DETAILED ACTION
This action is pursuant to claims filed on 11/03/2025. Claims 101-120 are pending. A first action on the merits of claims 101-120 is as follows.
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 .
Election/Restrictions
Claims 114-120 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference character “A” in Figures 1A, 3A, 4A, 5B, 6B, 7A, and 8A does not appear in the specification
Reference character “B” in Figures 1B, 3B, 7A, and 8B does not appear in the specification
Reference character “122” in Figure 7E does not appear in the specification
Reference character “2” in Figure 8C does not appear in the specification
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 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 109 and 112-113 are 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.
Regarding claim 109, the claim recites the limitation “the ridges” in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this limitation is meant to read “ridges”, or be dependent on a claim that has previously introduced the ridges. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as reading as “ridges”.
Regarding claim 112, the claim recites the limitation “sample receptacle” in line 3. It is unclear if this is meant to refer to the sample receptacle from claim 101, or a different sample receptacle. If it is referring to the sample receptacle from claim 101, it needs to refer back to it. If it is referring to a different sample receptacle, it needs to be distinguished from the sample receptacle from claim 101. For purposes of examination, it is being interpreted as referring to the sample receptacle from claim 101.
Regarding claim 113, the claim recites the limitation “the cap” in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this limitation is meant to read “a cap”, or be dependent on a claim that has previously introduced a cap. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as reading as “a cap”.
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 101-105, 107-108, 110-111, and 113 are rejected under 35 U.S.C. 103 as being unpatentable over Tariyal (US 20190125316) in further view of Goodfield (WO 9723596).
Regarding independent claim 101, Tariyal teaches a system for extracting and preserving components of a biological sample of a subject (Abstract: “The present disclosure provides systems, methods, devices, and kits for analysis of vaginal biological samples”) comprising:
a. a sample collector that collects and retains the biological sample from a vaginal canal of the subject ([0019]: “a sample collector insertable in a vaginal canal for collecting a vaginal biological sample”); and
b. a sample receptacle ([0019]: “a sample receptacle configured to receive the sample collector via an opening”); wherein the sample receptacle comprises:
(i) a first chamber that is configured to hold the sample collector (Fig. 21; Sample receptacle 2102 is the first chamber holding the sample collector);
(ii) a second chamber that is configured to contain a stabilization buffer (Fig. 21; [0327]: “The sample receptacle 2102 may contain a buffer, a solution, or reagent for preserving, hydrolyzing, or analyzing the biological sample, and/or for facilitating release of the biological sample from the sample collector. Alternatively and in a preferred embodiment, the sample receptacle 2102 may not contain a buffer or reagent. The pouch 2104 and/or the sample reservoir 2105 (e.g., collectively, reagent compartment 2108) may contain a buffer, a solution, or reagent for preserving, hydrolyzing, or analyzing the biological sample, and/or for facilitating, accelerating, or enhancing the release of the biological sample from the sample collector”. The pouch and sample reservoir is the second chamber.);
(iii) a disruptable member between the first chamber and the second chamber (Fig. 21; [0327]: “The pouch 2104 and/or the sample reservoir 2105 (e.g., collectively, reagent compartment 2108) may contain a buffer, a solution, or reagent for preserving, hydrolyzing, or analyzing the biological sample, and/or for facilitating, accelerating, or enhancing the release of the biological sample from the sample collector. The pouch 2104 may comprise a breakable membrane, such as the frangible seal 2106.”).
Tariyal teaches disrupting the disruptable member such that there is fluid communication between the first and second chamber ([0327]: “the frangible seal 2106 can be broken after placing the sample collector in the sample receptacle 2102 and securely closing the sample receptacle opening 2101.”), however Tariyal does not teach a displaceable shuttle used to disrupt the disruptable member.
Goodfield discloses a sampling and assay device. Specifically, Goodfield teaches a displaceable shuttle, wherein displacement of the displaceable shuttle from the first chamber towards the second chamber is configured to disrupt the disruptable member such that there is fluid communication between the first chamber and the second chamber (Abstract: “The device further comprises a sample swab (20) at least partially disposed within a cap-shaped shuttle (24). The swab is arranged to be moved longitudinally of the tubular enclosure to correspondingly displace the shuttle (24) and rupture the barrier or barriers (19) in order to mix the chemical components”). Tariyal and Goodfield are analogous arts as they are both related to biological sample collection devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the displaceable shuttle from Goodfield into the system from Tariyal as it incorporates a specific structure used to pierce the disruptable member, which can ensure a more accurate and controllable piercing action and reduces the likelihood of the member being accidentally pierced.
Regarding claim 102, the Tariyal/Goodfield combination teaches the system of claim 101, wherein the sample collector comprises an absorbent-diffuse material that collects, retains, or releases the biological material (Tariyal, [0021]: “the sample collector comprises an absorbent-diffuse material configured to collect, retain, or release the vaginal biological sample”), and wherein the sample collector is configured to be insertable in the vaginal canal (Tariyal, [0019]: “a sample collector insertable in a vaginal canal for collecting a vaginal biological sample”).
Regarding claim 103, the Tariyal/Goodfield combination teaches the system of claim 101, wherein the sample collector continuously interacts with the stabilization buffer after the disruptable member is disrupted (Tariyal, [0327]: “the frangible seal 2106 can be broken after placing the sample collector in the sample receptacle 2102 and securely closing the sample receptacle opening 2101.”. If the seal is broken, it is clear that the stabilization buffer continuously interacts with the sample collector.).
Regarding claim 104, the Tariyal/Goodfield combination teaches the system of claim 101, wherein the displaceable shuttle is configured such that it does not compress the sample collector and wherein the biological sample is released from the sample collector into the stabilization buffer (Goodfield, Page 5, lines 9-21: “in depressing the swab, the shuttle 24 is displaced longitudinally of the device, causing the shuttle 24 to rupture the membranes 19 of the reagent pot 18. All or most of the lyophilised contents of the reagent pot 18 are thereby forced out into the liquid 16. The shuttle 24 is further displaced into the cap-shaped end member 12 of the device, in which it is a close sliding fit. The re- hydrated reagent, resulting from the mixture of the lyophilised contents of the pot 18 with the liquid 16, is forced up through the apertures in the end of the shuttle 24 and into contact with the swab head 20. The liquid may also be forced through the swab head, thus increasing contact between the reagent and the sample on the swab head.”).
Regarding claim 105, the Tariyal/Goodfield combination teaches the system of claim 101.
However, the Tariyal/Goodfield combination does not teach the system further comprising a locking ring comprising a first detent and a second detent, wherein the locking ring is located within the first chamber.
Goodfield teaches the system further comprising a locking ring comprising a first detent and a second detent, wherein the locking ring is located within the first chamber (Page 4, lines 6 – 30: “Referring to Figure 1 of the drawings, there is shown a combined sample and assay device which comprises a tubular enclosure formed from a main body part 10 and a cap-shaped end member 12 fitted over opposite ends of a tubular collar 14 … The shuttle 24 is positioned within the collar 14 and is temporarily held in that position, preferably by being a sprung interference fit within the collar 14: a rim 15 around the top of the collar 14 prevents the shuttle 24 being withdrawn when, in use, the swab is withdrawn from the device.” The locking ring is the collar and the collar and rim are the first and second detent. The main body is analogous to the first chamber, therefore the collar is in the first chamber.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the locking ring from Goodfield into the Tariyal/Goodfield combination as it allows the displacement shuttle to be locked into place, which ensures it does not disrupt the disruptable member before it is intended to.
Regarding claim 107, the Tariyal/Goodfield combination teaches the system of claim 105, wherein placing a cap on the receptacle allows for disruption of the disrupting member ([0253]: “The extractor can have a cap that houses a spring-loaded compressor and a button, which, if pushed, compresses the sample collector, thereby allowing the cervicovaginal fluid from the sample collector to pass through the filter into the reservoir.”).
However, the Tariyal/Goodfield combination is silent on the relation of the cap to the displaceable shuttle.
Goodfield teaches wherein placing a cap on the receptacle displaces the displaceable shuttle from the first detent on the locking ring to the second detent on the locking ring (Page 5, lines 6-12: “In order to depress the swab into its tubular enclosure, it is necessary first to depress laterally a latching finger 23 of the handle 22, the finger 23 otherwise abutting the end of the body part 10. Then in depressing the swab, the shuttle 24 is displaced longitudinally of the device, causing the shuttle 24 to rupture the membranes 19 of the reagent pot 18”; Page 2, lines 21-26: “Preferably the swab includes a stem attached to a plug or stopper which is, initially, partially inserted into an open end of the tubular enclosure. Depression of the plug or stopper, to cause it to become fully inserted, displaces the swab and the shuttle, thereby rupturing the barrier or barriers.”; Page 2, lines 29-30: “Preferably the plug or stopper forms part of a handle”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the relation of the cap to the displaceable shuttle from Goodfield into the Tariyal/Goodfield combination as the combination is silent on the relation and Goodfield discloses a suitable relation in an analogous device.
