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 .
Information Disclosure Statement
The information disclosure statements (IDS) been submitted on 03/11/26, 04/22/25 and 06/18/24 have been considered by the examiner
Amendment Entered
In response to the amendment filed on July 7, 2026, amended claims 1-17 have been entered.
Response to Arguments
Applicant's remarks and amendments with respect to the objections have been fully considered and were persuasive. Therefore, these objections have been withdrawn
Applicant's remarks and amendments with respect to the rejections under U.S.C. 112 have been fully considered and were persuasive. Therefore, these rejections have been withdrawn
Applicant's remarks and amendments with respect to the rejections under U.S.C. 102 have been fully considered and were persuasive. Therefore, these rejections have been withdrawn. Secondary reference Bychkov has been added.
Applicant’s arguments filed with respect to the prior art rejections under U.S.C. 103 raised in the previous office action were fully considered and were not persuasive
Applicant argues that Qu fails to teach a fixed, no-moveable part. Examiner disagrees and notes that Qu teaches the collection swab is a single part [fig. 2, element 3, 4]. While Examiner agrees Qu teaches the container is a separate moveable part, the claims are interpreted as the collection member being a single part. Therefore, this equates to a fixed non-moveable collection element, when taking into consideration broadest reasonable interpretation
Applicant also argues that Qu does not disclose the graduated scale extends into the gripping portion, and that it is purely observational from the figures. Qu teaches “a first scale 31 is provided on the brush handle 3 of the specimen brush”, in addition to the figure showing the graduated scale extending to the bottom of the device. Therefore, this equates to the graduated scale extends into the gripping portion, when taking into consideration broadest reasonable interpretation.
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.
Claims 1-5, 7-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Qu (CN 108836403 A) and in further view of Bychkov (US 2023/0260627)
Qu was cited in Applicant’s IDS filed on 06/18/24
Qu and Bychkov were applied in the previous office aciton
Regarding claim 1, Qu teaches a device for collecting and transferring samples of biological material [fig. 1, 2; par. 19 “A specimen brush that can be inserted into or removed from the cannula 1 is provided inside the cannula 1”], comprising:
an elongated body [fig. 1, 2, element 3], at least partially extending along a main substantially axial development direction [fig. 1, 2, element 3] and comprising at least a gripping portion destined to be grasped by a user [fig. 1, 2, element 3; par. 19 “The specimen brush consists of a brush handle 3”] and at least an end portion [fig. 2, element 4];
a collection element [fig. 2, element 4] connected to the elongated body in substantial correspondence of said end portion [fig. 2, elements 3, 4] and configured to collect and/or absorb a quantity of a sample of biological material present in a cavity of the body of a subject [par. 19], at least the collection element being configured to be introduced inside a cavity of the body of the subject, [par. 19 “the sampling bristles 4 extend from the flexible blind tube 2 out of the cannula 1 to perform posterior nasal cavity sampling”],
wherein the elongated body comprises a graduated scale [fig. 1, element 31] provided with a plurality of measurement markings realized according to a predetermined distance measurement unit [par. 19], said measurement markings being configured to, and destined to, provide at least a visual and/or tactile indication of a measurement of a distance with respect to said end portion of the elongated body and/or with respect to a predefined portion of said collection element [par. 19 “a first scale 31 is provided on the brush handle 3 of the specimen brush, which allows medical staff to more accurately control the length of the specimen brush extending out of the cannula”]
the graduated scale is configured and destined to provide a visual and/or tactile indication of a preferred and predetermined introduction depth at least of the collection element inside said cavity of the body of the subject [par. 19 “a first scale 31 is provided on the brush handle 3 of the specimen brush, which allows medical staff to more accurately control the length of the specimen brush extending out of the cannula”],
wherein the elongated body is fixed with respect to the collection element, so that the elongated body does not slide with respect to the collection element, and wherein the graduated scale and the plurality of measurement markings are in a fixed position with respect to the collection element, the device being free from movable parts [fig. 2, element 3, 4]
However, Qu does not teach the graduated scale is configured and destined to provide a visual and/or tactile indication of a preferred and predetermined introduction depth at least of the collection element inside said cavity of the body of the subject
