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 .
Acknowledgment
Claims 1, 5, 11, 19, 23-24 are amended and filed on 9/30/2025.
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.
Claims 1-9, 11, 13-14, 16-17, 19, 21, 23-24 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.
Claim 1 recites the limitation “ wherein a fluid resistance of the first catheter… a catheter with a maximum outer diameter corresponding to an outer diameter of ..; or … a catheter with a maximum outer diameter corresponding to an outer diameter of …” in the last 7 lines. It is unclear if the maximum outer diameter is referring to first outer diameter as in line 7 so that the limitation means “wherein a fluid resistance of the first catheter… the first outer diameter is equal to an outer diameter of ..; or … the first outer diameter is equal to an outer diameter of …” or “the maximum outer diameter” is referring to new outer diameter so that the limitation means “ wherein a fluid resistance of the first catheter… the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter of ..; or … the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter an outer diameter of …” Note: for the purpose of examination, the examiner will interpret the limitation such as” wherein a fluid resistance of the first catheter… the first outer diameter is equal to an outer diameter of ..; or … the first outer diameter is equal to an outer diameter of …” .
Claim 5 recites the limitation “ wherein the first catheter… a catheter with a maximum outer diameter corresponding to an outer diameter of ..; or … a catheter with a maximum outer diameter corresponding to an outer diameter of …” in the last 6 lines. It is unclear if the maximum outer diameter is referring to first outer diameter as in line 7 of claim 1 so that the limitation means “wherein the first catheter… the first outer diameter is equal to an outer diameter of ..; or … the first outer diameter is equal to an outer diameter of …” or “the maximum outer diameter” is referring to new outer diameter so that the limitation means “ wherein the first catheter… the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter of ..; or … the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter an outer diameter of …” Note: for the purpose of examination, the examiner will interpret the limitation such as” wherein the first catheter… the first outer diameter is equal to an outer diameter of ..; or … the first outer diameter is equal to an outer diameter of …”.
Claim 11 recites the limitation “ wherein the first catheter… a catheter with a maximum outer diameter corresponding to an outer diameter of ..; a catheter with a maximum outer diameter corresponding to an outer diameter of … ; or … a catheter with a maximum outer diameter corresponding to an outer diameter of …” in the lines 17-23. It is unclear if the maximum outer diameter is referring to first outer diameter as in line 7 of claim 11 so that the limitation means “wherein the first catheter… the first outer diameter is equal to an outer diameter of ..; … the first outer diameter is equal to an outer diameter of …; or the first catheter with the first outer diameter is equal to an outer diameter of …” or “the maximum outer diameter” is referring to new outer diameter so that the limitation means “ wherein of the first catheter… the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter of … the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter an outer diameter of … or … the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter an outer diameter of …” Note: for the purpose of examination, the examiner will interpret the limitation such as” wherein a fluid resistance of the first catheter… the first outer diameter is equal to an outer diameter of … the first outer diameter is equal to an outer diameter of … ; or … the first outer diameter is equal to an outer diameter of …” .
Claim 19 recites the limitation “ wherein the first catheter… a catheter with a maximum outer diameter corresponding to an outer diameter of ..; a catheter with a maximum outer diameter corresponding to an outer diameter of … ; or … a catheter with a maximum outer diameter corresponding to an outer diameter of …” in the lines 17-23. It is unclear if the maximum outer diameter is referring to first outer diameter as in line 7 of claim 11 so that the limitation means “wherein the first catheter… the first outer diameter is equal to an outer diameter of ..; … the first outer diameter is equal to an outer diameter of …; or the first catheter with the first outer diameter is equal to an outer diameter of …” or “the maximum outer diameter” is referring to new outer diameter so that the limitation means “ wherein of the first catheter… the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter of … the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter an outer diameter of … or … the first [[a]] catheter with a maximum outer diameter is equal to an outer diameter an outer diameter of …” Note: for the purpose of examination, the examiner will interpret the limitation such as” wherein a fluid resistance of the first catheter… the first outer diameter is equal to an outer diameter of … the first outer diameter is equal to an outer diameter of … ; or … the first outer diameter is equal to an outer diameter of …” .
