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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/13/26 has been entered.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claims 1, 8 & 15 recite the newly added limitation “wherein the gripping portion is at least three times longer in the axial direction than wide in the radial direction;” which is not disclosed in the specification. Appropriate correction is required.
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 1-3, 5-9, 11-16 & 18-20 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 1 at Lines 8-9 recites the newly added limitation “wherein the gripping portion is at least three times longer in the axial direction than wide in the radial direction;” which seeks to introduce new matter as this limitation is not disclosed in the specification and the drawings are not explicitly labeled as being “to scale”, thus per MPEP 2125 which states “[I]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.”, the disclosure does not provide adequate support for the “at least three times longer” portion of the newly added limitation. Appropriate correction is required.
Claim 8 at Lines 10-11 recites the newly added limitation “wherein the gripping portion is at least three times longer in the axial direction than wide in the radial direction;” which seeks to introduce new matter as the limitation is not disclosed in the specification and the drawings are not explicitly labeled as being “to scale”, thus per MPEP 2125 which states “[I]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.”, the disclosure does not provide adequate support for the “at least three times longer” portion of the newly added limitation. Appropriate correction is required.
Claim 15 at Lines 6-7 recites the newly added limitation “wherein the gripping portion is at least three times longer in the axial direction than wide in the radial direction;” which seeks to introduce new matter as the limitation is not disclosed in the specification and the drawings are not explicitly labeled as being “to scale”, thus per MPEP 2125 which states “[I]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.”, the disclosure does not provide adequate support for the “at least three times longer” portion of the newly added limitation. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3 & 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teisen et al. (US PG Pub No. 2013/0331840) in view of Sweeney et al. (US PG Pub No. 2021/0315611).
Regarding Claims 1-3 & 11, Teisen et al. discloses an intraosseous access assembly (100, Figs. 1-6, Paragraphs [0037-0049]) defining an axial direction, a radial direction, and a circumferential direction (See examiner annotated Fig. 1 below), the intraosseous access assembly comprising: a driver (140, Fig. 1) defined between a proximal driver end/PDE (See examiner annotated Fig. 1 below) and a distal driver end/DDE (See examiner annotated Fig. 1 below), the driver defining an ergonomic gripping portion (See examiner annotated Fig. 1 below) between the PDE and the DDE, the driver defining a prong (See examiner annotated Fig. 1 below) extending from the DDE; a stylet (106, Fig. 1) extending from the DDE of the driver, the stylet extending between a distal stylet end/DSE (See examiner annotated Fig. 1 below) and a proximal stylet end/PSE (See examiner annotated Fig. 1 below); a catheter hub (146, Fig. 1) removably couplable to the driver at the DDE (Fig. 2), the catheter hub defining an aperture for receiving the prong of the driver (See examiner annotated Fig. 1 below) thereby locking the driver and the catheter hub with respect to rotation in either direction around a central axis (Fig. 2 and see examiner annotated Fig. 1 below), a catheter (104) extending from the catheter hub, the catheter extending between a proximal catheter end/PCE (See examiner annotated Fig. 1 below) and a distal catheter end/DCE (See examiner annotated Fig. 1 below), the catheter defining a longitudinal opening at the DCE (See examiner annotated Fig. 1 below), wherein the stylet extending from the DDE of the driver is selectively received through the catheter hub and the catheter (Fig. 2), the stylet having a tip (108, Fig. 3) defined at the DSE and extending through the opening at the DCE (Fig. 3).
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Teisen et al. does not disclose that the prong is one of a plurality of prongs extending from the DDE, and wherein the aperture is one of a plurality of apertures, wherein each of the plurality of prongs are received in a respective one of the plurality of apertures of the catheter hub around the central axis of the driver, thereby locking the driver and the catheter hub with respect to rotation in either direction around the central axis, and wherein the plurality of prongs are spaced circumferentially in an array around the central axis of the driver.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the driver of Teisen et al. to add a second prong on the opposite side of the central axis facing the first prong and modify the catheter hub to add a second aperture on the opposite side of the central axis facing the first aperture such that the prongs and corresponding apertures are arranged circumferentially about the central axis in order to provide the assembly with a more robust locking means between the driver and the catheter hub since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Teisen further fails to disclose wherein the gripping portion of the driver comprises an hourglass shaped portion between the PDE and the DDE positioned proximate the DDE, the hourglass shaped portion defined by a narrower portion axially bounded by two wider portions.
