DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendments filed 06/30/2025 have been entered.
Claims 1, 6 and 13 have thereby been amended.
Claims 1-16 are being examined in this office action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 6, and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz (US 20200170559) embodiment of Figure 6, herein referred to as Burkholz’6.
Regarding claim 1, Burkholz’6 discloses an introducer assembly, comprising: a syringe (Fig. 6D: 12), including: a barrel (Fig. 6D: 14); and a plunger (Fig. 6D: 16+78) disposed in the barrel, the plunger including: a one-piece plunger shaft (Fig. 6D: 16) including a longitudinal plunger-shaft passageway extending no more than ½ a length of the plunger shaft from a distal end of the plunger shaft (Figs. 6C and 6D: the plunger-shaft passageway being the passage between ribs 76 where instrument 22 sits and passes through, extending from distal end 46 to 81); and a piston (Fig. 6D: 78) fitted over the distal end of the plunger shaft, the piston including a piston through hole forming a portion of an access-guidewire passageway of the introducer assembly with the plunger-shaft passageway (Fig. 6D: hole through which 22 passes through 78; para. [0095], last two sentences; para. [0072], sentence 1, the instrument containing a guidewire); a needle fluidly connected to the syringe (paras. [0068]-[0069]), the needle including: a needle shaft (part of needle); and a needle hub (para. [0069]) over a proximal portion of the needle shaft.
Regarding claim 2, Burkholz’6 discloses the introducer assembly of claim 1, as described above, further comprising an access guidewire (40) slidably disposed in the access-guidewire passageway (para. [0072], sentence 1), a needle lumen of the needle forming another portion of the access-guidewire passageway (guidewire passing through needle when needle is attached: paras. [0068]-[0069]).
Regarding claim 6, Burkholz’6 discloses an introducer assembly, comprising: a syringe (Fig. 6D: 12), including: a barrel (Fig. 6D: 14); a syringe hub (at 26 in Fig. 6D) including a syringe tip extending from a distal portion of the barrel (at 26 in Fig. Fig. 6D), the syringe tip including a syringe-tip lumen extending from a distal end of the syringe tip into a barrel chamber of the barrel (at 26 in Fig. 6D); and a plunger disposed in the barrel (Fig. 6D: plunger 16+78), the plunger including: a one-piece plunger shaft (Fig. 6D: 16) including a longitudinal plunger-shaft passageway extending no more than ½ a length of the plunger shaft from a distal end of the plunger shaft (Figs. 6C and 6D: the plunger-shaft passageway being the passage between ribs 76 where instrument 22 sits and passes through, extending from distal end 46 to 81); and a piston fitted over the distal end of the plunger shaft (Fig. 6D: 78), the piston including a piston through hole (Fig. 6D: hole through which 22 passes through 78; para. [0095], last two sentences; para. [0072]); and a needle fluidly connected to the syringe (paras. [0068]-[0069]), the needle including: a needle shaft including a needle tip in a distal portion of the needle shaft (part of needle), the needle shaft including a needle-shaft lumen extending from an opening in the needle tip to a proximal end of the needle shaft (guidewire passing through needle when needle is attached: paras. [0068]-[0069]); and a needle hub (para. [0069]) over a proximal portion of the needle shaft, the needle hub including a needle-hub lumen extending from a proximal end of the needle-shaft lumen to a proximal end of the needle hub (para. [0069], lumen allowing 22 and guidewire to pass through when needle is attached); and an access-guidewire passageway configured to slidably accommodate an access guidewire therein (para. [0072], sentences 1-2), the access-guidewire passageway formed form an alignment of the needle-shaft lumen, the needle-hub lumen, the syringe-tip lumen, any intervening portion of the barrel chamber between the syringe tip and the piston, the piston through hole, and the plunger-shaft passageway (Figs. 6A-E: passageway at 22 formed with the alignment of all the introducer components connected at 26).
Regarding claim 12, Burkholz’6 discloses the introducer assembly of claim 6, as described above, wherein the plunger shaft includes orthogonal struts (Figs. 6C and 6D: ribs 76) meeting along their longitudinal edges at a central axis of the plunger shaft (Fig. 6C: 76 meet at center of 16).
Regarding claim 13, Burkholz’6 discloses the introducer assembly of claim 12, as described above, wherein the orthogonal struts (Figs. 6C and 6D: ribs 76) meet along their longitudinal edges at the central axis of the plunger shaft (Fig. 6C: 76 meet at center of 16) except for in a distal portion of the plunger shaft (Fig. 6D: distal portion of the plunger 78 without struts 76), which includes the plunger-shaft passageway extending from the distal end of the plunger shaft (Fig. 6D: passageway with guidewire exit illustrated in Fig. 6B).
Regarding claim 14, Burkholz’6 discloses the introducer assembly of claim 6, as described above, wherein the plunger-shaft passageway extends no more than 1/3 a length of the plunger shaft from the distal end of the plunger shaft (Fig. 6D: plunger-shaft passageway where 22 sits, from distal end 46 to 81, extending less than a third of 16 in Fig. 6D).
Regarding claim 15, Burkholz’6 discloses the introducer assembly of claim 6, as described above, wherein the plunger-shaft passageway extends no more than 1/4 a length of the plunger shaft from the distal end of the plunger shaft (Fig. 6D: plunger-shaft passageway where 22 sits, from distal end 46 to 81, extending less than a quarter of 16 in Fig. 6D).
Regarding claim 16, Burkholz’6 discloses the introducer assembly of claim 6, as described above, the syringe hub further including a threaded collar extending from the distal portion of the barrel around the syringe tip (para. [0120]), the threaded collar including internal threads configured to screw together with a needle-hub flange of the needle hub (para. [0069]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20200170559) embodiment of Figure 6, herein referred to as Burkholz’6, in view of Burkholz (US 20200170559) embodiment of Figure 8, herein referred to as Burkholz’8.
Regarding claim 5, Burkholz’6 discloses the introducer assembly of claim 1, as described above, but fails to explicitly disclose a ring and gasket around the inner hole of the piston around the guidewire.
The embodiment shown in Figure 8 of Burkholz teaches another embodiment of the introducer assembly wherein the piston includes at least a leading ring, the leading ring including a gasket around an inner perimeter of the piston through hole configured to form a seal around the access guidewire (Fig. 8D, piston surrounding gasket 98 around guidewire/instrument 22). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the piston of the Burkholz’6 embodiment (Fig. 6D: 78 with leading ring being the most distal portion of it) by incorporating the gasket taught by Burkholz’8 around the guidewire through-hole in order to create a tighter seal between piston 78 and 22.
Regarding claim 10, Burkholz’6 discloses the introducer assembly of claim 6, as described above, but fails to explicitly disclose a ring and gasket around the inner hole of the piston around the guidewire.
The embodiment shown in Figure 8 of Burkholz teaches another embodiment of the introducer assembly wherein the piston includes at least a leading ring, the leading ring including a gasket around an inner perimeter of the piston through hole configured to form a seal around the access guidewire (Fig. 8D, piston surrounding gasket 98 around guidewire/instrument 22). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the piston of the Burkholz’6 embodiment (Fig. 6D: 78 with leading ring being the most distal portion of it) by incorporating the gasket taught by Burkholz’8 around the guidewire through-hole in order to create a tighter seal between piston 78 and 22.
Regarding claim 11, Burkholz’6 in view of Burkholz’8 teaches the introducer assembly of claim 10, as described above, wherein the gasket includes one or more integrated 'O'-rings (Fig. 8D, feature at 98, with O-ring protrusions).
Claims 3 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20200170559) embodiment of Figure 6, herein referred to as Burkholz’6, in view of O’Fallon (US 20170035996).
Regarding claim 3, Burkholz’6 discloses the introducer assembly of claim 2, as described above, but fails to explicitly disclose the guidewire tip configuration.
O’Fallon teaches an analogous guidewire advancement assembly wherein the access guidewire includes a 'J'-shaped guidewire tip in a distal portion of the access guidewire (12D), a distal end of the access guidewire disposed proximal of the needle tip (Fig. 1A, 12D distal to catheter 20, becoming the needle of Burkholz upon the combination) in a ready-to-deploy state of the introducer assembly such that the guidewire tip assumes a straightened state in the ready-to-deploy state of the introducer assembly (page 5, para. [0077]). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Burkholz’6 device with the J-shaped guidewire tip taught by O’Fallon in order to improve its passage through vasculature while allowing for passage of the catheter over it when straightened (para. [0078]).
Regarding claim 7, Burkholz’6 discloses the introducer assembly of claim 6, as described above, further comprising an access guidewire slidably disposed in the access-guidewire passageway (para. [0072], sentences 1-2), but fails to teach the guidewire end proximal to the needle tip.
O’Fallon teaches an analogous guidewire advancement assembly wherein a distal end of the access guidewire proximal of the needle tip in a ready-to-deploy state of the introducer assembly (page 5, para. [0077], the guidewire being disposed in the needle of Burkholz’6 upon the combination, guidewire able to slide and be disposed along any position in the passage). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Burkholz device with the tip proximal of the needle tip taught by O’Fallon in order to improve its insertion and passage into the patient (para. [0078]).
