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 .
Response to Amendment
The amendments filed on 01/20/2026 has been entered. Claims 1, 21, and 22 have been amended; claims 2-6, 10-13, and 23 have been cancelled. Accordingly, claims 1, 7-9, 14-22, and 24-26 are pending and under consideration.
Response to Arguments
Applicant's arguments filed on 01/20/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “Williams’ separate funnel and vessel not equivalent to Applicant’s vessel comprising a collection means and a reservoir” on page 7-8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. The apparatus/system 100 of Williams, when assembled as seen in Fig. 2B, has the collection means 106 disposed at the top end of the assembled vessel 100, and reservoir 102 at the bottom end of the assembled vessel 100. Therefore, the limitation is read. See rejection of claims below.
Regarding Applicant’s remarks stating that “Williams’ lacks the continuous surface at the transition from the funnel to the collection vessel” on page 8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Williams does discuss the concern that Applicant had raised in the remarks regarding discontinuity from the funnel to the collection vessel. Par. 41 of Williams discuss that “Additionally, or alternatively, the funnel includes an interior surface that seamlessly (or without substantial gaps or discontinuities that would cause deposited biological sample to leak outside the funnel-collection vessel interaction region) directs a fluid sample to the opening and/or interior surface of the sample collection chamber 110”, thus suggesting and allowing the interior surfaces from the collection means 106 and reservoir 102 to be seamless, reducing deposition and leakage of sample. See rejection of claim 1 below as necessitated by amendment.
Regarding Applicant’s remarks stating that “Williams’ lacks a lid” on page 8 of Applicant’s remarks, Examiner acknowledged the remarks. Williams is further modified by Dodgson for a teaching of a lid. See rejection of claims below.
Regarding Applicant’s remarks stating that “Williams’ handle not equivalent to Applicant’s stabilizing means” on page 8 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. It is noted that the features upon which applicant relies (i.e., “stabilizing element interacts with the lid to produce axial force which is transmitted through the positioning element and the seal element to produce a seal between the sealing surface and the inner surface of Applicant’s vessel”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). According to the current recited limitations, any one of the seal element, the positioning element, and the stabilizing element can flex to produce a pressure, as opposed to the combined transmitted force of the stabilizing element, positioning element, and the seal element as traversed. Nonetheless, please see rejection of claim 1 below as necessitated by amendment.
Regarding Applicant’s remarks stating that “Dodgson is non-analogous prior art” on page 9-11 of Applicant’s remarks, Examiner acknowledged Applicant’s remarks, but respectfully disagrees. MPEP 214101(a).I states that a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). The claimed invention currently recites a mere vessel, an apparatus with vessels, and a collection device, which is substantially the field of Dodgson’s device. Moreover, as traversed by Applicant, it appears that the devices from Applicant and Dodgson both have storage capability and maintaining viability of biological fluids (page 10 of Applicant’s remarks).
Regarding Applicant’s remarks stating that “the lid of Dodgson is… incompatible due to interference with Williams’ handle. The proposed combination is physical impossible” on page 11-12 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Williams’ disclosure allows for a configuration such that the handle is flushed with the topmost part of the system/funnel (Par. 45 – “It should be appreciated that in some embodiments, the length of the stem can be adjusted or manufactured at a different height such that when the sample collection system is in an assembled state (as above), the handle is flush with the top of the funnel”). Therefore, the incorporation of Dodgson’s lid is physically possible without changing or contradicting Williams’ teachings.
Regarding Applicant’s remarks discussing the criticality of the reduced volume on of the second chamber 12-13 of Applicant’s remarks, Examiner acknowledged Applicant’s detailed remarks. However, the traversal has not explained the criticality of the claimed range of less than or equal to 0.20. Applicant’s statement of “an apparatus having the claimed reduced volume ratio of the second chamber to the first chamber would perform differently than the prior art device“ is considered merely conclusory. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
Regarding Applicant’s remarks stating that Gano is non-analogous prior art on page 14-16 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. The claimed invention currently recites a mere vessel, an apparatus with vessels, and a collection device, which is substantially the field of Gano’s device. Furthermore, while Applicant traversed that Gano’s generic “biological matter” with no teaching regarding viability or preservation mechanisms would not be considered in the same endeavor as the claimed invention, Par. 8 and Par. 91 of Gano also discuss the uses of storing and transporting fluids, tissues, organs, blood and/or medical-related items. Therefore, one of ordinary skill in the art would have understood that the devices from Applicant and Gano both have storage capability and maintaining viability of biological items.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 8, “the first vessel” should read “the vessel”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 8, 17, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. US 20180344568 A1 (previously cited, hereinafter Williams) in view of Dodgson et al. US 2010/0196871 A1 (previously cited, hereinafter Dodgson).
Regarding claim 1, Williams discloses a vessel 100 (Fig. 1 – sample collection system 100) comprising:
a. a collection means 106 (Fig. 2A-2B – funnel 106) at the upper end of the vessel 100 (Fig. 1 – funnel 106 is at the top of the system 100);
b. a reservoir 102 (Fig. 1 – sample collection vessel 102) at the lower end of the vessel 100 (Fig. 1 – vessel 102 is at the bottom of system 100),
c. a reservoir seal means 104 (Fig. 1 – removable stopper 104); and
wherein:
an inner surface IS (see annotated Fig. 2B below) of the reservoir 102 (Fig. 1) and an inner surface of the collection means 106 (Fig. 1-2A, and Par. 42 – “an interior surface of the funnel 106”) form a continuous inner surface of the first vessel 100 (Par. 41 – “Additionally… the funnel includes an interior surface that seamlessly (or without substantial gaps or discontinuities that would cause deposited biological sample to leak outside the funnel-collection vessel interaction region) directs a fluid sample to the opening and/or interior surface of the sample collection chamber 110”, thus forming a seamless inner surface of system 100);
the reservoir seal means 104 (Fig. 1 and Fig. 2A-2B) comprises a seal element 118 (Fig. 2A – plug 118), a positioning element 120 (Fig. 1 – stem 120), and a stabilizing element 122 (Fig. 1 – handle 122);
the seal element 118 (Fig. 2A-2B) has at its lower end a bottom surface BS (see annotated Fig. 1B below) surrounded by and adjacent to a sealing surface 124 (Fig. 1 – sealing mechanism 124);
the reservoir seal means 104 (Fig. 1) is configured to engage with the vessel 100 (Fig. 1) to form a first chamber 110 (Fig. 1 – sample collection chamber 110) circumscribed by the inner surface IS (see annotated Fig. 2B below) of the reservoir 102 (see annotated Fig. 2B below) and the bottom surface BS (see annotated Fig. 1 below) of the seal element 118 (see annotated Fig. 1 below, and Fig. 2A-2B – the annotated bottom surface BS of seal element 118 with the annotated inner surface IS form the chamber 110); and
the positioning element 120 (Fig. 2A-2B) comprises a cylindrical body (Fig. 2A-2B – stem 120 is a cylinder) disposed between the stabilizing element 122 (Fig. 2B) and the sealing element 118 (Fig. 2B – stem 120 is between plug 118 and handle 122);
the seal element 118 (Fig. 1 and Fig. 2A) produce a pressure between the sealing surface 124 (Fig. 1 and Fig. 2B) of the seal element 118 (Fig. 2B) and an inner surface of the vessel 100 (see annotated Fig. 2A below, and Par. 39 – “the plug 118 can include a sealing mechanism 124 disposed at a distal end and which is operable to create a seal within the opening 112 of the sample collection vessel 102”).
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Annotated Fig. 1 of Williams
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Annotated Fig. 2A and 2B of Williams
However, Williams does not currently disclose d. a lid suited of sealable attachment to the vessel; the stabilizing element is secured between the upper edge of the vessel and the lid when the lid is fully engaged with the upper edge of the vessel; and one or more of the seal element, the positioning element, and the stabilizing element flex to produce a pressure.
