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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/20/2025 has been entered.
Response to Arguments
Applicant’s arguments and amendments filed 10/20/2025 have been fully considered.
Regarding the Drawing Objection, the applicant argues “the applicant traverses the objection. Claim 1 recites "the vertex of the angle is located at the point where the first handle portion and the second handle portion connect." The figures clearly show the vertex of the angle being located at the point where the first handle portion and the second handle portion connect. FIG. lA is reproduced and annotated below to show an example in which the figures clearly show ‘the vertex of the angle is located at the point where the first handle portion and the second handle portion connect.’” However, the annotated Figure 1A identifies the vertex of the angle to be a curve, but there is no clear indication from the disclosure that the identified curve is the vertex of the angle or where exactly on the curve the vertex is intended to be located. Therefore, the applicant’s remarks are not persuasive to overcome the objection.
Regarding the 35 USC 112b Rejection, the amendments to claims 1 and 6 overcome the rejection.
Applicant’s arguments, see Pages 5-6, filed 10/20/2025, with respect to claims 1, 3-6, 8-11, and 13 have been fully 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. Specifically the Ching reference has been provided.
Response to Amendment
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show vertex of the angle as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-6, and 8-13 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amended claim 1 discusses “wherein the angle between the second handle portion and the first handle portion is a fixed angle.” The specification does not provide support regarding the “fixed angle.” This appears to be new matter as this fixed angle was never disclosed in the originally filed disclosure.
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, 3-6, and 8-13 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.
In Claim 1 and 6, the claim limitation “the point where the first handle portion and the second handle portion connect” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a point where the first handle portion and the second handle portion connect.”
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), 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
Conclusion
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-Thursday: 7:30-4:30 & Friday 7:30-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791