DETAILED ACTION
This action is responsive to the RESTRICTION RESPONSE filed 17 December 2025. The Examiner acknowledges the cancellation of claims 1, 14, 17-18, 22, 29, 38-43, and the addition of new claims 44-55 [the Examiner notes that the RESTRICTION RESPONSE recites a claim 56, but the presently filed claims only include up to claim 55]. Claims 30-37 and 44-55 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of claims 30-37 in the reply filed on 17 December 2025 is acknowledged.
Information Disclosure Statement
The information disclosure statement filed 1 March 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed [see annotated IDS for reference not considered]. It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The abstract of the disclosure is objected to because of undue length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). The Examiner suggests omitting the sentence “The blood sampling port is 2 mm to 20 mm proximal from the fluid transfer port”.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 30 and 48 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 10 of U.S. Patent No. 11,701,040, hereinafter Jones, in view of Hadford (US-4675004-A, cited by Applicant).
Conflicting claim 10 of Jones is considered to anticipate almost each and every limitation of claim 30 of the instant application [see comparison below], except for the limitation “wherein the blood sample is not contaminated by the fluid”.
Hadford discloses systems and methods for treating a patient, including steps to administer a fluid to the patient and obtaining a blood sample from the patient through a venous access device, wherein the blood sample is not contaminated by the fluid [blood flowing into the intake lumen 30 through the blood inlet 26 cannot mix with blood exiting the return lumen 32 through the blood outlet 24 (Hadford Col 3:20-22); The orientation of the blood inlet 26 encourages blood to enter the intake lumen transverse to the longitudinal axis of the shaft, whereas the orientation of the blood outlet 24 encourages blood to exit the blood return lumen 32 longitudinally. Thus, mixing or recirculation of the arterial blood with the venous blood is virtually eliminated (Hadford Col 3:58-64)].
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 the method of the instant application to employ wherein the blood sample is not contaminated by the fluid, so as to prevent mixing or recirculation of administered fluid with obtained blood.
Conflicting claim 10 of Jones as modified by Hadford is further considered to render obvious instant claim 48.
Claim 30 of the Instant Application
Claim 10 of Conflicting Patent 11,701,040, hereinafter Jones
A method of treating a patient, comprising:
A method of obtaining a blood sample, comprising: [Jones Col 9:17]
transferring fluids into the patient through the venous access device, wherein the obtaining occurs at the same time as the transferring [Jones Col 10:30-33]
administering a fluid to the patient through a venous access device in a peripheral vein of the patient; and
transferring fluids into the patient through the venous access device, wherein the obtaining occurs at the same time as the transferring [Jones Col 10:30-33]
obtaining a blood sample from the patient through the venous access device;
obtaining the blood sample from the patient through the venous access device [Jones Col 9:20-21]
wherein the blood sample is not contaminated by the fluid.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 30, 32-34, 47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hadford (US-4675004-A, cited by Applicant).
Regarding claim 30, Hadford teaches
A method of treating a patient, comprising:
administering a fluid to the patient through a venous access device in a peripheral vein of the patient [The venous or treated blood is returned through the blood outlet 24 longitudinally and therefore in the direction of blood flow (Hadford Col 4:27-29, Figs. 3, 5)]; and
obtaining a blood sample from the patient through the venous access device [A blood inlet 26 is provided on the neck 14 (Hadford Col 3:10-11); the blood inlet encourages blood to enter the intake lumen 30 in a direction transverse to the longitudinal axis of the shaft (Hadford Col 4:25-27)];
wherein the blood sample is not contaminated by the fluid [blood flowing into the intake lumen 30 through the blood inlet 26 cannot mix with blood exiting the return lumen 32 through the blood outlet 24 (Hadford Col 3:20-22); The orientation of the blood inlet 26 encourages blood to enter the intake lumen transverse to the longitudinal axis of the shaft, whereas the orientation of the blood outlet 24 encourages blood to exit the blood return lumen 32 longitudinally. Thus, mixing or recirculation of the arterial blood with the venous blood is virtually eliminated (Hadford Col 3:58-64)].
