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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the black and white depictions of the drawings/photograph of figures 1a-1c are lightly colored and unclear due to the shading (i.e. the examiner is unable to tell how far the barrel of the syringe goes or if there is a test tube where element 5 is points, ect…). Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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.
Currently, there are no limitations being interpreted as invoking 35 USC 112(f).
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 3-5 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 3; the claim is indefinite because it is unclear what is required by the scope of the claim. Specifically, claim 3 recites a self-sampling apparatus which appears to comprises two elements, an evacuated sample container and a fluid sample chamber adapted to receive a vaginal cellular sample which, and then describes their relationship when in use. The issue comes to the scope of the claim, if this is a single apparatus, then what is the relationship of the elements (evacuated sample container and fluid sample chamber) when not in use. It appears that preamble should instead recite a self-sampling system since there are multiple elements to only work together when in use, but are separate when not in use (based on the applicant’s specification).
Furthermore regarding claim 3, it is unclear as what “in use” means in the context of the claim in light of the specification. For example, one could argue that the fluid sample chamber is in use whenever it contains a sample or when a sample is being placed within, however according to the specification, the evacuated sample container is not always in fluid communication with the sample chamber when collecting the sample in the sample chamber. The examiner encourages the applicant to amend the claim to recite how the system is configured to as to avoid the issue with “when, in use” limitation issues outlined above. For the purpose of examination, the examiner will interpret the claim 3 as follows (bolded and italicized for changes):
A self-sampling system for collection of a vaginal cellular sample comprising:
an evacuated sample container having an openable end which is closed by a puncturable seal; and
a fluid sample chamber adapted to receive a vaginal cellular sample, wherein the fluid sample chamber is configured to be placed in fluid communication with the evacuated container 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 container.
Regarding claim 4, the limitation "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are required for the claimed invention. See MPEP § 2173.05(d).
For the purpose of advancing prosecution, the examiner will interpret the claim as if the “preferably a vaginal sample” is not required to meet the scope of the instant claim.
Regarding claim 5, the limitations "especially" and “preferably” render the claim indefinite because it is unclear whether the limitations following the limitation are required for the claimed invention. See MPEP § 2173.05(d).
For the purpose of advancing prosecution, the examiner will interpret the claims as if the limitations of “especially a 5 ml – 20 ml syringe” and “preferably having a safety shroud” are not required to meet the scope of the instant claim.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 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” (examiner provided NPL).
Regarding claim 3; Tariyal discloses a self-sampling apparatus 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) adapted to receive a vaginal cellular sample (column 42, lines 39-42) which, in use, is 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 container (wherein sample chamber 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 § 102/103
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.
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 4 and 5 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tariyal.
Regarding claim 4; Tariyal discloses a method of manually acquiring a cellular fluid sample (figures 15a-d), preferably a vaginal sample (column 42, lines 39-42), comprising:
providing an evacuated sample container (element 1509) having a puncturable seal (end of vacutainer which connects with luer lock element 1503) and a needle assembly (luer lock element 1503) and a fluid sample chamber (element 1510) for receiving a vaginal sample ((column 42, lines 39-42) wherein the needle assembly provides a fluid communication conduit between the fluid sample chamber and the evacuated chamber wherein upon piercing the puncturable seal, whereby the vaginal cellular sample is urged from the fluid sample chamber to the evacuated 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 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 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 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.
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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 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),
a needle assembly (luer lock adaptor device, element 1503), preferably having a safety shroud (cover surrounding elongate needle element, see annotated figure above), 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),
the kit further comprising one or more sanitary products sized to fit in the syringe wherein the needle assembly provides a fluid communication path between the syringe and the evacuated chamber (wherein sample collector element 120 is disclosed as being provided as part of a kit throughout as noted above; 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”, 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 assebly to puncture a vacutainer seal in order to transfer a fluid from a sample reservoir to an evacuated sample container element.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2003/0023188 A1 to Kritzman; discloses a method, device and kit for obtaining biological samples.
US 2023/0194391 A1 to Nishi et al; discloses a liquid collector and method for collecting liquid.
US 2016/0045187 A1 to Terbrueggen et al; discloses devices and methods for collecting and stabilizing biological samples.
US 2017/0036205 A1 to Bishop et al; discloses a fluid collection device.
US 2016/0273059 A1 to Benshaul; discloses a kit and method for collecting body fluid for medical diagnosis.
US 2011/0159533 A1 to Karkouche; discloses a bioparticle capture device and use thereof.
US 2023/0172591 A1 to Robbins et al; discloses liquid sample collection devices, systems and methods.
US 5,352,410 to Hansen et al; discloses fluid specimen collection and testing apparatus.
US 4,580,577 to O’Brien et al; discloses a method and apparatus for collecting saliva.
US 8,540,938 B2 to Wu et al; discloses a fluid sample collecting and analyzing apparatus and method.
US 5,000,193 to Heelis et al; discloses a medical swab device.
US 3,815,580 to Oster; discloses an apparatus for and method of collecting and preserving cytologic samples.
DE 10 2023 102 184 A1 to Guenou et al; discloses an adapter for transferring a preparing a sample containing menstrual excretions into a sealable sample container.
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