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 .
This Office action is responsive to an amendment filed April 3, 2023. Claims 1 & 3-21 are pending. Claims 1 & 3-16 have been amended. New claims 17-21 have been added.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 14, 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 & 3-21 is/are objected to because of the following informalities:
In regards to claim 1, at lines 3-4, the limitations “at least one manually actuable triggering element” should apparently read --at least one manually actuatable triggering element--.
In regards to claim 14, at lines 4-5, the limitations “at least one manually actuable triggering element” should apparently read --at least one manually actuatable triggering element--.
In regards to claim 21, at lines 3-4, the limitations “at least one manually actuable triggering element” should apparently read --at least one manually actuatable triggering element--.
Appropriate correction is required.
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.
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: “one manually actuable triggering element for triggering a relative movement between the outer needle and the inner needle” and “one finger grip element for holding and/or for operating the biopsy needle device by means of at least one finger of a user” in claims 1, 14 & 17, “a triggering element for triggering a relative movement between the outer needle and the inner needle” in claims 6 & 20-21, “a holding mechanism…to hold the pretensioning operating element, or a component connected thereto, in at least one holding position…in relation to the force of the pretensioned triggering spring” in claim 7, and “a docking holder…for holding an external actuator with which the triggering element can be actuated by the user by means of remote triggering” in claim 13. The term “manually actuable triggering element for triggering a relative movement between the outer needle and the inner needle” includes a placeholder (“manually actuable triggering element “) coupled to a function (“triggering a relative movement between the outer needle and the inner needle”). The specification discloses a carriage 50 that can be gripped by an operator to cock and/or fire a spring 7 (see at least fig. 1). Similarly, the term “finger grip element for holding and/or for operating the biopsy needle device by means of at least one finger of a user” includes a placeholder (“finger grip element”) coupled to a function (“holding and/or…operating the biopsy needle device by means of at least one finger of a user”). The specification discloses fingerloops (8, 58) (see at least figs. 1 & 12). Moreover, the term “triggering element for triggering a relative movement between the outer needle and the inner needle” includes the placeholder (“triggering element”) coupled to the function (“triggering a relative movement between the outer needle and the inner needle”). The specification discloses a carriage 50 that can be gripped by an operator to cock and/or fire a spring 7 through latching and/or unlatching (see at least fig. 1). Additionally, the term “docking holder…for holding an external actuator with which the triggering element can be actuated by the user by means of remote triggering” includes a placeholder “docking holder” coupled to a function (“holding an external actuator with which the triggering element can be actuated by the user by means of remote triggering”). The specification discloses a needle or cannula carriage/hub 6 that may be fixedly attached to the outer needle or cannula (see at least figs. 1 & 16).
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.
Claims 1 & 3-21 is/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.
In regards to claim 1, the limitations “wherein the biopsy needle device comprises at least one of the following features: a) the biopsy needle device has only one finger grip element or the biopsy needle device has one or more finger grip elements which are arranged asymmetrically with respect to a longitudinal axis of the outer needle, b) the biopsy needle device has at least one finger grip element at the proximal end of the housing, c) the biopsy needle device has precisely three finger grip elements, d) at least one finger grip element or an arrangement consisting of at least two finger grip elements is mounted displaceably relative to the housing in the direction of the longitudinal axis of the outer needle” render the claim indefinite because the limitations alternatively require different choices (a, b, c & d) that contradict each other; for example, the biopsy needle device cannot both have “only one finger grip element” and “precisely three finger grip elements” as claimed.
In regards to claim 3, the limitations “wherein at least one finger element or an arrangement consisting of at least two finger grip elements is configured simultaneously as a triggering element” render the claim indefinite; for example, from the contradictory alternative language from claim 1 from which the claim depends, it is unclear whether the claim only requires “at least one finger element” or “an arrangement consisting of at least two finger grip elements is configured simultaneously as a triggering element.”.
In regards to claim 6, at line 3, the limitations “a triggering element” renders the claim indefinite; for example, from the limitations “at least one manually actuable triggering element” at lines 3-4 of claim 1, from which the claim depends, it is unclear whether the claim requires another triggering element other than the at least one triggering element of claim 1.
In regards to claim 7, at line 4, the limitations “in particular” render the claim indefinite; for example, it is unclear whether the limitations following the term are part of the claim.
In regards to claim 10, at line 2, the limitations “the just single finger grip element” lack sufficient antecedent basis. Moreover, from the contradictory alternative language from claim 1 from which the claim depends, it is unclear whether the claim only requires a “single finger grip element.”
