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 24 APRIL 2026 is acknowledged and considered. In the claim set, Claims 1, 3-6, 8-12, 14-16 are ‘Currently Amended’; Claims 17-20 are ‘Original’; Claims 2 , 7 and 13 are ‘Canceled’.
Current pending claims are Claims 1, 3-6, 8-12 and 14-20 are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 24 APRIL 2026, with respect to the 112(b) rejections have been fully considered and are persuasive. The 112(b) rejections has been withdrawn.
Applicant's arguments filed 24 APRIL 2026 have been fully considered but they are not persuasive.
In the amendment to the claims filed on 24 APRIL 2026, Applicant has amended the preamble of the claims to move the phrase ‘blow molded’ into the body of the claim.
Applicant asserts that previously applied reference to SKIFFINGTON does not disclose a blow-molded vial body.
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.
In addition, once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).
Furthermore, “[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.” Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020).
Applicant goes on to assert that the SKIFFINGTON reference does not disclose a liquid contained in the hollow space of the blow-molded body. The assertion that liquid in the hollow body distinguishes it from the prior art is respectfully disagreed by the Examiner.
It should be brought Applicant’s attention that 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). The liquid within the hollow body does not further distinguish it structurally from SKIFFINGTON. The liquid in the hollow body is material worked upon by the device and/or what the device is capable of holding/containing.
As conceded by Applicant SKIFFINGTON is a test apparatus for reagent containment. A reagent can be a liquid. Therefore, SKIFFINGTON teaches this feature despite it not structurally not defining the instant invention.
Applicant goes on to assert that the SKIFFINGTON reference does not disclose a break-away tip from at the second end. Examiner respectfully disagrees.
As seen in Figure 1 of SKIFFINGTON, there is a microtube test unit 16 which is detachable from the cylinder 14 and indention 26, Column 9 line 66 – Column 10 line 6. The microtube test unit 16 is at a second end of the cylinder 14, Figure 1.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the claimed break-away tip serves an entirely different function, to create an opening at the second end , enabling liquid to be dispensed or dropped from the vial onto a testing substrate) 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).
The instant claim merely teaches a structure feature of “a break-away tip integrally formed at the second end of the blow-molded vial”.
Even if one was to consider the language of the claimed break-away tip enabling liquid to be dispensed or dropped from the vial onto a testing substrate, this is directed to a manner of operating the device and it does not differentiate the apparatus form the prior art. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
In response to Applicant’s amendments to the claims, the rejection below has been modified to reflect these changes, but still relies on the same prior art.
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 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the blow-molded vial" in the second to last line. Claim 12 recites the limitation "the blow-molded vial" in the second to third last lines. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this instance is referring to the ‘blow-molded vial body’ in line 2.
Claim 1 recites the limitation "the blow-molded body" in the last line. Claim 12 recites the limitation "the blow-molded body" in the last line. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this instance is referring to the ‘blow-molded vial body’ in line 2.
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 14-20 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 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, 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 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;
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 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).
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 SKFFINGTON would be merely a matter of obvious engineering choice.” In reLarson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) .
Additional Disclosures Included are: Claim 3: wherein the Claim 4: wherein the Claim 5: wherein the removable top portion to the vial body, Figure 8A/B, Column 11 line 18-48, Figure 5D-E.; Claim 6: wherein the Claim 8: wherein the 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 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 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
Applicant’s invention is directed towards a device, a vial, Column 6 line 34-44.
Regarding Claim 12, the SKIFFINGTON reference discloses a
a blow-molded 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;
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 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).
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 reLarson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) .
Additional Disclosures Included are : Claim 14: wherein the 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 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).
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 reLarson, 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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