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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, Species 2 of Species Set A, Species 4 of Species Set B, and Species 6 of Species Set C in the reply filed on 12/03/2025 is acknowledged.
Claims 2, 5, 13, 16, and 23-26 are thus withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/03/2025.
Claim Objections
Claims 2, 5, 13, 16, and 23-26 are objected to due improper claim listing as the claim set filed 12/03/2025 did not use the proper Status Identifiers to properly identify the withdrawn claims as withdrawn. Appropriate correction is required; see MPEP §714(II)(C) for further information.
Claims 8 and 19 are objected to because of the following informalities:
Claims 8 and 19 have a typographical error wherein they both recite “the remainder of the needle slot” and should instead recite “a remainder of the needle slot” to have proper antecedent basis for the claim element.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1, 3, 4, 6-11, 12, 14, 15, and 17-22 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.
As per MPEP 2173.05(p)(ll), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. It is not clear if the claims are drawn only to structures that are capable of performing the method steps or if the claims are intended to be written as method steps. For the sake of examination, the claims have been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed.
Claims 1 and 12 are thus considered to be indefinite where they are drawn to an apparatus (assemblies) and method steps (“such that the proximal- end portion of the needle slot catches the distal-end portion of the access guidewire preventing proximal withdrawal of the access guidewire from the needle shaft”). For the purposes of compact prosecution, Examiner has understood the claim limitations to be purely functional in nature (“such that the proximal- end portion of the needle slot is configured to catch the distal-end portion of the access guidewire such that the proximal- end portion of the needle slot is configured to prevent proximal withdrawal of the access guidewire from the needle shaft”).
Similarly, claims 3 and 14 are thus considered to be indefinite where they are drawn to an apparatus (assemblies) and method steps (“rigid tubular fitting thereover preventing the proximal portion of the distal-end portion of the access guidewire from bending, thereby directing the distal-end portion of the access guidewire”). For the purposes of compact prosecution, Examiner has understood the claim limitations to be purely functional in nature (“rigid tubular fitting thereover configured to prevent the proximal portion of the distal-end portion of the access guidewire from bending, thereby being configured to direct the distal-end portion of the access guidewire”).
Similarly, claims 4 and 15 are thus considered to be indefinite where they are drawn to an apparatus (assemblies) and method steps (“sheath body prevents the proximal withdrawal of the access guidewire from the needle shaft by interfering with the distal-end portion”). For the purposes of compact prosecution, Examiner has understood the claim limitations to be purely functional in nature (“sheath body is configured to prevent the proximal withdrawal of the access guidewire from the needle shaft by being configured to interfere with the distal-end portion”).
Similarly, claims 8 and 19 are thus considered to be indefinite where they are drawn to an apparatus (assemblies) and method steps (“sheath hub prevents the proximal withdrawal of the access guidewire from the needle shaft by interfering with the distal-end portion”). For the purposes of compact prosecution, Examiner has understood the claim limitations to be purely functional in nature (“sheath hub is configured to prevent the proximal withdrawal of the access guidewire from the needle shaft by being configured to interfere with the distal-end portion”).
Similarly, claims 9 and 20 are thus considered to be indefinite where they are drawn to an apparatus (assemblies) and method steps (“thereby preventing the proximal withdrawal of the access guidewire”). For the purposes of compact prosecution, Examiner has understood the claim limitations to be purely functional in nature (“thereby being configured to prevent the proximal withdrawal of the access guidewire”).
Dependent claims 6, 7, 10, 11, 17, 17, 21, and 22 are indefinite based on their dependence on, and thus requirements of the indefinite limitations of, their respective claims.
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.
Claim(s) 1, 3, 4, 6-10, 12, 14, 15, and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 20080262430, henceforth Anderson) in view of Blanchard et al. (US 20150119806, henceforth Blanchard), Nool et al. (US 20020072712, henceforth Nool), and Minar et al. (US 20150314109, henceforth Minar).
