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 .
This Office action is responsive to an amendment filed November 18, 2025. Claims 75-81 & 84-96 are pending. Claims 1-74 & 82-83 have been canceled. New claims 95-96 have been added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 75-78, 81, 84-90 & 93-96 is/are rejected under 35 U.S.C. 103 as being unpatentable over Middleton et al. (US 2022/0241552) (“Middleton” hereinafter) in view of Heyns et al. (US 2014/016528) (“Heyns” hereinafter).
In the following rejections, the Office has construed the limitations:
(a) “cut depth percentage” as a percentage of cut depth of the cuts or notches that have been cut in the at least one anterior flexibility region divided by the diameter of elongate body in the at least one anterior flexibility region,
“percent volume of material removed” as pertaining to a percentage of the volume of all the material removed to form the notches or cuts in the at least one anterior flexibility region divided by the total volume of the at least one anterior flexibility region, and,
“cut length percentage” as pertaining to a percentage of the sum of the plurality of lengths or widths of the notches or cuts that have been cut in the at least one anterior flexibility region divided by the total length of the at least one anterior flexibility region.
In regards to claim 75, Middleton discloses a method of navigating or positioning a urinary catheter 10, comprising:
navigating an elongate body 12 through a urethra of a patient (see at least par 0045), wherein:
the elongate body 12 has a distal segment 16 and a first lumen 25 defined by the elongate body 12 (see at least figs. 7, 9a-b & 11 and par 0067 & 0081), and
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at least one anterior (deflectable) flexibility region on or in the distal segment 16 of the elongate body 12 (see at least figs. 9b and par 0074-0080),
passively deflecting at least a portion of the distal segment 16 of the elongate body 12 during the navigating, wherein the deflecting occurs in proximity to one or more of: a bulbar urethra, or a membranous urethra of the patient (see at least figs. 10a-b and par 0046, 0059-0060, 0092, 0111 & 0120-0123); and
inflating a retention balloon 26 at least partially disposed around the distal segment 16 of the elongate body 12 to retain at least a region of the distal segment 16 in a bladder of the patient (see at least par 0081).
Middleton discloses a method, as described above, that fails to explicitly teach a method wherein the at least one anterior flexibility region: extends from an anterior external surface of the elongate body into the first lumen, extends from the anterior external surface at least partially circumferentially along an exterior sidewall of the elongate body without penetrating the first lumen along the exterior sidewall, has a cut depth percentage of about 40% to about 50% of an outer diameter of the elongate body, and has a percent volume of material removed of about 20% to about 40%.
However, Heyns teaches that it is known to provide a method wherein the at least one anterior flexibility region 53: extends from an anterior external surface of the elongate body 54 into the first lumen 66, extends from the anterior external surface at
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least partially circumferentially along an exterior sidewall of the elongate body 54 without penetrating the first lumen 66 along the exterior sidewall, has a cut depth percentage (of flex gaps 64) of about 40% to about 50% of an outer diameter of the elongate body 54 (see at least abstract, figs. 5A-C, 6B & 11 and par 0011, 0054, 0057, 0062-0063, 0078 & 0090-0094).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Middleton wherein the at least one anterior flexibility region: extends from an anterior external surface of the elongate body into the first lumen, extends from the anterior external surface at least partially circumferentially along an exterior sidewall of the elongate body without penetrating the first lumen along the exterior sidewall as taught by Heyns since such a modification would amount to applying a known technique (i.e., the anterior flexibility region as taught by Heyns) to a known device (i.e., as taught by Middleton) ready for improvement to achieve a predictable result such as providing for increased flexibility of the distal with flex gaps when compared to without the flex gaps (see at least par 0011 of Heyns)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Heyns further discloses (see par 0078) that the number and depths of the gaps 64 needs to be optimized (e.g., adjusted) to “provide more flexible potential in order to provide bending from 10 to 180 degrees” (see at least par 0054) and as such the cut depth percentage of about 40% to about 50% of an outer diameter of the elongate body, and the percent volume of material removed of about 20% to about 40% of the device is disclosed to be a result effective variable in that the cut depth percentage and the percent volume of material removed may be adjusted in order to provide more flexible potential so as to provide bending from 10 to 180 degrees (see at least par 0054 of Heyns). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Middleton as modified by Heyns to include the cut depth percentage of about 40% to about 50% of an outer diameter of the elongate body, and the percent volume of material removed of about 20% to about 40% since the cut depth percentage and the percent volume of material removed of the device is disclosed to be a result effective variable in that the cut depth percentage and the percent volume of material removed may be adjusted in order to provide more flexible potential so as to provide bending from 10 to 180 degrees (see at least par 0054 of Heyns) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, applicant places no criticality on the range claimed, indicating simply that the cut depth percentage and the percent volume of material removed may be within the claimed ranges (see specification, see at least par 0018, 0038, 0197 & 0250 of the original specification).
