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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a container configured substantially rotation symmetrical” in line 2. The specification does not use the term “substantial” or “substantially” either alone or in combination with “symmetrical” or “symmetry”. There appears to be no support for the expression “substantially rotation symmetrical” with respect to the container.
Claim 1 recites “at least one radial gap” in lines 19-20. The specification does not use the term “radial” or “radially” either alone or in combination with “gap”. There appears to be no support for the expression “radial gap”.
Claims 3-15 are rejected by virtue of their dependence from claim 1.
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 “a container configured substantially rotation symmetrical” in line 2, which is indefinite. First, the grammar is so awkward that its meaning is not clear. Second, expression “substantially rotation symmetrical” uses the relative term “substantially” which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Indeed, the specification does not use the term “substantially” or “substantial”.
Claim 1 recites “wherein the cover and the container jointly form an airtight seal in the sealing position of the set” in lines 8-9 and “wherein the at least one radial gap is caused by a deformation of the cover and/or the container caused by a contact between the container and the cover” in lines 22-24, 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 “the container rim” in line 27 in which there is insufficient antecedent basis for this limitation in the claim.
Claims 3-15 are rejected by virtue of their dependence from claim 1.
Claim 14 recites “air…from the ambient” in line 11, but it is not clear if this recitation is the same as, related to, or different from “air from the ambient” of claim 1, line 16. If they are the same, “the” should precede “air” in claim 14, line 11. 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).
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)(previously cited), in view of U.S. Patent Application Publication No. 2019/0315538 (Cheng).
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 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),
Cheng teaches a set, comprising a container (the container 110 of Cheng) and a cover (the cover 200 of Cheng), wherein the container includes an interior (the interior region 190 of Cheng), wherein the set is transferrable at least between a sealing position (the sealing engagements of FIGS. 7A and 7C of Cheng; paragraphs 0112-116 of Cheng) and a venting position (the disrupted position of FIG. 7B of Cheng; paragraphs 0112-116 of Cheng), wherein the cover and the container jointly form an airtight sealing seat with a flexible skirt 224 of the lid 200 in the sealing position of the set (the sealing engagement of FIGS. 7A and 7C of Cheng; paragraphs 0112-116 of Cheng). Also, Cheng teaches that the flexible skirt 224 of the lid is 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 0112-116 of Cheng). 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 flexible skirt 224 of Cheng formed into the container lid 24 of Dischino that is 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 and that moves the wall of the container (compare the locations of the sidewall 130 in FIG. 7A-7C of Cheng) 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 substantially rotation symmetrical and configured to store at least one bodily fluid; and
a cover (the container lid 24 of Dischino) configured to close the container and including a cover base (the element B in the below annotated FIG. 7A of Cheng),
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 engagements of FIG. 7A and 7C of Cheng; paragraphs 0112-116 of Cheng) and a venting position (the disrupted position of FIG. 7B of Cheng; paragraphs 0112-116 of Cheng), wherein the cover and the container jointly form an airtight seal in the sealing position of the set (abstract, paragraphs 0009, 0031, and 0033-0037 of Dischino; paragraphs 0112-116 of Cheng),
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 is able to flow into the interior of the container and vent the interior of the container in the venting position of the set (using the flexible skirt 224 of Cheng formed into the container lid 24 of Dischino that is 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; paragraphs 0112-116 of Cheng),
wherein the cover (the container lid 24 of Dischino) includes at least one venting element (the element A in the below annotated FIG. 7A of Cheng) that generates at least one radial gap (the gap seen in FIG. 7B of Cheng) in the seal between the cover and the container when the set is in the venting position,
wherein the at least one radial gap is caused by a deformation of the cover and/or the container caused by a contact between the container and the cover, wherein the air is able to flow from the ambient through the at least one radial gap into the interior of the container (FIG. 7B of Cheng; paragraphs 0112-116 of Cheng), and
wherein the cover base (the element B in the below annotated FIG. 7A of Cheng) is deformable by the vacuum to camber towards the container and contact the container rim to cause the container rim to deform radially outward in a contact area between the cover base and the container rim (compare the locations of the sidewall 130 in FIG. 7A-7C of Cheng) and cause a deformed portion of the container rim to generate the at least one radial gap in the seal (paragraphs 0112-116 of Cheng).
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Annotated FIG. 7A of Cheng
With respect to claim 3, the combination teaches or suggests that the venting element is configured as a cam (the element A in the above annotated FIG. 7A of Cheng).
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 element A in the above annotated FIG. 7A of Cheng).
With respect to claim 7, the combination teaches or suggests that the container (the container 22 of Dischino) is 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 element D in the above annotated FIG. 7A of Cheng), 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 seen in FIG. 7B of Cheng) when the set is in the venting position.
With respect to claim 13, the combination teaches or suggests that the airflow channel (the element D in the above annotated FIG. 7A of Cheng) is arranged in a contact portion between the cover and of the container in a circumferential annular face of the container in the sealing position of the set (see the location in FIG. 7A of Cheng).
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 the ambient, the method comprising the steps:
arranging the set in the sealing position and arranging the bodily fluid and air in the interior of the container (the sealing position suggested by Dischino and Cheng);
reducing a pressure in the interior of the container due to the extraction of the bodily fluid by the extraction unit from the interior so that the vacuum is generated in the interior of the container relative to the ambient of the set (paragraphs 0032-0033 and 0036 of Dischino) and
deforming the cover and/or the container of the set (using the flexible skirt 224 of Cheng that is 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; paragraphs 0112-116 of Cheng),
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 flexible skirt 224 of Cheng that is 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; paragraphs 0112-116 of Cheng).
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 flexible skirt 224 of Cheng that is 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; paragraphs 0112-116 of Cheng).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Dischino in view of Cheng, and further in view of U.S. Patent Application Publication No. 2017/0013825 (Faldt)(previously cited).
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 tubular, and wherein the extraction unit is 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 Cheng, and further in view of U.S. Patent No. 4,865,583 (Tu)(previously cited).
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).
Response to Arguments
The Applicant’s arguments filed 10/23/2025 have been fully considered.
Specification
The Applicant did not address the objection to the abstract, by either amendment or argument. The Examiner cannot find a reason to withdraw the objection.
Claim objections
In view of the claim amendments filed on 10/23/2025, the claim objections have been withdrawn.
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, that were necessitated by the claim amendments filed on 10/23/2025.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 10/23/2025.
Also, the Applicant did not address, by amendment or argument, the indefiniteness issues with respect to the recitations “wherein the cover and the container jointly form an airtight seal in the sealing position of the set” in claim 1, lines 8-9 and “wherein the at least one radial gap is caused by a deformation of the cover and/or the container caused by a contact between the container and the cover” in claim 1, lines 22-24. The Examiner cannot find a reason to withdraw the rejections.
Further, the Applicant did not address, by amendment or argument, the indefiniteness issue with respect to the recitation “air…from the ambient” in claim 14, line 11. The Examiner cannot find a reason to withdraw the rejection.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
In view of the claim amendments filed on 10/23/2025, the claim rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, have been withdrawn.
Prior art rejections
The Applicant’s arguments with respect to the rejections of claims 1 and 3-15 have been considered but are moot because the new grounds 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 10/23/2025.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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