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 .
Response to Amendment
This office action is responsive to the amendment filed on 10/2/2025. As directed by the amendment: claim 1 has been amended; no claims have been cancelled; and no claims have been added. Thus, claims 1-5 and 7 are presently pending in this application.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 20030225411 A1), under a first interpretation, in view of Shipp (US 5263937 A).
Regarding claim 1, Miller discloses an intraosseous infusion device (10, Figs. 3B, 5B-5C, and 6B), comprising,
a cannula (52/110, Figs. 5B and 8A), wherein the cannula is installed on a driver body (12, Fig. 6B), and the cannula comprises a cutter cannula tip (114, Fig. 8A), wherein an internal trocar (53/112, Figs. 5C and 8A) passes through the cutter cannula tip (Fig. 8A),
a driver shaft (54/62, Fig. 5C) directly connected to a reductor (38, 40, 45, and 20/66, Figs. 3B and 6B) directly connected to a driver motor (30, Figs. 3B and 6B),
the internal trocar (53/112), wherein the internal trocar is one-piece with the driver shaft (Fig. 5C).
Miller further discloses that the inner trocar is operable to releasably engage the connector (Paragraph [0012]).
Miller is silent regarding
wherein there is no connection component between the internal trocar and the driver shaft.
In analogous art, Shipp teaches a grip at a proximal end of a trocar that is formed either integrally with or connected to a proximal end of a shaft of a blade of a trocar (Col 4, lines 26-29).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the internal trocar and driver shaft of Miller to incorporate the teachings of Shipp to incorporate no connection component between both parts/both parts are formed integrally because Shipp teaches integrally forming the two is an alternative to connecting the two and because it is a well-known in the medical art/field to have the two parts integrally formed. Furthermore, having no connection component between the internal trocar and the driver shaft would reduce manufacturing costs since manufacturing one part is cheaper than manufacturing two parts and improve structural stability due to no connection points, which generally provide weak points.
Regarding claim 2, Miller in view of Shipp disclose the intraosseous infusion device according to claim 1, comprising one or more connection lugs (58, Miller), wherein the one or more connection lugs are located on a body (56, Miller) of the cannula (Fig. 5B, Miller), wherein the one or more lugs enable a connection of the cannula with the driver body (Fig. 6B, Miller).
Regarding claim 3, Miller in view of Shipp disclose the intraosseous infusion device according to claim 2, comprising a driver shaft female connection (54, Miller), wherein the driver shaft female connection is connected to the body of the cannula (Figs. 5A-5C, Miller).
Regarding claim 4, Miller in view of Shipp disclose the intraosseous infusion device according to claim 3, comprising one or more shaft connection notches (Image 1), wherein the one or more shaft connection notches are located on the driver shaft female connection and the one or more shaft connection notches are compatible with the one or more connection lugs (Figs. 5A-5C, Miller).
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Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 20030225411 A1), under a second interpretation, in view of Shipp (US 5263937 A).
Regarding claim 1, Miller discloses an intraosseous infusion device (10, Figs. 3B, 5B-5C, and 6B), comprising,
a cannula (51/110, Figs. 5B and 8A), wherein the cannula is installed on a driver body (60, Fig. 5B), and the cannula copmrises a cutter cannula tip (114, Fig. 8A), wherein an internal trocar (53/112, Figs. 5C and 8A) passes through the cutter cannula tip (Fig. 8A),
a driver shaft (54/62, Fig. 5C) directly connected to a reductor (38, 40, 45, and 20/66, Figs. 3B and 6B) directly connected to a driver motor (30, Figs. 3B and 6B),
the internal trocar (53/112), wherein the internal trocar is one-piece with the driver shaft (Fig. 5C).
Miller further discloses that the inner trocar is operable to releasably engage the connector (Paragraph [0012]).
Miller is silent regarding
wherein there is no connection component between the internal trocar and the driver shaft.
In analogous art, Shipp teaches a grip at a proximal end of a trocar that is formed either integrally with or connected to a proximal end of a shaft of a blade of a trocar (Col 4, lines 26-29).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the internal trocar and driver shaft of Miller to incorporate the teachings of Shipp to incorporate no connection component between both parts/both parts are formed integrally because Shipp teaches integrally forming the two is an alternative to connecting the two and because it is a well-known in the medical art/field to have the two parts integrally formed. Furthermore, having no connection component between the internal trocar and the driver shaft would reduce manufacturing costs since manufacturing one part is cheaper than manufacturing two parts and improve structural stability due to no connection points, which generally provide weak points.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 20030225411 A1, hereinafter Miller 2003), under the first interpretation, in view of Shipp (US 5263937 A) further in view of Miller et al. (US 20080215056 A1, hereinafter Miller 2008)).
Regarding claim 5, Miller 2003 in view of Shipp disclose the intraosseous infusion device according to claim 1, but are silent regarding comprising an LED light, wherein the LED light is located on the driver body, wherein the LED light illuminates an infusion procedure when desired or when a trigger is activated or the LED light dims out when desired or when the trigger is released.