In regards to claim 76, Middleton discloses the method of claim 75, further comprising intaking a liquid (i.e., urine) from the bladder of the patient through at least one port 14 defined by the distal segment 16 and fluidly connected to a second lumen 20 defined by the elongate body 12 (see at least par 0035, 0068-0069 & 0072).
In regards to claim 77, Middleton discloses the method of claim 75, further comprising deflating the retention balloon 26 (inherently after a number of days, see par 0081).
In regards to claim 78, Middleton discloses the method of claim 75, further comprising removing the elongate body 12 from the bladder and the urethra of the patient (inherently after a number of days, see par 0081).
In regards to claim 81, Middleton discloses the method of claim 75, further comprising removing particulate (from urine) from the bladder of the patient such that a distal end of the elongate body 12 defines an aperture therein (see at least par 0035, 0069 & 0072).
In regards to claim 84, Middleton discloses a method of navigating a catheter 10 through a bodily lumen, comprising:
navigating an elongate body 12 through the bodily lumen of a patient (see at least par 0045), wherein:
the elongate body 12 has a distal segment 16 and a first lumen 25 defined by the elongate body 12 (see at least figs. 7, 9a-b & 11 and par 0067 & 0081), and
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at least one anterior (deflectable) flexibility region on or in the distal segment 16 of the elongate body 12 (see at least figs. 9b and par 0074-0080); and
passively deflecting at least a portion of the distal segment 16 of the elongate body 12 during the navigating (see at least figs. 10a-b and par 0046, 0059-0060, 0092, 0111 & 0120-0123).
Middleton discloses a method, as described above, that fails to explicitly teach a method wherein the at least one anterior flexibility region: extends from an anterior external surface of the elongate body into the first lumen, extends from the anterior external surface at least partially circumferentially along an exterior sidewall of the elongate body without penetrating the first lumen along the exterior sidewall, and has a cut length percentage of about 70% to about 80%.
However, Heyns teaches that it is known to provide a method wherein the at least one anterior flexibility region 53: extends from an anterior external surface of the elongate body 54 into the first lumen 66, extends from the anterior external surface at
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least partially circumferentially along an exterior sidewall of the elongate body 54 without penetrating the first lumen 66 along the exterior sidewall and has an undisclosed cut length percentage (see at least abstract, figs. 5A-C, 6B & 11 and par 0011, 0054, 0057, 0062-0063, 0078 & 0090-0094).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Middleton wherein the at least one anterior flexibility region: extends from an anterior external surface of the elongate body into the first lumen, extends from the anterior external surface at least partially circumferentially along an exterior sidewall of the elongate body without penetrating the first lumen along the exterior sidewall as taught by Heyns since such a modification would amount to applying a known technique (i.e., the anterior flexibility region as taught by Heyns) to a known device (i.e., as taught by Middleton) ready for improvement to achieve a predictable result such as providing for increased flexibility of the distal with flex gaps when compared to without the flex gaps (see at least par 0011 of Heyns)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Heyns further discloses (see par 0078) that the number and width of the gaps 64 needs to be optimized (e.g., adjusted) to “provide more flexible potential in order to provide bending from 10 to 180 degrees” (see at least par 0054) and as such the cut length percentage of about 70% to about 80% of the device is disclosed to be a result effective variable in that the cut length percentage of about 70% to about 80% may be adjusted in order to provide more flexible potential so as to provide bending from 10 to 180 degrees (see at least par 0054 of Heyns). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Middleton as modified by Heyns to include the cut length percentage of about 70% to about 80% since the cut length percentage of about 70% to about 80% of the device is disclosed to be a result effective variable in that the cut length percentage of about 70% to about 80% may be adjusted in order to provide more flexible potential so as to provide bending from 10 to 180 degrees (see at least par 0054 of Heyns) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, applicant places no criticality on the range claimed, indicating simply that the cut length percentage may be within the claimed ranges (see specification, see at least par 0019 & 0039 of the original specification).
In regards to claim 85, Middleton discloses the method of claim 84, wherein the bodily lumen is a urinary tract (see at least abstract).
In regards to claim 86, Middleton discloses the method of claim 84, wherein the catheter 10 is a urinary catheter 10, and the bodily lumen is a urinary tract (see at least abstract).
In regards to claim 87, Middleton discloses the method of claim 84, further comprising inflating a retention balloon 26 disposed around the distal segment 16 of the elongate body 12 to retain at least a region of the distal segment 16 in the bodily lumen of the patient or in a target organ of the patient (see at least par 0081).
In regards to claim 88, Middleton discloses the method of claim 87, wherein the catheter 10 is a urinary catheter 10, and the target organ is a bladder (see at least par 0001 & 0069).
In regards to claim 89, Middleton discloses the method of claim 87, further comprising intaking one or both of a fluid or a particulate (i.e., urine) from the target organ of the patient through at least one port 14 defined by the distal segment 16 and fluidly connected to a second lumen 20 defined by the elongate body 12 (see at least par 0035, 0069 & 0072).
In regards to claim 90, Middleton discloses the method of claim 87, further comprising deflating the retention balloon 26 (inherently after a number of days, see par 0081).
In regards to claim 93, Middleton discloses the method of claim 87, further comprising removing particulate from the target organ of the patient such that a distal end of the elongate body 12 defines an aperture 14 therein (see at least par 0035, 0069 & 0072).
In regards to claim 94, Middleton as modified by Heyns discloses the method of claim 84, that fails to explicitly teach a method wherein the elongate body 12 has a cut depth percentage of about 40% to about 50% of an outer diameter of the elongate body 12; and has a percent volume of material removed of about 20% to about 40%. However, Heyns further discloses (see par 0078) that the number and depths of the gaps 64 needs to be optimized (e.g., adjusted) to “provide more flexible potential in order to provide bending from 10 to 180 degrees” (see at least par 0054) and as such the cut depth percentage of about 40% to about 50% of an outer diameter of the elongate body, and the percent volume of material removed of about 20% to about 40% of the device is disclosed to be a result effective variable in that the cut depth percentage and the percent volume of material removed may be adjusted in order to provide more flexible potential so as to provide bending from 10 to 180 degrees (see at least par 0054 of Heyns). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Middleton as modified by Heyns to include the cut depth percentage of about 40% to about 50% of an outer diameter of the elongate body, and the percent volume of material removed of about 20% to about 40% since the cut depth percentage and the percent volume of material removed of the device is disclosed to be a result effective variable in that the cut depth percentage and the percent volume of material removed may be adjusted in order to provide more flexible potential so as to provide bending from 10 to 180 degrees (see at least par 0054 of Heyns) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, applicant places no criticality on the range claimed, indicating simply that the cut depth percentage and the percent volume of material removed may be within the claimed ranges (see specification, see at least par 0018, 0038, 0197 & 0250 of the original specification).
