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 .
DETAILED ACTION
Status of Claims
Claims 1-17 are pending. Claims 1, 15 and 17 have been withdrawn as drawn to non-elected inventions. Claims 2-14 and 16 have been examined.
Election/Restriction
Applicant’s election of Group II, claims 2-14 and 16, in the reply filed on 12/04/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application, Serial No. 17/908,407 (PGPub: US2023/0090675) was filed 08/31/2022. This application is a 371 of PCT/JP2021/009804 filed 03/11/2021. This application claims priority to Foreign Application Japan 2020-042080 filed 03/11/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)- (d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statements
The Information Disclosure Statements filed 08/31/2022, 10/13/2022, 03/29/2024, 01/02/2025, 01/14/2025 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is 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 16 recites “the method” and there is no antecedent basis for this limitation as no method has been claimed in claim 2.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-3, 7-8, 12 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugimoto et al. (US 2017/0131189, Pub Date: 05/11/2017).
Regarding claims 2 and 7-8, Sugimoto teaches throughout the publication a blood collection container by which a predetermined amount of blood is collected (paragraph 0037), the blood collection container comprising:
a blood collection container main body (paragraph 0038, container 1); and
a hemocyte separation material contained in the blood collection container main body (paragraph 0038, polymer gelling agent for separation), the hemocyte separation material having a specific gravity at 25°C of 1.075 or more and 1.093 or less (paragraph 0028), and
the blood collection container including a configuration B2 below: the blood collection container including an osmotic pressure regulator contained in the blood collection container main body (paragraphs 0023 and 0038, dilution buffer).
While Sugimoto does not specifically teach that when a water-soluble component contained in the blood collection container main body is dissolved with physiological saline in an amount equal to the predetermined amount of blood to be collected in the blood collection container to obtain a solution for osmotic pressure measurement, the solution for osmotic pressure measurement having an osmotic pressure of 300 mOsm/L or more and 500 mOsm/L or less and more specifically, an osmotic pressure of 320-360 mOsm/L, as in claim 8, such limitations are drawn to intended use of the blood container main body and therefore the prior art only needs to be capable of performing the recited intended use. So long as the blood container of Sugimoto is capable of containing a water-soluble component to dissolve with saline and thus obtain a solution for osmotic pressure measurement, it reads on the claims. Sugimoto teaches the same structure as claimed in the device comprising a collection container and an osmotic pressure regulator (paragraphs 0014 and 0023) and therefore would be seen as capable of performing the recited intended use.
Regarding claim 3, Sugimoto teaches the container wherein the hemocyte separation material is a hemocyte separation composition having thixotropy (paragraph 0027).
Regarding claim 12, Sugimoto teaches the container comprising an anticoagulant contained in the blood collection container main body (paragraph 0057).
Regarding claim 16, Sugimoto teaches the method for separating leukocytes using the blood collection container according to claim 2 (described above), the method comprising the steps of: collecting blood in the blood collection container; and centrifuging the blood collection container by which the blood has been collected (paragraph 0046).
Claim(s) 2-3, 7-8, 10, 12 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carrol et al. (US 4,816,168, Patent Date 03/28/1989, IDS).
Regarding claims 2 and 7-8, Carrol teaches throughout the publication a blood collection container by which a predetermined amount of blood is collected (see column 15, claim 10a, container), the blood collection container comprising:
a blood collection container main body (column 15, claim 10a, container); and
a hemocyte separation material contained in the blood collection container main body (column 15, claim 10b, separation medium), the hemocyte separation material having a specific gravity at 25°C of 1.075 (see column 16, claim 26; column 10, lines 33-38), and
the blood collection container including a configuration B2 below: the blood collection container including an osmotic pressure regulator contained in the blood collection container main body (column 15, claim 10c, hypertonic fluid; column 8, lines 51-57).
While Carrol does not specifically teach that when a water-soluble component contained in the blood collection container main body is dissolved with physiological saline in an amount equal to the predetermined amount of blood to be collected in the blood collection container to obtain a solution for osmotic pressure measurement, the solution for osmotic pressure measurement having an osmotic pressure of 300 mOsm/L or more and 500 mOsm/L or less and more specifically, an osmotic pressure of 320-360 mOsm/L, as in claim 8, such limitations are drawn to intended use of the blood container main body and therefore the prior art only needs to be capable of performing the recited intended use. So long as the blood container of Carrol is capable of containing a water-soluble component to dissolve with saline and thus obtain a solution for osmotic pressure measurement, it reads on the claims. Carrol teaches the same structure as claimed in the device comprising a collection container and an osmotic pressure regulator (see reference claim 10) and therefore would be seen as capable of performing the recited intended use.
Regarding claim 3, Carrol teaches the container wherein the hemocyte separation material is a hemocyte separation composition having thixotropy (column 9, lines 63-67).
Regarding claim 10, Carrol teaches the container wherein the osmotic pressure regulator is sodium chloride (column 8, lines 54-57).
Regarding claim 12, Carrol teaches the container comprising an anticoagulant contained in the blood collection container main body (column 11, lines 47-48; reference claim 16).
Regarding claim 16, Carrol teaches the method for separating leukocytes using the blood collection container according to claim 2 (described above), the method comprising the steps of: collecting blood in the blood collection container; and centrifuging the blood collection container by which the blood has been collected (column 11, lines 64-67).
Claim Rejections - 35 USC § 103
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sugimoto et al. (US 2017/0131189, Pub Date: 05/11/2017), as applied to claim 2 above.
Regarding claim 9, Sugimoto teaches the container as described above wherein the separation material has a specific gravity up to 1.08 at 25 degrees C (paragraph 0028). While Sugimoto does not specifically teach that the separation material has a specific gravity at 25°C of 1.082 or more and 1.090 or less, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 9 are for any particular purpose or solve any stated problem, and the prior art teaches that the separation gel has a specific gravity based on the desired components to be separated in the blood sample. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the blood container art.
Regarding limitations drawn to the solution for osmotic pressure measurement, as described above, such limitations are drawn to intended use of the blood container main body and therefore the prior art only needs to be capable of performing the recited intended use. So long as the blood container of Sugimoto is capable of containing a water-soluble component to dissolve with saline and thus obtain a solution for osmotic pressure measurement, it reads on the claims. Sugimoto teaches the same structure as claimed in the device comprising a collection container and an osmotic pressure regulator (paragraph 0023) and therefore would be seen as capable of performing the recited intended use.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Carrol (US 4,816,168, Patent Date 03/28/1989, IDS), as applied to claim 2 above.
Regarding claim 9, Carrol teaches the container as described above wherein the separation material has a specific gravity up to 1.075 (See reference claim 26). While Carrol does not specifically teach that the separation material has a specific gravity at 25°C of 1.082 or more and 1.090 or less, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 9 are for any particular purpose or solve any stated problem, and the prior art teaches that the separation gel has a specific gravity based on the desired components to be separated in the blood sample. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the blood container art.
Regarding limitations drawn to the solution for osmotic pressure measurement, as described above, such limitations are drawn to intended use of the blood container main body and therefore the prior art only needs to be capable of performing the recited intended use. So long as the blood container of Carrol is capable of containing a water-soluble component to dissolve with saline and thus obtain a solution for osmotic pressure measurement, it reads on the claims. Carrol teaches the same structure as claimed in the device comprising a collection container and an osmotic pressure regulator (column 8, lines 54-57) and therefore would be seen as capable of performing the recited intended use.
Claim(s) 4-6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Sugimoto et al. (US 2017/0131189, Pub Date: 05/11/2017), as applied to claim 2 above, and further in view of Tan et al. (US 2018/0303395 Pub Date: 10/25/2018).
Regarding claims 4-6 and 11, Sugimoto teaches the container including configuration B2 as described above but fails to teach that the container also includes the configuration A2 wherein the hemagglutinating agent is dextran, hydroxyethyl starch, or polyethylene glycol.
