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 .
Response to Amendment
Applicant’s amendments filed 16th March 2026 have been entered. Claims 16-23 are pending, with Claims 1-8 & 13-14 canceled, and Claims 9-12, 15, & 24-30 withdrawn from consideration.
Response to Arguments
Applicant’s arguments regarding the restriction applied are not persuasive.
The Applicant alleges the Examiner’s basis for restriction is based on hypothetical claim limitations, stating ‘Examiner suggests that because the claim recites a swab it could encompass a swab made by a particular machine’. In contrast, the examiner never stated it could encompass a swab made by a particular machine, merely that machining is broadly cited in the group of claims that the Applicant is referring to.
Applicant further states “Examiner suggests that a claim which in part recites a ‘liquid buffer’ but is actually directed to a swab could be interpreted to read on ‘monomolecular materials’ because ‘the broadly cited liquid buffer, as such, polysaccharide-based liquid buffers would be an encompassed search term as polysaccharide-based liquid buffers are known and utilized within biological sample’ However, a restriction must be based on the claimed limitations, rather than potential extensions of the limitations.”. Examiner has responded to this argument previously in the office action dated 15th December 2025. The claims within Group IV make claim to a broadly cited ‘liquid buffer’, which includes ANY liquid buffer. Applicant is reminded that claims are given the broadest reasonable interpretation, and as such requires broadly searching terms.
The response to traversal of restriction from the previous office action dated 15th December 2025 is included below for ease of reference.
The restriction was deemed final in the last action dated 15th December 2025, and is maintained per MPEP § 821.01.
Applicant’s arguments with respect to prior art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Election/Restrictions
Claims 9-12, 15, 24-30 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 24th November 2025. The restriction was deemed as FINAL in the office action dated 15th December 2025 by Examiner.
Applicant's election with traverse of Group IV in the reply filed on 24th November 2025 is acknowledged. The traversal is on the ground(s) that all restricted Groups have improper classifications and Examiner has not presented evidence of distinctness. This is not found persuasive because the claims in the separate groups are distinct and searching each of the separate groups would be an undue burden.
The inventions require different fields of search, the prior art applicable to one invention would not likely be applicable to another invention. Even if an invention is classified in the same classification as another, it does not mean that a prior art found in that classification would be applicable to both inventions, as classifications encompass a wide variety in terms of scope. The classifications applied to each of the groups are inclusionary of supplemental requirements of search based on claim limitations, some limitations require searching in areas that the Applicant would not expect given the details of the specification, but the claims themselves dictate the search requirements overall. For example, the broad A61L31/042 Macromolecular materials, polysaccharides being applied to Group VI. Applicant states that this is clearly an incorrect classifications, as the claims are directed to a swab. However, the independent claim of Group VI contains the broadly cited liquid buffer, as such, polysaccharide-based liquid buffers would be an encompassed search term as they are utilized within biological sampling.
Group I Classifications: Applicant writes ‘Group I. Classified in A61 B10/0045 & A61 B10/0051: Devices for taking samples of body liquids AND for taking saliva or sputum samples (for receiving spittle). This is clearly an inaccurate classification since the claim specifically recites a swab for collecting specimens from one or more of: nostril, nasal cavity, mouth, ears, genital and rectal areas, for diagnostic testing. Thus, the second classification is inaccurate, and Group I should be classified only in A61B10/0045.’. Examiner respectfully disagrees with the Applicant’s assertion that A61B 10/0045 is inaccurate, as collecting specimens from a mouth would include taking saliva samples. Reasoning for restriction based on a search burden is applied when:
the inventions have acquired a separate status in the art in view of their classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
the prior art applicable to one invention would not likely be applicable to another invention; and
the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
Even if the classifications for all Groups were the same (e.g., A61B 10/0045 as Applicant insists), the prior art applicable to one invention would not likely be applicable to another invention within the same classification, therefore a search burden would be present regardless.
Group II Classifications: Applicant writes ‘Group II. Classified in G01N1/286 & G01N/40: preparing specimens involving mechanical work, e.g., chopping, disintegrating, compacting, homogenizing AND a classification which does not exist but we believe was intended to be G01N1/40, which is concentrating samples. The first classification is inaccurate, as it is not preparing of specimen but rather preparing of a swab to collect specimen.’. Examiner appreciates the correction of a typo, but respectfully disagrees with the Applicant’s assertion that G01N 1/286 is inaccurate, as preparing specimens would be encompassed by the claim language in the independent claim of Group II. Reasoning for restriction based on a search burden is applied when:
the inventions have acquired a separate status in the art in view of their classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
the prior art applicable to one invention would not likely be applicable to another invention; and
the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
Even if the classifications for all Groups were the same (e.g., A61B 10/0045 as Applicant insists), the prior art applicable to one invention would not likely be applicable to another invention within the same classification, therefore a search burden would be present regardless.
Group III Classifications: Applicant writes ‘Group III. Classified in B27N3/08 & B29C43/003: Manufacture of substantially flat articles, moulding or pressing AND compression moulding, characterized by choice of material. This classification is inaccurate, as the article of manufacture is not substantially flat. Thus, Group III should not be classified as a separate invention from the other classes of method claims.’. Examiner respectfully disagrees with the Applicant’s assertion that B27N 3/08 is inaccurate, as moulding or pressing would be encompassed by the claim language in the independent claim of Group III. Reasoning for restriction based on a search burden is applied when:
the inventions have acquired a separate status in the art in view of their classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
the prior art applicable to one invention would not likely be applicable to another invention; and
the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
Even if the classifications for all Groups were the same (e.g., A61B 10/0045 as Applicant insists), the prior art applicable to one invention would not likely be applicable to another invention within the same classification, therefore a search burden would be present regardless.
Group IV Classifications: Applicant writes ‘Group IV. Classified in A61B10/0045 & A61B2010/0216: Devices for taking samples of body liquids AND instruments for taking cell samples for biopsy, sampling brushes. While the first classification is accurate, the second is not, as "biopsy" is the removal of tissue or liquid internal to the body, rather than collecting specimens external areas as recited. Therefore, the accurate classification is A61 B10/0045. Thus, Group IV should not be classified as a separate invention from the other classes of apparatus claims.’. Examiner respectfully disagrees with the Applicant’s assertion that A61B 2010/0216 is inaccurate, A61B 2010/0216 encompasses instruments for taking cell samples or biopsy, not for biopsy as Applicant cites. Further, the structure cited by Group IV would be encompassed by A61B 2010/0216 as a sample brush. Reasoning for restriction based on a search burden is applied when:
the inventions have acquired a separate status in the art in view of their classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
the prior art applicable to one invention would not likely be applicable to another invention; and
the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
Even if the classifications for all Groups were the same (e.g., A61B 10/0045 as Applicant insists), the prior art applicable to one invention would not likely be applicable to another invention within the same classification, therefore a search burden would be present regardless.
Group V Classifications: Applicant writes ‘Group V. Classified in B27C5/00 & B27M3/00: Machines designed for producing special profiles or shaped work, e.g., by rotary cutters AND Manufacture or reconditioning of specific semi-finished or finished articles. These classifications are for the machines that produce special profiles, rather than for a swab produced, which is claimed. Thus, Group V should not be classified as a separate invention from the other classes of apparatus claims.’. Examiner respectfully disagrees with the Applicant’s assertion that the classifications are inaccurate. Group 5 broadly recites machining the piece to create cylindrical cuts in a first portion of the piece and retaining a second portion of the piece without cuts to form a handle. Examiner argues that shaped work and manufacture of specific semi-finished or finished articles is encompassed by the claim language of Group V. Reasoning for restriction based on a search burden is applied when:
the inventions have acquired a separate status in the art in view of their classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
the prior art applicable to one invention would not likely be applicable to another invention; and
the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
Even if the classifications for all Groups were the same (e.g., A61B 10/0045 as Applicant insists), the prior art applicable to one invention would not likely be applicable to another invention within the same classification, therefore a search burden would be present regardless.