Claim 23 recites the limitations “a catheter with a maximum outer diameter …an outer diameter” in line 1-2. It unclear if it is referring to the limitation of claim 1 or it is referring to new limitation. The examiner will interpret the limitation as it depends on the limitation in claim 1 such as “the catheter with the maximum outer diameter ...
Claim 24 recites the limitations “a catheter with a maximum outer diameter …an outer diameter” in line 1-2. It unclear if it is referring to the limitation of claim 1 or it is referring to new limitation. The examiner will interpret the limitation as it depends on the limitation in claim 1 such as “the catheter with the maximum outer diameter ...
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-9, 11, 13-14, 16-17, 19, 21, 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US 20190321590A1) (“Burkholz”) in view of Garrison et al. (US. 20150173782A1) (“Garrison”).
Re claim 1, Burkholz discloses a delivery device for delivering a catheter into an intravenous catheter assembly (abstract, Figs. 1-8), comprising: a housing (14), comprising a distal end (close to 16), a proximal end (close to 18, Fig. 4a, Fig. 7b) and a slot (20); a first catheter (12) comprising a proximal end (close to 34) and a distal end (close to 24), wherein the first catheter comprises a first portion (73), a second portion (30, Fig. 8), and a first transition portion disposed between the first portion and the second portion (74), wherein the first portion includes a first inner diameter along a length of the first portion and a first outer diameter along the length of the first portion (inner diameter of 73 and length of 73), wherein the second portion is disposed distal to the first portion (Fig. 1-Fig. 8), wherein the second portion includes a second inner diameter and a second outer diameter along a length of the second portion (inner diameter of 30 and length of 30), wherein the second inner diameter is less than the first inner diameter (Fig. 8), wherein the second outer diameter is less than the first outer diameter (Fig. 8); and an advancement tab (44) moveable along the slot to advance the first catheter in a distal direction (¶0050, ¶0062), wherein the first transition portion is disposed distal to the distal end of the housing when the first catheter is advanced (Fig. 4b), wherein the proximal end of the first catheter is coupled to an extension tube (34, Fig. 7b), wherein the first catheter or the extension tube extend through the proximal end of the housing (Fig. 7b), wherein a proximal end of the extension tube is configured to couple to a blood collection device (78, ¶0075), and moreover it discloses that the first catheter is at least one of : i) a catheter with a maximum outer diameter corresponding to an outer diameter of a 20G catheter ii) a catheter with a maximum outer diameter corresponding to an outer diameter of a 24G catheter (¶0038, the outer catheter 55 can be 26 G or more than 20 G, then the first catheter 12 which will be inserted inside the outer catheter 55 can be any one of 22G or 24G that can be inserted inside 20 G catheter), but it fails to specifically disclose that a fluid resistance of the first catheter is represented by Rf of the catheter is at least one of:(i) for 20 G has Rf between 4.40E6 1/in3 and 2.90E7 1/in3 or ii) for 24 G has Rf between 4.40E6 1/in3 and 5.00E8 1/in3.
However, Garrison discloses a catheter assembly ( Fig. 8) wherein the size of the catheter 222 (steeped catheter or telescopic catheter, ¶0066 Fig. 54-55) and wherein the length and inner diameter can be vary (¶0068, ¶0069) and the fluid resistance of the first catheter is represented by Rf can be measured using Poiseuille's law (¶0127, Fig. 54-55 for the steeped catheter or the telescopic catheter, wherein the inner diameters are involved in the equations), for example Rf = 1.73 E5 ( 1/cm4) and the length can be vary from 15 cm to 110 cm so that the Rf can be in between 4.40E6 1/in3 and 8.60E7 1/in3 , Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance.