Tan teaches throughout the publication methods and devices for separating components of whole blood (abstract). More specifically, Tan teaches that the sample collection receptable can include agents to help aggregate blood cells and enhance separation efficiency, with agents including high molecule weight polymers such as 6% hydroxyethyl starch, 3% dextran with a molecular weight >73,000 or polyethylene glycol of various molecule weight (paragraphs 0028 and 0030).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to combine the blood collection container of Sugimoto with an agent such as dextran (MW>73kDa) – claimed configuration A2 – as taught by Tan because Tan explicitly teaches that incorporation of these agents induces blood aggregation and enhances separation efficiency (paragraph 0030).
Claim(s) 4-6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Carrol (US 4,816,168, Patent Date 03/28/1989, IDS), as applied to claim 2 above, and further in view of Tan et al. (US 2018/0303395 Pub Date: 10/25/2018).
Regarding claims 4-6 and 11, Carrol teaches the container including configuration B2 as described above but fails to teach that the container also includes the configuration A2 wherein the hemagglutinating agent is dextran, hydroxyethyl starch, or polyethylene glycol.
Tan teaches throughout the publication methods and devices for separating components of whole blood (abstract). More specifically, Tan teaches that the sample collection receptable can include agents to help aggregate blood cells and enhance separation efficiency, with agents including high molecule weight polymers such as 6% hydroxyethyl starch, 3% dextran with a molecular weight >73,000 or polyethylene glycol of various molecule weight (paragraphs 0028 and 0030).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to combine the blood collection container of Carrol with an agent such as dextran (MW>73kDa) – claimed configuration A2 – as taught by Tan because Tan explicitly teaches that incorporation of these agents induces blood aggregation and enhances separation efficiency (paragraph 0030).
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sugimoto et al. (US 2017/0131189, Pub Date: 05/11/2017), as applied to claim 2 above, and further in view of Haghgooie et al. (US 2012/0275955 Pub Date: 11/01/2012).
Regarding claims 13-14, Sugimoto teaches the container as described above but does not specifically teach the inclusion of an antioxidant such as ascorbic acid or an inorganic salt of ascorbic acid.
Haghgooie teaches throughout the publication the separation of blood within a device (abstract). More specifically, Haghgooie teaches that the device can include anticoagulants or stabilizing agents to stabilize the fluid sample. Examples of agents that can be used in conjunction with anticoagulants include antioxidants such as ascorbic acid (paragraph 0183).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the container of Sugimoto, an antioxidant such as ascorbic acid as taught by Haghgooie because it would have been desirable to stabilize the blood sample (Haghgooie, paragraph 0183). One skilled in the art would have had a reasonable expectation of success in incorporating the antioxidant of Haghgooie within the container of Sugimoto since Sugimoto also incorporates an anticoagulant and Haghgooie teaches that the antioxidant can be utilized with the anticoagulant to stabilize the fluid sample.
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Carrol (US 4,816,168, Patent Date 03/28/1989, IDS), as applied to claim 2 above, and further in view of Haghgooie et al. (US 2012/0275955 Pub Date: 11/01/2012).
Regarding claims 13-14, Carrol teaches the container as described above but does not specifically teach the inclusion of an antioxidant such as ascorbic acid or an inorganic salt of ascorbic acid.
Haghgooie teaches throughout the publication the separation of blood within a device (abstract). More specifically, Haghgooie teaches that the device can include anticoagulants or stabilizing agents to stabilize the fluid sample. Examples of agents that can be used in conjunction with anticoagulants include antioxidants such as ascorbic acid (paragraph 0183).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the container of Carrol, an antioxidant such as ascorbic acid as taught by Haghgooie because it would have been desirable to stabilize the blood sample (Haghgooie, paragraph 0183). One skilled in the art would have had a reasonable expectation of success in incorporating the antioxidant of Haghgooie within the container of Carrol since Carrol also incorporates an anticoagulant and Haghgooie teaches that the antioxidant can be utilized with the anticoagulant to stabilize the fluid sample.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677