In regards to claim 11, at line 2, the limitations “the finger grip element” render the claim indefinite; for example, from the contradictory alternative language from claim 1 from which the claim depends, it is unclear which as to which finger grip element the claim refers.
In regards to claim 12, the limitations “the finger grip element” at line 2 and “other finger grip elements” at line 3 render the claim indefinite; for example, from the contradictory alternative language from claim 1 from which the claim depends, it is unclear which as to which finger grip element(s) the claim refers.
In regards to claim 13, at lines 3-4, the limitations “the triggering element” renders the claim indefinite; for example, from the limitations “at least one manually actuable triggering element” at lines 3-4 of claim 1, from which the claim depends, it is unclear whether the claim requires one or more than one triggering element.
In regards to claim 14, at line 2, the limitations “a biopsy needle device” at line 2 and “a biopsy needle device of claim 1” at line 6 render the claim indefinite; for example, it is unclear whether the claim requires two separate biopsy needle devices;
at line 8, the limitations “the triggering element” renders the claim indefinite; for example, from the limitations “at least one manually actuable triggering element” at lines 3-4 of claim 1, from which the claim depends, it is unclear whether the claim requires one or more than one triggering element; and,
at lines 8-9, the limitations “the biopsy needle device” at line 8-9 renders the claim indefinite because it is unclear as to which one of the two above-referenced biopsy needle device the claim refers.
In regards to claim 16, at lines 2-3, the limitations “the triggering element” renders the claim indefinite; for example, from the limitations “at least one manually actuable triggering element” at lines 3-4 of claim 1, from which the claim depends, it is unclear whether the claim requires one or more than one triggering element.
In regards to claim 17, at lines 4-5, the limitations “the manually actuable triggering element” renders the claim indefinite; for example, from the limitations “at least one manually actuable triggering element” at line 3 thereof, it is unclear whether the claim requires one or more than one triggering element.
In regards to claim 20, at lines 2-3, the limitations “the triggering element” renders the claim indefinite; for example, from the limitations “at least one manually actuable triggering element” at line 3 of claim 17, from which the claim depends, it is unclear whether the claim requires one or more than one triggering element.
In regards to claim 21, at lines 2-3, the limitations “the triggering element” renders the claim indefinite; for example, from the limitations “at least one manually actuable triggering element” at line 3 of claim 17, from which the claim depends, it is unclear whether the claim requires one or more than one triggering element.
Claim Rejections - 35 USC § 102
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, 3-9, 11 & 17-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arnholt et al. (US 2012/0253230) (“Arnholt” hereinafter).
In regards to claim 1, Arnholt discloses a biopsy needle device 100 having at least one hollow outer needle 108, an inner needle 106 guided in a longitudinally movable manner in the outer needle 108 (see at least fig. 2), and a housing 128 (see at least fig. 1),
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wherein the biopsy needle device 100 has at least one manually actuable triggering element (126, 140, 166) for triggering a relative movement between the outer needle 108 and the inner needle 106, and at least one finger grip element (136, 152) for holding and/or for operating the biopsy needle device 100 by means of at least one finger of a user, wherein the biopsy needle device 100 comprises at least one of the following features:
a) the biopsy needle device 100 has only one finger grip element 152 or the biopsy needle device 100 has one or more finger grip elements (136, 152) which are arranged asymmetrically with respect to a longitudinal axis of the outer needle 108 (see at least fig. 1),
b) the biopsy needle device 100 has at least one finger grip element 136 at the proximal end of the housing 128 (see at least fig. 1),
c) the biopsy needle device 100 has precisely three finger grip elements (136, 152) (see at least fig. 1),
d) at least one finger grip element 152 is mounted displaceably relative to the housing 128 in the direction of the longitudinal axis of the outer needle 108 (see at least fig. 1 and par 0027-0031).
In regards to claim 3, Arnholt discloses a biopsy needle device 100 as claimed in claim 1 wherein at least one finger grip element (136, 152) is configured simultaneously as a triggering element (126, 140, 166) (see at least fig. 1 and par 0030-0031).
In regards to claim 4, Arnholt discloses a biopsy needle device 100 as claimed in claim 1 wherein the biopsy needle has at least one pretensioning operating element 126 which can be used to carry out a relative movement between the outer needle 108 and the inner needle 106 in a tensioning (i.e., compression) direction counter to the force of a triggering spring 158 of the biopsy needle device 100 (see at least fig. 1 and par 0028 & 0030).