Group VI Classifications: Applicant writes ‘Group VI. Classified in A61L31/042: Macromolecular materials, polysaccharides. This is clearly an incorrect classification, as the claims are directed to a swab. Thus, Group VI should not be classified as a separate invention from the other classes of apparatus claims.’. Examiner respectfully disagrees with the Applicant’s assertion that the classification is inaccurate. The broad A61L31/042 Macromolecular materials, polysaccharides being applied to Group VI. The independent claim of Group VI contains the broadly cited liquid buffer, as such, polysaccharide-based liquid buffers would be an encompassed search term as polysaccharide-based liquid buffers are known and utilized within biological sampling. Reasoning for restriction based on a search burden is applied when:
the inventions have acquired a separate status in the art in view of their classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
the prior art applicable to one invention would not likely be applicable to another invention; and
the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
Even if the classifications for all Groups were the same (e.g., A61B 10/0045 as Applicant insists), the prior art applicable to one invention would not likely be applicable to another invention within the same classification, therefore a search burden would be present regardless.
The distinctness of the inventions are evidenced by mutual exclusivity as cited in the Requirement for Restriction/Election dated 23rd September 2025. Applicant suggests that Examiner has not indicated why the inventions are mutually exclusive or materially different. Applicant states that this is the case in addressing Groups I and IV, I and VI, and IV and VI.
Groups I and IV: As stated in the Requirement for Restriction/Election, Group I and IV are distinct because they claim related but non-overlapping devices. Group I requires alternating cylinders and a rounded tip for abrasive multi-area collection, while Group IV is limited to specifically nasopharyngeal use and does not comprise the cylindrical size limitations as Group I. The scope of the two groups do not overlap, and thus are shown to be clearly distinct. See MPEP 806.05(j).
Groups I and VI: As stated in the Requirement for Restriction/Election, Group I and VI are distinct because they claim different structural features and properties. Group I requires alternating cylinders and a rounded tip for abrasive multi-area collection, while Group VI requires hydrophilicity and grooves which do not require the alternating size limitations as Group I. Further, the utilities differ in scope via the claim language between Group I (collection-focused) and Group VI (release-enabled). These Groups are therefore clearly distinct. See MPEP 806.05(j).
Groups IV and VI: As stated in the Requirement for Restriction/Election, Group IV and VI are distinct because Group IV is specifically cited as for nasopharyngeal use, including cylinders of alternating sizes, whereas Group VI can be used on any orifice, utilizing groove structural properties and material properties in release-focused language utilizing a liquid buffer. The scope of the two groups do not overlap, and thus are shown to be clearly distinct. See MPEP 806.05(f)
Due to the distinct features in each grouping as previously presented in the Requirement for Restriction, a prior art search for each group would involve distinct additional CPC areas as well as distinct text searches and searching methods, thus presenting a search burden due to the varying characteristics required to be searched.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
It is noted that the Information Disclosure Statement (IDS) submissions (see attachments) are extremely long, citing over 750 references for consideration. The Examiner has considered the references submitted as part of the Information Disclosure Statements, but has found the majority have no relevance to patentability. Applicants are encouraged to provide a concise explanation of the information if Applicants are aware of document(s) or a section of a document that is highly relevant to patentability. See MPEP 609.04(a)(III) and MPEP 2004.13:
Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.
…
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the references have been considered in a cumulative manner. The Examiner further notes that numerous cited references appear to have little or no relevance at all to the claimed invention, many of which do not even mention photovoltaic devices. For example, most of the references are directed towards image sensors, optical fibers, LEDs, etc., which are not relevant to the claimed invention. Applicant has also submitted several documents in duplicate, which should be avoided in the future as this adds unnecessary volume to the record.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim(s) 16-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20230248338 A1 to Springer et al. (hereinafter, Springer).
