DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 28, 2026 has been entered.
This Office action is responsive to an amendment filed January 28, 2026. Claims 1-20 are pending. Claims 1 & 18 have been amended.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-4, 8, 10-12 & 18 is/are rejected under the judicially created doctrine of obviousness-type double patenting as unpatentable over claims 1, 3 & 9 of U.S. Patent No. 10,820,913 in view of Fleming, III (US 6,554,778) (“Fleming” hereinafter).
It is clear that all the elements of claims 1, 3-4, 8, 10-12 & 18 of the application are to be found in claims 1, 3 & 9 of the patent. The difference between claims 1, 3-4, 8, 10-12 & 18 of the application and claims 1, 3 & 9 of the patent lies in the fact that the application further requires an intraosseous device configured to penetrate bone and associated bone marrow, the intraosseous device including a cannula extending from a cannula hub and a stylet extending from a stylet hub, wherein the cannula hub is configured to be releasably connected to the stylet hub, and wherein the stylet is configured to be received within a longitudinal lumen of the cannula when the cannula hub is releasably connected to the stylet hub; and a body having a distal end including a distal opening and a proximal end including a proximal opening, and the proximal opening having at least one transverse dimension that is smaller than a corresponding transverse dimension of a portion of the passage portion located proximate to the proximal opening; and a coupling portion extending from the body of the handle and configured to lock the handle directly to the cannula hub when the cannula hub is received within the passage, and the coupling portion further configured to unlock the handle from the cannula hub by withdrawing the cannula hub from the passage by pulling the cannula hub away from the handle and withdrawing the cannula hub from the passage.
However, Fleming teaches that it is known to provide an intraosseous device 20 configured to penetrate bone and associated bone marrow, the intraosseous device 20 including a cannula 22 extending from a cannula hub 26 and a stylet 24 extending from a stylet hub 46, wherein the cannula hub 26 is configured to be releasably connected to the stylet hub 46, and wherein the stylet 24 is configured to be received within a longitudinal lumen of the cannula 22 when the cannula hub 26 is releasably connected to the stylet hub 46; and a body 60 having a distal end including a distal opening 66 and a proximal end including a proximal opening (see fig. 6a), and the proximal opening (see fig. 6a) having at least one transverse dimension (i.e., minor axis of the oblong shape of the opening 66, see fig. 6d) that is smaller than a corresponding transverse dimension (i.e., major axis connecting side portions 67, see fig. 6d) of a portion of the passage portion (of sheath housing 70) located proximate to the proximal opening (see fig. 6a); and a coupling portion (30, 68, 69, 71) extending from the body of the handle 28 configured to lock the handle 28 directly to the cannula hub 26 when the cannula hub 26 is received within the passage (of sheath housing 70), and the coupling portion (30, 68, 69, 71) configured to unlock the handle 28 from the cannula hub 26 by pulling the cannula hub 26 away from the handle 28 and withdrawing the cannula hub 26 from the passage (of sheath housing 70) (see at least abstract, figs. 1a-b, 6a-e & 7a-d and col. 5, lines 29-67; col. 6, lines 1-56).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the intraosseous device or apparatus of the patent configured to penetrate bone and associated bone marrow, the intraosseous device including a cannula extending from a cannula hub and a stylet extending from a stylet hub, wherein the cannula hub is configured to be releasably connected to the stylet hub, and wherein the stylet is configured to be received within a longitudinal lumen of the cannula when the cannula hub is releasably connected to the stylet hub; and a body having a distal end including a distal opening and a proximal end including a proximal opening, and the proximal opening having at least one transverse dimension that is smaller than a corresponding transverse dimension of a portion of the passage portion located proximate to the proximal opening; and a coupling portion extending from the body of the handle and configured to lock the handle directly to the cannula hub when the cannula hub is received within the passage, and the coupling portion further configured to unlock the handle from the cannula hub by withdrawing the cannula hub from the passage by pulling the cannula hub away from the handle and withdrawing the cannula hub from the passage as taught by Fleming since such a modification would amount to applying a known technique (i.e., as taught by Fleming) to a known device (i.e., of the patent) ready for improvement to achieve a predictable result such as providing: (i) a biopsy device with a separate handle assembly which is capable of being removed after the device is inserted into a patient, leaving the outer cannula and inner rod in place in the desired location, thereby eliminating the impediment to the imaging process presented by the presence of the outer cannula handle, (ii) a biopsy device which allows the user to readily unlock and remove the handle assembly without affecting the orientation of the outer cannula and the inner rod with respect to one another, in order to prevent an undesired corresponding change in orientation of the distal ends of each, and/or (iii) a biopsy device in which the handle assembly may be resterilized after use and reused, resulting in significant cost savings over similar devices with attached handles which are disposed along with the rest of the device after use (see at least col. 2, lines 3-26 of Fleming)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, 16 & 18 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Fleming, III (US 6,554,778) (“Fleming” hereinafter).
In regards to claim 1, Fleming discloses an apparatus comprising:
an intraosseous device 20 configured to penetrate bone and associated bone marrow, the intraosseous device 20 including a cannula 22 extending from a cannula hub 26 and a stylet 24 extending from a stylet hub 46 (see at least figs. 1a-b), wherein the cannula hub 26 is configured to be releasably connected to the stylet hub 46 (see at least fig. 1b), and wherein the stylet 24 is configured to be received within a longitudinal lumen of the cannula 22 when the cannula hub 26 is releasably connected to the stylet hub 46 (see at least fig. 1b); and
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a handle 28 configured to be removably coupled to the cannula hub 26 of the intraosseous device 20 to facilitate hand manipulation of the intraosseous device 20 by a user, the handle 28 including a body 60 having a distal end including a distal opening 66, a proximal end including a proximal opening (see fig. 6a), and a passage (of sheath housing 70) configured to receive the cannula hub 26 and extending from the distal end to the proximal end, the passage (of sheath housing 70) having a longitudinal axis and a passage (of sheath housing 70) portion disposed between the distal end and the proximal end, the passage (of sheath housing 70) portion configured to prevent rotation of the cannula hub 26 relative to the handle 28, and the proximal opening (see fig. 6a) having at least one transverse dimension (i.e., minor axis of oblong opening 66, see fig. 6d) that is smaller than a corresponding transverse dimension (i.e., major axis of oblong opening 66, see fig. 6d) of the passage (of sheath housing 70) portion, and the handle 28 further including a coupling portion (30, 68, 69, 71) configured to couple the handle 28 directly to the cannula hub 26 when the cannula hub 26 is received within the passage (of sheath housing 70), and the coupling portion (30, 68, 69, 71) extending from the body of the handle 28 configured to lock the handle 28 directly to the cannula hub 26 when the cannula hub 26 is received within the passage (of sheath housing 70), and the coupling portion (30, 68, 69, 71) configured to unlock the handle 28 from the cannula hub 26 by pulling the cannula hub 26 away from the handle 28 and withdrawing the cannula hub 26 from the passage (of sheath housing 70) (see at least abstract, figs. 1a-b, 6a-e & 7a-d and col. 5, lines 29-67; col. 6, lines 1-56).
In regards to claim 3, Fleming discloses the apparatus of claim 1, wherein the passage (of sheath housing 70) portion includes a non- circular (i.e., oblong) cross-sectional shape (see at least figs. 6a-e; col. 6, lines 45-49).
In regards to claim 4, Fleming discloses the apparatus of claim 1, wherein the passage (of sheath housing 70) portion extends from the distal end toward the proximal end (see at least figs. 6a-e).
In regards to claim 5, Fleming discloses the apparatus of claim 1, wherein the passage (of sheath housing 70) further includes an entry portion disposed between the distal end and the passage (of sheath housing 70) portion, and wherein the entry portion is configured to permit the handle 28 to rotate around the cannula hub 26 (i.e., handle assembly 28 is capable of at least partially rotating around portion 52 of hub 26 in distal end of passage of sheath housing 70 in the absence of the inner 24, see figs. 7a-d).
In regards to claim 16, Fleming discloses the apparatus of claim 1, wherein the body 60 further includes an opening 66 at the distal end having at least one transverse dimension (i.e., minor axis of oblong opening 66) that is smaller than a corresponding transverse dimension (i.e., major axis of oblong opening 66) of the passage (of sheath housing 70) (see figs. 6a & 6d; col. 6, lines 45-49).
