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 .
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.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 20 is objected to because of the following informalities:
in claim 20, line 4: “the” should be inserted before “above-mentioned fluids”. Appropriate correction is required.
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 7 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 7 recites “wherein a negative pressure interval is formed between the outer tube and the inner tube” in lines 1-2, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
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.
Claims 1, 10, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,506,167 (Ishimito)(previously cited), in view of U.S. Patent Application Publication No. 2022/0168729 (Noguchi)(previously cited).
Ishimito teaches a tube body (the tube 42 of Ishimito), a tube plug (the plug 180 of Ishimito); and a filter (the tube 40 and filter 20 of Ishimito). The tube plug 180 engages with the tube 40 of Ishimito (see FIG. 13 and 15A-15B of Ishimito). Noguchi teaches a more secure connection between a tube 120 and a tube plug 110 in which the tube 120 has a step between a protrusion 125 and a recess 126 that engages with a step of the plug 110 between a protrusion 112 and a recess 113 (paragraphs 0026-0027 and FIGS. 4 and 8 of Noguchi). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the plug 180 of Ishimito with a step between a protrusion 112 and a recess 113 and to provide the tube 40 of Ishimito with a step between a protrusion 125 and a recess 126 so as to form a more secure connection between the two components.
With respect to claim 1, the combination teaches or suggests a body fluid collection device, wherein the body fluid collection device comprises:
a tube body (the tube 42 of Ishimito), wherein the tube body is configured to accommodate a collected body fluid and is provided with one opened end;
a tube plug (the plug 180 of Ishimito), wherein the tube plug is configured to be able to hermetically close the opened end of the tube body; and
a filter (the tube 40 and filter 20 of Ishimito), wherein the filter is arranged in the tube body and configured to filter out specific components from the collected body fluid,
wherein the filter is configured to be capable of being attached to the tube plug at an open end (the tube 40 is attached to the plug 180 of Ishimito in FIGS. 13 and 15A-15B of Ishimito), and the tube plug is hermetically connected to the filter (the tube 40 and the plug 180 are so connected in FIGS. 13 and 15A-15B of Ishimito),
wherein the tube plug has a first section (the widest portion of the plug 180 that is above the first fitting part 18d in FIG. 13 of Ishimito), a second section (the first fitting part 18d of Ishimito), and a third section (the second fitting part 18e of Ishimito) with decreasing diameters in sequence,
wherein an outer diameter of the first section is larger than an outer diameter of the tube body (the widest portion of the plug 180 that is above the first fitting part 18d in FIG. 13 of Ishimito is larger than the tube 42 of Ishimito), the second section is configured to be able to form an interference fit with the tube body (the first fitting part 18d of Ishimito is fitted into the tube 42 of Ishimito without creating a gap; col. 9, lines 19-35 of Ishimito), and the third section is configured to be able to form an interference fit with the filter (the second fitting part 18e of Ishimito is fitted into the tube 40 of Ishimito without creating a gap; col. 9, lines 19-35 of Ishimito).
wherein the tube body is provided with a step on one side of the opened end (the step 42a of Ishimito).
wherein an open end of the filter connected to the tube plug is provided with a flange (the flange 40c of Ishimito),
wherein the flange is provided with a first sub-flange protruding radially outwardly from a cylinder body of the filter (the flange 40c extends radially outward from the cylindrical body of the tube 40 of Ishimito),
wherein the first sub-flange is configured to abut against the step (the flange 40c abuts against the step 42c of Ishimito in FIG. 13 of Ishimito).
wherein the flange has a second sub-flange protruding radially inwardly (the protrusion 125 of Noguchi formed on the tube 40 of Ishimito) from the cylinder body of the filter (the cylindrical body of the tube 40 of Ishimito),
wherein a groove (the recess 113 of Noguchi formed on the plug 180 of Ishimito) is provided between the second section and the third section of the tube plug, and the second sub-flange can engage into the groove (paragraphs 0026-0027 and FIGS. 4 and 8 of Noguchi).
With respect to claim 10, Ishimito teaches a tube 40 and a filter 20 in FIG. 13 of Ishimito. Ishimito also teaches a combination of tube and filter in which the filter 20 is placed at a second end of the tube 40 opposite to the open end of the tube 40 (FIGS. 8-10 of Ishimito). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the filter 20 at the second end of the tube 40 opposite the open end of the tube 40, as suggested by Ishimito, since it is a simple substitution of one known element for another to obtain predictable results. Thus, the combination teaches or suggests that a filter membrane (the filter 20 of Ishimito) is provided at a second end of the filter opposite to the open end, wherein the filter membrane (the filter 20 of Ishimito) is spaced at a predetermined distance from a bottom of the tube body (the tube 42 of Ishimito).
With respect to claim 13, the combination teaches or suggests that at least one of two end sides of the tube plug (the plug 180 of Ishimito) in an axial direction is provided with a recess (the recess at the top of the plug 180 in FIG. 13 of Ishimito).
With respect to claim 14, the combination teaches or suggests that a functional substance is arranged in the tube body (the blood of Ishimito; abstract of Ishimito).
With respect to claim 15, the combination teaches or suggests that the collected body fluid is blood, cerebrospinal fluid, gastric juice, digestive fluid, semen, saliva, sputum, tears, sweat, urine, vaginal secretion, hydrops, or liquid mixtures containing above-mentioned fluids (the blood of Ishimito; abstract of Ishimito).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,506,167 (Ishimito)(previously cited), in view of U.S. Patent Application Publication No. 2022/0168729 (Noguchi)(previously cited), in view of JP 2017099739 (Tatsuo)(previously cited). Citations to Tatsuo refer to the machine English translation that accompanied the Office Action mailed on 4/15/2026.
Ishimito teaches a tube body (the tube 42 of Ishimito), a tube plug (the plug 180 of Ishimito); and a filter (the tube 40 and filter 20 of Ishimito). Tatsuo teaches a double tube 1 that is frozen together with blood in order to store the collected blood in a frozen state (page 2 of Tatsuo). The double tube includes an outer tube body 12 with an inner tube body 11 having a flange 11e contacting the outer tube body 12 at the top and a lower face 11g contacting the bottom face 12d of the outer tube body 12 at the bottom (pages 1-2 and FIG. 5 of Tatsuo). The outer tube body 12 is made of PE, PET, or PS while the inner tube body 11 is made of PE, PET, PP, or PS (page 1 of Tatsuo). The plug member 3 extends from its widened portion outside the inner tube body 11 to a widened portion outside the outer tube body 12 (see FIG. 5 of Tatsuo). A negative pressure is formed in the gap between the inner and outer tube bodies (pages 1-2 of Tatsuo). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the outer tube body 12 of Tatsuo made of PE, PET, or PS, to provide the flange 11e and the lower face 11g of Tatsuo to the tube 42 of Ishimito, to extend the plug 180 from its widened portion outside the tube body 42 of Ishimito to a widened portion outside the outer tube body 12 of Tatsuo, and to form a negative pressure in the gap between the inner and outer tube bodies since it permits the tube and blood to be frozen for long-term storage.
With respect to claim 6, the combination teaches that the tube body is provided with an outer tube (the outer tube body 12 of Tatsuo) and an inner tube (the modified tube body 42 of Ishimito) connected together by a bridging portion (the flange 11e of Tatsuo on the modified tube body 42 of Ishimito), wherein an axial length of the inner tube is smaller than an axial length of the outer tube, and an open side of the inner tube is spaced apart from an open side of the outer tube (see the relative spacing of the inner and outer tubes suggested by FIG. 2 of Tatsuo).
With respect to claim 7, the combination teaches that a negative pressure interval is formed between the outer tube and the inner tube (a negative pressure is formed in the gap between the inner and outer tube bodies; pages 1-2 of Tatsuo).
With respect to claim 8, the combination teaches that the outer tube is made of polyethylene terephthalate (PET) (The outer tube body 12 is made of PET), and the bridging portion and the inner tube are made of polyethylene terephthalate (PET) or polypropylene (PP) (Tatsuo teaches that the inner tube body 11 with its flange 11e is made of PET or PP (page 1 of Tatsuo). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the tube 42 of Ishimito out of PET or PP as suggested by Tatsuo since it is a simple substitution of one known element for another to obtain predictable results); or the outer tube and the inner tube are made of polyethylene (PE), polystyrene (PS), polycarbonate (PC), polyamide (PA), or borosilicate glass (Tatsuo teaches that the outer tube body 12 is be made of PE or PS; Tatsuo also teaches that the inner tube body 11 is made of PE or PS (page 1 of Tatsuo). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the tube 42 of Ishimito out of PE or PS as suggested by Tatsuo since it is a simple substitution of one known element for another to obtain predictable results).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,506,167 (Ishimito)(previously cited), in view of U.S. Patent Application Publication No. 2022/0168729 (Noguchi)(previously cited), in view of U.S. Patent No. 6,534,016 (Cohen)(previously cited).
Ishimito teaches a device for collecting blood to achieve an increased speed of blood collection and separation as well as ease of handling of plasma components after blood separation (abstract of Ishimito). Cohen teaches that blood tubes are made of polyethylene terephthalate (col. 8, lines 10-20 of Cohen) with an application of a silicone surfactant and silica material as a clot activator so as to reduce the surface tension of blood and enhance clotting (col. 3, lines 1-66, col. 5, lines 25-65 of Cohen). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyethylene terephthalate with an application of a silicone surfactant and silica for the tube 42 of Ishimito since it reduces the surface tension of blood and enhances clotting.
With respect to claim 9, the combination teaches or suggest that an inner wall of the tube body is siliconized and is provided with a first material layer for the collected body fluids (the application of the silicone surfactant on the polyethylene terephthalate material of the tube 42 of Ishimito) and/or an inner wall of the filter is siliconized and is provided with a second material layer for the collected body fluids.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,506,167 (Ishimito)(previously cited), in view of U.S. Patent Application Publication No. 2022/0168729 (Noguchi)(previously cited), in view of U.S. Patent Application Publication No. 2013/0134122 (Niunoya)(previously cited).
Ishimito teaches a tube body (the tube 42 of Ishimito), a tube plug (the plug 180 of Ishimito); and a filter (the tube 40 and filter 20 of Ishimito). Niunoya teaches a cover member 3 with an annular shoulder 3e that engages with a grip part 2b of the plug body 2 (paragraph 0051 and FIGS. 1(a)-1(c) of Niunoya). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the cover member 3 with the annular shoulder 3e of Niunoya and to configure the grip part of the plug 180 of Ishimito so as to engage with the annular shoulder 3e of Niunoya since it better protects the plug 180 of Ishimito. Thus, the combination teaches or suggests that the body fluid collection device is provided with a cover (the cover member 3 of Niunoya), wherein the cover covers the tube plug (the cover member 3 of Niunoya covers the plug 180 of Ishimito) and is connected to the tube plug in a force transmission manner (the force transmission manner is via the engagement of the annular shoulder 3e of Niunoya with the grip portion of the plug body 180).
With respect to claim 12, the combination teaches or suggests that an inner wall of the cover (the cover member 3 of Niunoya) is provided with an annular projection (the annular shoulder 3e of Niunoya), wherein an inner diameter of a cross-section of the annular projection gradually decreases in a direction from an open side of the cover towards a top of the cover (see the decreasing cross-section in FIGS. 1(a)-1(c) of Niunoya), wherein the first section of the tube plug is located between the top of the cover and the annular projection (the widest portion of the plug 180 that is above the first fitting part 18d in FIG. 13 of Ishimito is located between the top of the cover member 3 of Niunoya and the annular shoulder 3e of Niunoya).
Response to Arguments
The Applicant's arguments filed 7/9/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 7/29/2026, the previous claim objections are withdrawn. However, there are new grounds of claim objections that were necessitated by the claim amendments filed on 7/9/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 7/29/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn with the exception to the rejection of claim 7.
With respect to the rejection to claim 7, the Applicant asserts:
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This argument is not persuasive since the recitation is couched in terms of an action using a present tense, passive voice verb “is formed”, rather than a participial phrase. For example, “wherein a negative pressure interval is formed between the outer tube and the inner tube” is an action while “further comprising a negative pressure interval formed between the outer tube and the inner tube” connotes a structure using a participial phrase. Since the claim recites an action step in an apparatus claim, the claim is indefinite.
Prior art rejection
The Applicant’s arguments with respect to the rejection of claims 6-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection that were necessitated by the claim amendments filed on 7/9/2026.
With respect to the rejection of claim 1, the Applicant asserts:
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This argument is not persuasive. Ishimito teaches a tube body (the tube 42 of Ishimito), a tube plug (the plug 180 of Ishimito); and a filter (the tube 40 and filter 20 of Ishimito). The tube plug 180 engages with the tube 40 of Ishimito (see FIG. 13 and 15A-15B of Ishimito). Noguchi teaches a more secure connection between a tube 120 and a tube plug 110 in which the tube 120 has a step between a protrusion 125 and a recess 126 that engages with a step of the plug 110 between a protrusion 112 and a recess 113 (paragraphs 0026-0027 and FIGS. 4 and 8 of Noguchi). That is, the combination teaches a more secure form of connection between a tube and a tube plug, which is applicable to the tube plug 180 and the tube 40 of Ishimito. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the plug 180 of Ishimito with a step between a protrusion 112 and a recess 113 and to provide the tube 40 of Ishimito with a step between a protrusion 125 and a recess 126 so as to form a more secure connection between the two components. As a result, the combination teaches that the flange has a second sub-flange protruding radially inwardly (the protrusion 125 of Noguchi formed on the tube 40 of Ishimito) from the cylinder body of the filter (the cylindrical body of the tube body 40 of Ishimito), wherein a groove (the recess 113 of Noguchi formed on the plug 180 of Ishimito) is provided between the second section and the third section of the tube plug, and the second sub-flange can engage into the groove (paragraphs 0026-0027 and FIGS. 4 and 8 of Noguchi).
The Applicant asserts:
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The argument is not persuasive. As previously mentioned, the combination of Ishimito and Noguchi teaches a more secure form of connection between a tube and a tube plug, which is applicable to the tube plug 180 and the tube 40 of Ishimito. Also, nothing in Noguchi directly disparages the use of the more secure connection in this context. As a result, Noguchi does not teach away from this combination.
Thus, the prior art provide sufficient motivation for the combination.
On pages 14-15, the Applicant asserts the present application’s beneficial technical benefits. However, these benefits do not provide a basis for physically distinguishing the prior art from the claimed language.
For at least these reasons, the rejection of claim 1 based on Ishimito and Noguchi is proper.
Claims 6-15 are properly rejected since the rejection of claim 1 is proper and the prior art teaches or suggests all the features of these claims.
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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