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 .
Terminal Disclaimer
The terminal disclaimer filed on 3/17/26 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12023159 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 1-17 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 "at least one of" a series of ranges (e.g., “1.43E7 1/in3± 30%”, “3.70E6 1/in3± 30%”, between 1.43E7 1/in3 and 3.70E6 1/in3, 1.43E7 1/in3± 10%, and 3.70E6 1/in3±10%"). This language fails to define the boundaries of the invention.
Specifically, it is unclear which of the listed ranges applies to the claimed element. The phrase "at least one of" combined with multiple ranges creates an open-ended and ambiguous scope. A person having ordinary skill in the art cannot determine if the device or method must satisfy all of the listed ranges, any single range, or a combination of them.
Claim 1 also recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “1.43E7 1/in3± 30%” or “3.70E6 1/in3± 30%”, and the claim also recites “between 1.43E7 1/in3 and 3.70E6 1/in3, 1.43E7 1/in3± 10%, or 3.70E6 1/in3±10%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-17 are rejected by virtue of their dependence from claim 1.
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.
Claims 1-11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bullington (US 20180140240) (cited by Applicant) in view of Burt (U.S. 9658628).
Regarding claim 1, Bullington teaches (Figs. 19-20) a blood collection device comprising a flow restrictor (1050), comprising a distal end (1052) and a proximal end (1051), and a fluid pathway (1024), wherein the proximal end is coupled to a blood collection container (Paragraph [0137]).
However, Bullington does not teach “wherein a geometric factor of the flow restrictor is represented by Gf, wherein Gf is at least one of: (i) 1.43E7 1/in3± 30%; (ii) 3.70E6 1/in3± 30%; (iii) between 1.43E7 1/in3 and 3.70E6 1/in3; (iv) 1.43E7 1/in3± 10%; or (v) 3.70E6 1/in3±10%.”
Burt, in the field of fluid control systems, teaches a flow restrictor (i.e., valve plug) comprising a “plug geometry factor” that varies based on the desired design and opening size of the valve. (Figure 9; Col. 15, lines 54-57; Col. 16, lines 2-7). With this teaching by Burt, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have determined an appropriate geometric factor for the flow restrictor of Bullington.
With regard to the specific geometric factors recited throughout the claims, it is noted that Applicant has failed to provide details of criticality or unexpected results in the specification pertaining to the claimed geometric factors. Therefore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to have determined the optimal geometric factor of the flow restrictor of Bullington. 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).
With regards to claims 2-6, Burt teaches a “plug geometry factor” that varies based on the desired design and opening size of the valve. (Figure 9; Col. 15, lines 54-57; Col. 16, lines 2-7). With this teaching by Burt, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have determined an appropriate geometric factor for the flow restrictor of Bullington.
With regard to the specific geometric factors recited throughout the claims, it is noted that Applicant has failed to provide details of criticality or unexpected results in the specification pertaining to the claimed geometric factors. Therefore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to have determined the optimal geometric factor of the flow restrictor of Bullington. 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).
Regarding claim 7, Bullington teaches (Fig. 3) wherein the blood collection container is a syringe (Paragraph [0094]).
Regarding claim 8, Bullington illustrates (Fig. 20) wherein an overall length of the restrictor (1050) is less than an overall length of the syringe.
Regarding claim 9, Bullington teaches wherein the flow restrictor is monolithically formed as a single unit. (Paragraph [0137]).
Regarding claim 10, Bullington illustrates (Figs. 19-20) wherein the proximal end (1051) of the flow restrictor (1050) comprises a first luer adapter (1030), the distal end (1052) comprises a second luer adapter (1020), and wherein the flow restrictor further comprises an extension tube (1054) disposed between the first luer adapter (1030) and the second luer adapter (1020).
Regarding claim 11, Bullington teaches wherein the distal end (1052) of the flow restrictor (1050) is configured to couple to a catheter assembly. (Paragraph [0129]).
Regarding claim 16, Bullington illustrates (Fig. 20) wherein the fluid pathway (1024) has a uniform diameter.
Regarding claim 17, Bullington illustrates (Figs. 19-20) wherein the fluid pathway (1024) has a variable inner diameter along a length of the fluid pathway. (Paragraph [0127] presence of gasket 1026 between the lumen 1024 of the first adapter 1020, restricting and/or reducing the pressure and/or flow rate, may cause variation in diameter).
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of Burt, further in view of Cash (US 20140296745), evidenced by “Evren Eker, H., et al. The impact of two arterial catheters, different in diameter and length, on postcannulation radial artery diameter, blood flow, and occlusion in atherosclerotic patients. J Anesth 23, 347–352 (2009). https://doi.org/10.1007/s00540-009-0753-4, and Katritsis et al, Wall Shear Stress: Theoretical Considerations and Methods of Measurement, Progress in Cardiovascular Diseases, Vol. 49, No. 5 (March/April), 2007: pp 307-329, doi:10.1016/j.pcad.2006.11.001
Regarding claim 12, Bullington as modified does not teach “a 20 gauge (G) catheter coupled to the flow restrictor, wherein a length of the fluid pathway is represented by L, wherein a diameter of the fluid pathway is represented by D, wherein D4/ L is equal to or less than 3.1E-07 cubic inches”.
Cash, in a related field of endeavor, teaches (Fig. 1) a blood transfer device comprising a 20 gauge (G) catheter, (Paragraph [0031]), coupled to the flow restrictor (split-septum T-connector 27) (Paragraph [0032]).
As a result, it would have have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Bullington as modified to teach “a 20 gauge (G) catheter coupled to the flow restrictor” as taught by Cash. Doing so provides an ideal balance of reliable fluid flow for low-volume blood collection that reduces the risk of infection in patients and caregivers by maintaining the entire system in a closed state and by minimizing the number of line accesses required to collect blood. (Paragraph [0015]).
However, the combination not further teach “wherein a length of the fluid pathway is represented by L, wherein a diameter of the fluid pathway is represented by D, wherein D4/ L is equal to or less than 3.1E-07 cubic inches.”
It is widely known in the art that a 20-gauge catheter is approximately 32 mm in length (L) and 1.1 mm in diameter (D). (See Abstract of Evren). Furthermore, the link between D4/L and wall shear stress can be derived by combining Poiseuille’s Law for volumetric flow rate (Q) with the fundamental formula for wall shear stress (τw) in a cylindrical pipe, which reveals that wider and shorter pathways drastically increase overall flow rate velocity (Q), spiking the flow rate (Q) gradient near the wall. (See Katritsis, pages 323-324).
Therefore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to have determined the optimal geometric factor ratio (D4/L) of the catheter when the flow restrictor is used with a 20-gauge catheter, such that it reduces wall shear stress. 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).
Regarding claim 13, Bullington teaches a blood collection device (Fig. 9), further comprising a catheter adapter (520), wherein the catheter (510) extends distally from the catheter adapter.
Regarding claim 14, Bullington as modified does not teach “a 22-gauge (G) catheter coupled to the flow restrictor, wherein a length of the fluid pathway is represented by L, wherein a diameter of the fluid pathway is represented by D, wherein D4/ L is equal to or less than 7.0E-08 cubic inches”.
Cash teaches (Fig. 1) a blood transfer device comprising a 22-gauge (G) catheter, (Paragraph [0031]), coupled to the flow restrictor (split-septum T-connector 27) (Paragraph [0032]).
As a result, it would have have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Bullington as modified to teach “a 22-gauge (G) catheter coupled to the flow restrictor” as taught by Cash. Doing so provides an ideal balance of reliable fluid flow for low-volume blood collection that reduces the risk of infection in patients and caregivers by maintaining the entire system in a closed state and by minimizing the number of line accesses required to collect blood. (Paragraph [0015]).
However, it does not further teach “wherein a length of the fluid pathway is represented by L, wherein a diameter of the fluid pathway is represented by D, wherein D4/ L is equal to or less than 7.0E-08 cubic inches.”
It is widely known in the art that a 22-gauge catheter is approximately 25 mm in length (L) and 0.9 mm in diameter (D). (See Abstract of Evren). Furthermore, the link between D4/L and wall shear stress can be derived by combining Poiseuille’s Law for volumetric flow rate (Q) with the fundamental formula for wall shear stress (τw) in a cylindrical pipe, which reveals that wider and shorter pathways drastically increase overall flow rate velocity (Q), spiking the flow rate (Q) gradient near the wall. (See Katritsis, pages 323-324).
Therefore, it would have been obvious to one of ordinary skill in the art, through routine optimization, to have determined the optimal geometric factor ratio (D4/L) of the catheter when the flow restrictor is used with a 22-gauge catheter such that it reduces wall shear stress. 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).
Regarding claim 15, Bullington teaches a blood collection device (Fig. 9), further comprising a catheter adapter (520), wherein the catheter (510) extends distally from the catheter adapter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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