Regarding claim 108, the Tariyal/Goodfield combination teaches the system of claim 107, wherein the cap is configured to engage the shuttle before fully closing (Tariyal, [0051]: “the closure of the sample receptacle removes air in the at least one chamber and breaks the breakable seal to release the reagent into the at least one chamber”; Goodfield, Page 5, lines 6-12: “In order to depress the swab into its tubular enclosure, it is necessary first to depress laterally a latching finger 23 of the handle 22, the finger 23 otherwise abutting the end of the body part 10. Then in depressing the swab, the shuttle 24 is displaced longitudinally of the device, causing the shuttle 24 to rupture the membranes 19 of the reagent pot 18”; Page 2, lines 21-26: “Preferably the swab includes a stem attached to a plug or stopper which is, initially, partially inserted into an open end of the tubular enclosure. Depression of the plug or stopper, to cause it to become fully inserted, displaces the swab and the shuttle, thereby rupturing the barrier or barriers.”; Page 2, lines 29-30: “Preferably the plug or stopper forms part of a handle”).
Regarding claim 110, the Tariyal/Goodfield combination teaches the system of claim 101, further comprising a harvester mechanism, wherein the harvester mechanism comprises a cap and a stem, wherein the stem is configured to be inserted into the sample receptacle and to compress the sample collector (Tariyal, [0295]: “an extraction device is included in the kit and includes a cylindrical housing or receptacle 140 in which a woman places her used sample collector 120 into the receptacle 140 via an open end 142 immediately upon removal of the sample collector from the vaginal canal. The extraction device is then scaled with a cap 144, which contains a spring-loaded compressor 146. After the extraction device is sealed, a button 148 located on the cap 144 is pressed, which releases the spring 146 and compresses the sample collector 120”; [0020]: “the extraction mechanism comprises a spring, threaded screw, lever, air-tight plunger, roller, or manual push syringe configured to force a compression element in the sample receptacle inwards into the sample receptacle in response to activation of the compression mechanism.” The plunger, screw, lever, or syringe are the stems used to compress the sample collector.).
Regarding claim 111, the Tariyal/Goodfield combination teaches the system of claim 101, wherein upon disruption of the disruptable member, the system is configured to retain the stabilization buffer between the first chamber and the second chamber when the device is rotated, placed horizontally, and/or inverted from its vertical position (Tariyal, [0327]: “the frangible seal 2106 can be broken after placing the sample collector in the sample receptacle 2102 and securely closing the sample receptacle opening 2101.”; [0295]: “After the extraction device is sealed, a button 148 located on the cap 144 is pressed, which releases the spring 146 and compresses the sample collector 120”).
Regarding claim 113, the Tariyal/Goodfield combination teaches the system of claim 101, wherein the sample collector has a string appended to one end (Tariyal, [0282]: “the sample collector has a removal element 130 attached to the base 128. The removal element 130 can be configured for pulling. In some embodiments, the removal element 130 is a loop or a knot that can be pulled via hooking into the loop or the knot. In some embodiments, the removal element 130 is a string”).
However, the Tariyal/Goodfield combination does not teach wherein the cap of the sample receptacle comprises a second notch or second plurality of notches configured to hold a string appended to one end of the sample collector when the cap is screwed on to the sample receptacle.
Goodfield teaches wherein the cap of the sample receptacle comprises a second notch or second plurality of notches configured to hold a string appended to one end of the sample collector when the cap is screwed on to the sample receptacle (Fig. 1, reference character 22; Page 2, lines 21-30: “Preferably the swab includes a stem attached to a plug or stopper which is, initially, partially inserted into an open end of the tubular enclosure … Preferably the plug or stopper forms part of a handle”; Page 4, lines 16-18: “the swab being inserted into the main body 10 and held in place by a plug part of a handle 22”. The swab is analogous to the string as they are both the removable element of the sample collector, and the swab is shown to be attached to a notch in the handle, which is analogous to the cap.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the notch from Goodfield into the Tariyal/Goodfield combination as it allows the system to secure the string of the sample collector, which ensures it stays in the correct location and does not interfere with the sampling processes of the system.
Claims 106 and 109 are rejected under 35 U.S.C. 103 as being unpatentable over the Tariyal/Goodfield combination as applied to claims 105 and 107 above, and further in view of Yuujiin (JP H05187976). Citations to JP H05187976 will refer to the English Machine Translation that accompanies this Office Action.
Regarding claim 106, the Tariyal/Goodfield combination teaches the system of claim 105, wherein the displaceable shuttle comprises a first end and a second end; wherein the second end of the displaceable shuttle comprises a piercing end configured to disrupt the disruptable member (Goodfield, Page 6, lines 10-16: “The end of the shuttle 24 may have a simple conical shape, as shown in Figure 2. Preferably however, the end of the shuttle 24 is provided with a series of radiating fins 26, as shown in Figure 3 or 4. These fins reduce the force required to puncture the membranes 19, which in turn allows the use of longer and/or more flexible swabs without unacceptable buckling”; Figs 2-4).
The Tariyal/Goodfield combination teaches an interference fit (Page 4, lines 26-27: “The shuttle 24 is positioned within the collar 14 and is temporarily held in that position, preferably by being a sprung interference fit within the collar 14”), however the Tariyal/Goodfield combination does not teach wherein the first end of the displaceable shuttle comprises ridges; wherein the displaceable shuttle is retained in the first chamber by the ridges fitting into the first detent on the locking ring.
Yuujiin discloses a sampling device. Specifically, Yuujiin teaches wherein the first end of the displaceable shuttle comprises ridges; wherein the displaceable shuttle is retained in the first chamber by the ridges fitting into the first detent on the locking ring ([0037]: “A flange 2154 on the sleeve 2131 engages an internal retention ridge 2146 on the top cap 2130 to secure the top cap 2130 to the sleeve 2131 . When the sample collector 2113 is pressed downwards and the seal breaking member 2151 breaks the breakable seal 2125 of the sample container 2111”). Tariyal, Goodfield, and Yuujiin are analogous arts as they are all related to biological sample collection devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the ridges from Yuujiin instead of the interference fit from the Tariyal/Goodfield combination as they are both known types of connections, and it would be a simple substitution to use the ridges instead of the interference fit.
Regarding claim 109. the Tariyal/Goodfield combination teaches the system of claim 107.
The Tariyal/Goodfield combination teaches an interference fit (Page 4, lines 26-27: “The shuttle 24 is positioned within the collar 14 and is temporarily held in that position, preferably by being a sprung interference fit within the collar 14”), however the Tariyal/Goodfield combination does not teach wherein the ridges of the displaceable shuttle are configured to prevent the displaceable shuttle from piercing the disruptable member before the cap is placed
Yuujiin teaches wherein the ridges of the displaceable shuttle are configured to prevent the displaceable shuttle from piercing the disruptable member before the cap is placed ([0037]: “A flange 2154 on the sleeve 2131 engages an internal retention ridge 2146 on the top cap 2130 to secure the top cap 2130 to the sleeve 2131 . When the sample collector 2113 is pressed downwards and the seal breaking member 2151 breaks the breakable seal 2125 of the sample container 2111”. The ridges hold the shuttle in place until it is pushed down, therefore the ridges prevent the shuttle from piercing the disruptable member before the cap is placed.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the ridges from Yuujiin instead of the interference fit from the Tariyal/Goodfield combination as they are both known types of connections, and it would be a simple substitution to use the ridges instead of the interference fit.
Claim 112 is rejected under 35 U.S.C. 103 as being unpatentable over the Tariyal/Goodfield combination as applied to claims 105 and 107 above, and further in view of Curry (US 20150151296).
Regarding claim 112, the Tariyal/Goodfield combination teaches the system of claim 101, wherein the sample collector has a string appended to one end (Tariyal, [0282]: “the sample collector has a removal element 130 attached to the base 128. The removal element 130 can be configured for pulling. In some embodiments, the removal element 130 is a loop or a knot that can be pulled via hooking into the loop or the knot. In some embodiments, the removal element 130 is a string”).
However, the Tariyal/Goodfield combination does not teach wherein the displaceable shuttle comprises a first notch or a first plurality of notches configured to catch a string appended to one end of the sample collector when the cap is placed on sample receptacle.
Curry discloses a sample receiving device. Specifically, Curry teaches wherein the displaceable shuttle comprises a first notch or a first plurality of notches configured to catch a string appended to one end of the sample collector when the cap is placed on sample receptacle. ([0091]: “The cutting assembly optionally includes one or more piercing tooth 42 that can be an integral part of the cutting rib, with or without an intermediate notch 41”. The cutting assembly is analogous to the shuttle, as they both perform the same function of piercing the membrane, and if the shuttle has a notch, it is capable of catching the string, as the structure is the same as the claimed structure.). Tariyal, Goodfield, and Curry are analogous arts as they are all related to biological sample collection devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the notch from Curry into the Tariyal/Goodfield combination as it allows the system to secure the string of the sample collector, which ensures it stays in the correct location and does not interfere with the sampling processes of the system.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791