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 on 12/23/2025 has been fully considered. Claims 1-15 are pending in this application. Claims 13-14 are withdrawn. Claims 1 is amended. Claims 15 is newly added.
Response to Arguments
Regarding the claim objection of claim 1, the amendment of claim 1 overcomes the claim objection of record. The claim objection is now withdrawn.
Applicant’s arguments with respect to amended independent claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on the prior art reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the argument that the prior art of Ching ‘261 would be unsuitable for the modification of the bristles to have hemispherical tips, the argument is unpersuasive. In Page 6 of the Remarks of the applicant, mailed on 12/23/2025, the applicant points to Ching ‘261 and more specifically claim 1, paragraph 8, and figure 5A of Ching ‘261. However, paragraphs 0008-0013, claim 1, and figure 5A of Ching ‘261 discusses the planar elongate bristle support member, and not the shapes of the bristle tips itself. More specifically, paragraph 0069 of Ching ‘261 discusses “In another embodiment the bristles may be flat (e.g. planar), rectangular or finial in shape…”. The “finial” shape of the bristle is interpreted to be a non-planar, ornament-shaped tip at the end of the bristle (see definition of “finial” of Cambridge Dictionary attached in PTO-892). Thus, the prior art of Ching ‘261 would support the modification of the bristle to have a hemispherical nub with a hemispherical tip (see rejection of claim 1 below).
Though overall some of the prior art references are used herein, at least applicant’s amended independent claim 1 and newly added dependent claim 15 changed the scope of the claims and required a change in the grounds of rejection as detailed below in the prior art rejection.
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.
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(s) 1, 4, 7-9, 11-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ching et al. (Publication No. US 2017/0065261 A1), hereby referred to as “Ching ‘261”, in view of Belmkaddem (Publication No. US 2020/0060877 A1).
Regarding claim 1, Ching ‘261 teaches a nasopharyngeal swab (Figure 1, 2B, 4A(VI)-4B(VI)), 5A, 5C) the swab comprising:
a tip section (i) that is elliptic-cylindrically shaped (distal portion of sampling member 110; Figure 1, 5A, 5C; Paragraph 0050), wherein the tip section provides an arrangement of nubs about a peripheral surface of the tip section (bristles 120 are about the peripheral surface of the distal portion of the sampling member 110; Figure 5A, 5C; Paragraph 0061, 0064, and 0069);
a shaft section (j) below the tip section that is elliptic-cylindrically shaped (male connector is an elliptic-cylindrical shape; Figure 4A(VI)-4B(VI)), wherein shaft section is flexible for pediatric use (Paragraph 0051);
a handle section (l) below the shaft section (section 100A; Figure 2B; Paragraph 0053), wherein the handle section has larger cross- sectional dimensions that the shaft section (section 100B has a larger cross-sectional dimension compared to male connector section; Figure 2B); and
a transition section (k) that transitions the shaft section to the handle section (section 100B between section 100A and male connector section; Figure 2B). Ching ‘261 does not teach an arrangement of hemispherical nubs, wherein the hemispherical nubs comprise hemispherical tips.
However, Belmkaddem teaches an arrangement of hemispherical nubs, wherein the hemispherical nubs comprise hemispherical tips (cap 106 have hemispherical nubs/protrusions that are hemispherical tips; Figures 1A-1B; Paragraph 0039-0041).
Ching ‘261 and Belmkaddem are both considered to be analogous to the claimed invention because they are in the same field of medical swabs. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ching ‘261 to have the to incorporate the teachings of Belmkaddem and have the bristles of Ching ‘261 to be the hemispherical nubs with the hemispherical tips of Belmkaddem. This allows for the swab to remove the dead skin in the orifice of the user (Belmkaddem; Paragraph 0039) with a soft surface that would not cause injury during use (Belmkaddem; Paragraph 0018).
Regarding claim 4, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. The combination of Ching ‘261 in view of Belmkaddem does not expressly teach wherein a length of the shaft section is 51 mm or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the shaft section of Ching ‘261 in view of Belmkaddem to be 51 mm or less in length since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the shaft section would not operate differently with the claimed length since the swab is constructed with similar components and structure and is intended to collect biological matter from the human body. Further, it appears that the applicant places no criticality on the range claimed.
Regarding claim 7, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. Ching ‘261 further teaches wherein the tip section provides a transition tip section (c) where a size of the tip reduces to a desired size of the shaft section (distal portion of sampling member 110 at grips 152 with the cross-section decreasing towards the male connection 140 of an elliptical shape; Figure 4A(VI), 4C, 5A).
Regarding claim 8, Ching ‘261 in view of Belmkaddem teaches the swab of claim 7. Ching ‘261 in view of Belmkaddem does not expressly teach wherein the transition tip section has a length of 1.8 mm or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the transition tip section of Ching ‘261 in view of Belmkaddem to be 1.8 mm or less in length since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the transition tip section would not operate differently with the claimed length since the swab is constructed with similar components and structure and is intended to collect biological matter from the human body. Further, it appears that the applicant places no criticality on the range claimed.
Regarding claim 9, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. Ching ‘261 in view of Belmkaddem does not expressly teach wherein the transition section (k) has a length of 14.3 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the transition section of Ching ‘261 in view of Belmkaddem to be 14.3 mm in length since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the transition section would not operate differently with the claimed length since the swab is constructed with similar components and structure and is intended to collect biological matter from the human body. Further, it appears that the applicant places no criticality on the range claimed.
Regarding claim 11, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. Ching ‘261 further teaches wherein the tip section is unflocked (distal sampling member 110; Figure 5A).
Regarding claim 12, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. Ching ‘261 further teaches wherein the swab is 3D printed, molded, injection molded, or reaction injection molded (swad is injection molded; Paragraph 0052).
Regarding claim 15, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. The claim limitation “wherein the swab is suitable for use in collecting specimen from nasal passages of pediatric patients” is a recitation of an intended use of the swab for collecting specimen from nasal passages of pediatric patients. Although the prior art of Ching ‘261 in view of Belmkaddem does not expressly teach “wherein the swab is suitable for use in collecting specimen from nasal passages of pediatric patients”, since the swab of the prior art combination is substantially identical to the claimed swab, it must also necessarily produce the same outcome. Therefore, the claims are taught by the combination of Ching ‘261 in view of Belmkaddem.
Claim(s) 2-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ching et al. (Publication No. US 2017/0065261 A1) in view of Belmkaddem (Publication No. US 2020/0060877 A1), as applied to claim 1 above, and further in view of Triva (Publication No. US 2016/0367227 A1).
Regarding claim 2, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. Ching ‘261 in view of Belmkaddem does not expressly teach wherein a semi-major axis and a semi-minor axis of the shaft section are equal to or less than 1.2 mm.
However, Triva teaches the support body (2; Figure 1), including the entirety of the length of the swab, can have a diameter between 0.8 mm to 5 mm (Paragraph 0023).
Ching ‘261 in view of Belmkaddem and Triva are both considered to be analogous to the claimed invention because they are in the same field of medical swabs. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ching ‘261 in view of Belmkaddem to have the to incorporate the teachings of Triva and have the shaft section of Ching ‘261 in view of Belmkaddem to have the elliptical cross-section with a diameter/length of semi-major and semi-minor axis to be the ranges, as taught by Triva. This allows for the swab to have high flexibility for ease of use (Triva; Paragraph 0009).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have elliptic-cylindrical cross-section of the shaft section of Ching ‘261 in view of Belmkaddem to be equal or less than 1.2 mm since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the shaft section would not operate differently with the claimed semi-major and semi-minor lengths since the swab is constructed with similar components and structure and is intended to collect biological matter from the human body. Further, it appears that the applicant places no criticality on the range claimed.
Regarding claim 3, Ching ‘261 in view of Belmkaddem and Triva teaches the swab of claim 2. The combination of Ching ‘261 in view of Belmkaddem and Triva further teaches wherein the semi-minor axis of the shaft section is equal to or less than 0.8 mm (Triva; length/diameter of cross-section can be 0.8 mm; Paragraph 0023).
Regarding claim 5, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. The combination of Ching ‘261 in view of Belmkaddem does not expressly teach wherein a semi-major axis and a semi-minor axis of the tip section are equal to or less than 2.7 mm.
However, Triva teaches the support body (2; Figure 1), including the entirety of the length of the swab, can have a diameter between 0.8 mm to 5 mm (Paragraph 0023).
Ching ‘261 in view of Belmkaddem and Triva are both considered to be analogous to the claimed invention because they are in the same field of medical swabs. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ching ‘261 in view of Belmkaddem to have the to incorporate the teachings of Triva and have the tip section of Ching ‘261 in view of Belmkaddem to have the elliptical cross-section with the diameter/length of semi-major and semi-minor axis to be the ranges, as taught by Triva. This allows for the swab to have high flexibility for ease of use (Triva; Paragraph 0009).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have elliptic-cylindrical cross-section of the tip section of Ching ‘261 in view of Belmkaddem to be equal or less than 2.7 mm since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the tip section would not operate differently with the claimed semi-major and semi-minor lengths since the swab is constructed with similar components and structure and is intended to collect biological matter from the human body. Further, it appears that the applicant places no criticality on the range claimed.
Regarding claim 6, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. The combination of Ching ‘261 in view of Belmkaddem does not expressly teach wherein a nubbed section (b) of the tip section is 8.5 mm in length.
However, Triva teaches that the nubbed section (collection portion 3) has a longitudinal extension between 3 mm and 40 mm (Paragraph 0023).
Ching ‘261 in view of Belmkaddem and Triva are both considered to be analogous to the claimed invention because they are in the same field of medical swabs. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ching ‘261 in view of Belmkaddem to have the to incorporate the teachings of Triva and have the nubbed section of Ching ‘261 in view of Belmkaddem to have the length of 8.5 mm, as taught by Triva. This allows for the sample to be collected effectively from the desired target area of the body (Triva; Paragraph 0005 and 0023).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the nubbed section of Ching ‘261 in view of Belmkaddem to be 8.5 mm in length since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the nubbed section would not operate differently with the claimed length since the swab is constructed with similar components and structure and is intended to collect biological matter from the human body. Further, it appears that the applicant places no criticality on the length claimed.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ching et al. (Publication No. US 2017/0065261 A1) in view of Belmkaddem (Publication No. US 2020/0060877 A1), as applied to claim 1 above, and further in view of Ching et al. (Publication No. US 2011/0087133 A1), hereby referred to as “Ching ‘133”.
Regarding claim 10, Ching ‘261 in view of Belmkaddem teaches the swab of claim 1. Ching ‘261 in view of Belmkaddem does not expressly teach wherein the handle section has a length of 78.4 mm.
However, Ching ‘133 teaches wherein the handle section is approximately 80 mm (Paragraph 0060).
Ching ‘261 in view of Belmkaddem and Ching ‘133 are both considered to be analogous to the claimed invention because they are in the same field of medical swabs. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ching ‘261 in view of Belmkaddem to have the to incorporate the teachings of Ching ‘133 and have the handle section of Ching ‘261 in view of Belmkaddem to have the length of 78.4 mm or approximately 80 mm, as taught by Ching ‘133. This allows for the handle to be sufficiently long for comfortable handling (Ching ‘133; Paragraph 0060).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the handle section of Ching ‘261 in view of Belmkaddem to be 78.4 mm in length since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the handle section would not operate differently with the claimed length since the swab is constructed with similar components and structure and is intended to collect biological matter from the human body. Further, it appears that the applicant places no criticality on the length claimed.
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781