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 .
Status of Claims
Claims 1-12 are pending and examined on the merits.
Claim 13 is withdrawn for being drawn to a nonelected invention.
Response to Amendment
Applicant’s amendments filed 02/27/2026 have been fully considered.
Response to Arguments
Applicant's arguments filed 02/27/2026 have been fully considered but they are not persuasive. Specifically, regarding Applicant’s arguments that Sugimoto does not disclose a vacuum blood collection tube (see pages 5-6 of Remarks filed 02/27/2026), Examiner respectfully disagrees. As discussed in more detail below, and as broadly recited, the claims, as amended, do not require creating a vacuum inside a container to collect minute amounts of liquid. Rather, the claims merely require that the blood collection container is a capable of having a vacuum applied to the container. For example, if the blood collection container of Sugimoto, Anraku, and Gelotte is subjected to negative pressure, such as by placing the blood collection container within a vacuum device, the blood collection container will necessarily be a vacuum blood collection container.
Regarding the argument that Sugimoto merely lists the specific gravity of a polymer gel for plasma separation and the osmotic pressure of dilution buffer separately (see pages 6-7 of Remarks filed 02/27/2026), Examiner respectfully disagrees. Specifically, since these limitations are considered intended use limitations, if the prior art apparatus teaches all the structural limitations of the claim, "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" (see MPEP 2144 II).
Sugimoto (U.S. Pre Grant Pub. No. 2017/0131189 A1), Anraku (U.S. Patent No. 7,090,970 B2,) and Gelotte (U.S. Patent No. 5,733,919 A) are reintroduced in the present rejection for disclosing and rendering obvious the limitations presented in the claims.
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 1-6, 8, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sugimoto (U.S. Pre Grant Pub. No. 2017/0131189 A1), in view of Anraku (U.S. Patent No. 7,090,970 B2) and further in view of Gelotte (U.S. Patent No. 5,733,919 A).
Regarding claim 1 Sugimoto teaches: A blood collection container into which a predetermined amount of blood is collected (see para. [0038]), the blood collection container comprising:
a blood collection container main body (see blood storage 1 in Fig. 1);
a blood plasma separation material contained in the blood collection container main body (see for example para. [0027] and plasma separation 3 in Fig. 1).
While Sugimoto fails to explicitly teach a specific gravity of the blood plasma separation material at 25°C being 1.030 or more and 1.120 or less, as required by the claim, Sugimoto teaches the blood separation gel having a specific gravity of 1.02-1.08 (see at least para. [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select the portion of the acceptable blood separation gel specific gravity range of Sugimoto that is within the claimed range since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists (MPEP 2144.05 I).
However, Sugimoto fails to explicitly teach an osmotic pressure regulator contained in the blood collection container main body, or an anticoagulant contained in the blood collection container main body, as required by the claim.
Anraku teaches a blood testing container which may additionally contain an anticoagulant, depending on the test purpose (see col. 8, lines 20-23).
Gelotte teaches that tonicity adjusting agents, including sodium chloride, are used to adjust tonicity for osmotic pressure and prevent blood cell lysing (see col. 4, lines 16-18).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Sugimoto to further comprise in the blood collection container main body an anticoagulant, as taught by Anraku, and sodium chloride, as taught by Gelotte, because these are suitable additional components for use in apparatus for blood collection/processing. Those of ordinary skill in the art would have been motivated to make this modification at least in order to prevent the blood sample from coagulating prior to plasma separation and to prevent lysis of the sample blood cells. Additionally, there would have been reasonable expectation of success in making this modification because all of the references are reasonably drawn to the same field of endeavor of blood collection and processing.
Regarding the limitations:
“when an osmotic pressure measurement solution is obtained by dissolving the osmotic pressure regulator and the anticoagulant contained in the blood collection container main body with a physiological saline solution in an amount equivalent to the predetermined amount of blood collected in the blood collection container,
when the specific gravity of the blood plasma separation material at 25°C is 1.030 or more and less than 1.040, an osmotic pressure of the osmotic pressure measurement solution being 300 mOsm/L or more,
when the specific gravity of the blood plasma separation material at 25°C is 1.040 or more and less than 1.050, the osmotic pressure of the osmotic pressure measurement solution being 330 mOsm/L or more,
when the specific gravity of the blood plasma separation material at 25°C is 1.050 or more and less than 1.060, the osmotic pressure of the osmotic pressure measurement solution being 350 mOsm/L or more,
when the specific gravity of the blood plasma separation material at 25°C is 1.060 or more and less than 1.070, the osmotic pressure of the osmotic pressure measurement solution being 500 mOsm/L or more, and
when the specific gravity of the blood plasma separation material at 25°C is 1.070 or more and 1.120 or less, the osmotic pressure of the osmotic pressure measurement solution being 650 mOsm/L or more”
These limitations are being considered intended use limitations and as such the "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114 II).
Examiner notes that osmotic pressure of a solution depends on the concentration of dissolved solute particles (see attached NPL: Osmotic Pressure).
Since modified Sugimoto has the identical composition as the claimed device (i.e. the blood collection container main body, blood plasma separation material within the claimed specific gravity, an osmotic pressure regulator, and an anticoagulant) and since it would appear that the resultant osmotic pressure from obtaining the osmotic pressure measurement solution is dependent on the amount of saline used, which is not required by the claim, it would be within the skill of a person having ordinary skill in the art to obtain the claimed osmotic pressures by varying the amount of saline/predetermined amount of blood. Additionally, since the combined device of Sugimoto, Anraku, and Gelotte teaches each and every structural limitation presented in the independent claim, the combined device of Sugimoto, Anraku, and Gelotte is also necessarily a vacuum blood collection tube at least because placing the blood collection container within a vacuum device, the blood collection container will necessarily result in a vacuum being applied to the blood collection container making it a vacuum blood collection container.
Regarding claims 2-3, Sugimoto, Anraku, and Gelotte teaches the invention as discussed above in claim 1. Additionally, Sugimoto teaches that the blood plasma separation material is a blood plasma separation composition (see at least para. [0003]) containing an organic component having fluidity at 250C (see at least para. [0004]) that contains a resin (see para. [0027]) and an inorganic fine powder (see para. [0004]) that contains fine powder silica (see para. [0004]).
Regarding claims 4 and 6, Sugimoto, Anraku, and Gelotte teaches the invention as discussed above in claim 3. Additionally, Anraku teaches that hydrophobic silica fine particles are preferred (see col. 6, lines 4-8). Therefore, it is well known in the art that fine powder silica can comprise hydrophilic silica and hydrophobic silica.
Regarding claim 5, Sugimoto, Anraku, and Gelotte teaches the invention as discussed above in claim 4. Additionally, Anraku teaches a range for a content of silica at 2 parts by weight (see col. 6, line 33).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Sugimoto, Anraku, and Gelotte to make the content of the hydrophilic silica 0.01 wt% or more and 2.50 wt% or less in 100 wt% of the blood plasma separation composition at least since it has been held that 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 reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); see also MPEP 2144.05(I).
Regarding claim 8, Sugimoto, Anraku, and Gelotte teaches the invention as discussed above in claim 3. Additionally, Sugimoto teaches wherein the resin comprises a petroleum resin, a cyclopentadiene-based resin, a polyester resin, or a (meth)acrylic-based resin (see para. [0027]).
Regarding claim 10, Sugimoto, Anraku, and Gelotte teaches the invention as discussed above in claim 1. Additionally, Sugimoto teaches that a buffer 2 is disposed on a surface of the blood plasma separation material 3 (see Fig. 1).
Therefore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Sugimoto, Anraku, and Gelotte to dispose the osmotic pressure regulator and anticoagulant on a surface of the blood plasma separation material as taught by Sugimoto in Fig. 1.
Regarding claim 11, Sugimoto, Anraku, and Gelotte teaches the invention as discussed above in claim 1. Additionally, Anraku teaches that the osmotic pressure regulator is sodium chloride (see col. 4, lines 16-18).
Regarding claim 12, Sugimoto, Anraku, and Gelotte teaches the invention as discussed above in claim 1. Since Sugimoto, Anraku, and Gelotte has the same structural features as the claimed device, it would be expected to function in the same way when in use. See MPEP 2112.01(I). Therefore Sugimoto, Anraku, and Gelotte is used for detecting extracellular nucleic acid in blood, as required by the claim.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sugimoto (U.S. Pre Grant Pub. No. 2017/0131189 A1), in view of Anraku (U.S. Patent No. 7,090,970 B2) further in view of Gelotte (U.S. Patent No. 5,733,919 A), as applied above to claim 3, and further in view of Okamoto (U.S. Pre Grant Pub. No. 2020/0209215 A1).
Regarding claim 7, Sugimoto, Anraku, and Gelotte teaches the invention as discussed above in claim 3. However, neither Sugimoto, Anraku, nor Gelotte explicitly teach wherein when the specific gravity of the blood plasma separation composition at 25°C is 1.05 or more, the inorganic fine powder contains an inorganic fine powder having a specific gravity larger than a specific gravity of the fine powder silica, as required by the claim.
Okamoto teaches an analogous composition for separating blood serum or blood plasma (see at least Abstract). Okamoto teaches the use of inorganic powder having a specific gravity greater than that of silica fine powder (see para. [0105]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Sugimoto, Anraku, and Gelotte to incorporate the teachings of Okamoto by making the inorganic fine powder contain an inorganic fine powder having a specific gravity larger than a specific gravity of the fine powder silica when the specific gravity of the blood plasma separation composition at 25°C is 1.05 or more at least because Okamoto teaches that this results in effectively increasing the specific gravity of the composition for separating blood plasma, and thus, the composition for separating blood plasma can be suitably used as the composition for separating white blood cell-containing blood plasma and the composition for separating mononuclear cell-containing blood plasma, as taught by Okamoto (see para. [0105]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sugimoto (U.S. Pre Grant Pub. No. 2017/0131189 A1), in view of Anraku (U.S. Patent No. 7,090,970 B2) further in view of Gelotte (U.S. Patent No. 5,733,919 A), as applied above to claim 1, further in view of Gerber (U.S. Pre Grant Pub. No. 2018/0021501 A1), and further in view of Ivosevic (U.S. Pre Grant Pub. No. 2016/0103046 A1).
Regarding claim 9, Sugimoto, Anraku, and Gelotte teaches the invention as discussed above in claim 1. However, neither Sugimoto, Anraku, nor Gelotte explicitly teach that the osmotic pressure regulator is contained in the blood collection container main body in a powder state or in a state of being dissolved in a liquid and that the anticoagulant is contained in the blood collection container main body in a powder state or in a state of being dissolved in a liquid, as required by the claim.
Gerber teaches an analogous medical device for separating components of blood (see at least Abstract describing the device as being used for peritoneal dialysis). Gerber further teaches the use of osmotic agents dissolved in a fluid (see para. [0071-0072]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Sugimoto, Anraku, and Gelotte to incorporate the teachings of Gerber by containing the osmotic pressure regulator in the blood collection container main body in a powder state or in a state of being dissolved in a liquid at least because Gerber teaches that dissolved osmotic agents are beneficial in driving a net movement of fluid by osmosis due to concentration differences of the osmotic agent (see at least para. [0071]).
However, neither Sugimoto, Anraku, Gelotte, nor Gerber explicitly teach that the anticoagulant is contained in the blood collection container main body in a powder state or in a state of being dissolved in a liquid, as required by the claim.
Ivosevic teaches an analogous blood collection device (see Abstract) comprising a housing containing an anticoagulant powder (see Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Sugimoto, Anraku, Gelotte, and Gerber to incorporate the teachings of Ivosevic by containing the anticoagulant in the blood collection container main body in a powder state or in a state of being dissolved in a liquid at least because the use of anticoagulant powder is well known in the art, as evidenced by the disclosure in Ivosevic, and at least in order to increase the surface area of the anticoagulant, thereby increasing the effectiveness of reducing coagulation in the blood that is collected in the blood collection container.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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/JIHAD DAKKAK/
Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
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