in relation to a distance between a first portion and a second portion of the body of a subject the graduated scale being configured and specifically destined to address, in use, the user to grasp the elongated body in correspondence of at least a measurement marking indicative of said preferred and predetermined introduction depth
Bychkov teaches the graduated scale is configured and destined to provide a visual and/or tactile indication of a preferred and predetermined introduction depth at least of the collection element inside said cavity of the body of the subject in relation to a distance between a first portion and a second portion of the body of a subject [fig. 10, element 1010; par. 170] the graduated scale being configured and specifically destined to address, in use, the user to grasp the elongated body in correspondence of at least a measurement marking indicative of said preferred and predetermined introduction depth [fig. 10, element 1010; par. 170]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Qu, to incorporate the graduated scale is configured and destined to provide a visual and/or tactile indication of a preferred and predetermined introduction depth at least of the collection element inside said cavity of the body of the subject
in relation to a distance between a first portion and a second portion of the body of a subject the graduated scale being configured and specifically destined to address, in use, the user to grasp the elongated body in correspondence of at least a measurement marking indicative of said preferred and predetermined introduction depth, for enabling determination of a penetration depth of the swab into a cavity, as evidence by Bychkov [par. 170]
Regarding claim 2, Qu further teaches wherein the predefined portion of the collection element is an end of said collection element opposed to the gripping portion and wherein said cavity of the body of the subject is the nasal cavity or the nasopharyngeal cavity [par. 19], and wherein said distance is the distance between a tragus or lobe or opening of an ear canal of the subject, and an opening or an end of a naris of the subject or between the tragus or lobe or opening of the ear canal, and the philtrum of the subject [par. 19 “a first scale 31 is provided on the brush handle 3 of the specimen brush, which allows medical staff to more accurately control the length of the specimen brush extending out of the cannula”; Examiner notes the distance is determined by the medical staff]
Regarding claim 3, Qu further teaches the plurality of measurement markings comprises at least a first and a second measurement marking reciprocally spaced for a predefined distance along said main development direction [fig. 2, element 31; par. 19; Examiner notes there are multiple measurement markings spaced apart along the elongated body],
However, Qu does not teach wherein said at least a first and a second measurement marking extend at least partially, preferably mainly, along a substantially oblique direction, optionally along a substantially orthogonal direction, with respect to the main development direction, and wherein said graduated scale allows the quantitative identification of said distance between at least part of the plurality of measurement markings and said at least one between said end portion and said collection element
Bychkov teaches wherein said at least a first and a second measurement marking extend at least partially, preferably mainly, along a substantially oblique direction, optionally along a substantially orthogonal direction, with respect to the main development direction, and wherein said graduated scale allows the quantitative identification of said distance between at least part of the plurality of measurement markings and said at least one between said end portion and said collection element [fig. 10, element 1020; par. 118 “Said identifier(s) may be… rotation determination marks (e.g. rotation determination mark 1020 shown in FIG. 10)”, which Examiner notes meets the orthogonal direction limitation of the claim]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Qu, to incorporate wherein said at least a first and a second measurement marking extend at least partially, preferably mainly, along a substantially oblique direction, optionally along a substantially orthogonal direction, with respect to the main development direction, for incorporating rotation determination marks, as evidence by Bychkov [par. 118]
Regarding claim 4 Qu further teaches wherein the graduated scale is at least partially etched, and/or realized through recesses or concavities, on said elongated body and/or is at least partially in relief on said elongated body and/or is fixed, impressed, molded, co-molded or painted on said elongated body, and/or wherein said graduated scale is realized in a material at least partially different with respect to the material with which is realized said elongated body, in particular wherein the elongated body presents at least a first color and wherein at least part of said graduated scale presents at least a second color different with respect to said first color [fig. 1, 2, element 31; par. 19; Examiner notes the graduated scale is shown in a differing color than the elongated body]
Regarding claim 5, Qu further teaches wherein the graduated scale extends at least partially in said gripping portion [fig. 2, element 3; Examiner notes the graduated scale extends along the length of the elongated body]
Regarding claim 7, Qu further teaches having a length at least equal to 10cm, wherein the elongated body presents a substantially constant transversal section along its extension along said main development direction [fig. 2, element 3; Examiner notes the figure shows a substantially constant shape]; the elongated body presenting a transversal section substantially circular [fig. 2, element 3; Examiner notes the figure shows a circular shape; par. 19 “along the circumferential direction”] or inscribable in a circumference, said transversal section substantially circular or said circumference having a diameter comprised between 1,5mm and 3mm, more preferably comprised between 2mm and 2,5mm
Regarding claim 8, Bychkov further teaches the elongated body is substantially flexible, and/or is realized at least partially in a natural or plastic material, and/or realized through a molding process, in particular through an injection molding or a co-molding, and/or a 3D printing [par. 118 “The swab can be disposable or reusable and its material may vary based on the particular diagnostic test type to be taken (e.g. cotton swab with wooden rod, flocked or spun polyester swab with plastic shaft, etc.)”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Qu, to incorporate the elongated body is substantially flexible, and/or is realized at least partially in a natural or plastic material, for having the appropriate material for the specific diagnostic condition, as evidence by Bychkov [par. 118]
Regarding claim 10, Qu teaches a container for a device for collecting and transferring samples of biological material [fig. 1, 2, element 1; par. 19], according to claim 1, comprising: a main body destined to contain and/or support at least temporarily at least a device for collecting and transferring samples of biological material [fig. 1, 2, element 3; par. 19 “A specimen brush that can be inserted into or removed from the cannula 1 is provided inside the cannula 1”]; - a graduated scale [fig. 1, element 11], comprising a plurality of measurement markings configured to, and destined to, supply an at least visual and/or tactile indication of a measurement of a distance [par. 19 “a second scale 11 is provided on the tube wall of the cannula 1, which allows medical staff to more accurately control the length of the cannula extending into the nasal cavity”]; said container being configured to allow a measurement of a distance between a first portion and a second portion of the body of a subject [par. 19 “scale 11 is provided on the tube wall of the cannula 1, which allows medical staff to more accurately control the length of the cannula extending into the nasal cavity”]
Regarding claim 11, Qu further teaches wherein said distance is the distance between a tragus or lobe or opening of the ear canal, and an opening or end of a naris of a subject and/or between a tragus or lobe or opening of the ear canal, and [[a]]the philtrum of the subject by means of said graduated scale [par. 19] the container having at least a closed operative configuration wherein it is configured to contain said at least a device in a condition of substantial sterility and/or of air insulation with respect to an outer environment [par. 19 “The head of the flexible blind tube 2 is divided into several openable and closable flaps along the circumference. The protection of the cannula 1 can effectively prevent the sampling specimen on the sampling bristles from being contaminated by nasal secretions when withdrawing from the nasal cavity, thus ensuring the quality of the sampling specimen”], said container being disposable and/or destined to contain a single device [fig. 2; Examiner notes the container only comprises the specimen brush] and/or being pocket-shaped and/or being substantially flexible and/or foldable, and/or comprising a first element, in particular a cover, and a second element, in particular a base portion, removably connectible to said cover
Regarding claim 13 Qu further teaches the container wherein said graduated scale is positioned at an end position, in particular in substantial correspondence of a side of said container [fig. 1, element 11; par. 19], and/or comprising a predefined opening portion, visually different and/or weakened and/or pre-cut, said predefined opening portion being destined to allow a direct access to said gripping portion
Regarding claim 14, Qu further teaches the container wherein the graduated scale is realized on said main body [fig. 1, element 11] and/or is at least partially etched, and/or realized through recesses or concavities, on said main body and/or is at least partially in relief on said main body and/or is fixed, impressed, molded, co-molded or painted on said main body, and/or wherein said graduated scale is realized in a material at least partially different with respect to the material with which is realized said main body, in particular wherein the main body presents at least a first color and wherein at least part of said graduated scale presents at least a second color different with respect to said first color [fig. 1, elements 1, 11; Examiner notes the graduated scale is shown to be in a different color than the container].
Regarding claim 15, Qu teaches a device according to claim 1; a container [fig. 1, 2, element 1] wherein the graduated scale of said container and the graduated scale of the device are quantitatively corresponding and are realized according to a same predetermined distance measurement unit [par. 19].
Regarding claim 16, Qu teaches a method of determination of a correct depth of insertion of a device [par. 19 “a first scale 31 is provided on the brush handle 3 of the specimen brush, which allows medical staff to more accurately control the length of the specimen brush extending out of the cannula, making sampling more convenient; in this embodiment, a second scale 11 is provided on the tube wall of the cannula 1, which allows medical staff to more accurately control the length of the cannula extending into the nasal cavity”] for collecting and transferring samples of biological material [par.19], according to claim 1, comprising: a step of determination or measurement of a distance between a first portion and a second portion of the body of the subject [par. 19 “a first scale 31 is provided on the brush handle 3 of the specimen brush, which allows medical staff to more accurately control the length of the specimen brush extending out of the cannula, making sampling more convenient; in this embodiment, a second scale 11 is provided on the tube wall of the cannula 1, which allows medical staff to more accurately control the length of the cannula extending into the nasal cavity”], said step of determination or measurement being carried out by the container [fig. 1, 2, elements 11, 31; par. 19] according to claim 10 and/or by a device for collecting and transferring samples of biological material according to claim 1 [fig. 1, 2, element 3; par. 19]; - a detection or reporting of said distance (D), or of a measurement correlated in predetermined way to said distance (D), on a device or collecting and transferring samples of biological material, in order to determine an end stroke position for the insertion of said device inside a cavity of the body of the subject [par. 19 “a first scale 31 is provided on the brush handle 3 of the specimen brush, which allows medical staff to more accurately control the length of the specimen brush extending out of the cannula, making sampling more convenient; in this embodiment, a second scale 11 is provided on the tube wall of the cannula 1, which allows medical staff to more accurately control the length of the cannula extending into the nasal cavity”], said step of detection or reporting being carried out on the graduated scale of said device [fig. 2, element 31] according to claim 1 [par. 19], - a step of grasping of the device, said step of grasping being carried out by a user, and being destined to allow, and/or being preliminary to, an introduction of the collection element [par. 20 “push the specimen brush forward so that the sampling bristles 4 of the specimen brush extend from the flexible blind tube 2 out of the cannula 1 until they reach the posterior nasal cavity wall”], inside said cavity of the body of the subject, according to an insertion depth corresponding or correlated to said distance [par. 20]
However, Qu does not teach wherein the step of grasping takes place at the elongated body in substantial correspondence of a predetermined measurement marking corresponding to said measured distance
Bychkov teaches wherein the step of grasping takes place at the elongated body in substantial correspondence of a predetermined measurement marking corresponding to said measured distance [fig. 10, element 1010; par. 170]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Qu, to incorporate wherein the step of grasping takes place at the elongated body in substantial correspondence of a predetermined measurement marking corresponding to said measured distance, for enabling determination of a penetration depth of the swab into a cavity, as evidence by Bychkov [par. 170]
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Qu and Bychkov and in further view of Wohl (US 2021/0298776)
Wohl was applied in the previous office action
Regarding claim 6, Qu and Bychkov teach a device for collecting and transferring samples of biological material, as disclosed above
However, Qu and Bychkov do not teach wherein said graduated scale is provided with a plurality of numerical indications realized according to a metric scale, for example according to the decimal metric system or to the United States customary system, associated respectively in correspondence of said plurality of measurement markings and/or wherein the graduated scale comprises at least a measurement marking substantially positioned in proximity of the collection element and in particular in substantial contact with the collection element
Wohl teaches wherein said graduated scale is provided with a plurality of numerical indications realized according to a metric scale, for example according to the decimal metric system or to the United States customary system, associated respectively in correspondence of said plurality of measurement markings and/or wherein the graduated scale comprises at least a measurement marking substantially positioned in proximity of the collection element and in particular in substantial contact with the collection element [fig. 1, element 31; par. 28]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Qu and Bychkov, to incorporate said graduated scale is provided with a plurality of numerical indications realized according to a metric scale, for example according to the decimal metric system or to the United States customary system, associated respectively in correspondence of said plurality of measurement markings and/or wherein the graduated scale comprises at least a measurement marking substantially positioned in proximity of the collection element and in particular in substantial contact with the collection element, for visually illustrating distances along the device, as evidence by Wohl [par. 28]
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Qu and Bychkov and in further view of Forsythe (US 2024/0358298)
Regarding claim 9, Qu further teaches the elongated body is realized as a single piece [fig. 2, element 3], and wherein the graduated scale is integral with said elongated body [fig. 2, element 31; par. 19 “a first scale 31 is provided on the brush handle 3 of the specimen brush,”], said graduated scale (4) being integrally realized with said elongated body (2) [fig. 2, element 3],
However, Qu does not teach through said molding process, in particular through the injection molding or the co- molding, and/or the 3D printing
Forsythe teaches through said molding process, in particular through the injection molding or the co- molding, and/or the 3D printing [par. 145]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Qu and Bychkov, to incorporate through said molding process, in particular through the injection molding or the co- molding, and/or the 3D printing, for manufacturing without the need for complex methods, as evidence by Forsythe [par. 145]
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Qu and Bychkov and in further view of Rostom (US 2023/0012231)
Rostom was applied in the previous office action
Regarding claim 12, Qu and Bychkov teach a container for a device for collecting and transferring samples of biological material, as disclosed above
However, Qu and Bychkov do not teach the container comprising a substantially transparent or translucid portion, and wherein the graduated scale is at least partially positioned in correspondence of said substantially transparent or translucid portion
Rostom teaches comprising a substantially transparent or translucid portion [fig. 11, element 51; par. 135], and wherein the graduated scale is at least partially positioned in correspondence of said substantially transparent or translucid portion [fig. 11, element 51; par. 135]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Qu and Bychkov, to incorporate the container comprising a substantially transparent or translucid portion, and wherein the graduated scale is at least partially positioned in correspondence of said substantially transparent or translucid portion, for controlling a volume of fluid, as evidence by Rostom [par. 135]
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Qu and Bychkov and in further view of Liu (CN 111700649 A)
Liu was cited in Applicant’s IDS filed on 06/18/24
Liu was applied in the previous office action
Regarding claim 17, Qu and Bychkov teach a method of determination of a correct depth of insertion of a device, as disclosed above
However, Qu and Bychkov not teach wherein the step of detection of said distance (D) comprises a step of positioning of the graduated scale of said device or of the graduated scale of the container in substantial proximity of a portion of the body of the subject, so that a first measurement marking of the graduated scale is aligned to said first portion or to said second portion of the body of the subject, and comprises a step of detection of said distance (D) by comparison with another measurement marking of the graduated scale, for quantitatively determining the measurement of said distance
Liu teaches wherein the step of detection of said distance (D) comprises a step of positioning of the graduated scale of said device or of the graduated scale of the container in substantial proximity of a portion of the body of the subject, so that a first measurement marking of the graduated scale is aligned to said first portion or to said second portion of the body of the subject, and comprises a step of detection of said distance (D) by comparison with another measurement marking of the graduated scale, for quantitatively determining the measurement of said distance [par. 21, 58, 63]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Qu and Bychkov, to incorporate wherein the step of detection of said distance (D) comprises a step of positioning of the graduated scale of said device or of the graduated scale of the container in substantial proximity of a portion of the body of the subject, so that a first measurement marking of the graduated scale is aligned to said first portion or to said second portion of the body of the subject, and comprises a step of detection of said distance (D) by comparison with another measurement marking of the graduated scale, for quantitatively determining the measurement of said distance, for determining the depth of the swab head 9 inside the nostril, as evidence by Liu [par. 63]
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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, Alexander Valvis can be reached on 5712724233. 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
/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights