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 .
Examiner’s Note
Prosecution of the instant application has been taken over by Examiner Eiseman from previous Examiner Quinichett. In accordance with MPEP 704.01, the examiner will give full faith and credit to the search and action of the previous examiner unless there is a clear error in the previous action or knowledge of other prior art. All future communications should be directed to Examiner Eiseman at the contact information provided at the end of this office action.
Response to Arguments
Applicant’s arguments, see the pre-appeal brief, filed 9/23/2025, with respect to the rejection of claims 1-5 and 8-18 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Muse (US 2019/0328370 A1) as provided in the rejection presented below.
Furthermore, the examiner is providing the 35 USC 112(a) written description rejection as outlined below for the use of the terminology “keyed” and “keying structure” throughout the claims.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a sampling device configured to be coupled to an insertion device configured to convey the needle to a tissue to be sample” in claims 10-18.
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.
A review of the specification does not appear to provide the corresponding structure of “a sampling device” as recited in claims 10-18, as the term “sampling device” is not used once within the specification and it isn’t clear what structure corresponds to “a sampling device” as there are multiple elements which are describe as sampling or sampling related.
Please see the 35 USC 112(a) and 112(b) rejections below for further details on how the limitation will be treated and interpreted for the purpose of advancing prosecution.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 and 8-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, the claims were amended in the response filed on 5/6/2025 to recite “a keyed guide tube” and “a keying structure protruding from an outer diameter to form a keyed outer cross-section” and similar in independent claims 1 and 10 (and dependents thereupon). However, a review of the specification shows that the term “keyed” is absent throughout, and instead the specification merely recites asymmetrical guide tube and further defines protruding structures in paragraphs [0092]-[0097] and depicted in figures 14-17. While the examiner appreciates the “a keyed guide tube” and “a keying structure” as recited in the claims may overlap with the scope of an asymmetrical guide tube and protruding structures, they are not commensurate in scope when considered on the totality of the evidence provided within the specification and to one of ordinary skill in the art. As such, the new terms amount to new matter, as they were not sufficiently described in the specification to show that the applicant had possession of the scope of the claimed subject matter at the time of filing.
The examiner encourages the applicant to amend the claims to recite language consistent with the specification in order to overcome the instant rejection, specifically referring to paragraphs [0092]-[0097] of the applicant’s submitted specification which describes “asymmetric guide tube” and “protruding structure” which are shaped to be received within a slot on the side of asymmetrical distal opening of the needle actuator.
Claims 10-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 10-18 lack written description support as the specification does not provide/describe the corresponding structure for “a sampling device configured to be coupled to an insertion device configured to convey the needle to a tissue to be sample” which is interpreted as invoking a 35 USC 112(f) interpretation. Accordingly, as the structure of the means plus function limitation is not described, there is insufficient written description as the specification does not show sufficient evidence to show that the applicant had possession of “a sampling device configured to be coupled to an insertion device configured to convey the needle to a tissue to be sample” which has no corresponding structure.
Claims 5, 6, 13 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, claims 5, 6, 13 and 14, recite the limitation “the needle actuator being configured to receive the distal end of the keyed guide tube responsive…” which is not described or supported in the specification. At least paragraphs [0023], [0109] and figures 5-8, describe that the needle actuator (element 140) is configured to receive the proximal end of the keyed guide tube (element 130) (bolded and underlined for emphasis). As the specification and drawings only show the needle actuator configured to coupling with the proximal end of the guide tube, there is insufficient written description top show that the applicant had possession of the needle actuator being configured to receive the distal end of the keyed guide tube as recited.
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 10-18 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.
Claim limitation “a sampling device configured to be coupled to an insertion device configured to convey the needle to a tissue to be sample” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. As described in the 35 USC 112(a) and 112(f) sections above, the specification does not describe or disclose what the corresponding structure of “a sampling device” comprises. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Further regarding claims 10-18; as it is unclear as to what structure “a sampling device” comprises, the claim itself is indefinite as it the scope of the claim becomes unclear. A review of the specification does not clearly identify what “a sampling device” comprises, and the context in the claim does not further elucidate what the relationship between the sampling device and the needle and actuation device comprises.