In regards to claim 18, Fleming discloses a kit comprising:
an intraosseous needle set (22, 24) comprising an outer penetrator 22 configured to penetrate bone and associated bone marrow, an inner penetrator 24 configured to penetrate bone and associated bone marrow, and a hub assembly (26, 46) including a first hub 26 and a second hub 46, wherein the outer penetrator 22 extends from the first hub 26 and the inner penetrator 24 extends from the second hub 46, wherein the first hub 26 is configured to be releasably connected to the second hub 46, and wherein the hub assembly (26, 46) is configured to releasably dispose the inner penetrator 24 within the outer penetrator 22 when the first hub 26 is releasably connected to the second hub 46 (see figs. 1a-b); and
an apparatus comprising a handle 28 configured to be removably coupled to the first hub 26 of the hub assembly (26, 46) to facilitate hand manipulation of the intraosseous needle set (22, 24) by a user, the handle 28 including a body 60 having a distal end including a distal opening 66, a proximal end including a proximal opening (see fig. 6a), and
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a passage (of sheath housing 70) configured to receive the hub assembly (26, 46) and extending from the distal end to the proximal end, the passage (of sheath housing 70) having a longitudinal axis and a passage (of sheath housing 70) portion disposed between the distal end and the proximal end, the passage (of sheath housing 70) portion configured to prevent rotation of the hub assembly (26, 46) relative to the handle 28, and the proximal opening (see fig. 6a) having at least one transverse dimension (i.e., minor axis of oblong opening 66) that is smaller than a corresponding transverse dimension (i.e., major axis of the oblong opening 66) of the passage (of sheath housing 70) portion, and the handle 28 further including a coupling portion (30, 68, 69, 71) extending from the body of the handle 28 configured to lock the handle 28 directly to the cannula hub 26 when the cannula hub 26 is received within the passage (of sheath housing 70), and the coupling portion (30, 68, 69, 71) configured to unlock the handle 28 from the cannula hub 26 by pulling the cannula hub 26 away from the handle 28 and withdrawing the cannula hub 26 from the passage (of sheath housing 70) (see at least abstract, figs. 1a-b, 6a-e & 7a-d and col. 5, lines 29-67; col. 6, lines 1-56).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fleming (US 6,554,778) in view of Miller (US 2005/0165404).
Fleming discloses the apparatus of claim 1, that fails to explicitly teach an apparatus comprising a body wherein the body has a substantially circular outer perimeter.
However, Miller teaches that it is known to provide an apparatus wherein the body 12a has a substantially circular outer perimeter (see at least figs. 1A-B and par 0013 & 0043).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming comprising a body wherein the body has a substantially circular outer perimeter as taught by Miller since such a modification would amount to applying a known technique (i.e., as taught by Miller) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as providing an ergonomically designed grip shape suitable for grasping with the hand or fingers during manual insertion of a penetrator (see at least par 0013 & 0043 of Miller)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fleming (US 6,554,778) in view of Islam (US 4,543,966).
Fleming discloses the apparatus of claim 1, that fails to explicitly teach an apparatus comprising a body wherein the body has a substantially circular outer perimeter.
However, Islam teaches that it is known to provide an apparatus wherein the body 28 has a substantially circular outer perimeter (see at least figs. 1, 3, 6 & 9 and col. 5, lines 7-16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming comprising a body wherein the body has a substantially circular outer perimeter as taught by Islam since such a modification would amount to applying a known technique (i.e., as taught by Islam) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as providing an ergonomically designed grip shape suitable for grasping with the hand or fingers during manual insertion of a penetrator (see at least col. 5, lines 7-16 of Islam)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 6-7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fleming (US 6,554,778) in view of Haddock et al. (US 2007/0260255) (“Haddock” hereinafter).
In regards to claim 6, Fleming discloses the apparatus of claim 5, that fails to explicitly teach an apparatus wherein the entry portion includes a circular cross-sectional shape. However, Haddock teaches that it is known to provide an apparatus wherein the entry portion (i.e., portion of passage 416) includes a circular cross-sectional shape (see at least figs. 1-5 & 6A-B and par 0033, 0036 & 0061). Therefore, since Fleming discloses an apparatus wherein the entry portion includes a non-circular cross-sectional shape (see at least figs. 6a & 6d thereof) and Haddock teaches that it is known to provide to provide an entry portion including circular cross-section as an alternative to an entry portion including a non-circular cross-section to provide the handle with matching transverse cross-sections that may be used to more effectively impart rotational motion to the components attached to the handle (see at least par 0033 thereof), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming wherein the entry portion includes a circular cross-sectional shape as taught by Haddock since such a modification would amount to applying a known technique (i.e., as taught by Haddock) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as providing the handle with matching transverse cross-sections that may be used to more effectively impart rotational motion to the components attached to the handle (see at least par 0033 of Haddock)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 7, Fleming discloses the apparatus of claim 5, wherein the entry portion includes a diameter (i.e., major axis of oblong opening 66) that is equal to a maximum transverse dimension (i.e., major axis of oblong opening 66) of the passage (of sheath housing 70) portion (see at least figs. 6a & 6d).
Claim(s) 8-12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fleming (US 6,554,778) in view of Goldenberg (US 6,340,351).
In regards to claim 8, Fleming discloses the apparatus of claim 1, that fails to explicitly teach an apparatus wherein the handle further comprises at least one resilient arm configured to be deflected away from the longitudinal axis of the handle to permit insertion and removal of the hub into the passage. However, Goldenberg teaches that it is known to provide an apparatus 10’ of claim 1, wherein the handle 16’ further
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comprises at least one resilient arm 54’ configured to be deflected away from the longitudinal axis of the handle 16’ to permit insertion and removal of the cannula hub (30, 50’) into the passage (see at least fig. 8 and col. 6, lines 51-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming wherein the handle further comprises at least one resilient arm configured to be deflected away from the longitudinal axis of the handle to permit insertion and removal of the hub into the passage as taught by Goldenberg since such a modification would amount to applying a known technique (i.e., as taught by Goldenberg) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as providing a secure engagement through a snap-lock connection between the operative handle and the cannula without the need for a threaded connector for manipulating the handle and cannula relative to one another, yet with minimal risk of separation (see at least col. 1, lines 52-67 & col. 2, lines 1-51 of Goldenberg)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 9, Fleming discloses the apparatus of claim 8, that fails to explicitly teach an apparatus wherein each resilient arm has a first end coupled in fixed relation to the body, and a second end extending from the first end such that the second end is movable toward the longitudinal axis. However, Goldenberg teaches that it is known to provide an apparatus 10’ wherein each resilient arm 54’ has a first end coupled in fixed relation to the body, and a second end extending from the first end such that the second end is movable toward the longitudinal axis (see at least fig. 8 and col. 6, lines 51-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming wherein each resilient arm has a first end coupled in fixed relation to the body, and a second end extending from the first end such that the second end is movable toward the longitudinal axis as taught by Goldenberg since such a modification would amount to applying a known technique (i.e., as taught by Goldenberg) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as providing a secure engagement through a snap-lock connection between the operative handle and the cannula without the need for a threaded connector for manipulating the handle and cannula relative to one another, yet with minimal risk of separation (see at least col. 1, lines 52-67 & col. 2, lines 1-51 of Goldenberg)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 10, Fleming discloses the apparatus of claim 8, that fails to explicitly teach an apparatus wherein each resilient arm includes a projection configured to resist removal of the cannula hub. However, Goldenberg teaches that it is known to provide an apparatus 10’ wherein each resilient arm 54’ includes a projection 58’ configured to resist removal of the cannula hub (30, 50’) (see at least fig. 8 and col. 6, lines 51-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming wherein each resilient arm includes a projection configured to resist removal of the cannula hub as taught by Goldenberg since such a modification would amount to applying a known technique (i.e., as taught by Goldenberg) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as providing a secure engagement through a snap-lock connection between the operative handle and the cannula without the need for a threaded connector for manipulating the handle and cannula relative to one another, yet with minimal risk of separation (see at least col. 1, lines 52-67 & col. 2, lines 1-51 of Goldenberg)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 11, Fleming discloses the apparatus of claim 10, that fails to explicitly teach an apparatus wherein each projection extends inward toward the longitudinal axis of the handle. However, Goldenberg teaches that it is known an apparatus 10’ of claim 10, wherein each projection 58’ extends inward toward the longitudinal axis of the handle 16’ (see at least fig. 8 and col. 6, lines 51-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming wherein each projection extends inward toward the longitudinal axis of the handle as taught by Goldenberg since such a modification would amount to applying a known technique (i.e., as taught by Goldenberg) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as providing a secure engagement through a snap-lock connection between the operative handle and the cannula without the need for a threaded connector for manipulating the handle and cannula relative to one another, yet with minimal risk of separation (see at least col. 1, lines 52-67 & col. 2, lines 1-51 of Goldenberg)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 12, although Goldenberg discloses the apparatus of claim 10, wherein each projection 58’ is tapered to permit a user to remove the hub from the passage (see at least fig. 8), Fleming as modified by Goldenberg discloses the apparatus of claim 10, wherein each projection would permit a user to remove the hub without first flexing the second end of each arm outward relative to the longitudinal axis. However, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the apparatus of Fleming as modified by Goldenberg wherein the projection thereof would permit a user to remove the hub without first flexing the second end of each arm outward relative to the longitudinal axis as claimed in order to facilitate removal of the hub from the handle.
