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 .
Response to Amendment
This Office action is responsive to the Amendment filed April 9, 2025. The Examiner acknowledges the amendments to claims 1-7. Claims 1-19 are pending.
Response to Arguments
Applicant’s arguments, see remarks, filed 04/09/2025, have been fully considered but they are not persuasive. Applicant argues that there is repeated reference to a sealable container in fig. 10 of the Briscoe reference, but the examiner fails to identify which element in fig. 10 of Briscoe is considered to be the sealable container. This argument has been found to be unpersuasive because as recited in the previous office action, fig. 10 & par 0043 & 0044 of Briscoe teach that the sweat from the sweat collector tubing can be transferred to a sealable container such that the tubing is unwound and a needle is used to draw fluid into the needle and expel fluid into a sealable container as shown in fig. 10 and described in paragraphs 0043 & 0044 of the Briscoe reference. The term “sealable container” is expressly recited in the last sentence of paragraph [0044]. A syringe as disclosed elsewhere in Briscoe might also be considered a sealable container.
Further, Applicant argues that claims 1 & 7 have been amended for the time series collection of sweat and the sweat collector tubing remains joined to the main body of the sweat collecting device when the sweat is delivered to the receptacle. Regarding Applicant’s amendments to the preamble of claims 1 & 7, Applicant’s arguments rely on language solely recited in preamble recitations. When reading the preamble in the context of the entire claim, the recitation "for time series collection of excreted sweat" is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Claim 1 has been amended to recite that the sweat collector tubing remains joined to the main body when collecting sweat and claim 7 has been amended to recite that the free end of the sweat collector tubing remains joined to the main body of the sweat collection device, but a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Additionally, regarding claim 7, it is unclear how the free end of the receptacle would be able to remove the sample if it is “joined” to the main body, and how the free end would be able to be directed into an open end of the receptacle as described in paragraph 0009 of the specification if connected/joined to the main body. Further, the amended language of claim 1 is such that the limitations cannot be broadly read in a plurality of scenarios, in that the limitations can only be read in the context of sweat being collected into the sweat collecting device. Regarding claim 7, the amended claim language does not avoid the interpretation that the free end of the sweat collector tubing remains joined to the main body through the rest of the tubing.
Additionally, Applicant argues that it would be contrary to the principle of operation of the Briscoe reference to modify Briscoe with Delente because Briscoe requires a needle to remove sweat from the sweat collector tubing, the sweat collector tubing must be cut/removed from the main body of the sweat collecting device, and the sweat is expelled using a needle. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, though Applicant argues that in Briscoe, sweat can only be removed by cutting the tubing, Briscoe discloses that the sweat collected in the sweat collector tubing can be expelled or withdrawn and tested in any convenient way (see Briscoe, par 0042). Therefore, though Briscoe discloses cutting the tubing to expel sweat from the device, it is not required to expel/withdraw sweat for collection in a container.
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. Claim 1
Dependent claims are similarly rejected as their base claim.
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.
Claim 1 recites “wherein the sweat collector tubing remains joined to said main body” at line 16. It is unclear what is meant by “joined” in this limitation as the claim precedingly states that the length of sweat collector tubing “[has] one end joined to said main body at said axial bore and a free end extending outwardly from the outwardly-oriented surface of said main body”. Therefore, it is unclear what is meant by “joined” as the claim already states how the sweat collector tubing is joined to the surface of the main body. The examiner respectfully requests clarification of this limitation.
Claim 7 recites “collecting sweat from the person’s skin using said sweat collection device wherein sweat travels into said sweat collector tubing and then into said receptacle while the free end of the sweat collector tubing remains joined to said main body” [emphasis added] at step c). It is unclear how the free end of the sweat collector tubing “remains” joined to the main body as the claim precedingly states that the free end of the sweat collector tubing “[extends] outwardly from the outwardly-oriented surface of said main body” at lines 11-12. Therefore, it is unclear how the free end of the sweat collector tubing “remains” joined to the main body when the claim also states that the free end of the sweat collector tubing extends outwardly from the outwardly-oriented surface of the main body. The examiner respectfully requests clarification of this limitation.
Dependent claims are similarly rejected as their base claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 6-7, 9-10 & 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2016/0030012 A1 --as previously cited--, hereinafter referenced as "Briscoe", in view of US Patent 5,327,901--as previously cited--, hereinafter referenced as "Delente".
With respect to claim 1, Briscoe teaches a system for time series collection of excreted sweat comprising: a sweat collecting device comprising:
a main body having two surfaces comprising a sweat-collecting surface 15 (Briscoe, see fig. 3) and an opposing outwardly-oriented surface (Briscoe, see fig. 1), wherein said sweat-collecting surface has a concave configuration 13 which defines a rim 14 lying wholly within a common plane (Briscoe, see fig. 3, par 0027), wherein said main body has an axial bore 18 between the sweat-collecting surface and the outwardly-oriented surface (Briscoe, see fig. 3);
a length of sweat collector tubing 17 having one end joined to said main body at said axial bore (Briscoe, see fig. 3, par 0028) and a free end extending outwardly from the outwardly-oriented surface of said main body (Briscoe, see par 0008 & 0042).
Furthermore, Briscoe teaches a sealable container that is used for transferring collected sweat from the sweat collector tubing to a testing site or sweat testing apparatus (see Briscoe, fig. 10, par 0044). When the collected sweat is being deposited into the sealable container, the tubing is unwound and inserted into a closure of the sealable container (i.e., into a closure of a receptacle) (see Briscoe, par 0044, fig. 10). The sealable container has a closed end for containing the collected sweat and an open that permits entry to the sealable container for depositing the collected sweat (see Briscoe, fig. 10). The sealable container can be configured to be positioned such that the free end of the sweat collector tubing is directed into an open end of the sealable container and such that the sealable container is positioned closer to the outwardly-oriented surface of the main body than to the sweat-collecting surface of the main body, since the tubing is flexible and can therefore permit the receptacle to be placed on top of the outwardly-oriented surface of the main body (see Briscoe, fig. 10, par 0044). Moreover, one of ordinary skill would readily realize the receptacle would be positioned closer to the outwardly-oriented surface than the sweat collecting surface of the main body because the sweat collecting surface interfaces with the skin of a user during sweat collection (see Briscoe, fig. 1, par 0030).
Briscoe fails to teach details of the sealable container, such as the sealable container comprising a closure, wherein the closure has a hole therethrough, and wherein the hole is sized to fit at least partially around the sweat collector tubing adjacent the free end of the sweat collector tubing.
Delente teaches an apparatus and method for collecting fluid (i.e., breath) samples comprising a container 1, cap 25, and closure 26, wherein the cap 25 and closure 26 respectively comprise holes 28, 39, 30 and holes 26a, 26b that permit the insertion of a sampling device (i.e., a tube or needle) through the cap 25 without having to remove the cap 25 after it has been secured in place on the container (see Delente, figs. 5 & 6, Col. 6, lines 12-31). During operation of the fluid collecting apparatus, the cap 25 is twisted loosely onto the container to open holes 28, 29, 30 that align with holes 26a, 26b of the closure, and fluid is input into the container through one of the holes in the cap and respective hole in the closure via a fluid delivery means 27 (i.e., via a tubing) (see Delente, figs. 5 & 6, Col. 6, lines 32-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Briscoe such that it comprises a closure for a receptacle, wherein the closure has a hole therethrough, and wherein the hole is sized to fit at least partially around the sweat collector tubing adjacent the free end of the sweat collector tubing, because that would enable the sealable container of the device of Briscoe to collect sweat samples without having to remove the cap of the container, thereby enabling samples to be collected more quickly since the cap doesn’t have to be reopened/reclosed each time a fluid sample is deposited into the container (see Delente, figs. 5 & 6, Col. 6, lines 12-31).
Furthermore, in the combination of Briscoe as modified by Delente, the receptacle and the closure are capable of being positioned closer to the outwardly-oriented surface than the sweat collecting surface.
With respect to claim 4, Briscoe in view of Delente teaches the system of claim 1. Briscoe in view of Delente further teaches the receptacle is removably joined to the sweat collector tubing and further shows the receptacle is removably joined to the main body of the device via the sweat collector tubing (i.e., when the sweat collector tubing of Briscoe is inserted into the cap of Delente, the receptacle is removably joined to the sweat collector tubing and thus is also removably joined to the main body of the device as the sweat collector tubing is attached to the main body of the device) (see Briscoe, par 0044, fig. 10).
With respect to claim 6, Briscoe in view of Delente teaches the system of claim 1. Briscoe does not teach that the sweat collection system comprises additional receptacles for sequentially connecting to the free end of the sweat collector tubing by joining the receptacles to the closure.
Delente teaches an embodiment of the collection apparatus is part of a diagnostic kit 60, that contains a plurality of collection apparatuses for taking a plurality of fluid samples either at different times or under different conditions for subsequent analysis (see Delente, Col. 8, lines 29-46, fig. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Briscoe such that it comprises additional receptacles for sequentially connecting the free end of the member that enables fluid communication to the receptacle by joining the receptacles to the closure because using additional receptacles allows for large-batch sampling of sweat from an individual (see Delente, Col. 8, lines 29-46, fig. 10).
