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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 30, 2025 was considered by the examiner. The IDS submitted on June 03, 2024 was considered, with corrections made to U.S. Patent cite 8 and U.S. Patent Application Publication cite 14, except NPL cite 1 was not considered because there is no translation or statement of relevance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required. Claim 1 recites “having at least one liquid biological sample therein” in line 3, followed by steps 2 and 3, with lines 8-9 indicating that “reaching the desired vacuum level to create an evacuated container”. The specification (both the present specification and that in the parent 17/056,874) details that the biological fluid sample is collected within the collection module within an evacuated container (see specification ¶[0034]). This indicates that the evacuated container is already created/manufactured when the fluid sample is introduced into the collection module. This is further supported by the specification ¶[0042] details that “[t]he presently disclosed device and method results in the collection of blood samples into a vacuum chamber or into the evacuated container 34 where blood is exposed to the same atmospheric partial pressure of oxygen (PO2) and partial pressure of carbon dioxide (PCO2) levels found in a standard arterial blood gas syringe”; as well as the manufacture steps of the evacuated container. The improvement to shelf life of the evacuated container further support this (see specification ¶[0045]). The specification of the present application and the parent does not disclose that the container can be provided having at least one liquid biological sample therein (emphasis added) as presently recited in step 1, before the evacuated container is even created/manufactured.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: testing device in claim 16.
Prong 1: “device” is a generic placeholder. See MPEP 2181 §I, subsection A, ¶1.
Prong 2: no transition word is used, modified by functional language.
“testing device”
Prong 3: there is not sufficient structure to modify the generic placeholder “device”.
The examiner interprets the cartridge tester (see specification ¶[0004] incorporated patent U.S. 9,649,061, see col. 5 ln. 57-67) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the testing device.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 15 are objected to because of the following informalities:
in claim 1, line 5: “the” should be inserted before “container”;
in claim 1, line 6: “the” should be inserted before “container”; and
in claim 15, line 4: “months respectively” was changed to “months, respectively”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “having at least one liquid biological sample therein” in line 3, followed by steps 2 and 3, with lines 8-9 indicating that “reaching the desired vacuum level to create an evacuated container”. The specification (both the present specification and that in the parent 17/056,874) details that the biological fluid sample is collected within the collection module within an evacuated container (see specification ¶[0034]). This indicates that the evacuated container is already created/manufactured when the fluid sample is introduced into the collection module. This is further supported by the specification ¶[0042] details that “[t]he presently disclosed device and method results in the collection of blood samples into a vacuum chamber or into the evacuated container 34 where blood is exposed to the same atmospheric partial pressure of oxygen (PO2) and partial pressure of carbon dioxide (PCO2) levels found in a standard arterial blood gas syringe”; as well as the manufacture steps of the evacuated container. The improvement to shelf life of the evacuated container further support this (see specification ¶[0045]). The specification of the present application and the parent does not disclose that the container can be provided having at least one liquid biological sample therein (emphasis added) as presently recited in step 1, before the evacuated container is even created/manufactured. As such, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claims 2-15 are rejected by virtue of their dependence from claim 1.
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 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a container” in line 3, but it is not clear if this recitation is the same as, related to, or different from the recitation “a biological liquid container” in line 1. The similar phraseology suggests that they are the same, but the indefinite article “a” suggests that they are different. If the recitations are the same, the present recitation should be “the biological liquid container”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 1 recites “having at least one liquid biological sample therein” in line 3, followed by steps 2 and 3, with lines 8-9 indicating that “reaching the desired vacuum level to create an evacuated container”. The specification details that the biological fluid sample is collected within the collection module within an evacuated container (see specification ¶[0034]). This indicates that the evacuated container is already created/manufactured when the fluid sample is introduced into the collection module. This is further supported by the specification ¶[0042] details that “[t]he presently disclosed device and method results in the collection of blood samples into a vacuum chamber or into the evacuated container 34 where blood is exposed to the same atmospheric partial pressure of oxygen (PO2) and partial pressure of carbon dioxide (PCO2) levels found in a standard arterial blood gas syringe”; as well as the manufacture steps of the evacuated container. The improvement to shelf life of the evacuated container further support this (see specification ¶[0045]). It is not clear how the container can be provided having at least one liquid biological sample therein (emphasis added) as presently recited in step 1, before the evacuated container is even created/manufactured. The specification details a vented plug 44 of the housing 12 of the collection module 10 that “allows air to pass therethrough and out of the collection module 10 while preventing the blood sample from passing therethrough and may include a hydrophobic filter” (see specification ¶[0038]). However, this is not referencing the creation of the evacuated chamber, rather, this is referencing the filling of the collection module with the sample while air leaves the collection chamber to maintain a constant pressure. Furthermore, the collection chamber’s gas composition is not altered, as only the gas composition of the evacuated container, which holds the collection chamber therewithin, is altered (see specification ¶[0042]). Therefore, the inconsistency between what is claimed (i.e., the sample already collected before the evacuated chamber is created) and what appears to be required for the sample to be collected (i.e., the already created/manufactured evacuated chamber) renders claim 1 indefinite. For the purposes of examination, the recitation of claim 1 is interpreted to read “providing a container for receiving at least one liquid biological sample therein”.
Claim 1 recites “at atmospheric pressure (760 mmHg)”; however, the usage of the parenthesis is not clear, such that, it is not clear whether “760 mmHg” is required in the claim or not. This renders the metes and bounds of the claim unclear. Amending the recitation to “at atmospheric pressure of 760 mmHg” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 1 recites the limitation “the desired vacuum level” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Amending the recitation to recite “a desired vacuum level” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claims 2-15 are rejected by virtue of their dependence from claim 1.
Claim 9 recites the phrase “preferably” in line 2, which renders the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the limitation following “preferably” is not being given patentable weight.
Claim 11 recites the phrase “as well as other trace gasses” in line 2, which renders the claim indefinite because it is unclear whether the limitation following the phrase “as well as” are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the limitation following “as well as” is not being given patentable weight. Furthermore, it is not clear what is supposed to be encompassed by “trace gasses”. It is not clear what gasses would be encompassed by this term, the specification does not indicate what may be considered a “trace gas” (see specification ¶[0051]), which causes the bounds of the claim to be unclear. Therefore, the purposes of examination, the term “other trace gasses” is not being given patentable weight.
Claim 13 recites “a shelf life of the evacuated container is at least 1.5 times longer as a result of Step 3” in lines 1-2, which is unclear. It is not clear as to what the shelf life is longer than, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, this recitation is not being given patentable weight.
Claim 14 recites “a shelf life of the evacuated container is at least 1.8 times longer as a result of Step 3” in lines 1-2, which is unclear. It is not clear as to what the shelf life is longer than, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, this recitation is not being given patentable weight.
Claim 16 recites “a fluid sample” in lines 1 and 8; and “the biological liquid sample” in line 7. The relationship among these recitations is not clear. The similar phraseology and the definite article “the” in the line 7 recitation suggest that they are the same/related, but the indefinite article “a” and “biological liquid” in the line 7 recitation suggest that they are different. The relationship between these recitations should be made clear. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). Furthermore, if the recitations are different, the limitation “the biological liquid sample” in line 7 lacks antecedent basis. Appropriate clarification is required.
Claims 17-18 are rejected by virtue of their dependence from claim 16.
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.
Claims 1-2, 5-10, and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8, 11, 13, and 22-26 of U.S. Patent No. 11,986,297. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1-2, 5-10, and 12-15, patented claims 8, 11, 13, and 22-26 correspond to and teach every element of pending claims 1-2, 5-10, and 12-15. Note that the atmospheric compositions of Step 1 would be inherent to such a manufacture (i.e., patented claim 21) as the tube before purging is open to the atmosphere.
Claims 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 11, 13, and 22-26 of U.S. Patent No. 11,986,297 in view of Felts et al. (US Patent Application Publication 2015/0098084 – cited by Applicant), hereinafter Felts.
Regarding Claims 3-4, patented claims 8, 11, 13, and 22-26 correspond to and teach every element of pending claims 3-4, except the pressure at Step 2.
Felts teaches a method for inspecting the product of a coating process on vessels (see abstract and Fig. 1), in which the vessel may be an evacuated blood collection tube (see ¶[0009]-[0010] and ¶[0086]-[0087]), in which after the tube has been fabricated, an initial vacuum is applied to the tube to reduce the pressure in the tube to less than 20 Torr, less than 50 Torr, and among other pressures (see ¶[0391]-[0392]). Note that 1 Torr = 1 mmHg.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the initial vacuum pressure of Felts with the patented claims 8, 11, 13, and 22-26 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) the patented claims 8, 11, 13, and 22-26 require an initial vacuum pressure (i.e., the Step 2 pressure) and Felts teaches one such pressure.
For claim 4, the modified patented claims 8, 11, 13, and 22-26 teaches that the pressure may be 50 mmHg or less, which would correspond to partial pressures of 10.5 mmHg or less oxygen and 39.5 mmHg or less nitrogen. Therefore, the less than 10.5 mmHg range of oxygen partial pressure of the modified patented claims 8, 11, 13, and 22-26 suggests the value of the present claim because 4 mmHg falls within the range of less than 10.5 mmHg. Furthermore, the less than 39.5 mmHg range of nitrogen partial pressure of the modified Wolters suggests the value of the present claim because 16 mmHg falls within the range of less than 39.5 mmHg. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 11, 13, and 22-26 of U.S. Patent No. 11,986,297 in view of Kasai et al. (US Patent 4,936,314 – cited by Applicant), hereinafter Kasai.
Regarding Claim 11, patented claims 8, 11, 13, and 22-26 correspond to and teach every element of pending claim 11, except the internal atmosphere of the evacuated container further comprises 1% argon as well as other trace gasses.
Kasai teaches an evacuated blood collecting device with a gas sealed within the space of the cylindrical member (see abstract and Figs. 1-3), in which the gases sealed may comprise helium, argon, neon, oxygen, carbon dioxide, carbon monoxide, ethane, propane, ethylene, propylene and butane, with argon can carbon dioxide being most desirable (see col. 4 ln. 30 – col. 5 ln. 9, see also claim 6, argon and nitrogen gas sealed in the tightly sealed contained).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the argon and other trace gases of Kasai with the patented claims 8, 11, 13, and 22-26 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) such concentrations of gases within the tube would help to maintain a pressure balance between the inside of the sealed tube and the outside atmosphere (see Kasai col. 4 ln. 30 – col. 5 ln. 9).
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 11, 13, and 22-26 of U.S. Patent No. 11,986,297 in view of Ivosevic et al. (US Patent 9,649,061 – cited by Applicant), hereinafter Ivosevic.
Regarding Claims 16-18, patented claims 8, 11, 13, and 22-26 correspond to and teach every element of pending claims 16-18, except the testing device and the point of care cartridge.
Ivosevic teaches a biological fluid collection device including a collection module with openings for the sample within an outer housing (see abstract and Figs. 1-4), in which, once the collection module 10 is separated from the outer housing 34, pressure may be applied onto elastic sleeve 40 so as to force blood out from the holding chamber 18 onto a point-of-care testing device, such as a cartridge tester or via a port while minimizing the exposure of the medical practitioner to the blood sample (see col. 5 ln. 42-67; Fig. 5F).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the point-of-care testing of Ivosevic with the patented claims 8, 11, 13, and 22-26 because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) this modality of testing provides quick blood dispensing while minimizing the exposure of the medical practitioner to the blood sample (see col. 5 ln. 57-67; Fig. 5F).
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.
The succeeding art rejections to the claims under 35 U.S.C. § 102 and 103 below are made with the claims as best understood and interpreted in light of the preceding rejections under 35 U.S.C. § 112 above.
Claims 1-2, 5-7, 9, and 12-14 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Wolters et al. (WIPO Publication WO 2014/070514 A1 – cited by Applicant), hereinafter Wolters.
Regarding Claim 1, Wolters teaches methods for fabricating a culture container (see abstract; Fig. 1). Wolters teaches a method for atmospherically balancing a biological liquid container (see abstract, ¶[0002] the container 10 for use with a biosample, ¶[0049] the biosample may be blood; Fig. 1) comprising the steps of:
Step 1 – providing a container (¶[0059] the container 10; Fig. 1) for receiving at least one liquid biological sample therein (see abstract, ¶[0002] the container 10 for use with a biosample, ¶[0049] the biosample may be blood; Fig. 1),
wherein container is at atmospheric pressure (760 mmHg) (¶[0017], ¶[0023], and ¶[0052] detail that a vacuum is applied to the container during the manufacturing process, before such a vacuum is applied and when the container is not sealed, it would necessarily be at atmospheric pressure as the inside of the container would be exposed to the atmosphere; atmospheric pressure is about 760 mmHg, see for example “Air Pressure”, National Oceanic and Atmospheric Administration, Department of Commerce, updated on February 17, 2026, accessed on March 04, 2026, accessed at https://www.noaa.gov/jetstream/atmosphere/air-pressure, pg. 2 ¶5-6, 29.92 in Hg and 1013.2 millibars, which is converted to about 760 mmHg);
Step 2 – pulling a high vacuum from within container such that most of the gas is removed from a chamber of container (¶[0017], ¶[0023], ¶[0052], and ¶[0069]-[0070] the vacuum applied within the container; Fig. 6); and
Step 3 – back purging the container with a deliberately proportioned gas composition of oxygen (O2), nitrogen (N2), and carbon dioxide (CO2) until reaching the desired vacuum level to create an evacuated container (¶[0057] the container 10 can have the headspace 16 that can accommodate a gas or gas mixture, including O2, N-2, and CO2).
Regarding Claim 2, Wolters teaches the method of claim 1 as stated above. Wolters further teaches in Step 1, the container has an internal atmosphere composition of approximately 21% oxygen and approximately 79% nitrogen, with a partial pressure of oxygen (PO2) being approximately 160 mmHg and a partial pressure of nitrogen (PN2) being approximately 600 mmHg (¶[0017], ¶[0023], and ¶[0052] detail that a vacuum is applied to the container during the manufacturing process, before such a vacuum is applied and when the container is not sealed, it would necessarily be at atmospheric pressure and composition as the inside of the container would be exposed to the atmosphere). The contents of the atmosphere include approximately 21% oxygen and 79% nitrogen; see for example “The Atmosphere”, National Oceanic and Atmospheric Administration, Department of Commerce, updated on July 02, 2024, accessed on March 04, 2026, accessed at https://www.noaa.gov/jetstream/atmosphere, pg. 2, table. As the atmospheric compositions would be present at atmospheric pressure, such partial pressures would also be inherent (i.e., oxygen 0.21 * 760 mmHg = 159.6 mm Hg and nitrogen 0.78-0.79 * 760 mmHg = 592.8-600.4 mmHg).
Regarding Claim 5, Wolters teaches the method of claim 1 as stated above. Wolters further teaches in Step 3, the evacuated container has an internal atmosphere composition wherein oxygen and carbon dioxide make up more than 50% of the total vacuum pressure in the evacuated container (¶[0057] in an embodiment, oxygen makes up about 55%, carbon dioxide makes up about 2.5%, and nitrogen makes up about 42.4% of the gas composition). Here, the composition of oxygen and carbon dioxide would be 57.5%, which is more than 50% of the total vacuum pressure in the evacuated container.
Regarding Claim 6, Wolters teaches the method of claim 1 as stated above. Wolters further teaches in Step 3, the evacuated container has an internal atmosphere pressure of approximately 300 mmHg (¶[0057] the gas introduced into the container such as between 3-20 inch Hg, which is converted to 76.2-508 mmHg).
The 76.2-508 mmHg range of Wolters suggests the range of the present claim because 300 mmHg falls within the range of 76.2-508 mmHg. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 7, Wolters teaches the method of claim 1 as stated above. Wolters further teaches the partial pressure of oxygen within the evacuated container is approximately 160 mmHg (¶[0057] the gas introduced into the container such as between 3-20 inch Hg, which is converted to 76.2-508 mmHg, in an embodiment, oxygen makes up about 55% of the gas composition).
Here, Wolters teaches that oxygen is present at about 55% over a range of pressures, which would yield a range of partial pressures: 0.55 * 76.2-508 mmHg = 41.91-279.4 mmHg.
The 41.91-279.4 mmHg range of Wolters suggests the range of the present claim because 160 mmHg falls within the range of 41.91-279.4 mmHg. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 9, Wolters teaches the method of claim 1 as stated above. Wolters further teaches the gas composition in the evacuated container comprises approximately 53.3% oxygen, or preferably approximately 55% oxygen (¶[0057] in an embodiment, oxygen makes up about 55% of the gas composition).
Regarding Claim 12, Wolters teaches the method of claim 1 as stated above. Wolters further teaches in Step 3, the evacuated container has an internal atmosphere pressure of approximately 300 mmHg (¶[0057] the gas introduced into the container such as between 3-20 inch Hg, which is converted to 76.2-508 mmHg), and wherein the partial pressure of oxygen within the evacuated container is greater than 160 mmHg (¶[0057] in an embodiment, oxygen makes up about 55% of the gas composition).
The 76.2-508 mmHg range of the internal pressure of Wolters suggests the range of the present claim because 300 mmHg falls within the range of 76.2-508 mmHg. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Here, Wolters teaches that oxygen is present at about 55% over a range of pressures, which would yield a range of partial pressures: 0.55 * 76.2-508 mmHg = 41.91-279.4 mmHg.
The 41.91-279.4 mmHg range of oxygen partial pressures Wolters suggests the range of the present claim because great than 160 mmHg overlaps with the range of 41.91-279.4 mmHg. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Regarding Claim 13, Wolters teaches the method of claim 1 as stated above. Wolters further teaches a shelf life of the evacuated container is at least 1.5 times longer as a result of Step 3 (¶[0057] container can have headspace 16 introduced into container, which may comprise nitrogen, oxygen, and carbon dioxide). Here, the claim merely recites a limitation that is a direct result of the Step 3, such that, if the container is back purged as claimed in Step 3, the shelf life will be increased as claimed. Because the Step 3 elements are met by Wolters, the improved shelf life is inherent to the container of Wolters, thus meeting the limitation of the present claim.
Regarding Claim 14, Wolters teaches the method of claim 13 as stated above. Wolters further teaches a shelf life of the evacuated container is at least 1.8 times longer as a result of Step 3 (¶[0057] container can have headspace 16 introduced into container, which may comprise nitrogen, oxygen, and carbon dioxide). Here, the claim merely recites a limitation that is a direct result of the Step 3, such that, if the container is back purged as claimed in Step 3, the shelf life will be increased as claimed. Because the Step 3 elements are met by Wolters, the improved shelf life is inherent to the container of Wolters, thus meeting the limitation of the present claim.
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.
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 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wolters as applied to claim 1 above.
Regarding Claim 8, Wolters teaches the method of claim 1 as stated above. Wolters further teaches the gas composition includes carbon dioxide and nitrogen, wherein the partial pressure of carbon dioxide within the evacuated container is approximately 0.3 mmHg and the nitrogen within the evacuated container is approximately 140 mmHg (¶[0057] the gas introduced into the container such as between 3-20 inch Hg, which is converted to 76.2-508 mmHg, in an embodiment carbon dioxide makes up about 2.5% and nitrogen makes up about 42.4% of the gas composition).
Here, Wolters teaches that nitrogen is present at about 42.4% over a range of pressures, which would yield a range of partial pressures: 0.424 * 76.2-508 mmHg = 32.309-215.392 mmHg. The 32.309-215.392 mmHg range of Wolters suggests the range of the present claim because 140 mmHg falls within the range of 32.309-215.392 mmHg. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Wolters teaches that carbon dioxide is present at about 2.5% over a range of pressures, which would yield a range of partial pressures: 0.025 * 76.2-508 mmHg = 1.905-12.7 mmHg. The specification of the present application does not give a specific definition for “approximately”. Wolters defines “about” such that the recited number or value can vary by +/- 20% (see ¶[0047]). Even with such a variation, the range of Wolters would not overlap with 0.3 mmHg (i.e., -20% = 1.5264 mmHg).
Nevertheless, the range in Wolters suggests that the partial pressure of carbon dioxide within the evacuated container is subject to optimization based on the desired performance (i.e., the recovery/interaction of organisms within the sample, see Wolters ¶[0004]). As such, the desired partial pressure of carbon dioxide within the evacuated container is a results-effective variable that would have been optimized through routine experimentation based on the desired performance. It would have been obvious to one of ordinary skill in the art before the effective filing date of the of the claimed invention to select a partial pressure of carbon dioxide within the evacuated container, using the range of Wolters as a starting point, so as to obtain the desired performance. Thus, the partial pressure of carbon dioxide within the evacuated container being approximately 0.3 mmHg, would have been obvious.
Regarding Claim 10, Wolters teaches the method of claim 1 as stated above. Wolters further teaches the gas composition in the evacuated container further comprises approximately 46.7% nitrogen and approximately 0.1% carbon dioxide (¶[0057] in an embodiment carbon dioxide makes up about 2.5% and nitrogen makes up about 42.4% of the gas composition). The specification of the present application does not give a specific definition for “approximately”. Wolters defines “about” such that the recited number or value can vary by +/- 20% (see ¶[0047]). This gives a range of the percentages, for nitrogen that is 33.92-50.88%, and for carbon dioxide that is 2-3%.
The 33.92-50.88% range of nitrogen of Wolters suggests the range of the present claim because 46.7% falls within the range of 33.92-50.88%. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
The range of carbon dioxide of Wolters does not overlap with 0.1% carbon dioxide as claimed. Nevertheless, the range in Wolters suggests that the percentage of carbon dioxide within the evacuated container is subject to optimization based on the desired performance (i.e., the recovery/interaction of organisms within the sample, see Wolters ¶[0004]). As such, the desired percentage of carbon dioxide within the evacuated container is a results-effective variable that would have been optimized through routine experimentation based on the desired performance. It would have been obvious to one of ordinary skill in the art before the effective filing date of the of the claimed invention to select a percentage of carbon dioxide within the evacuated container, using the range of Wolters as a starting point, so as to obtain the desired performance. Thus, the percentage of carbon dioxide within the evacuated container being approximately 0.1% would have been obvious.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wolters as applied to claim 1 above, and in view of Felts et al. (US Patent Application Publication 2015/0098084 – cited by Applicant), hereinafter Felts.
Regarding Claim 3, Wolters teaches the method of claim 1 as stated above. Wolters teaches the pressure of the gas introduction (i.e., the back purging) (see ¶[0057]), but does not specifically teach the pressure at Step 2.
Felts teaches a method for inspecting the product of a coating process on vessels (see abstract and Fig. 1), in which the vessel may be an evacuated blood collection tube (see ¶[0009]-[0010] and ¶[0086]-[0087]), in which after the tube has been fabricated, an initial vacuum is applied to the tube to reduce the pressure in the tube to less than 20 Torr, less than 50 Torr, and among other pressures (see ¶[0391]-[0392]). Note that 1 Torr = 1 mmHg.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the initial vacuum pressure of Felts with the method of Wolters because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) Wolters requires an initial vacuum pressure (i.e., the Step 2 pressure) and Felts teaches one such pressure.
Regarding Claim 4, Wolters teaches the method of claim 1 as stated above. Wolters further teaches in Step 2, the container has an internal atmosphere composition of approximately 21% oxygen and approximately 79% nitrogen (¶[0017], ¶[0023], and ¶[0052] detail that a vacuum is applied to the container during the manufacturing process, before and during such a vacuum is applied, before back purging it would necessarily be at atmospheric composition as the inside of the container was last exposed to the atmosphere). The contents of the atmosphere include approximately 21% oxygen and 79% nitrogen; see for example “The Atmosphere”, National Oceanic and Atmospheric Administration, Department of Commerce, updated on July 02, 2024, accessed on March 04, 2026, accessed at https://www.noaa.gov/jetstream/atmosphere, pg. 2, table.
Wolters teaches the pressure of the gas introduction (i.e., the back purging) (see ¶[0057]), but does not specifically teach the pressure at Step 2.
Felts teaches a method for inspecting the product of a coating process on vessels (see abstract and Fig. 1), in which the vessel may be an evacuated blood collection tube (see ¶[0009]-[0010] and ¶[0086]-[0087]), in which after the tube has been fabricated, an initial vacuum is applied to the tube to reduce the pressure in the tube to less than 20 Torr, less than 50 Torr, and among other pressures (see ¶[0391]-[0392]). Note that 1 Torr = 1 mmHg.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the initial vacuum pressure of Felts with the method of Wolters because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) Wolters requires an initial vacuum pressure (i.e., the Step 2 pressure) and Felts teaches one such pressure.
The modified Wolters teaches that the pressure may be 50 mmHg or less, which would correspond to partial pressures of 10.5 mmHg or less oxygen and 39.5 mmHg or less nitrogen. Therefore, the less than 10.5 mmHg range of oxygen partial pressure of the modified Wolters suggests the value of the present claim because 4 mmHg falls within the range of less than 10.5 mmHg. Furthermore, the less than 39.5 mmHg range of nitrogen partial pressure of the modified Wolters suggests the value of the present claim because 16 mmHg falls within the range of less than 39.5 mmHg. See MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wolters as applied to claim 10 above, and in view of Kasai et al. (US Patent 4,936,314 – cited by Applicant), hereinafter Kasai.
Regarding Claim 11, Wolters teaches the method of claim 10 as stated above. Wolters further teaches the internal atmosphere of the evacuated container further comprises other trace gasses (¶[0057] the gases may comprise helium), but does not specifically teach the presence of argon.
Kasai teaches an evacuated blood collecting device with a gas sealed within the space of the cylindrical member (see abstract and Figs. 1-3), in which the gases sealed may comprise helium, argon, neon, oxygen, carbon dioxide, carbon monoxide, ethane, propane, ethylene, propylene and butane, with argon can carbon dioxide being most desirable (see col. 4 ln. 30 – col. 5 ln. 9, see also claim 6, argon and nitrogen gas sealed in the tightly sealed contained).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the argon gas of Kasai with the method of Wolters because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) such a concentration of argon gas within the tube would help to maintain a pressure balance between the inside of the sealed tube and the outside atmosphere (see Kasai col. 4 ln. 30 – col. 5 ln. 9).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wolters as applied to claim 1 above, and in view of BD Life Sciences (“BD Life Sciences – Preanalytical Systems”, BD, Product Catalog, printed June 2015), hereinafter BD Life Sciences.
Regarding Claim 15, Wolters teaches the method of claim 1 as stated above. Wolters further teaches that the container may have a tubular body (see ¶[0055]-[0056]), but does not teach any specific sizes.
BD Life Sciences teaches the usage of several known tubes including a 10 mL 16X125 tube (see Venous Products – 3, Reference Number 367985), a 10 mL 16X100 tube (see Venous Products – 5, Reference Number 367001), a 5 mL 13X100 tube (see Venous Products – 5, Reference Number 367814), a 2 mL 13X75 tube (see Venous Products – 5, Reference Number 367587 or 367921), and a 1.8 mL 13X75 tube (see Venous Products – 8, Reference Number 363080).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the known tubes of BD Life Sciences with the method of Wolters because (1) it is the simple substitution of one known element for another to yield predictable results and/or (2) Wolters requires tubes (see Wolters ¶[0055]-[0056]) and BD Life Sciences teaches such tubes.
Here, the claim merely recites a limitation that is a direct result of the method and specific tube, such that, if the specific tube has the method performed as claimed in claim 1, the shelf life will be as claimed. Because the method steps are met by the modified Wolters on the specifically claimed tubes, the shelf life is inherent to the containers of the modified Wolters, thus meeting the limitation of the present claim.
Allowable Subject Matter
No prior art has been applied to claims 16-18 of the present application due to the following rationale below, but the claims are not in condition for allowance due to the rejection of the claims under 35 U.S.C. § 112.
Felts et al. (US Patent Application Publication 2015/0098084 – cited by Applicant) teaches a method for inspecting the product of a coating process on vessels (see abstract and Fig. 1), in which the vessel may be an evacuated blood collection tube (see ¶[0009]-[0010] and ¶[0086]-[0087]), in which after the tube has been fabricated, an initial vacuum is applied to the tube to reduce the pressure in the tube to less than 20 Torr, less than 50 Torr, and among other pressures (see ¶[0391]-[0392]). Note that 1 Torr = 1 mmHg.
Kasai et al. (US Patent 4,936,314 – cited by Applicant) teaches an evacuated blood collecting device with a gas sealed within the space of the cylindrical member (see abstract and Figs. 1-3), in which the gases sealed may comprise helium, argon, neon, oxygen, carbon dioxide, carbon monoxide, ethane, propane, ethylene, propylene and butane, with argon can carbon dioxide being most desirable (see col. 4 ln. 30 – col. 5 ln. 9, see also claim 6, argon and nitrogen gas sealed in the tightly sealed contained).
Ivosevic et al. (US Patent 9,649,061 – cited by Applicant) teaches a biological fluid collection device including a collection module with openings for the sample within an outer housing (see abstract and Figs. 1-4), in which, once the collection module 10 is separated from the outer housing 34, pressure may be applied onto elastic sleeve 40 so as to force blood out from the holding chamber 18 onto a point-of-care testing device, such as a cartridge tester or via a port while minimizing the exposure of the medical practitioner to the blood sample (see col. 5 ln. 42-67; Fig. 5F).
BD Life Sciences (“BD Life Sciences – Preanalytical Systems”, BD, Product Catalog, printed June 2015) teaches the usage of several known tubes including a 10 mL 16X125 tube (see Venous Products – 3, Reference Number 367985), a 10 mL 16X100 tube (see Venous Products – 5, Reference Number 367001), a 5 mL 13X100 tube (see Venous Products – 5, Reference Number 367814), a 2 mL 13X75 tube (see Venous Products – 5, Reference Number 367587 or 367921), and a 1.8 mL 13X75 tube (see Venous Products – 8, Reference Number 363080).
Wolters et al. (WIPO Publication WO 2014/070514 A1 – cited by Applicant) teaches methods for fabricating a culture container (see abstract; Fig. 1). Wolters teaches a method for atmospherically balancing a biological liquid container (see abstract, ¶[0002] the container 10 for use with a biosample, ¶[0049] the biosample may be blood; Fig. 1) comprising the steps of:
Step 1 – providing a container (¶[0059] the container 10; Fig. 1) for receiving at least one liquid biological sample therein (see abstract, ¶[0002] the container 10 for use with a biosample, ¶[0049] the biosample may be blood; Fig. 1),
wherein container is at atmospheric pressure (760 mmHg) (¶[0017], ¶[0023], and ¶[0052] detail that a vacuum is applied to the container during the manufacturing process, before such a vacuum is applied and when the container is not sealed, it would necessarily be at atmospheric pressure as the inside of the container would be exposed to the atmosphere; atmospheric pressure is about 760 mmHg, see for example “Air Pressure”, National Oceanic and Atmospheric Administration, Department of Commerce, updated on February 17, 2026, accessed on March 04, 2026, accessed at https://www.noaa.gov/jetstream/atmosphere/air-pressure, pg. 2 ¶5-6, 29.92 in Hg and 1013.2 millibars, which is converted to about 760 mmHg);
Step 2 – pulling a high vacuum from within container such that most of the gas is removed from a chamber of container (¶[0017], ¶[0023], ¶[0052], and ¶[0069]-[0070] the vacuum applied within the container; Fig. 6); and
Step 3 – back purging the container with a deliberately proportioned gas composition of oxygen (O2), nitrogen (N2), and carbon dioxide (CO2) until reaching the desired vacuum level to create an evacuated container (¶[0057] the container 10 can have the headspace 16 that can accommodate a gas or gas mixture, including O2, N-2, and CO2).
Betts et al. (JP patent H8-119653 – cited by Applicant) teaches a sealed glass container for blood gas analysis (see abstract), including a headspace 26 which may comprise oxygen, nitrogen, and/or carbon dioxide (see pg. 20 of reference/translation; Figs. 1 & 5).
Bullington et al. (US Patent Application Publication 2019/0076074 – cited by Applicant) teaches a fluid control device (see abstract), which can apply a negative pressure, which may be about atmospheric pressure at sea level (see ¶[0087]).
Tanaami et al. (US Patent 9,061,280 – cited by Applicant) teaches a chemical reaction cartridge (see abstract; Figs. 4A-4C) in which the internal chamber may be atmospheric pressure (see col. 13 ln. 51-53).
Winkler et al. (US Patent Application Publication 2009/0162941 – cited by Applicant) teaches a container covered with a stopper (see abstract; Fig. 1) including a conduit with atmospheric air, nitrogen, oxygen, carbon dioxide and resultant mixtures (see ¶[0009]).
Savur et al. (US Patent Application Publication 2014/0308409) teaches controlling gas composition within a container for produce (see abstract; Fig. 1), including maintaining nitrogen, oxygen, and carbon dioxide levels at desired levels (see ¶[0006]-[0007]).
Brancazio (US Patent Application Publication 2012/0123297 – cited by Applicant) teaches a device for receiving blood from a subject (see abstract), including a vacuum chamber 907 to help draw fluid into the vacuum chamber 907 or collection chamber 908 (see ¶[0087]-[0090]; Fig. 13A), in which the vacuum chamber has a pressure less than atmospheric pressure (see ¶[0013] and ¶[0140]).
None of the cited references teach or suggest placing the particular fluid collection module within an atmospherically balanced fluid collection container, along with the other claimed elements. Note that “atmospherically balanced fluid collection container” is defined by the specification of the present application (see specification ¶[0014]-[0015] and ¶[0041]-[0042]) and is thus being interpreted to include “the desired vacuum level of approximately 300 mmHg that coincides with atmospheric partial pressures of O2 and CO2 forming the atmospherically balanced evacuated tube 34”.
Claim 16 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791