Regarding claim 8, Burkholz’6 discloses the introducer assembly of claim 7, as described above, but fails to explicitly disclose the guidewire tip configuration.
O’Fallon teaches an analogous guidewire advancement assembly wherein the access guidewire includes a 'J'-shaped guidewire tip in a distal portion of the access guidewire (12D), the guidewire tip assuming a straightened state in the ready-to-deploy state of the introducer assembly and a curved state when the guidewire tip is advanced beyond the needle tip in a deployed state of the introducer assembly (page 5, para. [0077]). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Burkholz’6 device with the J-shaped guidewire tip taught by O’Fallon in order to improve its passage through vasculature while allowing for passage of the catheter over it when straightened (para. [0078]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20200170559) embodiment of Figure 6, herein referred to as Burkholz’6, in view of O’Faron (CN 106422031).
Regarding claim 4, Burkholz’6 discloses the introducer assembly of claim 2, as described above, but fails to disclose the wound-wire and bare-wire portions of the guidewire.
O’Faron teaches an analogous guidewire advancement assembly wherein the access guidewire includes a bare-wire portion (translation: page 2, third paragraph) and a wound-wire portion (Fig. 6B, wound-wire 12) proximal of the bare-wire portion (translation: page 2, third paragraph), the bare- wire portion distally extending from at least the piston through hole in a deployed state of the introducer assembly (translation: page 1, second paragraph and Fig. 1A, 12D extending distally). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Burkholz’6 device with the wound and bare wire portions of the guidewire taught by O’Faron in order to maintain flexible bare and more rigid wound portions of the wire for improved maneuvering and usage (page 2, third paragraph).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20200170559) embodiment of Figure 6, herein referred to as Burkholz’6, in view of O’Fallon (US 20170035996) in further view of O’Faron (CN 106422031).
Regarding claim 9, Burkholz’6 in view of O’Fallon teaches the introducer assembly of claim 7, as described above, but fails to teach the wound-wire and bare-wire portions of the guidewire.
O’Faron teaches an analogous guidewire advancement assembly wherein the access guidewire includes a bare-wire portion (translation: page 2, third paragraph) and a wound-wire portion (Fig. 6B, wound-wire 12) proximal of the bare-wire portion (translation: page 2, third paragraph), the bare- wire portion extending from at least the piston through hole to the distal end of the access guidewire in the ready-to-deploy state of the introducer assembly (translation: page 1, second paragraph and Fig. 1A, 12D extending distally). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Burkholz’6-O’Fallon device with the wound-wire and bare-wire portions of the guidewire taught by O’Faron in order to maintain flexible bare and more rigid wound portions of the wire for improved maneuvering and usage (page 2, third paragraph).
Response to Arguments
Applicant's arguments filed 01/23/2026 regarding the combination of Burkholz embodiments are considered moot in light of the new rejections above, in which Burkholz’6 and Burkholz’8 are distinguished and properly combined. Applicant's arguments filed 01/23/2026 regarding the prior art rejections of claims 1-16 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Burkholz’6 fails to teach “a one-piece plunger shaft including a longitudinal plunger-shaft passageway extending no more than ½ a length of the plunger shaft from a distal end of the plunger shaft,” Examiner maintains the above rejections of independent claims 1 and 6 as anticipated by Burkholz’6. As the current claim language is silent as to the position of the plunger/plunger shaft relative to the barrel when the plunger-shaft passage extends no more than ½ the length of the plunger shaft, as claims are currently written, Examiner interprets Burkholz to disclose all limitations of the independent claims as described in the above rejections, as depicted by the positioning shown in Fig. 6D. Applicant argues that Burkholz fails to disclose a one-piece plunger-shaft passageway. However, Examiner points to only 16 as the plunger shaft, and not to element 81 and Applicant argues. Rather, Examiner relies upon 81 to determine the proximal ending position of the passageway. Furthermore, as they are currently written, the claims do not specify the movement or permanence of the structures such as the plunger-shaft passageway. As such, Examiner maintains the interpretation of figure 6D of Burkholz, as reading on the plunger-shaft passageway, defined as the space along the rib (76) of the shaft between the tab (81) and the distal end of the shaft (at 78) as being able to exist/be located at a position in which that passageway does not extend more than ½ the length of the plunger shaft from the distal end.
Therefore, Examiner maintains that the independent claims, even in light of the amendments, are anticipated by Burkholz, and that the rejections as recited above are maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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