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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim Objections
In claim 58, last line, “position” should be –positioned--.
In claim 59, “in a manner selected from a member of group consisting of” is a little confusing. Examiner suggests either listing the elements, separated by commas, with an –or—instead of “and” before the last element, or using Markush language – selected from the group consisting of--.
In claim 60, each occurrence, “selected from a group consisting of” should be –selected from the group consisting of--. In section b, “selected from a group consisting of one or more glue or adhesive” should be –one or more selected from the group consisting of glue and adhesive--.
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 57-75 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.
Claims 57, 58, 59, 61, and 73 recite the phrase “pouch-like envelope”. The Examiner submits this term is unclear. Regarding the cited claims, the phrase "-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "pouch-like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claims 57, 58, and 61 recite the phrase “sleeve-like or sock-like”. The Examiner submits this term is unclear. Regarding the cited claims, the phrase "-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "sleeve-like or sock-like”), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 57 recites “the same” on line 1, “The same” should be replaced by –the substance--. Claim 57recites “said pouch” on like 2. There is no antecedent basis for this term. Claim 57 recites “said main longitudinal axis” and “flexible pouch-like envelope” on line 6, there is no antecedent basis for these terms On line 7, “the said a mail longitudinal axis” is not clear. On line 8, claim 57 recites “within two case’s walls”. The Examiner submits this is unclear as a case has not been claimed in claim 57. Therefore, the claim is unclear and correction is required.
Claim 58 recites “the said a mail longitudinal axis” which is not clear and “at least two external case’s walls” which has no clear antecedent basis.
Claim 59 recites that the handle is a hand or at least one finger. An appendage cannot be claimed as part of the device. In claim 59, section b, recites a number of elements, which are overlapping in what they cover, which makes the metes and bounds of the group unclear.
Claims 60, 62 and 73 contain the trademark/trade name Velcro™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a physical sealing means and, accordingly, the identification/description is indefinite.
Claim 69 recites “The method of claim 57” in line 1, but claim 57 recites a device. Therefore, the claim is unclear and correction is required.
Claim 63 recites the limitation “the desire reagent" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 64 recites “by one of a group consisting enzymatic solution, chemic solution, powder and any combination thereof”. The Examiner submits this is improper Markush group format and therefore unclear.
Claim 65 recites the limitation “the contaminated swab”, the preheated-stored diagnostic solution”, and “the case” in line 3 and recites the limitation of “the desire reagent” in line 4. There is insufficient antecedent basis for each of these limitations in the claim.
Claim 66 recite the phrase “gel-like material”. The Examiner submits this term is unclear. Regarding the cited claims, the phrase "-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "gel-like”), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 67 recites the limitation “the case" in lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim. Claim 67 recites the limitation “the contaminated swab" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 67 recites “A method of diagnosing by a kit” in the preamble of the claim, but does not recite a kit element in the body of the claim. Therefore, the method is unclear.
Claim 68 recites the limitation "the substance" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 68 recites the limitation "the sample" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 70 recites “said swab(s)” in line 3. The Examiner submits this alternative term is unclear as it cannot be “swab”. Claim 70 recites “said upper” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 71 recites the limitation "said cells" in lines 5 and 6. There is insufficient antecedent basis for this limitation in the claim. Claim 71 recites the limitation “said external cover lids” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 72 recites the limitation "the same" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 73 recites the phrase “sponge-like” in line 20. The Examiner submits this term is unclear. Regarding the cited claims, the phrase "-like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "sponge-like”), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Claim 73 also recites “a member of a group consisting of a fluid”. The Examiner submits this is unclear as no group is recited n the claim. Claim 73 also recites “define it” and stabilize it”. The Examiner submits it is unclear what feature or limitation is referred to with the pronoun “it”.
