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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 29, 2025 has been entered.
Claims 1-5, 7, 9-16, 18-22, and 27 are currently pending.
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 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) 1-2, 4, 7, 9-11, 13-16, 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 2021/0001105, hereinafter “Schmidt”) in view of Lund et al. (US 2013/0253260, hereinafter “Lund”).
Regarding claims 1, 10, and 14-15, Schmidt discloses the invention substantially as claimed, including a surgical drain introducer (device 100 fully capable of introducing a surgical drain; Fig 3A) comprising: a central axis, a proximal end, and a distal end (tubular member 102), the proximal end disposed along the central axis and opposite the distal end, the proximal end configured to couple to a drain (fully capable of being coupled to a drain; it is noted the surgical drain is not positively claimed), and the distal end having a blunt distal tip (para [0064]), the introducer constantly tapering from an area proximate the proximal end (112) to an area proximate the distal end (104) such that a diameter of the introducer decreases continuously along a length of the introducer from the proximal end to the distal end (para [0047-0048, 0055]), wherein the introducer has a length of 30 cm or greater (para [0051, 0061, 0066]) and the introducer is comprised of a rigid material to prevent bending of the introducer (para [0066]).
Schmidt discloses the introducer comprises a middle portion (combination of sections 108 and 110, which are bounded by distal end portion 104 and proximal end portion 112) disposed between the proximal end (112) and the distal end (104) and including the mid-point of the surgical drain introducer equidistant from the proximal end and the distal end (see annotated Fig 3A below), the middle portion having an arc (at 108) resulting in the distal end being offset from the central axis (Fig 3A; para [0053).
[AltContent: arrow][AltContent: textbox (Arc)][AltContent: oval][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Distal end)][AltContent: textbox (Mid-Point)][AltContent: textbox (Proximal end)][AltContent: textbox (Middle Portion)][AltContent: connector][AltContent: ]
PNG
media_image1.png
773
388
media_image1.png
Greyscale
However, Schmidt fails to disclose the arc extends through the mid-point. Schmidt teaches “Embodiments of the remote access, tunneling dilator 100-1200 and methods of use discussed herein provide exemplary configurations only. Additional dilator embodiments may have any appropriate length, diameter, curvature, and/or material hardness variance, and may include any appropriate degree or slope of tapering, or any appropriate progressive stepping in outer diameter French catheter sizes” (para [0121]). Lund discloses a similar introducer comprising an elongate shaft (8) wherein the shaft may have various shapes and sizes, including various curvatures (Fig 3; para [0078]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the shaft of Schmidt such that the introducer comprised a curvature with the arc extending through the mid-point, as claimed, in an attempt to provide an introducer designed for a particular anatomy as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp, since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success, and since Schmidt teaches additional embodiments may have any appropriate curvature (para [0078]). Changes in shape are generally considered to be obvious to one of ordinary skill in the art, absent a showing a particular configuration is significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The applicant fails to state the particular bending shape solves a particular problem, has an advantage or a particular purpose. Accordingly, the claimed bending shape is a configuration which cannot be considered significant and would have been obvious to one of ordinary skill in the art.
Regarding claims 2 and 4, wherein the proximal end includes one or more ferrules extending radially from the central axis, wherein the one or more ferrules are tapered and frustoconically shaped (forming hub 122 – para [0060]).
Regarding claim 7, Schmidt fails to disclose the introducer comprises a distal portion being straight, a proximal portion being straight and smaller than the distal portion, wherein the arc of the middle portion extends from the proximal portion to the distal portion, and wherein the middle portion is longer than each of the proximal portion and the distal portion and extends more toward the proximal end than the distal end, as claimed. As noted above, Schmidt teaches “Embodiments of the remote access, tunneling dilator 100-1200 and methods of use discussed herein provide exemplary configurations only. Additional dilator embodiments may have any appropriate length, diameter, curvature, and/or material hardness variance, and may include any appropriate degree or slope of tapering, or any appropriate progressive stepping in outer diameter French catheter sizes” (para [0121]). Lund discloses a similar introducer comprising an elongate shaft (8) wherein the shaft may have various shapes and sizes, including various curvatures (Fig 3; para [0078]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try further modifying the shaft of Schmidt such that a distal portion is straight, a proximal portion is straight and smaller than the distal portion, wherein the arc of the middle portion extends from the proximal portion to the distal portion, and wherein the middle portion is longer than each of the proximal portion and the distal portion and extends more toward the proximal end than the distal end, as claimed, in an attempt to provide an introducer designed for a particular anatomy as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp, since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success, and since Schmidt teaches additional embodiments may have any appropriate curvature (para [0078]). Changes in shape are generally considered to be obvious to one of ordinary skill in the art, absent a showing a particular configuration is significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The applicant fails to state the particular bending shape solves a particular problem, has an advantage or a particular purpose. Accordingly, the claimed bending shape is a configuration which cannot be considered significant and would have been obvious to one of ordinary skill in the art.
Regarding claim 9, Schmidt discloses the distal end is offset from the central axis by an angle BAA. (Fig 3A), wherein the angle may be 40 degrees or “may form any appropriate angle including, for example, an angle of 5 degrees, 45 degrees, or 90 degrees, depending on the intended dilation application” (para [0053]), thus establishing the angle as a result effective variable. Schmidt additionally teaches “Embodiments of the remote access, tunneling dilator 100-1200 and methods of use discussed herein provide exemplary configurations only. Additional dilator embodiments may have any appropriate length, diameter, curvature, and/or material hardness variance, and may include any appropriate degree or slope of tapering, or any appropriate progressive stepping in outer diameter French catheter sizes” (para [0121]). Thus, although Schmidt fails to disclose the specific offset angle claimed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schmidt such that the angle was approximately 30 degrees since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 11, Schmidt teaches the introducer is comprised of a rigid material to prevent bending of the introducer (para [0066]), but fails to disclose the introducer is comprised of stainless steel. Schmidt additionally teaches “Embodiments of the remote access, tunneling dilator 100-1200 and methods of use discussed herein provide exemplary configurations only. Additional dilator embodiments may have any appropriate length, diameter, curvature, and/or material hardness variance, and may include any appropriate degree or slope of tapering, or any appropriate progressive stepping in outer diameter French catheter sizes” (para [0121]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schmidt such that the introducer was comprised of stainless steel since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 13, wherein the introducer comprises one or more radiopaque markers (120 – para [0056]).
Regarding claim 16, Schmidt fails to disclose the maximum diameter of the introducer is approximately 0.5 cm. However, Schmidt teaches the introducer extends from a maximum diameter adjacent a proximal end to a minimum diameter adjacent a distal end (para [0011-0016]), thus establishing the diameter as a result effective variable. Schmidt additionally teaches “Embodiments of the remote access, tunneling dilator 100-1200 and methods of use discussed herein provide exemplary configurations only. Additional dilator embodiments may have any appropriate length, diameter, curvature, and/or material hardness variance, and may include any appropriate degree or slope of tapering, or any appropriate progressive stepping in outer diameter French catheter sizes” (para [0121]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schmidt such that the maximum diameter of the introducer was approximately 0.5 cm to appropriately size the introducer for the intended use and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 18-21, Schmidt teaches the length of the introducer is 30 cm or greater (para [0051, 0061, 0066]) and teaches the introducer extends from a maximum diameter adjacent a proximal end to a minimum diameter adjacent a distal end (para [0011-0016]), thus establishing the length and diameter as a result effective variables. Schmidt additionally teaches “Embodiments of the remote access, tunneling dilator 100-1200 and methods of use discussed herein provide exemplary configurations only. Additional dilator embodiments may have any appropriate length, diameter, curvature, and/or material hardness variance, and may include any appropriate degree or slope of tapering, or any appropriate progressive stepping in outer diameter French catheter sizes” (para [0121]). However, Schmidt fails to teach a ratio of the length of the introducer to a maximum diameter of the introducer, as claimed. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schmidt such that a ratio of the length of the introducer to a maximum diameter of the introducer was greater than 50:1, greater than or equal to 80:1, greater than or equal to 100:1 or greater than or equal to 120:1 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt and Lund, as applied to claim 1 above, further in view of Tandon et al. (US 2021/0154379, hereinafter “Tandon”). Schmidt and Lund disclose the invention substantially as claimed, as shown above, but fail to disclose one or more gripping portions including a plurality of ridges as claimed. Tandon teaches a tool shaft (102) can include knurling or ridges to enable a better grip of the shaft by the surgeon (para [0041]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that the introducer comprises one or more gripping portions between the proximal and distal end including a plurality of ridges to enable a better grip of the shaft by the surgeon, as taught by Tandon.
Claim(s) 1-5, 7, 9-12, 14-16, and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feeley et al. (US 2007/0078396, hereinafter “Feeley”) in view of Marlon (US 4,432,752, hereinafter “Marlon”), Schmidt (US 2021/0001105), and Lund (US 2013/0253260).
Regarding claim 1, Feeley discloses the invention substantially as claimed including a surgical drain introducer (100) comprising: a central axis, a proximal end (106), and a distal end (112), the proximal end disposed along the central axis and opposite the distal end, the proximal end configured to couple to a drain (proximal end includes protrusion 108 to secure within a lumen of a catheter – para [0026], wherein the catheter is fully capable of functioning as a surgical drain), and the distal end having a blunt distal tip (112; para [0025]), the introducer tapering from an area proximate the proximal end to an area proximate the distal end such that a diameter of the introducer decreases along a length of the introducer from the proximal end to the distal end (Figs 1-2; para [0025]), and the introducer is comprised of a rigid material to prevent bending of the introducer (stainless steel – para [0025]).
[AltContent: arrow][AltContent: textbox (Central axis)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Proximal end)][AltContent: arrow][AltContent: textbox (Distal end)]
PNG
media_image2.png
722
237
media_image2.png
Greyscale
Feely teaches the introducer has a length “which may be selected to be substantially equal to a length of a subcutaneous tunnel to be formed” (para [0025]). However, Feeley fails to disclose the specific length of the introducer. Marlon discloses a similar introducer (hollow catheter 13) capable of introducing a surgical drain and teaches the introducer “preferably has a length of about 34.5 cm” (col 4, ln 59-60) to form a subcutaneous tunnel between first (10) and second (12) incisions for inserting an indwelling catheter (15) (col 4, ln 40 - col 5, ln 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feeley such that the introducer had a length of 30 cm or greater since Marlon teaches such a length is desired for a subcutaneous tunnel in at least one method and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Feely teaches the introducer tapers from an area proximate the proximal end to an area proximate the distal end such that a diameter of the introducer decreases along a length of the introducer from the proximal end to the distal end (Figs 1-2; para [0025]). However, Feely fails to disclose the introducer constantly tapers such that a diameter of the introducer decreases continuously along a length of the introducer from the proximal to the distal end. Schmidt discloses a similar introducer comprising an elongate shaft that constantly tapers such that a diameter of the introducer decreases continuously along a length of the introducer from the proximal (112) to the distal end (104) (para [0047-0048, 0055]; Figs 3A, B). Schmidt teaches “the continuously tapered configuration allows embodiments of the dilator to be advanced through vascular narrowings, or strictures, without the use of an angioplasty balloon catheter, which saves both procedure time and the added expense of a dilator balloon kit. Because the continuous taper enables embodiments of the remote access, tunneling dilator to be advanced through vascular strictures, the clinician may gain access through a vein that would otherwise be unavailable, thereby forcing clinician to choose a less advantageous route. Embodiments of the tapered dilator allow easy treatment of and therapeutic access through these strictures. This reduces procedural time and also allows treatment of some conditions which were not previously considered for minimally invasive surgical techniques” (para [0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Feely such that the introducer constantly tapers such that a diameter of the introducer decreases continuously along a length thereof, as taught by Schmidt, to have the advantage of smooth advancement and further minimize injury to surrounding tissue (Feely para [0003]).
Feely teaches the introducer further comprising: a middle portion disposed between the proximal end and the distal end, the middle portion having an arc resulting in the distal end being offset from the central axis (Fig 1).
[AltContent: textbox (Central axis)][AltContent: textbox (Offset distal end)]
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Middle portion having arc resulting in distal being offset from central axis; curve in radial direction)][AltContent: arrow]
PNG
media_image2.png
722
237
media_image2.png
Greyscale
However, Feely fails to disclose the arc extends through the mid-point. Lund discloses a similar introducer comprising an elongate shaft (8) wherein the shaft may have various shapes and sizes, including various curvatures (Fig 3; para [0078]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the shaft of Feely such that the introducer comprised a curvature with the arc extending through the mid-point, as claimed, in an attempt to provide an introducer designed for a particular anatomy as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp, since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success, and since Lund teaches “Various other shapes and sizes can also be employed without deviating from the spirit and scope of the present invention” (para [0078]). Changes in shape are generally considered to be obvious to one of ordinary skill in the art, absent a showing a particular configuration is significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The applicant fails to state the particular bending shape solves a particular problem, has an advantage or a particular purpose. Accordingly, the claimed bending shape is a configuration which cannot be considered significant and would have been obvious to one of ordinary skill in the art.
