DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 3/5/2026 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 13 is 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.
Claim 13 recites “vaginal tissue” in line 2, but it is not clear if this recitation is the same as, related to, or different from “vaginal tissue” of claim 1, line 10. If they are the same, “vaginal tissue” in claim 13 should be “the vaginal tissue”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Under the interpretation that “vaginal tissue” in claim 13, line 2 is the same as “vaginal tissue” of claim 1, line 10, claim 13 does not further limit the scope of claim 1. In particular, the recitation “wherein the extension is configured to deflect vaginal tissue away from the collection head” of claim 13 is already present in the recitation “wherein the extension…is configured to deflect vaginal tissue of the user away from the collection head” of claim 1, lines 9-11. Since claim 13 does not recite any further recitation, claim 13 does not further limit claim 1, which is improper.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2017/0303903 (de Koning)(previously cited).
With respect to claim 1, de Koning teaches a kit for self-collecting and storing a biological sample, the kit comprising:
a device configured to be self-inserted into a vaginal canal of a user, the device including:
a sheath (the expansion section 10 with the fingers 11 of de Koning) comprising a distal end configured to transition between an open configuration (FIG. 7 of de Koning) and a closed configuration (FIG. 10A of de Koning);
a shaft (the shaft 24 of de Koning) at least partially within the sheath having a collection head (the sample collector 12 of de Koning) at a distal end thereof and configured to collect the biological sample;
a slider (the core 16 and imaging device 56 of de Koning) comprising an extension (the tapered distal end of the core 16 of de Koning) coupled to a distal portion of the shaft, wherein the slider comprises different materials (the core 16 and imaging device 56 of de Koning are different materials), and wherein the extension is disposed below the collection head (see FIGS. 5, 6A, 7 of de Koning) and is configured to deflect vaginal tissue of the user away from the collection head (the tapered distal end of the core 16 is capable of deflecting tissue away from the sample collector 12 by causing the expansion section 10 to open; paragraph 0055 of de Koning); and
a vial to store the biological sample (the sample container 44 of de Koning).
With respect to claim 13, de Koning teaches that the extension is configured to deflect vaginal tissue away from the collection head (the tapered distal end of the core 16 is capable of deflecting tissue away from the sample collector 12 by causing the expansion section 10 to open; paragraph 0055 of de Koning).
With respect to claim 14, de Koning teaches that the biological sample comprises cervical cells (paragraph 0066 of de Koning).
With respect to claim 15, de Koning teaches that the biological sample comprises vaginal cells (paragraphs 0009, 0052, and 0058 of de Koning).
With respect to claim 16, de Koning teaches that the distal end of the sheath comprises at least two flexible segments (the fingers 11 of the expansion section 10 of de Koning).
With respect to claim 17, de Koning teaches that the device further comprises an actuator configured to advance the collection head through the distal end of the sheath (the engagement member 26 of de Koning).
With respect to claim 18, de Koning teaches that the actuator is at least one of a knob, a roller, or a button (the engagement member 26 of de Koning is a knob).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-3, 7, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over de Koning, in view of U.S. Patent Application Publication No. 2015/0297196 (Ching)(previously cited).
With respect to claims 2 and 3, Ching teaches a kit 300 employed for collecting, storing, identifying and/or transporting biological samples (FIG. 12a of Ching). The kit includes a tray 320 having a recess for the vessel 330, a recess for the collection device, and a recess used to hold the vessel steady without using their hands to do so (paragraphs 0107-0115 of Ching; FIGS. 12a and 12d of Ching). The patient may store the sample in a manner suitable for safe transportation and transport the sample and relevant patient information by mail to a lab (paragraphs 0107-0115 of Ching). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the kit with a tray having a recess for the vessel, a recess for the collection device, and a recess used to hold the vessel steady without using their hands to do so, as suggested by Ching, since (1) the patient can store the sample in a manner suitable for safe transportation, (2) the patient can secure the collection device and the vessel before their use, and (3) the patient has the ability to hold the vessel upright during use without the need to use their hands.
With respect to claim 2, the combination teaches or suggests a frame (the kit of Ching) including a first cavity to receive the device (the recess of the collection device as suggested by Ching) and a second cavity to receive the vial (the recess for the vessel as suggested by Ching).
With respect to claim 3, the combination teaches or suggests that, while transferring the biological sample from the device to the vial, the frame is configured to hold the vial in an upright position (the recess to hold the vessel upright without using the patient’s hands as suggested by Ching).
With respect to claims 7 and 19, de Koning teaches a vial to store the biological sample (the sample container 44 of de Koning). Ching teaches the use of a preservative fluid or solution in the vessel to help preserve the sample for testing (paragraph 0115-0016 of Ching). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a preservative fluid, as suggested by Ching, in the vessel of de Koning since it will preserve the integrity of the sample for testing.
With respect to claim 7, the combination teaches or suggests that the vial includes a preservative fluid to store the biological sample (the preservation fluid of Ching).
With respect to claim 19, the combination teaches or suggest that the vial contains one or more preservatives for storing the biological sample (the preservation fluid of Ching).
Claims 8, 12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over de Koning, in view of U.S. Patent Application Publication No. 2018/0243736 (Li)(previously cited).
De Koning teaches a vial to store the biological sample (the sample container 44 of de Koning). Li teaches the use reagents for nucleic acid amplification in the collection vessel (abstract and paragraphs 0005, 0012-0013, 0016, 0044, 0046, 0051, 0059-0063, and 0068 of Li) and a seal mechanism (e.g., a gasket in the cap) between the cap and the collection vessel (paragraph 0005, 0007, 0037, 0053, and 0063 of Li). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use reagents for nucleic acid amplification in the collection vessel, as suggested by Li, since it improves nucleic acid amplification testing allowing for the detection of even trace amounts of pathogens in a sample. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a sealing mechanism, as suggested by Li, since it isolates the sample-reagents mixture from contamination and/or leakage.
With respect to claim 8, the combination teaches or suggests that the vial includes at least one reagent to analyze the biological sample (the reagents for nucleic acid amplification suggested by Li).
With respect to claim 12, the combination teaches or suggests that the vial includes a vial cap with a locking mechanism to seal the biological sample in the vial (the sealing mechanism of Li).
With respect to claim 20, the combination teaches or suggests that the vial contains one or more biological sample reagents (the reagents for nucleic acid amplification suggested by Li).
Claims 1, 5-6, 9, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2008/0188769 (Lu)(previously cited), in view of U.S. Patent Application Publication No. 2007/0073186 (Decker)(previously cited), and further in view of WO 2020/028143 (Thakor)(previously cited).
First Interpretation
Lu teaches a device configured to be self-inserted into a portion of a user’s body, the including a sheath (the sheath 21 of Lu) comprising a distal end configured to transition between an open configuration (the opened configuration of the cover 211 or caps 212; paragraph 0031 of Lu) and a closed configuration (the closed configuration of the cover 211 or caps 212; paragraph 0031 of Lu), and a brush bar 22 configured to collect the biological sample.
Decker discloses a biopsy device that includes a handle 6 and a removable head 8 (paragraph 0032-0034 and 0038 of Decker). The head 8 can be placed in a container 2 that facilitates the collection, preservation, and transportation of the sample (paragraphs 0011-0012 and 0043 of Decker). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the head of the brush bar of Lu removable and placed in a container so as to facilitate the collection, preservation, and transportation of the sample.
The combination teaches the use of a brush bar 22 of Lu. Thakor teaches alternative collecting heads in FIGS. 6A-8B with protrusions/fingers 108/128/132/146, backings 102/122/142, and lips 110/130/148. Such structures can be made of polyurethane (paragraph 0012 of Thakor). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the polyurethane structure of any of FIGS. 6A-6AB, FIGS. 7A-7B, and FIG. 8A-8B with their respective protrusions/fingers 108/128/132/146, backing 102/122/142, and lip 110/130/148 since it is a simple substitution of one known element for another to obtain predictable results. Further, Thakor teaches that the such structures may be coated to provide sufficient abrasiveness to collect and retain cells without damaging tissue (paragraph 0012 of Thakor). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to coat the polyurethane structure to provide sufficient abrasiveness to collect and retain cells without damaging tissue.
With respect to claim 1, the combination teaches or suggests a kit for self-collecting and storing a biological sample, the kit comprising:
a device configured to be self-inserted into a vaginal canal of a user, the device including:
a sheath (the sheath 21 of Lu) comprising a distal end configured to transition between an open configuration (the opened configuration of the cover 211 or caps 212; paragraph 0031 of Lu) and a closed configuration (the closed configuration of the cover 211 or caps 212; paragraph 0031 of Lu);
a shaft (the stem 221 of Lu) at least partially within the sheath having a collection head (the protrusions/fingers 108/128/132/146 and backing 102/122/142 of Thakor) at a distal end thereof and configured to collect the biological sample;
a slider comprising an extension (the lip 110/130/148 of Thakor) coupled to a distal portion of the shaft (the stem 221 of Lu), wherein the slider comprises different materials (the polyurethane structure with coating as suggested by Thakor), and wherein the extension is disposed below the collection head (see FIGS. 1A-1C of Lu and FIGS. 6A-6AB, FIGS. 7A-7B, and FIG. 8A-8B of Thakor) and is configured to deflect vaginal tissue of the user away from the collection head (the lip 110/130/148 of Thakor is capable of deflecting the tissue away from the protrusions/fingers 108/128/132/146 and backing 102/122/142 of Thakor); and
a vial to store the biological sample (the container suggested by Decker).
With respect to claim 5, the combination teaches or suggests that, after collecting the biological sample, the collection head is configured to expand (the diameter of the container is larger relative to the periphery of the unobstructed collection head as suggested in FIGS. 14-15 of Decker such that Decker suggests that the head is fully expanded when placed in the container).
With respect to claim 6, the combination teaches or suggests that a diameter of a bottom portion of the vial is greater than a diameter of the collection head when the collection head is expanded (the diameter of the container is larger relative to the periphery of the unobstructed collection head as suggested in FIGS. 14-15 of Decker such that Decker suggests that the head is fully expanded when placed in the container).
With respect to claim 9, the combination teaches or suggest that the collection head includes polyurethane (the polyurethane of Thakor).
With respect to claim 12, the combination teaches or suggests that the vial includes a vial cap with a locking mechanism to seal the biological sample in the vial (paragraphs 0024, 0026, and 0043-0044 and claim 15 of Decker).
With respect to claim 13, the combination teaches or suggests that the extension is configured to deflect vaginal tissue away from the collection head (the lip 110/130/148 of Thakor is capable of deflecting the tissue away from the protrusions/fingers 108/128/132/146 and backing 102/122/142 of Thakor; see FIGS. 1A-1B of Lu and FIGS. 6A-6AB, FIGS. 7A-7B, and FIG. 8A-8B of Thakor).
With respect to claim 14, the combination teaches or suggests that the biological sample comprises cervical cells (paragraphs 0018 and 0034-0035 of Lu).
With respect to claim 15, the combination teaches or suggests that the biological sample comprises vaginal cells (the device is capable of collecting cells in the vagina).
With respect to claim 16, the combination teaches or suggests that the distal end of the sheath comprises at least two flexible segments (the two caps 212 of Lu).
Second Interpretation
Lu teaches a device configured to be self-inserted into a portion of a user’s body, the including a sheath (the sheath 21 of Lu) comprising a distal end configured to transition between an open configuration (the opened configuration of the cover 211 or caps 212; paragraph 0031 of Lu) and a closed configuration (the closed configuration of the cover 211 or caps 212; paragraph 0031 of Lu), and a brush bar 22 configured to collect the biological sample.
Decker discloses a biopsy device that includes a handle 6 and a removable head 8 (paragraph 0032-0034 and 0038 of Decker). The head 8 can be placed in a container 2 that facilitates the collection, preservation, and transportation of the sample (paragraphs 0011-0012 and 0043 of Decker). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the head of the brush bar of Lu removable and placed in a container so as to facilitate the collection, preservation, and transportation of the sample.
The combination teaches the use of a brush bar 22 of Lu. Thakor teaches alternative collecting heads in FIGS. 6A-8B with protrusions/fingers 108/128/132/146, backings 102/122/142, and lips 110/130/148. Such structures can be made of polyurethane (paragraph 0012 of Thakor). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the polyurethane structure of any of FIGS. 6A-6AB, FIGS. 7A-7B, and FIG. 8A-8B with their respective protrusions/fingers 108/128/132/146, backing 102/122/142, and lip 110/130/148 since it is a simple substitution of one known element for another to obtain predictable results. Further, Thakor teaches that materials may be incorporated to promote sterility, enhance elasticity, allow folding, and the like (paragraph 0012 of Thakor). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate materials for promoting sterility, enhancing elasticity, and/or allowing folding in the polyurethane structure to provide improve sterility and/or elasticity of the polyurethane structure.
With respect to claim 1, the combination teaches or suggests a kit for self-collecting and storing a biological sample, the kit comprising:
a device configured to be self-inserted into a vaginal canal of a user, the device including:
a sheath (the sheath 21 of Lu) comprising a distal end configured to transition between an open configuration (the opened configuration of the cover 211 or caps 212; paragraph 0031 of Lu) and a closed configuration (the closed configuration of the cover 211 or caps 212; paragraph 0031 of Lu);
a shaft (the stem 221 of Lu) at least partially within the sheath having a collection head (the protrusions/fingers 108/128/132/146 and backing 102/122/142 of Thakor) at a distal end thereof and configured to collect the biological sample;
a slider comprising an extension (the lip 110/130/148 of Thakor) coupled to a distal portion of the shaft (the stem 221 of Lu), wherein the slider comprises different materials (the polyurethane structure with materials for promoting sterility, enhancing elasticity, and/or allowing folding as suggested by Thakor), and wherein the extension is disposed below the collection head (see FIGS. 1A-1C of Lu and FIGS. 6A-6AB, FIGS. 7A-7B, and FIG. 8A-8B of Thakor) and is configured to deflect vaginal tissue of the user away from the collection head (the lip 110/130/148 of Thakor is capable of deflecting the tissue away from the protrusions/fingers 108/128/132/146 and backing 102/122/142 of Thakor); and
a vial to store the biological sample (the container suggested by Decker).
With respect to claim 5, the combination teaches or suggests that, after collecting the biological sample, the collection head is configured to expand (the diameter of the container is larger relative to the periphery of the unobstructed collection head as suggested in FIGS. 14-15 of Decker such that Decker suggests that the head is fully expanded when placed in the container).
With respect to claim 6, the combination teaches or suggests that a diameter of a bottom portion of the vial is greater than a diameter of the collection head when the collection head is expanded (the diameter of the container is larger relative to the periphery of the unobstructed collection head as suggested in FIGS. 14-15 of Decker such that Decker suggests that the head is fully expanded when placed in the container).
With respect to claim 9, the combination teaches or suggest that the collection head includes polyurethane (the polyurethane of Thakor).
With respect to claim 12, the combination teaches or suggests that the vial includes a vial cap with a locking mechanism to seal the biological sample in the vial (paragraphs 0024, 0026, and 0043-0044 and claim 15 of Decker).
With respect to claim 13, the combination teaches or suggests that the extension is configured to deflect vaginal tissue away from the collection head (the lip 110/130/148 of Thakor is capable of deflecting the tissue away from the protrusions/fingers 108/128/132/146 and backing 102/122/142 of Thakor; see FIGS. 1A-1B of Lu and FIGS. 6A-6AB, FIGS. 7A-7B, and FIG. 8A-8B of Thakor).
With respect to claim 14, the combination teaches or suggests that the biological sample comprises cervical cells (paragraphs 0018 and 0034-0035 of Lu).
With respect to claim 15, the combination teaches or suggests that the biological sample comprises vaginal cells (the device is capable of collecting cells in the vagina).
With respect to claim 16, the combination teaches or suggests that the distal end of the sheath comprises at least two flexible segments (the two caps 212 of Lu).
Claims 1, 5-7, 9, 12-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of U.S. Patent No. 3,815,580 (Oster)(previously cited), and further in view of Thakor.
Lu teaches a device configured to be self-inserted into a portion of a user’s body, the device including a sheath (the sheath 21 of Lu) comprising a distal end configured to transition between an open configuration (the opened configuration of the cover 211 or caps 212; paragraph 0031 of Lu) and a closed configuration (the closed configuration of the cover 211 or caps 212; paragraph 0031 of Lu), and a brush bar 22 configured to collect the biological sample.
Oster discloses a biopsy device that includes a notched shaft 36 for removing the collection head 26 (FIG. 4 of Oster; col. 2, line 20 to col. 3, lines 5 of Oster). The head 26 can be placed in a preservation container 16 having preservation fluid and a sealing mechanism that facilitates the preservation of the sample (FIG. 8 of Oster; col. 3, line 35 to col. 4, line 25 of Oster). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the head of the brush bar of Lu removable and placed in a container having preservation fluid and a sealing mechanism so as to facilitate the preservation of the sample.
The combination teaches the use of a brush bar 22 of Lu. Thakor teaches alternative collecting heads in FIGS. 6A-8B with protrusions/fingers 108/128/132/146, backings 102/122/142, and lips 110/130/148. Such structures can be made of polyurethane (paragraph 0012 of Thakor). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the polyurethane structure of any of FIGS. 6A-6AB, FIGS. 7A-7B, and FIG. 8A-8B with their respective protrusions/fingers 108/128/132/146, backing 102/122/142, and lip 110/130/148 since it is a simple substitution of one known element for another to obtain predictable results. Further, Thakor teaches that materials may be incorporated to promote sterility, enhance elasticity, allow folding, and the like (paragraph 0012 of Thakor). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate materials for promoting sterility, enhancing elasticity, and/or allowing folding in the polyurethane structure to provide improve sterility and/or elasticity of the polyurethane structure.
With respect to claim 1, the combination teaches or suggests a kit for self-collecting and storing a biological sample, the kit comprising:
a device configured to be self-inserted into a vaginal canal of a user, the device including:
a sheath (the sheath 21 of Lu) comprising a distal end configured to transition between an open configuration (the opened configuration of the cover 211 or caps 212; paragraph 0031 of Lu) and a closed configuration (the closed configuration of the cover 211 or caps 212; paragraph 0031 of Lu);
a shaft (the stem 221 of Lu) at least partially within the sheath having a collection head (the protrusions/fingers 108/128/132/146 and backing 102/122/142 of Thakor) at a distal end thereof and configured to collect the biological sample;
a slider comprising an extension (the lip 110/130/148 of Thakor) coupled to a distal portion of the shaft (the stem 221 of Lu), wherein the slider comprises different materials (the polyurethane structure with materials for promoting sterility, enhancing elasticity, and/or allowing folding as suggested by Thakor), and wherein the extension is disposed below the collection head (see FIGS. 1A-1C of Lu and FIGS. 6A-6AB, FIGS. 7A-7B, and FIG. 8A-8B of Thakor) and is configured to deflect vaginal tissue of the user away from the collection head (the lip 110/130/148 of Thakor is capable of deflecting the tissue away from the protrusions/fingers 108/128/132/146 and backing 102/122/142 of Thakor); and
a vial to store the biological sample (the container suggested by Oster).
With respect to claim 5, the combination teaches or suggests that, after collecting the biological sample, the collection head is configured to expand (the diameter of the container is larger relative to the periphery of the unobstructed collection head as suggested in FIG. 8 of Oster such that Oster suggests that the head is fully expanded when placed in the container).
With respect to claim 6, the combination teaches or suggests that a diameter of a bottom portion of the vial is greater than a diameter of the collection head when the collection head is expanded (the diameter of the container is larger relative to the periphery of the unobstructed collection head as suggested in FIG. 8 of Oster such that Oster suggests that the head is fully expanded when placed in the container).
With respect to claim 7, the combination teaches or suggests that the vial includes a preservative fluid to store the biological sample (the preservation fluid of Oster; col. 3, line 35 to col. 4, line 25 of Oster).
With respect to claim 9, the combination teaches or suggest that the collection head includes polyurethane (the polyurethane of Thakor).
With respect to claim 12, the combination teaches or suggests that the vial includes a vial cap with a locking mechanism to seal the biological sample in the vial (the sealing mechanism of Oster; col. 3, line 35 to col. 4, line 25 of Oster).
With respect to claim 13, the combination teaches or suggests that the extension is configured to deflect vaginal tissue away from the collection head (the lip 110/130/148 of Thakor is capable of deflecting the tissue away from the protrusions/fingers 108/128/132/146 and backing 102/122/142 of Thakor; see FIGS. 1A-1B of Lu and FIGS. 6A-6AB, FIGS. 7A-7B, and FIG. 8A-8B of Thakor).
With respect to claim 14, the combination teaches or suggests that the biological sample comprises cervical cells (paragraphs 0018 and 0034-0035 of Lu).
With respect to claim 15, the combination teaches or suggests that the biological sample comprises vaginal cells (the device is capable of collecting cells in the vagina).
With respect to claim 16, the combination teaches or suggests that the distal end of the sheath comprises at least two flexible segments (the two caps 212 of Lu).
With respect to claim 19, the combination teaches or suggests that the vial contains one or more preservatives for storing the biological sample (the preservation fluid of Oster; col. 3, line 35 to col. 4, line 25 of Oster).
Response to Arguments
The Applicant’s arguments filed 3/5/2026 have been fully considered.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 3/5/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn. There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph.
Prior art rejection based on de Koning
The Applicant asserts:
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This argument is not persuasive in view of the new grounds of claim rejections. In particular, the core 16 and imaging device 56 of de Koning are interpreted to be the slider of claim 1. The core 16 and imaging device 56 of de Koning are different materials as seen in FIG. 10A of de Koning, Thus, the rejection of claim 1 is proper.
The 103 rejections based on de Koning are proper since de Koning does not have the deficiencies alleged by the Applicant and the prior art teaches or suggests the features of the respective claims.
Prior art rejection based on Lu, Decker, and Thakor
The Applicant did not directly address this rejection in the response. However, there are new grounds of rejections based on the teachings of these references, as indicated in the above rejections.
Prior art rejection based on Lu, Oster, and Thakor
The Applicant did not directly address this rejection in the response. However, there are new grounds of rejections based on the teachings of these references, as indicated in the above rejections.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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