DETAILED ACTION
This is a final rejection in response to amendments filed 7/17/26. Claims 1-20 are currently pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-20 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 "the inner surface of the introducer tube and outer surface of the stylet". There is insufficient antecedent basis for this limitation in the claim. Subsequent dependent claims 2-17 are further rejected.
Claim 18 recites the limitation "the inner surface of the introducer tube and outer surface of the stylet". There is insufficient antecedent basis for this limitation in the claim. Subsequent dependent claims 19-20 are further rejected.
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) 18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murphy (US 2013/0226210).
Regarding independent claim 18, Murphy teaches a needle assembly comprising: an introducer tube 116 extending along an axis and providing a central lumen 132 and sized for percutaneous introduction through the skin of a patient [0052]; a stylet 112 having a tip 136 and being slidably receivable coaxially within the introducer tube to extend therethrough to expose the tip from a distal end of the introducer tube [0054]; and wherein a material of the stylet has an x-ray absorption measured along the axis equivalent to a material with an atomic number measured along the axis of less than 20 [0054].
Regarding dependent claim 20, Murphy teaches wherein the stylet has an average effective atomic number of greater than 6 [0054].
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.
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(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murphy.
Regarding dependent claim 19, Murphy teaches the invention as claimed and discussed above. Murphy is silent to wherein a distal portion of the stylet has a higher effective atomic number than a proximal portion of the stylet.
However, Murphy discloses the stylet’s tip is complementary to the tip of the cannula and that the solid shaft is preferably made from substantially the same material as shaft 132, such that shaft 148 is hard enough and/or rigid to pierce a target area [0053], evidencing that harder relatively higher atomic number materials are desirable at the piercing tip for mechanical performance. Murphy separately discloses in Table 1, a range of lower atomic number materials suitable for the remainder of the stylet shaft to reduce imaging artifact, and states that the stylet’s material is selected from a group including aluminum, carbon fiber, plastic, nitinol, and iconel [0056], expressly contemplating multiple, functionally distinct materials.
It would have been obvious to one of ordinary skill in the art at the time of filing to construct Murphy’s stylet with a distal tip portion of a relatively higher atomic number material (such as aluminum) and a proximal shaft portion of a relatively lower atomic number material (such as carbon fiber) because Murphy already teaches the tip benefits from a harder more rigid material to pierce tissue and the shaft benefits from a lower density material to minimize CT imaging artifacts as part of an obvious combination of known prior art structures to achieve predictable results. See KSR; MPEP 2141 III A.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG SANG KIM whose telephone number is (571)270-1418. The examiner can normally be reached 7:00 AM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at 571-272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG KIM/
Primary Examiner
Art Unit 3741
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