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 .
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.
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 1, 3-6, 8-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Triva (U.S. 10517575 B2) in view of Ching et al. (US 20150297196 A1).
Regarding Claim 1, Triva discloses an angled sampling swab (flocked swab – element 1), comprising:
a swab head (flocked swab head – element 3) comprising an absorbent material for specimen sample collection (Abstract, a flocked collecting portion aimed at absorbing a quantity of a sample of biological material);
and a handle (support body – element 2, Col 4 line 67 to Col 5 lines 1-6), comprising:
a first handle portion (First Portion element 2a), wherein the swab head is attached to the first handle portion (Figures 2-3; Paragraph 12, The collecting portion 3 for the sample can be conformed as a swab. The collecting portion 3 is of a flocked type, realized by flocking of a plurality of fibers 6 on the first portion 2a of the support body aimed at defining a flocked layer on the first portion 2a); and
a second handle portion (second portion – element 2b) comprising a notch (first and second weakening point – elements 4a & 4b) enabling separation (Col 1 lines 17-18, Abstract, a separation of a first part of the flocked collecting portion from a second part of the flocked collecting portion and from the gripping portion) of part of the second handle portion to enable insertion of the swab head and the first handle portion into a transport vial (Col 1 lines 17-18, Col 6 lines 57-62),
the second handle portion arranged at an angle of 80 degrees or greater and less than 170 degrees (Col 3 lines 44-47, Col 6 lines 1-21) with respect to the first handle portion, such that the swab head is arranged at the same angle with respect to the second handle portion, wherein the vertex of the angle is located at the point where the first handle portion and the second handle portion connect (first and second weakening point – elements 4a & 4b; [Examiner’s note, one skilled in the art would understand the weakening points is the vertex of the angle because the weakening points are where the first handle portion (2a) and second handle connect (2b)].
Triva is silent in disclosing the angle between the second handle portion and the first handle portion is a fixed angle, and the first handle portion and the second handle portion maintain the angle during specimen collection;
Ching teaches the angle between the second handle portion (Ching | handle – element 105; Figure 1b) and the first handle portion (Ching | 130 is inserted into element 110; Figure 1b) is a fixed angle (Ching | Paragraphs 0076-0077; Figure 1b; [Examiner’s note, the fixed angle is the vertex of the angle.]), and the first handle portion and the second handle portion maintain the angle during specimen collection (Ching | Paragraphs 0076-0077; Figures 1b and 3) and the second handle portion arranged at an angle of 80 degrees or greater and less than 170 degrees (Figures 1a-1b). One having an ordinary skill in the art the time the invention was filed would have found it obvious to flocked swab of Triva to incorporate the teachings of a fixed angle between the first and second handle portion during specimen collection from Ching. Doing so would allow the user or physician to properly insert the flocked swab, preventing injury by stopping the device from being inserted too far (Ching | Paragraph 0077, 0087).
Regarding Claim 3, Triva in view of Ching teaches the angled sampling swab as defined in claim 1, wherein the outer diameter of the swab head is at least 1 millimeter (mm) and less than 4.5 millimeters (Triva | Claim 13, Col 4 lines 55-64).
Regarding Claim 4, Triva in view of Ching teaches the angled sampling swab as defined in claim 1, wherein the angle is between 85 degrees and 95 degrees (Triva | Col 3 lines 44-47, Col 6 lines 1-21).
Regarding Claim 5, Triva in view of Ching teaches the angled sampling swab as defined in claim 1, wherein the angle is between 130 degrees and 140 degrees (Triva | Col 3 lines 44-47, Col 6 lines 1-21).
Regarding Claim 6, Triva in view of Ching teaches the angled sampling swab as defined in claim 1, wherein the notch is between 40 mm and 110 mm from the point where the first handle portion and the second handle portion connect (Triva | Claim 13, Col 5 lines 37-41).
Regarding Claim 8, Triva in view of Ching teaches the angled sampling swab as defined in claim 1, wherein the handle is an injection molded plastic handle (Triva | Col 3 lines 40-41). Claim 8 is structured as a product-by-process claim because the product, Angled Sampling Swab, does not depend on the material of the handle to conduct its structural function. Triva discloses that the material of the handle is the same “the support body can be made by injection moulding or by extrusion” (Triva | Col 3 lines 40-41).
Regarding Claim 9, Triva in view of Ching teaches the angled sampling swab as defined in claim 1, wherein the handle is an extruded plastic handle (Triva | Claim 12, Col 3 lines 40-41). Claim 9 is structured as a product-by-process claim because the product, Angled Sampling Swab, does not depend on the material of the handle to conduct its structural function. Triva discloses that the material of the handle is the same “the support body can be made by injection moulding or by extrusion” (Triva | Col 3 lines 40-41).
Regarding Claim 10, Triva in view of Ching teaches the angled sampling swab as defined in claim 1, wherein the first handle portion comprises a rounded end, wherein the swab head surrounds the rounded end (Triva | Figure 1).
Regarding Claim 11, Triva in view of Ching teaches the angled sampling swab as defined in claim 1, wherein the swab head is flocked and comprises nylon, polyester, or bi-component microfiber (Triva | Col 4 lines 41-49, Abstract, A flocked swab for collection and transfer of samples of biological material).
Regarding Claim 13, Triva in view of Ching teaches the angled sampling swab as defined in claim 1, wherein the swab head and the first handle portion have respective lengths that are each less than 15 mm (Triva | Col 5 lines 37-41).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Triva (U.S. 10517575 B2) in view of Ching et al. (US 20150297196 A1) and Morrison et al. (U.S 20070249961 A1).
Regarding Claim 12, Triva in view of Ching teaches the angled sampling swab as defined in claim 1. Triva in view of Ching is silent in teaching the swab head comprises medical-grade open-cell polyurethane;
Morrison teaches the swab head (Morrison | Biological Sample Collection Device, The Head – element 1) comprises medical-grade, open-cell polyurethane foam (Morrison | Paragraph 0159).
Triva, Ching, and Morrison are both considered analogous to the claimed invention because they are in the same field of specimen collection via a swab. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Triva in view of Ching to incorporate the teachings of Morrison by providing a swab material coupled to the open-cell polyurethane. Doing so would allow for a spongy porous material, like the polyurethan open-cell or medical foam, for better capturing the cellular material, preferably the whole cells (Morrison | Paragraph 0160, a porous swab material may be selected so that it is capable of capturing cellular material, i.e. whole cells.). Further, the courts have held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness (Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07
Response to Arguments
Applicant’s arguments and amendments filed 05/04/2026 have been fully considered.
The applicant’s argument regarding the drawing objection is persuasive and overcome the objection.
Regarding the 35 U.S.C 112(a) Rejection, the applicant’s arguments are persuasive and have overcome the rejection.
Regarding the 35 U.S.C. 112(b) Rejection, the applicant’s amendments have overcome the rejection to Claim 1.
Regarding the 35 U.S.C 103 Rejection, the applicant argues that Triva in view of Ching do not teach the claim limitations found in Claims 1 and 4. Therefore Claims 1 and its dependent claims are allowable. However, the examiner respectfully disagrees and the arguments are not persuasive.
Regarding Claim 1, the applicant argues the combination of Triva and Ching fails to teach or suggest “the angle between the second handle portion and the first handle portion is a fixed angle, and the first handle portion and the second handle portion maintain the handle during specimen collection.” The applicant is correct that the notch taught by Triva cannot maintain a fixed angle for specimen collection. However, Triva is modified by Ching because it teaches the fixed angle (Ching | Figure 1b and Paragraphs 0076-0077). As shown in the reference figure and text, the fixed angle acts as a physical barrier that prevents users from inserting the device too deeply, which helps avoid any risk of injury.
Regarding Claim 4, the applicant argues “Triva and Ching do not teach or suggest such a fixed angle between 85 degrees and 95 degrees.” Claim 4, as filed on 05/04/2026, states “the angle sampling swab as defined in claim 1, where the angle is between 85 degrees and 95 degrees.” The applicant’s argument is not persuasive because they are claiming Claim 4 discusses of a fixed angle between 85 to 95 degrees whereas the claim states the angle is between 85 and 95 degrees. Therefore, the applicant’s argument is not persuasive.
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 SRISTI DIVINA GOMES whose telephone number is (571)272-1356. The examiner can normally be reached Monday-Friday: 9AM to 5PM EST.
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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