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 .
Claims 1-20 are pending and have been considered on the merits herein.
Claim Interpretation
The claims are drawn to methods (for determining a patient’s likelihood of experiencing a thromboembolic event when receiving an implantable blood contacting medical device) comprising exposing blood samples to metal, metal alloy or ceramic, specifically titanium or zirconia, measuring a thromboembolic marker and determining that if the marker is higher than a threshold, one can determine that the patient is likely to experience a thromboembolic event when receiving an implantable blood contacting medical device. Neither the Specification or the claims disclose the threshold, thus, the threshold is interpreted to be any amount. Further, the Specification does not disclose a particular thromboembolic event and thus, under a broadest reasonable interpretation the term is given its plain meaning by those of ordinary skill in the art and is therefore interpreted to be the formation of a blood clots (thrombi). Thus, for examination purposes, the claimed invention is interpreted as, when a thromboembolic marker in blood, for example TAT complex, is higher than a baseline/threshold when exposed to metal, it is determined that the patient is likely to experience a thromboembolic event.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities: the second recitations of “agitating the sample of blood” and “agitating each sample of the plurality of sample of blood”, respectively, are redundant. It is suggested that applicant amend the claims as followed “The method of claim 1, wherein agitating the sample of blood is performed on a roller…or wherein the sample is agitated on a roller…” Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim1-14, 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) method for determining the likelihood of experiencing a thromboembolic event comprising exposing a blood sample to metal, metal alloy or ceramic, measuring a thromboembolic marker in the sample and determining the marker to be higher than a threshold and based upon said determining, determining the patient is likely to experience a thromboembolic event. The claimed invention is directed to a naturally occurring correlation between the marker level and determining the likelihood of a thromboembolic event, i.e., a law of nature or natural phenomenon with an abstract idea which are themselves the judicial exception. The method sets forth a judicial exception, because this type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo. The correlation is based upon levels of the naturally occurring markers in the blood and therefore includes a natural principle which exists in principle apart from any human action and thus simply describes a relation set forth by a natural law and the likelihood of an event. Additionally, the determining steps could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Thus, the claim is directed to at least one exception (Step 2A: YES), which may be termed a law of nature, an abstract idea, or both.
The detected level does nothing more than inform the audience about the law of nature. Additionally, the steps of determining can be performed by a human using mental steps or critical thinking, which are themselves abstract ideas. This judicial exception is not integrated into a practical application because the claims do nothing more than inform the audience of the law of nature and does not require any particular application other than to “apply it”. The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." Essentially, appending conventional steps such as assaying a sample and c) determining, specified at a high level of generality, i.e., determining levels of markers, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because step of determining a patient has a likelihood of experiencing a thromboembolic event based upon the measured marker levels does not require any particular application other than “apply it” to the judicial exception. Mere instruction to apply an exception cannot provide an inventive concept. Assaying levels of markers in a bodily fluid from a patient is routine and conventional in art (see Thor and Cattaneo below). As claimed, one merely determines whether a marker in the sample is above a threshold value, which is not defined. Determining the level of markers in the sample merely instructs scientists to use a well-known detecting technique at a high level of generality and therefore there is no meaningful limitation which is unconventional to detect the marker. The steps of determining levels in a sample having a threshold value and determining based upon said value does nothing more than instruct to “apply the natural law”. In order to integrate the exception into a practical application, one must add additional elements in which the judicial exception.
Next, one must evaluate whether the claims as a whole integrate the judicial exception into a practical application, thereby imposing a meaningful limit on the judicial exception. Thus, one must identify whether there are any additional elements recited in the claim beyond the judicial exception. The Supreme Court’s decisions make it clear that judicial exceptions need not be old or long-prevalent, and that even newly discovered or novel judicial exceptions are still exceptions. For example, the mathematical formula in Flook, the laws of nature in Mayo, and the isolated DNA in Myriad were all novel or newly discovered, but nonetheless were considered by the Supreme Court to be judicial exceptions because they were "‘basic tools of scientific and technological work’ that lie beyond the domain of patent protection." Myriad, 569 U.S. 576, 589, 106 USPQ2d at 1976, 1978 (noting that Myriad discovered the BRCA1 and BRCA1 genes and quoting Mayo, 566 U.S. 71, 101 USPQ2d at 1965); Flook, 437 U.S. at 591-92, 198 USPQ2d at 198 ("the novelty of the mathematical algorithm is not a determining factor at all"); Mayo, 566 U.S. 73-74, 78, 101 USPQ2d 1966, 1968 (noting that the claims embody the researcher's discoveries of laws of nature). The Supreme Court’s cited rationale for considering even "just discovered" judicial exceptions as exceptions stems from the concern that "without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and thereby ‘inhibit future innovation premised upon them.’" Myriad, 569 U.S. at 589, 106 USPQ2d at 1978-79 (quoting Mayo, 566 U.S. at 86, 101 USPQ2d at 1971). See also Myriad, 569 U.S. at 591, 106 USPQ2d at 1979 ("Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.").
Besides the law of nature, the claim recites additional steps of exposing a blood sample to metal, agitating the sample and measuring a marker in said sample. Exposing the blood to metal does not change the blood sample to a different state or thing according to MPEP 2106.05(c).
Obtaining a sample in order to perform tests is well-understood, routine and conventional activity for those in the field of diagnostics. Further, the step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., a mere data gathering step necessary to use the correlation. Detecting a marker level in the blood sample merely instructs a scientist to use any detection technique and when recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in this step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed, e.g., the routine and conventional techniques of measuring a marker. Further, it is well established that the mere physical or tangible nature of additional elements does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)). Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not invoke any of the considerations that courts have identified as providing significantly more than an exception. Even when viewed as a combination, the additional elements fail to transform the exception into a patent eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself (Step 2B: NO).
In this case, the claims to do not integrate the exception because it does not rely on, use or act on the judicial exception, i.e., the claim does not do anything after arriving at the relevant information, for example a treatment step. Thus, there is not practical application beyond the judicial exception.
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 1-14, 18-20 is/are determined to be directed to a judicial exception.
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, 9, 10, 11, 19, 20 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.
The claims fail to establish a connection between the implantable device/pump and the metal, metal alloy or ceramic tested. It is not clear how the exposure to metal and measuring of a marker correlate specifically to the implantable medical device. Is the device made of the metal tested or is the metal representative of the device? Further regarding claims 9 and 10, the claims to not particularly point out if the markers of the first and second sample are the same and how the comparison between a first and second marker allow one to determine the likelihood of experiencing a thromboembolic event. For example, how does one make the comparison between the markers (what is the comparison) and what makes the comparison indicative or not indicative of an event, i.e. does the marker in the second sample have to be higher than the first marker to be indicative, how do the measured markers correlate with each other to allow one to make the determination of the likelihood of an event? Additionally, how does the measured marker of the metal correlate to the measured marker from blood in fluid communication with the device?
For examination purposes and when given its broadest reasonable interpretation consistent with the specification, the connection of the metal to the device/pump is interpreted as the implantable medical device/pump would comprise a metal, metal alloy or ceramic tested and thus is representative of a device, and a marker concentration higher than any threshold is indicative of a thromboembolic event.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 requires the container to be a test tube, however claim 15 already claims a test tube container. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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) 1-5, 7, 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thor et al. (Biomaterials, vol. 28, p. 966-974, 2007).
Regarding claim 1, Thor teaches a method for determining a thrombotic response comprising exposing a blood sample from a patient to titanium, i.e. a metal, in a container, agitating on a rotator, and measuring the generation of the thrombin-antithrombin (TAT) complex, i.e. a thromboembolic marker. Thor find that whole blood samples in contact with the titanium showed a 1000-fold increase in the TAT complex (abstract). Thor teaches that blood in contact with titanium and titanium alloy surfaces triggers the coagulation cascade thereby having a thrombogenic effect as well as platelet activation (p. 971, 1st , 3rd-6th parag., p. 972, 2nd col., 1st full parag.). Titanium is used for surgical implants and it shown to be more thrombogenic than other biomaterials used for medical implants (introduction).
Regarding claim 2, Thor teaches using 1.5 mL of blood for tests (p. 968, section 2.5).
Regarding claims 3 and 4, the blood is agitated by rotating for a predetermined period of time, i.e. 60 min.
Regarding claim 5, the blood is extracted before receiving an implantable medical device (p. 968, section 2.4).
Regarding claim 7, blood is taken from 4 volunteers and TAT complex is measured before exposure to titanium and after exposure to titanium (Fig. 1). The reference teaches that the activation of the coagulation cascade system, reflected in the generation of the TAT complex seen in whole blood, is increased 3000-fold from baseline values (p. 968, Results section 3.1, Fig. 1, p. 969 section 3.3, 3rd parag., Fig. 3).
Regarding claim 8, the metal is titanium (p. 967, section 2.1).
Thus, the reference anticipates the claimed subject matter.
Claim(s) 1, 5, 7, 8, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cattaneo et al. (J. Mat. Sci.:Mat. In Med, vol. 30, p. 1-12, 2019).
Regarding claims 1, 11, Cattaneo teach a method of determining thrombogenicity and hemocompatibility of implantable medical devices, i.e. neurovascular titanium (Nitinol) stents/blood flow diverter (intro., section 2.1 test specimens) comprising exposing a blood sample to Nitinol discs and electropolished discs containing a layer of titanium oxynitride or titanium oxide + titanium nitride (abstract, p. 3, 2nd col, 1st full parag., p. 4, section 2.8) in tubes simulating blood circulation. Before and after blood circulation in the tubes containing the titanium discs, TAT complex and Sc5b-9 concentrations were measured (p. 4, section 2.8 and 2.10). Cattaneo teaches that when stents are implanted and in contact with blood, different biochemical and hemostatic reactions may occur thus activating the coagulation cascade and complement system (p. 7-8, section 3.6) and may include ischaemic complications including distal embolism, in-stent thrombosis and stenosis (p. 10, 1st parag.). Compared to baseline and control blood samples not treated with the metal, TAT concentrations and SC5b-9 significantly increased in native stents (not electropolished) and electropolished stents (p. 7-8, section 3.6, Fig. 6B and C). Those samples exposed to the electropolished stents showed some improvement in thrombogenicity and may improve thrombo-ischaemic complications including distal embolism, in-stent thrombosis and occlusion (p. 10, 2nd col, 1st full parag., p. 11, last 2 parag.).
Regarding claim 5, the blood is extracted before the patient receives an implantable device, i.e. volunteers having not received an implantable device (p. 4, section 2.6).
Regarding claim 7, the reference teaches establishing baseline values from 5 donors (section 2.8).
Regarding claim 8, the metal is titanium and electropolished titanium containing titanium nitride (p. 3, section 2.1).
Thus, the reference anticipates the claimed subject matter.
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.
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) 6, 9, 10, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thor et al. (Biomaterials, vol. 28, p. 966-974, 2007) as applied to claims 1-5, 7, 8 above.
The teachings of Thor are found above.
Thor does not teach the blood to be extracted from a patient after receiving an implantable blood contacting medical device according to claim 6; however as stated above, the connection of the metal (tested in the claim) to the device/pump is interpreted as the implantable medical device/pump (if implanted, which is not required by the claims) would comprise a metal, metal alloy or ceramic tested. Before the effective filing date of the claimed invention, blood tests comprising exposing blood samples to metal materials used in or as implantable devices to test their thrombogenicity were known and disclosed by Thor and thus, it would have been obvious to test blood from a patient exposed to an implantable medical device comprising a metal or metal alloy according to the method of Thor because the reference teaches that blood samples in contact with the titanium showed a 1000-fold increase in the TAT complex and that blood in contact with titanium and titanium alloy surfaces triggers the coagulation cascade thereby having a thrombogenic effect as well as platelet activation. Titanium is used for surgical implants and it shown to be more thrombogenic than other biomaterials used for medical implants, therefore, one would have been motivated by the teachings of Thor to test blood (and markers therein) which has been exposed to an implantable medical device which may trigger a thrombogenic effect in said patient to determine the likelihood of experiencing a thromboembolic event when receiving said device. Additionally, regarding claims 9, 10, it would also be obvious to compare blood exposed to an implantable blood contacting medical device with a first sample exposed to metal having a marker value higher than a threshold which is indicative of the likelihood of a thromboembolic event to determine if the patient whose blood has been exposed to the device is also likely to experience a thromboembolic event based upon said comparison.
Regarding claim 16, Thor teaches the container to comprise an anticoagulant, i.e. heparin, at a concentration of 1.0 U/mL ((section 2.4).
Regarding claims 15, 17, 18, while Thor teaches blood collected into anticoagulant containing test tubes, i.e. heparinized Falcon® tubes and an additional coupon test in a container (slide chamber) containing at least one metal, metal alloy or ceramic, wherein the metal is 25 mm x 25 mm flat squares which are 2-3 mm thick and circular test discs of 25 mm diameter made of titanium for blood evaluations (p. 967, section 2.1), they do not specifically teach the coupon test to be in a test tube or the container to be a test tube; however test tubes are routinely used in the art for blood collection and testing and thus it would have been well within the purview of the skilled artisan to pursue known options within his or her technical grasp.
Claim(s) 11-14, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thor et al. (Biomaterials, vol. 28, p. 966-974, 2007) as applied to claims 1-10, 15-18 above, and further in view of Cattaneo et al. (J. Mat. Sci.:Mat. In Med, vol. 30, p. 1-12, 2019).
The teachings of Thor are found above.
Thor does not teach exposing the blood separately to titanium and titanium nitride according to claim 11.
Cattaneo teach a method of determining thrombogenicity and hemocompatibility of implantable medical devices, i.e. neurovascular titanium (Nitinol) stents/blood flow diverter (intro., section 2.1 test specimens) comprising exposing a blood sample to Nitinol discs and electropolished discs containing a layer of titanium oxynitride or titanium oxide + titanium nitride (abstract, p. 3, 2nd col, 1st full parag., p. 4, section 2.8) in tubes simulating blood circulation. Before and after blood circulation in the tubes containing the titanium discs, TAT complex and Sc5b-9 concentrations were measured (p. 4, section 2.8 and 2.10). Cattaneo teaches that when stents are implanted and in contact with blood, different biochemical and hemostatic reactions may occur thus activating the coagulation cascade and complement system (p. 7-8, section 3.6) and may include ischaemic complications including distal embolism, in-stent thrombosis and stenosis (p. 10, 1st parag.). Compared to baseline and control blood samples not treated with the metal, TAT concentrations and SC5b-9 significantly increased in native stents (not electropolished) and electropolished stents (p. 7-8, section 3.6, Fig. 6B and C). Those samples exposed to the electropolished stents showed some improvement in thrombogenicity and may improve thrombo-ischaemic complications including distal embolism, in-stent thrombosis and occlusion (p. 10, 2nd col, 1st full parag., p. 11, last 2 parag.). Cattaneo teaches a container containing a metal or metal alloy disc having a diameter of 10 mm and thickness of 0.2 mm (p. 3, 2nd col, 1st full parag., p. 4, section 2.8),wherein the container contains the anticoagulant heparin in an amount of 1.5 U/mL (section 2.8).
Thus, before the effective filing date of the claimed invention, it would have been obvious to expose blood separately to both titanium and titanium nitride in the method of Thor because Cattaneo teaches that the samples exposed to the electropolished stents showed some improvement in thrombogenicity and may improve thrombo-ischaemic complications including distal embolism, in-stent thrombosis and occlusion compared to native titanium implants not containing titanium nitride. Therefore, a posita would have been motivated by the teachings of Cattaneo to test both titanium and titanium nitride in a method to determine the likelihood of a patient experiencing a thromboembolic event because both biomaterials are taught to cause increased TAT complex levels and thrombo-ischaemic complications, with titanium nitride providing some improvements over native titanium. Further, regarding claims 19, 20, it would also be obvious to compare blood exposed to an implantable blood pump with a first sample exposed to metal having a marker value higher than a threshold which is indicative of the likelihood of a thromboembolic event to determine if the patient whose blood has been exposed to the device/pump is also likely to experience a thromboembolic event based upon said comparison.
Claim(s) 6, 9, 10, 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cattaneo et al. (J. Mat. Sci.:Mat. In Med, vol. 30, p. 1-12, 2019) as applied to claims 1, 5, 7, 8, 11 above.
The teachings of Cattaneo are found above.
Cattaneo does not teach the blood to be extracted from a patient after receiving an implantable blood contacting medical device according to claim 6; however as stated above, the connection of the metal (tested in the claim) to the device/pump is interpreted as the implantable medical device/pump (if implanted, which is not required by the claims) would comprise a metal, metal alloy or ceramic tested. Before the effective filing date of the claimed invention, blood tests comprising exposing blood samples to metal materials used in or as implantable devices to test their thrombogenicity were known and disclosed by Cattaneo and thus, it would have been obvious to test blood from a patient exposed to an implantable medical device comprising a metal or metal alloy according to the method of Cattaneo because the reference teaches that before and after blood circulation in the tubes containing the titanium discs, TAT complex and Sc5b-9 concentrations were measured and compared to baseline and control blood samples not treated with the metal, TAT concentrations and SC5b-9 significantly increased in native stents (not electropolished) and electropolished stents. Cattaneo teaches that when stents are implanted and in contact with blood, different biochemical and hemostatic reactions may occur thus activating the coagulation cascade and may include ischaemic complications including distal embolism, in-stent thrombosis and stenosis. Therefore, one would have been motivated by the teachings of Cattaneo to test blood (and markers therein) which has been exposed to an implantable medical device which may trigger a thrombogenic effect in said patient to determine the likelihood of experiencing a thromboembolic event when receiving said device. Additionally, regarding claims 9, 10, 19 and 20, it would also be obvious to compare blood exposed to an implantable blood contacting medical device with a first sample exposed to metal having a marker value higher than a threshold (which is indicative of the likelihood of a thromboembolic event) to determine if the patient whose blood has been exposed to the device is also likely to experience a thromboembolic event based upon said comparison.
Regarding claim 16, Cattaneo teaches the container to comprise an anticoagulant, i.e. heparin, at a concentration of 1.5 U/mL (section 2.8).
Regarding claims 15, 17, 18, while the reference teaches blood collected into a container (polyvinyl chloride tubes) containing a metal or metal alloy disc having a diameter of 10 mm and thickness of 0.2 mm (p. 3, 2nd col, 1st full parag., p. 4, section 2.8), they do not specifically teach the coupon test to be in a test tube or the container to be a test tube; however test tubes are routinely used in the art for blood collection and testing and thus it would have been well within the purview of the skilled artisan to pursue known options within his or her technical grasp.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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/TIFFANY M GOUGH/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651