Regarding claim 1, Anderson discloses an introducer assembly (access device 102, fig. 1), comprising: an introducer (needle 20 and sheath 58 combine to make the claimed introducer, see fig. 1) including: an introducer needle (needle 20, fig. 2A) including a needle shaft (needle body 22, fig. 1) with a proximal portion of the needle shaft (proximal portion 24, fig. 2A) through a distal needle tip (bevel tip 108, fig. 2A); and a splittable introducer sheath (sheath 58 is considered to be splittable where a user is physically capable of splitting the sheath by breaking apart its sheath hub 53 as disclosed in [0066]) including a sheath body (sheath body 54, fig. 4A) over the needle shaft (see fig. 1, sheath body 54 is placed radially around, or over, needle body 22 in the assembled device) with a sheath-body opening in a proximal portion of the sheath body (see figs. 14 and 15, the proximal opening in the sheath is the proximal ending of the sheath which is open to allow guidewire 120 to be inserted thereinto as shown); and an access guidewire (guidewire 120, fig. 14) including a distal-end portion disposed in the introducer (see at least figs. 1 and 14, guidewire 120 is disposed in the introducer in the assembled device).
Anderson does not disclose the needle shaft having a longitudinal needle slot extending from the proximal portion of the needle shaft through the distal tip, that the sheath body seals the needle slot thereunder but for the sheath-body opening, or the distal-end portion of the access guidewire having an outer diameter greater than at least a proximal-end portion of the needle slot such that the proximal- end portion of the needle slot catches the distal-end portion of the access guidewire preventing proximal withdrawal of the access guidewire from the needle shaft. Blanchard teaches an introducer assembly (see fig. 15B) comprising a needle shaft (needle 216, fig. 15B) having a longitudinal needle slot (needle slot 226 and the shown beveled tip make up the slot, fig. 15B) extending from a proximal portion of the needle shaft (see fig. 15B, the proximal portion is the portion which is proximal to the distal most tip along the shaft) through a distal tip of the needle (see fig. 15B and see fig. 17A). Blanchard additionally teaches that an equivalent arrangement in a different embodiment is to insert the guidewire through a proximal opening (see fig. 4B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the needle slot and beveled tip of Blanchard to the needle shaft of Anderson as it allows for an alternative insertion method for the guidewire (see Blanchard [0076]-[0078], and figs. 15-18) such that the needle could be removed with the other elements left in place, and further because Blanchard teaches that the arrangements are equivalent and that inserting a guidewire through a proximal opening or through a needle slot are equivalently effective methods of inserting a guidewire into a needle.
In the modified device, the proximal portion of the needle shaft is thus considered to be the length of the needle body 22 of Anderson between the needle hub 21 and the distal tip which includes a wider slotted opening as shown in Blanchard fig. 17A and as called out in the provided annotated figure.
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Annotated fig. 17A from Blanchard showing the distal most end of the proximal portion of the needle of Anderson in the modified device where it is adjacent to the distal tip
Anderson as modified by Blanchard does not explicitly disclose that the sheath body is configured to seal the needle slot thereunder except for the opening at the proximal end of the sheath body. Nool teaches that it is beneficial to provide sealing around guidewires in introducer assemblies to prevent unwanted blood flashback during use, and that seals can be provided through tolerancing of tubes arranged within each other to minimize blood backflow (see at least [0027], [0029], and [0115], and note that the filters referred to in Nool appear to be similarly structured to guidewires).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the sheath of Anderson to have sealed the slotted needle shaft of Anderson as modified to prevent unwanted blood flashback and blood flow as in Nool by configuring the sheath of Anderson to provide a good seal against the needle through their relative dimensions (see at least Nool [0029] and [0115]). In the modified device, this could be achieved where the inner diameter of the sheath of Anderson should be approximately equal to the outer diameter of the needle of Anderson such that the two components are sealed relative to each other even with the added needle slot.
Anderson as modified by Blanchard and Nool discloses that it is desirable to limit the proximal withdrawal of the guidewire by providing elements with interfering diameters such that relative movement beyond a certain point is prohibited (see at least Anderson [0090] and [0092], stops 180 can be used for limiting backward movement; this is also referenced in Anderson at Abstract and [0020]).
