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 .
Election/Restrictions
Applicant’s election of Group I and Species A, drawn to claims 1-6 and 8 without traverse in the reply filed on 12/02/2025 is acknowledged.
Claims 7 and 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-6 and 8 are hereby under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/16/2023 and 09/07/2023 have been considered by the examiner.
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 Objections
Claims 2-5 are objected to because of the following informalities:
Claim 2 recites “a plurality of collection neighboring blade groups is disposed” in line 4. This should read “a plurality of collection neighboring blade groups are disposed”.
Claims 3-5 recite “wherein the plurality of neighboring blade groups is disposed” in lines 1-2 of each claim. This should read “wherein the plurality of neighboring blade groups are disposed”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2021/0290209 by Decker et al. hereinafter “Decker”.
Regarding claim 1, Fig. 1 of Decker teaches a specimen collection stick (swab 100) comprising: a rod-shaped or bar-shaped support unit having a predetermined length (shaft 110 has a length that must be predetermined before forming): and a specimen collection unit located at a front end of the support unit (tip portion 130), the specimen collection unit being configured to collect a specimen in a body of a subject that comes into contact with the specimen collection unit ([0068]; swab 100 is configured for collecting biological samples from a subject), wherein the specimen collection unit comprises: a hub coupled to a front of the support unit (body 132); and a plurality of collection blades supported by the hub ([0075]; each of the protrusions 140 may have an elliptical or oval cross section, thereby defining collection blades), the plurality of collection blades being disposed on an outside of the hub in rotational symmetry or axial symmetry with respect to a central axis of the hub in a longitudinal direction thereof (Fig. 1B-C show the protrusions in axial symmetry around the body 132), each of the plurality of collection blades is formed in a plate shape (the flattened nature of an elliptical or oval cross section can be considered a plate shape), and such that a thickness of the collection blade is less than the lateral width of the collection blade (an elliptical or oval cross section would comprise a greater dimension along the major axis (i.e., width) relative to a dimension of the minor axis (i.e., thickness)), and each of the collection blades or the hub is made of a flexible or elastic material ([0069]; “In some embodiments, the swab 100, or at least a portion of the swab 100, may be flexible such that the swab 100 may be elastically deformed from its linear shape but has a tendency to return to its original, linear shape.”).
Fig. 1 of Decker does not teach wherein each of the plurality of collection blades being formed such that a longitudinal length of the collection blade from one end abutting an outer surface of the hub to the outer end thereof is equal to or greater than a lateral width of the collection blade at a center point of the longitudinal length.
Decker teaches that each of the protrusions may extend radially away from the body 132 and define a length of the protrusions ([0074]) and a lateral width is a property of the dimension along the major axis of the elliptical or oval cross section ([0075]). The courts have held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the longitudinal length of the collection blades being greater than or equal to a lateral width of the collection blade. Therefore, it would have been obvious to a person of ordinary skill in the art, to change the size and proportions of Decker such that each of the plurality of collection blades being formed such that a longitudinal length of the collection blade from one end abutting an outer surface of the hub to the outer end thereof is equal to or greater than a lateral width of the collection blade at a center point of the longitudinal length. See MPEP 2144.04.IV.B.
Regarding claim 2, modified Decker teaches the specimen collection stick according to claim 1, wherein the plurality of collection blades arranged at an outer circumferential surface of the hub on the same circumference constitute a blade group (the protrusions along the same row can be considered a blade group), and a plurality of neighboring blade groups is disposed on the outer circumferential surface of the hub such that each of the blade groups is spaced apart from a corresponding one of the blade groups neighboring thereto by a predetermined distance in a longitudinal direction of the hub (See Fig. 1B, the neighboring blade groups are equally spaced apart along the length of body 132, corresponding to axis AL).
Regarding claim 3, modified Decker teaches the specimen collection stick according to claim 2, wherein the plurality of neighboring blade groups is disposed on the outer circumferential surface of the hub (All blade groups are disposed on the outer surface of body 132.) such that the collection blades belonging to one of the blade groups and the collection blades belonging to another of the blade groups neighboring thereto are aligned parallel to the longitudinal direction of the hub (See Fig. 1B. Every other neighboring blade group is aligned parallel in the longitudinal direction of the hub).
Regarding claim 4, modified Decker teaches the specimen collection stick according to claim 2, wherein the plurality of neighboring blade groups is disposed on the outer circumferential surface of the hub (All blade groups are disposed on the outer surface of body 132.) such that the collection blades belonging to one of the blade groups are rotated relative to the collection blades belonging to another of the blade groups neighboring thereto by a predetermined angle about the central axis of the hub in the longitudinal direction thereof (See Fig. 1B. Every adjacent neighboring blade group is rotated by the same (i.e., predetermined) angle relative to the next about an axis in the longitudinal direction of the hub).
Regarding claim 6, modified Decker teaches the specimen collection stick according to claim 1, but does not teach wherein each of the collection blades is formed such that the lateral width or the thickness is gradually reduced to the other end thereof in at least a part of the longitudinal length section.
Decker further teaches an embodiment wherein the protrusions are frustoconical in shape ([0075]). This configuration would comprise the protrusions being formed such that the lateral width and thickness is gradually reduced along the length of the of the protrusion.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the specimen collection stick of Decker such that the collection blades are formed such that the lateral width or the thickness is gradually reduced to the other end thereof in at least a part of the longitudinal length section, as taught by Decker ([0075]). This modification merely comprises a simple substitution of one known element for another to obtain predictable results. See MPEP 2143.I.B.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Decker in view of US Patent Publication 2017/0065261 by Ching et al. – cited by Applicant, hereinafter “Ching”.
Regarding claim 5, modified Decker teaches the specimen collection stick according to claim 2, but does not teach wherein the plurality of collection blades is disposed on the outer circumferential surface of the hub such that a central axis of each of the collection blades in a horizontal direction thereof parallel to a horizontal plane of each of the collection blades or a width of each of the collection blades is inclined relative to the central axis of the hub in the longitudinal direction thereof by a predetermined angle.
Fig. 6 of Ching teaches a specimen collection device comprising a plurality of planar bristles (i.e., projections or collection blades) disposed on the outer surface of a hub wherein the plane coincident with the width of each collection blade (shown as 182) is inclined relative to the central axis of the hub in the longitudinal direction (longitudinal axis 185) by a predetermined angle ([0078]). This enables the collection device to maintain an orientation of the projections relative to a helical path, enabling the device to collect more biological material ([0079]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the specimen collection stick taught by modified Decker such that the plurality of collection blades is disposed on the outer circumferential surface of the hub such that a central axis of each of the collection blades in a horizontal direction thereof parallel to a horizontal plane of each of the collection blades or a width of each of the collection blades is inclined relative to the central axis of the hub in the longitudinal direction thereof by a predetermined angle, in order to enable the device to collect more biological material by the plurality of collection blades maintaining an orientation relative to a helical path, as taught by Ching ([0079]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Decker in view of US Patent Publication 2011/0085948 by Poll et al., hereinafter “Poll”.
Regarding claim 8, modified Decker teaches the specimen collection stick according to claim 1, but does not teach wherein a coupling projection or coupling protrusion is formed at an outer circumferential surface of the support unit so as to protrude therefrom, or a lid fastening groove is formed in the outer circumferential surface of the support unit, such that the support unit can be fixed to a lid of a specimen container configured to receive the specimen collection unit therein by coupling.
Figs 1-2 of Poll teaches a specimen collection member 30 comprising a proximal portion 82. Proximal portion 82 comprises a plurality of ridges 84 (i.e., protrusions) and channels 80 (i.e., grooves) configured to couple to lid 90 (0043-0044]) as seen in Fig. 2. The coupling of the collection member 30 with the lid 90 allows solution to pass through the lid and the risk of cross-contamination is limited by reducing the need to transfer the specimen from one container to another in the field and while processing of the specimen sample ([0046]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the specimen collection stick taught by modified Decker to include a lid fastening groove is formed in the outer circumferential surface of the support unit, such that the support unit can be fixed to a lid of a specimen container configured to receive the specimen collection unit therein by coupling. This modification would limit the risk of cross-contamination by reducing the need to transfer the specimen from one container to another in the field and while processing of the specimen sample allow for the addition of solution to the specimen sample, as taught by Poll ([0046]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2016/0317132 by Markowitz et al. teaches a sample collecting device with collection blades made from a flexible polymer and disposed on the outside of a hub that gradually taper.
US Patent Publication 2021/0307972 by El-Fahmawi teaches a molded swab for the collection of biological samples comprising a plurality of protrusions disposed on a hub in axial and rotational symmetry.
US Patent Publication 2021/0321991 by Elliott et al. teaches a collection swab for the collection of biological samples comprising protrusions among different groups disposed on the outside of a hub.
US Patent Publication 2023/0181381 by Boey et al. teaches a swab for the collection of biological samples comprising flat projections at a front end of a stick.
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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791