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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07 AUGUST 2026 has been entered.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 8 , 9, 12, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by NASON, US Patent 5,266,266.
Applicant’s invention is directed towards a device, a vial.
Regarding Claim 1, the NASON reference discloses a top vial, Figure 1, 3, 4, 6-12, comprising:
a blow-molded dispensing vial body, abstract, Column 2 line 35-48, comprising:
a first end, Figures 1, 3, 4, and 6-12, first end is interpreted to be end where lower end 40 is annotated;
a vial connection feature on an exterior surface of the vial body adjacent the first end, Figure 1, 3, and 13, overcap 44 or 44’ is press fitted relation for closing, Column 5 line 30-33, Column 8 line 15-18;
a second end, Figure 1, 3, 4 and 6-12, second end is interpreted to be end where base 14 is annotated; and
a hollow space between the first end and the second end, Figures 1, 3, 4 and 6-12, component 16, Column 3 line 61-64, Column 3 line 67-Column 4 line 2, Column 4 line 49-56;
a liquid contained in the hollow space of the vial body , Figure 10, as seen in component 16, there is liquid;
a removable top portion attached to the first end, Figure 1, 3, and 13, overcap 44 or 44’, Column 5 line 30-33, Column 8 line 15-18; and
a break-away tip integrally formed at the second end of the vial body , Figure 3, solid rod segment 28, Column 4 line 35-43, Figures 4, 6-9, Column 5 line 48-Column 6 line 2, Column 6 line 35-Column 7 line 2, configured to dispense the liquid from the second end after removal of the break-away tip, Column 5 line 49-56, Column 6 line 63-Column 7 line 2.
The preamble recited a ‘threaded top’ vial. When reading the preamble in the context of the entire claim, the recitation ‘threaded top’ is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention' s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Additional Disclosures Included are: Claim 3: wherein the threaded top vial of claim 1, wherein the second end is sealed, Figure 1-9, end where base 14 is noted; it is sealed.; Claim 8: wherein the threaded top vial of claim 1, wherein the liquid further comprises a reagent, Column 5 line 19-20. The instant claim is directed to a material or article worked upon in the device. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 9: wherein the threaded top vial of claim 1, wherein the liquid further comprises a liquid carrier fluid. The instant claim is directed to a material or article worked upon in the device. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Applicant’s invention is directed towards a device, a vial.
Regarding Claim 12, the NASON reference discloses a vial, Figure 1, 3, 4, 6-12, comprising:
a blow-molded dispensing vial body, abstract, Column 2 line 35-48, comprising:
a first end, , Figures 1, 3, 4, and 6-12, first end is interpreted to be end where lower end 40 is annotated;
a second end, , Figure 1, 3, 4 and 6-12, second end is interpreted to be end where base 14 is annotated; and
a hollow space between the first end and the second end, Figures 1, 3, 4 and 6-12,component 16, Column 3 line 61-64, Column 3 line 67-Column 4 line 2, Column 4 line 49-56;
a liquid contained in the hollow space of the vial body, Figure 10, as seen in component 16, there is liquid;
a removable plug attached to the first end, Figure 13, dropper tip 82, Column 8 line 15-20; and
a break-away tip integrally formed at the second end of the vial body, Figure 3, solid rod segment 28, Column 4 line 35-43, Figures 4, 6-9, Column 5 line 48-Column 6 line 2, Column 6 line 35-Column 7 line 2, configured to dispense the liquid from the second end after removal of the break-away tip, Column 5 line 49-56, Column 6 line 63-Column 7 line 2.
Additional Disclosures Included are : Claim 14: wherein the plug top vial of claim 12, wherein the liquid further comprises a reagent, Column 5 line 19-20. The instant claim is directed to a material or article worked upon in the device. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 15: wherein the plug top vial of claim 12, wherein the liquid further comprises a liquid carrier fluid. The instant claim is directed to a material or article worked upon in the device. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-6, 8-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over SKIFFINGTON, US Patent 5,827,675 A, and further in view of NASON, US Patent 5,266,266.
Applicant’s invention is directed towards a device, a vial.
