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 statement (IDS) submitted on 04/09/2026 was 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, 26, 67, and 68 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 “to ensure an orientation” in line 24. The phrase appears to be incomplete, so it is unclear what aspect of the orientation is being ensured. For the purposes of examination, the recitation will be interpreted to be “tomaintain an orientation”.
Claims 26, 67, and 68 are rejected by virtue of their dependence from claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0298831 A1 (Browne) (previously cited) in view of US 2010/0298784 A1 (Miller ‘784) (previously cited), and US 2017/0245885 A1 (Lenker).
With regards to claim 1, to the extent that it can be argued that all features taught by Browne are not provided in a single embodiment, Browne discloses a variety of alternative and additional embodiments that are provided in a variety of combinations so that the benefits of these various features can be utilized. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the various features in the alternative and additional embodiments so as to derive the benefits of these features, as suggested by Browne. See ¶¶ [0069], [0229] of Browne.
The above combination of Browne teaches a penetrator assembly operable to provide access to an intraosseous space (Abstract depicts introducer tools for bone portals; also see ¶¶ [0005]-[0023]), the penetrator assembly comprising: a flexible outer penetrator including a cannula connected to a flexible tube (Figs. 10A-10D and 13 and ¶¶ [0164]-[0165], [0168] depict a bone portal 200A (i.e., a cannula) configured to be connected to an infusion tube; Figs. 14A-E and ¶¶ [0162]-[0163] depict the portal being connected to the flexible infusion tube), wherein a proximal end of the cannula is received within a distal end of the flexible tube (Figs 10A-10C depict barbs on a shank portion for engaging an inside of the infusion tube; See analogous Fig. 9B and ¶¶ [0162]-[0163] which depict barbs 208 on shank portion 209 for engaging an inside of a flexible infusion tube which connects directly to portal 200) and a distal end of the cannula is operable to penetrate bone and associated bone marrow (Figs. 10A-10D and ¶ [0164] depict a distal end of the portal 200A having teeth for penetrating bone), a hub having a distal end connected to a proximal end of the flexible tube (Figs. 22A-22B and ¶ [0181] depict a distal end of fitting 415C connected to a proximal end of the infusion tube 415B), a connector having a distal end connected to a proximal end of the rigid inner penetrator (Fig. 20 and ¶ [0216] depict a base 482 onto which a stylet 420 is mounted, wherein Fig. 20 depicts a distal end of the base 482 connected to the stylet), the flexible outer penetrator is configured to removably receive the rigid inner penetrator to prevent or minimize the flexible tube of the flexible outer penetrator from bending during an insertion procedure (Figs. 14A-14E depict the bone portal and the flexible infusion tube receiving a stylet; ¶ [0030] depicts a stylet capable of supporting an infusion tube assembly, which indicate that the stylet minimizes bending), and the flexible tube of the flexible outer penetrator is configured to bend after removal of the rigid inner penetrator from the flexible outer penetrator (¶¶ [0217], [0227] depicts the stylet being removed from the flexible tube, which allows the tube to be in an unsupported and bendable state), wherein the rigid inner penetrator comprises a distal section having a first diameter, a proximal section having a second diameter, and a key section having a third diameter, the key section disposed between the distal and proximal sections (Figs. 13, 14A-14E, 15A-15B, 16A-16B depict a stylet, wherein Figs. 14A-16B depict the stylet having a distal section having a first diameter, a proximal end having a second diameter, and a key section adjacent the key or notch having a third diameter, the key section between the distal and proximal sections) and a distal end of the key section including a key portion configured to mate with a lock portion at the proximal end of the cannula of the flexible outer penetrator when the rigid inner penetrator is fully inserted into the flexible outer penetrator to ensure an orientation of a distal end of the flexible outer penetrator relative to the distal end of the rigid inner penetrator for forming a cutting tip operable to penetrate the bone and associated bone marrow (Figs. 13, 14E, 15A-15B, 16A-16B depict the key or notch on the stylet which is configured to cooperate with the key or notch of the portal to maintain an orientation of the elements and form a cutting tip; Figs. 10A-10D and 13 and ¶ [0165] depict an embodiment in which a rear edge of portal 200A has a key or notch 213 for receiving a corresponding key or notch on a stylet or other driving member on a tool being used to drive the insertion of portal 200A), wherein the third diameter is larger than the first diameter (Figs. 15A-16B depict the diameter of the key section being larger than the diameter of the distal section).
Although Browne teaches stylets and bone portals could also be applied in embodiments in which a motor is provided to drive rotation of the stylets and/or bone portals (¶ [0139]), Browne is silent regarding a connector having a distal end connected to a proximal end of the rigid inner penetrator and a proximal end configured to releasably engage a drive shaft of a driver.