In order to advance prosecution for the purpose of examining the claims on the basis of prior art and practice compact prosecution, the examiner will interpret the claim as follows:
Claim 10:
A system comprising:
a sampling device comprising:
a needle defining a first lumen;
a needle actuator configured to be coupled to a proximal end of the needle, wherein the needle actuator includes a keyed distal opening configured to receive the keyed guide tube responsive to the needle actuator being oriented to cause a distal end of the needle to face in a pre-defined direction;
wherein the sampling device is configured to be couple to an insertion device configured to convey the needle to a tissue to be sampled;
a keyed guide tube defining a second lumen configured to slidably convey the needle from a proximal end of the keyed guide tube to a distal end of the keyed guide tube, wherein the keyed guide tube includes a keying structure disrupting a circular outer diameter to prevent rotation of the keyed guide tube related to the sampling device.
Claim 11 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.
Claim 11 recites “the keyed guide tube is coupled with an insertion device” which is indefinite in view of claim 10 which claim 11 is dependent upon. Specifically, “an insertion device” is already recited in claim 10, but it is referred to in the functional sense in that it is not positively recited; and now there is “an insertion device” recited in claim 11, but it is unclear if it is the same insertion device, and if it is the same insertion device as recited in claim 10, if the insertion device is now required or if it this is simply functionally claiming that the keyed guide tube is for coupling to the insertion device.
In order to advance prosecution on the basis of prior art and practice compact prosecution, based on a review of the specification, the examiner will interpret the claim as follows:
Claim 11:
The system of claim 10, further comprising an insertion device configured to convey the needle to a location adjacent to a tissue to be samples;
wherein the keyed guide tube is couple to the insertion device.
Claims 5, 6, 9, 13 and 14 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.
The limitation “needle actuator being configured to receive the distal end of the keyed guide tube” of claims 5, 6, 9, 13-18 is indefinite in light of the specification and drawings. Specifically, the specification and drawings only describe the needle actuator configured to receive the proximal end of the keyed guide tube, and as such the scope of the claim is indefinite as it is unclear as to how the needle actuator would receive the distal end of the keyed guide tube which is inserted into the insertion device.
For the purpose of advancing examination on the basis of prior art and practicing compact prosecution, the examiner will interpret the limitation as if it recited “the needle actuator being configured to receive the proximal end of the keyed guide tube”.
Claim 16 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.
Claim 16 recites “a second channel extending longitudinally along an inner surface of the needle actuator”, which is indefinite as there is confusion as to what the second channel comprises. Specifically, there is no first channel recited in the claim dependency of claim 16, so it is unclear if there the claim limitation requires there to also be a first channel, or if the second channel recited in claim 16 is just a channel.
For the purpose of advancing examination on the basis of prior art and practicing compact prosecution, the examiner will interpret the limitation as if it recited “a channel extending longitudinally along an inner surface of the needle actuator”
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muse (US 2019/0328370 A1), at least as broadly as currently recited.
Regarding claims 1-5, 8 and 9; Muse discloses an apparatus comprising:
a keyed guide tube (element 420) defining an inner lumen (element 424) configured to slidably convey a needle (element 410) from a proximal end of the keyed guide tube to a distal end of the keyed guide tube (figure 9, wherein element 410 is inserted from the proximal end at element 422 and extends from the distal end at element 426), wherein the keyed guide tube (element 420) includes a keying structure (element 422) protruding from an outer diameter to form a keyed outer cross-section (wherein the examiner notes that element 422 extends from the outer circumference of the hollow cannula element 424 and includes keying structure element 496 that ensure that needle element 410 can only be inserted into guide tube element 420 in a pre-defined orientation; paragraphs [0193]); and
a needle actuator (element 412) configured to be coupled to a proximal end of the needle (wherein element 412 is fixed to element 414; figure 9), wherein the needle actuator (element 412) includes a distal opening (element 481; figure 10a) configured to receive the keying structure (element 496; figure 10c) of the keyed guide tube (element 420; figure 10c) responsive to the needle actuator being oriented to cause a distal end of the needle to face in a pre-defined direction (wherein the needle element 410 is inserted into guide tube element 420 in a pre-defined orientation determined by the interface and socket, elements 481 and 482 respectively, such that the tip will emerge from the distal end of the tube element 420 is a pre-defined unique rotation/angular orientation determined as the needle element 410 is fixed to element 412 and element 412 only receives element 422 of guide tube element 420 is a single unique angular/rotational orientation; paragraph [0185]; figure 9, 10a and 10c).