Anderson as modified does not explicitly disclose the distal-end portion of the access guidewire having an outer diameter greater than at least a proximal-end portion of the needle slot such that the proximal- end portion of the needle slot catches the distal-end portion of the access guidewire preventing proximal withdrawal of the access guidewire from the needle shaft. Minar teaches a guidewire (see fig. 1) with different regions providing different stiffness characteristics (see Abstract and see fig. 1) including the use of different diameters and tapered regions in changing between different stiffness regions (see at least fig. 1 and tapered portion 20, as well as reduced diameter portions 22, 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the guidewire of Anderson with the guidewire of Minar as the guidewire of Minar provides better pushability characteristics at its distal end (see Abstract) and more customizable stiffness characteristics (see at least Minar Abstract, [0028], [0037], and [0041]).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have chosen outer diameters in reduced diameter and tapered sections of the guidewire such that the reduced diameter sections could be pushed through the needle slot of the modified needle of Anderson and would catch at the wider outer diameter distal tip such as to provide a means for preventing unwanted proximal withdrawal of the guidewire as Anderson teaches the use of changeable outer diameter elements of a guidewire for this purpose (see at least Anderson [0090] and [0092], stops 180 can be used for limiting backward movement; this is also referenced in Anderson at Abstract and [0020]; in the modified device, since there are already thicker and thinner portions of the guidewire of Minar, it would have been obvious to have relied on these variable outer diameter dimensions to achieve the functionality of stops 180 of Anderson since the modified device can see the guidewire inserted as shown in Anderson or through the added needle slot as shown in Blanchard).
{Examiner notes that all subsequent references are to Anderson unless otherwise called out.}
Regarding claim 3, Anderson as modified discloses the assembly of claim 1, wherein a proximal portion of the distal-end portion of the access guidewire (from Minar: this is the radial interior of stainless steel proximal shaft 1, fig. 1) includes a rigid tubular fitting thereover (the stainless steel tube which radially surrounds the radial interior of proximal shaft 1 is a rigid tubular fitting where stainless steel is rigid where it is not superelastic, it is tubular fitting as it is a casing surrounding the radial interior core, and it is over the core radially) preventing the proximal portion of the distal-end portion of the access guidewire from bending (from Minar: see [0006], the stainless steel proximal section is relatively stiff which means it is configured to prevent bending), thereby directing the distal-end portion of the access guidewire to engage the proximal-end portion of the needle slot over a remainder of the needle slot (in the modified device, the pushability from the proximal section 1 of Minar’s guidewire is configured to direct the distal end of the guidewire to engage the slot as claimed as it provides a structure which the guidewire can be pushed from to cause engagement between the larger outer diameter tip of the guidewire and the narrower slot which is a remainder of the slot where the other portion of the slot is the beveled tip of Blanchard).
Regarding claim 4, Anderson as modified discloses the assembly of claim 3, wherein the sheath-body opening extends over the proximal-end portion of the needle slot without substantially extending over the remainder of the needle slot (in the modified device, the needle 20 of Anderson could be partially removed such that the proximal opening at the proximal end of sheath 58 is arranged to extend radially around, or over, the proximal portion of the needle slot; since the opening is a small radial slice, the opening would not extend substantially over the remainder of the needle slot since it only exists at one longitudinal position along the needle) such that the sheath body prevents the proximal withdrawal of the access guidewire from the needle shaft by interfering with the distal-end portion of the access guidewire (since the distal end portion of the access guidewire is configured to engage with the needle slot to prevent proximal withdrawal of the guidewire in the modified device, and since the guidewire is insertable through the added slot in the modified device similar to the arrangement shown in Blanchard fig. 18 where the sheath of Anderson radially surrounds and seals the needle distal to the insertion point of the guidewire into the needle, the sheath body is configured as claimed since the needle and guidewire could be arranged similar to Blanchard fig. 18 and then inserted further distally into the sheath such that the sheath seals the needle within itself as it is configured for in claim 1, and this sealing prevents proximal withdrawal since the sheath seals the needle and thus prevents the guidewire from being withdrawn from said needle).
Regarding claim 6, Anderson as modified discloses the assembly of claim 1, wherein the proximal-end portion of the needle slot is narrower than a remainder of the needle slot (see annotated fig. 17A from Blanchard above; the proximal end portion of the needle slot is narrower across its radius than where the distal beveled tip exists as there is a radius across this beveled tip, with the bevel considered to be part of the slot, which has a wider radius than the top, proximal portion of the needle slot as shown).
Regarding claim 7, Anderson as modified discloses the assembly of claim 1, the introducer sheath further including a splittable sheath hub (sheath hub 53, fig. 4A, which is splittable as in [0066]) around the proximal portion of the sheath body (sheath hub 53 is configured to radially surround sheath body 54 as shown in fig. 4A, and thus it is around proximal portion 58 thereof as claimed).
Regarding claim 8, Anderson as modified discloses the assembly of claim 7, wherein the sheath hub extends over the remainder of the needle slot exposed by the sheath-body opening (the sheath hub extends proximally to the sheath-body opening as the sheath body does not extend as far proximally as the sheath hub, and the proximal opening of the sheath hub is wider than the sheath body such as to allow for locking with the needle hub similar to the opening shown in fig. 3C, see also fig. 5; because of this, the sheath hub 53 extends radially around, or over, a portion of the needle slot which has not been fully inserted into the sheath body 54 in the modified device which is an extension as claimed) such that the sheath hub prevents the proximal withdrawal of the access guidewire from the needle shaft by interfering with the distal-end portion of the access guidewire (since the distal end portion of the access guidewire is configured to engage with the needle slot to prevent proximal withdrawal of the guidewire in the modified device, and since the guidewire is insertable through the added slot in the modified device similar to the arrangement shown in Blanchard fig. 18 where the sheath of Anderson radially surrounds and seals the needle distal to the insertion point of the guidewire into the needle with the sheath hub extending proximally to the sheath body in a similar sealing manner until the proximal opening, the sheath hub is configured as claimed since the needle and guidewire could be arranged similar to Blanchard fig. 18 and then inserted further distally into the sheath such that the sheath and sheath hub seal the needle within the sheath as it is configured for in claim 1, and this sealing prevents proximal withdrawal since the sheath and sheath hub seal the needle and thus prevents the guidewire from being withdrawn from said needle).
Regarding claim 9, Anderson as modified discloses the assembly of claim 7, wherein the sheath hub includes a port (see [0065], sheath hub 53 has a port which is an opening at its proximal most end to allow dilator 30 to be inserted thereinto) over the remainder of the needle slot exposed by the sheath-body opening (in the modified device, the sheath hub 53 and needle 20 are still configured as in fig. 1; that is, sheath hub 53 still radially surrounds, or is arranged over, the needle slot as claimed), the port configured to exclusively direct the access guidewire into the proximal-end portion of the needle slot (in the modified device, the opening at the proximal end of the sheath hub 53 is configured such that guidewire 120 could be inserted into the slot of modified needle 20 where the opening allows space for the guidewire to be inserted thereinto as claimed), thereby preventing the proximal withdrawal of the access guidewire from the needle shaft (in the modified device, once the guidewire has been inserted into the needle slot and the needle has been fully inserted into the sheath, the guidewire is prevented from being withdrawn due to interference with the smaller, proximal most portion of the needle slot and the sheath).
Regarding claim 10, Anderson as modified discloses the assembly of claim 1, further comprising a needle hub (needle hub 21, fig. 2A) around a proximal-end portion of the needle shaft (see fig. 4a, needle hub 21 is arranged radially around the proximal portion 24 of needle body 22).
Regarding claim 12, Anderson discloses a rapidly insertable central catheter ("RICC") insertion assembly (access device 102, fig. 1), comprising: a RICC (dilator 28, fig. 1); introducer (needle 20 and sheath 58 combine to make the claimed introducer, see fig. 1) including: an introducer needle (needle 20, fig. 2A) including a needle shaft (needle body 22, fig. 1) with a proximal portion of the needle shaft (proximal portion 24, fig. 2A) through a distal needle tip (bevel tip 108, fig. 2A); and a splittable introducer sheath (sheath 58 is considered to be splittable where a user is physically capable of splitting the sheath by breaking apart its sheath hub 53 as disclosed in [0066]) including a sheath body (sheath body 54, fig. 4A) over the needle shaft (see fig. 1, sheath body 54 is placed radially around, or over, needle body 22 in the assembled device) with a sheath-body opening in a proximal portion of the sheath body (see figs. 14 and 15, the proximal opening in the sheath is the proximal ending of the sheath which is open to allow guidewire 120 to be inserted thereinto as shown); and an access guidewire (guidewire 120, fig. 14) including a proximal portion disposed in the RICC (see fig. 1, guidewire 120 is disposed in dilator 28) and a distal-end portion disposed in the introducer (see at least figs. 1 and 14, guidewire 120 is disposed in the introducer in the assembled device).
Anderson does not disclose the needle shaft having a longitudinal needle slot extending from the proximal portion of the needle shaft through the distal tip, that the sheath body seals the needle slot thereunder but for the sheath-body opening, or the distal-end portion of the access guidewire having an outer diameter greater than at least a proximal-end portion of the needle slot such that the proximal- end portion of the needle slot catches the distal-end portion of the access guidewire preventing proximal withdrawal of the access guidewire from the needle shaft. Blanchard teaches an introducer assembly (see fig. 15B) comprising a needle shaft (needle 216, fig. 15B) having a longitudinal needle slot (needle slot 226 and the shown beveled tip make up the slot, fig. 15B) extending from a proximal portion of the needle shaft (see fig. 15B, the proximal portion is the portion which is proximal to the distal most tip along the shaft) through a distal tip of the needle (see fig. 15B and see fig. 17A). Blanchard additionally teaches that an equivalent arrangement in a different embodiment is to insert the guidewire through a proximal opening (see fig. 4B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the needle slot and beveled tip of Blanchard to the needle shaft of Anderson as it allows for an alternative insertion method for the guidewire (see Blanchard [0076]-[0078], and figs. 15-18) such that the needle could be removed with the other elements left in place, and further because Blanchard teaches that the arrangements are equivalent and that inserting a guidewire through a proximal opening or through a needle slot are equivalently effective methods of inserting a guidewire into a needle.
In the modified device, the proximal portion of the needle shaft is thus considered to be the length of the needle body 22 of Anderson between the needle hub 21 and the distal tip which includes a wider slotted opening as shown in Blanchard fig. 17A and as called out in the provided annotated figure.
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Annotated fig. 17A from Blanchard showing the distal most end of the proximal portion of the needle of Anderson in the modified device where it is adjacent to the distal tip
Anderson as modified by Blanchard does not explicitly disclose that the sheath body is configured to seal the needle slot thereunder except for the opening at the proximal end of the sheath body. Nool teaches that it is beneficial to provide sealing around guidewires in introducer assemblies to prevent unwanted blood flashback during use, and that seals can be provided through tolerancing of tubes arranged within each other to minimize blood backflow (see at least [0027], [0029], and [0115], and note that the filters referred to in Nool appear to be similarly structured to guidewires).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the sheath of Anderson to have sealed the slotted needle shaft of Anderson as modified to prevent unwanted blood flashback and blood flow as in Nool by configuring the sheath of Anderson to provide a good seal against the needle through their relative dimensions (see at least Nool [0029] and [0115]). In the modified device, this could be achieved where the inner diameter of the sheath of Anderson should be approximately equal to the outer diameter of the needle of Anderson such that the two components are sealed relative to each other even with the added needle slot.
Anderson as modified by Blanchard and Nool discloses that it is desirable to limit the proximal withdrawal of the guidewire by providing elements with interfering diameters such that relative movement beyond a certain point is prohibited (see at least Anderson [0090] and [0092], stops 180 can be used for limiting backward movement; this is also referenced in Anderson at Abstract and [0020]).
Anderson as modified does not explicitly disclose the distal-end portion of the access guidewire having an outer diameter greater than at least a proximal-end portion of the needle slot such that the proximal- end portion of the needle slot catches the distal-end portion of the access guidewire preventing proximal withdrawal of the access guidewire from the needle shaft. Minar teaches a guidewire (see fig. 1) with different regions providing different stiffness characteristics (see Abstract and see fig. 1) including the use of different diameters and tapered regions in changing between different stiffness regions (see at least fig. 1 and tapered portion 20, as well as reduced diameter portions 22, 23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the guidewire of Anderson with the guidewire of Minar as the guidewire of Minar provides better pushability characteristics at its distal end (see Abstract) and more customizable stiffness characteristics (see at least Minar Abstract, [0028], [0037], and [0041]).
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have chosen outer diameters in reduced diameter and tapered sections of the guidewire such that the reduced diameter sections could be pushed through the needle slot of the modified needle of Anderson and would catch at the wider outer diameter distal tip such as to provide a means for preventing unwanted proximal withdrawal of the guidewire as Anderson teaches the use of changeable outer diameter elements of a guidewire for this purpose (see at least Anderson [0090] and [0092], stops 180 can be used for limiting backward movement; this is also referenced in Anderson at Abstract and [0020]; in the modified device, since there are already thicker and thinner portions of the guidewire of Minar, it would have been obvious to have relied on these variable outer diameter dimensions to achieve the functionality of stops 180 of Anderson since the modified device can see the guidewire inserted as shown in Anderson or through the added needle slot as shown in Blanchard).
