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 § 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.
Claim(s) 1-2, 4-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller US 2010/0204649.
Regarding claim 1, Miller discloses an intraosseous access system, comprising: an intraosseous driver 10; an access assembly, See fig. 3, the receptacle 34 receives the driver, coupled with the driver, comprising: an obturator assembly including an obturator 42, and a needle assembly including an access needle 71, the needle assembly coupled with the obturator assembly such that the obturator is disposed within a needle lumen of the access needle, see para. [0056]; and an extension set 140 coupled with the access assembly, see fig. 5b, the extension set comprising extension tube 100 extending between an extension tube hub at a proximal end 140 and a bag attachment member 116 at a distal end, see fig. 8a, wherein the extension tube hub is coupled with the access assembly such that the bag attachment member is in fluid communication with the needle lumen, see fig. 5b, 8a, the bag is coupled to the needle lumens.
Regarding claim 2, Miller discloses the access assembly is rotatably coupled with the extension tube hub to enable the access assembly to rotate with respect to the extension set. Referring to fig. 5b, Miller shows the access assembly is rotatably coupled with the extension hub 140 since the needle and the tube and hub can rotate with respect to each other in the bone.
Regarding claim 4, Miller discloses during use, the bag attachment member is coupled with a fluid bag 112 having a fluid therein.
Regarding claim 5, Miller discloses, during use, the fluid flows from the fluid bag to the needle lumen. See para. [0080].
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(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller in view of Scribner US 6,241,734.
Regarding claim 6, Miller disclose all elements except for a first sterile package, wherein the access assembly is contained within the first sterile package.
Scribner teaches instrument groups 14, 16, 18 are packaged in a sterile kit to verify to the physician that the contents are sterile. See col. 12, lines 6-14. When packaged as a sterile assembly, the physician is cautioned against reuse and the components are sealed from the outside environment to not compromise the sterility of the contents. See col. 11, line 66- col. 12, line 63.
It would have been obvious to an ordinary skilled worker to provide a first sterile package covering the access assembly of Miller, as taught by Scribner, in order to ensure the sterility of the components and to caution operators against reuse. Supra.
Regarding claim 7, Miller, in view of Scribner, does not disclose that the extension tube extends between a sterile interior of the first package and a non-sterile exterior of the first sterile package. However, Scribner teaches that certain instruments should be packaged in sterile kits, supra, i.e. components in contact with the patient. Thus, it would have been obvious to an ordinary skilled worker to provide sterile packaging of the access assembly, including the portion of the extension tube in contact therewith, in a sterile packaging, but not those components, i.e. the tubing not in contact with the interior of the patient.
Regarding claims 8-9, Miller, in view of Scribner, discloses elements in contact with the patient should be in sterile packaging. Therefore, an ordinary skilled worker would find it obvious to place a second sterile package to contain the bag attachment member and for the reasons stated in claim 7, equally obvious to not place the tube portion of the extension tube in the sterile packaging since it doesn’t touch the internal area of the patient.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims for the reasons previously stated.
Response to Arguments
Applicant's arguments filed 4/23/2026 have been fully considered but they are not persuasive.
The Applicant argues that Miller does not anticipate the claims because the intraosseous driver, the extension set, and the access assembly are not coupled together at the same time. The Applicant argues that the driver must be removed before the extension set can be engaged and that the driver is not functionally capable of being connected to the connector assembly 90. Distilled in sum, the Applicant is arguing that the access assembly, the extension set and the intraosseous driver are not configured to be connected together at the same time.
While the Examiner concurs that the driver of Miller is designed to be removed to connect the extension set, the Examiner disagrees with the assertion that the claims require the simultaneous connection. The claims recite “an access assembly coupled with the (intraosseous) driver… an extension set coupled with the access assembly…”. The claims thus require that the driver be coupled to the access assembly and the extension set be coupled to the access assembly, but does not recite that the driver be coupled to the extension set or that the driver and the extension set are coupled to the access assembly at the same time. Thus, the Applicant appears to be arguing a recitation not required by the claims and thus, the rejection is maintained to finality.
Conclusion
THIS ACTION IS MADE FINAL. 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 GERALD LUTHER SUNG whose telephone number is (571)270-3765. The examiner can normally be reached 9-5 PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/GERALD L SUNG/Primary Examiner, Art Unit 3741
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