In regards to claim 5, Arnholt discloses a biopsy needle device 100 as claimed in claim 4 wherein the pretensioning operating element 126 is configured simultaneously as a triggering element (126, 140, 166) for triggering a relative movement between the outer needle 108 and the inner needle 106, said relative movement being brought about by the force of the pretensioned triggering spring 158 and being opposed to the tensioning (i.e., compression) direction (see at least fig. 1 and par 0028 & 0030).
In regards to claim 6, Arnholt discloses a biopsy needle device 100 as claimed in claim 4, wherein the biopsy needle device 100 has, in addition to the pretensioning operating element 126, a triggering element 166 for triggering a relative movement between the outer needle 108 and the inner needle 106, said relative movement being brought about by the force of the pretensioned triggering spring 158 and being opposed to the tensioning (i.e., compression) direction (see at least fig. 1 and par 0028 & 0030).
In regards to claim 7, Arnholt discloses a biopsy needle device 100 as claimed in claim 4 wherein the biopsy needle device 100 has a holding mechanism (104, 138) which is used, when the triggering spring 158 is pretensioned, to hold the pretensioning operating element 126, or a component connected thereto, in at least one holding position, in particular in at least two different holding positions (i.e., due to ratchet teeth 138 providing an adjustable throw), in relation to the force of the pretensioned triggering spring 158 (see at least fig. 1 and par 0029-0030).
In regards to claim 8, Arnholt discloses a biopsy needle device 100 as claimed in claim 1 wherein one finger grip element (136, 152), a plurality of finger grip elements (136, 152) or all of the finger grip elements (136, 152) has/have a ring shape, the ring shape being able to be configured as a ring completely closed circumferentially (see at least fig. 1).
In regards to claim 9, Arnholt discloses a biopsy needle device 100 as claimed in claim 1 wherein one finger grip element (136, 152), a plurality of finger grip elements (136, 152) or all of the finger grip elements (136, 152) is/are configured as a separate component which is coupled rigidly or movably to the housing 128 (i.e., finger loop 136 is movably coupled to the housing 128 while finger loops 152 are rigidly coupled to the housing 128, see at least fig. 1 and par 0027-0028 & 0030).
In regards to claim 11, Arnholt discloses a biopsy needle device 100 as claimed in claim 1, wherein the distance between the finger grip element 136 arranged at the proximal end of the housing 128 and the distal end of the housing 128 is unchangeable (see at least fig. 1).
In regards to claim 17, Arnholt discloses a biopsy needle device 100 having at least one hollow outer needle 108, an inner needle 106 guided in a longitudinally movable manner in the outer needle 108 (see at least fig. 2), and a housing 128 (see at least fig. 1),
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wherein the biopsy needle device 100 has at least one manually actuable triggering element (126, 140, 166) for triggering a relative movement between the outer needle 108 and the inner needle 106, wherein the manually actuable triggering element 140 is actuable in an actuating direction which is arranged transversely with respect to the longitudinal axis of the outer needle 108 (see at least fig. 1 and par 0027).
In regards to claim 18, Arnholt discloses the biopsy needle device 100 as claimed in claim 17, wherein at least one finger grip element 152 is configured simultaneously as a triggering element (126, 140, 166) (see at least fig. 1 and par 0028 & 0031).
In regards to claim 19, Arnholt discloses the biopsy needle device 100 as claimed in claim 17, wherein the biopsy needle device 100 has at least one pretensioning operating element 126 which can be used to carry out a relative movement between the outer needle 108 and the inner needle 106 in a tensioning (i.e., compression) direction counter to the (compression) force of a triggering spring 158 of the biopsy needle device 100 (see at least fig. 1 and par 0030).
In regards to claim 20, Arnholt discloses the biopsy needle device 100 as claimed in claim 19, wherein the pretensioning operating element 126 is configured simultaneously as a triggering element (126, 140, 166) for triggering a relative movement between the outer needle 108 and the inner needle 106, said relative movement being brought about by the (compression) force of the pretensioned triggering spring 158 and being opposed to the tensioning (i.e., compression) direction (see at least fig. 1 and par 0030).
In regards to claim 21, Arnholt discloses the biopsy needle device 100 as claimed in claim 19, wherein the biopsy needle device 100 has, in addition to the pretensioning operating element 126, a triggering element (140, 166) for triggering a relative movement between the outer needle 108 and the inner needle 106, said relative movement being brought about by the (compression) force of the pretensioned triggering spring 158 and being opposed to the tensioning (i.e., compression) direction (see at least fig. 1 and par 0027-0028 & 0030).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnholt (US 2012/0253230) in view of Bacon et al. (US 2009/0299221) (“Bacon” hereinafter).
Arnholt discloses a biopsy needle device 100 as claimed in claim 1, that fails to explicitly teach a biopsy needle device wherein the just single finger grip element of the biopsy needle device is arranged on the housing in a manner laterally offset with respect to the longitudinal axis of the outer needle.
However, Bacon teaches that it is known to provide a biopsy needle device wherein the just single finger grip element 130 of the biopsy needle device is arranged
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on the housing 40 in a manner laterally offset with respect to the longitudinal axis of the outer needle 20 (see at least fig. 1, 3, 8A & 12A and par 0048-0049).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle device of Arnholt wherein the just single finger grip element of the biopsy needle device is arranged on the housing in a manner laterally offset with respect to the longitudinal axis of the outer needle as taught by Bacon since such a modification would amount to a simple substitution of one known element (i.e., the triggering mechanism as taught by Arnholt) for another (i.e., the triggering mechanism as taught by Bacon) to obtain predictable results such as facilitating cocking device by grasping and drawing the pull in a proximal direction to provide comfortable grip to the user (see at least par 0049 of Bacon)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnholt (US 2012/0253230).
Arnholt discloses a biopsy needle device 100 as claimed in claim 1, that fails to explicitly teach a biopsy needle device wherein the distance between the finger grip element arranged at the proximal end of the housing and other finger grip elements of the biopsy needle device is at least 2 cm or at least 50% of the housing length of the biopsy needle device in every operating state of the biopsy needle device. Arnholt discloses (see at least fig. 1) a biopsy needle device 100 including a distance between the finger grip element 152 arranged at the proximal end of the housing 128 and other finger grip elements 136 of the biopsy needle device 100 is at least 2 cm or at least 50% of the housing length of the biopsy needle device 100 in every operating state of the biopsy needle device 100 and as such the distance of the device is disclosed to be a result effective variable in that the distance is sized to simultaneously allow the user to ergonomically place the index and middle finger inside the other finger grip elements 136 (see par 0027) and the thumb inside the finger grip element 152 (see par 0028). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Arnholt by making the distance be at least 2 cm or at least 50% of the housing length of the biopsy needle device in every operating state of the biopsy needle device as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arnholt (US 2012/0253230) in view of Nakamura (US 6,464,648).
In regards to claim 13, Arnholt discloses a biopsy needle device 100 as claimed in claim 1, that fails to explicitly teach a biopsy needle device wherein a docking holder is arranged on the housing of the biopsy needle device for holding an external actuator with which the triggering element can be actuated by the user by means of remote triggering. However, Nakamura teaches that it is known to provide a biopsy needle device 1 wherein a docking holder (54, 89) is arranged on the housing of the biopsy needle device for holding an external actuator (i.e., eccentric cam 58 via cable W2, switch lever 96 via cable W9) with which the triggering element 26 can be actuated by the user by means of remote triggering (see at least abstract, figs. 1-2, 5-11 & 15 and col. 5, lines 17-33, col. 6, lines 49-67, col. 7, lines 1-6 & 20-26, col. 8, lines 4-12 & 42-49 and col. 9, lines 22-54). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle device of Arnholt wherein a docking holder is arranged on the housing of the biopsy needle device for holding an external actuator with which the triggering element can be actuated by the user by means of remote triggering as taught by Nakamura since such a modification would amount to applying a known technique (i.e., the remote triggering as taught by Nakamura) to a known device (i.e., as taught by Arnholt) ready for improvement to achieve a predictable result such as operating the biopsy needle by remote control, which prevents the operator from being exposed to harmful doses of radiation when the biopsy needle device is used in a biopsy performed under the guidance of CT or MRI (see col. 1, lines 8-11 & 45-51 of Nakamura)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 14, Arnholt discloses a set consisting of
- a biopsy needle device 100 having at least one hollow outer needle 108, an inner needle 106 guided in a longitudinally movable manner in the outer needle 108 (see at least fig. 2), and a housing 128 (see at least fig. 1), wherein the biopsy needle
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device 100 has at least one manually actuable triggering element (126, 140, 166) for triggering a relative movement between the outer needle 108 and a biopsy needle device 100 as claimed in claim 1 (see at least fig. 1 and par 0027-0031).
Arnholt discloses a set, as described above, that fails to explicitly teach a set comprising an external actuator with which the triggering element of the biopsy needle device can be actuated by the user by means of remote triggering.
