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 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 intraosseous driver, the intraosseous driver is inserted into the access assembly via the obturator, the access assembly comprising: an obturator assembly including an obturator 42; an extension set comprising an extension tube hub at about 60 coupled to a bag attachment member, 116 via an extension tube 100; and a needle assembly including an access needle 32, wherein the obturator 42 extends through the extension tube hub and into a needle lumen of the access needle, see fig. 3, the receptacle 34 accepts the drill at 20, the threads 67 connect the hub 60 to the assembly 30 so as to put the obturator 42 through the needle 70; wherein the bag attachment member is in fluid communication with the needle lumen, see fig. 5b showing the bag in fluid communication with the needle via the tubing 100.
Claim(s) 1-2, 4-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pollins US 6,458,117.
Regarding claim 1, Pollins discloses an intraosseous access system, see title intraosseous infusion system, comprising: an intraosseous driver 40; an access assembly, at about 32, 16, coupled with the intraosseous driver, the intraosseous driver is inserted into the access assembly via the obturator, the access assembly comprising: an obturator assembly including an obturator 50; an extension set, at about 20 comprising an extension tube hub at about 30 coupled to a bag attachment member, the joint between bag 62 via an extension tube 28; and a needle assembly including an access needle 32, wherein the obturator extends through the extension tube hub and into a needle lumen of the access needle, see col. 3, line 55- col. 4, line 9; wherein the bag attachment member is in fluid communication with the needle lumen, see figs. 2-3 showing the bag in fluid communication with the needle, see abstract the generally hollow member is selectively connected to a source 62.
Regarding claim 2, Pollins 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. The portion of the access assembly 16 is rotatably coupled to the extension tube hub 30 by threading 22.
Regarding claim 4, Pollins discloses during use, the bag attachment member is coupled with a fluid bag 62 having a fluid 64 therein.
Regarding claim 5, Pollins discloses wherein, during use, the fluid flows from the fluid bag through the needle lumens. See fig. 3 showing infusion from the bag.
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, Pollins 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 Pollins, as taught by Scribner, in order to ensure the sterility of the components and to caution operators against reuse. Supra.
Regarding claim 7, Pollins, 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, Pollins, 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 7/20/2026 have been fully considered but they are not persuasive, in part, and moot, in part.
The Applicant argues that Miller does not teach the obturator extending through the extension hub. The rejection above is provided with a new interpretation of the extension hub as element 60 through which the obturator clearly extends.
The Examiner notes that the claims as presented provide little limiting structure as to what each of the elements must be. As seen above, the extension set hub can be interpreted as element 60 to which previously interpreted extension set hub 140 is connected to. While the claims do provide additional structure that precludes 140 from being the extension set hub, the language is not specific enough to warrant withdrawal of the prior art. Thus, the independent claim remains rejected over Miller.
The Examiner has now provided a manual intraosseous driver in lieu of the drill type of Miller. The reference appears to show closer structure to that of the disclosed invention in that the infusion line 60 is connected to the access needle at the same time as the obturator being connected to the access needle.
The Examiner notes that the invention seeks provide the infusion line to the access needle during the drilling process when the obturator is connected to the needle. Claim 3 is objected to allowability because structure consistent with that connection is recited, namely, the o-ring assemblies that allow for the rotation of the needle/drill during the drilling process. Structure adequately capturing the type of intraosseous driver and the ability to have the infusion line connected thereto would likely be necessary to overcome the prior art.
An interview would likely expedite prosecution.
Conclusion
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
