DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In response to amendment filed March 31, 2026, claims 1, 7-8, 10-17 and 19-20 are amended. No claims are cancelled and no new claims have been added. Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed March 31, 2026, with respect to claim objection have been fully considered and are persuasive in view of the amendments. The objection of claim 10 has been withdrawn.
Applicant's arguments filed March 31, 2026 with respect to the prior art rejections have been fully considered but they are not persuasive.
With respect to the newly added limitation “the first portion and the second portion of the channel extending within an arc of a cross-section of the body”, Examiner respectfully disagrees. Burkholz teaches in Fig. 6A that the various grooves #56 extend within an arc of a cross-section of the body #58 as the dashed red line in the Figure 1 below show a sample cross section which can be taken along the groove of the body where the first and second portion of the channel extend within it which meets the claimed limitation.
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Figure 1.
Claim Objections
Claim 1 is objected to because of the following informalities:
“within in arc” in lines 10 should be “within an arc” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-11, 14 and 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Burkholz (US 20210228127 A1; previously cited by applicant).
With respect to claim 1, Burkholz discloses
a flow restriction device (see paragraph 0055 and Figs. 6A-6C, adapter #55), comprising:
a housing (see paragraph 0055-0057 and Figs. 6A-6C, outer component #60) defining a first lumen, a second lumen, and a cavity disposed between the first lumen and the second lumen (see paragraph 0055-0056 and Figs. 6A-6C, outer component #60 has a first lumen where #14 is pointing and a second lumen on the distal end of where a cavity is in between; and see paragraph 0055, adapter #55 may be similar or identical in terms of the features to the adapter #10, adapter #44 and adapter #48; and see paragraph 0044 and Fig.4B, adapter #48 includes a first lumen on proximal side where #24 is, a second lumen on distal end where #20 is and a cavity in between both lumens where #30 is); and
an insert body disposed within the cavity (see paragraph 0055-0057 and Figs. 6A-6C, an inner component #58), the insert body comprising:
a first end (see paragraph 0055-0057 and Figs. 6A-6C, #58 has a first end on one side);
a second end (see paragraph 0055-0057 and Figs. 6A-6C, #58 has a second end on another side);
a longitudinal axis extending through the first and second ends (see paragraph 0055-0057 and Figs. 6A-6C, an longitudinal axis can pass between two ends of #58);
an outer surface (see paragraph 0055-0057 and Figs. 6A-6C, #58 has an outer surface that contacts #60); and
a channel, the channel defined on the outer surface (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56), wherein the channel extends between the first and second ends (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 between its two ends), the channel comprising a first portion that extends in a first direction away from the longitudinal axis and a second portion that extends in a second direction toward the longitudinal axis (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 that extends in two directions on the top and bottom with a hole #62 and an opening #63), the first portion and the second portion of the channel extending within an arc of a cross-section of the body (see Fig. 6A: a cross section can be taken along the groove of the body where the first and second portion of the channel extend within it), and the channel and an inner surface of the cavity define a fluid passage in fluid communication with the first lumen and the second lumen (see paragraph 0055-0060 and Figs. 6A-6C, #56 may include hole #62 that fluidly connects #56 to and opening #64).
With respect to claim 4, all limitations of claim 1 apply in which Burkholz further discloses wherein the channel defines a serpentine fluid passage (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 which may include a coil or spiral shape).
With respect to claim 5, all limitations of claim 1 apply in which Burkholz further discloses wherein the channel is at least partially sinusoidal (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 which may include a coil or spiral shape).
With respect to claim 6, all limitations of claim 1 apply in which Burkholz further discloses wherein the insert body comprises a cylindrical body (see paragraph 0055-0060 and Figs. 6A-6C, #58 is cylindrical).
With respect to claim 7, all limitations of claim 6 apply in which Burkholz further discloses wherein the first portion and second portion of the channel extend within an arc of 180 degrees of the cross-section of the cylindrical body (see paragraph 0055-0060 and Figs. 6A-6C, #58 is cylindrical where #56 extends along the outer surface within an arc of 180 degrees as seen best in Fig. 6A).
With respect to claim 8, all limitations of claim 1 apply in which Burkholz further discloses wherein the housing comprises a male luer connector portion defining the first lumen (see paragraph 0053-0060, distal end #12 of outer component #60 may include distal connector #14 which can be a male luer connector) and a female luer connector portion defining the second lumen (see paragraph 0059, inner component #58 may include on the proximal end #16 a proximal connector #18 such as a female luer connector; and see paragraph 0055, adapter #55 may be similar or identical in terms of the features to the adapter #10, adapter #44 and adapter #48; and see paragraph 0044 and Fig.4B, adapter #48 includes proximal connector #18 on proximal end of adapter #48 as seen in Fig. 4B where the housing is the adapter structure that is formed), and the male luer connector portion and the female luer connector portion are coupled together to cooperatively define the cavity (see paragraph 0055-0056 and Figs. 6A-6C, outer component #60 has a first lumen where #14 is pointing and a second lumen on the distal end of where a cavity is in between).
With respect to claim 9, all limitations of claim 1 apply in which Burkholz further discloses wherein the first lumen is configured to be coupled to a catheter hub (see paragraph 0029-0032, catheter assembly includes catheter hub with a distal and proximal end).
With respect to claim 10, all limitations of claim 1 apply in which Burkholz further discloses wherein the second lumen is configured to be coupled to a fluid collection device (see paragraph 0033, adapter includes proximal end #16 which includes proximal connector #18 configured to couple to blood collection device).
With respect to claim 11, Burkholz discloses
a flow restriction device (see paragraph 0055 and Figs. 6A-6C, adapter #55), comprising:
a male luer connector portion defining a first lumen (see paragraph 0053-0060, distal end #12 of outer component #60 may include distal connector #14 which can be a male luer connector);
a female luer connector portion defining a second lumen (see paragraph 0059, inner component #58 may include on the proximal end #16 a proximal connector #18 such as a female luer connector), wherein the male luer connector portion and the female luer connector portion cooperatively define a cavity (see paragraph 0055-0056 and Figs. 6A-6C, outer component #60 has a first lumen where #14 is pointing and a second lumen on the distal end of where a cavity is in between; and see paragraph 0055, adapter #55 may be similar or identical in terms of the features to the adapter #10, adapter #44 and adapter #48; and see paragraph 0044 and Fig.4B, adapter #48 includes a first lumen on proximal side where #24 is, a second lumen on distal end where #20 is and a cavity in between both lumens where #30 is); and
an insert body disposed within the cavity (see paragraph 0055-0057 and Figs. 6A-6C, an inner component #58), the insert body comprising:
a first end (see paragraph 0055-0057 and Figs. 6A-6C, #58 has a first end on one side);
a second end (see paragraph 0055-0057 and Figs. 6A-6C, #58 has a second end on another side);
an outer surface (see paragraph 0055-0057 and Figs. 6A-6C, #58 has an outer surface that contacts #60); and
a serpentine channel defined on the outer surface (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 which may include a coil or spiral shape), wherein the serpentine channel extends between the first and second ends of the insert body (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 between its two ends) and entirely within an arc of a cross-section of the body (see Fig. 6A: a cross section can be taken along the groove of the body where the first and second portion of the channel extend entirely within it) and the serpentine channel and an inner surface of the cavity define a fluid passage in fluid communication with the first lumen and the second lumen (see paragraph 0055-0060 and Figs. 6A-6C, #56 may include hole #62 that fluidly connects #56 to and opening #64).
With respect to claim 14, Burkholz discloses
a peripheral intravenous catheter assembly (see paragraph 0029-0032, catheter assembly) configured to limit hemolysis during drawing of blood from a patient (see paragraph 0029-0032, reduce likelihood of hemolysis during blood collection), comprising:
a catheter hub having a proximal end and a distal end (see paragraph 0029-0032, catheter assembly includes catheter hub with a distal and proximal end);
a fluid collection device (see paragraph 0033, adapter includes proximal end #16 which includes proximal connector #18 configured to couple to blood collection device); and
a flow restriction device (see paragraph 0055 and Figs. 6A-6C, adapter #55), comprising:
a housing (see paragraph 0055-0057 and Figs. 6A-6C, outer component #60) defining a first lumen, a second lumen, and a cavity disposed between the first lumen and the second lumen (see paragraph 0055-0056 and Figs. 6A-6C, outer component #60 has a first lumen where #14 is pointing and a second lumen on the distal end of where a cavity is in between; and see paragraph 0055, adapter #55 may be similar or identical in terms of the features to the adapter #10, adapter #44 and adapter #48; and see paragraph 0044 and Fig.4B, adapter #48 includes a first lumen on proximal side where #24 is, a second lumen on distal end where #20 is and a cavity in between both lumens where #30 is) wherein the first lumen is in fluid communication with the catheter hub and the second lumen is in fluid communication with the fluid collection device (see paragraph 0029-0032, catheter assembly includes catheter hub with a distal and proximal end; and see paragraph 0033, adapter includes proximal end #16 which includes proximal connector #18 configured to couple to blood collection device); and
an insert body disposed within the cavity (see paragraph 0055-0057 and Figs. 6A-6C, an inner component #58), the insert body comprising:
a first end (see paragraph 0055-0057 and Figs. 6A-6C, #58 has a first end on one side);
a second end (see paragraph 0055-0057 and Figs. 6A-6C, #58 has a second end on another side);
a longitudinal axis extending through the first and second ends (see paragraph 0055-0057 and Figs. 6A-6C, an longitudinal axis can pass between two ends of #58);
an outer surface (see paragraph 0055-0057 and Figs. 6A-6C, #58 has an outer surface that contacts #60); and
a tortuous channel, the tortuous channel defined on the outer surface (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 where #56 can be a coil or spiral), wherein the tortuous channel extends between the first and second ends of the insert body (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 between its two ends) and entirely within an arc of a cross-section of the body (see Fig. 6A: a cross section can be taken along the groove of the body where the first and second portion of the channel extend entirely within it) and the tortuous channel and an inner surface of the cavity define a fluid passage in fluid communication with the first lumen and the second lumen (see paragraph 0055-0060 and Figs. 6A-6C, #56 may include hole #62 that fluidly connects #56 to and opening #64).
With respect to claim 17, all limitations of claim 14 apply in which Burkholz further discloses wherein the tortuous channel is at least partially sinusoidal (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 which may include a coil or spiral shape).
With respect to claim 18, all limitations of claim 14 apply in which Burkholz further discloses wherein the insert body comprises a cylindrical body (see paragraph 0055-0060 and Figs. 6A-6C, #58 is cylindrical).
With respect to claim 19, all limitations of claim 18 apply in which Burkholz further discloses wherein the tortuous channel extends comprises a first portion that extends in a first direction away from a longitudinal axis of the insert body, a second portion that extends in a second direction towards the longitudinal axis (see paragraph 0055-0060 and Figs. 6A-6C, #58 has a groove #56 that extends in two directions on the top and bottom with a hole #62 and an opening #63), and the first and second portions of the tortuous channel extend within an arc of 180 degrees of the cross-section of the cylindrical body (see paragraph 0055-0060 and Figs. 6A-6C, #58 is cylindrical where #56 extends along the outer surface within an arc of 180 degrees as seen best in Fig. 6A).
With respect to claim 20, all limitations of claim 14 apply in which Burkholz further discloses wherein the housing comprises a male luer connector portion defining the first lumen (see paragraph 0053-0060, distal end #12 of outer component #60 may include distal connector #14 which can be a male luer connector) and a female luer connector portion defining the second lumen (see paragraph 0059, inner component #58 may include on the proximal end #16 a proximal connector #18 such as a female luer connector; and see paragraph 0055, adapter #55 may be similar or identical in terms of the features to the adapter #10, adapter #44 and adapter #48; and see paragraph 0044 and Fig.4B, adapter #48 includes proximal connector #18 on proximal end of adapter #48 as seen in Fig. 4B where the housing is the adapter structure that is formed)), and the male luer connector portion and the female luer connector portion are coupled together to cooperatively define the cavity (see paragraph 0055-0056 and Figs. 6A-6C, outer component #60 has a first lumen where #14 is pointing and a second lumen on the distal end of where a cavity is in between; and see paragraph 0055, adapter #55 may be similar or identical in terms of the features to the adapter #10, adapter #44 and adapter #48; and see paragraph 0044 and Fig.4B, adapter #48 includes a first lumen on proximal side where #24 is, a second lumen on distal end where #20 is and a cavity in between both lumens where #30 is).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-3, 12-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Cabot (US 20120191010 A1; previously cited).
With respect to claim 2, all limitations of claim 1 apply in which Burkholz does not specifically disclose wherein the channel has a diameter of about 0.02 inches to about 0.03 inches.
Cabot teaches that a collection catheter with a channel can be any diameter so as long as it fits into a catheter (see paragraph 0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burkholz with the teachings of Cabot to have a channel be a specified diameter because it would have resulted in the predictable result of having a channel be able to fit within a catheter (Cabot: see [0032]) to allow the channel to flow through the catheter (Cabot: see [0032]).
Alternatively, Cabot is suggesting that the diameter is subject to change. The diameter would depend upon the factors of materials and designer preference. As such, the diameter is a results-effective variable that would have been optimized through routine experimentation based on the factors materials and designer preference. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the diameter so as to obtain the desired materials and designer preference.
With respect to claim 3, all limitations of claim 1 apply in which Burkholz does not specifically disclose wherein the channel has a length of about 0.97 inches to about 1.30 inches.
Cabot teaches that a collection catheter with a channel can be any length (see paragraph 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burkholz with the teachings of Cabot to have a channel be a specified length because it would have resulted in the predictable result of having a channel extend through a placed catheter to collect fluid and allow a fluid sample to be taken directly from a source and avoids pain and clotting issues (Cabot: see [0031]).
Alternatively, Cabot is suggesting that the length is subject to change. The diameter would depend upon the factors of materials and designer preference. As such, the length is a results-effective variable that would have been optimized through routine experimentation based on the factors materials and designer preference. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the length so as to obtain the desired materials and designer preference.
With respect to claim 12, all limitations of claim 11 apply in which Burkholz does not specifically disclose wherein the serpentine channel has a diameter of about 0.02 inches to about 0.03 inches.
Cabot teaches that a collection catheter with a channel can be any diameter so as long as it fits into a catheter (see paragraph 0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burkholz with the teachings of Cabot to have a channel be a specified diameter because it would have resulted in the predictable result of having a channel be able to fit within a catheter (Cabot: see [0032]) to allow the channel to flow through the catheter (Cabot: see [0032]).
Alternatively, Cabot is suggesting that the diameter is subject to change. The diameter would depend upon the factors of materials and designer preference. As such, the diameter is a results-effective variable that would have been optimized through routine experimentation based on the factors materials and designer preference. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the diameter so as to obtain the desired materials and designer preference.
With respect to claim 13, all limitations of claim 11 apply in which Burkholz does not specifically disclose wherein the serpentine channel has a length of about 0.97 inches to about 1.30 inches.
Cabot teaches that a collection catheter with a channel can be any length (see paragraph 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burkholz with the teachings of Cabot to have a channel be a specified length because it would have resulted in the predictable result of having a channel extend through a placed catheter to collect fluid and allow a fluid sample to be taken directly from a source and avoids pain and clotting issues (Cabot: see [0031]).
Alternatively, Cabot is suggesting that the length is subject to change. The diameter would depend upon the factors of materials and designer preference. As such, the length is a results-effective variable that would have been optimized through routine experimentation based on the factors materials and designer preference. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the length so as to obtain the desired materials and designer preference.
With respect to claim 15, all limitations of claim 14 apply in which Burkholz does not specifically disclose wherein the tortuous channel has a diameter of about 0.02 inches to about 0.03 inches.
Cabot teaches that a collection catheter with a channel can be any diameter so as long as it fits into a catheter (see paragraph 0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burkholz with the teachings of Cabot to have a channel be a specified diameter because it would have resulted in the predictable result of having a channel be able to fit within a catheter (Cabot: see [0032]) to allow the channel to flow through the catheter (Cabot: see [0032]).
Alternatively, Cabot is suggesting that the diameter is subject to change. The diameter would depend upon the factors of materials and designer preference. As such, the diameter is a results-effective variable that would have been optimized through routine experimentation based on the factors materials and designer preference. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the diameter so as to obtain the desired materials and designer preference.
With respect to claim 16, all limitations of claim 14 apply in which Burkholz does not specifically disclose wherein the tortuous channel has a length of about 0.97 inches to about 1.30 inches.
Cabot teaches that a collection catheter with a channel can be any length (see paragraph 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burkholz with the teachings of Cabot to have a channel be a specified length because it would have resulted in the predictable result of having a channel extend through a placed catheter to collect fluid and allow a fluid sample to be taken directly from a source and avoids pain and clotting issues (Cabot: see [0031]).
Alternatively, Cabot is suggesting that the length is subject to change. The diameter would depend upon the factors of materials and designer preference. As such, the length is a results-effective variable that would have been optimized through routine experimentation based on the factors materials and designer preference. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the length so as to obtain the desired materials and designer preference.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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