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 .
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 1-15 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 term “complementary” in independent claims 1 and 11 (regarding the first and second marker shapes) is a relative term which renders the claim indefinite. The term “complementary” 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. It is unclear what is and is not considered to be “complementary” shapes. Therefore, for examination purposes, the claim is being interpreted broadly such that and shapes for the first and second markers that can exist on the same medical device handle will be considered “complementary”.
Examiner notes dependent claims 2-10 and 12-15 are also rejected by virtue of their dependency from independent claims 1 and 11, respectively.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, 7-10, 16, 17, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGee (2013/0267834).
Regarding claim 1, McGee discloses a medical device (see at least figures 1 and 4) comprising: a needle (24); and a handle (the combination of elements 10, 31, 32, and 33; see figure 1 and at least paragraph [0032]) coupled to the needle, wherein the handle includes a body (10) comprising a radiolucent material (see at least paragraph [0013]), a first marker (17) proximate a proximal end of the body and a second marker (14) proximate a distal end of the body, each of the first marker and the second marker comprising a radiopaque material (see at least paragraph [0027]), wherein the first marker has a shape complementary to the second marker (both are ring shaped) to align a position of the needle relative to a subject when visualized by X-ray imaging (see at least paragraphs [0013], [0014], [0029]-[0031], and [0037]).
Regarding claim 3, the first marker and the second marker are visible (via 21) from a proximal-most end of the handle through the radiolucent material (see figure 1).
Regarding claim 4, the first marker and the second marker are oriented perpendicular to a longitudinal axis defined by the needle (see figure 1).
Regarding claim 5, one of the first marker or the second marker is a shaded shape and the other of the first marker or the second marker is a perimeter of the shaded shape (see figure 1).
Regarding claim 7, the needle is at least 10 cm in length (see at least paragraph [0009] where it states the needle can be 5 inches, which converts to approximately 12.7 cm).
Regarding claim 8, the handle includes a hub (the combination of elements 32 and 33; see figure 1) at a distalmost end of the body between the second marker and the needle.
Regarding claim 9, McGee discloses a medical system comprising the medical device of claim 1 (see the rejection of claim 1 above) and a fixture (the combination of elements 32 and 33; see figure 1) configured to receive the needle and maintain a position of the needle relative to the fixture during a medical procedure.
Regarding claim 10, the fixture includes a camera (21) configured to observe the needle during the medical procedure (see figure 1).
Regarding claim 16, McGee discloses a method of treating a subject (see at least figures 1 and 4), the method comprising: adjusting an orientation of a medical device relative to a back of the subject (see figure 4, the area within cone 34), wherein the medical device comprises: a needle (24); and a handle (the combination of elements 10, 31, 32, and 33; see figure 1 and at least paragraph [0032]) coupled to the needle, wherein the handle includes a body (10) comprising a radiolucent material (see at least paragraph [0013]), a first marker (17) proximate a proximal end of the body and a second marker (14) proximate a distal end of the body, each of the first marker and the second marker comprising a radiopaque material (see at least paragraph [0027]); and inserting the needle into the subject to access a kidney of the subject; wherein adjusting the orientation of the medical device includes aligning the first marker with the second marker by X-ray imaging (see at least figure 4 and paragraph [0011]).
Regarding claim 17, the needle is inserted while the needle forms an angle between about 25 degrees and about 35 degrees relative to the back of the subject (see figure 4, the area defined by cone 34).
Regarding claim 19, the needle is inserted through an opening of a fixture secured to the back of the subject (see figure 1), wherein the fixture maintains the orientation of the medical device relative to the subject.
Regarding claim 20, the fixture includes a camera (21), and the method further comprises monitoring insertion of the needle with the camera (see figure 1).
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.
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.
Claims 2, 11, 12, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over McGee (2013/0267834) in view of Holmin et al. (2022/0409855).
Regarding claim 2, McGee discloses the medical device substantially as described with respect to claim 1, but fails to disclose the needle includes a plurality of measurement marks along a length of the needle. Attention is drawn to Holmin et al., who teach it is known to include measurement marks on a needle (11; see at least figure 3A and paragraph [0068]) to accurately provide depth of insertion indications to the operator. Therefore, Examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided measurement marks on the needle of McGee, per the teachings of Holmin et al., to obtain the same depth of insertion indication advantages.
Regarding claim 11, McGee discloses a medical system (see at least figures 1 and 4) comprising: a medical device comprising: a needle (24); and a handle (the combination of elements 10, 31, 32, and 33; see figure 1 and at least paragraph [0032]) coupled to the needle, wherein the handle includes a body (10) comprising a radiolucent material (see at least paragraph [0013]), a first marker (17) proximate a proximal end of the body, and a second marker (14) proximate a distal end of the body, each of the first marker and the second marker comprising a radiopaque material (see at least paragraph [0027]); and a fixture (the combination of elements 32 and 33; see figure 1) configured to receive the needle and maintain a position of the needle relative to a subject during a medical procedure; wherein the first marker has a shape complementary to the second marker (both are ring shaped) to align a position of the needle relative to the fixture and relative to the subject when visualized by X-ray imaging (see at least paragraphs [0013], [0014], [0029]-[0031], and [0037]). However, McGee fails to disclose the needle includes a plurality of measurement marks along a length of the needle. Attention is drawn to Holmin et al., who teach it is known to include measurement marks on a needle (11; see at least figure 3A and paragraph [0068]) to accurately provide depth of insertion indications to the operator. Therefore, Examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided measurement marks on the needle of McGee, per the teachings of Holmin et al., to obtain the same depth of insertion indication advantages.
Regarding claim 12, the first marker and the second marker are visible (via 21) from a proximal-most end of the handle through the radiolucent material (see figure 1).
Regarding claim 13, the fixture includes a camera (21) configured to observe the needle during the medical procedure (see figure 1).
Regarding claim 15, the handle includes a hub (the combination of elements 32 and 33; see figure 1) at a distalmost end of the body, the hub being between the second marker and the needle.
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over McGee (2013/0267834) in view of Chu et al. (2020/0352672).
Regarding claim 6, McGee discloses the medical device substantially as described with respect to claim 1, but fails to disclose the radiolucent material comprises glass or a polymer. Attention is drawn to Chu et al., who teach it is known that silicone (a known polymer) can be used as a radiolucent material (see at least paragraph [0024]). Additionally, Examiner notes it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Therefore, Examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the radiolucent handle of McGee of silicone (a known polymer) per the teachings of Chu et al. as it is a known radiolucent material and each of McGee and Chu et al. describe a need for radiolucent materials.
Regarding claim 18, McGee discloses the method of treating a subject substantially as described with respect to claim 16, but fails to disclose the radiolucent material comprises glass or a polymer. Attention is drawn to Chu et al., who teach it is known that silicone (a known polymer) can be used as a radiolucent material (see at least paragraph [0024]). Additionally, Examiner notes it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Therefore, Examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the radiolucent handle of McGee of silicone (a known polymer) per the teachings of Chu et al. as it is a known radiolucent material and each of McGee and Chu et al. describe a need for radiolucent materials.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over McGee (2013/0267834) in view of Holmin et al. (2022/0409855) as applied to claim 11 above, and further in view of Chu et al. (2020/0352672).
Regarding claim 14, McGee as modified by the teachings of Holmin et al. discloses the medical system substantially as described with respect to claim 11, but fails to disclose the radiolucent material comprises glass or a polymer. Attention is drawn to Chu et al., who teach it is known that silicone (a known polymer) can be used as a radiolucent material (see at least paragraph [0024]). Additionally, Examiner notes it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Therefore, Examiner contends it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the radiolucent handle of McGee of silicone (a known polymer) per the teachings of Chu et al. as it is a known radiolucent material and each of McGee and Chu et al. describe a need for radiolucent materials.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN J SEVERSON whose telephone number is (571)272-3142. The examiner can normally be reached Monday-Friday 6:00-4:00 central.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan J. Severson/Primary Examiner, Art Unit 3771
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