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 .
Status of Claims
The claim set submitted on 07 AUGUST 2023 is acknowledged and considered. In the claim set, Claims 1-20 are presented and considered on the merits below.
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 5, 9, 10 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "the top portion" in the last line of the instant claim. There is insufficient antecedent basis for this limitation in the claim.
It is unclear if "the top portion" is referring back to " top portion thread", "the top portion connection feature", "removable top portion" in preceding Claims 1 and 4.
In Claims 9 and 15, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 9 and 15 recites the broad recitation ‘carrier fluid’, and the claim also recites liquid which is the narrower statement of the range/limitation in claims 7 and 13, respectively. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A liquid is a specific state of matter with fixed volume but no fixed shape, while a fluid is a broader category for any substance that flow including both liquids and gases.
The carrier fluid is broader than the claimed liquid.
Claim 10 recites the limitation "the top portion" in the claim. There is insufficient antecedent basis for this limitation in the claim.
It is unclear if "the top portion" is referring back to " the removable top portion" in preceding Claim 1.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by SKIFFINGTON, US Patent 5,827,675 A.
Applicant’s invention is directed towards a device, a vial.
Regarding Claim 1, the reference SKIFFINGTON discloses a blow-molded, Column 6 line 21-33, 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 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; and
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.
Additional Disclosures Included are: Claim 2: wherein the blow-molded, threaded top vial of claim 1, further comprising a break-away tip attached to the second end, Figure 5F, unit 16, Column 10 line 58-59, Figure 8B, Column 11 line 49-Column 12 line 16.; Claim 3: wherein the blow-molded, 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 blow-molded, 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 blow-molded, 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 top portion to the vial body, Figure 8A/B, Column 11 line 18-48, Figure 5D-E.; Claim 6: wherein the blow-molded, 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 7: wherein the blow-molded, threaded top vial of claim 1, further comprising a liquid in the vial body, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32. ; Claim 8: wherein the blow-molded, threaded top vial of claim 7, 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 blow-molded, threaded top vial of claim 7, wherein the liquid further comprises a 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 blow-molded, threaded top vial of claim 1, wherein the 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 blow-molded, 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.
Applicant’s invention is directed towards a device, a vial, Column 6 line 34-44.
Regarding Claim 12, the SKIFFINGTON reference discloses a blow-molded, Column 6 line 21-33, plug top vial, Column 6 line 34-44, slidably fit, 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 plug attached to the first end, Figure 5A-E, cover 12, Figure 8A/B, cover/plunger 52; and
a break-away tip attached to the second end, Figure 5F, unit 16, Figure 8B, Column 11 line 49-Column 12 line 16.
Additional Disclosures Included are : Claim 13: wherein the blow-molded, plug top vial of claim 12, further comprising a liquid in the vial body, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32. ; Claim 14: wherein the blow-molded, plug top vial of claim 13, 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 blow-molded, plug top vial of claim 13, wherein the liquid further comprises a 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).
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; and
a fluid in the hollow space, Figure 7, Column 11 line 49-Column 12 line 7, Column 4 line 7-32;
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; and
dispensing a portion of the sample containing fluid 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.
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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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797