Further regarding claim 2; Muse discloses the keyed guide tube (element 420) is coupled with an insertion device (drill) configured to convey the needle to a location adjacent to a tissue to be sampled (wherein combined element 410 and 420 are coupled together and are configured to be coupled to a drill/driver in order to insert/convey the combined element 410/420 to the location adjacent to where a tissue is to be sampled; paragraph [0186]; paragraph [0210]) .
Further regarding claim 3; Muse discloses the distal end of the needle (element 416) is oriented in the pre-defined direction when the distal end of the needle is oriented to move outwardly from a distal opening in the insertion device toward the tissue to be sampled (paragraph [0185]-[0186]; figure 11)
Further regarding claim 4; Muse discloses the keyed guide tube (element 420) includes a first protrusion (uneven sides of octagon; element 496) along the keyed outer cross-section configured to be received in a first recess (element 482) of the distal opening (element 481) of the needle actuator (element 412), the needle actuator being configured to receive the proximal end of the keyed guide tube responsive to the first protrusion being received within the first recess (paragraph [0185]-[0186]; figures 9, 11).
Further regarding claim 5; Muse discloses the first protrusion (element 496) is at an end of a first channel (channel of cannula element 424) that extends longitudinally along an outer surface of the keyed guide tube (wherein lumen of cannula element 424 extends along the outer surface of the guide tube in that the outer surface of element 424 is adjacent and extends in the same direction of the lumen of element 424), the first channel being configured to maintain an orientation of the needle as the needle actuator is moved along the keyed guide tube (wherein the orientation of the needle is maintained as the actuator element 412 is moved into contact with the post of element 422 of the guide tube along for the height of the post element 496; paragraph [0185], thus meeting the BRI of the claim which does not require the orientation of the needle to be maintained the entire distance of the guide tube; figures 9, 10a, 10c and 11).
Further regarding claim 8; Muse discloses the keyed guide tube (element 420) includes a shaped outer surface (connection interface and post, elements 495 and 496, respectively) configured to engage a shaped inner surface (connection interface and recess, elements 481 and 482, respectively) of the needle actuator (element 412) to maintain an orientation of the needle as the needle actuator is moved along the keyed guide tube (wherein the orientation of the needle is maintained as the actuator element 412 is moved into contact with the post of element 422 of the guide tube along for the height of the post element 496; paragraph [0185], thus meeting the BRI of the claim which does not require the orientation of the needle to be maintained the entire distance of the guide tube; figures 9, 10a, 10c and 11).
Further regarding claim 9; Muse discloses the shaped outer surface (element 495 and 496) includes at least one ridge (extended shape side of octagon post, element 496) configured to be received in at least one indentation (extended shape side of opening recess, element 482) in the distal opening (element 481 and 482) of the needle actuator (element 412) wherein the needle actuator receives the proximal end of the keyed guide tube only when the at least one ridge is received within the at least one indentation (paragraph [0185]-[0186]).
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 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 10-12 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Muse in view of Mercier et al (US 2013/0274778 A1).
Regarding claims 10 and 15-18; Muse discloses A system (figure 9) comprising:
a sampling device (element 440) comprising:
a needle (element 444) defining a first lumen (element 445);
a needle actuator (element 442) configured to be coupled to a proximal end of the needle (element 444; figures 13, 14, 16), wherein the needle actuator includes a keyed distal opening (elements 491 and 492) configured to receive the keyed guide tube (element 420, specifically element 495 and 496) responsive to the needle actuator being oriented to cause a distal end of the needle to face in a pre-defined direction (wherein Muse discloses in paragraph [0240] that element 449 can be locked to element 442 and thus prevent rotation of element 444, which in turn thus locks the needle element 444 to a pre-defined direction with relation to the distal end of the keyed guide tube element 420 since element 442 of element 440 is only insertable over element 420 in a unique orientation by keying interfaces 491 of element 442 and 495 of element 422; paragraphs [0189], [0240]; figures 10B, 10C, 13);
wherein the sampling device (element 440) is configured to convey the needle (element 444) to a tissue to be sampled (figures 15B-E);
a keyed guide tube (element 420) defining a second lumen (lumen defined by element 424) configured to slidably convey the needle from a proximal end of the keyed guide tube to a distal end of the keyed guide tube (wherein element 440 is inserted into element 420 to move element 444 from the proximal end of element 420 at element 422 to the distal end of element 420 at element 426), wherein the keyed guide tube (element 420) includes a keying structure (element 422) disrupting a circular outer diameter (wherein element 422 is connected to and thus disrupts the circular outer diameter of element 420 at the proximal end where element 422 is fixed) to prevent rotation of the keyed guide tube (element 420) related to the sampling device (element 440) (wherein interface element 495 and 496 of keyed guide tube element 422 interface with interface elements 491 and 492 of sampling element 440 and thus prevents rotation of the guide tube element 420 in relation to the sampling device element 440 when the post element 496 interacts with recess element 492).
However, Muse does not explicitly disclose that the sampling device is configured to be coupled to an insertion device configured to convey the needle to a tissue to be sampled.
Mercier teaches the use of an insertion device (elements 10) configured to be coupled with a sampling device (wherein guide tube element 16 is configured to receive a biopsy device or similar) in order to direct the biopsy instrument to the correct location within the body for sampling (paragraph [0027]; figures 1, 2 and 5).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify Muse’s biopsy device to be configured to couple to an insertion device as taught by Mercier in order to ensure that the biopsy device is guided to the correct location for sampling in the body.
Further regarding claim 11; the Muse/Mercier combination as described above discloses the keyed guide tube (element 420 of Muse) is coupled with an insertion device (element 10 comprising biopsy insertion guide, element 16) configured to convey the needle to a location adjacent to a tissue to be sampled (wherein Mercier discloses surgical guide, element 10, helps locate the biopsy device adjacent to tissue to be sampled (paragraph [0027]).
Further regarding claim 12; the Muse/Mercier combination as described in the rejection of claims 10 and 11 above teaches the distal end of the needle (element 446) is oriented in a pre-defined direction (wherein the orientation of the needle matches the orientation of the guide tube element 16 of Mercier) when the distal end of the needle (element 446) is oriented to move outwardly from a distal opening in the insertion device (wherein when Muse’s combined elements 440 and 420 are inserted into guide element 16 of Mercier, the distal end of the needle is oriented is the same angle and direction as the guide tube element 16 of Mercier).
Further regarding claim 15 and 16; the Muse/Mercier combination discloses the keyed guide tube (element 420) includes a protrusion along an outer-cross section (extended side of the interface elements 495 and 496; figure 10C) configured to engage a recess (space of interface element 492 for receiving oblong extended side of interface element 496) in a circumference in the keyed distal opening (elements 491 and 492) of the needle actuator (element 442), the needle actuator (element 442) being configured to receive the proximal end of the keyed guide tube (element 420) responsive to the protrusion being received by the recess (wherein element 440 is configured to couple and mate with element 420 when keyed interface elements 495 and 491 are aligned).
Further regarding claim 16; the Muse/Mercier combination discloses the recess (element 492) is at an end of a second channel extending longitudinally along the inner surface of the needle actuator (wherein the interior of element 442 includes a channel through which element 444 extends, and element 492 is located at the end of the channel; see figure 13) and configured to maintain an orientation of the needle (element 444) as the needle actuator (element 442) is moved along the keyed guide tube (wherein the needle is maintains an orientation as it is locked into place by locking mechanism as described in paragraph [0240] and thus as the socket element 492 of actuator element 442 moved along post element 496 of element 422, the needle will maintain is orientation for that distance; wherein examiner notes that the claims to not require that the needle mountain is orientation as its moved along the entire length/distance of the guide tube).
