seconds as the needle is removed from a subject. However, Gilliland teaches a biopsy ablation probe with a battery-powered resistive heating for cauterization during withdrawal ([0014] and [0035]), where DC electrical power is provided to prevent bleeding and kill cancer cells ([0035], [0029]), thus motivating one having an ordinary skill in the art to provide such no frequency, direct current during needle withdrawal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5827305 A to Gordon teaches the structural aspects of Claim 1, except the reference explicitly prohibits rotation.
US 20070027464 A1 teaches that the inner needle covers the opening in a sheath, not the other way around.
US 20120150066 A1 teaches a device where the cutting mechanism and inner needle are rotatable, but they are never exposed via the sheath.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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