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 12/15/2025 was considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-6, 9-11, 15-18, 24, and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 recites “a depth control collar connected to the outer penetrator adjacent to the distal end of the outer penetrator” in lines 2-3, which is new matter. Claim 1 recites “a flexible outer penetrator including a cannula connected to a flexible tube, a longitudinal bore, a proximal end of the cannula being received within a distal end of the flexible tube” in lines 3-5. The originally-filed specification does not provide support for a depth control collar adjacent to a distal end of an outer penetrator including the claimed cannula and flexible tube. The flexible outer penetrator of claim 1 appears to be directed to the embodiment of Figs. 25A-C and ¶¶ [0168]-[0171] of the published application. However, there is no teaching or suggestion of how the depth control collar would interact with the cannula 110d or flexible tube 150. Additionally, one of ordinary skill in the art would not be able determine, for example, whether the depth control collar would be connected to the cannula 110d, tube 150, or a combination of both. Therefore, there is insufficient written description for the claimed invention. Claim 24 recites similar features, so it is rejected on similar grounds.
Claim 3 recites “a distal cutting sleeve fixed to the distal end of the outer penetrator” in line 2, which is new matter. Claim 1 recites “a flexible outer penetrator including a cannula connected to a flexible tube, a longitudinal bore, a proximal end of the cannula being received within a distal end of the flexible tube” in lines 3-5. The originally-filed specification does not provide support for a distal cutting sleeve fixed to a distal end of an outer penetrator including the claimed cannula and flexible tube. The flexible outer penetrator of claim 1 appears to be directed to the embodiment of Figs. 25A-C and ¶¶ [0168]-[0171] of the published application. However, there is no teaching or suggestion of how the cutting sleeve would be fixed in relation to the cannula 110d or flexible tube 150. Additionally, one of ordinary skill in the art would not be able determine, for example, whether the distal cutting would be connected to the cannula 110d, tube 150, or a combination of both. Therefore, there is insufficient written description for the claimed invention. Claim 25 recites similar features, so it is rejected on similar grounds.
Claim 4 recites “the flexible outer penetrator includes a plurality of slits” in line 2, which is new matter. Claim 1 recites “a flexible outer penetrator including a cannula connected to a flexible tube, a longitudinal bore, a proximal end of the cannula being received within a distal end of the flexible tube” in lines 3-5. The originally-filed specification does not provide support for a flexible outer penetrator including the claimed cannula and flexible tube while also having a plurality of slits. The flexible outer penetrator of claim 1 appears to be directed to the embodiment of Figs. 25A-C and ¶¶ [0168]-[0171] of the published application. However, there is no teaching or suggestion of how the plurality of slits are related to the flexible sleeve or tube 150d or the cannula 110d. One of ordinary skill in the art would not be able determine, for example, whether the plurality of slits are arranged along the cannula 110d, flexible tube 150d, or a combination of both. The specification further teaches a flexible sleeve 150 directed to a different embodiment (¶ [0154]), but fails to teach or suggest that those embodiments have flexible sleeves with a plurality of slits. In fact, the sleeve 150 of ¶ [0154] is supposed to “prevent or minimize fluid leakage” by being placed over cuts or slits 115, which suggests that the sleeve should not have any slits. Therefore, there is insufficient written description of a flexible outer penetrator including the claimed cannula and flexible tube while also having a plurality of slits. Claims 5-6, 9-11, and 16 recite features regarding the slits, which amount to new matter for similar reasons.
Claims 5-6, 9-11, 15-18, 24, and 25 are rejected by virtue of their dependence from claim 4.
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 1-6, 9-11, 15-18, and 24-26 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 “a flexible outer penetrator including a cannula connected to a flexible tube, a longitudinal bore, a proximal end of the cannula being received within a distal end of the flexible tube, and a distal end of the cannula being operable to penetrate bone and associated bone marrow;” in lines 3-6. Due to the grammatical structure, it is unclear how the longitudinal bore is related to the outer penetrator, cannula, and flexible tube. Is the longitudinal bore part of the flexible outer penetrator? Is it connected to the cannula? The Examiner suggests amending the recitation to be:
“a flexible outer penetrator including:
a cannula connected to a flexible tube, wherein a proximal end of the cannula is received within a distal end of the flexible tube, and a distal end of the cannula is operable to penetrate bone and associated bone marrow; and
a longitudinal bore;”
Claim 1 recites “the distal end of the flexible outer penetrator” in line 22. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear how it is related to the distal end of the cannula (line 5 of claim 1) and the distal end of the flexible tube (lines 4-5 of claim 1), both of which are distal ends of the flexible outer penetrator. For the purposes of examination, the recitation of “the distal end of the flexible outer penetrator” in line 22 will be interpreted to be “the distal end of the cannula”. Recitations of “the distal end of the outer penetrator” in claims 2, 3, 5, 24, and 25 also lack sufficient antecedent basis, so the recitations will be interpreted to be “the distal end of the cannula”.
Claim 1 recites “and forming a cutting tip operable to penetrate the bone and associated bone marrow” in lines 23-24. Due to the grammatical inconsistencies, it is unclear how this recitation is related to the other limitations. What is forming a cutting tip? For the purposes of examination, the recitation will be interpreted to be “such that the distal end of the cannula and the distal end of the rigid inner penetrator form a cutting tip operable to penetrate the bone and associated bone marrow”.
Claims 2-6, 9-11, 15-18, and 24-26 are rejected by virtue of their dependence from claim 1.
Claim 5 recites “the distal and proximal ends of the flexible outer penetrator” in line 2. There is insufficient antecedent basis for the recitation of the proximal end of the flexible other penetrator. Additionally, it is unclear whether the proximal end of the flexible outer penetrator is the same as, related to, or different from the proximal end of the cannula. For the purposes of examination, the recitation will be interpreted to be “the distal end of the cannula and the proximal end of the flexible tube”.
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, 2, 4-6, 9, 15-18, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0049727 A1 (Papenfuss) (cited by Applicant) in view of US 2010/0298784 A1 (Miller ‘784) (previously cited), and US 2010/0298831 A1 (Browne)
With regards to claim 1, Papenfuss 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 flexible outer penetrator including a longitudinal bore and a distal end operable to penetrate bone and associated bone marrow (Figs. 1-2 and ¶ [0049] disclose a hollow shaft 110 including a passage 119 and a distal end portion 113; ¶ [0050] and Fig. 2 depict an articulating section 120 that allows the distal end portion 113 to articulate or bend; ¶ [0053] and Fig. 2 depict distal end portion 113 including a core drill 150 for shaving bone and cutting through bone marrow); a rigid inner penetrator including a distal end operable to penetrate the bone and the associated bone marrow (Fig. 3 and ¶ [0062] disclose a sharp-tipped trocar portion 201 with a distal end 204 having a penetrating portion); and the longitudinal bore of the flexible outer penetrator configured to removably receive the rigid inner penetrator to prevent or minimize the flexible outer penetrator from bending during an insertion procedure (Fig. 4 and ¶ [0063] depict the shaft 110 of the collection instrument 100 being configured to removably receive shaft 206 of trocar portion 201, wherein the trocar would prevent the articulating section 120 of the shaft 110 from bending; ¶ [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 outer penetrator configured to bend after removal of the rigid inner penetrator 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), wherein the distal end of the cannula of the flexible outer penetrator and the distal end of the rigid inner penetrator form a cutting tip operable to penetrate the bone and associated marrow (Fig. 5 and ¶ [0].
Although Papenfuss teaches a hub having a distal end connected to a proximal end of the flexible outer penetrator (Fig. 1 and ¶ [0049] depict handle portion 160 connected to a proximal end portion 112) and 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 driver (Fig. 3 and ¶ [0062] depict a handle portion 260 having a distal end connected to proximal end 202 of trocar portion 201 and a proximal end configured to be releasably gripped by a driving user), Papenfuss is silent with regards to 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 hub having a distal end connected to a proximal end of an outer penetrator (Figs. 1B-1D and ¶¶ [0044]-[0047] depict a hub 200 having a distal end connected to a proximal end of an outer penetrator 210), and 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 substituted the hub and connector of Papenfuss with the hub and connector of Miller ‘784. Both hubs and connectors are capable of being used for translating rotational motion to the penetrators (¶ [0059] of Miller ‘784; ¶ [0056] of Papenfuss). 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. Therefore, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent regarding a flexible outer penetrator including a cannula connected to a flexible tube, a proximal end of the cannula being received within a distal end of the flexible tube and a distal end of the cannula being operable to penetrate bone and associated bone marrow, a hub having a distal end connected to a proximal end of the flexible tube, the rigid inner penetrator prevents or minimizes the flexible tube of the flexible outer penetrator from bending during an insertion procedure, and the flexible tube of the flexible outer penetrator is configured to bend after removal of the rigid inner penetrator from the longitudinal bore, wherein the rigid inner penetrator comprises a key section 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 the distal end of the cannula of the flexible outer penetrator relative to the distal end of the rigid inner penetrator and forming a cutting tip operable to penetrate the bone and associated bone marrow.
In the same field of endeavor of intraosseous devices, Browne teaches a flexible outer penetrator including a cannula connected to a flexible tube (Fig. 9A-9D and 13 and ¶¶ [0157], [0162]-[0163] depict a bone portal 200 (i.e., a cannula) connected to a flexible infusion tube), a proximal end of the cannula being received within a distal end of the flexible tube (Fig. 9B and ¶¶ [0162]-[0163] 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 being operable to penetrate bone and associated bone marrow (Figs. 9A-9D and ¶ [0158] depict a bone-penetrating portion 201 on the distal end of the bone portal 200), 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), the rigid inner penetrator prevents or minimizes the flexible tube of the flexible outer penetrator from bending during an insertion procedure (¶ [0030] depicts a stylet capable of supporting an infusion tube assembly), and the flexible tube of the flexible outer penetrator is configured to bend after removal of the rigid inner penetrator from the longitudinal bore (¶ [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 key section 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 the distal end of the cannula of the flexible outer penetrator relative to the distal end of the rigid inner penetrator and forming a cutting tip operable to penetrate the bone and associated bone marrow (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; 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). 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 to incorporate the flexible outer penetrator including a cannula connected to a flexible tube, a proximal end of the cannula being received within a distal end of the flexible tube and a distal end of the cannula being operable to penetrate bone and associated bone marrow, a hub having a distal end connected to a proximal end of the flexible tube, the rigid inner penetrator prevents or minimizes the flexible tube of the flexible outer penetrator from bending during an insertion procedure, and the flexible tube of the flexible outer penetrator is configured to bend after removal of the rigid inner penetrator from the longitudinal bore, wherein the rigid inner penetrator comprises a key section 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 the distal end of the cannula of the flexible outer penetrator relative to the distal end of the rigid inner penetrator and forming a cutting tip operable to penetrate the bone and associated bone marrow as taught by Browne. Because both the arrangements of Papenfuss and Browne are capable of penetrating bone (Fig. 14E and ¶ [0002] of Browne and ¶ [0044] of Papenfuss), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 2, the above combination teaches or suggests a depth control collar connected to the outer penetrator adjacent to the distal end of the outer penetrator (Fig. 9A-9B and ¶ [0159] of Browne teach the bone portal 200 comprising a bone stop 205), the depth control collar comprising a distal end operable to contact the bone for preventing further penetration of the inner and outer penetrators into the intraosseous space (Fig. 9A and 14E and ¶¶ [0159], [0170] of Browne teach a tapered front face 205 of bone stop for lodging against the outer surface of the bone).
With regards to claim 4, the above combination is silent regarding whether the flexible outer penetrator includes a plurality of slits operable to allow the outer penetrator to bend when the rigid inner penetrator is removed from the longitudinal bore of the flexible outer penetrator.
Papenfuss further teaches the flexible outer penetrator includes a plurality of slits operable to allow the outer penetrator to bend when the rigid inner penetrator is removed from the longitudinal bore of the flexible outer penetrator (Fig. 8 and ¶ [0066] of Papenfuss discloses small gaps 121 created by the cutting lines between the interlocking sections of articulating section 120. Fig. 2 of Papenfuss depicts the gaps being slits). 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 outer penetrator of the above combination to include the plurality of slits operable to allow the outer penetrator to bend when the rigid inner penetrator is removed from the longitudinal bore of the flexible outer penetrator as taught by Papenfuss. The motivation would have been to provide the outer penetrator with the flexibility to allow the shaft to yield and bend as it advances through marrow (¶ [0045] of Papenfuss).