Claim(s) 13-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fleming (US 6,554,778) in view of Zohmann (US 6,558,353).
In regards to claim 13, Fleming discloses the apparatus of claim 1, that fails to explicitly teach an apparatus wherein the body further comprises a plurality of ribs. However, Zohmann teaches that it is known to provide an apparatus wherein the body 20 further comprises a plurality of ribs 22 (see at least figs. 1-8 and col. 5, lines 53-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming wherein the body further comprises a plurality of ribs as taught by Zohmann since such a modification would amount to applying a known technique (i.e., the raised areas and flat portions of Zohmann) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as allowing the body to be manipulated more easily, even when the user is wearing surgical gloves (see col. 5, lines 53-60 of Zohmann)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 14, Fleming discloses the apparatus of claim 13, that fails to explicitly teach an apparatus wherein the ribs comprise a plurality of longitudinal ribs extending parallel to the longitudinal axis of the handle, and at least one circumferential rib extending between longitudinal ribs. However, Zohmann teaches that it is known to provide an apparatus wherein the ribs 22 comprise a plurality of longitudinal ribs 22 extending parallel to the longitudinal axis of the handle 20, and at least one circumferential rib 22 extending between longitudinal ribs 22 (see at least figs. 1-8 and col. 5, lines 53-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming wherein the ribs comprise a plurality of longitudinal ribs extending parallel to the longitudinal axis of the handle, and at least one circumferential rib extending between longitudinal ribs as taught by Zohmann since such a modification would amount to applying a known technique (i.e., the raised areas and flat portions of Zohmann) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as allowing the body to be manipulated more easily, even when the user is wearing surgical gloves (see col. 5, lines 53-60 of Zohmann)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 15, Fleming discloses the apparatus of claim 14, that fails to explicitly teach an apparatus wherein each rib has a distal edge, and the ribs are configured such that a circle disposed in a plane that is perpendicular to the rotational axis contacts the distal edges of at least three ribs. However, Zohmann teaches that it is known to provide an apparatus wherein each rib 22 has a distal edge, and the ribs 22 are configured such that a circle disposed in a plane that is perpendicular to the rotational axis contacts the distal edges of at least three ribs 22 (see at least figs. 1-8 and col. 5, lines 53-60). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming wherein each rib has a distal edge, and the ribs are configured such that a circle disposed in a plane that is perpendicular to the rotational axis contacts the distal edges of at least three ribs as taught by Zohmann since such a modification would amount to applying a known technique (i.e., the raised areas and flat portions of Zohmann) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as allowing the body to be manipulated more easily, even when the user is wearing surgical gloves as well as allowing the body or handle to be gripped with a conventional or uniform grip from almost any angle (see col. 5, lines 53-60 of Zohmann)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 17 & 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fleming (US 6,554,778) in view of Scribner et al. (US 6,241,734) (“Scribner” hereinafter).