Regarding claim 2, wherein the proximal end includes one or more ferrules (108) extending radially from the central axis (para [0026]).
Regarding claim 3, Feely and Marlon disclose a surgical drain assembly comprising: the surgical drain introducer of claim 2 (100 or 200); and a drain (catheter 202) coupled to the introducer (100 or 200) (catheter is fully capable of functioning as a drain), wherein the one or more ferrules (protrusions 108 or 216) are friction fit with an inner surface of the drain to resist decoupling the drain from the introducer (Fig 5; para [0030]).
Regarding claim 4, wherein the one or more ferrules (protrusions 108 or 216) are tapered and frustoconically shaped (Figs 1-2 and 5).
Regarding claim 5, wherein the one or more ferrules include a plurality of tapered ferrules forming a saw-tooth cross sectional profile (Figs 1-2 and 5).
Regarding claim 7, Feely fails to disclose the introducer comprises a distal portion being straight, a proximal portion being straight and smaller than the distal portion, wherein the arc of the middle portion extends from the proximal portion to the distal portion, and wherein the middle portion is longer than each of the proximal portion and the distal portion and extends more toward the proximal end than the distal end, as claimed. Lund discloses a similar introducer comprising an elongate shaft (8) wherein the shaft may have various shapes and sizes, including various curvatures (Fig 3; para [0078]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try further modifying the shaft of Feely such that the introducer comprised a distal portion being straight, a proximal portion being straight and smaller than the distal portion, wherein the arc of the middle portion extends from the proximal portion to the distal portion, and wherein the middle portion is longer than each of the proximal portion and the distal portion and extends more toward the proximal end than the distal end, as claimed, in an attempt to provide an introducer designed for a particular anatomy as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp, since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success, and since Lund teaches “Various other shapes and sizes can also be employed without deviating from the spirit and scope of the present invention” (para [0078]). Changes in shape are generally considered to be obvious to one of ordinary skill in the art, absent a showing a particular configuration is significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The applicant fails to state the particular bending shape solves a particular problem, has an advantage or a particular purpose. Accordingly, the claimed bending shape is a configuration which cannot be considered significant and would have been obvious to one of ordinary skill in the art.
Regarding claim 9, Feeley teaches the distal end is offset from the central axis by an acute angle (Fig 1), but fails to disclose the degree of offset. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feeley such that the distal end was offset from the central axis by approximately 30 degrees since it has been held that where the general conditions of a claim are disclosed in the prior art (offset by an acute angle), discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 10, wherein a diameter of the proximal end (proximal portion 106 includes expanded diameter section 107) is greater than a diameter of the distal end (tapered distal tip 112) (para [0025-0026]).
Regarding claim 11, wherein the introducer is comprised of stainless steel (para [0025]).
Regarding claim 12, wherein the introducer includes one or more gripping portions disposed between the proximal end and the distal end, the one or more gripping portions including a plurality of ridges (ferrules 108 may be interpreted as gripping portions – para [0026]).
Regarding claim 14, wherein one or both of a portion of the middle portion and a portion of the distal end curves away from the central axis (Fig 1).
Regarding claim 15, wherein a maximum diameter of a portion adjacent the proximal end (proximal portion 106 includes expanded diameter section 107) is greater than the diameter of the distal end (tapered distal tip 112) (para [0025-0026]).
Regarding claim 16, Feeley fails to disclose the maximum diameter of the introducer. Marlon discloses a similar introducer (hollow catheter 13) capable of introducing a surgical drain and teaches the introducer preferably has an external diameter of 5.75 mm (col 4, ln 59-60) to form a subcutaneous tunnel between first (10) and second (12) incisions for inserting an indwelling catheter (15) (col 4, ln 40 - col 5, ln 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Feeley such that the introducer had a maximum diameter of approximately 0.5 cm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 18-21, Feeley as modified by Marlon, teach an introducer length of at least 30cm and a maximum diameter of approximately 0.5 cm, as discussed above. Therefore, it is also obvious Feeley as modified by Marlon teaches a ratio of the length of the introducer to a maximum diameter of the introducer is greater than 50:1. Furthermore, Feely teaches the introducer has a length “which may be selected to be substantially equal to a length of a subcutaneous tunnel to be formed” (para [0025]) and thus it would be obvious to select a length for a particular anatomical location and such that a ratio of the length of the introducer to a maximum diameter of the introducer is greater than or equal to 80:1, or wherein a ratio of the length of the introducer to a maximum diameter of the introducer is greater than or equal to 100:1, or wherein a ratio of the length of the introducer to a maximum diameter of the introducer is greater than or equal to 120:1 since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feeley (US 2007/0078396), Marlon (US 4,432,752), Schmidt (US 2021/0001105), and Lund (US 2013/0253260), as applied to claim 1 above, further in view of Hyde et al. (US 2014/0296769, hereinafter “Hyde”). Feely, Marlon, Schmidt and Lund disclose the invention substantially as claimed, as shown above. However, Feely fails to disclose the introducer includes at least one radiopaque marker. Hyde discloses a similar device including a dilator (645) and teaches the dilator “contains a radiopaque marker at the distal tip so that the tip position is easily visible under fluoroscopy” (para [0097]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to further modify the combination such that the introducer included at least one radiopaque marker so that the introducer would be easily visible under fluoroscopy, as taught by Hyde.
Allowable Subject Matter
Claim 22 is allowed.
Claim 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach “wherein the introducer includes one or more apertures disposed proximate the distal end, the one or more apertures extending axially in the proximal direction along the central axis” in combination with the other limitations of the claim.
Response to Arguments
Applicant’s arguments, see amendment, filed December 29, 2025, with respect to the rejection(s) of claim(s) 1,2,4,6,8,10, and 12-15 under 35 USC 102 as being anticipated by Schmidt (US 2021/0001105) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lund (US 2013/0253260).
Applicant’s arguments, see amendment, filed December 29, 2025, with respect to the rejection(s) of claim(s) 1-6, 8-12, 14-16, and 18-22 under 35 USC 103 as being unpatentable over Feeley (US 2007/0078396) in view of Marlon (US 4,432,752) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lund (US 2013/0253260).
Applicant's arguments filed December 29, 2025, with respect to the rejection(s) of claim(s) 7 under 35 USC 103 as being unpatentable over Schmidt in view of Lund, have been fully considered but they are not persuasive. Applicant argues Lund relates to tool sand implants for treating pelvic conditions and thus does not relate to implanting a surgical drain through a ribcage and out of an abdomen. Furthermore, Applicant argues Lund merely states different shapes or sizes can be employed but does not provide any such direction toward the instantly claimed invention. The Examiner respectfully disagrees and notes Lund clearly teaches an embodiment having an arc extending through the mid-point and straight proximal and distal ends with the arc extending therebetween since it is noted the portions may be defined as any length along the shaft. Thus, Lund clearly shows an example of the claimed configuration and furthermore Schmidt teaches “Embodiments of the remote access, tunneling dilator 100-1200 and methods of use discussed herein provide exemplary configurations only. Additional dilator embodiments may have any appropriate length, diameter, curvature, and/or material hardness variance, and may include any appropriate degree or slope of tapering, or any appropriate progressive stepping in outer diameter French catheter sizes” (para [0121]) indicating the curvature may be optimized. Changes in shape are generally considered to be obvious to one of ordinary skill in the art, absent a showing a particular configuration is significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The applicant fails to state the particular bending shape solves a particular problem, has an advantage or a particular purpose. Accordingly, the claimed bending shape is a configuration which cannot be considered significant and would have been obvious to one of ordinary skill in the art. It is noted the instant specification states “In some embodiments, introducer 104 is substantially devoid of any bends or curves such that the entirety of introducer 104 extends along central axis 116. However, introducer 104 may include one or more curves or bends causing one or more portions of introducer 104 to deviate from central axis 116.” (paragraph [0035]). Thus, Applicant acknowledges embodiments ranging from one or more curves or bends to embodiments devoid of bends, but does not place significance on any particular curved shape such as the claimed curved shape.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771