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify length of the first catheter of Burkholz so that a fluid resistance of the first catheter is represented by Rf of the catheter is at least one of:(i) for 20 G has Rf between 4.40E6 1/in3 and 2.90E7 1/in3 or ii) for 24 G has Rf between 4.40E6 1/in3 and 5.00E8 1/in3 as taught by Garrison for the purpose of minimizing the flow resistance to improve flow characteristic and to avoid risk of thromboembolism (Garrison, ¶0129, ¶0135, Note: Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance).
Re claim 2, Burkholz discloses wherein a distal end of the second portion forms a distal end of the first catheter (Fig. 4b).
Re claim 3, Burkholz discloses wherein the first transition portion is immediately between the first portion and the second portion (Fig. 8).
Re claim 4, Burkholz discloses wherein at least a portion of an outer surface of the first transition portion is tapered or stepped (¶0043, ¶0062), wherein at least a portion of an inner surface of the first transition portion is tapered or stepped (¶0043, ¶0062).
Re claim 5, Burkholz discloses wherein the first catheter further comprises a third portion (28) and a second transition portion disposed between the third portion and the second portion (32, ¶0043) wherein the third portion is disposed distal to the second portion (Fig. 8), wherein the third portion includes a third inner diameter along a length of the third portion (inner diameter of 28) and a third outer diameter along a length of the third portion (Fig. 8), wherein the third inner diameter is less than the second inner diameter, wherein the third outer diameter is less than the second outer diameter (Fig. 8) but it fails to disclose that the first catheter is at least one of: the first catheter is at least one of:(i) a catheter with a maximum outer diameter corresponding to an outer diameter of a 20G catheter (¶0038), or a catheter with a maximum outer diameter corresponding to an outer diameter of a 24G catheter (¶0038), but it fails to disclose that 20G catheter with Rf equal to approximately 1.91E7 1/in3; or the 24G catheter with Rf equal to approximately 1.86E8 1/in3 (i (see ¶0062 of the current application ). As such, parameters such as lengths/ inner diameters are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the first catheter is at least one of: a 20G catheter with Rf equal to approximately 1.91E7 1/in3; or a 24G catheter with Rf equal to approximately 1.86E8 1/in3.
Re claim 6, Burkholz discloses wherein at least a portion of an outer surface of the second transition is tapered or stepped, wherein at least a portion of an inner surface of the second transition is tapered or stepped (Fig. 8).
Re claim 7, Burkholz discloses wherein a distal end of the third portion forms a distal end of the first catheter (Fig. 8).
Re claim 8, Burkholz discloses wherein the second transition portion is immediately between the third portion and the second portion (Fig. 8).
Re claim 9, Burkholz discloses wherein the first portion comprises the proximal end of the catheter (Fig. 8).
Re claim 11, Burkholz discloses an intravenous catheter system (abstract, Figs.1-8), comprising: a delivery device (Fig.1-Fig. 8), comprising: a housing (14), comprising a distal end (close to16), a proximal end (close to 18) and a slot (20, Fig. 4a, Fig. 7b); a first catheter (12), comprising a proximal end (close to 34) and a distal end (close to 24), wherein the first catheter comprises a first portion (Fig. 8, 73), a second portion (30), and a first transition portion (74 ¶0064) disposed between the first portion and the second portion (Fig. 8, ¶0062), wherein the first portion includes a first inner diameter along a length of the first portion and a first outer diameter along the length of the first portion (first inner diameter of 73 and outer diameter of 73, Fig. 8), wherein the second portion is disposed distal to the first portion (Fig. 8), wherein the second portion includes a second inner diameter and a second outer diameter along a length of the second portion ( the inner diameter of 30 and outer diameter of 30, Fig. 8), wherein the second inner diameter is less than the first inner diameter (Fig. 8), wherein the second outer diameter is less than the first outer diameter (Fig. 8), wherein the first catheter comprises a third portion (28, Fig. 8) and a second transition portion (32, Fig. 8) disposed distal to the first portion and the second portion (Fig. 8), wherein the third portion includes a third inner diameter ( inner diameter of 24) along a length of the third portion and a third outer diameter along a length of the third portion (outer diameter of 28), wherein the third inner diameter is less than the second inner diameter (Fig. 8), wherein the third outer diameter is less than the second outer diameter (Fig. 8, ¶0042); and an advancement tab (44) moveable along the slot to advance the first catheter in a distal direction (¶0050, ¶0062); and a catheter assembly (Fig. 5d), comprising: a catheter adapter (60 and 66, 72), comprising a distal end, a proximal end, a lumen extending between the distal end and the proximal end (Fig. 5d); and a second catheter (66, 55) secured to the catheter adapter and extending distally from the catheter adapter (Fig. 5d), wherein when the first catheter is advanced, the third portion extends distally from the second catheter (Fig. 5d), the first transition portion is disposed within the catheter adapter (Fig. 5b, the transition 73 or 32 can be located inside the adapter as the first catheter advances and the catheter may has one or several transition ¶0064) and the second transition portion is disposed within the second catheter (Fig. 5d), and moreover it discloses that the first catheter is at least one of : i) a catheter with a maximum outer diameter corresponding to an outer diameter of a 20G catheter ii) a catheter with a maximum outer diameter corresponding to an outer diameter of a 22G catheter , or iii) a catheter with a maximum outer diameter corresponding to an outer diameter of a 24G catheter (¶0038, the outer catheter 55 can be 26 G or more than 20 G, then the first catheter 12 which will be inserted inside the outer catheter 55 can be any one of 22G or 24G that can be inserted inside 20 G catheter), but it fails to specifically disclose that a fluid resistance of the first catheter is represented by Rf of the catheter is at least one of:(i) for 20 G catheter , Rf is equal approximately 1.90E7 1/in3 , ii) for 22 G catheter, Rf is equal approximately 3.37E7 1/in3 , or iii) for 24 G catheter, Rf is equal approximately 1.86E8 1/in3.
However, Garrison discloses a catheter assembly ( Fig. 8) wherein the size of the catheter 222 (steeped catheter or telescopic catheter, ¶0066 Fig. 54-55) and wherein the length and inner diameter can be vary (¶0068, ¶0069) and the fluid resistance of the first catheter is represented by Rf can be measured using Poiseuille's law (¶0127, Fig. 54-55 for the steeped catheter or the telescopic catheter, wherein the inner diameters are involved in the equations), for example Rf = 1.73 E5 ( 1/cm4) and the length can be vary from 15 cm to 110 cm so that so that the Rf can be approximately 1.9E7 1/in3 Or 3.37E7 1/in3 , Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance.
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify length of the first catheter of Burkholz so that a fluid resistance of the first catheter is represented by Rf of the catheter is at least one of:(i) for 20 G catheter , Rf is equal approximately 1.90E7 1/in3 , ii) for 22 G catheter, Rf is equal approximately 3.37E7 1/in3 , or iii) for 24 G catheter, Rf is equal approximately 1.86E8 1/in3 as taught by Garrison for the purpose of minimizing the flow resistance to improve flow characteristic and to avoid risk of thromboembolism (Garrison, ¶0129, ¶0135, Note: Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance).
Re claim 13, Burkholz discloses wherein an inner surface of the second catheter comprises a distal taper (75, Fig. 5b), wherein the distal end of the second portion contacts the distal taper when the first catheter is advanced (Fig. 5b).
Re claim 14, Burkholz discloses wherein the second catheter comprises a distal opening (opening at 75), wherein an outer diameter of the second portion is greater than a diameter of the distal opening to prevent movement of the first catheter through the distal opening (¶0063).
Re claim 16, Burkholz discloses wherein an inner surface of the second catheter comprises a distal taper (75), wherein the second transition portion contacts the distal taper when the first catheter is advanced (30 can contact 75, ¶0063).
Re claim 17, Burkholz discloses wherein the second transition portion is immediately between the third portion and the second portion (Fig. 8).
Re claim 19, Burkholz discloses a method (abstract, Figs. 1-8), comprising: coupling a delivery device (10) to a catheter assembly (Fig. 5d), wherein the delivery device (Fig. 4a) comprises: a housing (14), comprising a distal end (close to 16), a proximal end (close to 18) and a slot (20); a first catheter (12), comprising a proximal end (close to 34) and a distal end (close to 28), wherein the first catheter comprises a first portion (73, Fig. 8), a second portion ( 30, Fig. 8), and a first transition portion (74) disposed between the first portion and the second portion (Fig. 8), wherein the first portion includes a first inner diameter along a length of the first portion and a first outer diameter along the length of the first portion (inner and outer diameters of 73), wherein the second portion (30) is disposed distal to the first portion (Fig. 8), wherein the second portion includes a second inner diameter and a second outer diameter along a length of the second portion (inner and outer diameter of 30), wherein the second inner diameter is less than the first inner diameter (Fig. 8), wherein the second outer diameter is less than the first outer diameter (Fig. 8), wherein the first catheter further comprises a third portion (28, Fig. 8) and a second transition portion (32) disposed distal to the first portion and the second portion (Fig. 8), wherein the third portion includes a third inner diameter (inner diameter of 28) along a length of the third portion and a third outer diameter along a length of the third portion (outer diameter of 28), wherein the third inner diameter is less than the second inner diameter (Fig. 8, ¶0042), wherein the third outer diameter is less than the second outer diameter (Fig. 8), where and an advancement tab (44, ¶0050) moveable along the slot to advance the first catheter in a distal direction, wherein the first transition portion is disposed distal to the distal end of the housing when the first catheter is advanced (Fig. 5b, 73 or 30 ¶0064), and wherein the catheter assembly comprises: a catheter adapter, comprising a distal end (close to 56), a proximal end (62), a lumen extending between the distal end and the proximal end (Fig. 5a); and a second catheter (55) secured to the catheter adapter (Fig. 5a) and extending distally from the catheter adapter (Fig. 5a), and advancing the first catheter in a distal direction, wherein in response to advancing the first catheter in the distal direction, the first transition portion is disposed within the catheter adapter (Fig. 5b, ¶0062), and the second transition portion is disposed within the second catheter (32, Fig. 8, Fig. 5b, ¶0074 ), and moreover it discloses that the first catheter is at least one of : i) a catheter with a maximum outer diameter corresponding to an outer diameter of a 20G catheter ii) a catheter with a maximum outer diameter corresponding to an outer diameter of a 22G catheter , or iii) a catheter with a maximum outer diameter corresponding to an outer diameter of a 24G catheter (¶0038, the outer catheter 55 can be 26 G or more than 20 G, then the first catheter 12 which will be inserted inside the outer catheter 55 can be any one of 22G or 24G that can be inserted inside 20 G catheter), but it fails to specifically disclose that a fluid resistance of the first catheter is represented by Rf of the catheter is at least one of:(i) for 20 G catheter , Rf is equal approximately 1.90E7 1/in3 , ii) for 22 G catheter, Rf is equal approximately 3.37E7 1/in3 , or iii) for 24 G catheter, Rf is equal approximately 1.86E8 1/in3.
However, Garrison discloses a catheter assembly ( Fig. 8) wherein the size of the catheter 222 (steeped catheter or telescopic catheter, ¶0066 Fig. 54-55) and wherein the length and inner diameter can be vary (¶0068, ¶0069) and the fluid resistance of the first catheter is represented by Rf can be measured using Poiseuille's law (¶0127, Fig. 54-55 for the steeped catheter or the telescopic catheter, wherein the inner diameters are involved in the equations), for example Rf = 1.73 E5 ( 1/cm4) and the length can be vary from 15 cm to 110 cm so that the Rf can be approximately 1.9E7 1/in3 Or 3.37E7 1/in3 , Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance.
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the length/inner diameters of the first catheter of the method of Burkholz so that a fluid resistance of the first catheter is represented by Rf of the catheter is at least one of:(i) for 20 G catheter , Rf is equal approximately 1.90E7 1/in3 , ii) for 22 G catheter, Rf is equal approximately 3.37E7 1/in3 , or iii) for 24 G catheter, Rf is equal approximately 1.86E8 1/in3 as taught by Garrison for the purpose of minimizing the flow resistance to improve flow characteristic and to avoid risk of thromboembolism (Garrison, ¶0129, ¶0135, Note: Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance).
As to claim 21, Burkholz is silent to the specifics of wherein the third portion has a length of 1.25 inches. The instant disclosure describes the parameter of the length as being merely preferable, and does not describe the length as contributing any unexpected results to the system (see ¶0062 of the current application ). As such, parameters such as length are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art at the time the invention was made that the limitation of the length of the third portion of the catheter would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Re claim 23, Burkholz discloses that first catheter is a catheter with a maximum outer diameter corresponding to tan outer diameter of a 20G catheter (¶008), but it fails to disclose that Rf is between 4.40E6 1/in3 and 2.90E7 1/in3.
However, Garrison discloses a catheter assembly ( Fig. 8) wherein the size of the catheter 222 (steeped catheter or telescopic catheter, ¶0066 Fig. 54-55) and wherein the length and inner diameter can be vary (¶0068, ¶0069) and the fluid resistance of the first catheter is represented by Rf can be measured using Poiseuille's law (¶0127, Fig. 54-55 for the steeped catheter or the telescopic catheter, wherein the inner diameters are involved in the equations), for example Rf = 1.73 E5 ( 1/cm4) and the length 110 cm so that the Rf is between 4.40E6 1/in3 and 2.90E7 1/in3., Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance.
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the length/inner diameters of the first catheter of the method of Burkholz so that Rf is between 4.40E6 1/in3 and 2.90E7 1/in3 as taught by Garrison for the purpose of minimizing the flow resistance to improve flow characteristic and to avoid risk of thromboembolism (Garrison, ¶0129, ¶0135, Note: Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance).
Re claim 24, Burkholz discloses that first catheter is a catheter with a maximum outer diameter corresponding to tan outer diameter of a 24G catheter (¶008), but it fails to disclose that Rf is between 4.40E6 1/in3 and 5.00E8 1/in3.
However, Garrison discloses a catheter assembly ( Fig. 8) wherein the size of the catheter 222 (steeped catheter or telescopic catheter, ¶0066 Fig. 54-55) and wherein the length and inner diameter can be vary (¶0068, ¶0069) and the fluid resistance of the first catheter is represented by Rf can be measured using Poiseuille's law (¶0127, Fig. 54-55 for the steeped catheter or the telescopic catheter, wherein the inner diameters are involved in the equations), for example Rf = 1.73 E5 ( 1/cm4) and the length 110 cm so that the Rf is between 4.40E6 1/in3 and 5.00E8 1/in3. Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance.
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the length/inner diameters of the first catheter of the method of Burkholz so that RF is between 4.40E6 1/in3 and 5.00E8 1/in3 as taught by Garrison for the purpose of minimizing the flow resistance to improve flow characteristic and to avoid risk of thromboembolism (Garrison, ¶0129, ¶0135, Note: Also, the instant disclosure describes the Rf parameter equal to the length/ diameter ^4 as being merely preferable; see ¶0062 of the current application and parameter of the length/ diameter depends on patient’s age: infant, child, adult; see ¶0069 of Garrison, therefore such inner diameter and length can vary to provide desired resistance).
Response to Arguments
Applicant’s arguments, see remark, filed 9/30/2025 with respect to the rejection(s) of claim(s) 1, 11, 19 under 103 using Burkholz in view of Cabot 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 over Burkholz in view of Garrison.
Conclusion
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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783