Further regarding claim 17 and 18; the Muse/Mercier combination discloses the keyed guide tube (element 420) includes a shaped outer surface (element 495/496) configured to engage a shaped inner surface (element 491/492) of the needle actuator (element 442) to maintain an orientation of the needle as the needle actuator is moved along the keyed guide tube (wherein Muse discloses in paragraph [0240] that element 449 can be locked to element 442 and thus prevent rotation of element 444, which in turn thus locks the needle element 444 to a pre-defined direction with relation to the distal end of the keyed guide tube element 420 since element 442 of element 440 is only insertable over element 420 in a unique orientation by keying interfaces 491/492 of element 442 and keying interfaces 495/496 of element 422; paragraphs [0189], [0240]; figures 10B, 10C, 13).
Further regarding claim 18; the Muse/Mercier combination discloses the shaped outer surface (elements 495/496) includes at least one ridge (extended side of octagon on the keyed surface 495/496) configured to be received in at least one indentation (part of receiving socket 491/492 that receives extended side of keyed surface 495/496) in the keyed distal opening (element 491/492) of the needle actuator (element 442) wherein the needle actuator received the proximal end of the keyed guide tube only when the at least one ridge is received within the at least one indentation (paragraphs [0189]; figures 10B, 10C, 13, 16).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Muse in view of Mercier as applied to claim 10 above, and further in view of Weitzner et al (US 2008/0188890 A1).
The Muse/Mercier combination is described in the rejection of claim 10 above; Muse teaches the use of a keying feature to ensure the guide tube and actuator are in a unique configuration/orientation and prevent rotation of the tube and actuator relative to each other.
However, it does not explicitly disclose the keyed guide tubes includes a first recess along an outer cross section configured to receive a first protrusion extending inwardly from the keyed distal opening of the needle actuator, the needle actuator being configured to receive the distal end of the keyed guide tube responsive to the first protrusion being received within the housing.
Weitzner teaches another known keying feature configuration wherein the male part includes a channel which received a protrusion/keying feature from the female part in order to prevent rotation of the male part relative to the female part while allowing translational movement (paragraph [0277]; figure 56).
Regarding claims 13 and 14; the Muse/Mercier combination teaches a system wherein the keyed guide tube is prevented from rotation relative to the actuator through the use of a keying feature. Weitzner teaches another well known configuration for a keying feature. Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the Muse/Mercier keying feature configuration between the keyed guide tube and the actuator with Weitzner’s keying feature configuration as simple substitution of one known element for another to yield a predictable result (in this case, where the male post element 495/496 includes a slot/groove and the femail receiving slot element 491/492 includes a protrusion that corresponds to the slot/groove in order to ensure a unique orientation and prevent rotation of one relative to the other as taught by both Muse and Weitzner. After making such a modification, the Muse/Mercier/Weitzner combination would disclose the keyed guide tube includes a first recess along an outer cross section configured to receive a first protrusion extending inwardly from the keyed distal opening of the needle actuator, the needle actuator being configured to receive the distal end of the keyed guide tube responsive to the first protrusion being received within the housing
Further regarding claim 14; the Muse/Mercier/Weitzner discloses the first recess is at an end of a first channel (lumen of keyed guide tube) that extends longitudinally along an outer surface of the keyed guide tube (wherein by definition as the lumen extends along the length of the guide tube, then the first channel does extend longitudinally along the outer surface of the guide tube), the first channel being configured to maintain an orientations of the needle as the needle actuator is moved along the keyed guide tube (wherein the keyed structure of the guide tube maintains the orientation of the needle as the actuator is moved along the keyed guide tube when the actuator is being extended over the keying structure/post of the guide tube).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2018/0116645 A1 to Nosler; discloses a needle combination for collecting samples during endoscopic procedures which includes a keying feature to prevent relative rotation of one element relative to another.
US 2009/0192408 A1 to Mark; discloses a surgical site marker delivery system which includes keying a tube guide to a tissue cutting device.
US 2012/0226101 A1 to Tinkham et al; discloses an endoscopic ultrasound device which includes configurations for keying one needle/tube relative to another.
US 12,551,201 B2 to McGillicuddy et al; discloses a bone access, bone capture, and aspiration devices which includes keying features to prevent rotation of one element relative to another.
US 5,990,382 to Fox; discloses an introducer for providing access for another device such as a biopsy device.
US 2021/0059648 A1 to Panzenbeck et al; discloses a real-time sampling system which includes a keying feature for preventing relative rotation of one element to another.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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