In analogous art, Miller 2008 teaches an LED light (60, Paragraph [0079], Fig. 1), wherein the LED light is located on the driver body (32, Fig. 1), wherein the LED light illuminates an infusion procedure when desired or when a trigger is activated (Paragraph [0075]) or the LED light dims out when desired or when the trigger is released.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the intraosseous infusion device of Miller 2003 in view of Shipp to incorporate the teachings of Miller 2008 to incorporate an LED light, wherein the LED light is located on the driver body, wherein the LED light illuminates when a trigger is activated in order to illuminate an insertion site (Paragraph [0064], Miller 2008).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 20030225411 A1, hereinafter Miller 2003), under the second interpretation, in view of Shipp (US 5263937 A) further in view of Miller et al. (US 20090194446 A1, hereinafter Miller 2009).
Regarding claim 7, Miller 2003 in view of Shipp disclose the intraosseous infusion device according to claim 1, wherein the cannula is connected to the driver body (Fig. 5B, Miller 2003).
Miller 2003 in view of Shipp disclose are silent regarding wherein the cannula is connected to the driver body and sterilized together.
In analogous art, Miller 2009 teaches a combined medical procedure tray(s) (such as 20 in FIG. 1A or 20 in FIG. 1B) may be sterilized after being assembled (Paragraph [0134], Claim 10).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the cannula and driver body of Miller 2003 to incorporate the teachings of Miller 2009 to incorporate being sterilized together in order to provide a sterilized containment bag which may be used to engage a non-sterile medical device with a sterile medical device (Paragraph [0134], Miller 2009) and to further decrease the spread of bacteria and other pathogens to the patients which would decrease the risk of infections.
Response to Arguments
Applicant's arguments filed 10/2/2025 have been fully considered but they are not persuasive.
In response to applicant’s arguments, on page 3, that “the female connecting piece (54) is merely a connector rather than a driver shaft because claim 1 has clearly defined the driver shaft is connected to the a redactor directed connected to a driver motor” and “the connector receptacle (64), the pentagonal connecting piece (66) or connecting receptacle (72) of the powered drill apparatus (10) may be understood as the driver shaft”, the examiner respectfully disagrees. The applicant has failed to further explain why the female connecting piece 54 cannot be interpreted as the driver shaft. The claims do not further define the driver shaft, therefore Miller teaches a driver shaft (54/62), see Fig. 5C, that is directly connected to a reductor (38/40/45/20/66), see Figs. 3B and 6B, that is directly connected to a driver motor (30), see Figs. 3B and 6C.
In response to applicant’s arguments, on page 4, regarding Figs. 7A-7G of Miller, the examiner notes that this embodiment of the inner trocar 82 and stylet 100 is not being relied upon in the rejection.
In response to applicant’s arguments, on page 5, that the grip 20 of Shipp is neither a driver shaft nor a connector connected to a driver, which cannot teach the driver shaft of claim 1, the examiner respectfully disagrees. The examiner is not relying on Shipp to teach a driver shaft connected to a driver. Miller teaches a driver shaft (54/62), at one end, connected to an internal trocar (53/112). Like Miller, Shipp teaches a component (20), at one end, connected to a trocar (26) and how those pieces can be connected to each other, either integrally with or connected to. Therefore, the modification of Miller in view of Shipp teaches an internal trocar being one-piece with the driver shaft, and wherein there is no connection component between the internal trocar and the driver shaft.
In response to applicant’s arguments, on page 6, that Shipp is not analogous art, the examiner respectfully disagrees. In Miller, the trocar 53 is used to penetrate bone marrow and in Shipp, the trocar 26 is used to penetrate a body cavity. Both trocars are used in order to gain access to a particular part of the body, therefore they are considered analogous art.
In response to applicant’s arguments, on pages 7-9, that the combination of Miller in view of Shipp would destroy functionality and change the principle of operation of Miller, the examiner respectfully disagrees. The examiner not modifying the connection of the inner trocar 50 to the outer penetrator 52, nor is the examiner modifying the connection between trocar (50) and the alleged “driver shaft” (64/66/72). As noted above, the examiner has mapped the internal trocar to 53/112 and the driver shaft to 54/62 in Miller (see Fig. 3) and modified it in view of Shipp in order to make them one-piece with one another. The modification of Miller in view of Shipp in view of the examiner’s mapping would not be destroying the functionality or changing the principle of operation of Miller.
In response to applicant’s arguments, on pages 10-11, that Miller teaches away from its combination with Shipp, the examiner respectfully disagrees. Again, as noted before, the examiner is not modifying the connection between the inner trocar 50 and the outer penetrator 52. As noted above, the examiner has mapped the internal trocar to 53/112 and the driver shaft to 54/62 in Miller (see Fig. 3) and modified it in view of Shipp in order to make them one-piece with one another. Therefore the modification of Miller in view of Shipp does not teach away.
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.
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/ Primary Examiner, Art Unit 3783
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