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 statement (IDS) submitted on 4/30/2026 was filed after the mailing date of the non-final rejection on 1/21/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 4/21/2026. These drawings are accepted by the examiner and placed in the record on file.
Election/Restrictions
Newly submitted claim 7 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 7 is drawn to different embodiments/species depicted in figures 4-5 which is mutually exclusive to the previously presented claims 3-5 which only recited generic claims (claims 3 and 4) and a claim to the embodiment/species depicted in figures 1-3 (claim 5). As the claims to the different species recite mutually exclusive characteristics of such species and require different search and consideration (e.g. searching different CPC classes/symbols or electronic resources or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a), there is a search burden and the claims are restricted.
Since applicant has received an action on the merits for the originally presented invention (species depicted in figures 1-3), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 7 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendments/Arguments
The applicant’s replacement drawings and arguments presented in the response on 4/21/2026 have been received and are persuasive. As such the replacement drawings were entered into the record on file and the previously held drawing objections are withdrawn.
Applicant’s amendments and arguments with regard to the 35 USC 112(b) rejection have been fully considered and are persuasive. Specifically, the amendments in the 4/21/2026 response, address the previously held issues and have been entered. Accordingly, the previously held 35 USC 112(b) rejections of claims 3-5 have been withdrawn. The examiner does note that some of the amendments have resulted in new 35 USC 112(b) rejection(s) as described in the 35 USC 112 section below.
As noted above, claim 7 is withdrawn by restriction by original presentation as the previously presented claim 3-5 only presented generic claims (claims 3 and 4) and to the species depicted in figures 1-3 and described in paragraphs [0041]-[0045] of the specification. As the embodiment described in claim 7 recites mutually exclusive features which were not previously presented at the time of initial examination with the non-final rejection mailed on 1/21/2026, claim 7 is withdrawn. The restriction is described in more detail in the elections/restrictions section above.
Applicant's amendments and arguments/remarks with respect to claims 3-5 have been fully considered but they are not persuasive. Specifically, the applicant has amended the claims to recite that the fluid sample chamber is “selected from a syringe and a fluid sample chamber comprising a probe…” and argues that Tariyal et al (US 11,864,740 B2) does not disclose or suggest that either the sample collector or the extractor include a syringe or fluid sample chamber including a probe, and points to figures 15A-15D of Tariyal. The applicant argues that Tariyal discloses an extractor having an extractor chamber for receiving a sample collector, wherein the sample is processed by mechanical compression using a screw-cap arrangement to express the sample from the collector; and that such a mechanism is neither a syringe or a fluid sample chamber including a probe.
The examiner respectfully disagrees with the applicant’s assertion that Tariyal’s extractor does not meet the broadest reasonable interpretation (BRI) of a syringe or a fluid sample chamber including a probe. The first point of emphasis is that the claim merely recites “a syringe or a fluid sample chamber including a probe” in claims 3 and 4, and recites some further structure in claim 5. Regarding claims 3 and 4, as no structure of the syringe is recited in the claim, the examiner is left to interpret the claim limitation in light of the specification and the level of one of ordinary skill in the art at the time of filing to determine what constitutes a syringe or a fluid sample chamber including a probe. In such an analysis, the applicant’s specification gives some structure as to what constitutes the structure of a syringe, particularly in paragraph [0027] and [0028] which describes the syringe as having a hollow body, an outlet, a syringe inlet capable of receiving a cellular sample or a body containing a cellular sample, and a plunger which can be inserted into the syringe body and move within the body to compress/expel the sample through the outlet. As such, the examiner contends that Tariyal’s extractor (element 1500) meets the BRI of a syringe, at least as broadly as currently recited in the instant claims, for the same reasons as pointed out in the rejection of claim 5 in the office action mailed on 1/21/2026, which the applicant’ does not provide any specific arguments against other than the mere conclusory statement that Tariyal’s extractor is not a syringe. However, as noted in the rejection of claim 5 in the non-final rejection, Tariyal’s extractor meets the BRI of a syringe as it discloses:
“a syringe (element 1500) comprising a body (element 1506) and a plunger (element 1505), the plunger (element 1505) being removable to present an inlet (element 1508, figures 15c) for receiving a sanitary product having a vaginal cellular sample (element 120) and an outlet (element 1504) at the opposite end of the syringe (figures 15a and 15c), especially a 5ml-20ml syringe (not requires as per 35 USC 112b interpretation as presented above) (column 41, line 63 - column 44, line 8, specifically column 41, line 63 - column 43, line 13; figures 15a-d),”
Accordingly, as Tariyal’s extractor includes all of the structural elements that the applicant uses to describe a syringe in the specification and in claim 5, the examiner contends that Tariyal’s extractor element 1500 meets the BRI of a syringe.