Regarding claim 32, Hadford teaches
The method of claim 30, wherein the administering occurs at the same time as the obtaining [Hadford Col 3:20-22].
Regarding claim 33, Hadford teaches
The method of claim 30, wherein the peripheral vein is in an arm or a hand of the patient [Hadford Fig. 5].
Regarding claim 34, Hadford teaches
The method of claim 30,further comprising inserting the venous access device into the peripheral vein of the patient, before the obtaining [wherein as depicted in Hadford Fig. 5, the device is already inserted into the peripheral vein of the patient, such that any obtaining that occurs is considered to be after the insertion].
Regarding claim 47, Hadford teaches
The method of claim 30, further comprising transferring fluids into the patient through the venous access device [Hadford Col 4:27-29],
wherein the obtaining occurs at the same time as the transferring [Hadford Col 3:20-22].
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.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadford, as applied to claim 30 above, in view of Sansoucy (US-7211074-B2).
Regarding claim 31, Hadford teaches
The method of claim 30.
However, Hadford fails to explicitly disclose wherein the fluid comprises a medication or an electrolyte.
Sansoucy discloses systems and methods for employing dual lumen peripheral catheters for separate and simultaneous fluid introduction and fluid withdrawal, wherein Sansoucy discloses known applications of such catheters including hemodialysis and administration of fluids including medication and saline [The exemplary embodiments of the catheter apparatus and methods of use disclosed are discussed in terms of medical catheters for the administration of fluids (withdrawal, introduction, etc.) with the body of a subject and more particularly, in terms of a catheter apparatus that facilitates bidirectional fluid flow… It is envisioned that the present disclosure may be employed with a range of catheter applications including surgical, diagnostic and related treatments of diseases, body ailments, etc. of a subject. It is further envisioned that the principles relating to the catheter apparatus disclosed include employment with various catheter related procedures, such as, for example, hemodialysis, cardiac, abdominal, urinary, intestinal, etc., in chronic, acute, etc. applications. It is contemplated that the catheter apparatus can be used for administration of fluids such as, for example, medication, saline, bodily fluids such as, blood, urine, etc. (Sansoucy Col 4:44-62)].
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 the method of Hadford to employ wherein the fluid comprises a medication or an electrolyte, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [MPEP § 2143(I)(D)].
Claim(s) 35-37 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadford, as applied to claim 30, in view of Schulte (US-20100298751-A1).
Regarding claim 35, Hadford teaches
The method of claim 30.
However, while Hadford is generally directed towards methodology for performing dialysis treatments on a patient, Hadford fails to explicitly disclose further comprising performing a blood test with the blood sample obtained from the patient through the venous access device.
Schulte discloses systems and methods for performing dialysis treatments on a patient, wherein Schulte discloses performing a blood glucose test on blood withdrawn from the patient through a venous access device [Measurement of the glucose concentration and/or insulin concentration may take place by means of one or several sensors in the extracorporeal blood circulation. In the case of a dialysis treatment of the patient, it is moreover also possible to perform a measurement on the dialysate side (in addition to further measurements or exclusively), for glucose may pass through the filters that are customary in dialysis treatments (Schulte ¶0020); In a preferred embodiment it is thus proposed to change the concentration of sugar, or glucose, in the dialysate--i.e., the glucose customarily added to a dialysate liquid for the treatment of the patient when composing said dialysate liquid--based on the measured glucose concentration, and particularly based on a measured blood sugar level (Schulte ¶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 the method of Hadford to employ performing a blood test with the blood sample obtained from the patient through the venous access device, so as to facilitate dialysis treatments of the patient.
Regarding claim 36, Hadford in view of Schulte teaches
The method of claim 35, wherein the blood test is a blood glucose test [Schulte ¶¶0020, 0031].
Regarding claim 37, Hadford in view of Schulte teaches
The method of claim 36, wherein the patient has diabetes [Schulte ¶0014].