However, Nakamura teaches that it is known to provide a set comprising an external actuator (i.e., eccentric cam 58 via cable W2, switch lever 96 via cable W9) with which the triggering element 25 of the biopsy needle device 1 can be actuated by the user by means of remote triggering (see at least abstract, figs. 1-2, 5-11 & 15 and col. 5, lines 17-33, col. 6, lines 49-67, col. 7, lines 1-6 & 20-26, col. 8, lines 4-12 & 42-49 and col. 9, lines 22-54). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle device of Arnholt comprising an external actuator with which the triggering element 25 of the biopsy needle device can be actuated by the user by means of remote triggering as taught by Nakamura since such a modification would amount to applying a known technique (i.e., the remote triggering as taught by Nakamura) to a known device (i.e., as taught by Arnholt) ready for improvement to achieve a predictable result such as operating the biopsy needle by remote control, which prevents the operator from being exposed to harmful doses of radiation when the biopsy needle device is used in a biopsy performed under the guidance of CT or MRI (see col. 1, lines 8-11 & 45-51 of Nakamura)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 15, Arnholt discloses a set as claimed in claim 14, that fails to explicitly teach a set wherein the external actuator has at least one fastening element with which the external actuator is fastenable to the biopsy needle device in a form-fitting and/or force-fitting manner. However, Nakamura teaches that it is known to provide a set wherein the external actuator (i.e., eccentric cam 58 via cable W2, switch lever 96 via cable W9) has at least one fastening element (59, 95) with which the external actuator (i.e., eccentric cam 58 via cable W2, switch lever 96 via cable W9) is fastenable to the biopsy needle device in a form-fitting and/or force-fitting manner (see at least abstract, figs. 11 & 15 and col. 5, lines 17-33, col. 6, lines 49-67, col. 7, lines 1-6 & 20-26, col. 8, lines 4-12 & 42-49 and col. 9, lines 22-54). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the set of Arnholt wherein the external actuator has at least one fastening element with which the external actuator is fastenable to the biopsy needle device in a form-fitting and/or force-fitting manner as taught by Nakamura since such a modification would amount to applying a known technique (i.e., the remote triggering as taught by Nakamura) to a known device (i.e., as taught by Arnholt) ready for improvement to achieve a predictable result such as operating the biopsy needle by remote control, which prevents the operator from being exposed to harmful doses of radiation when the biopsy needle device is used in a biopsy performed under the guidance of CT or MRI (see col. 1, lines 8-11 & 45-51 of Nakamura)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 16, Arnholt discloses a set as claimed in claim 14, that fails to explicitly teach a set wherein the external actuator has an actuation plunger for remote actuation of the triggering element of the biopsy needle device 100, the actuation plunger being longitudinally movable in a direction which runs transversely with respect to the longitudinal axis of the outer needle. However, Nakamura teaches that it is known to provide a set wherein the external actuator (i.e., eccentric cam 58 via cable W2, switch lever 96 via cable W9) has an actuation plunger 59 for remote actuation of the triggering element 26 of the biopsy needle device 1, the actuation plunger 59 being longitudinally movable in a direction which runs transversely with respect to the longitudinal axis of the outer needle 12 (see at least abstract, figs. 1-2, 5-11 & 15 and col. 5, lines 17-33, col. 6, lines 49-67, col. 7, lines 1-6 & 20-26, col. 8, lines 4-12 & 42-49 and col. 9, lines 22-54). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the set of Arnholt wherein the external actuator has an actuation plunger for remote actuation of the triggering element of the biopsy needle device 100, the actuation plunger being longitudinally movable in a direction which runs transversely with respect to the longitudinal axis of the outer needle as taught by Nakamura since such a modification would amount to applying a known technique (i.e., the remote triggering as taught by Nakamura) to a known device (i.e., as taught by Arnholt) ready for improvement to achieve a predictable result such as operating the biopsy needle by remote control, which prevents the operator from being exposed to harmful doses of radiation when the biopsy needle device is used in a biopsy performed under the guidance of CT or MRI (see col. 1, lines 8-11 & 45-51 of Nakamura)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0055493 to Krueger et al. discloses methods and apparatuses for reducing the sound profile of biopsy devices.
US 2017/0164934 to Hartley et al. discloses a method and device for extracting multiple tissue samples.
US 2012/0253230 to Williams et al. discloses an adjustable-throw biopsy needle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/Primary Examiner, Art Unit 3791