{Examiner notes that all subsequent references are to Anderson unless otherwise called out.}
Regarding claim 14, Anderson as modified discloses the assembly of claim 12, wherein a proximal portion of the distal-end portion of the access guidewire (from Minar: this is the radial interior of stainless steel proximal shaft 1, fig. 1) includes a rigid tubular fitting thereover (the stainless steel tube which radially surrounds the radial interior of proximal shaft 1 is a rigid tubular fitting where stainless steel is rigid where it is not superelastic, it is tubular fitting as it is a casing surrounding the radial interior core, and it is over the core radially) preventing the proximal portion of the distal-end portion of the access guidewire from bending (from Minar: see [0006], the stainless steel proximal section is relatively stiff which means it is configured to prevent bending), thereby directing the distal-end portion of the access guidewire to engage the proximal-end portion of the needle slot over a remainder of the needle slot (in the modified device, the pushability from the proximal section 1 of Minar’s guidewire is configured to direct the distal end of the guidewire to engage the slot as claimed as it provides a structure which the guidewire can be pushed from to cause engagement between the larger outer diameter tip of the guidewire and the narrower slot).
Regarding claim 15, Anderson as modified discloses the assembly of claim 14, wherein the sheath-body opening extends over the proximal-end portion of the needle slot without substantially extending over the remainder of the needle slot (in the modified device, the needle 20 of Anderson could be partially removed such that the proximal opening at the proximal end of sheath 58 is arranged to extend radially around, or over, the proximal portion of the needle slot; since the opening is a small radial slice, the opening would not extend substantially over the remainder of the needle slot since it only exists at one longitudinal position along the needle) such that the sheath body prevents the proximal withdrawal of the access guidewire from the needle shaft by interfering with the distal-end portion of the access guidewire (since the distal end portion of the access guidewire is configured to engage with the needle slot to prevent proximal withdrawal of the guidewire in the modified device, and since the guidewire is insertable through the added slot in the modified device similar to the arrangement shown in Blanchard fig. 18 where the sheath of Anderson radially surrounds and seals the needle distal to the insertion point of the guidewire into the needle, the sheath body is configured as claimed since the needle and guidewire could be arranged similar to Blanchard fig. 18 and then inserted further distally into the sheath such that the sheath seals the needle within itself as it is configured for in claim 1, and this sealing prevents proximal withdrawal since the sheath seals the needle and thus prevents the guidewire from being withdrawn from said needle).
Regarding claim 17, Anderson as modified discloses the assembly of claim 12, wherein the proximal-end portion of the needle slot is narrower than a remainder of the needle slot (see annotated fig. 17A from Blanchard above; the proximal end portion of the needle slot is narrower across its radius than where the distal beveled tip exists as there is a radius across this beveled tip, with the bevel considered to be part of the slot, which has a wider radius than the top, proximal portion of the needle slot as shown).
Regarding claim 18, Anderson as modified discloses the assembly of claim 12, further comprising a splittable sheath hub (sheath hub 53, fig. 4A, which is splittable as in [0066]) around the proximal portion of the sheath body (sheath hub 53 is configured to radially surround sheath body 54 as shown in fig. 4A, and thus it is around proximal portion 58 thereof as claimed).
Regarding claim 19, Anderson as modified discloses the assembly of claim 18, wherein the sheath hub extends over the remainder of the needle slot exposed by the sheath-body opening (the sheath hub extends proximally to the sheath-body opening as the sheath body does not extend as far proximally as the sheath hub, and the proximal opening of the sheath hub is wider than the sheath body such as to allow for locking with the needle hub similar to the opening shown in fig. 3C, see also fig. 5; because of this, the sheath hub 53 extends radially around, or over, a portion of the needle slot which has not been fully inserted into the sheath body 54 in the modified device which is an extension as claimed) such that the sheath hub prevents the proximal withdrawal of the access guidewire from the needle shaft by interfering with the distal-end portion of the access guidewire (since the distal end portion of the access guidewire is configured to engage with the needle slot to prevent proximal withdrawal of the guidewire in the modified device, and since the guidewire is insertable through the added slot in the modified device similar to the arrangement shown in Blanchard fig. 18 where the sheath of Anderson radially surrounds and seals the needle distal to the insertion point of the guidewire into the needle with the sheath hub extending proximally to the sheath body in a similar sealing manner until the proximal opening, the sheath hub is configured as claimed since the needle and guidewire could be arranged similar to Blanchard fig. 18 and then inserted further distally into the sheath such that the sheath and sheath hub seal the needle within the sheath as it is configured for in claim 1, and this sealing prevents proximal withdrawal since the sheath and sheath hub seal the needle and thus prevents the guidewire from being withdrawn from said needle).
Regarding claim 20, Anderson as modified discloses the assembly of claim 18, wherein the sheath hub includes a port (see [0065], sheath hub 53 has a port which is an opening at its proximal most end to allow dilator 30 to be inserted thereinto) over the remainder of the needle slot exposed by the sheath-body opening (in the modified device, the sheath hub 53 and needle 20 are still configured as in fig. 1; that is, sheath hub 53 still radially surrounds, or is arranged over, the needle slot as claimed), the port configured to exclusively direct the access guidewire into the proximal-end portion of the needle slot (in the modified device, the opening at the proximal end of the sheath hub 53 is configured such that guidewire 120 could be inserted into the slot of modified needle 20 where the opening allows space for the guidewire to be inserted thereinto as claimed), thereby preventing the proximal withdrawal of the access guidewire from the needle shaft (in the modified device, once the guidewire has been inserted into the needle slot and the needle has been fully inserted into the sheath, the guidewire is prevented from being withdrawn due to interference with the smaller, proximal most portion of the needle slot and the sheath).
Regarding claim 21, Anderson as modified discloses the assembly of claim 12, further comprising a needle hub (needle hub 21, fig. 2A) around a proximal-end portion of the needle shaft (see fig. 4a, needle hub 21 is arranged radially around the proximal portion 24 of needle body 22).
Claim(s) 11 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 20080262430, henceforth Anderson) in view of Blanchard et al. (US 20150119806, henceforth Blanchard), Nool et al. (US 20020072712, henceforth Nool), and Minar et al. (US 20150314109, henceforth Minar) as applied to claims 1 and 21 above, respectively, and further in view of Sugita et al. (US 20070100294, henceforth Sugita).
Regarding claims 11 and 22, Anderson as modified discloses the assembly of claims 1 and 21, respectively, wherein there is a tapered female needle-hub connector (luer connection 35, fig. 2A) in a proximal portion of the needle hub (see fig. 2A and see [0057], luer connection 35 is meant for being used with a syringe) which is configured for use with a syringe ([0057]).
Anderson as modified does not explicitly disclose the assembly further comprising a syringe including a tapered male syringe tip extending from a distal portion of the syringe, the syringe tip configured to insert into the tapered female needle-hub connector in the proximal portion of the needle hub. Sugita teaches the use of a conventional syringe (syringe 1, fig. 1) where the syringe is including a tapered male syringe tip (this is sleeve 2 and the tapered inner member shown as an outline in fig. 2) extending from a distal portion of the syringe (see fig. 2, the distal portion is the portion opposite the finger flange as shown), the syringe tip configured to insert into a female luer connector ([0002]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the conventional syringe of Sugita for the syringe referred to in Anderson as Sugita teaches this syringe to be well known in the art (Sugita [0004]) and because Anderson teaches that it is meant to be used with a syringe (Anderson [0054]), and because using such a syringe would have provided the predictable result of a luer lock connection mating a male and female connector to connect the syringe to the assembly of Anderson.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pizzato (US 20230381481) is considered relevant prior art very similar to the disclosure of the relied upon Anderson reference above.
Tafeen (US Pat. No. 3539034) is considered relevant prior art regarding the use of a slot with variable widths for holding an element in place (see 32).
Gallacher et al. (US 20140100552) is considered relevant prior art teaching guidewire migration to be unwanted and potentially harmful and teaching radial clamping to be a useful way of preventing guidewire migration.
Khaw (US 20070276288) is considered relevant prior art teaching a needle slot.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783