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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2025 has been entered.
Response to Amendment
The examiner notes that claims 6 and 11 are stated to have been withdrawn. However, withdrawn claims should still have their subject matter in written form, as opposed to a canceled claim being completely removed from prosecution. The examiner advises either returning the subject matter of claims 6 and 11 if the intent is for withdrawing the subject matter from further consideration, or changing the status of claims 6 and 11 to canceled.
Response to Arguments
There are new claim objections in view of the amendment.
Applicant’s arguments, see Remarks page 1, filed 11/16/2025, with respect to the 35 USC 112 rejection of claims 1-2, 4-5, 7-9, and 12-20 have been fully considered and are persuasive. The applicant has amended the claims to resolve the 35 USC 112 rejection. The 35 USC 112 rejection of claims 1-2, 4-5, 7-9, and 12-20 has been withdrawn.
Applicant's arguments, see Remarks pages 2-4, filed 11/16/2025, with respect to the 35 USC 103 rejection of claims 1-2, 4-5, 7-9, and 12-20 have been fully considered but they are not persuasive.
In response to the applicant’s argument that the claimed apparatus is structurally and functionally distinct from the prior art references used in the previous office action, the examiner respectfully disagrees. The applicant asserts that the test tube element and heat transfer element are encapsulated together, which allegedly distinguishes the invention from Kieffer. However, the examiner notes that the “exterior shell” [Fig 2 Item 121] discloses in Kieffer is configured to encapsulate [see Fig. 2] the “heat transfer element” [the reagents that create the reaction, Fig. 2 Items 133 and 134, are located within Fig. 2 Item 123 “breakable membrane”] and the “test tube element” [Fig. 1 Item 102].
In response to applicant's argument that the chemical reaction occurs contemporaneously with the extraction of blood, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to the applicant’s argument that the entire apparatus is dimensioned to be mated with a standard blood collection needle holder, which allegedly distinguishes the claimed invention from the combination of Kieffer and Burkholz, the examiner respectfully disagrees. The examiner notes that Burkholz discloses in para. 0047 “The sample container collection device 112 includes a generally cylindrical body 140…”. The examiner notes that the “sample container collection device” being “generally cylindrical” is being interpreted as a non-specific dimension with the purpose of being an appropriate size to “…receive the sample container 138” [Burkholz 0047].
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would be motivated to modify the “generally cylindrical” circumference of the “sample collection device” of Burkholz to accommodate the blood collection system of Kieffer as doing so allows the sample to remain cooled while being connected to the “sample collection device”.
In response to applicant's argument that the claimed invention eliminates delay and error associated with external cooling while maintaining compatibility with standard blood collection hardware so as to enable more accurate diagnostic testing and operational efficiency, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Therefore, for the reasons provided above, the 35 USC 103 rejection of claims 1-2, 4-5, 7-9, and 12-20 is maintained.
Specification
The use of the term “vacutainer”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1, 8, 13, and 17-19 are objected to because of the following informalities:
Claim 1 line 14 should include a hyphen “-“ between “general” and “purpose”;
Claim 8 line 12 should include a hyphen “-“ between “general” and “purpose”;
Claim 13 line 8 should include a hyphen “-“ between “general” and “purpose”;
Claim 17 lines 2-4 (three instances) should include a hyphen “-“ between “general” and “purpose”;
Claim 18 line 4 should include a hyphen “-“ between “general” and “purpose”;
Claim 19 line 6 should include a hyphen “-“ between “general” and “purpose”.
Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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, 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 1-2, 4-5, 8-9, 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kieffer (US 10981173 B1) in view of Burkholz (US 20140309551 A1).
Regarding claim 1, Kieffer teaches a blood collection apparatus comprising:
a test tube element [Fig. 1 Item 102] comprising a vacuum facilitating an extraction of blood from a patient [col. 1 ln. 48], and further comprising a test tube septum [Fig. 2 Item 122];
a heat transfer element [Fig. 2 Item 101] encapsulating the test tube element and storing at least two reagents [Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively] capable of initiating a chemical reaction contemporaneously with the extraction of the blood from the patient [intended use limitation, the release and subsequent reaction of the reagents is possible with the system of Kieffer], the chemical reaction exchanging heat with the blood [col. 4 lns. 46-47, the “contents of the storage chamber” being the tube with the blood sample], the heat transfer element further comprising a fracturable element [Fig. 2 Item 123 “breakable membrane”] that when fractured enables the at least two reagents to initiate the chemical reaction [col. 4 lns. 44-47];
an insulation element [Fig. 2 Item 121] encapsulating the heat transfer element, the insulation element inhibiting a loss of a temperature change of the blood resulting from the chemical reaction initiated by the at least two reagents [col. 3 lns. 54-55, col. 6 lns. 58-61], wherein the insulation element does not interfere with a fracturing of the fracturable element [col. 4 lns. 17-19].
Kieffer teaches a system configured to be mated with a test tube [Fig. 1 Item 102], but fails to wherein the blood collection has a circumference suitable to be mated with a general purpose test tube needle holder.
Burkholz teaches wherein the blood collection has a circumference suitable to be mated with a general purpose test tube needle holder [0047 “The sample container collection device 112 includes a generally cylindrical body 140…”], see also 0060 “The extravascular system 10 may also be used to fill a standard sample container 138 to send to a laboratory for traditional testing”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Kieffer and incorporate the teachings of Burkholz to include wherein the blood collection has a circumference suitable to be mated with a general purpose test tube needle holder.. Doing so configures the system to “…facilitate the entire blood sampling process for clinicians by reducing the number of process steps and reducing the amount of time between sampling and obtaining test results”, as recognized by Burkholz para. 0060 and to modify the “generally cylindrical” circumference of the “sample collection device” of Burkholz to accommodate the blood collection system of Kieffer as doing so allows the sample to remain cooled while being connected to the “sample collection device”.
Regarding claim 2, Kieffer and Burkholz teach the blood collection apparatus of claim 1, wherein the chemical reaction is an endothermic reaction [Kieffer col. 4 lns. 20-23] described by an equation q = mc∆T, wherein "q" is a symbol for heat energy, "m" is a symbol for mass, "c" is a symbol for specific heat, and ∆T is a symbol for change in temperature [an endothermic reaction follows the laws of thermodynamics and thus is defined by the specific heat formula], and wherein the endothermic reaction absorbs heat from the blood [Kieffer col. 2 lns. 64-66].
Regarding claim 4, Kieffer and and Burkholz teach the blood collection apparatus of claim 1, wherein the chemical reaction is an endothermic reaction [Kieffer col. 4 lns. 20-23], and wherein the test tube septum comprises an indicator [Kieffer Fig. 1 Item 113 “marker”] of an endothermic capability of the blood collection apparatus [Kieffer col. 3 lns. 48-51].
Regarding claim 5, Kieffer and Burkholz teach the blood collection apparatus of claim 1, wherein the chemical reaction is an endothermic reaction [Kieffer col. 4 lns. 20-23], and wherein the at least two reagents are water [Kieffer col. 4 lns 31-32] and ammonium nitrate [Kieffer col. 4 lns. 36-37].
Regarding claim 8, Kieffer teaches a blood collection apparatus comprising:
a test tube element [Fig. 1 Item 102] comprising a vacuum facilitating an extraction of blood from a patient [col. 1 ln. 48], and further comprising a test tube septum [Fig. 2 Item 122];
a heat transfer element [Fig. 2 Item 101] encapsulating the test tube element and storing at least two reagents [Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively] capable of initiating a chemical reaction contemporaneously with the extraction of the blood from the patient [intended use limitation, the release and subsequent reaction of the reagents is possible with the system of Kieffer], the chemical reaction exchanging heat with the blood [col. 4 lns. 46-47, the “contents of the storage chamber” being the tube with the blood sample], the heat transfer element further comprising a fracturable element [Fig. 2 Item 123 “breakable membrane”] that when fractured enables the at least two reagents to initiate the chemical reaction [col. 4 lns. 44-47]; and
wherein a perimeter of the heat transfer element includes insulation [Fig. 2 Item 121] inhibiting a loss of a temperature change of the blood resulting from a heat exchange resulting from the chemical reaction [col. 3 lns. 54-55, col. 6 lns. 58-61].
Kieffer teaches a system configured to be mated with a test tube [Fig. 1 Item 102], but fails to wherein the blood collection has a circumference suitable to be mated with a general purpose test tube needle holder.
Burkholz teaches wherein the blood collection has a circumference suitable to be mated with a general purpose test tube needle holder [0047 “The sample container collection device 112 includes a generally cylindrical body 140…”], see also 0060 “The extravascular system 10 may also be used to fill a standard sample container 138 to send to a laboratory for traditional testing”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Kieffer and incorporate the teachings of Burkholz to include wherein the blood collection has a circumference suitable to be mated with a general purpose test tube needle holder.. Doing so configures the system to “…facilitate the entire blood sampling process for clinicians by reducing the number of process steps and reducing the amount of time between sampling and obtaining test results”, as recognized by Burkholz para. 0060 and to modify the “generally cylindrical” circumference of the “sample collection device” of Burkholz to accommodate the blood collection system of Kieffer as doing so allows the sample to remain cooled while being connected to the “sample collection device”.
Regarding claim 9, Kieffer and Burkholz teach the blood collection apparatus of claim 8, wherein the chemical reaction is an endothermic reaction [Kieffer col. 4 lns. 20-23], and wherein the test tube septum comprises an indicator [Kieffer Fig. 1 Item 113 “marker”] of an endothermic capability of the blood collection apparatus [Kieffer col. 3 lns. 48-51].
Regarding claim 13, Kieffer teaches a blood collection apparatus comprising:
a test tube element [Fig. 1 Item 102] comprising a vacuum facilitating an extraction of blood from a patient [col. 1 ln. 48], and further comprising a test tube septum [Fig. 2 Item 122];
a heat transfer element [Fig. 2 Item 101] encapsulating the test tube element and capable of initiating a heat transfer process contemporaneously with the extraction of the blood from the patient [intended use limitation, the release and subsequent reaction of the reagents is possible with the system of Kieffer].
Kieffer teaches a system configured to be mated with a test tube [Fig. 1 Item 102], but fails to wherein the blood collection has a circumference suitable to be mated with a general purpose test tube needle holder.
Burkholz teaches wherein the blood collection has a circumference suitable to be mated with a general purpose test tube needle holder [0047 “The sample container collection device 112 includes a generally cylindrical body 140…”], see also 0060 “The extravascular system 10 may also be used to fill a standard sample container 138 to send to a laboratory for traditional testing”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Kieffer and incorporate the teachings of Burkholz to include wherein the blood collection has a circumference suitable to be mated with a general purpose test tube needle holder.. Doing so configures the system to “…facilitate the entire blood sampling process for clinicians by reducing the number of process steps and reducing the amount of time between sampling and obtaining test results”, as recognized by Burkholz para. 0060 and to modify the “generally cylindrical” circumference of the “sample collection device” of Burkholz to accommodate the blood collection system of Kieffer as doing so allows the sample to remain cooled while being connected to the “sample collection device”.
Regarding claim 14, Kieffer and Burkholz teach the blood collection apparatus of claim 13, wherein the heat transfer element encapsulating the test tube element stores a heat transfer agent [Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively] for initiating the heat transfer process [col. 2 lns. 54-55] contemporaneously with the extraction of the blood from the patient [intended use limitation, the release and subsequent reaction of the reagents is possible with the system of Kieffer].
Regarding claim 15, Kieffer and Burkholz teach the blood collection apparatus of claim 13, wherein a perimeter of the heat transfer element includes insulation [Fig. 2 Item 121] inhibiting a loss of a temperature change of the blood resulting from the heat transfer process [col. 3 lns. 54-55, col. 6 lns. 58-61].
Regarding claim 16, Kieffer and Burkholz teach the blood collection apparatus of claim 13, further comprising an insulation element [Fig. 2 Item 121] encapsulating the heat transfer element [Fig. 2 Item 101], the insulation element inhibiting a loss of a temperature change of the blood resulting from the heat transfer process [col. 3 lns. 54-55, col. 6 lns. 58-61]; and
wherein the heat transfer element [Fig. 2 Item 101] encapsulating the test tube element comprises a heat transfer agent [Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively] for initiating the heat transfer process contemporaneously with the extraction of the blood from the patient [intended use limitation, the release and subsequent reaction of the reagents is possible with the system of Kieffer].
Regarding claim 17, Kieffer and Burkholz teach the blood collection apparatus of claim 13, wherein the blood collection apparatus further comprises a circumference suitable to be mated with a general purpose device selected from the group consisting of a general purpose test tube needle holder [Fig. 1 Item 112, 0060 “The extravascular system 10 may also be used to fill a standard sample container 138 to send to a laboratory for traditional testing”] and a general purpose syringe.
Regarding claim 18, Kieffer and Burkholz teach the blood collection apparatus of claim 13, wherein the heat transfer element [Fig. 2 Item 101] encapsulating the test tube element [Fig. 1 Item 102] stores a heat transfer agent [Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively] for initiating the heat transfer process [col. 2 lns. 54-55] contemporaneously with the extraction of the blood from the patient [intended use limitation, the release and subsequent reaction of the reagents is possible with the system of Kieffer]; and
wherein the test tube element [Fig. 1 Item 102] is a general purpose test tube removable from the heat transfer element contemporaneously with an initiation of a blood test [intended use, the system of Kieffer teaches the “test tube element” Item 102 “inserts into the endothermic sleeve” which comprises the insulation element Item 121 and is capable of being removed].
Claims 7, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kieffer and Burkholz as applied to claim 1, 8, and 13 above, and further in view of Rajagopal (US 20120009588 A1).
Regarding claim 7, Kieffer and Burkholz teach the blood collection apparatus of claim 1, wherein the heat transfer element further comprises storing at least one of the at least two reagents [Kieffer Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively].
Kieffer and Burkholz fail to teach an ampoule stores the reagents.
Rajagopal teaches an ampoule stores the reagents [0094 “…liquid reagents (optionally, in a frangible compartment, such as an ampoule)…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Kieffer and Burkholz and incorporate the teachings of Rajagopal to include an ampoule stores the reagents. Doing so is a simple substitution of one known element for another to obtain predictable results.
Regarding claim 12, Kieffer and Burkholz teach the blood collection apparatus of claim 8, wherein the heat transfer element further comprises storing at least one of the at least two reagents [Kieffer Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively].
Kieffer and Burkholz fail to teach an ampoule stores the reagents.
Rajagopal teaches an ampoule stores the reagents [0094 “…liquid reagents (optionally, in a frangible compartment, such as an ampoule)…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Kieffer and Burkholz and incorporate the teachings of Rajagopal to include an ampoule stores the reagents. Doing so is a simple substitution of one known element for another to obtain predictable results.
Regarding claim 19, Kieffer and Burkholz teach the blood collection apparatus of claim 13, wherein the heat transfer element encapsulating the test tube element stores at least two reagents capable of initiating an endothermic reaction [Kieffer Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively] contemporaneously with the extraction of the blood from the patient [intended use limitation, the release and subsequent reaction of the reagents is possible with the system of Kieffer], the endothermic reaction absorbing heat from the blood [Kieffer col. 2 lns. 64-66]; and
wherein the test tube element [Kieffer Fig. 1 Item 102] is a general purpose test tube [Burkholz 0060 “standard sample container”] removable from the heat transfer element contemporaneously with an initiation of a blood test [intended use, the system of Kieffer teaches the “test tube element” Item 102 “inserts into the endothermic sleeve” which comprises the insulation element Item 121 and is capable of being removed].
Kieffer and Burkholz teach the heat transfer element contains two reageants [Kieffer Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively], but fail to teach an ampoule stores the reagents.
Rajagopal teaches an ampoule stores the reagents [0094 “…liquid reagents (optionally, in a frangible compartment, such as an ampoule)…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Kieffer and Burkholz and incorporate the teachings of Rajagopal to include an ampoule stores the reagents. Doing so is a simple substitution of one known element for another to obtain predictable results.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kieffer and Burkholz as applied to claim 8 above, and further in view of Iwaki (US 20030186457 A1).
Regarding claim 20, Kieffer and Burkholz teach the blood collection apparatus of claim 13, wherein the heat transfer element [Kieffer Fig. 2 Item 101] encapsulating the test tube element stores at least two reagents [Kieffer Fig. 2 Items 133 and 134, water and ammonium nitrate, respectively] capable of initiating a reaction contemporaneously with the extraction of the blood from the patient [intended use limitation, the release and subsequent reaction of the reagents is possible with the system of Kieffer], but fails to teach the reagents are capable of initiating an exothermic reaction, the exothermic reaction releasing heat to the blood.
Iwaki teaches the reagents [0045 “Preferable examples of the substances capable of generating heat in the presence of water include an alumino-silicate, such as zeolite; slaked lime; and a mixture of iron powder and an oxidizing agent”] are capable of initiating an exothermic reaction [0045 “…generating heat…”], the exothermic reaction releasing heat to the blood [0045 “…the blood testing unit in accordance with the present invention should preferably be modified such that the region for spreading the blood plasma and/or the blood serum, which region constitutes the reagent layer, contains a substance capable of generating heat in the presence of water”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Kieffer and Burkholz and incorporate the teachings of Iwaki to include the reagents are capable of initiating an exothermic reaction, the exothermic reaction releasing heat to the blood. Doing so configures the system so that the ”…time required for the blood testing unit to reach the predetermined temperature in the incubator is capable of being kept short, and therefore the blood test is capable of being performed with a high efficiency”, as recognized by Iwaki para. 0136.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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/JONATHAN M HANEY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791