With regards to claim 5, the above combination teaches or suggests the plurality of slits are provided along an intermediate section of the flexible outer penetrator (Figs. 1-2of Papenfuss depict the gaps being provided along an articulating section 120), the intermediate section located between the distal and proximal ends of the flexible outer penetrator (Fig. 1 of Papenfuss depicts the articulating section 120 being located between a distal end portion 113 and a proximal end portion 111).
With regards to claim 6, the above combination teaches or suggests the plurality of slits are arranged in a pattern along the length of the intermediate section of the flexible outer penetrator (Fig. 2 of Papenfuss depicts the gaps being arranged in a pattern).
With regards to claim 9, the above combination teaches or suggests at least one of the plurality of slits is an elongated cut in a wall of the flexible outer penetrator (Fig. 2 and ¶ [0066] of Papenfuss depict the gaps being formed by cutting lines through tubular wall 118, wherein the cutting lines are elongated).
With regards to claim 15, the above combination teaches or suggests a covering sleeve attached to the flexible outer penetrator, the covering sleeve operable to prevent or minimize leakage of material from the flexible outer penetrator (Fig. 9 and ¶ [0067] of Papenfuss disclose a flexible sheath or sleeve 400 placed over shaft 110 to cover gaps 121, wherein the sheath or sleeve 400 would block or minimize leakage of materials through the gaps 121).
With regards to claim 16, the above combination teaches or suggests the covering sleeve is configured to cover the intermediate section of the flexible outer penetrator, the covering sleeve operable to prevent or minimize leakage of material from the plurality of slits (Fig. 9 and ¶ [0067] of Papenfuss disclose a flexible sheath or sleeve 400 placed over shaft 110 to cover gaps 121, wherein the sheath or sleeve 400 would block or minimize leakage of materials through the gaps 121).
With regards to claim 17, the above combination teaches or suggests the covering sleeve bends when bending the flexible outer penetrator (¶ [0067] of Papenfuss disclose the sheath or sleeve 400 is flexible, thereby indicating that it may be bent with the bending of the articulating section 120).
With regards to claim 18, the above combination teaches or suggests the covering sleeve is operable to prevent or reduce leakage of material passing through the outer penetrator (¶ [0067] of Papenfuss discloses that the sleeve 400 prevents suction forces from drawing in liquid through the gaps, thereby indicating that the sleeve 400 is a physical barrier that reduces leakage of material of material passing through the outer penetrator ).
With regards to claim 26, the above combination teaches or suggests the distal end of the connector is configured to releasably engage a proximal end of the hub (Fig. 3 and ¶ [0064] of Papenfuss depict the distal end of the handle 260 releasably engaging the proximal end of the handle of instrument 100).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Papenfuss in view of Miller ‘784, and Browne, as applied to claim 1 above, and in view of US 2011/0152866 A1 (Knutson) (previously presented).
With regards to claim 3, the above combination is silent with regards to a distal cutting sleeve fixed to the distal end of the outer penetrator, the distal cutting sleeve operable to penetrate the bone and the associated bone marrow.
In the same field of endeavor of penetrating bone, Knutson discloses a distal cutting sleeve fixed to the distal end of the outer penetrator, the distal cutting sleeve operable to penetrate bone and associated bone marrow (Fig. 5A and ¶¶ [0120]-[0121] depicts an a sleeve 42 covering a portion of countersink 14, wherein the sleeve 42 has a bur 44 for cutting bone and is capable of cutting bone marrow). 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 outer penetrator of the above combination to incorporate a distal cutting sleeve as taught by Knutson. The motivation would have been to provide a cutting tip which allows for better penetration of the bone.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Papenfuss in view of Miller ‘784, and Browne, as applied to claim 4 above, and in view of US 5,152,744 A (Krause) (previously presented)
With regards to claim 10, the above combination is silent with regards to whether the at least one of the plurality of slits is a perforation in a wall of the flexible outer penetrator.
In the system related to the problem of flexible tubes, Krause discloses a tube with a flexible region comprising a plurality of slits, wherein at least one of the plurality of slits is a perforation in a wall of the flexible outer penetrator (Col. 5, lines 7-24 disclose slots 60, 62 formed in the wall of the tube 14, wherein the slots are perforations). 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 mechanism for forming the flexible region of the outer penetrator of Papenfuss with the slotted mechanism as taught by Krause. Because both the interlocking elements of Papenfuss and the slots of Krause are capable of providing flexibility to a tube, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 11, the above combination is silent with regards to whether the at least one of the plurality of slits is a notch or groove in a wall of the flexible outer penetrator.
In the system related to the problem of flexible tubes, Krause discloses a tube with a flexible region comprising a plurality of slits, wherein at least one of the plurality of slits is a notch or a groove in a wall of the flexible outer penetrator (Col. 5, lines 7-24 disclose slots 60, 62 formed in the wall of the tube 14, wherein the slots are notches or grooves into the wall of the tube 14). 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 mechanism for forming the flexible region of the outer penetrator of Papenfuss with the slotted mechanism as taught by Krause. Because both the interlocking elements of Papenfuss and the slots of Krause are capable of providing flexibility to a tube, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Papenfuss in view of Miller ‘784, and Browne, as applied to claim 15 above, and in view of US 2008/0140014 A1 (Miller ‘014) (previously presented).
With regards to claim 24, the above combination is silent regarding a depth control collar connected to the outer penetrator adjacent to the distal end of the outer penetrator, wherein an outer diameter of the covering sleeve is less than or equal to the size of an outer diameter of the collar.
In a system related to the problem of accessing an intraosseous space, Miller ‘014 discloses a depth control collar connected to a penetrator adjacent to the distal end of the penetrator (Fig. 7B and ¶¶ [0095]-[0097] disclose a collar stop or depth limiter 150 connected to a distal end of the needle 70 and adjacent to the distal end of the needle), wherein the depth control collar is sized to accept the penetrating members (Fig. 7B depicts 150 having an inner diameter which is sized to accept needle 70). 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 outer penetrator of Papenfuss to incorporate a depth control collar as taught by Miller ‘014. The motivation would have been to prevent extraneous insertion of the penetrators into the intraosseous space.
The above combination teaches or suggests a collar which is sized to accept the penetrating members. Because the covering sleeve of Papenfuss is a part of the penetrating members, the inner diameter of the collar would be sized to accept the covering sleeve. The outer diameter of the collar would therefore be larger than the outer diameter of the covering sleeve.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Papenfuss in view of Miller ‘784, and Browne, as applied to claim 15 above, and in view of US 2003/0199879 A1 (Spranza, III) (previously cited)
With regards to claim 25, the above combination is silent with regards to a distal cutting sleeve fixed to the distal end of the outer penetrator, wherein an outer diameter of the covering sleeve is less than or equal to an outer diameter of the distal cutting sleeve.
In the same field of endeavor of penetrating bone, Spranza, III discloses a distal cutting sleeve fixed to the distal end of the outer penetrator (¶ [0036] and Figs. 1-6 depict a cutting head 11 attached to a shank 12, wherein the cutting head 11 is being interpreted to be the cutting sleeve), the distal cutting sleeve operable to penetrate bone and associated bone marrow (¶ [0036] discloses the cutting head is for cutting bone), wherein an outer diameter of the shank is less than or equal to an outer diameter of the distal cutting sleeve (Fig. 4 and ¶ [0036] discloses an outer diameter of the cutting end of cutting head 11 being greater than that of a root end). 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 outer penetrator of Papenfuss of the above combination to incorporate a distal cutting sleeve having an outer diameter larger than the shank/tube as taught by Spranza, III. The motivation would have been to provide a cutting tip which allows for better penetration of the bone. Because the covering sleeve of Papenfuss is a part of the outer penetrator of Papenfuss, the above combination teaches or suggests the cutting sleeve of Spranza, III having an outer diameter that is greater than or equal to an outer diameter of the covering sleeve.
Allowable Subject Matter
Claims 34, 36, and 37 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 37 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. §103
Applicant' s amendment and arguments filed 12/16/2025 with respect to the prior art rejections set forth in the Non-Final Rejection mailed 07/16/2025 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 in view of US 2010/0298831 A1 (Browne). See the above rejections.
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 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