Sweeney et al. discloses an intraosseous device and methods for performing intraosseous fusion (Paragraph [0001]), comprising an access assembly (100, Fig. 1, Paragraphs [0007, 0021, 0032-0035]) including a driver (112) with an ergonomic handle (116, Figs. 4-5) comprising a proximal end/PDE (408) and a distal end/DDE (404), and an hourglass shaped cross-sectional portion (at 424, Fig. 5) defined between a bulbous proximal portion (124, Fig. 5) and a distal connection portion (120) thereof, wherein the hourglass shaped cross-sectional portion is defined by a narrower portion axially bounded by two wider portions (shoulder above and shoulder below portion 424, Fig. 5), wherein the ergonomic handle is elongated and longer in an axial direction along a longitudinal axis therethrough (axis A, Fig. 5) than wide in a radial direction thereof (See examiner annotated Fig. 5 below), such that it is compatible with an operator’s hand (Paragraph [0047]).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the shape of the gripping portion of the driver of Teisen et al. to be elongate along the axial direction, such that the driver includes an hourglass shaped cross-sectional portion between the DDE and the PDE and a bulbous portion at the PDE, as taught by Sweeney et al. in order to provide the driver with an alternate and functionally equivalent ergonomic shape which is easily grippable by a hand of an operator during use.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teisen et al. (US PG Pub No. 2013/0331840) in view of Sweeney et al. (US PG Pub No. 2021/0315611) as applied to Claim 1 above, and further in view of Miller et al. (US PG Pub No. 2008/0045965), hereinafter Miller 2.
Regarding Claims 5-7, the combination of Teisen et al. and Sweeney et al. discloses the claimed invention as stated above in claim 1, except wherein the catheter further defines a fenestration rearward from the longitudinal opening between the PCE and the DCE, wherein the fenestration comprises a plurality of lateral fenestrations, and wherein each lateral fenestration of the plurality of lateral fenestrations is circumferentially spaced apart.
Miller 2 discloses an intraosseous device and methods for biopsy and aspiration of bone marrow (Abstract), comprising an access assembly (Figs. 2-5D) comprising a driver (102/250, Figs. 3B-3C, 5A-5F), a stylet (120) extending from the driver, a catheter hub (140a), and a cannula (110a) extending from the catheter hub, wherein the cannula comprises a plurality of lateral fenestrations (ports 106, Fig. 3B, Paragraph [0146]) located rearward from the distal-most end (111a) of the cannula and arranged circumferentially about a longitudinal axis extending through the cannula (Figs. 3A-3B). Miller 2 teaches providing the side ports when the assembly is used “for some applications”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the driver, stylet and catheter of the assembly of the combination to add a cannulation extending through the driver and stylet, add a plurality of ports arranged circumferentially about the longitudinal axis of the stylet, and add a plurality of ports arranged circumferentially about the longitudinal axis of the catheter, as taught by Miller 2 in order to allow the assembly to disperse injected materials such as bone cement or local anesthetics into the surgical site during use.
Claim(s) 8-9, 12-16, & 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teisen et al. (US PG Pub No. 2013/0331840) in view of Sweeney et al. (US PG Pub No. 2021/0315611) and Miller et al. (US PG Pub No. 2008/0045965), hereinafter Miller 2.