In the same field of endeavor of intraosseous devices, Miller ‘784 teaches a connector having a distal end connected to a proximal end of an inner penetrator and a proximal end configured to releasably engage a drive shaft of a driver (Figs. 1B-1D and ¶¶ [0044]-[0047] depict a connector 180 having a distal end connected to a proximal end of trocar 220 and a proximal end having an opening 186 configured to releasably engage with a drive shaft 16a of a manual or powered driver). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Browne to incorporate a connection with a drive shaft of a driver such that the connector has a proximal end configured to releasably engage a drive shaft of a driver as taught by Miller ‘784. The motivation would have been to provide a configuration which would allow for the stylet, tube, and portal to be applied using a motor (see ¶ [0139] of Browne). Additionally, it has been held that broadly providing a mechanical or automated means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
The above combination is silent regarding whether the proximal section of the rigid inner penetrator has second diameter, wherein the third diameter is larger than the second diameter.
In a system relevant to the problem of designing stylets for supporting and guiding elements, Lenker teaches proximal section of an inner stylet has second diameter, wherein a diameter of a more distal section of the stylet is larger than the second diameter (Fig. 32A and ¶¶ [0259]-[0261] depict a proximal stylet shaft 3208 having a smaller diameter than a more distal portion of the stylet 3102). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal section of the rigid inner penetrator of the above combination to incorporate, based on the teachings of Lenker, that the third diameter is larger than the second diameter. Both (a) a proximal section having the same diameter as a central portion of Browne and (B) a proximal section having a smaller diameter than a central portion of Lenker are capable of being used for a stylet. Additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV) and Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In this case, there is no teaching or suggestion that the third diameter being larger than the second diameter provides a different function.
With regards to claim 26, the above combination is silent regarding whether the distal end of the connector is configured to releasably engage a proximal end of the hub.
In the same field of endeavor of intraosseous devices, Miller ‘784 teaches a distal end of the connector is configured to releasably engage a proximal end of the hub (Figs. 1B-1D and ¶¶ [0044]-[0047] depict a distal end 182 of a connector 180 configured to releasably engage with a proximal end 201 of hub 200 of outer penetrator 210). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination of Browne to incorporate a distal end of the connector is configured to releasably engage a proximal end of the hub as taught by Miller ‘784. The motivation would have been to provide a configuration which would allow for the stylet, tube, and portal to be applied using a motor (see ¶ [0139] of Browne). Additionally, it has been held that broadly providing a mechanical or automated means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0298831 A1 (Browne) (previously cited) in view of US 2010/0298784 A1 (Miller ‘784) (previously cited), and US 2017/0245885 A1 (Lenker), as applied to claim 1 above, and further in view of CA 2205623 A1 (Findlay).
With regards to claim 67, the above combination is silent regarding whether a portion of the flexible tube is bonded to an exterior surface of the proximal end of the cannula.
In the same field of endeavor of intraosseous infusion and aspiration, Findlay teaches a portion of the flexible tube is bonded to an exterior surface of the proximal end of the cannula (Page 18, lines 8-24 and Figs. 2A-2B depict an infusion tube connected to the bone portal 21 at its operative end, wherein the infusion tube 18 is glued to a remote end of the bone portal 21). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the connection between the flexible tube and the cannula of Browne with a connection wherein a portion of the flexible tube is bonded to an exterior surface of the proximal end of the cannula as taught by Findlay. Because both elements are suitable for providing a fluidic connection between a cannula and a flexible tube, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0298831 A1 (Browne) (previously cited) in view of US 2010/0298784 A1 (Miller ‘784) (previously cited), and US 2017/0245885 A1 (Lenker), as applied to claim 1 above, and further in view of US 2009/0062614 A1 (Adzich).
With regards to claim 68, the above combination is silent regarding whether the flexible tube comprises a transparent polymer.
In a system relevant to the problem of transporting elements through tubes, Adzich teaches a flexible tube comprising a transparent polymer (¶ [0047] depicts an outer tube 12 comprising a transparent plastic body made of a transparent polyvinylchloride (PVC) plastisol material). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible tube of the above combination to incorporate that it comprises a transparent polymer as taught by Adzich. The motivation would have been to visualization of elements that may have been retracted into the tube (¶ [0047] of Adzich).
Allowed Subject Matter
Claims 34, 36, and 47 are allowed.
With regards to claim 34, the prior art does not teach or suggest “a fluted drill tip operable to penetrate bone and associated bone marrow; a flexible cannula including a longitudinal bore and a distal end connected to the fluted drill tip; a rigid stylet configured to be releasably received within the longitudinal bore of the flexible cannula, the rigid stylet operable to prevent or minimize the flexible cannula from bending during an insertion procedure when the rigid stylet is received within the longitudinal bore of the flexible cannula” and “wherein the fluted drill tip comprises a head portion, a body portion received within the distal end of the flexible cannula”, along with the other features of claim 34.
