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 (SG10202109369P – filed 08/26/2021) required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed of 02/26/2024 has been certified and made of record.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “rotatable base” in claim 21 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The use of the term General® Tools, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 2, 3, 8, 11, 13-15, 25 are objected to because of the following informalities:
Regarding claim 2, “The apparatus according to claim 1, further comprising a visual data acquisition device for capturing images of a vulva, sampling vaginal discharge or fluid and results generated by the at least two LFAs” should read “The apparatus according to claim 1, further comprising a visual data acquisition device for capturing images of a vulva, sampling vaginal discharge or fluid, and displaying results generated by the LFAs.”
Regarding claim 3, “The apparatus according to claim 1, wherein the collection apparatus is shaped to be handheld and to comfortably fit a vagina of a user of the apparatus for diagnosis of vaginal disorders” should read “The apparatus according to claim 1, wherein the collection apparatus is shaped to be handheld and to comfortably fit in a vagina of a user of the apparatus for diagnosis of vaginal disorders.
Regarding claim 8, “The apparatus according to claim 1 wherein the at least two LFAs is selected from the group consisting of tests or kits for candida species antigenic, trichomonas vaginalis antigenic, sialidase enzyme activity, chlamydia trachomatis antigenic, rapid nucleic acid detection of microorganism presence, and detection of vaginal amines molecules typical of vaginitis” should read “The apparatus according to claim 1 wherein the LFAs are selected from the group consisting of tests or kits for candida species antigenic, trichomonas vaginalis antigenic, sialidase enzyme activity, chlamydia trachomatis antigenic, rapid nucleic acid detection of microorganism presence, and detection of vaginal amines molecules typical of vaginitis”
Regarding claim 11, “The apparatus according to claim 1, wherein the sensing device comprises a housing having a top part and a flat base, the top part is elevated compared with the flat base, allowing for mixed vaginal fluids to flow to the at least two LFAs and wherein the housing is shaped to comport to the shape of the collection apparatus” should read “The apparatus according to claims 1, wherein the sensing device comprises a housing having a top part and a flat base, the top part is elevated compared with the flat base, allowing for mixed vaginal fluids to flow to the LFAs and wherein the housing is shaped to conform to the shape of the collection apparatus”
Regarding claim 13, “The apparatus according to claim 1, wherein the sensing device further comprises a sampling and mixing chamber formed of walls and a bottom at a proximal end and at least two view ports a distal end” should read “The apparatus according to claim 1, wherein the sensing device further comprises a sampling and mixing chamber formed by walls and a bottom at a proximal end and at least two view ports at a distal end”.
Regarding claim 14, “The apparatus according to claim 1, wherein the sensing device further comprises a delivery mechanism, the delivery mechanism comprises a delivery conduit connecting the sampling and mixing chamber and at least two LFAs” should read “The apparatus according to claim 1, wherein the sensing device further comprises a delivery mechanism, the delivery mechanism comprises a delivery conduit connecting the sampling and mixing chamber and the LFAs.”
Regarding claim 15, “The apparatus according to claim 13, wherein the sampling and mixing chamber further comprises a buffer solution or reagents for preparation of collected sample prior to delivery to the at least two LFAs: and a mixing mechanism” should read “The apparatus according to claim 13, wherein the sampling and mixing chamber further comprises a buffer solution or reagents for preparation of collected sample prior to delivery to the LFAs: and a mixing mechanism”
Regarding claim 25, “The kit according to claim 24, wherein the at least two LFAs is selected from the group consisting of tests or kits for candida species antigenic, trichomonas vaginalis antigenic, sialidase enzyme activity, chlamydia trachomatis antigenic, rapid nucleic acid detection of microorganism presence, and detection of vaginal amines molecules typical of vaginitis” should read “The kit according to claim 24, wherein the LFAs are selected from the group consisting of tests or kits for candida species antigenic, trichomonas vaginalis antigenic, sialidase enzyme activity, chlamydia trachomatis antigenic, rapid nucleic acid detection of microorganism presence, and detection of vaginal amines molecules typical of vaginitis”.
Appropriate correction is required.
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 4 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. Specifically, a pH sensor is claimed to be found within the collection apparatus. However, the specification teaches pH sensor as a strip. Sensors hold specific structure with possessing electronic elements, yet a pH strip fails to specifically possess such features. Thus, the claim fails to particularly point out the subject matter which the inventor or a joint inventor regards as the invention. For examination purposes, any prior art containing the claim limitation of a pH sensor (whether through a test strip or through electronic means) will be seen as meeting the limitation.
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 1-3, 8, 24, 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tariyal et al. (US 20160324506 A1) (referenced in 892).
Regarding claim 1, Tariyal et al. teaches a medical kit for analysis of vaginal biological samples (abstract), which includes a sample collector, an extractor, and an assay cartridge (abstract), comprising:
a sample collector (element 400) for collecting and sampling vaginal discharge or fluid (sample collector 400 – configured to be inserted into a human body cavity (vagina) (para. [0104-0105]),
a sensing device (assay cartridge – element 500) for processing the sampling vaginal discharge or fluid “testing of the presence of certain fungi, bacteria, viruses, viroids, parasites, protozoa, biological markers present on these pathogens” (para. [0120]), said sensing device comprising at least two lateral flow assays (Tariyal et al. teaches that assay cartridge is configured to run a plurality of assays – either in parallel or in series (para. [0120]), as assay cartridge is configured to include lateral flow materials (para. [0131]) – thus, the claim limitation of at least two lateral flow assays is anticipated).
Regarding claim 2, Tariyal et al. teaches the apparatus of claim 1. Tariyal et al. further teaches interface (element 112) with camera (element 115), that interprets and tracks a user’s results (para. [0100]). This anticipates the claim limitation “sampling vaginal discharge or fluid and results generated by the at least two LFA”. Furthermore, the camera (element 115) would be structurally capable of capturing images of a vulva. Thus, the claim is anticipated by Tariyal et al.
Regarding claim 3, Tariyal et al. teaches the apparatus of claim 1. Tariyal et al. further teaches that collection apparatus (sample collector – element 400) is shaped to be handheld (removable element 404 is pulled, and therefore can be “handheld”) and to comfortably fit in a vagina “the sample collector 400 is a cylinder having a head 402 configured to cradle the os of the cervix” (para [0104]). Sample collector (element 400) collects sample menstrual fluid, reproductive tissue, mucosa, and foreign bodies (para. [0105]), which is used for diagnosis. Thus, the claim is anticipated.
Regarding claim 8, Tariyal et al. teaches the apparatus of claim 1. Tariyal et al. further teaches that the device can be applied “to the detection of a wide variety of infections, as it allows for detection of antigen or antibody analytes associated with any disease or disorder for which an antibody or antigen analyte is known, such as for a variety of STIs and cancers.” (para. [0245]). This includes Chlamydia trachomatis (para. [0250]) and Trichomoniasis (para. [0253]). Thus, the claim is anticipated.
Regarding claim 24, Tariyal et al. teaches a medical kit for analysis of vaginal biological samples (abstract), which includes a sample collector (structurally the collection apparatus), an extractor, and an assay cartridge (structurally the sensing device) (abstract), comprising:
a sample collector (element 400) for collecting and sampling vaginal discharge or fluid (sample collector 400 – configured to be inserted into a human body cavity (vagina) (para. [0104-0105]),
a sensing device (assay cartridge – element 500) for processing the sampling vaginal discharge or fluid “testing of the presence of certain fungi, bacteria, viruses, viroids, parasites, protozoa, biological markers present on these pathogens” (para. [0120]), said sensing device comprising at least two lateral flow assays (Tariyal et al. teaches that assay cartridge is configured to run a plurality of assays – either in parallel or in series (para. [0120]), as assay cartridge is configured to include lateral flow materials (para. [0131]) – thus, the claim limitation of at least two lateral flow assays is anticipated).
Regarding claim 25, Tariyal et al. teaches the kit according to claim 25. Tariyal et al. further teaches that the device can be applied “to the detection of a wide variety of infections, as it allows for detection of antigen or antibody analytes associated with any disease or disorder for which an antibody or antigen analyte is known, such as for a variety of STIs and cancers.” (para. [0245]). This includes Chlamydia trachomatis (para. [0250]) and Trichomoniasis (para. [0253]). Thus, the claim is anticipated.
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.
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 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Tariyal et al. (already referenced) in view of Rieth (US 20100036279 A1) (referenced in 892).
Regarding claim 4, Tariyal et al. teaches the apparatus according to claim 1. Tariyal et al. further teaches that collection apparatus further comprises at least one swab head (sample collector (element 400) holds head (element 402), which is a cotton or other organic fiber-based apparatus (para. [0105]). Tariyal et al. fails to teach that the collection apparatus comprises a pH sensor. Rieth teaches an apparatus (vaginal health apparatus 100), containing pH sensor (element 250) on distal portion (element 230) (para. [0097-0098]). Rieth teaches that “vaginal pH is an important part of in the diagnosis of vaginal infections such as Bacterial Vaginitis (BV). The normal vaginal pH in reproductive age women is usually 3.5 to 4.5. A value greater the 4.5 can indicate a variety of vaginal infections which are usually accompanied by unusual discharge, itching, burning and irritation.” (para. [0007]).
It would have been prima facie obvious to one of ordinary skill in the art to use Rieth’s teaching of a pH sensor in Tariyal et al.’s collection apparatus because pH sensors in vaginal apparatuses can aid in identifying vaginal infections present in the woman. This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Rieth. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Rieth to obtain the claimed invention as specified in claim 4.
Regarding claim 5, Tariyal et al. teaches the apparatus according to claim 1. Tariyal et al. fails to teach, however, that the collection apparatus is shaped as a spoon, and comprises a handle and a collection cup having an opening. Rieth teaches an apparatus (vaginal health apparatus 100), containing distal end portion (element 250) (para. [0098]) with a collection cup (fluid sample well (element 240)), which structurally is shaped as a spoon. Furthermore, the collection apparatus contains a handle component (element 300), as this general structure enables insertion into the human vagina so that pH measurement can be taken either in the vaginal tract or at the cervix. (para. [0095/0096]).
It would have been prima facie obvious to one of ordinary skill in the art to use Rieth’s teaching a handle and spoon design in Tariyal et al. collection apparatus because this structure enables insertion in the vagina for pH measurements in the tract. This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Rieth. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Rieth to obtain the claimed invention as specified in claim 5.
Regarding claim 6, Tariyal et al. teaches the apparatus according to claim 1. Tariyal et al. fails to teach, however, that the collection apparatus further comprises a pH sensor mounted such that when a sample is collected, the pH sensor is immersed in vaginal fluid. Rieth teaches an apparatus (vaginal health apparatus 100), containing distal end portion (element 250) (para. [0098]) with a collection cup (fluid sample well (element 240)). Rieth further teaches “The well 240 acts as a reservoir for holding biological fluids, such as urine, saliva, blood, cervical, fluids, vaginal fluids and/or other bodily fluids. A pH sensor 250, a temperature sensor 260 and a diaphragm 270 are located within the well 240” (para. [0098]). This is structurally the same as a pH sensor mounted such that when the sample is collected, the pH sensor is immersed.
It would have been prima facie obvious to one of ordinary skill in the art to use Rieth’s teaching pH sensor mounted inside a reservoir in Tariyal et al.’s collection apparatus because this structure enables biological fluids to be captured in the reservoir and measured with the pH sensor. This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Rieth. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Rieth to obtain the claimed invention as specified in claim 6.
Regarding claim 7, modified Tariyal et al. teaches the apparatus according to claim 6. Furthermore, Rieth teaches that probe is designed with a material such as PEEK (plastic), which can be transparent. The structure resulting in the combination of claim 6 would encompass a structure of a pH sensor comprising a wall made of a transparent material (plastic).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tariyal et al. (already referenced) in view of Joseph (US 20180180583 A1) (referenced in 892).
Regarding claim 9, Tariyal et al. teaches the apparatus according to claim 1. Tariyal et al. fails to teach that the sensing device further comprises a portable spectrometer. Joseph teaches a mobile scientific platform (abstract) that uses atomic/molecular vapor collectors (AMVC) that may be inserted into body cavities including the vagina (para. [0115]). Specifically, portable mass spectrometers may be used to sample the air in the body cavity and detect materials (atomic elements) (para. [0115]).
It would have been prima facie obvious to one of ordinary skill in the art to use Joseph’s teaching of a mass spectrometer in Tariyal et al.’s sampling apparatus because mass spectrometer specifically may be used to measure and detect materials (atomic elements). This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Joseph. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Joseph to obtain the claimed invention as specified in claim 9.
Claims 11, 13, 14, 17, 20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Tariyal et al. (already referenced) in view of Imrich (US 5415994 A) (referenced in 892).
Regarding claim 11, Tariyal et al. teaches the apparatus according to claim 1. Tariyal et al. fails to teach specifically that the sensing device further comprises a housing having a top part and a flat base, a top part elevated compared with the flat base, and wherein the housing is shaped to conform to the shape of the collection apparatus. Imrich teaches an apparatus for diagnosing vaginal disorders housing having a top part elevated (extraction chamber – element 10) compared with a flat base allowing for mixed vaginal fluids to flow to the LFA (FIG. 4). Imrich further teaches that after swab (40) is positioned in the chamber, sample flows through exit port (element 16) to the receiving zone (element 30) (Col. 4, 5th and 6th paragraph).
It would have been prima facie obvious to one of ordinary skill in the art to use Imrich’s teaching of a housing having a top part elevated (extraction chamber – element 10) compared with a flat base in Tariyal et al.’s sampling apparatus because this structure enables the sample to flow into a receiving zone for testing. This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Imrich. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Imrich to obtain the claimed invention as specified in claim 11.
Regarding claim 13, Tariyal et al. teaches the apparatus according to claim 1. Tariyal et al. fails to teach that the sensing device further comprises a sampling and mixing chamber formed of walls and a bottom at a proximal end and at least two view ports at a distal end. Imrich teaches an apparatus for diagnosing vaginal disorders with a sampling (extraction chamber – element 10) and mixing chamber (sample receiving zone 30), and at least two view ports (observation window (element 20) and end of assay window (element 26)) (FIG. 4). Imrich teaches that extraction chamber enables the sample to flow into a receiving zone for testing, while the observation windows enable the user to see results (Col. 4, 5th and 6th paragraph).
It would have been prima facie obvious to one of ordinary skill in the art to use Imrich’s teaching of observation windows and an elevated chamber in Tariyal et al.’s sampling apparatus because this structure enables the sample to flow into a receiving zone for testing, while the windows enable the user to see results. This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Imrich. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Imrich to obtain the claimed invention as specified in claim 13.
Regarding claim 14, Tariyal et al. teaches the apparatus according to claim 1. Tariyal et al. fails to teach a delivery conduit between a mixing and sampling chamber. Imrich teaches a delivery conduit (exit port – element 16), which connects extraction chamber (element 10) and sample receiving zone (element 30) (FIG. 4). This allows the analyte to be extracted prior to capturing in capture zone (element 34) (Col. 4, 5th and 6th paragraph).
It would have been prima facie obvious to one of ordinary skill in the art to use Imrich’s teaching of a delivery conduit in Tariyal et al.’s sampling apparatus because a delivery conduit enables the analyte to be extracted prior to entering a capturing zone. This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Imrich. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Imrich to obtain the claimed invention as specified in claim 14.
Regarding claim 17, modified Tariyal et al. teaches the apparatus according to claim 14. Tariyal et al. teaches a delivery mechanism as an exit port (element 16), which structurally is equivalent to a tube extending between the sampling and mixing chamber. Furthermore, although Tariyal et al. fails to teach the usage of two tubes, it has been established that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP § 2144.04 B). Using two tubes to form the delivery mechanism would amount to mere duplication of parts.
Regarding claim 20, modified Tariyal et al. teaches the apparatus according to claim 13, including the usage of a sampling and mixing chamber. Modified Tariyal et al. fails to specifically teach two sampling and mixing chambers specifically. Although modified Tariyal et al. fails to teach the usage of two mixing and sampling chambers, it has been established that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP § 2144.04 B). Using two mixing and sampling chambers would amount to mere duplication of parts.
Regarding claim 23, modified Tariyal et al. teaches the apparatus according to claim 20, including the usage of a swab head in collection apparatus. However, modified Tariyal et al. fails to teach a second swab head. Although modified Tariyal et al. fails to teach the usage of two mixing and sampling chambers, it has been established that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP § 2144.04 B). Using two swab heads in the collection apparatus would amount to mere duplication of parts.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tariyal et al. (already referenced) in view of Imrich (already referenced) as applied to claim 13, and in further view of Day et al. (US 20080090305 A1) (referenced in 892).
Regarding claim 15, modified Tariyal et al. teaches the apparatus according to claim 13. Modified Tariyal et al. includes a sampling and mixing chamber, as Imrich teaches that “Following placement of the sample in the extraction chamber, an extraction solution may be added to the chamber which prepares the sample for detection. By "extraction solution", it is meant a solution comprising reagents which will treat the sample so that detection of the target analyte is enhanced” (Col 4, 2nd paragraph) (structurally the same as a buffer solution or reagents for preparation). However, modified Tariyal et al. fails to teach a mixing mechanism.
Day et al. teaches a test device for quantitively measuring concentration of an analyte in a biological fluid sample (abstract). Day et al. specifically teaches that test device and test well includes a mixer (para. [0010]), as the mixer specifically allows a conjugate to be rapidly dissolved and distributed homogenously through the fluid sample, forming a complex (para. [0076]). Furthermore, this mixing promotes maximum binding between the analyte and the conjugate, which may increase the reliability of the assay at low concentrations of an analyte (para. [0076]).
It would have been prima facie obvious to one of ordinary skill in the art to use Day et al.’s teaching of a mixer in Tariyal et al.’s apparatus because a mixer would promote binding with a conjugate, which can increase reliability of the assay at low concentrations of an analyte. This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Day et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Day et al. to obtain the claimed invention as specified in claim 15.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tariyal et al. (already referenced) in view of Imrich (already referenced) as applied to claim 20, and in further view of Holmes et al. (US 20130079599 A1) (referenced in 892).
Regarding claim 21, modified Tariyal et al. teaches the apparatus according to claim 20., but fails to specifically teach a rotatable base. Holmes et al. teaches a device for detection within a provided sample (abstract), where the invention may be directed to a base having a bottom surface being configured to rotate around an axis orthogonal to the bottom surface (para. [0207]). Specifically, the usage of a rotatable base may be used for centrifugation (para. [0207]).
It would have been prima facie obvious to one of ordinary skill in the art to use Holmes et al.’s teaching of a rotatable base in Tariyal et al.’s apparatus because a rotatable base would enable centrifugation to be performed on the apparatus. This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Holmes et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Holmes et al. to obtain the claimed invention as specified in claim 21.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Tariyal et al. (already referenced) in view of Imrich (already referenced) as applied to claim 20, and in further view of Lai (US 20110105953 A1) (referenced in 892).
Regarding claim 22, modified Tariyal et al. teaches the apparatus according to claim 20, but fails to teach a puncture element. Lai teaches a sampling device for vaginal specimens (abstract), where sampling device (element 20) includes a tube (element 22) with a push rod (element 24) inserted into the tube (para. [0006]). Piston (element 242) is disposed on the front end of the push rod, and is used for injecting/drawing solution and collecting specimens (para. [0006]). Structurally, the piston and push rod are the same as puncture elements, and would be capable of forming apertures.
It would have been prima facie obvious to one of ordinary skill in the art to use Lai’s teaching of a piston and push rod in Tariyal et al.’s apparatus because the piston and pushrod would enable injection and drawing of solution for collecting specimens. This method of improving Tariyal et al.’s apparatus was within the ability of one of ordinary skill in the art based on the teachings of Lai. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Tariyal et al. and Lai to obtain the claimed invention as specified in claim 22.
Conclusion
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/J.F.Y./Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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