Regarding Claims 8-9, Teisen et al. discloses an intraosseous access assembly (100, Figs. 1-6, Paragraphs [0037-0049]) defining an axial direction, a radial direction, and a circumferential direction (See examiner annotated Fig. 1 above), the intraosseous access assembly comprising: a driver (140, Fig. 1) defined between a proximal driver end/PDE (See examiner annotated Fig. 1 above) and a distal driver end/DDE (See examiner annotated Fig. 1 above) in the axial direction, the driver defining a gripping portion (See examiner annotated Fig. 1 above) between the PDE and the DDE, the driver comprising a driving portion defined in the PDE (See examiner annotated Fig. 1 above); a stylet (106, Fig. 1) extending from the DDE of the driver, the stylet extending between a distal stylet end/DSE (See examiner annotated Fig. 1 above) and a proximal stylet end/PSE (See examiner annotated Fig. 1 above); a catheter hub (146, Fig. 1) removably couplable to the driver at the DDE (Fig. 2); and a catheter (104) extending from the catheter hub, the catheter extending between a proximal catheter end/PCE (See examiner annotated Fig. 1 above) and a distal catheter end/DCE (See examiner annotated Fig. 1 above), the catheter defining a longitudinal opening at the DCE (See examiner annotated Fig. 1 above), wherein the stylet extending from the DDE of the driver is selectively received through the catheter hub and the catheter (Fig. 2), the stylet having a tip (108, Fig. 3) defined at the DSE and extending through the opening at the DCE (Fig. 3).
Teisen does not disclose wherein the gripping portion of the driver comprises an hourglass shaped portion between the PDE and the DDE, the hourglass shaped portion defined by a narrower portion axially bounded by two wider portions.
Sweeney et al. discloses an intraosseous device and methods for performing intraosseous fusion (Paragraph [0001]), comprising an access assembly (100, Fig. 1, Paragraphs [0007, 0021, 0032-0035]) including a driver (112) with an ergonomic handle (116, Figs. 4-5) having a hourglass shaped cross-sectional area (at 424, Fig. 5) defined between a proximal end (408) and a distal end (404) thereof, wherein the hourglass shaped cross-sectional area is defined by a narrower portion axially bounded by two wider portions (shoulder above and shoulder below portion 424, Fig. 5), wherein the ergonomic handle is longer in an axial direction along a longitudinal axis therethrough (axis A, Fig. 5) than wide in a radial direction thereof (See examiner annotated Fig. 5 above), such that it is compatible with an operator’s hand (Paragraph [0047]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the shape of the proximal driving end of the gripping portion of the driver of Teisen et al. with the elongate shape of the ergonomic handle including an hourglass shaped cross-sectional area proximate the PDE as taught by Sweeney et al. in order to provide the driver with an alternate and functionally equivalent ergonomic shape which is easily grippable by a hand of an operator during use.
Teisen et al. further fails to disclose the driving portion defining a female receiving end to accept a complementary/matched male tool bit enabling mated rotation of the driver, wherein the female receiving end of the driving portion defines an opening for receipt of the male tool bit within the PDE of the driver.
Miller 2 discloses the intraosseous device and methods for biopsy and aspiration of bone marrow (Abstract) as stated above, comprising the access assembly (Figs. 2-5D) comprising a driver (102/250, Figs. 3B-3C, 5A-5F), a stylet (120) extending from the driver, a catheter hub (140a), and a cannula (110a) extending from the catheter hub, wherein the driver includes a driving portion (receptacle 264, Figs. 5D, 5F, Paragraph [0136]) defined in the proximal most end (262), the driving portion defining a female receiving end/tool receptacle configured to accept a complementarily shaped male tool bit (224, Fig. 5A) enabling mated rotation of the driver via a driving tool (200, Paragraph [0136]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the driver of Teisen et al. to add a tool receptacle in the PDE as taught by Miller 2 in order to provide the driver with a means for engaging a tool bit of a driving tool so that the assembly can be rotated via the driving tool if need be during a procedure based on a particular patient’s needs.
Regarding Claims 12-14, the combination of Teisen et al., Sweeney et al. and Miller 2 discloses the claimed invention as stated above in claim 8, except wherein the catheter further defines a fenestration rearward from the longitudinal opening between the PCE and the DCE, wherein the fenestration comprises a plurality of lateral fenestrations, and wherein each lateral fenestration of the plurality of lateral fenestrations is circumferentially spaced apart.
Miller 2 discloses the intraosseous device and methods for biopsy and aspiration of bone marrow (Abstract) as stated above, wherein the cannula (110a) comprises a plurality of lateral fenestrations (ports 106, Fig. 3B, Paragraph [0146]) located rearward from the distal-most end (111a) of the cannula and arranged circumferentially about a longitudinal axis extending through the cannula (Figs. 3A-3B). Miller 2 teaches providing the side ports when the assembly is used “for some applications”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the driver, stylet and catheter of the assembly of the combination to add a cannulation extending through the driver and stylet, add a plurality of ports arranged circumferentially about the longitudinal axis of the stylet, and add a plurality of ports arranged circumferentially about the longitudinal axis of the catheter, as taught by Miller 2 in order to allow the assembly to disperse injected materials such as bone cement or local anesthetics into the surgical site during use.
Regarding Claims 15-16, Teisen et al. discloses an intraosseous access assembly (100, Figs. 1-6, Paragraphs [0037-0049]), comprising: a driver (140, Fig. 1) defined between a proximal driver end/PDE (See examiner annotated Fig. 1 above) and a distal driver end/DDE (See examiner annotated Fig. 1 above), the driver defining a gripping portion (See examiner annotated Fig. 1 above) between the PDE and the DDE, the driver defining a prong (See examiner annotated Fig. 1 below) extending from the DDE; a stylet (106, Fig. 1) extending from the DDE of the driver, the stylet extending between a distal stylet end/DSE (See examiner annotated Fig. 1 above) and a proximal stylet end/PSE (See examiner annotated Fig. 1 above); a catheter hub (146, Fig. 1) removably couplable to the driver at the DDE (Fig. 2), the catheter hub defining an aperture for receiving the prong of the driver (See examiner annotated Fig. 1 above); and a catheter (104) extending from the catheter hub, the catheter extending between a proximal catheter end/PCE (See examiner annotated Fig. 1 above) and a distal catheter end/DCE (See examiner annotated Fig. 1 above), the catheter defining a longitudinal opening at the DCE (See examiner annotated Fig. 1 above), wherein the stylet extending from the DDE of the driver is selectively received through the catheter hub and the catheter (Fig. 2), the stylet comprising a tapered tip (108/116, Fig. 3) defined at the DSE and extending through the opening at the DCE (Fig. 3), the tapered tip of the stylet form a cutting tip at the DSE (Fig. 3, Paragraph [0042]).
Teisen et al. does not disclose that the prong is one of a plurality of prongs extending from the DDE, and wherein the aperture is one of a plurality of apertures, wherein each of the plurality of prongs are received in a respective one of the plurality of apertures of the catheter hub around the central axis of the driver, thereby locking the driver and the catheter hub with respect to rotation in either direction around the central axis, and wherein the plurality of prongs are spaced circumferentially in an array around the central axis of the driver.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the driver of Teisen et al. to add a second prong on the opposite side of the central axis facing the first prong and modify the catheter hub to add a second aperture on the opposite side of the central axis facing the first aperture such that the prongs and corresponding apertures are arranged circumferentially about the central axis in order to provide the assembly with a more robust locking means between the driver and the catheter hub since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Teisen further fails to disclose wherein the gripping portion of the driver comprises an hourglass shaped portion between the PDE and the DDE, the hourglass shaped portion defined by a narrower portion axially bounded by two wider portions.
Sweeney et al. discloses an intraosseous device and methods for performing intraosseous fusion (Paragraph [0001]), comprising an access assembly (100, Fig. 1, Paragraphs [0007, 0021, 0032-0035]) including a driver (112) with an ergonomic handle (116, Figs. 4-5) having a hourglass shaped cross-sectional area (at 424, Fig. 5) defined between a proximal end (408) and a distal end (404) thereof, wherein the hourglass shaped cross-sectional area is defined by a narrower portion axially bounded by two wider portions (shoulder above and shoulder below portion 424, Fig. 5), wherein the ergonomic handle is longer in an axial direction along a longitudinal axis therethrough (axis A, Fig. 5) than wide in a radial direction thereof (See examiner annotated Fig. 5 above), such that it is compatible with an operator’s hand (Paragraph [0047]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the shape of the proximal driving end of the gripping portion of the driver of Teisen et al. with the elongate shape of the ergonomic handle including an hourglass shaped cross-sectional area proximate the PDE as taught by Sweeney et al. in order to provide the driver with an alternate and functionally equivalent ergonomic shape which is easily grippable by a hand of an operator during use.
Teisen et al. further fails to disclose the catheter defining a cutting edge at the DCE, the cutting edge of the catheter and the tapered tip of the stylet form a cutting tip at the DSE, wherein the cutting edge of the catheter comprises a pair of tapers defining a recessed portion at the longitudinal opening at the DCE.
Miller 2 discloses the intraosseous device and methods for biopsy and aspiration of bone marrow (Abstract) as stated above, wherein the catheter (110a) comprises a cutting edge at the distal-most end thereof (111a, Fig. 3B, 3F-3G, Paragraphs [0145, 0160]), wherein the cutting edge comprises a pair of tapers (Fig. 3B, 3D, 3E, Paragraph [0160]) defining a recessed portion at the opening formed in the distal most end of the catheter (Figs. 3B, 3D-3J), and wherein a distal-most end of the stylet also includes a sharpened tapered tip (121, Fig. 3A, 3D-3E, 3I, 3J) such that the cutting edge of the catheter and the tapered tip of the stylet form a cutting tip at a distal-most end of the assembly (Fig. 3I, Paragraphs [0145, 0160]). Miller 2 teaches providing the distal most end of the catheter with a tapered cutting edge configuration for the purpose of providing improved drilling performance when the assembly penetrates bone.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Teisen et al. to include a cutting edge including a pair of tapers defining a recessed portion at the longitudinal opening at the DCE, such that the cutting edge of the catheter and the tapered tip of the stylet form a cutting tip at the DSE, as taught by Miller 2 in order to provide the assembly with improved drilling performance during bone penetration.
Regarding Claims 18-20, the combination of Teisen et al., Sweeney et al., and Miller 2 discloses the claimed invention as stated above in claim 15, except wherein the catheter further defines a fenestration rearward from the longitudinal opening between the PCE and the DCE, wherein the fenestration comprises a plurality of lateral fenestrations, and wherein each lateral fenestration of the plurality of lateral fenestrations is circumferentially spaced apart.
Miller 2 discloses the intraosseous device and methods for biopsy and aspiration of bone marrow (Abstract) as stated above, wherein the cannula (110a) comprises a plurality of lateral fenestrations (ports 106, Fig. 3B, Paragraph [0146]) located rearward from the distal-most end (111a) of the cannula and arranged circumferentially about a longitudinal axis extending through the cannula (Figs. 3A-3B). Miller 2 teaches providing the side ports when the assembly is used “for some applications”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the driver, stylet and catheter of the assembly of the combination to add a cannulation extending through the driver and stylet, add a plurality of ports arranged circumferentially about the longitudinal axis of the stylet, and add a plurality of ports arranged circumferentially about the longitudinal axis of the catheter, as taught by Miller 2 in order to allow the assembly to disperse injected materials such as bone cement or local anesthetics into the surgical site during use.
Response to Arguments
Applicant’s amendments, filed in the RCE on 05/13/26, have overcome the 112(b) rejections for claims 1, 8, 11 & 15.
In regards to Applicant’s arguments, filed in the RCE 05/13/26, with respect to the rejections of independent claims 1, 8 & 15: The Applicant’s arguments have been fully considered but are moot in view of the new grounds of rejection based on the newly amended claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
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