In regards to claim 95, Middleton discloses a method of navigating or positioning a urinary catheter 10, comprising:
navigating an elongate body 12 through a urethra of a patient (see at least par 0045), wherein:
the elongate body 12 has a distal segment 16 and a first lumen 25 defined by the elongate body 12 (see at least figs. 7, 9a-b & 11 and par 0067 & 0081),
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a retention balloon 26 disposed at least partially around the distal segment 16 of the elongate body 12 (see at least figs. 7, 9a-b & 11 and par 0081), and
an anterior (deflectable) flexibility region on or in the distal segment 16 of the elongate body 12, wherein the anterior (deflectable) flexibility region: is distal to the retention balloon 26 on the elongate body 12 (see at least fig. 9b),
passively deflecting at least a portion of the distal segment 16 of the elongate body 12 during the navigating, wherein the deflecting occurs in proximity to one or more of: a bulbar urethra, or a membranous urethra of the patient (see at least figs. 10a-b and par 0046, 0059-0060, 0092, 0111 & 0120-0123); and
inflating the retention balloon 26 to retain at least a region of the distal segment 16 in a bladder of the patient (see at least figs. 9b and par 0081).
Middleton discloses a method, as described above, that fails to explicitly teach a method comprises two or more anterior flexibility regions on or in the distal segment of the elongate body, wherein the two or more anterior flexibility regions: are distal to the retention balloon on the elongate body, extend from an anterior external surface of the elongate body into the first lumen, and extend from the anterior external surface at least partially circumferentially along an exterior sidewall of the elongate body without penetrating the first lumen along the exterior sidewall.
However, Heyns teaches that it is known to provide a method comprises two or more anterior flexibility regions 53 (i.e., alternating from both sides, see par 0062) on or in the distal segment of the elongate body 54, wherein the two or more anterior flexibility regions 53 (i.e., alternating from both sides, see par 0062): extend from an anterior
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external surface of the elongate body 54 into the first lumen 66, and extend from the anterior external surface at least partially circumferentially along an exterior sidewall of the elongate body 54 without penetrating the first lumen 66 along the exterior sidewall (see at least abstract, figs. 5A-C, 6B & 11 and par 0011, 0054, 0057, 0062-0063, 0078 & 0090-0094).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Middleton comprises two or more anterior flexibility regions on or in the distal segment of the elongate body, as taught by Heyns, wherein the two or more anterior flexibility regions as taught by Heyns: are distal to the retention balloon on the elongate body as taught by Middleton, extend from an anterior external surface of the elongate body into the first lumen as taught by Heyns, and extend from the anterior external surface at least partially circumferentially along an exterior sidewall of the elongate body without penetrating the first lumen along the exterior sidewall as taught by Heyns since such a modification would amount to applying a known technique (i.e., the anterior flexibility region as taught by Heyns) to a known device (i.e., as taught by Middleton) ready for improvement to achieve a predictable result such as providing for increased flexibility of the distal with flex gaps when compared to without the flex gaps (see at least par 0011 of Heyns)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 96, Middleton as modified by Heyns discloses the method of claim 95, wherein each anterior (deflectable) flexibility region has a cut depth percentage of about 40% to about 50% of an outer diameter of the elongate body 12, and has a percent volume of material removed of about 20% to about 40%. However, Heyns further discloses (see par 0078) that the number and depths of the gaps 64 needs to be optimized (e.g., adjusted) to “provide more flexible potential in order to provide bending from 10 to 180 degrees” (see at least par 0054) and as such the cut depth percentage of about 40% to about 50% of an outer diameter of the elongate body, and the percent volume of material removed of about 20% to about 40% of the device is disclosed to be a result effective variable in that the cut depth percentage and the percent volume of material removed may be adjusted in order to provide more flexible potential so as to provide bending from 10 to 180 degrees (see at least par 0054 of Heyns). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the method of Middleton as modified by Heyns to include the cut depth percentage of about 40% to about 50% of an outer diameter of the elongate body, and the percent volume of material removed of about 20% to about 40% since the cut depth percentage and the percent volume of material removed of the device is disclosed to be a result effective variable in that the cut depth percentage and the percent volume of material removed may be adjusted in order to provide more flexible potential so as to provide bending from 10 to 180 degrees (see at least par 0054 of Heyns) as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, applicant places no criticality on the range claimed, indicating simply that the cut depth percentage and the percent volume of material removed may be within the claimed ranges (see specification, see at least par 0018, 0038, 0197 & 0250 of the original specification).
Claim(s) 79-80 & 91-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Middleton (US 2022/0241552) in view of Heyns (US 2014/016528) further in view of Glassman (US 4,501,580).
In regards to claim 79, Middleton as modified by Heyns discloses the method of claim 75, that fails to explicitly teach a method further comprising irrigating at least a portion of the bladder. However, Glassman teaches that it is known to provide a method further comprising irrigating at least a portion of the bladder 14 (i.e., with sterile
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anti-septic or anti-biotic fluid) (see at least figs. 1 & 7; col. 2, lines 22-27, col. 3, lines 56-68 and col. 4, lines 28-35).Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Middleton as modified by Heyns further comprising irrigating at least a portion of the bladder as taught by Glassman since such a modification would amount to applying a known technique (i.e., as taught by Glassman) to a known device (i.e., as taught by Middleton) ready for improvement to achieve a predictable result such as irrigating or medicating the urethral canal and the outside surface of the catheter (see at least abstract of Glassman)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 80, Middleton as modified by Heyns discloses the method of claim 79, that fails to explicitly teach a method wherein the irrigating occurs via at least one irrigation port fluidly connected to an irrigation lumen defined by the elongate body. However, Glassman teaches that it is known to provide a method wherein the irrigating occurs via at least one irrigation port fluidly connected to an irrigation lumen defined by the elongate body 11 (see at least figs. 1 & 7; col. 2, lines 22-27, col. 3, lines 56-68 and col. 4, lines 28-35). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Middleton as modified by Heyns wherein the irrigating occurs via at least one irrigation port fluidly connected to an irrigation lumen defined by the elongate body as taught by Glassman since such a modification would amount to applying a known technique (i.e., as taught by Glassman) to a known device (i.e., as taught by Middleton) ready for improvement to achieve a predictable result such as irrigating or medicating the urethral canal and the outside surface of the catheter (see at least abstract of Glassman)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 91, Middleton as modified by Heyn discloses the method of claim 87, that fails to explicitly teach a method further comprising irrigating at least a portion of the target organ. However, Glassman teaches that it is known to provide a method further comprising irrigating at least a portion of the target organ (see at least figs. 7-8 & 12; col. 2, lines 22-27, col. 3, lines 56-68 and col. 4, lines 28-35). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Middleton as modified by Heyns further comprising irrigating at least a portion of the target organ as taught by Glassman since such a modification would amount to applying a known technique (i.e., as taught by Glassman) to a known device (i.e., as taught by Middleton) ready for improvement to achieve a predictable result such as irrigating or medicating the urethral canal and the outside surface of the catheter (see at least abstract of Glassman)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 92, Middleton as modified by Heyn discloses the method of claim 91, that fails to explicitly teach a method wherein the irrigating occurs via at least one irrigation port fluidly connected to an irrigation lumen defined by the elongate body. However, Glassman teaches that it is known to provide a method wherein the irrigating occurs via at least one irrigation port fluidly connected to an irrigation lumen defined by the elongate body 11 (see at least figs. 1 & 10; col. 2, lines 22-27, col. 3, lines 56-68 and col. 4, lines 28-35). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Middleton as modified by Heyns wherein the irrigating occurs via at least one irrigation port fluidly connected to an irrigation lumen defined by the elongate body as taught by Glassman since such a modification would amount to applying a known technique (i.e., as taught by Glassman) to a known device (i.e., as taught by Middleton) ready for improvement to achieve a predictable result such as irrigating or medicating the urethral canal and the outside surface of the catheter (see at least abstract of Glassman)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant’s arguments with respect to claim(s) 75-81 & 84-96 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2022/0241551 to Middleton et al. discloses a urinary catheter and method of catheterizing a bladder using an actively deflectable urethral catheter and a deflection mechanism.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/Primary Examiner, Art Unit 3791