Claim 74 recites “said envelope” in lines 2, 4, 6 and 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites “its case” in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 57-62, 69 and 72-74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al. (WO 2019/079563). The Examiner is also citing US 2021/0199541 and US 11,680,873 – which are the US PgPub and US Patent versions of the published WIPO document. The Examiner will be referring to US 2021/0199541 in the rejection. Brown teaches an apparatus for sampling a food products and surfaces. The embodiments of the device most relevant to the instant claims are shown in Figures 4-7 and described in Paragraphs 0014-0038 and the claims.
Regarding claims 57-59, 69 and 72-74 – As shown in Figures 4-7, teaches an apparatus for sampling a substance comprised of a pouch-like envelope (bag 500/700) having a sleeve-like swab (collection material 530/730). During use the pouch-like envelope (bag 500/700) is first 100% inverted. Next, the user places a handle (hand) into the sleeve-like swab (530/730) and contacts at least one surface to collect material on the sample collector (collection material 530/730). The bag is then re-inverted to enclose the sample collection material (collection material 530/730) and the bag is finally sealed. The collected sample material is then cultured, incubated and examined for detection of an analyte to be identified. See Paragraphs 0028-0037. With respect to the limitation directed to the case (lines 6-8 of claim 1), the Examiner submits that the case has not been positively recited in the claim and the bag (500/700) and collection material (530/730). The Examiner also notes that the phrase “wherein at least one of the following is true “ has been treated as alternative language such that if ANY ONE of the features recited in the body of the claim after this phrase are present in the device of Brown, then the device of Brown meets the claim.
Regarding claims 60, 61, 62 – Brown teaches a mechanical seal (420/520) for the top opening of the bag in Figures 4-5 and Paragraphs 0028-0029.
Inventorship
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 63-66 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (WO 2019/079563) in view of Barnes, Sr. et al. (US 7,938,776).
Brown as disclosed in Paragraphs 11-13 above teaches every element of claims 63-66 except for the diagnostic solution. Barnes teaches an examination glove for detecting the presence of blood or fecal matter in biological samples. The embodiment of the glove most relevant to the instant device is shown in Figures 1-2 and 6-7 and described in columns 7-11. As shown in the Figures, the device is comprised of a glove (100) having fingers (102, 104) with collection element (106) that contact the sample. The glove further includes a test pad (108) having reagents that detect the presence of blood in the sample. Once a sample is collected, the test pad (108) is brought into contact with the collection element (106) and a change of color is produced when blood is present in the sample. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the reagents from Barnes with the device and method of Brown. Brown teaches collecting the sample and then evaluating the sample by culturing, incubation, and detection. See Paragraphs 0034-0037 of Brown. One of ordinary skill in the art would add the reagents to Brown in order to provide an instant result during testing as taught by Barnes.
Claims 67, 68, 70, 71, 75 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (WO 2019/079563) in view of Oliver (US 2006/0286606). Brown as disclosed in Paragraphs 11-13 above teaches every element of claims 67, 68, 70, 71, 75 except for the kit or case with a plurality of compartments. Oliver teaches a kit and method for collecting a sample for testing. The embodiments of the device and method most relevant to the instant claims are shown in Figures 1-2F and described in Paragraphs 0086-0121. As shown in Figure 1, the kit contains a case having lower cover with a plurality of compartments having a plurality of wipes. The case further includes an upper cover for closing the kit. During use, the kit is opened and the wipes are used to collect a sample that is then placed in the kit case for shipping or transport to a laboratory. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the case and kit from Oliver with the device and method of Brown. Brown teaches collecting the sample and then evaluating the sample by culturing, incubation, and detection. See Paragraphs 0034-0037 of Brown. One of ordinary skill in the art would add the reagents to Brown in order to provide a collection and/or shipping container as taught by Oliver.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Utecht (US 5,715,841) discloses collection pads connected to closable bag which is turned inside out during use. Peters, Jr. (6,539,549) teaches a glove contained within a bag which may be used to contain and seal the glove. O’Brien (US 5,476,974) teaches a sampling glove.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 September 06, 2025
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798