Williams, in another embodiment, teaches the stabilizing element is secured between the upper edge of the vessel (Par. 45 – “when the sample collection system is in an assembled state (as above), the handle is flush with the top of the funnel”, thus indicating secure positioning of handle 122 within the top end of system 100).
Williams, in another embodiment, teaches the reservoir seal means 900 (Fig. 9 – sealing cap 900, which as established above, includes a stabilizing element and a positioning element) flex to produce a pressure (Par. 52 – “the sealing cap 900 is made from rubber, silicone, thermoplastic elastomer, or similar material that can flex to tightly fit within the opening but which is also rigid enough to maintain a seal when placed therein”).
Dodgson, in the same field of endeavor of containers for biological materials (Par. 16), teaches further comprising a lid 14 (Fig. 2 – cap 14) suited for sealable attachment to the vessel 12 (Fig. 2 – housing 12, and Abstract – “an essentially gas-tight gas closure means (14) adapted to restrict the passage of gas into the container from the exterior environment”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stabilizing element of Williams to have it secure between the upper edge of the vessel, also as taught by Williams, in order to create an airtight seal with the funnel and prevent contamination (Par. 45 of Williams).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the seal element of Williams to be able to flex, also as taught by Williams, in order to provide an interference fit that tightly seals the vessel (Par. 52 of Williams).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Williams to further include a lid as taught by Dodgson, in order to provide a gas-tight closure from the exterior environment for the container (Abstract of Dodgson).
Once the modification is made as discussed, since the stabilizing element 122 of Williams will be flush with the top of the funnel, the added lid 14 as taught by Dodgson will be disposed on top and against said element 122 of Williams, in a similar manner as seen in Fig. 1C, Fig. 2, and Par. 56 of Dodgson – “the inner face 34 of the cap is pressed hard up against the seal face 36 of the insert”. Thus, limitation “the stabilizing element is secured between the upper edge of the vessel and the lid when the lid is fully engaged with the upper edge of the vessel” is met.
Regarding claim 8, Williams in view of Dodgson discloses the invention of claim 1. The combination further discloses wherein:
the inner surface of the vessel 100 (see annotated Fig. 2A of Williams above) and the inner surface of the lid 14 (Fig. 2 of Dodgson – the interior surface of cap 14) circumscribe a second chamber (see annotated Fig. 2B of Williams above; Examiner notes that once the modification is made as disused in claim 2, cap 14 of Dodgson will be incorporated into the device of Williams, such that lid 14 covers over the funnel 106 and closes the system 100; thus, the space/second chamber in funnel 106 is enclosed by the inner surface of vessel 100 of Williams and the lid 14 of Dodgson).
However, the combination does not disclose a ratio of the first chamber to the second chamber is less than or equal to 0.20.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of Williams in view of Dodgson’s first chamber and the second chamber such that their respective ratio is less than or equal to 0.20, in order to fit the particular procedure being done, since this claimed relative dimension of the chambers does not change the vessel/chamber ability to contain a sample. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Par. 44 of Applicant’s PG-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 17, Williams discloses a collection device 100 (Fig. 1 – sample collection system 100) for a bodily fluid (Par. 2 – “vials and vessels for collecting and storing biological samples”), the collection device 100 (Fig. 1) comprising:
a. a first vessel 100 (Fig. 1) comprising a reservoir 102 (Fig. 1 – sample collection vessel 102) for containing the bodily fluid (Par. 38 – “the sample collection vessel 102… configured to receive a biological sample”);
c. a reservoir seal means 104 (Fig. 1 – removable stopper 104) removably (Par. 36 – removable stopper 104) configured for sealing said bodily fluid within said reservoir 102 (Fig. 2B);
wherein:
the reservoir 102 (Fig. 1) comprises an inner surface IS (see annotated Fig. 2B above);
the reservoir seal means 104 (Fig. 1 and Fig. 2A-2B) comprises a seal element 118 (Fig. 2A – plug 118), a positioning element 120 (Fig. 1 – stem 120), and a stabilizing element 122 (Fig. 1 – handle 122);
the seal element 118 (Fig. 2A-2B) has at its lower end a bottom surface BS (see annotated Fig. 1B above) surrounded by and adjacent to a sealing surface 124 (Fig. 1 – sealing mechanism 124);
the reservoir seal means 104 (Fig. 1) is configured to engage with the first vessel 100 (Fig. 1) to form a first chamber 110 (Fig. 1 – sample collection chamber 110) circumscribed by the inner surface IS (see annotated Fig. 2B above) of the reservoir 102 (see annotated Fig. 2B below) and the bottom surface BS (see annotated Fig. 1 above) of the seal element 118 (see annotated Fig. 1 above, and Fig. 2A-2B – the annotated bottom surface BS of seal element 118 with the annotated inner surface IS form the chamber 110); and to provide a sealing force (Par. 43 – “the removable stopper 104 can be advanced from into the opening and secured therein by turning the handle 122. In some embodiments, the handle 122 may advantageously include ridges or grooves, e.g., like a coin or poker chip, to enhance grip by a user's fingers and/or engagement with a removal tool”) between the sealing surface 124 (Fig. 1) of the sealing element 118 (Fig. 1) and the inner surface of the vessel 100 (see annotated Fig. 2A above);
the positioning element 120 (Fig. 2A-2B) comprises a cylindrical body (Fig. 2A-2B – stem 120 is a cylinder) disposed between the stabilizing element 122 (Fig. 2B) and the sealing element 118 (Fig. 2B – stem 120 is between plug 118 and handle 122);
However, Williams does not disclose b. a lid suited for sealable attachment to the first vessel; and the inner surface of the first vessel and the inner surface of the lid circumscribe a second chamber; and a ratio of the first chamber to the second chamber is less than or equal to 0.20.
Dodgson, in the same field of endeavor of containers for biological materials (Par. 16), teaches further comprising a lid 14 (Fig. 2 – cap 14) suited for sealable attachment to the first vessel 12 (Fig. 2 – housing 12, and Abstract – “an essentially gas-tight gas closure means (14) adapted to restrict the passage of gas into the container from the exterior environment”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Williams to further include a lid as taught by Dodgson, in order to provide a gas-tight closure from the exterior environment for the container (Abstract of Dodgson). Examiner notes that once the modification is made as disused, cap 14 of Dodgson will be incorporated into the device of Williams, such that lid 14 covers over the funnel 106 and closes the system 100; thus, the space/second chamber (see annotated Fig. 2B of Williams above) in funnel 106 is enclosed by the inner surface of vessel 100 of Williams and the lid 14 of Dodgson. Thus, the limitation is met.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of the combination’s first chamber and the second chamber such that their respective ratio is less than or equal to 0.20, in order to fit the particular procedure being done, since this claimed relative dimension of the chambers does not change the vessel/chamber ability to contain a sample. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Par. 44 of Applicant’s PG-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 21, Williams in view of Dodgson suggests the invention of claim 1. Williams further discloses wherein the collection means 106 (Fig. 1 of Williams) comprises a wall having a conical shape (see annotated Fig. 1 above, and Par. 41 of Williams – “the top opening 128 of the funnel 106 is larger in diameter than the opening 112 such that when the funnel is attached to the sample collection vessel 102”).
