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 .
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.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “alignment means” in Claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. According to the specification, the recited “alignment means” include “ribs”.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The applicant has amended the claims such that “a defined volume of specimen adhering to the elongated part of the sampling utensil or exiting the fenestrated segment is retained in the proximal compartment”. However, the instant application’s specification states that “any fecal matter…is retained in the proximal compartment” (Paragraph [0031]). The applicant further states that “a pre-defined volume of dense sample…transferred into the buffer of the distal chamber” (Paragraphs [0008], [0021], and [0032]). The applicant’s specification reads that a “defined volume of specimen” is retained in the “buffer of the distal chamber” and not the “proximal chamber” as currently recited in Claim 1.
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 1-19 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 1, the limitation “a defined volume of specimen adhering to the elongated part of the sampling utensil or exiting the fenestrated segment is retained in the proximal compartment” recited in lines 19-21 of the claim are indefinite. It is unclear how a “fitting hole” can control a “defined volume of specimen” to be scraped off an “elongated part of the sampling utensil” given that the “fitting hole” would scrape any excess off that the “fitting hole” is in contact with the “elongated part of the sampling utensil”. The volume of specimen would depend on how much sample of the specimen is adhered to the “elongated part of the sampling utensil” when obtaining the sample. The applicant’s specification further fails to add clarity to how this would occur. This is being interpreted to mean “any excess specimen adhering to the elongated part of the sampling utensil”.
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
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 1, 4-5, 7-9, 12-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wan et. al.'705 (U.S. Patent Publication 20090005705 – previously cited) in view of Rutty et. al.'126 (U.S. Patent Publication 20100184126 – previously cited).
Regarding Claim 1, Wan et. al.'705 discloses a specimen collecting system with an elongated sampling utensil for fecal matter and an integrated vessel for extraction of the collected fecal sample (Paragraph [0023] - the fecal specimen collector according to the first embodiment of the present invention), comprising:
a tubular structure open at top and bottom ends, wherein there is a fitting hole at an intermediate position dividing the tubular structure into a proximal compartment and a distal chamber, and which is closable at both ends by a top cap and a bottom cap, respectively (Paragraph [0023] - fecal specimen collector comprises a hollow bottle body 20 with openings at both ends thereof, an top cover 10 coupled with one of the opening of the bottle body 20 at one end);
a top cap integral with or attached to the elongated sampling utensil that can be inserted in the axial direction into the tubular structure and through the fitting hole into the distal chamber (Paragraph [0024] - The top cover 10 is formed with a handle 16 at the upper end thereof, and a sampling end 15 at the lower end thereof. The sampling end 15 can be inserted into the bottle body 20 from the upper end of the bottle body 20. The specimen output end 30 is inserted into the opening at the lower end of the bottle body 20 so as to achieve an interference fit between the specimen output end 30 and the lower portion of the bottle body 20; Paragraph [0027] - When the sampling end 15 is inserted into the bottle body 20, it goes into the liquid storing chamber 22 by passing through the hole 26);
a bottom cap which, with the tubular structure and the elongated sampling utensil, when inserted axially into the fitting hole, forms a liquid-tight distal chamber capable of containing a buffer solution (Paragraph [0024] - the bottom cover 40 is coupled to the bottle body 20 by screwing; Paragraph [0027] - The bottom cover 40 is formed with a convex 42 at the inner bottom center thereof. When the bottle body 20 and the bottom cover 40 are threaded-coupling, the convex 42 on the inner bottom center of the bottom cover 40 is inserted into the specimen output port 37 to seal the passage for preventing the liquid in the bottle body from leaking out) wherein:
the elongated sampling utensil has at its axial distal end a fenestrated segment with a sampling cavity, the outer dimensions of the sampling cavity and the fenestrated segment cooperating with the dimensions of the fitting hole (Paragraph [0034] - The sampling end 115 has a stick structure having sheets protruding from its stick so as to ensure adequate amount of sample to be collected once during the operation; Paragraph [0036] - When the sampling end 115 is inserted into the bottle body 120, it goes into the liquid storing chamber 122 by passing through the hole 126); and in that
the proximal compartment contains integrally with the inner wall of the tubular structure and before the intermediate position spaced guide ribs which direct the fenestrated segment of the elongated sampling utensil through the fitting hole so that any excess amount of specimen adhering to the elongated part of the sampling utensil or exiting the fenestrated segment is retained in the proximal compartment and displaced into a free space between the guide ribs or within the proximal compartment (Paragraph [0030] - the specimen will be blocked by the spacing septum 25 so that the form and shape of the feces sample can be observed through the observing window. After that, the user tightly screws the top cover 10 and shakes the bottle body 20 to flush the feces sample away from the sampling end 15 by the diluent in the liquid storing chamber 22 and make it uniform).
Wan et. al.'705 fails to disclose the elongated sampling utensil has at its forward end a cut-out member. Rutty et. al.'126 teaches a fenestrated sampling utensil with a cut-out member (Paragraph [0025] - Advantageously, the use of a single punch is a very simple mechanism by which the sample may be extracted from the subject; Paragraph [0033] - The punch is provided with at least one lateral opening via which sample preservative can pass into the lumen of the punch and hence come into contact with a sample held in that lumen). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Wan et. al.’705 to include a fenestrated sampling utensil with a cut-out member at the forward in order to punch a fecal sample and retain the contents within the openings as seen in Rutty et. al.’126.
Regarding Claim 4, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses wherein the sampling utensil comprises an elongated distal part whose outer dimensions match the dimensions of the fitting hole and a central portion whose larger dimensions are sized to take a seat on the spaced guide ribs that lead the elongated part to the fitting hole and to displace retained specimen into the free space between the guide ribs and within the proximal compartment (Paragraph [0037] - The spacing septum 125 is disposed with a sealing ring 127 thereon. When the top cover 110 and the bottle body 120 are closely connected with each other, the round plate 118, the sealing ring 127 and the spacing septum 125 are closely disposed in sequence, which may prevent the diluent liquid contained between the spacing septum 125 and the specimen output end 130 from leaking into the observing chamber 121; Paragraph [0041] - Then the user inserts the sampling end 115 and the round plate 118 of the upper cover 110 into the specimen of fecal matter so as to dip a portion of the specimen…At this time, a part of the specimen will be blocked on the round plate 118 so that the form and shape of the feces sample can be observed through the observing window).
Regarding Claim 5, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above but fails to disclose wherein the fenestrated segment is provided with multiple lateral openings for an exit of excess sample material from the sampling cavity and at an open front end of the sampling cavity with a cut-out member. Rutty et. al.’126 teaches a sampling utensil containing lateral openings (Paragraph [0033] - The punch is provided with at least one lateral opening via which sample preservative can pass into the lumen of the punch and hence come into contact with a sample held in that lumen). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Wan et. al.’705 to include a system comprising a sampling utensil containing lateral openings in order to enable an obtained sample to come into direct contact with a sample preservative as seen in Rutty et. al.’126.
Regarding Claim 7, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses wherein the elongated sampling utensil comprises: (i) a central portion dimensioned to seat on the guide ribs integral with the inner wall of the tubular structure and located proximal to the fitting hole (Paragraph [0041] - Then the user inserts the sampling end 115 and the round plate 118 of the upper cover 110 into the specimen of fecal matter so as to dip a portion of the specimen…At this time, a part of the specimen will be blocked on the round plate 118 so that the form and shape of the feces sample can be observed through the observing window);
a distal elongated part sized for sliding and sealing engagement with the fitting hole and which projects axially with its fenestrated segment into the distal chamber when inserted (Paragraph [0036] - When the sampling end 115 is inserted into the bottle body 120, it goes into the liquid storing chamber 122 by passing through the hole 126); and
a proximal portion sized to abut the inner wall of the tubular structure at the top opening when inserted (Paragraph [0026] - The top cover 10 further comprises a stick 17 connected between the handle 16 and the sampling end 15, wherein an external thread portion 18 is formed between the handle 16 and the stick 17; see Annotated Figure 1 below).
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Annotated Figure 1
Regarding Claim 8, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses wherein the distal chamber is pre-filled with the buffer for preservation, solubilization, and/or extraction of analytes of a fecal matrix (Paragraph [0027] - a liquid storing chamber 22 between the spacing septum 25 and the lower end of the bottle body 20 for preserving the diluent for diluting the specimen of fecal matter; Paragraph [0030] - After that, the user tightly screws the top cover 10 and shakes the bottle body 20 to flush the feces sample away from the sampling end 15 by the diluent in the liquid storing chamber 22 and make it uniform).
Regarding Claim 9, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses wherein the tubular structure is provided near the top and bottom end with external threads configured to screw the top cap and bottom cap onto the top and bottom ends and, when fully screwed on, and the top and bottom caps engage with locking devices or latches for being secured against accidental or unintentional loosening or dislodgement (Paragraph [0027] - The bottle body 20 is a hollow tube, disposed with an internal thread portion 23 on an inner surface of the upper end, which is to be coupled to the external thread portion 18 of the top cover 10; Paragraph [0028] - The opening has an internal thread 41 coupled to an external thread 24 on the lower end of the bottle body 20. The bottle body 20 contains the diluent therein and the top cover 10 and the bottom cover 10 are sealed from all directions to prevent the diluent from leaking out).
Regarding Claim 12, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses wherein the top cap attached to the sampling utensil is knurled at its outside for better handling and provided with engagement and alignment means mating or suitable for a mechanical bushing or a positioning means (see Annotated Figure 4 below).
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Regarding Claim 13, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses wherein at least one cap is provided with a receptacle capable of cooperating with an opening tool of an automated analyzer unit (Paragraph [0029] - the convex 42 on the inner bottom center of the bottom cover 40 is inserted into the specimen output port 37 to seal the passage for preventing the liquid in the bottle body from leaking out; Paragraph [0030] - the checker screws off the bottom cover 40 so that the sample can drop from the specimen output port 37 of the bottle body 20 for the microscopic examination or the test paper examination).
Regarding Claim 14, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses wherein the tubular structure is provided with one or more stop rims, with a fillet, for tight closure of the screw caps (Paragraph [0024] - the bottom cover 40 is coupled to the bottle body 20 by screwing; Paragraph [0030] - the user tightly screws the top cover 10 and shakes the bottle body 20; see Annotated Figure 4 below).
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Regarding Claim 15, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses wherein at least one cap has placement means for an upright placement of the tubular specimen collecting system on a flat surface (Paragraph [0035] - The handle 116 generally has a shape of cylinder; see Annotated Figure 4 below).
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Regarding Claim 17, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses method of collecting and extracting a defined amount of pasty fecal material which comprises the use of a specimen collecting system (Paragraph [0005] - The method of collecting the specimen of fecal matter directly affects the accuracy of the examination), comprising the steps of:
removal of the top cap with the elongated sampling utensil from the specimen collecting system and dipping the fenestrated segment of the sampling utensil into pasty fecal material to excise a volume of fecal sample (Paragraph [0030] - When sampling, the user first looses the upper cover 10 so as to take out the upper cover 10. Then the user inserts the sampling end 15 of the upper cover 10 into the specimen of fecal matter so as to dip a portion of the specimen), and
reinserting the elongated sampling utensil with the fenestrated segment in an axial direction through the fitting hole to obtain a defined volume of fecal material while wiping off and retaining in the proximal compartment any excess fecal material exiting lateral openings of the fenestrated segment or adhering to the elongate part of the sampling utensil (Paragraph [0030] - the sampling end 15 dipping with the specimen into the bottle body 20 again. At this time, most of the specimen will be blocked by the spacing septum 25 so that the form and shape of the feces sample can be observed through the observing window); and
extracting and solubilizing the excised volume of fecal matter in the sampling cavity in an aqueous buffer pre-filled into the distal buffer chamber of the specimen collecting system, which is then suitably shaken and agitated (Paragraph [0030] - After that, the user tightly screws the top cover 10 and shakes the bottle body 20 to flush the feces sample away from the sampling end 15 by the diluent in the liquid storing chamber 22 and make it uniform).
Regarding Claim 18, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 fails to disclose collecting a defined volume of fecal matter as claimed in claim 17 for collecting a volume of a fecal sample of 100 microliters or a mass of a fecal sample of 100 micrograms. Rutty et. al.'126 teaches collecting volumes containing a mass of a fecal sample containing 100 micrograms (Paragraph [0059] - The amount of biological sample excised by the sample collecting means may be from about 10 mg to about 1000 mg, preferably about 20 mg to about 750 mg, more preferably about 30 mg to about 500 mg, and most preferably about 50 mg to about 250 mg. The inventors have surprisingly found that such small amounts of sample provide sufficient nucleic acid for analysis purposes). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Wan et. al.’705 to include a system that is capable of collecting 100 micrograms of a sample of fecal matter in order to obtain a sample size large enough to analyze fecal properties such as nucleic acid analysis as seen in Rutty et. al.’126. Furthermore, it is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to the volume or mass obtained of a sample. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine optimal volume or mass of a sample obtained. 2144.04 MPEP Section IV. A. states “Where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Regarding Claim 19, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses the steps of analyzing the patient's microbiome (Paragraph [0030] - At last, the checker screws off the bottom cover 40 so that the sample can drop from the specimen output port 37 of the bottle body 20 for the microscopic examination). It is to be noted that the analyzing could be done in an automated analysis unit.
Claims 2-3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Wan et. al.'705 (U.S. Patent Publication 20090005705 – previously cited) in view of Rutty et. al.'126 (U.S. Patent Publication 20100184126 – previously cited), as applied to Claim 1 above, and further in view of Booker et. al.'729 (U.S. Patent Publication 20210307729 – previously cited).
Regarding Claim 2, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above but fails to disclose wherein the elongated sampling utensil, when inserted into the tubular structure and engaged in a first position "1", provides a semi-tight wiping seal at the fitting hole, and when inserted into the tubular structure and engaged in an axially forward second position "2", provides a liquid-tight seal at the fitting hole. Booker et. al.'729 teaches more than one locking ridge (Paragraph [0033] - In certain aspects, the interior surface (113) of the upper cap (103) includes one or more lock ridges (119) that are substantially complementary to lock grooves of the upper end of the container body…The positioning of the one or more lock ridges (119) on the interior surface (113) of the upper cap (113) can be such that when a portion of the body above the lock grooves is inserted into the upper cap (103), the upper cap (103) seals the upper end of the body in a removable fashion. If instead a sufficient portion of the body, e.g., a portion including the lock grooves, is inserted into the upper cap, then the lock grooves mate with the lock ridges (119), and the upper cap (103) seals the upper end of the body in a locked fashion in which the upper cap (103) is not easily removable. In this manner, a chain-of-custody of the sample is maintained). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Wan et. al.’705 to include more than one locking ridge in order for the sampling utensil to be held at an easily removable position or a not easily removable position based on the need of the apparatus as seen in Booker et. al.’729.
Regarding Claim 3, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above but fails to disclose wherein a top cap formed integrally with or connected to the elongated sampling utensil snaps in position "2" onto a detent arranged at the end of external threads near the top opening of the tubular structure. Booker et. al.'729 teaches a cap with a second locking position closer to a sampling container than first locking position that is further away from the sampling container (Paragraph [0033] - The positioning of the one or more lock ridges (119) on the interior surface (113) of the upper cap (113) can be such that when a portion of the body above the lock grooves is inserted into the upper cap (103), the upper cap (103) seals the upper end of the body in a removable fashion. If instead a sufficient portion of the body, e.g., a portion including the lock grooves, is inserted into the upper cap, then the lock grooves mate with the lock ridges (119), and the upper cap (103) seals the upper end of the body in a locked fashion in which the upper cap (103) is not easily removable. In this manner, a chain-of-custody of the sample is maintained). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Wan et. al.’705 to include a second locking ridge closer to a housing body than a first locking ridge in order to provide a seal between a sampling utensil and the housing body once the sampling utensil is inserted into the housing body as seen in Booker et. al.’729.
Regarding Claim 6, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above but fails to disclose wherein the sampling cavity of the sampling utensil provides a cut-out volume of 50 microliters to 250 microliters. Booker et. al.’729 teaches a sampling utensil containing cut-outs that are capable of collecting volumes containing 50 to 250 microliters of a sample (Paragraph [0035] - The dimensions of the one or more sampling grooves can be configured such that the combined interior volumes of the grooves corresponds with a targeted amount of the biological sample to be collected. In this way, the design of the sampling grooves and the sampling pin, in combination with the design of the internal flange of the container body, can effectively control the amount of solid sample added to the lower portion of the body. The total volume defined by the sampling grooves can be, for example, between 10 μL and 1000 μL). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Wan et. al.’705 to include a system that is capable of collecting 50 to 250 microliters of a sample in order to obtain an appropriate volume of a predetermined sample size as seen in Booker et. al.’729 (Paragraph [0051] - In operation 503, the sampling pin is removed from the biological sample, thereby collecting a portion of the biological sample within the at least one sampling groove. The at least one sampling groove can have an interior volume configured to have a size suitable for holding a predetermined amount of sample to be stored). Furthermore, it is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to the volume obtained of a sample. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine optimal volume of a sample obtained. 2144.04 MPEP Section IV. A. states “Where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wan et. al.'705 (U.S. Patent Publication 20090005705 – previously cited) in view of Rutty et. al.'126 (U.S. Patent Publication 20100184126 – previously cited), as applied to Claim 9 above, and further in view of Wang et. al.'448 (U.S. Patent Publication 20060210448 - cited by applicant).
Regarding Claim 10, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 9 above but fails to disclose wherein the threads near the top and bottom ends are left-handed and right- handed to avoid unintentional opening of the other screw cap during handling. Wang et. al.'448 teaches a first cap and a second cap threaded in different directions (Paragraph [0024] - The plug is further formed to have an outer male threaded portion 46 on the end opposite the breakable nib 6. The threaded portion of the plug releasably engages a corresponding inner female threaded portion 47 in the vessel 2 proximate to the first end 3; Paragraph [0025] - Screw threads 14 matingly cooperating with the threaded plunger are provided along the inside wall of the vessel from the second end 10 down toward a median portion 15 of the vessel; see Annotated Figure 1 below). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Wan et. al.’705 to include a top and bottom cap with opposite threading directions in order to secure the caps separately as seen in Wang et. al.’448 (Paragraph [0022] - to secure the cover). Furthermore, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine optimal rotation direction of the caps. 2144.04 MPEP Section VI. A. states “mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification” In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955).
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Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wan et. al.'705 (U.S. Patent Publication 20090005705 – previously cited) in view of Rutty et. al.'126 (U.S. Patent Publication 20100184126 – previously cited), as applied to Claim 9 above, and further in view of Baillie et. al.'076 (U.S. Patent Publication 20200139076 – previously cited).
Regarding Claim 11, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 9 above but fails to disclose an audible click is heard when a screw cap engages in a locking device. Baillie et. al.'076 teaches a device containing a lid that produces an audible click when in a locked position (Paragraph [0077] - In the same manner, rear cap 70 may define a small tab in the thread system which passes over a small protruding detent on the percussive ventilation breathing head body 10, generating both an audible click-to-lock indicator; Paragraph [0085] - The click turn seal/lock provides both tactile confirmation to the patient or care giver that the nebulizer body 20 is securely mounted on the overmold lid 80 and an audible indicator of the same). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Wan et. al.’705 to include an audible click whenever a device is locked in order to provide confirmation that a sample device has a secure connection to the lid as seen in Baillie et. al.’076.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wan et. al.'705 (U.S. Patent Publication 20090005705 – previously cited) in view of Rutty et. al.'126 (U.S. Patent Publication 20100184126 – previously cited), as applied to Claim 1 above, and further in view of Wisherd et. al.'200 (U.S. Patent Publication 20210038200 – previously cited).
Regarding Claim 16, Wan et. al.'705 in view of Rutty et. al.'126 discloses the system outlined in Claim 1 above. Wan et. al.’705 further discloses a fitting hole with a partition (Paragraph [0037] - the sealing ring 127 and the spacing septum 125 are closely disposed in sequence, which may prevent the diluent liquid contained between the spacing septum 125 and the specimen output end 130 from leaking into the observing chamber 121), but fails to disclose the fitting hole within a partition is provided with axially spaced annular sealing elements such as sealing beads or sealing lips. Wisherd et. al.'200 teaches annular detents around a hole within a partition (Paragraph [0044] - The projection 136 further includes one or more features 138 that engage with the one or more features 128 of the dipstick 122 to remove, or at least substantially remove, all of the material retained by the one or more features 128. In one or more embodiments, the one or more features 138 can be an annular detent or ring configured to fit within the helical grooves on the second end 126 of the dipstick 122, as discussed further below. In one or more embodiments, the one or more features 138 can be a complementary ridge that fits the one or more features 128 on the second end 126 of the dipstick 122). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Wan et. al.’705 to include annular detents within the hole of a partition in order to remove excess material from the sample utensil as seen in Wisherd et. al.’200.
Response to Arguments
Applicant's arguments filed 30 June 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior drawing objections.
Applicant’s amendments have overcome the prior claim objections.
Provided that no response was made by the applicant in regards to the previous 112f interpretation for Claim 12, the examiner stands by their previous interpretation for element "alignment means" to include "ribs".
Applicant’s amendments have created a 35 U.S.C. 112a rejection as addressed in Paragraph 4 above.
Applicant’s amendments have overcome the prior 35 U.S.C. 112b rejections, but an additional 112b rejection has been addressed in Paragraph 5 above.
It is noted by the examiner that they are unable to see the elements referred as "highlighted in yellow" on pages 10 and 11 of the applicant’s submitted "Remarks". Additionally, the examiner and was unable to get in contact with the attorney or applicant regarding the “highlighted features” when attempting to call on 15 August 2026. Therefore, the examiner has addressed the arguments as best as possible.
Claims 1-19 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 6-10 above.
The examiner has considered the applicant’s arguments pertaining to Wan et. al.'705 disclosing obtaining an “adequate” amount of specimen versus the applicant’s intended purpose of obtaining a “defined” amount of specimen, but has found these arguments to not be persuasive. Applicant appears to be equating a “defined volume” with a “predetermined” or “predefined” volume. The claims do not require that a predetermined/predefined volume of specimen adhering to the elongated part of the sampling utensil or exiting the fenestrated segment is retained in the proximal compartment and displayed into a free space between the guide ribs or within the proximal compartment. The claims require “a defined volume”. Any volume of specimen is a “defined volume” of specimen; the specimen has volume that can be defined (by measurement).
The examiner makes note that if Claim 1 is amended in a manner that overcomes the current rejections and recites a distal compartment configured to receive a “predefined amount of specimen”, prior art of record Booker et. al.'729 (recited above in Paragraph 7) discloses a sampling pin with grooves and a flange that control a defined amount of specimen to enter a distal compartment from a proximal compartment (Paragraph [0028] - The inner diameter of the internal flange (116) opening can also be configured to be small enough to prevent material that is attached to the sampling pin, and not within the sampling groove, from entering the lower portion (118)… the design of the internal flange (116), in combination with the design of the sampling pin and its sampling groove(s), can effectively control the amount of solid sample material added to the lower portion (118) of the body. In other words, a precise amount of sample is delivered into the lower portion of the body. In certain instances, the amount of sample is proportional to the number of groove(s); Paragraph [0029] - entire paragraph; Paragraph [0035] - entire paragraph - The dimensions of the one or more sampling grooves can be configured such that the combined interior volumes of the grooves corresponds with a targeted amount of the biological sample to be collected. In this way, the design of the sampling grooves and the sampling pin, in combination with the design of the internal flange of the container body, can effectively control the amount of solid sample added to the lower portion of the body).
The examiner has considered the applicant’ arguments pertaining to Want et. al.’705 failing to disclose “guide ribs”, but has found these arguments to not be persuasive. The element “spaced guide ribs” were not provided with any structural limitations within the recited claim beyond the function to “direct the fenestrated segment of the elongated sampling utensil through the fitting hole”. The examiner believes that element 25 of Wan et. al.’705 provides the same function. Element 25 of Wan et. al.’705 is a “spacing septum” configured to direct the “sampling end” (15) into the “through hole” (26) in order to make contact with a buffer solution in the lower end (distal chamber).
The examiner has considered the applicant’s arguments pertaining to Wan et. al.'705 disclosing “the sealing ring on the septum only to keep the diluent from going into the observing chamber, not to keep excess feces out of the distal chamber", but has found these arguments to not be persuasive. This is found to be not persuasive as a sealing ring that keeps liquid out of a chamber would also be able to keep larger particles such as excess feces from going between the two chambers.
The examiner has considered the applicant’s arguments pertaining to Rutty et. al.’126, but they have found to not be persuasive. Rutty et. al.’126 discloses a punch to obtain a sample amount (Paragraph [0025] - Advantageously, the use of a single punch is a very simple mechanism by which the sample may be extracted from the subject) as well as openings to allow solution to reach what sample has been punched into the lumen as addressed in Paragraph 6 above (Paragraph [0033] - The punch is provided with at least one lateral opening via which sample preservative can pass into the lumen of the punch and hence come into contact with a sample held in that lumen). The punch portion is to obtain the sample and the openings are used to allow a sample preservative (buffer) to get into contact with the punched sample.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Saito et. al.'744 (U.S. Patent Publication 20160278744) discloses using stool containers to connect to automatic inspection apparatus (Paragraph [0007] - Such a stool collection container 101, which has been designed to be suitable for use in an automatic inspection apparatus, has a liquid reservoir 103b in the front end thereof formed via a filter retaining part 103a).
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 SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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