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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Parent Application 10 2022 114 101.2, filed in Germany on 03 June 2022 has been received.
Claim Objections
The claims contain minor informalities.
In claim 13, the language “… wherein a clamp is located in the second tube section, which is initially closed, and which can be opened and then [[closes]] closed again reversibly or irreversibly.” should be revised for clarity.
Claim Rejections - 35 USC § 112(b)
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 5-7, 9, 11, 12, 14 and 15 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 pre-AIA the applicant regards as the invention.
Claim 5 recites “… wherein the predonation bag has a volume of 10 to 50 mL, in particular 25 to 35 mL.”
This language includes a narrow numerical range that falls within a broader range in the same claim, and renders the claim indefinite since the boundaries of the claim are not discernible. If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim. See MPEP 2173.05(c).
Claim 6 recites “… such that a concentration in the whole blood of the predonation bag of greater than or equal to 1.2 mg/mL, and preferably 1.4 to 1.8 mg/mL is obtained.”
This language includes a narrow numerical range that falls within a broader range in the same claim, and renders the claim indefinite.
Claim 7 calls for “…wherein the first anticoagulant is introduced as a pill or tablet into the predonation bag or the sealable first tube section, in particular in a pill chamber.” This language is ambiguous because the term “in particular” does not clearly specify whether both a tube section and pill chamber are included in the claim scope, or whether only the pill chamber is included.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d).
Claim 9 calls for “…wherein the sealable first tube section has an initially open and later sealable closure, in particular later irreversibly closeable.” This language is ambiguous because the term “in particular” does not clearly specify whether the sealable closure must be irreversibly closeable, or whether other closures are included in the claim scope.
Claim 11 calls for “…wherein the first anticoagulant is preferably arranged exclusively in the sealable first tube section behind the closure and/or exclusively in the predonation bag.” This language is ambiguous because the term “preferably” does not clearly specify whether the first anticoagulant may be located in the first tube section, or must be located only in the predonation bag.
Claim 12 calls for “… for opening and closing again and, optionally, reopening the inflow into the whole blood bag.” The claim does not provide sufficient antecedent basis for this limitation. Examiner suggests to rephrase this feature in terms of closing and reopening fluid communication into the whole blood bag.
Claim 14 calls for “…into one or more sample containers, preferably automatically, and the sample container is supplied to …” This language is ambiguous because the term “preferably” does not clearly specify whether the one or more sample containers must be filled automatically, or whether they may be filled with non-automatic techniques.
Claim 15 calls for “…by means of the entry in the database and preferably sample containers of different donors …” This language is ambiguous because the term “preferably” does not clearly specify whether different donors’ containers must be included, or whether the claim also operates for only a single donor.
Claim 15 calls for determining a number of sample containers per predonation bag. This claim should be rephrased to clearly express guidelines for calculating the number of sample containers (¶ [0022], [0026], [0048]). Examiner suggests to rephrase this claim to clarify that the sample container count depends on how many tests are required for the blood sample.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-6 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mathias, Jean-Marie et al. (US 20050148993 A1) in view of Delorme; Bruno et al. (US 20150306288 A1) in view of Walenciak, Matthew et al. (US 20040043505 A1).
Regarding claim 1, Mathias discloses a blood bag system (¶ [0015], , [0018], [0040] Turning now to FIG. 1 … a disposable processing set 10);
comprising a predonation bag system (¶ [0046], FIG. 1, sampling system 18); and
at least one whole blood bag (¶ [0041] The blood processing set 10 may include a single blood collection container 16 or, more preferably, as shown in FIG. 1, may be a multiple blood container system including additional containers 20 and 24);
wherein the predonation bag system comprises at least: a predonation bag (¶ [0046], FIG. 3, sampling system 18 may include a container 42; ¶ [0050] Sampling system 18 may further include a receptacle or holder 68 as shown in FIG. 3);
a venipuncture adapter (¶ [0040], venipuncture needle 12); and
a blood collection line with a) a first tube section which is sealable with respect to the blood collection line as a feed from the blood collection line into the predonation bag (¶ [0049] As further shown in FIG. 3, sampling device 18 may include tubing segment 62 attached to container 42 at inlet port 46); and
b) a second tube section as a feed from the blood collection line into the whole blood bag (¶ [0042], integrally attached donor tubings 14 and 15; ¶ [0049], tubing segment 15);
wherein the predonation bag or the sealable first tube section comprises an adapter for filling of one or more sample containers (¶ [0050] Sampling system 18 may further include a receptacle or holder 68 as shown in FIG. 3. As will be described in more detailed below, holder 68 is adapted to receive a blood sampling tube 70; ¶ [0052] Holder 68 may include a piercing member 74 as generally shown in FIG. 3 (or FIG. 4)); and
wherein in the whole blood bag a second anticoagulant is contained which is not EDTA and is CPD, CPDA1 and/or CP2D (¶ [0042], Container 16 typically includes a suitable anticoagulant such as citrate phosphate dextrose (CPD), citrate phosphate dextrose adenine (CPDA) or acid citrate dextrose (ACD)).
Mathias teaches the invention substantially as claimed by Applicant except for a first anticoagulant in the predonation bag and/or the sealable first tube section. Delorme discloses a method and system of bags for preserving whole placental blood (¶ [0001], [0016], [0037], [0121]);
comprising a predonation bag system (¶ [0128], secondary bag 8); and
at least one whole blood bag (¶ [0122] a placental blood collection bag 1);
wherein the predonation bag system comprises at least: a predonation bag (¶ [0128], secondary bag 8); and
a blood collection line with a) a first tube section; and b) a second tube section (Figs. 1 and 3 show tubes connecting the placental blood collection bag 1 and secondary bag 8);
wherein the predonation bag or the first tube section or both comprises/comprise a first anticoagulant for whole blood (¶ [0128] Advantageously, the system of bags comprises a secondary bag 8 containing an anticoagulant solution that may be different or identical to that of the collection bag 1);
wherein in the whole blood bag a second anticoagulant is contained which is different from the first anticoagulant and which is not EDTA and is CPD, CPDA1 and/or CP2D (¶ [0127] In FIGS. 1 and 3, the collection bag 1 contains a CPD or ACD type anticoagulant solution in order to avoid coagulation of the collected placental blood).
Delorme demonstrates that a blood sample may be preserved with more than one type of anticoagulant. One would be motivated to modify Mathias by providing both first and second anticoagulants as taught by Delorme to preserve blood in both the whole blood bag and also in the predonation bag. Therefore, it would have been obvious to modify Mathias with Delorme’s pair of anticoagulants in order to preserve blood in both of Mathias’s bags.
Mathias and Delorme do not explicitly disclose EDTA as a first anticoagulant in a predonation bag. Walenciak discloses a method and device for collecting and stabilizing a biological sample (¶ [0002], [0012], [0023], [0026] Referring to FIG. 1 … a sample collection device 10);
wherein a first anticoagulant for whole blood is EDTA (¶ [0026] Referring to FIG. 1, the apparatus of the present invention includes a sample collection device 10, which is provided with a stoppered-container 12 and which includes about 5.6 to about 37.5 mM, preferably about 5.6 to about 10.1 mM, EDTA 14. FIG. 1 shows the EDTA in solution; however, the EDTA may also be present in solid form).
Walenciak selects a commonly available anticoagulant for a blood sample. One would be motivated to modify Mathias and Delorme with Walenciak’s EDTA since both Mathias and Delorme list multiple anticoagulants (Mathias ¶ [0042]; Delorme ¶ [0070], [0127]). Therefore, it would have been obvious to modify Mathias and Delorme with Walenciak’s EDTA in order to use another commonly known anticoagulant.
Regarding claims 2 and 3, Mathias and Delorme lack K2-EDTA or K3-EDTA. Walenciak discloses a system wherein the first anticoagulant is K2-EDTA or K3-EDTA or both (¶ [0009], EDTA ratios (mg EDTA/ml of blood) specified in the NCCLS publication are: (1) disodium EDTA dehydrate (Na.sub.2EDTA-2H.sub.2O) 1.4 to 2.0 mg/ml; (2) dipostassium EDTA dehydrate (K.sub.2EDTA-2H.sub.2O) 1.5 to 2.2 mg/ml; and (3) tripotassium EDTA anhydrous (K.sub.3EDTA) 1.5 to 2.2 mg/ml);
3. Blood bag system according to claim 1, wherein the first anticoagulant b) is applied as a solid to the inner surface of a predonation container (¶ [0016], The pre-filled EDTA can be in solution or in a dry form. Current collection containers include glass or plastic tubes with EDTA in solution or with EDTA spray-dried to a portion of the container).
Walenciak selects commonly known anticoagulant formulas and formulations for preserving a blood sample. One would be motivated to modify Mathias and Delorme with Walenciak’s K2-EDTA or K3-EDTA since these represent specific sub-types of EDTA. Therefore, it would have been obvious to modify Mathias and Delorme with Walenciak’s K2-EDTA or K3-EDTA in order to select known, specific EDTA formulas.
Regarding claim 4, Mathias does not explicitly disclose a first anticoagulant. Delorme discloses that the first anticoagulant is introduced into the predonation bag dissolved in water (¶ [0070] For example, the anticoagulant solution may be an acid citrate dextrose solution (ACD) or a citrate phosphate dextrose (CPD) solution).
Delorme formulates a first anticoagulant according to standard formulas. Regarding the rationale and motivation to modify Mathias with Delorme’s first anticoagulant, see the discussion of claim 1 above.
Regarding claims 5, 8-10, 12 and 13, Mathias discloses a blood bag system wherein the predonation bag has a volume of 10 to 50 mL, in particular 25 to 35 mL (¶ [0048], In one embodiment, interior chamber 54 of container 42 may have a volume of approximately 20-100 ml and, more preferably, approximately 30-70 ml and, in some countries, a minimum volume of approximately 50 ml);
wherein the sealable first tube section and the predonation bag are formed as a dead end (Fig. 1, container 42 forms a fluidic dead-end that captures a blood sample);
wherein the sealable first tube section has an initially open and later sealable closure, in particular later irreversibly closeable (¶ [0049], In one embodiment, clamp 65 on tubing segment 62 may be a substantially irreversibly closeable clamp of the type described in WO 03/063945, which is incorporated herein by reference);
wherein the first tube section has a break-off part with a predetermined breaking point inside the first tube section, which is mechanically broken off and thereby releases the flow into the predonation bag via the sealable first tube section and/or wherein the second tube section has a break-off part with a predetermined breaking point inside the second tube section, which is mechanically broken off and thereby releases the flow into the whole blood bag via the first tube section (¶ [0049], Tubing segments 62 may further include an openable barrier 64 such as a frangible cannula or connector of the type described in U.S. Pat. No. 5,330,464 … incorporated by reference herein);
wherein a reversible clamp is located in the second tube section for opening and closing again and, optionally, reopening the inflow into the whole blood bag; wherein a clamp is located in the second tube section, which is initially closed, can be opened and then closes again reversibly or irreversibly (¶ [0049], Roberts-type clamps 65 and 66 (FIG. 1), on tubing segment 62 and tubing segment 15 may also be provided; ¶ [0054], disposable processing set 10 may be provided with clamps 65 and 66 in a closed position, as shown in FIG. 5A; ¶ [0055], After isolation by seal 67, clamp 65 is closed and the clamp 66 is opened to allow blood flow into container 16 as shown in FIG. 5C).
Regarding claim 11, Mathias discloses that the sealable first tube section comprises a sealable closure (¶ [0049], Roberts-type clamps 65 and 66 (FIG. 1), on tubing segment 62 and tubing segment 15 may also be provided).
Mathias does not explicitly disclose a first anticoagulant. Delorme discloses a first anticoagulant (¶ [0128] Advantageously, the system of bags comprises a secondary bag 8 containing an anticoagulant solution that may be different or identical to that of the collection bag 1).
Regarding the rationale and motivation to modify Mathias with Delorme’s first anticoagulant, see the discussion of claim 1 above.
This rejection modifies Mathias by arranging Delorme’s first anticoagulant in Mathias’s sample container 42. This locates the first anticoagulant in the predonation bag and behind the closure.
Regarding claim 6, Mathias, Delorme and Walenciak are silent whether a concentration in the whole blood of the predonation bag of greater than or equal to 1.2 mg/mL, and preferably 1.4 to 1.8 mg/mL is obtained.
The post-mixing anticoagulant concentration is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The post-mixing anticoagulant concentration determines whether the blood sample will coagulate and whether it will remain viable for later testing through routine experimentation.
Too low
The blood sample will coagulate and become unsuitable for later testing
Optimized range
The blood sample will avoid coagulating and also remain suitable for testing
Too high
The blood sample will contain an excessive amount of anticoagulant which will interfere with later tests
A skilled artisan would have been able to optimize the post-mixing anticoagulant concentration by measuring Mathias’s predonation bag volume, and then adjusting the amount of anticoagulant until a suitable concentration is achieved. For example, Mathias specifies a volume range for the predonation bag (¶ [0048], In one embodiment, interior chamber 54 of container 42 may have a volume of approximately 20-100 ml).
Therefore, it would have been obvious to adjust the post-mixing anticoagulant concentration in order to prevent coagulation while minimizing interference with tests. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 14, Mathias discloses a method for collecting whole blood wherein the whole blood provided with first anticoagulant or a part thereof from the predonation bag after transportation to a laboratory is filled by means of the adapter into one or more sample containers, preferably automatically, and the sample container is supplied to an analysis or the sample containers are each supplied to different analyses (¶ [0007] After collection but prior to transfusion to a patient, the blood is typically tested for determining blood type and the presence of pathogens such as virus, bacteria and/or other foreign substances in the donor's blood).
Regarding the sample container being supplied to an analysis, Mathias tests for blood type and pathogens (¶ [0007]). Mathias does not explicitly fill the container automatically. However, this claim is rejected under 112(b) for ambiguity as discussed above.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mathias, Delorme and Walenciak in view of Goch; Thomas A. et al. (US 4653511 A).
Regarding claim 7, Mathias, Delorme and Walenciak lack a pill and pill chamber. Goch discloses a microsample device for blood sample collection (col. 1, lines 55-60; col. 2, lines 35-40, device 10);
wherein a first anticoagulant is introduced as a pill or tablet into a first tube section, in particular in a pill chamber (col. 3, lines 1-5, Located within mixing chamber 14 is a supply of a solid soluble anticoagulant 29 in an amount sufficient to prevent coagulation of the blood sample collected by the device. Anticoagulant 29 can be any material having anticoagulating properties and which is readily soluble in blood).
Goch rapidly mixes a solute by generating turbulent motion (col. 3, lines 45-50, The restricted bore diameter of inlet conduit 18 causes the blood to enter mixing chamber 14 in the form of a jet which creates a swirling action within zone 23, further insuring the rapid dissolution of the anticoagulant contained therein). One would be motivated to modify Mathias, Delorme and Walenciak with Goch’s pill and pill chamber to store anticoagulant in a dry form and later reconstitute it reliably. Therefore, it would have been obvious to modify Mathias, Delorme and Walenciak with Goch’s pill and pill chamber in order to reliably store and reconstitute an anticoagulant.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mathias, Delorme and Walenciak in view of Pedrazzini; Gianandrea (US 20110145006 A1).
Regarding claim 15, Mathias, Delorme and Walenciak are silent whether a number of sample containers per predonation bag is determined as a function of the donor and a comparison with an entry in a database. Pedrazzini discloses an apparatus described for identifying a patient and marking laboratory test tubes (¶ [0001], [0020], [0048], [0051] The apparatus of FIG. 1 also comprises a personal computer 4 … and an automatic or semi-automatic labelling unit 5);
wherein a number of sample containers is determined as a function of the donor and a comparison with an entry in a database for the donor and the sample containers and their number are labeled (¶ [0029] obtaining the list of test tubes needed to sample the biological material; ¶ [0052] Said labelling unit 5 comprises a rolled tape 6 bearing labels 7 (FIG. 9), a bar-code printer 8 (FIG. 10); ¶ [ 0076] The printer 8 produces a label with bar code containing the information needed to identify the sample of biological material, and provide a number of details useful to the operators, such as, for example, the person to which the sample belongs (patient), the tests to be performed and the physical characteristics of the test tube identified by the apparatus before the labelling phase; ¶ [0077] The label supplied by the labelling unit is affixed to the test tube by rotating this on its own axis);
with regard to the tests selected by means of the entry in the database (¶ [0049], The personal details are also contained in a database 3 of the laboratory; ¶ [0051] The apparatus of FIG. 1 also comprises a personal computer 4 with monitor (preferably a touch-screen) 30 and Internet link to the database 3 of the laboratory; ¶ [0063], The application interrogates the database 3 of the laboratory to extract the list of tests to be performed (entered in the database 3 during the check-in phase) which are associated with the patient); and
preferably sample containers of different donors (¶ [0018], it must be stressed that a laboratory, albeit of average size, receives hundred (or thousands) of test tubes to be examined every day; ¶ [0063] In other words, the system, after ascertaining the correct identification of the patient by using the smart card 1 provides the application with the patient's personal details; ¶ [0076] The printer 8 produces a label with bar code containing the information needed to identify the sample of biological material, and provide a number of details useful to the operators, such as, for example, the person to which the sample belongs (patient); ¶ [0078] The indicated steps are repeated until all the envisaged test tubes have been filled).
Pedrazzini automatically generates and prints labels for sample tubes, while preventing mismatches between patients (¶ [0015], it is understandable how a lot of errors can occur due to so-called "mismatching", meaning the switch-over of test tubes and/or analytical results (reports) belonging to different patients; ¶ [0019], to overcome the problems indicated above). A skilled artisan would have been able to modify Mathias, Delorme and Walenciak with Pedrazzini’s sample container formula and database by printing labels for Mathias’s sample containers with Pedrazzini’s label printer. In this way, each donor will be assigned only one blood bag system. One would be motivated to modify Mathias, Delorme and Walenciak with Pedrazzini’s sample container formula and database since Mathias calls for filling vacutainers and testing their contents (¶ [0007] After collection but prior to transfusion to a patient, the blood is typically tested for determining blood type and the presence of pathogens such as virus, bacteria and/or other foreign substances in the donor's blood; ¶ [0053] During a collection procedure, a sampling tube 70, as shown in FIG. 3, may be inserted into the interior of holder 68; ¶ [0056] In any event, once sampling system 18 has been isolated from the remainder of the blood processing set 10, blood collected in sample container 42 may be transferred to a sampling tube 70 as shown in FIG. 5D). Therefore, it would have been obvious to modify Mathias, Delorme and Walenciak with Pedrazzini’s sample container formula and database in order to print labels for sample containers.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights