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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on August 14th, 2026, is acknowledged. The traversal is on the ground(s) that claim 20 presents a single general inventive concept common to both Groups I and II, and because the Office Action did not address whether the combination recited in claim 20 makes a contribution over the prior art, the Office Action has not met its burden of establishing that Group I and Group II lack unity. The Examiner has withdrawn the restriction requirement between Group I and Group II. Both Groups I-II will be examined in this Office Action.
Claims 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Group III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 14th, 2026.
Claim Objections
Claims 2, 5, 8, 11, 14, 17, and 20 are objected to because of the following informalities:
Claim 2 recites “tab that releases” in line 2, but should read “tab that is configured to release”
Claim 5 recites “colorant to identify” in line 2, but should read “colorant configured to identify”
Claim 8 recites “portion removably attached” in line 2, but should read “portion configured to be removably attached”
Claim 11 recites “tab that releases” in line 2, but should read “tab that is configured to release”
Claim 14 recites “colorant to identify” in line 2, but should read “colorant configured to identify”
Claim 17 recites “portion removably attached” in line 2, but should read “portion configured to be removably attached”
Claim 20 recites “the cover” in line 9, but should read “the cover member”
Claim 20 recites “the cover” in line 10, but should read “the cover member”
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 1-17 and 20 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.
The term “smooth” in claim 1 is a relative term which renders the claim indefinite. The term “smooth” 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.
Claim 4 recites “wherein the cover member is integrally formed with the collection container” in lines 1-2. This limitation is unclear because the “cover member” is one of the components that make up the “collection container”. Therefore, it is unclear as to how the cover member can be integrally formed with the collection container if the cover member is part of the collection container. Clarification is requested.
Claim 8 recites “a bottom end of the tube” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “closed bottom end” in line 3 of Claim 1, or a separate element.
The term “smooth” in claim 9 is a relative term which renders the claim indefinite. The term “smooth” 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.
Claim 9 recites “to create a more uniform banded smooth surface around a circumference of the collection container” in lines 9-10. It is unclear as to how the plurality of ribs can “create a more uniform banded smooth surface around a circumference of the collection container”.
Claim 13 recites “wherein the plurality of ribs is integrally formed with the collection container” in lines 1-2. This limitation is unclear because the “plurality of ribs” is one of the components that make up the “collection container”. Therefore, it is unclear as to how the plurality of ribs can be integrally formed with the collection container if the plurality of ribs is part of the collection container. Clarification is requested.
Claim 17 recites “a bottom end of the tube” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “closed bottom end” in line 3 of Claim 9, or a separate element.
The term “smooth” in claim 20 is a relative term which renders the claim indefinite. The term “smooth” 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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7, 9-13, 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robbins et al (U.S. Patent No. 4,390,111; cited by Applicant).
Regarding Claim 1, Robbins discloses a collection container for holding a blood sample (an improved sealable vial for storage of materials; Abstract), the collection container comprising:
a tube (vial 10; Figure 1) having an open end (aperture 24; Figure 1), a closed bottom end (flat bottom surface of vial 10; Figure 1), and a sidewall (tube wall 18; Figure 1) extending therebetween that defines a collection cavity (At one end of the tube 12 a base wall which seals that end of the tube…base wall 20 is recessed from the end of tube wall 18 sufficiently that the base wall 20 does not interfere with the flat bottom surface of the vial; Column 4 Lines 10-22; Figure 1), the sidewall defining an exterior side surface (The tube 12 includes a tube wall 18 having an interior diameter greatly exceeding its thickness so as to form a cylindrical interior cavity; Column 4 Lines 5-8; Figure 1);
a lid removably engageable with the open end of the tube (sealing insert 14; Column 4 Lines 45-52); and
a cover member (separate cap 16) for covering at least a portion of the exterior side surface of the tube proximate the lid (The exterior surface of tube wall 18 in the vicinity of aperture 24 is provided with a male spiral thread 26. The male thread 26 extends downward in a spiral manner from the aperture 24 for a distance sufficient to provide for a firm attachment of the cap 16 to the tube 12; Column 4 Lines 31-36; Figure 1),
wherein the cover member is configured to circumferentially cover at least a portion of the exterior side surface of the collection container to create a uniform smooth surface around a circumference of the collection container (As cap 16 is tightened onto male threads 26 the central depression 42 is forced into the interior of frustum section 32 of insert 14 such that the deformable sealing insert 14 is forced to radially expand into an improved tight seal with the tapered section 28 of tube 12. The downward pressure of top portion 38 of cap 16 on the wing portion 34 and protrusion 35 of the insert 14 further forces the insert 14 into the tube 12 and enhances the integrity of the seal therebetween; Column 5 Lines 34-42; Figures 1-2).