Regarding Claim 16, Springer discloses a nasopharyngeal swab (Springer: Abstract) comprising:
a single-piece construction comprising a handle and a collector head made of a natural cellulose-based material (Springer: Para. [0136] ‘In various embodiments, each of the cap, threaded portion, neck, and/or head can be formed of a single molded part (e.g., a unitary part or item) or as separate parts, in any combination or permutation.’; Para. [0122]);
the collector head comprising a plurality of cylinders that form surfaces for specimen collection (Springer: Para. [0095]; Fig. 1, the collector head item 102 appears to comprise a plurality of cylinders or ‘rings’ that form surfaces for specimen collection; Note: A ring can be considered a cylinder; a ring is a shorter cylinder shape and also the elements are part of the cylindrical rod, thus any section of said rod would still be considered cylindrical.).
Regarding Claim 17, Springer discloses the swab of claim 16, Springer further discloses further comprising:
wherein the collector head is cylindrical, and the plurality of cylinders on the collector head comprise alternating smaller and larger cylinders (Springer: Para. [0097] ‘the axial shaft comprises a cylindrical rod’; Para. [0095]; Fig. 1, the collector head item 102 comprising a plurality of cylinders or ‘rings’; Note: The grooves created by the spaced apart ‘rings’ form smaller cylinders by way of having the spaced rings spaced apart along the shaft of the sample head.; A ring can be considered a cylinder; a ring is a shorter cylinder shape and also the elements are part of the cylindrical rod, thus any section of said rod would still be considered cylindrical.),
where the larger cylinders scrape off epithelial cells and the smaller cylinders collect and retain the scraped epithelial cells (Springer: Para. [0109] ‘the rounding of the rings facilitates insertion and withdrawal into the sample or subject’; Para. [0055]; Fig. 1).
Regarding Claim 18, Springer discloses the swab of claim 16, Springer further discloses further comprising a rounded front, the rounded front to enable the swab to be inserted into an orifice safely and with reduced resistance (Springer: Para. [0094]; Note: the functional use of the rounded front is not given patentable weight as it does not result in a structural difference; thus the limitations are met by the citations presented here.).
Regarding Claim 19, Springer discloses the swab of claim 16, Springer further discloses wherein the natural material comprises one of: bamboo, wood, and molded wood particles with a biodegradable adhesive (Springer: Para. [0122] ‘wood’; Examiner notes the other limitations of bamboo and molded wood particles with a biodegradable adhesive are considered optional and thus not required by the claimed invention).
Regarding Claim 20, Springer discloses the swab of claim 19, regarding the limitation of wherein the biodegradable adhesive comprises one of: starch-based glue, lignin-based binder, and protein-based adhesive (Per Claim 19, the ‘molded wood particles with a biodegradable adhesive’ is optional and therefore claim 20 presents a narrowing of a limitation not required by the claimed invention and therefore not required to be taught by the prior art.).
Regarding Claim 21, Springer discloses the swab of claim 16, Springer further discloses wherein the collector head releases a specimen upon insertion into a liquid buffer (Springer: Para. [0156]).
Regarding Claim 22, Springer discloses the swab of claim 21, Springer further discloses wherein the natural material is hydrophilic, and an absorption of water releases epithelial cells for a nasal swab (Springer: Para. [0122]; Note: Wood is known to be naturally hydrophilic; Para. [0170] ‘the swab 100 is deposited into a container tube. In some embodiments, the container tube contains sample transport media. In some embodiments after the contacting step, the swab or at least a portion of the swab (e.g., the soluble portion) is dissolved, e.g., with water or an aqueous solution if the swab material is water-soluble. Such a dissolving step can permit faster release of the sample from the swab for downstream applications.’).
Regarding Claim 23, Springer discloses the swab of claim 16, Springer further discloses wherein the swab is configured to be sterilized using gamma irradiation (Springer: Para. [0240]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SHAWN CURTIS BROUGHTON whose telephone number is (571)272-2891. The examiner can normally be reached Monday - Friday, 8am-4pm EST..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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