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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/18/25 and 09/27/24 have been considered by the examiner
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 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 1 recites the limitation “having the front end” in line 19. There is no antecedent basis to this limitation. Does this refer to “the front end of the needle unit” mentioned previously?
Claim 3 recites the limitation “a front end of the needle”. There is no antecedent basis to this term. Does this refer to “the front end of the needle unit” mentioned previously? Or is this a new term?
Claim 4 recites the limitation “the needle guide (130) is provided at a front thereof”. To which “front thereof” is this referring to?
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (KR 101844649) and in further view of Bendory (US 2022/0151479)
Kang was cited in Applicant’s IDS
Regarding claim 1, Kang teaches a biopsy needle module [fig. 2, element 50] that is inserted into a biopsy site of a patient using medical imaging equipment to perform a biopsy procedure [par. 1, 21], the biopsy needle module comprising: a needle unit [fig. 2, 11, element 150] comprising an inner needle [fig. 11, element 152] and an outer needle [fig. 11, element 151] disposed so as to overlap each other [fig. 12a, elements 151, 152], the needle unit being made of a highly rigid superelastic material [par. 89, 90]; a needle curving frame formed so as to be curved in a vertical direction [fig. 11, element 110; par. 89], the needle curving frame being provided at a front thereof with a needle front end exposure hole configured to expose a front end of the needle unit to an outside [fig. 12a-12d; par. 97-101]
However, Kang does not teach the needle curving frame being provided at a rear thereof with a curved rail formed so as to be open along a curved surface; and a needle guide slidably coupled along the curved rail of the needle curving frame, the needle guide being configured to support a rear end of the needle unit having the front end inserted into the needle front end exposure hole in a straight shape and to guide the needle unit so as to be moved forward and backward in a curved state along the needle curving frame
Bendory teaches the needle curving frame being provided at a rear thereof with a curved rail formed so as to be open along a curved surface [fig. 1A-1D, element 104]; and a needle guide [fig. 1A-D, element 106] slidably coupled along the curved rail of the needle curving frame [par. 66, 70], the needle guide being configured to support a rear end of the needle unit having the front end inserted into the needle front end exposure hole in a straight shape and to guide the needle unit so as to be moved forward and backward in a curved state along the needle curving frame [par. 74-77]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kang, to incorporate the needle curving frame being provided at a rear thereof with a curved rail formed so as to be open along a curved surface; and a needle guide slidably coupled along the curved rail of the needle curving frame, the needle guide being configured to support a rear end of the needle unit having the front end inserted into the needle front end exposure hole in a straight shape and to guide the needle unit so as to be moved forward and backward in a curved state along the needle curving frame, for advancing each of the supporters separately or advancing all or some of the supporters together, as evidence by Bendory [par. 70]
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Kang and Bendory and in further view of Bircher (US 2022/0000458)
Regarding claim 2, Kang and Bendory teach a biopsy needle module that is inserted into a biopsy site of a patient using medical imaging equipment to perform a biopsy procedure, as disclosed above
Kang further teaches Kang further teaches wherein the inner needle and the outer needle and attachments are coupled to an end effector of a biopsy needle manipulation robotic system to receive information as to whether the inner needle (113) and the outer needle (111) have been moved from the end effector [par. 1, 21]
However, Kang and Bendory do not teach an inner needle fixing rib (114) fixedly coupled to a rear end of the inner needle (113), the inner needle fixing rib being provided at an upper part thereof with a rear guide coupling protrusion (114a) movably coupled to the needle guide (130); and an outer needle fixing rib (112) fixedly coupled to a rear end of the outer needle (111) in front of the inner needle fixing rib (114), the outer needle fixing rib being provided at an upper part thereof with a front guide coupling protrusion (112a) movably coupled to the needle guide (130)
Bircher teaches an inner needle fixing rib (114) fixedly coupled to a rear end of the inner needle (113) [fig. 2A, elements 108, 103; par. 69], the inner needle fixing rib being provided at an upper part thereof with a rear guide coupling protrusion (114a) movably coupled to the needle guide (130) [par. 70]; and an outer needle fixing rib (112) fixedly coupled to a rear end of the outer needle (111) in front of the inner needle fixing rib (114) [fig. 2A, elements 110, 113; par. 66, 67], the outer needle fixing rib being provided at an upper part thereof with a front guide coupling protrusion (112a) movably coupled to the needle guide (130) [par. 66, 67]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kang and Bendory, to incorporate an inner needle fixing rib (114) fixedly coupled to a rear end of the inner needle (113), the inner needle fixing rib being provided at an upper part thereof with a rear guide coupling protrusion (114a) movably coupled to the needle guide (130); and an outer needle fixing rib (112) fixedly coupled to a rear end of the outer needle (111) in front of the inner needle fixing rib (114), the outer needle fixing rib being provided at an upper part thereof with a front guide coupling protrusion (112a) movably coupled to the needle guide, such that the carrier is moveable in relation to the handle and, as a result, the cannula is slidable in relation to the inner needle, as evidence by Bircher [par. 69]
Regarding claim 3, Kang further teaches wherein straighteners [fig. 11, element 110 (lower portion causing the needle to exit straight); par. 79], in which markers configured to indicate a position of a front end of the needle are received [fig. 11, element 40; par. 87], are integrally coupled to both sides of a front end of the needle curving frame, in which the needle front end exposure hole is formed [par. 79]
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kang, Bendory and Bircher and in further view of Goldenberg (US 2018/0289362)
Regarding claim 4, Kang, Bendory and Bircher teach a biopsy needle module that is inserted into a biopsy site of a patient using medical imaging equipment to perform a biopsy procedure, as disclosed above
However, Kang, Bendory and Bircher do not teach the curved rail (125) is provided with a guide insertion channel (125a) formed so as to be depressed inward along a curved path, the guide insertion channel being configured to allow the needle guide (130) to be moved in a state of being inserted thereinto, a pair of protrusion guide slits (125b) is formed in both sides of a plate surface of the curved rail (125) in which the guide insertion channel (125a) is formed, the needle guide (130) is provided at a front thereof with a rail insertion end (133) inserted into the guide insertion channel (125a), and a pair of guide protrusions (135) inserted into the protrusion guide slits (125b) is formed on both sides of the rail insertion end (133) so as to protrude therefrom, the guide protrusions being configured to support the rail insertion end (133) so as to be moved along the guide insertion channel (125a).
Goldenberg teaches the curved rail (125) is provided with a guide insertion channel (125a) formed [fig. 22, 23, element 1001] so as to be depressed inward along a curved path, the guide insertion channel being configured to allow the needle guide (130) to be moved in a state of being inserted thereinto [par. 106, 107, 109]; a pair of protrusion guide slits [fig. 22, 23, element 1430] is formed in both sides of a plate surface of the curved rail (125) [fig. 22, 23, elements 1413, 1415] in which the guide insertion channel (125a) is formed [fig. 22, 23, element 1001], the needle guide (130) is provided at a front thereof with a rail insertion end (133) inserted into the guide insertion channel (125a), and a pair of guide protrusions (135) inserted into the protrusion guide slits (125b) is formed on both sides of the rail insertion end (133) so as to protrude therefrom [fig. 22, 23, element 1005], the guide protrusions being configured to support the rail insertion end (133) so as to be moved along the guide insertion channel (125a) [par. 106, 107, 109]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kang, Bendory and Bircher, to incorporate the curved rail (125) is provided with a guide insertion channel (125a) formed so as to be depressed inward along a curved path, the guide insertion channel being configured to allow the needle guide (130) to be moved in a state of being inserted thereinto, a pair of protrusion guide slits (125b) is formed in both sides of a plate surface of the curved rail (125) in which the guide insertion channel (125a) is formed, the needle guide (130) is provided at a front thereof with a rail insertion end (133) inserted into the guide insertion channel (125a), and a pair of guide protrusions (135) inserted into the protrusion guide slits (125b) is formed on both sides of the rail insertion end (133) so as to protrude therefrom, the guide protrusions being configured to support the rail insertion end (133) so as to be moved along the guide insertion channel, results in a release of a second actuator 1500 that is configured to both axially advance the inner tube 1020 and outer cannula 1030 and then subsequently cause the controlled rotation of the inner tube 1020 relative to the outer cannula, as evidence by Goldenberg [par. 109]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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