Regarding Claim 2, Robbins discloses wherein the lid includes a release tab (protrusion 35; Figure 1) that releases the collection container from a blood collector attachment when pressed (The wing portion 34 is provided with a protrusion 35 situated opposite the connecting strip 30. Protrusion 35 is particularly shown in FIG. 3. Protrusion 35 provides a leverage point for applying pressure to remove sealing insert 14 from the closed position. This is particularly important if the seal between the insert 14 and the body 12 is lodged such as by chemical action or by a relative internal vacuum. Protrusion 35 is also adapted for fitting into cap 16 so as to allow maximum attachment of cap 16 with downward pressure on insert 14; Column 5 Lines 7-16).
Regarding Claim 3, Robbins discloses wherein the lid is connected to the collection container via a living hinge (The sealing insert 14 is connected to the tube 12 b a connecting strip 30. Connecting strip 30 is selected to be flexible to the extent that the sealing insert 14 may be rotated from an open position, as shown in FIG. 1, in which the aperture 24 is open, to a closed position in which the sealing insert 14 mates with the tapered section 28 and provides a seal isolating the contents of vial 10 from the surrounding environment; Column 4 Lines 45-52).
Regarding Claim 7, Robbins discloses wherein a diameter of the lid is greater than a diameter of the tube (A wing portion 34 of the sealing insert 14 extends about the top perimeter of frustum section 32 and is adapted to rest on top of the tube 12 when the insert 14 is in the closed position. The wing portion 34 receives the connecting strip 30 and further extends upward into the interior of cap 16 when the cap 16 is attached. The wing portion 34 is provided with a protrusion 35 situated opposite the connecting strip 30; Column 4 Line 68 – Column 5 Line 8; Figures 1 and 3).
Regarding Claim 9, Robbins discloses collection container for holding a blood sample (an improved sealable vial for storage of materials; Abstract), the collection container comprising:
a tube (vial 10; Figure 1) having an open end (aperture 24; Figure 1), a closed bottom end (flat bottom surface of vial 10; Figure 1), and a sidewall (tube wall 18; Figure 1) extending therebetween that defines a collection cavity (At one end of the tube 12 a base wall which seals that end of the tube…base wall 20 is recessed from the end of tube wall 18 sufficiently that the base wall 20 does not interfere with the flat bottom surface of the vial; Column 4 Lines 10-22; Figure 1), the sidewall defining an exterior side surface (The tube 12 includes a tube wall 18 having an interior diameter greatly exceeding its thickness so as to form a cylindrical interior cavity; Column 4 Lines 5-8; Figure 1);
a lid removably engageable with the open end of the tube (sealing insert 14; Column 4 Lines 45-52); and
a plurality of ribs (male spiral thread 26) configured to cover at least a portion of the exterior side surface of the tube proximate the lid, wherein the plurality of ribs are configured to circumferentially cover at least a portion of the exterior side surface to create a more uniform banded smooth surface around a circumference of the collection container (The exterior surface of tube wall 18 in the vicinity of aperture 24 is provided with a male spiral thread 26. The male thread 26 extends downward in a spiral manner from the aperture 24 for a distance sufficient to provide for a firm attachment of the cap 16 to the tube 12; Column 4 Lines 31-36; Figure 1).
Regarding Claim 10, Robbins discloses wherein the plurality of ribs are disposed axially (The exterior surface of tube wall 18 in the vicinity of aperture 24 is provided with a male spiral thread 26. The male thread 26 extends downward in a spiral manner from the aperture 24 for a distance sufficient to provide for a firm attachment of the cap 16 to the tube 12; Column 4 Lines 31-36; Figure 1).
Regarding Claim 11, Robbins discloses wherein the lid includes a release tab (protrusion 35; Figure 1) that releases the collection container from a blood collector attachment when pressed (The wing portion 34 is provided with a protrusion 35 situated opposite the connecting strip 30. Protrusion 35 is particularly shown in FIG. 3. Protrusion 35 provides a leverage point for applying pressure to remove sealing insert 14 from the closed position. This is particularly important if the seal between the insert 14 and the body 12 is lodged such as by chemical action or by a relative internal vacuum. Protrusion 35 is also adapted for fitting into cap 16 so as to allow maximum attachment of cap 16 with downward pressure on insert 14; Column 5 Lines 7-16).
Regarding Claim 12, Robbins discloses wherein the lid is connected to the collection container via a living hinge (The sealing insert 14 is connected to the tube 12 b a connecting strip 30. Connecting strip 30 is selected to be flexible to the extent that the sealing insert 14 may be rotated from an open position, as shown in FIG. 1, in which the aperture 24 is open, to a closed position in which the sealing insert 14 mates with the tapered section 28 and provides a seal isolating the contents of vial 10 from the surrounding environment; Column 4 Lines 45-52).
Regarding Claim 13, Robbins discloses wherein the plurality of ribs is integrally formed with the collection container (The exterior surface of tube wall 18 in the vicinity of aperture 24 is provided with a male spiral thread 26. The male thread 26 extends downward in a spiral manner from the aperture 24 for a distance sufficient to provide for a firm attachment of the cap 16 to the tube 12; Column 4 Lines 31-36; Figure 1).
Regarding Claim 16, Robbins discloses wherein a diameter of the lid is greater than a diameter of the tube (A wing portion 34 of the sealing insert 14 extends about the top perimeter of frustum section 32 and is adapted to rest on top of the tube 12 when the insert 14 is in the closed position. The wing portion 34 receives the connecting strip 30 and further extends upward into the interior of cap 16 when the cap 16 is attached. The wing portion 34 is provided with a protrusion 35 situated opposite the connecting strip 30; Column 4 Line 68 – Column 5 Line 8; Figures 1 and 3).
Regarding Claim 20, Robbins discloses a collection container for holding a blood sample (an improved sealable vial for storage of materials; Abstract), the collection container comprising:
a tube (vial 10; Figure 1) having an open end (aperture 24; Figure 1), a closed bottom end (flat bottom surface of vial 10; Figure 1), and a sidewall (tube wall 18; Figure 1) extending therebetween that defines a collection cavity (At one end of the tube 12 a base wall which seals that end of the tube…base wall 20 is recessed from the end of tube wall 18 sufficiently that the base wall 20 does not interfere with the flat bottom surface of the vial; Column 4 Lines 10-22; Figure 1), the sidewall defining an exterior side surface (The tube 12 includes a tube wall 18 having an interior diameter greatly exceeding its thickness so as to form a cylindrical interior cavity; Column 4 Lines 5-8; Figure 1);
a lid removably engageable with the open end of the tube (sealing insert 14; Column 4 Lines 45-52);
a cover member (separate cap 16) for covering at least a portion of the exterior side surface of the tube proximate the lid (The exterior surface of tube wall 18 in the vicinity of aperture 24 is provided with a male spiral thread 26. The male thread 26 extends downward in a spiral manner from the aperture 24 for a distance sufficient to provide for a firm attachment of the cap 16 to the tube 12; Column 4 Lines 31-36; Figure 1); and
a plurality of ribs (female spiral threads 40) positioned on the cover member and configured to cover at least a portion of the cover, wherein the cover and the plurality of ribs are configured to circumferentially cover at least a portion of the exterior side surface to create a more uniform banded smooth surface around a circumference of the collection container (The cap 16 is in the shape of a cylindrical solid open at one end. The cap 16 includes a side wall 36 and a top portion 38. The side wall 36 is formed into a cylinder having a minimum inside diameter equal to the outside diameter of the tube 12. The interior of the side wall 36 is provided with a female spiral thread 40 adapted to precisely mate with male spiral thread 26 of the tube 12 so as to form a tight seal between the cap 16 and the tube 12. The exterior of side wall 36 may either be smooth, as shown, or may be provided with gripping ridges or other friction enhancing structure to facilitate tightening and loosening the cap 16; Column 5 Lines 17-29).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Robbins et al in view of Conway (U.S. Publication No. 2003/0133844).
Regarding Claim 4, Robbins fails to specifically teach wherein the cover member is integrally formed with the collection container.
In a similar technical field, Conway teaches a microcollection tube assembly (Abstract), wherein the cover member (cap seating flange 40) is integrally formed with the collection container (Upper portion 28 has a cap seating flange 40 positioned around the outer surface of the container which defines a well or trough 42 and an outer surface 41. The cap seating flange has an upper surface edge 43 and a plurality of lugs 44 each having a cam surface 46; [0040]; As shown in FIG. 5, when cap 14 is removably secured to container 12, space 68 of the cap receives the top portion of the container including the integral lip, protrusions 70 bear against lower edge 52 of locking ring 48 of the container, sealing ring 67 bears against inner surface 27 of the container and cam follower 74 contacts cam surface 46. Shield 66 covers outer surface 44 of cap seating flange 40 and bottom stop ledge 56 abuts with upper surface edge 43 of the cap seating flange 40, so as to form a non-permanent lock and substantially prevent any excess fluid in well 42 of the cap seating flange from spilling out. Any fluid that migrates between upper surface edge 43 and bottom stop ledge 56 is directed in a downward direction along the container. Further, any fluid in well 42 is substantially contained by the upper surface edge of the cap seating flange and the bottom stop ledge of the cap; [0045]; Figures 2 and 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the integrally formed member teachings of Conway into those of Robbins in order to form a non-permanent lock with the cap and substantially prevent any excess fluid in well of the cap seating flange from spilling out (Conway [0045]).
Claims 5-6, 8, and 17 rejected under 35 U.S.C. 103 as being unpatentable over Robbins et al in view of Manoussakis (U.S. Publication No. 2005/0065454; cited by Applicant).
Regarding Claim 5, Robbins fails to specifically teach wherein the cover member includes a colorant to identify the cover member.
In a similar technical field, Manoussakis teaches a blood collection tube (Abstract), wherein the cover member includes a colorant to identify the cover member (cap element 56 may be color-coded, providing the user with an identification of the contents of the tube 12, or the intended use or intended testing of the contents of the tube 12; [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the color-coding teachings of Manoussakis into those of Robbins in order to provide the user with an identification of the contents of the tube, or the intended use or intended testing of the contents of the tube (Manoussakis [0028]).
Regarding Claim 6, Robbins fails to specifically teach wherein the colorant is opaque and/or translucent.
In a similar technical field, Manoussakis teaches a blood collection tube (Abstract), wherein the colorant is opaque and/or translucent (cap element 56 may be color-coded, providing the user with an identification of the contents of the tube 12, or the intended use or intended testing of the contents of the tube 12; [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the color-coding teachings of Manoussakis into those of Robbins in order to provide the user with an identification of the contents of the tube, or the intended use or intended testing of the contents of the tube (Manoussakis [0028]).
Regarding Claim 8, Robbins fails to specifically teach an extended portion removably attached to a bottom end of the tube.