Furthermore, the examiner contends that Tariyal’s extractor as set forth in figures 15A-15D also meets the BRI of a fluid sample chamber comprising a probe as Tariyal’s extractor discloses a fluid sample chamber (element 1506) comprising a probe (sample collector element 120) which is inserted into the fluid sample chamber element 1506 of the extractor element 1500 to express the sample (column 41, line 63 - column 44, line 8, specifically column 41, line 63 - column 43, line 13; figures 15a-d). Therefore, as the extractor has both a fluid sample chamber and a probe, it meets the BRI of the claim.
Accordingly, the applicant’s arguments/remarks with regards to claims 3-5 are found to be non-persuasive as Tariyal’s extractor element 1500 meets the BRI of both a syringe and fluid sample chamber comprising a probe, at least as broadly as currently recited.
Newly presented claims 6, 8 and 9 are rejected in a similar manner over Tariyal as presented below.
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 3-6, 8 and 9 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.
Claims 3-6, 8 and 9 are rejected for reciting “a fluid sample chamber” twice, thus that it creates confusion as to what constitutes a fluid sample chamber. Specifically, the amended claims were amended to recite “a fluid sample chamber selected from a syringe and a fluid sample chamber comprising a probe, wherein the fluid sample chamber is…”. This is confusing and indefinite because it is unclear if “the fluid sample chamber” is referring to the broad “a fluid sample chamber” which can be either “a syringe or a fluid sample chamber with a probe”, or just to the “a fluid sample chamber with a probe”. Accordingly, the metes and bounds of the claims cannot be determined.
For the purpose of advancing examination and providing compact prosecution, the examiner will interpret the claim limitation to be referring to the broad “a fluid sample chamber” (i.e. the first recitation which is a genus to which the species of “a syringe” and “a fluid sample chamber comprising a probe” belong to for examination purposes.
Further regarding claims 3; lines 4-6 of claim 3 recite “wherein the fluid sample container is adapted to receive a vaginal cellular sample and is configured to be placed in fluid communication with the evacuated sample container…” This limitation is indefinite because it appears that the claim interchanges chamber and container in the amendment. Container was previously only used to described the evacuated sample container, and chamber is used to describe the fluid sample chamber which is configured to be placed into fluid communication with the evacuated sample container. However, the amendment recites “the fluid sample container is adapted to receive a vaginal cellular sample and is configured to be placed in fluid communication with the evacuated sample container…”. The confusion between container and chamber in the amendment makes the claim indefinite as it is appears to interchange a fluid sample container and a fluid sample chamber without ever establishing them as equivalents.
For the purpose of advancing examination and providing compact prosecution, the examiner will interpret the amended claim limitation to recite “wherein the fluid sample chamber is adapted to receive a vaginal cellular sample and is configured to be placed in fluid communication with the evacuated sample container…”.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 3 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tariyal et al (US 11,864,740), as evidenced by “BD Vacutainer® CPT™ Mononuclear Cell Preparation Tube - Sodium Heparin” (previously provided).
Regarding claim 3; Tariyal discloses a self-sampling system for collection of a vaginal cellular sample (figures 15a-d) comprising:
an evacuated sample container (Vacutainer element 1509, column 41, line 63 – column 44, line 8, specifically column 42, lines 48-51; wherein evidential vacutainer BD Vacutainer CPT fact sheet discloses that the tube is an evacuated, sterile collection tube) having an openable end which is closed by a puncturable seal (end which engages with fluid port element 1504 or luer lock adapter element 1503, column 41, line 63 – column 44, line 8, specifically column 42, lines 46-67) and
a fluid sample chamber (element 1506) selected from a syringe (extractor, element 1500) and a fluid sample chamber (element 1506) comprising probe (element 120), wherein the fluid sample chamber is adapted to receive a vaginal cellular sample (column 42, lines 39-42) and is configured to be placed in fluid communication with the evacuated container (element 1509) through the puncturable seal such that a vaginal cellular fluid sample is drawn into the evacuated sample container upon establishing fluid communication between the fluid sample chamber and the evacuated sample container (wherein element 1510 engages via fluid port element 1504 or luer lock adapter element 1503 with evacuated sample container element 1509 to transfer the sample; column 41, line 63 – column 44, line 8, specifically column 42, lines 46-67; figures 15a-d).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 4-6, 8 and 9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tariyal in view of applicant admitted prior art.
Regarding claim 4 and 8; Tariyal discloses a method of manually acquiring a cellular fluid sample (figures 15a-d), comprising:
providing an evacuated sample container (element 1509) having a puncturable seal (end of vacutainer which connects with luer lock element 1503), a needle assembly (luer lock element 1503) and a fluid sample chamber (element 1510) for receiving a vaginal sample ((column 42, lines 39-42) which is selected from a syringe (element 1500) and a fluid sample chamber (element 1506) comprising a probe (element 120) wherein the needle assembly provides a fluid communication conduit between the fluid sample chamber and the evacuated sample container wherein upon piercing the puncturable seal, the vaginal cellular sample is urged from the fluid sample chamber to the evacuated sample container (wherein sample chamber element 1510 engages via luer lock adapter element 1503 with evacuated sample container element 1509 to transfer the sample; column 41, line 63 – column 44, line 8, specifically column 42, lines 46-67; figures 15a-d).
Further regarding claims 4 and 8, Tariyal discloses the use of luer lock element 1503 for transferring the fluid from the fluid sample chamber element 1510 to evacuated sample container element 1509 via various methods (column 42, lines 51-67), Tariyal does not explicitly disclose the luer lock assembly as a “needle assembly”. For the purposes of 102, the examiner contends that the extending element of luer lock adaptor device 1503 (see annotated figure below) meets the BRI of needle, and thus discloses and anticipates a needle assembly. However, in the alternative, if the elongate element of Tariyal were not considered to meet the BRI of “a needle assembly”, it would have been obvious to one of ordinary skill in the art at the time of filing to use a well-known needle assembly as the luer lock adapter element 1503 to puncture a vacutainer seal in order to transfer a fluid from a sample reservoir to an evacuated sample container element. The examiner notes that official notice was previously taken in the non-final rejection mailed on 1/21/2026, and thus the examiner previous statement of common knowledge that using a needle assembly to puncture a vacutainer seal in order to transfer a fluid from a sample reservoir to an evacuated sample container element is taken to be admitted prior art because the applicant has failed to traverse the examiner’s assertion of official notice. See MPEP 2144.03 C.
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Further regarding claim 8; Tariyal discloses the cellular fluid sample is a vaginal sample (column 42, lines 39-44).
Regarding claim 5; Tariyal discloses a self-sampling or home-testing kit (figures 15a-d; column 71, line 46 – column 74, line 19) for use by a subject to acquire a sample from themselves comprising:
A fluid sample chamber selected from a fluid sample chamber (element 1506) comprising a probe (element 120) and a syringe (element 1500) comprising a body (element 1506) and a plunger (element 1505), the plunger (element 1505) being removable to present an inlet (element 1508, figures 15c) for receiving a sanitary product having a vaginal cellular sample (element 120) and an outlet (element 1504) at the opposite end of the syringe (figures 15a and 15c), (column 41, line 63 – column 44, line 8, specifically column 41, line 63 – column 43, line 13; figures 15a-d),
a needle assembly (luer lock adaptor device, element 1503), adapted to attach to the syringe outlet (element 1503 attached to outlet element 1504) (column 41, line 63 – column 44, line 8, specifically column 41, line 63 – column 43, line 13; figures 15a-d), and
an evacuated container (element 1509) having a puncturable seal (seal on open end of vacutainer element 1509) and containing a cell preservation solution (column 43, lines 25-62),
wherein the needle assembly provides a fluid communication path between the syringe and the evacuated chamber (wherein element 1503 connects extractor fluidically couple extractor/syringe, element 1500, to the evacuated container element 1509; column 41, line 63 – column 44, line 8, specifically column 41, line 63 – column 43, line 13; figures 15a-d).
Further regarding claim 5, in the similar manner as described in the rejection of claim 4, Tariyal discloses the use of luer lock element 1503 for transferring the fluid from the fluid sample chamber element 1510 to evacuated sample container element 1509 via various methods (column 42, lines 51-67), Tariyal does not explicitly disclose the luer lock assembly as a “needle assembly”. For the purposes of a 35 USC 102(a)(2) rejection, the examiner contends that the extending element of luer lock adaptor device 1503 (see annotated figure above) meets the BRI of needle, and thus discloses a needle assembly. However, in the alternative, if the elongate element of Tariyal were not considered to meet the BRI of “a needle assembly”, it would have been obvious to one of ordinary skill in the art at the time of filing to use a well-known needle assembly as the luer lock adapter element 1503 to puncture a vacutainer seal in order to transfer a fluid from a sample reservoir to an evacuated sample container element. The examiner notes that official notice was previously taken in the non-final rejection mailed on 1/21/2026, and thus the examiner’s previous statement of common knowledge that using a needle assembly to puncture a vacutainer seal in order to transfer a fluid from a sample reservoir to an evacuated sample container element is taken to be admitted prior art because the applicant has failed to traverse the examiner’s assertion of official notice. See MPEP 2144.03 C.
Regarding claim 6; A self-sampling apparatus (figures 15a-d; column 71, line 46 – column 74, line 19) for collection of a vaginal cellular sample comprising:
an evacuated sample container (element 1509) having an openable end which is closed by a puncturable seal (seal on open end of vacutainer element 1509), a fluid sample chamber (element 1500) adapted to receive a vaginal cellular sample which is selected from a syringe (element 1500) and a fluid sample chamber (element 1506) comprising a probe (element 120), and a needle assembly (luer lock adaptor device, element 1503) configured to provide a fluid communication conduit between the fluid sample chamber (element 1506) and the evacuated container (element 1509) through the puncturable seal such that a vaginal cellular fluid sample is drawn into the evacuated sample container upon establishing fluid communication between the fluid sample chamber and the evacuated sample container via the needle assembly (wherein extractor/syringe, element 1500, and/or chamber, element 1506, comprising probe, element 120, is connected to evacuated tube, element 1509 through the luer lock needle assembly, element 1503 to draw a sample into the vacuum container; column 41, line 63 – column 44, line 8, specifically column 41, line 63 – column 43, line 13; figures 15a-d).
Further regarding claim 6, Tariyal discloses the use of luer lock element 1503 for transferring the fluid from the fluid sample chamber element 1506 to evacuated sample container element 1509 via various methods (column 42, lines 51-67); however, Tariyal does not explicitly disclose the luer lock assembly as a “needle assembly”. For the purposes of the 35 USC 102(a)(1), the examiner contends that the extending element of luer lock adaptor device 1503 (see annotated figure above) meets the BRI of a needle, and thus discloses a needle assembly. However, in the alternative, if the elongate element of Tariyal were not considered to meet the BRI of “a needle assembly”, the examiner takes official notice that it would have been obvious to one of ordinary skill in the art at the time of filing to use well-known and common means of transferring fluids from a sample reservoir to an evacuated sample container element with a puncturable seal, including the well-known and common laboratory practice of using a needle assembly to puncture a vacutainer seal in order to transfer a fluid from a sample reservoir to an evacuated sample container element.
Regarding claim 9; Tariyal discloses a method of screening for cervical cancer (column 152, lines 5-37), comprising:
acquiring a vaginal cellular sample (sample within collector element 120; column 42, lines 24-26), placing the sample in a fluid sample chamber (element 1500 or 1506) selected from a syringe (element 1500) and a fluid sample chamber (element 1506) comprising a probe (element 120), which sample chamber (element 1500 or 1506) is in, or configured to be placed in, fluid communication with an evacuated sample container (element 1509) having a puncturable seal (seal on open end of vacutainer element 1509) via a needle assembly (element 1503) upon the needle of the needle assembly piercing the puncturable seal, whereby the vaginal cellular sample is urged from the fluid sample chamber to the evacuated container and analyzing the vaginal cellular sample to screen for cervical cancer (column 41, line 63 – column 44, line 8, specifically column 41, line 63 – column 43, line 13 and column 152, lines 5-37; figures 15a-d).
Further regarding claim 9, Tariyal discloses the use of luer lock element 1503 for transferring the fluid from the fluid sample chamber element 1506 to evacuated sample container element 1509 via various methods (column 42, lines 51-67); however, Tariyal does not explicitly disclose the luer lock assembly as a “needle assembly”. For the purposes of the 35 USC 102(a)(1), the examiner contends that the extending element of luer lock adaptor device 1503 (see annotated figure above) meets the BRI of a needle, and thus discloses a needle assembly. However, in the alternative, if the elongate element of Tariyal were not considered to meet the BRI of “a needle assembly”, the examiner takes official notice that it would have been obvious to one of ordinary skill in the art at the time of filing to use well-known and common means of transferring fluids from a sample reservoir to an evacuated sample container element with a puncturable seal, including the well-known and common laboratory practice of using a needle assembly to puncture a vacutainer seal in order to transfer a fluid from a sample reservoir to an evacuated sample container element.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 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, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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