DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/8/2025 has been entered.
Response to Amendment
The applicant’s arguments/remarks, filed on 10/8/2025, has been entered. The previous prior art rejection stands.
The applicant’s arguments/remarks, filed on 10/8/2025, has been entered. The previous 112(a) rejection of claim 2 is withdrawn.
Claim Status
Claims 2-34 are pending with claims 2-16 being examined and claims 17-34 are withdrawn.
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 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.
Claims 2-12, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Fay (US 4920975 A) in view of Wickstead et al (US 20050142031 A1; hereinafter “Wickstead”; already of record), and in further view of Cho (US 20040200742 A1; hereinafter “Cho”; already of record).
Regarding claim 2, Fay teaches a collection device for receiving and storing a saliva sample (Fay; Abstract; an apparatus for collecting biological fluids; the examiner notes that “saliva” is intended use of the collection device, thus it is deemed that the apparatus of Fay is capable of storing saliva as the apparatus teaches collecting biological fluids), comprising:
a tube (Fay; Fig. 1, 3; col 5, line 14; container 12) comprising a first end configured to receive the saliva sample (Fay; Fig. 1; col 5, line 7; cylindrical portion 14 includes an open end 18), a closed second end (Fay; Fig. 1; col 5, line 8; conical portion 16 terminates in a closed lower end 20), and a sample storage chamber (Fay; Fig. 1; col 5, line 5-6; a translucent 50 ml tubular container 12 having a cylindrical portion 14);
a funnel (Fay; Fig. 1; col 5, line 11; Funnel 24) comprising a first cylindrical end, a second cylindrical end, and a channel extending from the first cylindrical end to the second cylindrical end (Fay; Fig. 1; the examiner interprets the top/upper end of the funnel as the first cylindrical end, and the bottom/lower end of the funnel as the second cylindrical end), wherein
the first cylindrical end is configured to receive the saliva sample (Fay; col 6, line 3-5; To collect a specimen, tab 38 is grasped and cover 34 is removed. The patient then deposits the sputum sample into the funnel 24) wherein
the second cylindrical end has a diameter less than the diameter of the first cylindrical end and greater than the diameter of the tube’s first end (Fay; Fig. 1, 2; examiner notes that the top portion has a larger diameter than the bottom portion of the funnel) and is configured to twist onto the tube at the tube's first end to position the tube’s first end in the second cylindrical end of the funnel (Fay; Fig. 1, 2; examiner notes that the funnel is screwed onto the tube as seen in Fig. 2), the second cylindrical end being releasably attached to the tube’s first end (Fay; Fig. 1, 2; col 5, lines 53-56; Container 12 is itself received within peripheral lip 32 of discharge portion 28 which sealably engages the outer surface of the container, and specifically the threads 22);
a lid, wherein the lid is configured to twist onto the funnel at the funnel's first cylindrical end (the limitation is directed to the function and/or the manner of operating the lid, all the structural limitations of the claim has been disclosed by Fay and the lid of Fay is capable of “twist onto the funnel at the funnel's first cylindrical end”. As such, it is deemed that the claimed lid is not differentiated from the lid of Fay (see MPEP §2114). The lid is interpreted as the cover and cap when engaged with the funnel);
and a tube cap configured to seal the tube’s first end when the second cylindrical end of the funnel is detached therefrom (Fay; col 6, lines; 17-19; cap 70 is rotated to engage the threads 22 of container 12 with threads 74 of cap 70).
Fay does not teach the funnel comprises three piercing members, and wherein the three piercing members are arranged on an interior surface of the funnel between the first cylindrical end and the second cylindrical end.
However, Wickstead teaches an analogous art of a funnel collector for fluid samples (Wickstead; Abstract; para [83]; a funnel collector for use with a sample testing device…samples in the testing system of the present invention include, but are not limited to, saliva) comprising a funnel which comprises piercing members (Wickstead; Fig. 11; para [56]; sample collector 40 also includes piercing member 43. The upper edge of piercing member 43 includes a sharp piercing edge 44), and wherein the piercing members are arranged on an interior surface of the funnel between a first cylindrical end and a second cylindrical end (Wickstead; Fig. 11; examiner notes that the piercing member 43 as seen in Fig. 11 is arranged in the middle of the sample collector 40).It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the funnel of Fay to comprise the piercing members as taught by Wickstead, because Wickstead teaches that the piercing member mixes the sample with buffer fluid (Wickstead; para [71]) which allows the sample to be processed and analyzed more rapidly (Wickstead; para [7]). Examiner notes this would be advantageous to Fay, because Fay teaches that the container is used to transport the sample to a laboratory for analysis (Fay; col 2, lines 10-12) which Wickstead can expedite. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the piercing members comprise three from the finite number of piercing members as identified by Wickstead in order to achieve the desired purpose of piercing a membrane (Wickstead; para [71]) with a reasonable expectation of success.
Modified Fay does not teach the lid comprising: a closed end; an opposing open end; an outer cylindrical wall and an inner cylindrical wall each extending from the closed end of the lid, said outer cylindrical wall and said inner cylindrical wall defining an annular gap therebetween, said annular gap having a volume, wherein the inner cylindrical wall forms a reservoir of stabilizing liquid sealed by a pierceable membrane, wherein the lid is configured to twist onto the funnel at the funnel's first cylindrical end, wherein the piercing members pierce and disrupt a pierceable membrane, thereby releasing the liquid from a reservoir into the tube.
However, Cho teaches an analogous art of a cap device (Cho; Abstract; cap device for mixing two different additives) comprising a funnel (Cho; Fig. 1a, 1b, 2; para [20]; cap body 50) and a lid (Cho; Fig. 2; Image 1; cap cover 100), lid comprising: a closed end; an opposing open end; an outer cylindrical wall and an inner cylindrical wall each extending from the closed end of the lid, said outer cylindrical wall and said inner cylindrical wall defining an annular gap therebetween, said annular gap having a volume (Cho; Fig. 2; Image 1; examiner notes that all of the lid structures are annotated below) wherein the inner cylindrical wall forms a reservoir of stabilizing liquid sealed by a pierceable membrane, wherein the lid is configured to twist onto the funnel at the funnel's first cylindrical end, wherein the piercing members pierce and disrupt a pierceable membrane, thereby releasing the liquid from a reservoir into the tube (Cho; Fig. 2; para [20]; a cap cover 100 acting as an additive containing part… The cap body 50 has a second funnel part 54 and a breaking means 22F. The breaking means 22F acts as a valve means to break the breakable sheet 32 and thereby open the lower end of the first funnel part 52). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the lid of modified Fay to comprise the outer cylindrical wall and said inner cylindrical wall which forms the annular gap as taught by Cho, because Cho teaches that the gap comprises internal threads to screw engage onto the cap body (Cho; para [23]). Examiner notes that the modification of the cap is applicable to modified Fay, as modified Fay teaches mixing samples with the contents inside the cap.
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Image 1. Annotated Figure 2 of Cho.
Regarding claim 3, modified Fay teaches collection device of claim 2 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein the funnel consists of three piercing members. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the piercing members comprise three from the finite number of piercing members as identified by Wickstead in order to achieve the desired purpose of piercing a membrane (Wickstead; para [71]) with a reasonable expectation of success.
Regarding claim 4, modified Fay teaches collection device of claim 2 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein the lid is configured to fully twist onto the funnel in about one quarter turn. The limitation is directed to the function and/or the manner of operating the lid, all the structural limitations of the claim has been disclosed by Fay and the lid of Fay is capable of being “configured to fully twist onto the funnel in about one quarter turn”. As such, it is deemed that the claimed lid is not differentiated from the lid of Fay (see MPEP §2114)
Regarding claim 5, modified Fay teaches collection device of claim 4 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein each of the piercing members is at least partially separated from the lid's inner cylindrical wall when the lid is fully twisted onto the funnel (Wickstead; Fig. 11; para [56]; a sharp piercing edge 44 that contacts and pierces pierceable membrane 38 of buffer container 30 when buffer container 30 is joined to sample collector 40, thereby releasing the buffer fluid).
Regarding claim 6, modified Fay teaches collection device of claim 4 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein each of the piercing members is fully separated from the lid's inner cylindrical wall when the lid is fully twisted onto the funnel (Wickstead; Fig. 11). Examiner notes that the wedges remains separated from the inner cylindrical wall once fully twisted onto the funnel as the piercing edge is part of the funnel.
Regarding claim 7, modified Fay teaches collection device of claim 4 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein the chamber is sealed against leakage to the outside of the collection device when the lid is fully twisted onto the funnel (Wickstead; para [55]; Pierceable membrane 38 of buffer container 30 forms a frangible, fluid impermeable barrier for retaining buffer fluid in the buffer container 30).
Regarding claim 8, modified Fay teaches collection device of claim 2 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein at least two of the piercing members are arranged in a semi-circular fashion (Cho; Fig. 2).
Regarding claim 9, modified Fay teaches collection device of claim 2 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein the piercing members extend perpendicularly from the funnel's interior surface toward the funnel's first cylindrical end (Wickstead; Fig. 10, 11). Examiner notes that Fig. 11 shows that the piecing member 40 is perpendicular to the funnel’s interior surface and toward the funnel’s first cylindrical end, because the member opens the membrane that is introduced at the top of first cylindrical end (Wickstead; para [90]).
Regarding claim 10, modified Fay teaches collection device of claim 2 (the lid of modified Fay is modified to comprise the annular gap to screw onto the funnel as taught by Cho discussed above in claim 2), wherein the lid comprises helical threads arranged on an inner surface of the lid's outer cylindrical wall and configured to engage the funnel (Cho; para [23]; The cap body 50 is assembled at an externally threaded upper end thereof with an internally threaded lower end of the cap cover 100 through a screw-type engagement).
Regarding claim 11, modified Fay teaches collection device of claim 2 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein the funnel comprises helical threads arranged on an inner surface of the funnel's second cylindrical end and configured to engage the tube (Fay; Fig. 1, 2; col 5, lines 53-56; Container 12 is itself received within peripheral lip 32 of discharge portion 28 which sealably engages the outer surface of the container, and specifically the threads 22).
Regarding claim 12, modified Fay teaches collection device of claim 2 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein the lid and funnel are configured so that the piercing members pierce the pierceable membrane as the lid twists onto the funnel (Wickstead; para [90]; buffer container 30 and twisting, threads 39 and 49 will engage and, owing to relative rotation therebetween, draw buffer container 30 toward the base 47 of sample collector 40. As buffer container 30 moves toward the sample collector, pierceable membrane 38 is pierced by piercing edge 44 of piercing member 43).
Regarding claim 15, modified Fay teaches collection device of claim 2 (the funnel of Fay is modified to comprise the piercing element as taught by Wickstead discussed above in claim 2), wherein the lid and funnel are configured to be placed in a first position prior to piercing, then be placed in a piercing position, and then be twisted (Wickstead; para [90]; buffer container 30 and twisting, threads 39 and 49 will engage and, owing to relative rotation therebetween, draw buffer container 30 toward the base 47 of sample collector 40. As buffer container 30 moves toward the sample collector, pierceable membrane 38 is pierced by piercing edge 44 of piercing member 43).
Regarding claim 16, modified Fay teaches collection device of claim 2 (the lid of modified Fay is modified to comprise the annular gap to screw onto the funnel as taught by Cho discussed above in claim 2), wherein the funnel's first cylindrical end is configured to fit in the annular gap between the lid's outer cylindrical wall and the lid's inner cylindrical wall (Cho; para [23]; The cap body 50 is assembled at an externally threaded upper end thereof with an internally threaded lower end of the cap cover 100 through a screw-type engagement).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fay in view of Wickstead in view of Cho, and in further view of Huff (US 20070196234 A1; hereinafter “Huff”; domestic priority filed 9/22/2005; already of record).
Regarding claim 13, modified Fay teaches collection device of claim 2, with the lid.
Modified Fay does not teach wherein the lid comprises outwardly extending ribs that can be gripped to twist the lid onto the funnel.
However, Huff teaches an analogous art of a collection device (Huff; Abstract) comprising a lid (Huff; Fig. 1; para [20]; lid 200) wherein the lid comprises outwardly extending ribs (Huff; Fig. 1; para [25]; lid has serrations or other similar features 210 that exist around the exterior of the lid). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the lid of modified Fay to comprise outwardly extending ribs as taught by Huff, because Huff teaches that the serrations aid in gripping the lid for opening and closing to prevent spills (Huff; para [25]).
Regarding claim 14, modified Fay teaches collection device of claim 2, with the tube cap.
Modified Fay does not teach wherein the tube cap comprises outwardly extending ribs that can be gripped to twist the tube cap onto the tube.
However, Huff teaches an analogous art of a collection device (Huff; Abstract) comprising a tube cap (Huff; Fig. 1; para [20]; lid 200) wherein the tube cap comprises outwardly extending ribs (Huff; Fig. 1; para [25]; lid has serrations or other similar features 210 that exist around the exterior of the lid). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the tube cap of modified Fay to comprise outwardly extending ribs as taught by Huff, because Huff teaches that the serrations aid in gripping the lid for opening and closing to prevent spills (Huff; para [25]).
Response to Arguments
Applicant’s arguments filed, 10/8/2025, have been considered and some are not persuasive and the non-persuasive arguments are addressed below.
In the applicant’s arguments, on page 6-7, the applicant argues that support for the annular gap is provided in Figure 19. The examiner agrees and the previous 112(a) rejection is withdrawn.
In the applicant’s arguments, on page 8, the applicant argues there is no motivation to modify Fay in view of Wickstead and Cho. The examiner respectfully disagrees. The modifications made to Fay would not render the prior art unsatisfactory. Specifically, the modifications allow the cap and lid to still be secured to the funnel.
In the applicant’s arguments, on page 9, the applicant argues Fay, Wickstead, and Cho do not teach the claim amendments. The examiner notes that the previous prior art rejection is withdrawn and a new prior art rejection is applied to address the claim amendments. Cho teaches the claimed limitations as depicted above in Image 1. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the lid of modified Fay to comprise the outer cylindrical wall and said inner cylindrical wall which forms the annular gap as taught by Cho, because Cho teaches that the gap comprises internal threads to screw engage onto the cap body (Cho; para [23]). Examiner notes that the modification of the cap is applicable to modified Fay, as modified Fay teaches mixing samples with the contents inside the cap.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796