In a similar technical field, Manoussakis teaches a blood collection tube (Abstract), further comprising an extended portion removably attached to a bottom end of the tube (a cap element 86 may further be provided and mated with second end 18 of tube 12 about hybrid stopper 70. More particularly, cap element 86 may be provided including a front face 88 with an annular skirt 90 depending therefrom. Front face 88 of cap element 86 includes a central opening such as through-hole 92 extending therethrough. Cap element 86 is desirably positioned over hybrid stopper 70 and is engaged with the outer surface of tube 12 at second end 18 thereof, such as through a friction-fit, a snap-fit, a threaded engagement or the like, or may be adhesively affixed or adhered thereto; [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the removable cap element teachings of Manoussakis into those of Robbins in order to enable the cap to be engaged with the tube such as through a friction-fit, a snap-fit, a threaded engagement, to provide a tactile surface, and to offer color-coding (Manoussakis [0033]).
Regarding Claim 17, Robbins fails to specifically teach an extended portion removably attached to a bottom end of the tube.
In a similar technical field, Manoussakis teaches a blood collection tube (Abstract), further comprising an extended portion removably attached to a bottom end of the tube (a cap element 86 may further be provided and mated with second end 18 of tube 12 about hybrid stopper 70. More particularly, cap element 86 may be provided including a front face 88 with an annular skirt 90 depending therefrom. Front face 88 of cap element 86 includes a central opening such as through-hole 92 extending therethrough. Cap element 86 is desirably positioned over hybrid stopper 70 and is engaged with the outer surface of tube 12 at second end 18 thereof, such as through a friction-fit, a snap-fit, a threaded engagement or the like, or may be adhesively affixed or adhered thereto; [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the removable cap element teachings of Manoussakis into those of Robbins in order to enable the cap to be engaged with the tube such as through a friction-fit, a snap-fit, a threaded engagement, to provide a tactile surface, and to offer color-coding (Manoussakis [0033]).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Robbins et al in view of Takinami et al (WO 2008/072414 A1).
Regarding Claim 14, Robbins fails to specifically teach wherein the plurality of ribs includes a colorant to identify the plurality of ribs.
In a similar technical field, Takinami teaches a puncture instrument (Abstract), wherein the plurality of ribs includes a colorant to identify the plurality of ribs (the outer peripheral portion 216 of the casing 21 is covered with the extension portion 24A in a non-extended state and exposed in the extended state, that is, a portion on the base end side from the rib 215 and a casing excluding the portion. It can be divided into 21 other parts, that is, a part on the tip side from the rib 215. In the puncture device 2A, it is preferable that the partial force on the proximal end side from the rib 215 is colored with a color different from that on the distal end side from the rib 215. Hereinafter, the portion on the base end side from the colored rib 215 is referred to as “colored portion 25” (see FIG. 10). By providing the colored portion 25, in the extended state, the colored portion 25 is exposed so that the colored portion 25 can be visually recognized; [0104-0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the color teachings of Takinami into those of Robbins in order to enable the colored portion to be visually recognized (Takinami [0104-0105]).
Regarding Claim 15, Robbins fails to specifically teach wherein the colorant is opaque and/or translucent.
In a similar technical field, Takinami teaches a puncture instrument (Abstract), wherein the colorant is opaque and/or translucent (the outer peripheral portion 216 of the casing 21 is covered with the extension portion 24A in a non-extended state and exposed in the extended state, that is, a portion on the base end side from the rib 215 and a casing excluding the portion. It can be divided into 21 other parts, that is, a part on the tip side from the rib 215. In the puncture device 2A, it is preferable that the partial force on the proximal end side from the rib 215 is colored with a color different from that on the distal end side from the rib 215. Hereinafter, the portion on the base end side from the colored rib 215 is referred to as “colored portion 25” (see FIG. 10). By providing the colored portion 25, in the extended state, the colored portion 25 is exposed so that the colored portion 25 can be visually recognized; [0104-0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the color teachings of Takinami into those of Robbins in order to enable the colored portion to be visually recognized (Takinami [0104-0105]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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