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 .
Specification
The abstract of the disclosure is objected to because “including” in line 1 should be “includes”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 5, 7, and 12-14 are objected to because of the following informalities:
in claim 1, line 21: “the” should be inserted before “air”;
in claim 5, line 2: “to be” should be inserted after “configured”;
in claim 5, line 3: “to” should be inserted after “configured”;
in claim 7, line 1: “to be” should be inserted after “configured”;
in claim 12, line 3: “the” should be inserted before “air”;
in claim 13, line 3: the comma before the period should be deleted;
in claim 14, line 2: “an ambient” should be “the ambient”;
in claim 14, line 4: “a bodily fluid” should be “the bodily fluid”;
in claim 14, line 6: “an interior” should be “the interior”;
in claim 14, line 6: “an extraction of a bodily fluid” should be “the extraction of the bodily fluid”;
in claim 14, line 7: “a vacuum” should be “the vacuum”; and
in claim 14, line 8: “an ambient” should be “the ambient”.
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.
Claims 1 and 3-15 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 “wherein the cover and the container jointly form an airtight sealing seat in the sealing position of the set” in lines 7-8, “wherein air from the ambient flows into the interior of the container and vents the interior of the container in the venting position of the set” in lines 15-16, and “wherein the gap is caused by a deformation of the cover and/or the container caused by a contact with the container and/or the cover” in lines 20-21, which are action steps 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 1 recites “wherein the gap is caused by a deformation of the cover and/or the container caused by a contact with the container and/or the cover” in lines 20-21, but it is not clear what the container and/or cover comes in contact with so as to cause the deformation. This ambiguity renders claim 1 indefinite.
Claims 3-4 and 12-13 depend from now canceled claim 2, which renders the metes and bounds of these claims indefinite since it is not clear what is encompassed by the recitation of the canceled claim. For the purposes of examination, these claims will be considered to be dependence from claim 1.
Claims 3-15 are rejected by virtue of their dependence from claim 1.
Claim 13 recites “wherein the airflow channel is arranged in a contact portion of the cover and of the container in a circumferential annular face of the container in the sealing position of the set” in lines 1-3, which is so grammatically awkward that its meaning is not clear.
Claim 14 recites “air” in line 4 and “air…from the ambient” in line 11, but it is not clear if these recitations are the same as, related to, or different from “air from the ambient” of claim 1, line 15. If they are the same, “the” should precede “air” in both instances in claim 14. If they are different, they should be clearly distinguished from the recitation of claim 1 (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).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-4 and 12-13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 3-4 and 12-13 depend from now canceled claim 2, which is improper. For the purposes of examination, these claims will be considered to be dependence from claim 1.
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, 3-4, and 7-15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/006258 (Dischino)(cited by Applicant), in view of U.S. Patent Application Publication No. 2019/0015830 (Blaszcak).
Dischino teaches a set, comprising: a container (the container 22 of Dischino) configured to store at least one bodily fluid; and a cover (the container lid 24 of Dischino) configured to close the container, wherein the container includes an interior configured to store the bodily fluid (the interior of the container 22 of Dischino). Dischino also teaches that the set is transferrable at least between a sealing interface 70 configured to at least partially contact the collection container when the container lid is coupled to the collection container, wherein the sealing interface includes a textured sealing surface region configured to allow air into or out of the container assembly when the container lid is coupled to the collection container, while maintaining a substantially fluid-tight seal between the container lid and the collection container (abstract, paragraphs 0009, 0031, and 0033-0037 of Dischino),
Blaszcak teaches a set, comprising: a container (the tube 100, 200, 500, 600 of Blaszcak) configured to store at least one bodily fluid; and a cover (the cap 300, 500, 600, 700 of Blaszcak) configured to close the container, wherein the container includes an interior configured to store the bodily fluid (the interior of the tube 100, 200, 500, 600 of Blaszcak), wherein the set is transferrable at least between a sealing position (the sealing engagement of Blaszcak) and a venting position (the disruption of the seal of Blaszcak), wherein the cover and the container jointly form an airtight sealing seat in the sealing position of the set (the sealing seat formed by the annular projections or ribs of Blaszcak; Abstract, paragraphs 0003, 0005, 0011, 0017, 0020-0021, 0024, 0027, 0029-0031, 0034, 0038-0041, 0043, 0046, 0091-0094, 0115-0117 of Blaszcak). Also, Blaszcak teaches that the cover and the container are deformable by a pressure differential between the interior of the container and an ambient so that the set is transferrable from the sealing position into the venting position (paragraphs 0020, 0039, 0091-0094, 0115-0117 of Blaszcak). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sealing seat formed by the annular projections or ribs of Blaszcak that are deformable by a pressure differential between the interior of the container and an ambient so that the set is transferrable from the sealing position into the venting position in lieu of the sealing interface 70 of Dischino since it is a simple substitution of one known element for another to obtain predictable results and/or it permits a higher form of sealing in the sealing position.
With respect to claim 1, the combination teaches or suggests a set, comprising:
a container (the container 22 of Dischino) configured to store at least one bodily fluid; and
a cover (the container lid 24 of Dischino) configured to close the container,
wherein the container (the interior of the container 22 of Dischino) includes an interior configured to store the bodily fluid,
wherein the set is transferrable at least between a sealing position (the sealing engagement of Blaszcak) and a venting position (the disruption of the seal engagement of Blaszcak), wherein the cover and the container jointly form an airtight sealing seat in the sealing position of the set (abstract, paragraphs 0009, 0031, and 0033-0037 of Dischino; Abstract, paragraphs 0003, 0005, 0011, 0017, 0020-0021, 0024, 0027, 0029-0031, 0034, 0038-0041, 0043, 0046, 0091-0094, 0115-0117 of Blaszcak),
wherein the cover includes an extraction unit (the receptacle 52 of Dischino) configured to extract the bodily fluid from the container when the set is in the sealing position,
wherein the cover and/or the container are deformable by a pressure differential between the interior of the container and an ambient when a vacuum is present in the interior of the container caused by the extraction of the bodily fluid by the extraction unit from the container, so that the set is transferrable from the sealing position into the venting position, wherein air from the ambient flows into the interior of the container and vents the interior of the container in the venting position of the set (using the annular projections or ribs of Blaszcak that are deformable by a pressure differential between the interior of the container and an ambient so that the set is transferrable from the sealing position into the venting position in lieu of the sealing interface 70 of Dischino when allowing air into or out of the container; paragraphs 0009-0010, 0012-0013, 0034, and 0036 of Dischino; Abstract, paragraphs 0003, 0005, 0011, 0017, 0020-0021, 0024, 0027, 0029-0031, 0034, 0038-0041, 0043, 0046, 0091-0094, 0115-0117 of Blaszcak),
wherein the cover (the container lid 24 of Dischino) includes at least one venting element (one of the annular projections or ribs of Blaszcak) that generates at least one gap (the gap caused by the one disrupted annular projection or rib of Blaszcak) in the sealing seat between the cover and the container when the set is in the venting position, and wherein the gap is caused by a deformation of the cover and/or the container caused by a contact with the container and/or the cover, wherein air is able to flow from the ambient through the at least one gap into the interior of the container (the gap caused by the one disrupted annular projection or rib permits air to flow).
With respect to claim 3, the combination teaches or suggests that the venting element is configured as a cam (the annular projections or ribs of Blaszcak).
With respect to claim 4, the combination teaches or suggests that the cam is arranged at a bottom side of the cover that is oriented towards the container when the set is in the sealing position (the position of the annular projections or ribs, suggested by Blaszcak).
With respect to claim 7, the combination teaches or suggests that the container (the container 22 of Dischino) is configured cup shaped (FIGS. 1-2 of Dischino).
With respect to claim 8, the combination teaches or suggests that the cover (the container lid 24 of Dischino) has a circular cross section (FIG. 1 of Dischino).
With respect to claim 9, the combination teaches or suggests that the cover is supportable at the container by an attachment device configured as a screw thread (the threaded portions 40 and 68 of Dischino).
With respect to claim 10, the combination teaches or suggests that a diameter of the cover (the container lid 24 of Dischino) is greater than a diameter of the container (the container 22 of Dischino), so that the cover reaches around the container at least partially in the sealing position of the set (FIG. 1 of Dischino).
With respect to claim 11, the combination teaches or suggests that an opening cross section of the extraction unit (the receptacle 52 of Dischino) is arranged in a plane with a cover surface arranged at a bottom side of the cover (the container lid 24 of Dischino; FIGS. 4A and 5A of Dischino).
With respect to claim 12, the combination teaches or suggests that the cover (the container lid 24 of Dischino) includes at least one airflow channel (the gap between the container 22 and the container lid 24 of Dischino), and wherein air is able to flow from the ambient into the interior of the container through the at least one airflow channel before or after flowing through the at least one gap (the gap in the disrupted annular projections or ribs of Blaszcak) when the set is in the venting position.
With respect to claim 13, the combination teaches or suggests that the airflow channel (the gap between the container 22 and the container lid 24 of Dischino) is arranged in a contact portion of the cover and of the container in a circumferential annular face of the container in the sealing position of the set (see the location of the sealing interface 70 of Dischino).
With respect to claim 14, the combination teaches or suggests a method for generating a pressure equalization between an interior of a container of a set according to claim 1 (see the above rejection of claim 1) and an ambient, the method comprising the steps:
arranging the set in the sealing position and arranging a bodily fluid and air in the interior of the container (the sealing position suggested by Dischino and Blaszcak);
reducing a pressure in an interior of the container due to an extraction of a bodily fluid by the extraction unit from the interior so that a vacuum is generated in the interior of the container relative to an ambient of the set (paragraphs 0032-0033 and 0036 of Dischino) and
deforming the cover and/or the container of the set (using the annular projections or ribs of Blaszcak that are deformable by a pressure differential between the interior of the container and an ambient so that the set is transferrable from the sealing position into the venting position in lieu of the sealing interface 70 of Dischino when allowing air into or out of the container; paragraphs 0009-0010, 0012-0013, 0034, and 0036 of Dischino; Abstract, paragraphs 0003, 0005, 0011, 0017, 0020-0021, 0024, 0027, 0029-0031, 0034, 0038-0041, 0043, 0046, 0091-0094, 0115-0117 of Blaszcak),
wherein the deformation transfers the set from the sealing position into the venting position in which air flows from the ambient into the interior of the container and vents the interior of the container so that the set is transferred back into the sealing condition (using the annular projections or ribs of Blaszcak that are deformable by a pressure differential between the interior of the container and an ambient so that the set is transferrable from the sealing position into the venting position in lieu of the sealing interface 70 of Dischino when allowing air into or out of the container; paragraphs 0009-0010, 0012-0013, 0034, and 0036 of Dischino).
With respect to claim 15, the combination teaches or suggests that the set is automatically transferred between the sealing position and the venting position (using the annular projections or ribs of Blaszcak that are deformable by a pressure differential between the interior of the container and an ambient so that the set is transferrable from the sealing position into the venting position in lieu of the sealing interface 70 of Dischino when allowing air into or out of the container; paragraphs 0009-0010, 0012-0013, 0034, and 0036 of Dischino).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Dischino in view of Blaszcak, and further in view of U.S. Patent Application Publication No. 2017/0013825 (Faldt).
The combination teaches or suggests that the extraction unit (the receptacle 52 of Dischino) is configured tubular and includes a needle or cannula configured to pierce a stopper of a specimen collection tube so as to allow the specimen to be drawn from the collection container 22 into the specimen collection tube (paragraph 0029 of Dischino). Also, the needle is well-protected within the receptacle 52 (paragraph 0029 of Dischino). Faldt teaches that such a needle has a protective silicon sleeve over it (paragraph 0022 and FIG. 1B of Faldt). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the protective silicon sleeve of Faldt over the needle of Dischino since it provides protection to the needle and/or it assists in isolating the sample from contaminant or inadvertent leaking.
With respect to claim 5, the combination teaches or suggests that the extraction unit (the receptacle 52 of Dischino) is configured tubular, and wherein the extraction unit is configured open at a first end (the open end of the needle of Dischino) and provided with a membrane that is self-closing after puncture at a second end (the protective silicon sleeve of Faldt).
With respect to claim 6, the combination teaches or suggests that the membrane (the protective silicon sleeve of Faldt) includes a predetermined puncture location, and wherein the membrane is slotted in an area of the predetermined puncture location (the slot formed upon insertion of the specimen collection tube).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Dischino in view of Blaszcak, and further in view of U.S. Patent No. 4,865,583 (Tu).
The combination teaches or suggests that the extraction unit (the receptacle 52 of Dischino) is configured tubular and includes a needle or cannula configured to pierce a stopper of a specimen collection tube so as to allow the specimen to be drawn from the collection container 22 into the specimen collection tube (paragraph 0029 of Dischino). Also, the needle is well-protected within the receptacle 52 (paragraph 0029 of Dischino). Tu teaches an alternative removal regime in the form of a sampling site 23 with a diaphragm 32 and a sampling syringe 19 (col. 5, lines 10-50 of Tu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the removal regime in the form of a sampling site 23 with a diaphragm 32 at the bottom of the receptacle 52 of Dischino and a sampling syringe 19 of Tu in place of the needle at the bottom of the receptacle 52 of Dischino and the specimen collection tube of Dischino since it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 5, the combination teaches or suggests that the extraction unit (the receptacle 52 of Dischino) is configured tubular, and wherein the extraction unit is configured open at a first end (the open top end of the receptacle 52 of Dischino) and provided with a membrane that is self-closing after puncture at a second end (the diaphragm of Tu at the bottom of the receptacle 52 of Dischino).
With respect to claim 6, the combination teaches or suggests that the membrane (the diaphragm of Tu) includes a predetermined puncture location, and wherein the membrane is slotted in an area of the predetermined puncture location (the slot formed upon insertion of the sampling syringe 19 of Tu).
Conclusion
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