Regarding claim 44, Hadford in view of Schulte teaches
The method of claim 35, wherein the blood test is selected from the group consisting of a blood glucose test [Schulte ¶0020], an amylase test, an antinuclear antibody (ANA) test, a partial thromboplastin time (PTT) test, an international normalized ration (INR) test, a prothrombin time (PT) test, a hemoglobinA1C test, a basic metabolite panel (BMP),a complete blood count (CBC) test, a comprehensive metabolic panel (OMP), an electrolyte test, an erythrocyte sedimentation rate (ESR) test, a flu test, a human chorionic gonadotropin (hCG) test, an HIV antibody test, a lipid profile, a liver panel, a microalbumin test, a prostate-specific antigen(PSA)test, and a thyroid-stimulating hormone (TSH) test.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadford, as applied to claim 30 above, in view of Sansoucy (US-7211074-B2) and Edgerton (“Long-Term Fate of Patients Discharged to Extended Care Facilities After Cardiovascular Surgery”, NPL attached).
Regarding claim 45, Hadford teaches
The method of claim 30.
However, Hadford fails to explicitly disclose wherein the patient is recovering from cardiac surgery.
Sansoucy discloses systems and methods for employing dual lumen peripheral catheters for separate and simultaneous fluid introduction and fluid withdrawal, wherein Sansoucy discloses known applications of such catheters including surgical and cardiac related applications, as well as administration of fluids including medication and saline [Sansoucy Col 4:44-62].
Edgerton discloses methods for assessing patients for discharge following cardiovascular surgery, wherein Edgerton discloses the use of peripherally inserted central catheter lines for patients following cardiovascular surgery [To obtain consistency in discharge patterns, the hospital has developed printed guidelines outlining the appropriate patient status for transfer to the different facilities from the acute care hospital as well as the care and services provided. [Guidelines: Rehab is for the medically stable patient, focused on regaining pre-illness level of function; SNF is for patients requiring licensed skilled nursing or rehab staff care, daily evaluation, and care for PICC (peripherally inserted central catheter) lines, wound care, speech therapy, intravenous medications; LTAC is for the hemodynamically stable patient with needs too extensive for SNF such as on a ventilator, chest tube, needing renal dialysis, or continuous cardiac monitoring.] (Edgerton p. 871-872)].
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 the method of Hadford to employ wherein the patient is recovering from cardiac surgery, as this modification would amount to mere application of a known technique to a known device (method, or product) with similar expected results [MPEP § 2143(I)(D)].
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hadford, as applied to claim 30 above, in view of Sansoucy (US-7211074-B2) and Kowarski (US-3908657-A).
Regarding claim 46, Hadford teaches
The method of claim 30.
However, Hadford fails to explicitly disclose wherein the obtaining occurs while the patient is sleeping.
Sansoucy discloses systems and methods for employing dual lumen peripheral catheters for separate and simultaneous fluid introduction and fluid withdrawal, wherein Sansoucy discloses known applications of such catheters including diagnostics [Sansoucy Col 4:44-62].
Kowarski discloses systems and methods for continually withdrawing blood from a patient for analysis via a peripheral catheter, wherein Kowarski discloses obtaining blood samples while the patient is asleep [Referring to FIGS. 3, 4 and 5, a peripheral vein 52 in a lower portion of the arm of the subject 50 is selected and the adjacent skin area 54 is sterilized. The needle 14 is then injected into the vein 52 as illustrated in FIG. 3 and the catheter 22 is inserted into the opening 20 of the plastic sleeve 18 (Kowarski Col 4:45-50, Fig. 2); The portability of the system 10 permits normal activity, including sleep, for the subject 50 while the blood is being withdrawn from the subject during the blood-withdrawing period. The blood drawn continuously over the extended period of up to 24 hours by use of the system 10 permits analyzation of the blood with more accurate results than are attainable with methods where the subject is immobilized or where there are numerous, separate blood withdrawals (Kowarski Col 4:18-26)].
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 the method of Hadford to employ wherein the obtaining occurs while the patient is sleeping, as this modification would amount to mere application of a known technique to a known device (method, or product) with similar expected results [MPEP § 2143(I)(D)].
Claim(s) 48, 50, and 52-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sansoucy (US-7211074-B2) in view of Hamatake (US-20060004325-A1, cited by Applicant).
Regarding claim 48 [written in longhand format to include the subject matter of claim 30 therein], Sansoucy teaches
A method of treating a patient, comprising:
administering a fluid to the patient through a venous access device in a peripheral vein of the patient [Arterial lumen 28 is configured for fluid flow, such as, for example, arterial blood flow in a second opposite direction, as shown by arrows B (Sansoucy Col 5:52-54, Fig. 3); It is contemplated that the catheter apparatus can be used for administration of fluids such as, for example, medication, saline, bodily fluids such as, blood, urine, etc. (Sansoucy Col 4:59-62)]; and
obtaining a blood sample from the patient through the venous access device [Venous lumen 26 is configured for fluid flow, such as, for example, venous blood flow, in a first direction, as shown by arrows A (Sansoucy Col 5:50-52, Fig. 3)];
wherein the venous access device comprises:
(a) a hub [tubular body 22 (Sansoucy Fig. 3)], comprising
(i) a bifurcated connecting arm [see Annotated Fig. 1],
(ii) a blood sampling arm, connected to the bifurcated connecting arm [see Annotated Fig. 1],
(iii) a fluid transfer arm, connected to the bifurcated connecting arm [tubular venous adapter 32 (Sansoucy Fig. 3)],
(iv) a blood sampling channel, passing through the blood sampling arm and the bifurcated connecting arm [Arterial lumen 28 is configured for fluid flow, such as, for example, arterial blood flow in a second opposite direction, as shown by arrows B (Sansoucy Col 5:52-54, Fig. 3)], and
(v) a fluid transfer channel, passing through the fluid transfer arm and the bifurcated connecting arm [Venous lumen 26 is configured for fluid flow, such as, for example, venous blood flow, in a first direction, as shown by arrows A (Sansoucy Col 5:50-52, Fig. 3)]; and
(b) a bifurcated cannula, coupled to the bifurcated connecting arm [Venous lumen 26 and arterial lumen 28 are disposed in a substantially parallel orientation adjacent a distal portion 30 of tubular body 22. Distal portion 30 may extend various lengths (Sansoucy Col 6:1-4)], having
(i) a blood sampling lumen, having a blood sampling port [Arterial lumen 28 includes a second lateral port 80 disposed adjacent distal end 24 of tubular body 22. Second lateral port 80 includes an opening 82 that is configured for fluid flow (Sansoucy Col 8:18-21, Fig. 3)],
(ii) a fluid transfer lumen, having a fluid transfer port [Venous lumen 26 includes a first lateral port 54 disposed adjacent distal end 24 of tubular body 22. First lateral port 54 includes an opening 55 that is configured for fluid flow (Sansoucy Col 7:4-6, Fig. 3)], and
(iii) a dividing member, separating the blood sampling lumen from the fluid transfer lumen [Referring to FIGS. 3 8, tubular body 22 defines a first lumen such as, for example, venous lumen 26 and a second lumen such as, for example, arterial lumen 28. Venous lumen 26 and arterial lumen 28 each have a substantially D-shaped or semi-circular configuration. Venous lumen 26 includes an inner surface 27 having a substantially planar portion 27A and a substantially arcuate portion 27B, as shown in FIG. 3A. Arterial lumen 28 includes an inner surface 29 having a substantially planar portion 29A and a substantially arcuate portion 29B (Sansoucy Col 5:34-43, Fig. 3), wherein the material defined on one side by surface portion 27A and on an opposite side by surface portion 29A is considered to read on the claimed dividing member];
the blood sampling channel being fluidly connected to the blood sampling lumen [wherein lumen 28 extending from distal end 24 to tubular arterial adapter 58 and the distal end 24 and tubular arterial adapter 58 being defined as distinct components of the catheter apparatus 20 is considered to read on the claimed limitation (see Sansoucy Fig. 3)],
the fluid transfer channel being fluidly connected to the fluid transfer lumen [wherein lumen 26 extending from distal end 24 to tubular venous adapter 32 and the distal end 24 to tubular venous adapter 32 being defined as distinct components of the catheter apparatus 20 is considered to read on the claimed limitation (see Sansoucy Fig. 3)], and
the bifurcated cannula and the hub being a monolithic component [wherein as depicted in Sansoucy Fig. 3, the tubular body 22 and the distal portion 30 form a single body of the catheter apparatus 20].
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Annotated Fig. 1. The Examiner has annotated Fig. 3 of Sansoucy to identify the portions of tubular body 22 that is considered to define a bifurcated connecting arm and blood sampling arm of the hub [tubular body 22].
However, Sansoucy fails to explicitly disclose wherein the blood sample is not contaminated by the fluid; and the blood sampling port being at least 15 mm proximal from the fluid transfer port.
Hamatake discloses systems and methods employing multi-lumen catheters, wherein Hamatake discloses positioning ports of separate lumens of the multi-lumen catheter such that fluid flow in one lumen is not contaminated by fluid flow in a different lumen, and wherein the ports of the separate lumens are positioned at least 15 mm away from each other [In one aspect of the invention, the catheter comprises three or more lumens with staggered openings at the distal portion of the catheter which exit into the blood stream in intervals of predefined distance(s). Preferably, each of the lumens in the catheter has a separate opening at the distal end so that each of the lumens is in independent fluid communication with the interior of a blood vessel. FIG. 1 illustrates one variation of the catheter 2, with three lumens 4, 6, 8. The openings 12, 14, 16 for the three corresponding lumens 4, 6, 8 are staggered along the length of the catheter 2. The distance between the distal opening 12 and the middle opening 14 is indicated as "L1", and the distance between the middle opening 14 and the proximal opening 16 is indicated as "L2." L1 may be larger, smaller, or equal to L2. Preferably, the staggered distance between the openings (e.g., L1, L2) is between about 0.5 cm to about 10 cm (Hamatake ¶0051, Fig. 1), wherein based on Fig. 1, there is a distance of about 1 cm to about 20 cm from opening 12 to opening 16].
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 the method of Sansoucy to employ wherein the blood sample is not contaminated by the fluid; and the blood sampling port being at least 15 mm proximal from the fluid transfer port, so as to allow for each lumen to be in independent fluid communication with the interior of a blood vessel.
Regarding claim 50, Sansoucy in view of Hamatake teaches
The method of claim 48, wherein the bifurcated cannula is flexible [Semi-rigid and rigid polymerics are contemplated for fabrication, as well as resilient materials, such as molded medical grade polypropylene (Sansoucy Col 5:15-21)].
Regarding claim 52, Sansoucy in view of Hamatake teaches
The method of claim 48, wherein the hub comprises a material selected from the group consisting of polypropylenes [Sansoucy Col 5:15-21], polyethylenes, polycarbonates, and polyamides.
Regarding claim 53, Sansoucy in view of Hamatake teaches
The method of claim 48, wherein the venous access device further comprises a first fitting coupled to the blood sampling arm [Second luer fitting 68 is configured for attachment to arterial blood line 76 (Sansoucy Col 7:48-49, Fig. 4)], and a second fitting coupled to the fluid transfer arm [First luer fitting 42 is configured for attachment to venous blood line 50 (Sansoucy Col 6:35-36, Fig. 4)].
Claim(s) 49 and 54-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sansoucy (US-7211074-B2) in view of Hamatake (US-20060004325-A1, cited by Applicant), as applied to claim 48 above, in further view of Kamath (US-8364231-B2, cited by Applicant).
Regarding claim 49, Sansoucy in view of Hamatake teaches
The method of claim 48, wherein the blood sampling port is 15 mm to 20 mm proximal from the fluid transfer port [see § 103 modification above; Hamatake ¶0051].
However, Sansoucy and Hamatake are non-specific regarding the length and gauge of the bifurcated cannula, such that Sansoucy in view of Hamatake fails to explicitly disclose wherein the bifurcated cannula has a length of 20 to 75 millimeters, and the bifurcated cannula is a 17 to 24 gauge cannula.
Kamath discloses systems and methods employing a catheter inserted into a patient’s blood stream, wherein Kamath discloses known sizes of catheters include lengths of 20-75 mm and gauges of 17-24 G [FIGS. 1A to 1E illustrate one embodiment of an exemplary analyte sensor system 10 for measuring an analyte (e.g., glucose, urea, potassium, pH, proteins, etc.) that includes a catheter 12 configured to be inserted or pre-inserted into a host's blood stream. In clinical settings, catheters are often inserted into hosts to allow direct access to the circulatory system without frequent needle insertion (e.g., venipuncture). Suitable catheters can be sized as is known and appreciated by one skilled in the art, such as but not limited to from about 1 French (0.33 mm) or less to about 30 French (10 mm) or more; and can be, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 French (3 French is equivalent to about 1 mm) and/or from about 33 gauge or less to about 16 gauge or more, for example, 33, 32, 31, 30, 29, 28, 27, 26, 25, 24, 23, 22, 21, 20, 19, 18, 17, or 16 gauge. Additionally, the catheter can be shorter or longer, for example 0.75, 1.0, 1.25, 1.5, 1.75, 2.0 inches in length or longer. In some embodiments, the catheter is a venous catheter (Kamath Col 34:11-28)].
“[W]here 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); MPEP § 2144.05(II).
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) recited in claim 49 is/are somehow ‘critical’ or lead to unexpected results [see ¶38 of Applicant’s Specification].
Regarding claim 54, Sansoucy in view of Hamatake teaches
The method of claim 48.
However, Sansoucy and Hamatake are non-specific regarding the gauge of the bifurcated cannula, such that Sansoucy in view of Hamatake fails to explicitly disclose wherein the bifurcated cannula is a 17, 18, or 19 gauge cannula.
Kamath discloses systems and methods employing a catheter inserted into a patient’s blood stream, wherein Kamath discloses known sizes of catheters include gauges of 17-24 G [Kamath Col 34:11-28].
“[W]here 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); MPEP § 2144.05(II).
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) recited in claim 49 is/are somehow ‘critical’ or lead to unexpected results [see ¶38 of Applicant’s Specification].
Regarding claim 55, Sansoucy in view of Hamatake teaches
The method of claim 48.
However, Sansoucy and Hamatake are non-specific regarding the gauge of the bifurcated cannula, such that Sansoucy in view of Hamatake fails to explicitly disclose wherein the bifurcated cannula is a 20, 21, 22, 23, or 24 gauge cannula.
Kamath discloses systems and methods employing a catheter inserted into a patient’s blood stream, wherein Kamath discloses known sizes of catheters include gauges of 17-24 G [Kamath Col 34:11-28].
“[W]here 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); MPEP § 2144.05(II).
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) recited in claim 49 is/are somehow ‘critical’ or lead to unexpected results [see ¶38 of Applicant’s Specification].
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sansoucy (US-7211074-B2) in view of Hamatake (US-20060004325-A1, cited by Applicant), as applied to claim 48 above, in further view of Borden (US-20070078437-A1, cited by Applicant).
Regarding claim 51, Sansoucy in view of Hamatake teaches
The method of claim 48.
However, while Sansoucy discloses the use of materials suitable for medical application, including polymerics and resilient materials [Sansoucy Col 5:15-21], Sansoucy in view of Hamatake fails to explicitly disclose wherein the bifurcated cannula comprises a material selected from the group consisting of polyurethanes, polyamides, polyether block amides (PEBA), and polytetrafluoroethylenes (PTFE).
Borden discloses systems and methods employing a multi-lumen catheter, wherein Borden discloses that the catheter may comprise polyurethane [Both the multiple lumen catheter tube 12 and the hub 14 may be made from plastic, such as a silicon polymer or polyurethane polymer, but preferably, the multiple lumen catheter tube 12 may be made from an alcohol resistant polyurethane, such as a polycarbonate polyurethane (Borden ¶0042)].
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 the method of Sansoucy in view of Hamatake to employ wherein the bifurcated cannula comprises a material selected from the group consisting of polyurethanes, polyamides, polyether block amides (PEBA), and polytetrafluoroethylenes (PTFE), as this modification would amount to mere simple substitution of one known element for another [materials used to make catheters] with similar expected results [MPEP § 2143(I)(B)].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791