Claims 36 and 47 are allowed by virtue of their dependence from claim 34.
US 3,806,270 A (Tanner) teaches a drill tip 11 comprising a head part 15, a tail 18 received in drill step 12, and helical flutes 13 which extend along 15 and 18 (Fig. 2 and Col. 2, lines 23-35). However, Tanner does not teach the other features of claim 34. Specifically, Tanner does not teach a rigid stylet configured to be releasably received within the longitudinal bore of the flexible cannula, the rigid stylet operable to prevent or minimize the flexible cannula from bending during an insertion procedure when the rigid stylet is received within the longitudinal bore of the flexible cannula.
The closest prior art is US 2018/0049727 A1 (Papenfuss) which discloses a penetrator assembly operable to provide access to an intraosseous space (¶¶ [0044]-[0045] discloses a collection device for penetrating bone and collecting bone marrow from bone; Figs. 3-5 and ¶ [0062] depict a collection instrument 100 being used in combination with a piercing instrument 200; also see ¶¶ [0071]-[0072]), the penetrator assembly comprising: a fluted drill tip operable to penetrate bone and associated bone marrow (Fig. 2 and ¶ [0053] depict a core drill 150 that can shave bone and cut through bone marrow, wherein the core drill 150 has flutes 156 extending longitudinally); a flexible cannula including a longitudinal bore and a distal end connected to the fluted drill tip (Figs. 1-2 and ¶ [0049] disclose a hollow shaft 110 including a passage 119 and a second end 116b which is a distal end of middle section 116; ¶ [0050] and Fig. 2 depict an articulating section 120 that allows the distal end portion 113 to articulate or bend; ¶ [0053] and Figs. 1-2 depict second end 116b being connected to the core drill 150); a rigid stylet configured to be releasably received within the longitudinal bore of the flexible cannula (Fig. 3 and ¶ [0062] disclose a sharp-tipped trocar portion 201 with a distal end 204 having a penetrating portion; Fig. 4 and ¶ [0063] depict the shaft 110 of the collection instrument 100 being configured to removably receive shaft 206 of trocar portion 201), the rigid stylet operable to prevent or minimize the flexible cannula from bending during an insertion procedure when the rigid stylet is received within the longitudinal bore of the flexible cannula (¶ [0072] discloses that shaft 110 has a moderate amount of freedom to bend when it is no longer supported internally by piercing instrument 200, thereby indicating that it does not have an amount of freedom to bend when the shaft 110 is supported by 200), and the flexible cannula configured to bend after removal of the rigid stylet from the longitudinal bore (¶ [0072] discloses that shaft 110 has a moderate amount of freedom to bend when it is no longer supported internally by piercing instrument 200).
Papenfuss does not teach or suggest a fluted drill tip comprises a head portion, a body portion received within the distal end of the flexible cannula, and a cutting flute extending along both the head and body portions. However, it would not have been obvious for one of ordinary skill in the art to have modified the end 116b of shaft 110 of Papenfuss to incorporate the fluted drill tip of as taught by Tanner. Such a modification would plug the end of the shaft 110 and prevent the sharp-tipped trocar portion 201 of the piercing instrument of Papenfuss from being exposed through the distal end of the shaft (¶ [0070] and Figs. 4-5 of Papenfuss) and be used to pierce cortical bone (¶ [0071] of Papenfuss). Therefore, the modification would render Papenfuss unsatisfactory for its intended purpose. Additionally, Papenfuss does not teach or suggest any embodiments in which the piercing instrument 200 is not used to pierce bone.
Response to Arguments
Claim Rejections – 35 U.S.C. §112
In view of the claim amendments filed 06/24/2026, the previous grounds of claim rejections under 35 U.S.C. §112(a),(b) were withdrawn.
There are new grounds of rejections under 35 U.S.C. §112(b).
Claim Rejections – 35 U.S.C. §103
Applicant's amendment and arguments filed 06/24/2026 with respect to the 35 USC 103 rejections set forth in the Final Rejection mailed 03/24/2026 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over US 2010/0298831 A1 (Browne) (previously cited) in view of US 2010/0298784 A1 (Miller ‘784) (previously cited), and US 2017/0245885 A1 (Lenker).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2003/0233114 A1 (Kapec) which includes a bone marrow aspiration instrument (Fig. 1).
US 2018/0146982 A1 (Brockman) which includes a lock assembly for releasably coupling a stylet handle to a cannula handle (Abstract and Fig. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights