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 .
Response to Amendment
The amendment filed on June 12, 2026 was considered by the examiner. Claims 1-2, 4-12, 15-18 are pending in the application.
Terminal Disclaimer
The terminal disclaimer filed on June 12, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 11,986,297 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claims 1-2, 4-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wolters et al. (WIPO Publication WO 2014/070514 A1 – cited by Applicant), hereinafter Wolters, and in view of Felts et al. (US Patent Application Publication 2015/0098084 – cited by Applicant), hereinafter Felts.
Regarding Claim 1, Wolters teaches methods for fabricating a culture container (see abstract; Fig. 1). Wolters teaches a method for atmospherically balancing a container for a biological liquid (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 the container (¶[0059] the container 10; Fig. 1; see also ¶[0002] the container 10 for use with a biosample, ¶[0049] the biosample may be blood; Fig. 1),
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 – cited in prior action);
Step 2 – pulling a high vacuum from within the container such that most of the gas is removed from a chamber of the 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 a 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).
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 2, Wolters in view of Felts 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 4, Wolters in view of Felts teaches the method of claim 1 as stated above. 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)”.
Regarding Claim 5, Wolters in view of Felts 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 in view of Felts 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 in view of Felts 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 8, Wolters in view of Felts 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 9, Wolters in view of Felts 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 approximately 55% oxygen (¶[0057] in an embodiment, oxygen makes up about 55% of the gas composition).
Regarding Claim 10, Wolters in view of Felts 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.
Regarding Claim 12, Wolters in view of Felts 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)”.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wolters in view of Felts 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 in view of Felts teaches the method of claim 10 as stated above. The modified Wolters 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 the modified 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 in view of Felts as applied to claim 1 above, and in view of BD Life Sciences (“BD Life Sciences – Preanalytical Systems”, BD, Product Catalog, printed June 2015 – cited in prior action), hereinafter BD Life Sciences.
Regarding Claim 15, Wolters in view of Felts 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 the modified 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.
Response to Arguments
Applicant’s arguments, objections to the specification
Applicant’s arguments, see pg. 5, filed June 12, 2026, with respect to the objection to the specification have been fully considered and are persuasive. Therefore, the objection has been withdrawn.
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 5, filed June 12, 2026, with respect to the objections of claims 1 and 15 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(a)
Applicant’s arguments, see pg. 5, filed June 12, 2026, with respect to the rejections of claims 1-15 under 35 U.S.C. § 112(a) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 5, filed June 12, 2026, with respect to the rejections of claims 1-18 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, double patenting
Applicant’s arguments, see pg. 6, filed June 12, 2026, with respect to the rejections of claims 1-18 on the ground of nonstatutory double patenting have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, prior art
Applicant’s arguments, see pg. 6-7, filed June 12, 2026, with respect to the rejections of claims 1-15 under 35 U.S.C. § 102(a) (1) and § 103 have been fully considered and are NOT persuasive. Applicant argues that the “pressure ranges recited in Felts are specifically, and exclusively, for testing and inspecting the integrity of a sealing coating”; and thus, there is “no motivation for one of skill in the art to modify Wolters in view of Felts as the examiner proposes”. The examiner respectfully disagrees. While Felts details testing and inspecting coatings, Felts also provides details on various vacuum sealed containers, such as evacuated blood containers. The testing for sealing makes reference to the initial vacuum level, and Felts further recites initial vacuum levels for those vacuum sealed containers, with evacuated blood containers mentioned specifically (see Felts ¶[0391]-[0392]). The initial vacuum level is directly given as a value for evacuated blood containers in Felts, which directly relates to the culture containers of Wolters. Furthermore, there are motivations to combine the references, including that 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. Therefore, Applicant’s arguments are not persuasive, and the rejections to the claims are maintained.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: claim 16 remains allowable for the reasons of record as indicated in the Non-Final Office Action mailed on March 13, 2026. Claims 17-18 are allowable by virtue of their dependence from claim 16.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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