Regarding claim 22, Williams in view of Dodgson suggests the invention of claim 1. The combination further discloses wherein:
a. the stabilizing element 122 (Fig. 1 of Williams) comprises a flange 122 (Fig. 2B of Williams – handle 122 being a disk) at the upper end of the reservoir seal means 104 (Fig. 1 of Williams, and Par. 39 of Williams – “the removable stopper 104 includes a stem 120 with a plug 118 coupled to a first end of the stem 120 and a handle 122 coupled to a second end thereof”); and
b. the flange 122 (Fig. 1 of Williams) is configured to provide a sealing force (Par. 43 of Williams – “the removable stopper 104 can be advanced from into the opening and secured therein by turning the handle 122. In some embodiments, the handle 122 may advantageously include ridges or grooves, e.g., like a coin or poker chip, to enhance grip by a user's fingers and/or engagement with a removal tool”) between the sealing surface 124 (Fig. 1 of Williams) of the sealing element 118 (Fig. 1 of Williams) and the inner surface of the vessel 100 (see annotated Fig. 2A of Williams above).
However, Williams in view of Dodgson does not disclose a flexible flange.
Williams, in another embodiment, teaches that the material that forms the sealing cap can be made from rubber, silicone, or similar material that can flex (Par. 52).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flange of Williams in view of Dodgon’s reservoir seal means to be made out of rubber as taught by Williams, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143. Here all elements of the claim are well known in the art of container. Modifying Williams in view of Dodgson’s flange to be an elastic rubber material would not change the device’s function of containing fluid sample. Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the flange of the combination out of elastic material such as rubber, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 7, 18, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Dodgson as applied to claim 1 claim 17 above, and further in view of Gano et al. US 2004/0200232 A1 (previously cited, hereinafter Gano).
Regarding claim 7, Williams in view of Dodgson suggests the invention of claim 1. However, the combination does not disclose further comprising an external layer of insulation.
Gano, in the same field of endeavor of storing containers (Title), teaches further comprising an external layer of insulation 150 (Fig. 7 – a layer of insulation 150).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Williams to further include an external layer of insulation as taught by Gano, in order to maintain the temperature of the content (Par. 5 and Par. 8 of Gano).
Regarding claim 18, Williams in view of Dodgson suggests the invention of claim 17. However, the combination does not disclose further comprising a second vessel, wherein the first vessel is inserted into the second vessel.
Gano, in the same field of endeavor of storing containers (Title), teaches b. a second vessel 110 (Fig. 7 – outer shell 110), wherein the first vessel 170 (Fig. 7 – storage chamber 170) is inserted into the second vessel 110 (Fig. 7).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Williams in view of Dodgson to further include a second vessel outside of the first vessel as taught by Gano, in order to form a substantially rigid material for protecting items placed within the container/first vessel (Par. 48 of Gano).
Regarding claim 19, Williams in view of Dodgson in view of Gano suggests the invention of claim 18. The combination further discloses further comprising a layer of insulation 150 (Fig. 7 of Gano – a layer of insulation 150) between the first vessel 100 (Fig. 1 of Williams) and the second vessel 110 (Fig. 7 of Gano).
Examiner notes that once the modification is made as discussed in claim 18, the second vessel outside 110 of Gano will be disposed outside of the first vessel 100 of Williams, including the layer of insulation 150. Thus, the limitation is met.
Regarding claim 20, Williams in view of Dodgson discloses the invention of claim 17. However, Williams in view of Dodgson does not disclose further comprising a layer of insulation surrounding the collection device.
Gano, in the same field of endeavor of storing containers (Title), teaches further comprising a layer of insulation 150 (Fig. 7 – a layer of insulation 150) surrounding the collection device 170 (Fig. 7).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Williams in view of Dodgson to further include an external layer of insulation as taught by Gano, in order to maintain the temperature of the content (Par. 5 and Par. 8 of Gano).
Claims 9, 14-16, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Gano in view of Dodgson.
Regarding claim 9, Williams discloses an apparatus 100 (Fig. 1 – sample collection system 100) comprising:
a. a first vessel 100 (Fig. 1) having a collection means 106 (Fig. 2A-2B – funnel 106) at the upper end of the first vessel 100 (Fig. 1 – funnel 106 is at the top of the system 100) and a reservoir 102 (Fig. 1 – sample collection vessel 102) at the lower end of the first vessel 100 (Fig. 1 – vessel 102 is at the bottom of system 100);
d. a reservoir seal means 104 (Fig. 1 – removable stopper 104);
wherein:
the reservoir 102 (Fig. 1) comprises an inner surface IS (see annotated Fig. 2B above);
the reservoir seal means 104 (Fig. 1 and Fig. 2A-2B) comprises a seal element 118 (Fig. 2A – plug 118), a positioning element 120 (Fig. 1 – stem 120), and a stabilizing element 122 (Fig. 1 – handle 122);
the seal element 118 (Fig. 2A-2B) has at its lower end a bottom surface BS (see annotated Fig. 1B above) surrounded by and adjacent to a sealing surface 124 (Fig. 1 – sealing mechanism 124);
the reservoir seal means 104 (Fig. 1) is configured to engage with the first vessel 100 (Fig. 1) to form a first chamber 110 (Fig. 1 – sample collection chamber 110) circumscribed by the inner surface IS (see annotated Fig. 2B above) of the reservoir 102 (see annotated Fig. 2B above) and the bottom surface BS (see annotated Fig. 1 above) of the seal element 118 (see annotated Fig. 1 above, and Fig. 2A-2B – the annotated bottom surface BS of seal element 118 with the annotated inner surface IS form the chamber 110);
the first vessel 100 (Fig. 1) has an inner surface (see annotated Fig. 2A above); and
the sealing surface 124 (Fig. 2B) is configured to engage with the inner surface of the first vessel 100 (see annotated Fig. 2A above) by friction, pressure (Par. 39 – “a sealing mechanism 124 disposed at a distal end and which is operable to create a seal…”).
However, Williams does not disclose b. a second vessel, wherein the first vessel is inserted into the second vessel; c. a lid suited for sealable attachment to the first vessel.
Gano, in the same field of endeavor of storing containers (Title), teaches b. a second vessel 110 (Fig. 7 – outer shell 110), wherein the first vessel 170 (Fig. 7 – storage chamber 170) is inserted into the second vessel 110 (Fig. 7).
Dodgson, in the same field of endeavor of containers for biological materials (Par. 16), teaches further comprising a lid 14 (Fig. 2 – cap 14) suited for sealable attachment to the first vessel 12 (Fig. 2 – housing 12, and Abstract – “an essentially gas-tight gas closure means (14) adapted to restrict the passage of gas into the container from the exterior environment”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Williams to further include a second vessel outside of the first vessel as taught by Gano, in order to form a substantially rigid material for protecting items placed within the container/first vessel (Par. 48 of Gano).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Williams in view of Gano to further include a lid as taught by Dodgson, in order to provide a gas-tight closure from the exterior environment for the container (Abstract of Dodgson).
Regarding claim 14, Williams in view of Gano in view of Dodgson suggests the invention of claim 9. The combination further discloses further comprising a layer of insulation 150 (Fig. 7 of Gano – a layer of insulation 150) between the first vessel 100 (Fig. 1 of Williams) and the second vessel 110 (Fig. 7 of Gano).
Examiner notes that once the modification is made as discussed in claim 9, the second vessel outside 110 of Gano will be disposed outside of the first vessel 100 of Williams, including the layer of insulation 150. Thus, the limitation is met.
Regarding claim 15, Williams in view of Gano in view of Dodgson suggests the invention of claim 9. The combination further discloses further comprising a layer of insulation 150 (Fig. 7 of Gano – a layer of insulation 150) surrounding the apparatus 100 (Fig. 1 of Williams).
Examiner notes that once the modification is made as discussed in claim 9, the second vessel outside 110 of Gano will be disposed outside of the first vessel 100 of Williams, including the layer of insulation 150. Thus, the limitation is met.
Regarding claim 16, Williams in view of Gano in view of Dodgson suggests the invention of claim 9. The combination further discloses wherein:
a. the inner surface of the first vessel 100 (see annotated Fig. 2A of Williams above) and the inner surface of the lid 14 (Fig. 2 of Dodgson – the interior surface of cap 14) circumscribe a second chamber (see annotated Fig. 2B of Williams above; Examiner notes that once the modification is made as disused in claim 9, cap 14 of Dodgson will be incorporated into the device of Williams, such that lid 14 covers over the funnel 106 and closes the system 100; thus, the space/second chamber in funnel 106 is enclosed by the inner surface of vessel 100 of Williams and the lid 14 of Dodgson).
However, the combination does not disclose b. a ratio of the first chamber to the second chamber is less than or equal to 0.20.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimension of the combination’s first chamber and the second chamber such that their respective ratio is less than or equal to 0.20, in order to fit the particular procedure being done, since this claimed relative dimension of the chambers does not change the vessel/chamber ability to contain a sample. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see Par. 44 of Applicant’s PG-Pub), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 24, Williams in view of Gano in view of Dodgson suggests the invention of claim 9. The combination further discloses wherein the positioning element 120 (Fig. 2A-2B of Williams) comprises a cylindrical body (Fig. 2A-2B of Williams – stem 120 is a cylinder) disposed between the stabilizing element 122 (Fig. 2B of Williams) and the sealing element 118 (Fig. 2B of Williams – stem 120 is between plug 118 and handle 122).
Regarding claim 25, Williams in view of Gano in view of Dodgson suggests the invention of claim 9. The combination further discloses wherein:
a. the stabilizing element 122 (Fig. 1 of Williams) comprises a flange 122 (Fig. 2B of Williams – handle 122 being a disk) at the upper end of the reservoir seal means 104 (Fig. 1 of Williams, and Par. 39 of Williams – “the removable stopper 104 includes a stem 120 with a plug 118 coupled to a first end of the stem 120 and a handle 122 coupled to a second end thereof”); and
b. the flange 122 (Fig. 1 of Williams) is configured to provide a sealing force (Par. 43 of Williams – “the removable stopper 104 can be advanced from into the opening and secured therein by turning the handle 122. In some embodiments, the handle 122 may advantageously include ridges or grooves, e.g., like a coin or poker chip, to enhance grip by a user's fingers and/or engagement with a removal tool”) between the sealing surface 124 (Fig. 1 of Williams) of the sealing element 118 (Fig. 1 of Williams) and the inner surface of the first vessel 100 (see annotated Fig. 2A of Williams above).
However, the combination does not disclose a flexible flange.
Williams, in another embodiment, teaches that the material that forms the sealing cap can be made from rubber, silicone, or similar material that can flex (Par. 52).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flange of the combination’s reservoir seal means to be made out of rubber as taught by Williams, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. MPEP 2143. Here all elements of the claim are well known in the art of container. Modifying Williams in view of Dodgson’s flange to be an elastic rubber material would not change the device’s function of containing fluid sample. Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the flange of the combination out of elastic material such as rubber, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding clam 26, Williams in view of Gano in view of Dodgson suggests the invention of claim 25. The combination further discloses wherein engagement of the lid 14 (Fig. 2 of Dodgson) to the vessel 100 (Fig. 1 of Williams) induced the sealing force between the sealing surface 124 (Fig. 1 of Williams) of the sealing element 118 (Fig. 2B of Williams) and the inner surface of the first vessel 100 (see annotated Fig. 2A of Williams above).
Examiner notes that once the modification is made as discussed in claim 9, the lid 14 of Dodgson will be incorporated into the device of Williams, such that lid 14 covers over the funnel 106 and closes the system 100 of Williams. Since lid 14 of Dodgson produces a gas-tight seal to the vessel (Par. 54 of Dodgson), lid 14 of Dodgson has to press down on the reservoir sealing means 104, thus securing the engagement between the sealing surface 124 and the inner surface of vessel 100. Thus, the limitation is met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Herr et al. US 2007/0031895 A1 teaches a single unit semen collection and storage device
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781