Regarding Claim 1, the reference SKIFFINGTON discloses a threaded top vial, Column 6 line 34-44, Figure 8A/B, Column 11 line 18-40, threads 56 on cylinder 54, Figure 5C-E, comprising:
a blow-molded dispensing, Column 6 line 21-33, vial body, Figure 8A/B, cylinder 54, Column 11 line 18-40, Figure 5C-E, cylinder 14, Column 11 line 49 -Column 12 line 16, comprising:
a first end, Figure 5C-E, top 15 and cover 12 is, Figure 8A/B, top is considered cover 52 is located, where ;
a vial connection feature on an exterior surface of the vial body adjacent the first end, Figure 5C-E, Figure 8A/B, marks 22 and threads 58, Column 6 line 34-44;
a second end, Figure 5C-E, end opposite top 15 and cover 12 is, which is where grips 24 and seal 20, Figure 8A/B, opposite where top is considered cover 52 is located, which is where indentation 66 and grip 64 are located; and
a hollow space between the first end and the second end, Figure 5C-E and 8A/B, cylinder 14 and 54;
a liquid contained in the hollow space of the vial body , Column 3 line 59-63, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32, The “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935);
a removable top portion attached to the first end, Figure 5A-E, top end 15 and cover 12, Column 10 line 43-64, as seen in Figure 5B, cover is removable and attachable; and
a break-away tip attached to the second end of the blow-molded vial, Figure 5F, unit 16, Column 10 line 58-59, Figure 8B, Column 11 line 49-Column 12 line 16.
The phrase to describe the vial body to be blow-molded does not further define the invention structurally but rather only described how the vial body is made. The fact that the vial body is now blow-molded does not distinguish it from the prior art reference. The ‘blow-molded’ vial body only describes how the vial body is made and does not distinguish it from any other vial body. It should be brought to Applicant’s attention that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). A claim directed to a product is not defined by how it is made or its method of production.
SKIFFINGTON discloses the claimed invention, but is silent in regards to wherein the break-away tip is integrally form.
However, it would be obvious to one having ordinary skill before the effective filing date to make the break-away tip integrally formed at the second end since “the use of a one-piece construction instead of the structure disclosed in SKFFINGTON would be merely a matter of obvious engineering choice.” In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) .
SKIFFINTON is also silent in regard to the functional language of the break away tip, ‘configured to dispense the liquid form the second end after removal of the break away tip’.
The NASON reference discloses a top vial, Figure 1, 3, 4, 6-12, comprising:
a blow-molded dispensing vial body, abstract, Column 2 line 35-48, comprising:
a first end, Figures 1, 3, 4, and 6-12, first end is interpreted to be end where lower end 40 is annotated;
a vial connection feature on an exterior surface of the vial body adjacent the first end, Figure 1, 3, and 13, overcap 44 or 44’ is press fitted relation for closing, Column 5 line 30-33, Column 8 line 15-18;
a second end, Figure 1, 3, 4 and 6-12, second end is interpreted to be end where base 14 is annotated; and
a hollow space between the first end and the second end, Figures 1, 3, 4 and 6-12, component 16, Column 3 line 61-64, Column 3 line 67-Column 4 line 2, Column 4 line 49-56;
a liquid contained in the hollow space of the vial body , Figure 10, as seen in component 16, there is liquid;
a removable top portion attached to the first end, Figure 1, 3, and 13, overcap 44 or 44’, Column 5 line 30-33, Column 8 line 15-18; and
a break-away tip integrally formed at the second end of the vial body , Figure 3, solid rod segment 28, Column 4 line 35-43, Figures 4, 6-9, Column 5 line 48-Column 6 line 2, Column 6 line 35-Column 7 line 2, configured to dispense the liquid from the second end after removal of the break-away tip, Column 5 line 49-56, Column 6 line 63-Column 7 line 2.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the SKIFFINGTON reference with the break way tip configured to dispense the liquid from the second end after removal of the break-away tip as taught by NASON to provide substantially immediate reagent delivery when the nib breaks, Column 5 line 62-Column 6 line 2.
Additional Disclosures Included by the combination are: Claim 3: wherein the threaded top vial of claim 1, wherein the second end is sealed, Figure 5F-G, seal 20 or bottom of unit 16 is sealed closed, Column 12 line 8-16.; Claim 4: wherein the threaded top vial of claim 1, further comprising a top portion connection feature on an interior surface of the removeable top portion, Figure 5A-E, Column 6 line 34-44 .; Claim 5: wherein the threaded top vial of claim 4, wherein the vial connection feature comprises a vial thread on the exterior surface of the vial body, Figure 8A/B; wherein the top portion connection feature comprises a top portion thread on an interior surface of the removable top portion, Column 6 line 34-44; and wherein the vial thread and the top portion thread may interact to seal the removable top portion to the vial body, Figure 8A/B, Column 11 line 18-48, Figure 5D-E.; Claim 6: wherein the threaded top vial of claim 4, wherein the vial connection feature and the top portion connection feature comprise complementary connection features selected from the group consisting of thread features, bayonet features, and snap fitment features, Figure 5-E, 8A/B, Column 6 line 34-44, Column 11 line 18-48. ; Claim 8: wherein the threaded top vial of claim 1, wherein the liquid further comprises a reagent, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32. The instant claim is directed to a material or article worked upon in the device. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 9: wherein the threaded top vial of claim 1, wherein the liquid further comprises a liquid carrier fluid, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32. The instant claim is directed to a material or article worked upon in the device. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 10: wherein the threaded top vial of claim 1, wherein the removable top portion is removed and further comprising a closure configured to attach to the vial connection feature, Figure 4, 51a-E, Figure 7, foil 20, Column 10 line 39-64.; and Claim 11: wherein the threaded top vial of claim 10, wherein the closure further comprises a closure having a connection feature selected from the group consisting of thread features, bayonet features, and snap fitment features, Figure 5-E, 8A/B, Column 6 line 34-44, Column 11 line 18-48.
Regarding Claim 12, the SKIFFINGTON reference discloses a plug top vial, Column 6 line 34-44, slidably fit, comprising:
a blow-molded dispensing vial body, Figure 8A/B, cylinder 54, Column 11 line 18-40, Figure 5C-E, cylinder 14, Column 11 line 49 -Column 12 line 16, comprising:
a first end, Figure 5C-E, where top 15 and cover 12 is, Figure 8A/B, top is considered cover 52 is located;
a second end Figure 5C-E, end opposite top 15 and cover 12 is, which is where grips 24 and seal 20, Figure 8A/B, opposite where top is considered cover 52 is located, which is where indentation 66 and grip 64 are located; and
a hollow space between the first end and the second end, Figure 5C-E and 8A/B, cylinder 14 and 54;
a liquid contained in the hollow space of the blow-molded body, Column 3 line 59-63, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32, The “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935);
a removable plug attached to the first end, Figure 5A-E, cover 12, Figure 8A/B, cover/plunger 52;
a break-away tip attached to the second end of the blow-molded vial, Figure 5F, unit 16, Column 10 line 58-59, Figure 8B, Column 11 line 49-Column 12 line 16.
The phrase to describe the vial body to be blow-molded does not further define the invention structurally but rather only described how the vial body is made. The fact that the vial body is now blow-molded does not distinguish it from the prior art reference. The ‘blow-molded’ vial body only describes how the vial body is made and does not distinguish it from any other vial body. It should be brought to Applicant’s attention that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). A claimed directed to a product is not defined by how it is made or its method of production.
SKIFFINGTON discloses the claimed invention, but is silent in regards to wherein the break-away tip is integrally form.
However, it would be obvious to one having ordinary skill before the effective filing date to make the break-away tip integrally formed at the second end since “the use of a one piece construction instead of the structure disclosed in SKIFFINGTON would be merely a matter of obvious engineering choice.” In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) .
SKIFFINTON is also silent in regard to the functional language of the break away tip, ‘configured to dispense the liquid form the second end after removal of the break away tip’.
The NASON reference discloses a vial, Figure 1, 3, 4, 6-12, comprising:
a blow-molded dispensing vial body, abstract, Column 2 line 35-48, comprising:
a first end, , Figures 1, 3, 4, and 6-12, first end is interpreted to be end where lower end 40 is annotated;
a second end, , Figure 1, 3, 4 and 6-12, second end is interpreted to be end where base 14 is annotated; and
a hollow space between the first end and the second end, Figures 1, 3, 4 and 6-12,component 16, Column 3 line 61-64, Column 3 line 67-Column 4 line 2, Column 4 line 49-56;
a liquid contained in the hollow space of the vial body, Figure 10, as seen in component 16, there is liquid;
a removable plug attached to the first end, Figure 13, dropper tip 82, Column 8 line 15-20; and
a break-away tip integrally formed at the second end of the vial body, Figure 3, solid rod segment 28, Column 4 line 35-43, Figures 4, 6-9, Column 5 line 48-Column 6 line 2, Column 6 line 35-Column 7 line 2, configured to dispense the liquid from the second end after removal of the break-away tip, Column 5 line 49-56, Column 6 line 63-Column 7 line 2.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the SKIFFINGTON reference with the break way tip configured to dispense the liquid from the second end after removal of the break-away tip as taught by NASON to provide substantially immediate reagent delivery when the nib breaks, Column 5 line 62-Column 6 line 2.
Additional Disclosures Included by the combination are : Claim 14: wherein the plug top vial of claim 12, wherein the liquid further comprises a reagent, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32. The instant claim is directed to a material or article worked upon in the device. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). ; Claim 15: wherein the plug top vial of claim 12, wherein the liquid further comprises a liquid carrier fluid, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32. The instant claim is directed to a material or article worked upon in the device. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over SKIFFINGTON, US Patent 5,827,675 A.
Applicant’s invention is directed towards a method.
Regarding Claim 16, the SKIFFINGTON reference discloses a method of collecting and testing a biological sample, Column 8 line 5-18, comprising: providing a blow-molded vial, Column 8 line 5-18, Column 6 line 21-33, Column 6 line 34-44, Figure 8A/B, Column 11 line 18-40, threads 56 on cylinder 54, Figure 5C-E , comprising:
a vial body, Figure 8A/B, cylinder 54, Column 11 line 18-40, Figure 5C-E, cylinder 14, Column 11 line 49 -Column 12 line 16, comprising:
a first end, Figure 5C-E, where top 15 and cover 12 is, Figure 8A/B, top is considered cover 52 is located;
a second end, Figure 5C-E, end opposite top 15 and cover 12 is, which is where grips 24 and seal 20, Figure 8A/B, opposite where top is considered cover 52 is located, which is where indentation 66 and grip 64 are located; and
a hollow space between the first end and the second end, Figure 5C-E and 8A/B, cylinder 14 and 54;
a removable portion attached to the first end, Figure 5A-E, cover 12, Figure 8A/B, cover 52;
a break-away tip attached to the second end of the blow-molded vial, Figure 5F, unit 16, Column 10 line 58-59, Figure 8B, Column 11 line 49-Column 12 line 16; and
a liquid in the hollow space, Column 3 line 59-63, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32, The “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
SKIFFINGTON discloses the claimed invention, but is silent in regards to wherein the break-away tip is integrally form.
However, it would be obvious to one having ordinary skill before the effective filing date to make the break-away tip integrally formed at the second end since “the use of a one piece construction instead of the structure disclosed in SKIFFINGTON would be merely a matter of obvious engineering choice.” In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) .
SKIFFINTON further discloses :
removing the removable portion, Figure 5A-F, Column 10 lines 43-64;
providing a swab, Figure 5A-E, swab 18, Column 10 lines 43-64;
collecting a sample using the swab, Figure 5B, Column 10 lines 43-64;
inserting the swab with sample into the hollow space in the vial body through the first end so that the swab with sample contacts the fluid, Figure 5C-E, Column 10 lines 43-64;
removing the swab, Figure 5E-F, Column 10 lines 43-64;
sealing the first end, Figure 5E;
providing a testing substrate, Figure 5G, unit 16, Column 10 lines 43-64;
removing the break-away tip from the second end, Figure 4, Column 10 line 40-41; and
dispensing a portion of the sample containing liquid onto the testing substrate, Figure 5F-5G, Column 10 lines 43-64.
Additional Disclosures Included are: Claim 17: wherein the method of claim 16, wherein sealing the first end further comprises sealing the first end with the removeable portion, Figure 5E, Claim 14, threadable means to longitudinally move prove in sequential non-use, use and non-use, interpreted by the Examiner to be removable portion to be removed, as required by Claim 1 above and reattached as required by the instant claim. ; Claim 18: wherein the method of claim 16, wherein providing a vial body further comprises providing a vial body comprising an attachment feature on an exterior surface of the vial body adjacent the first end, Figure 5C-E, Figure 8A/B, marks 22 and threads 58, Column 6 line 34-44, grips 24, Column 10 line 5 ; Claim 19: wherein the method of claim 18, wherein sealing the first end further comprises attaching the first end to the attachment feature on the exterior surface of the vial body adjacent the first end, Column 6 line 34-44, Claim 14, threadable means to longitudinally move prove in sequential non-use, use and non-use, interpreted by the Examiner to be removable portion to be removed, as required by Claim 1 above and reattached as required by the instant claim. ; and Claim 20: wherein the method of claim 18, wherein the attachment feature is selected from the group consisting of a threaded feature, a bayonet feature, and a snap fitment feature, Column 6 line 34-44.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over NASON, US Patent 5,266,266 in view of SKIFFINGTON, US Patent 5,827,675 A.
Applicant’s invention is directed towards a method.
Regarding Claim 16, the reference NASSON discloses a method of collecting and testing a biological sample, Column 2 line 21-24, comprising:providing a blow-molded vial, abstract, Column 2 line 35-48, comprising:
a vial body abstract, Column 2 line 35-48, comprising:
a first end, Figures 1, 3, 4, and 6-12, first end is interpreted to be end where lower end 40 is annotated;
a second end, Figure 1, 3, 4 and 6-12, second end is interpreted to be end where base 14 is annotated; and
a hollow space between the first end and the second end, Figures 1, 3, 4 and 6-12, component 16, Column 3 line 61-64, Column 3 line 67-Column 4 line 2, Column 4 line 49-56;
a removable portion attached to the first end, Figure 1, 3, and 13, overcap 44 or 44’, Column 5 line 30-33, Column 8 line 15-18; and
a break-away tip integrally formed at the second end of the blow-molded vial, Figure 3, solid rod segment 28, Column 4 line 35-43, Figures 4, 6-9, Column 5 line 48-Column 6 line 2, Column 6 line 35-Column 7 line 2; and
a liquid in the hollow space, Figure 10, as seen in component 16, there is liquid;
removing the removable portion, Column 6 line 5-10;
providing a swab, Figure 3, swab shaft 22/swab tip 24/ specimen chamber 46, Column 5 line 40-47;
collecting a sample using the swab, Column 5 line 40-47;
inserting the swab with sample into the hollow space in the vial body through the first end so that the swab with sample contacts the liquid, Figure 1, 3, 13, Column 7 line 64-Column 8 line 4;
sealing the first end, Column 5 line 30-33;
removing the break-away tip from the second end, Figure 4, 5, 9 and 11, Column 5 line 47-Column 6 line 2, Column 6 line 35-56.
37. NASON is silent in regards to the steps of removing the swab; providing a testing substrate; and dispensing a portion of the sample containing liquid onto the testing substrate.
38. SKIFFINTON discloses :
removing the removable portion, Figure 5A-F, Column 10 lines 43-64;
providing a swab, Figure 5A-E, swab 18, Column 10 lines 43-64;
collecting a sample using the swab, Figure 5B, Column 10 lines 43-64;
inserting the swab with sample into the hollow space in the vial body through the first end so that the swab with sample contacts the fluid, Figure 5C-E, Column 10 lines 43-64;
removing the swab, Figure 5E-F, Column 10 lines 43-64;
sealing the first end, Figure 5E;
providing a testing substrate, Figure 5G, unit 16, Column 10 lines 43-64, Column 15 line 40-54;
removing the break-away tip from the second end, Figure 4, Column 10 line 40-41; and
dispensing a portion of the sample containing liquid onto the testing substrate, Figure 5F-5G, Column 10 lines 43-64, Column 15-54.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the NASON reference with the steps of removing the swab; providing a testing substrate; and dispensing a portion of the sample containing liquid onto the testing substrate to eliminate operational mistakes due to inaccurate pipetting, Column 17 line 27-29.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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