In regards to claim 17, Fleming discloses the apparatus of claim 1, that fails to explicitly teach an apparatus wherein the handle is configured to permit a fluid source or suction source to be coupled to the cannula hub when the handle is coupled to the cannula hub. However, Scribner teaches that it is known to provide an apparatus wherein the handle 60 is configured to permit a fluid source 104 or suction source 104
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to be coupled to the cannula hub 50 when the handle 60 is coupled to the cannula hub 30 (see at least abstract, figs. 25-26; col. 15, lines 41-44; col. 16, lines 10-13 & 31-34). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the apparatus of Fleming wherein the handle is configured to permit a fluid source or suction source to be coupled to the cannula hub when the handle is coupled to the cannula hub as taught by Scribner since such a modification would amount to applying a known technique (i.e., as taught by Scribner) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as facilitating introduction of material into a bone cavity while using the handle to provide help stabilize the cannula (see col. 15, lines 41-44 of Scribner)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 19, Fleming discloses the kit of clam 18, that fails to explicitly teach a kit further comprising a tray within which the apparatus and needle set are sealed. However, Scribner teaches that it is known to provide a kit 12 further comprising a tray 130 within which the apparatus and needle set (28, 30, 32)
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are sealed (i.e., sealed with outer wrap 134) (see at least figs. 1-3 and col. 9, lines 24-67; col. 5, lines 37-63). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the kit of Fleming further comprising a tray within which the apparatus and needle set are sealed as taught by Scribner since such a modification would amount to applying a known technique (i.e., as taught by Scribner) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as providing a prepackaged group of instruments that facilitates gaining subcutaneous access to a bone interior (see col. 5, lines 37-63 of Scribner)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fleming (US 6,554,778) in view of Cervi (US 2002/0042581).
While Fleming discloses a method of accessing an intraosseous space, the method comprising: providing an apparatus according to claim 1 and coupling the handle to the intraosseous device (see at least abstract and figs. 1a-b), Fleming discloses a method, as described above, that fails to explicitly teach a method comprising inserting the cannula of the apparatus into a bone using a powered driver that is coupled to the intraosseous device; de-coupling the powered driver from the intraosseous device; and manipulating the cannula via the handle to access the intraosseous space.
However, Cervi teaches that it is known to provide a method comprising inserting the cannula 3 of the apparatus into a bone using a powered driver 27 that is coupled to
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the intraosseous device; de-coupling the powered driver 27 from the intraosseous device; and manipulating the cannula 3 via the handle 2 to access the intraosseous space (see at least abstract, figs. 1B, 4A-B & 7A-H and par 0058-0060 & 0062-0068).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Fleming comprising inserting the cannula of the apparatus into a bone using a powered driver that is coupled to the intraosseous device; de-coupling the powered driver from the intraosseous device; and manipulating the cannula via the handle to access the intraosseous space as taught by Cervi since such a modification would amount to applying a known technique (i.e., as taught by Cervi) to a known device (i.e., as taught by Fleming) ready for improvement to achieve a predictable result such as optionally providing the biopsy needle with a removable drive coupling for connecting motor drive such that a motor drive can be attached when it is difficult to manually core the bone when substantial resistance is encountered when manually coring the bone (see at least par 0058 & 0064 of Cervi)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant's arguments filed January 28, 2026 have been fully considered but they are not persuasive. Applicant contends that Fleming fails to teach “"the handle further including a coupling portion extending from the body of the handle and configured to lock the handle directly to the cannula hub when the cannula hub is received within the passage, and the coupling portion further configured to unlock the handle from the cannula hub by pulling the cannula hub away from the handle and withdrawing the cannula hub from the passage." The Office respectively traverses. For example, although in Fleming, multiple prior acts are required in order to lock or unlock the cannula from the handle, Fleming nonetheless requires the coupling portion (30, 68, 69, 71) extending from the body of the handle 28 to lock the handle 28 directly to the cannula hub 26 when the cannula hub 26 is received within the passage (of sheath housing 70), and the coupling portion (30, 68, 69, 71) is configured to unlock the handle 28 from the cannula hub 26 by pulling the cannula hub 26 away from the handle 28 and withdrawing the cannula hub 26 from the passage (of sheath housing 70) (see at least abstract, figs. 1a-b, 6a-e & 7a-d and col. 5, lines 29-67; col. 6, lines 1-56). Applicant may amend the claim to recite, inter alia, that the coupling portion further configured to unlock the handle from the cannula hub by only withdrawing the cannula hub from the passage by only pulling the cannula hub away from the handle and withdrawing the cannula hub from the passage without previously unlocking the cannula from the handle.
In view of the foregoing, the rejections over at least Fleming are maintained.
Conclusion
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/RENE T TOWA/Primary Examiner, Art Unit 3791
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