Moreover, even though Briscoe as modified by Delente discloses additional receptacles for sequentially connecting to the free end of the sweat collector tubing by joining the receptacles to the closure, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the system of Briscoe such that it comprises additional receptacles for sequentially connecting to the free end of the sweat collector tubing by joining the receptacles to the closure because that would merely be a matter of duplication of parts. According to MPEP section 2144.04 VI. B. Duplication of Parts, the court has held that a mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
With respect to claim 7, Briscoe teaches a method for time series collection of sweat from a person's skin for testing, said method comprising:
step a) attaching a sweat collection device over an area of the person's skin (Briscoe, see par 0026), wherein said sweat collection device comprises: a main body having two surfaces comprising a sweat-collecting surface 15 (Briscoe, see fig. 3) and an opposing outwardly-oriented surface (Briscoe, see fig. 1), wherein said sweat-collecting surface has a concave configuration 13 which defines a rim 14 lying wholly within a common plane (Briscoe, see fig. 3, par 0027), wherein said main body has an axial bore 18 extending between the sweat-collecting surface and the outwardly-oriented surface (Briscoe, see fig. 3);
a length of sweat collector tubing 17 having one end joined to said main body at said axial bore (Briscoe, see fig. 3, par 0028) and a free end extending outwardly from the outwardly-oriented surface of said main body (Briscoe, see par 0008 & 0042);
and step c) collecting sweat from the person's skin using said sweat collection device wherein sweat travels into said sweat collector tubing and then into said receptacle (Briscoe, see par 0044, wherein the sweat is collected into the sweat collector tubing and transferred into a sealable container, i.e., a receptacle).
Furthermore, Briscoe teaches a sealable container that is used for transferring collected sweat from the sweat collector tubing to a testing site or sweat testing apparatus (see Briscoe, fig. 10, par 0044). When the collected sweat is being deposited into the sealable container, the tubing is unwound and inserted into a closure of the sealable container (i.e., into a closure of a receptacle) (see Briscoe, par 0044, fig. 10). The sealable container has a closed end for containing the collected sweat and an open that permits the sweat collector tubing to enter the sealable container for depositing the collected sweat (see Briscoe, fig. 10). The sealable container can be configured to be positioned such that the free end of the sweat collector tubing is directed into an open end of the sealable container and such that the sealable container is positioned closer to the outwardly-oriented surface of the main body than to the sweat-collecting surface of the main body, since the tubing is flexible and can therefore permit the receptacle to be placed on top of the outwardly-oriented surface of the main body (see Briscoe, fig. 10, par 0044). Moreover, one of ordinary skill would readily realize the receptacle is positioned closer to the outwardly-oriented surface than the sweat collecting surface of the main body because the sweat collecting surface interfaces with the skin of a user during sweat collection (see Briscoe, fig. 1, par 0030).
Briscoe fails to teach details of the sealable container, such as the sealable container comprising a closure, wherein the closure has a hole therethrough, and wherein the hole is sized to fit at least partially around the sweat collector tubing adjacent the free end of the sweat collector tubing.
Delente teaches an apparatus and method for collecting fluid (i.e., breath) samples comprising a container 1, cap 25, and closure 26, wherein the cap 25 and closure 26 respectively comprise holes 28, 39, 30 and holes 26a, 26b that permit the insertion of a sampling device (i.e., a tube or needle) through the cap 25 without having to remove the cap 25 after it has been secured in place on the container (see Delente, figs. 5 & 6, Col. 6, lines 12-31). During operation of the fluid collecting apparatus, the cap 25 is twisted loosely onto the container to open holes 28, 29, 30 such that they align with holes 26a, 26b of the closure, and fluid is input into the container through one of the holes in the cap and respective hole in the closure via a fluid delivery means 27 (i.e., via a tubing) (see Delente, figs. 5 & 6, Col. 6, lines 32-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Briscoe such that it comprises a closure for a receptacle, wherein the closure has a hole therethrough, and wherein the hole is sized to fit at least partially around the sweat collector tubing adjacent the free end of the sweat collector tubing, because that would enable the sealable container of the device of Briscoe to collect sweat samples without having to remove the cap of the container, thereby enabling samples to be collected more quickly since the cap doesn’t have to be reopened/reclosed each time a fluid sample is deposited into the container (see Delente, figs. 5 & 6, Col. 6, lines 12-31).
With respect to claim 9, Briscoe in view of Delente teaches the method of Claim 7. Briscoe in view of Delente further teaches the receptacle is removably joined to the sweat collector tubing and further shows the receptacle is removably joined to the main body of the device via the sweat collector tubing (i.e., when the sweat collector tubing of Briscoe is inserted into the cap of Delente, the receptacle is removably joined to the sweat collector tubing and thus is also removably joined to the main body of the device as the sweat collector tubing is attached to the main body of the device) (see Briscoe, par 0044, fig. 10).
With respect to claim 10, Briscoe in view of Delente teaches the method of claim 7. Briscoe does not teach that the receptacle is a first receptacle, wherein the method further comprises providing additional receptacles for sequentially connecting to the closure, wherein each additional receptacles has a closed end and an open end, and joining the open end of an additional receptacle to said closure.
Delente teaches an embodiment of the collection apparatus is part of a diagnostic kit 60, that contains a plurality of collection apparatuses for taking a plurality of fluid samples either at different times or under different conditions for subsequent analysis (see Delente, Col. 8, lines 29-46, fig. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Briscoe such that it comprises providing additional receptacles for sequentially connecting to the closure because using additional receptacles allows for large-batch sampling of sweat from an individual (see Delente, Col. 8, lines 29-46, fig. 10).
Moreover, even though Briscoe as modified by Delente discloses additional receptacles for sequentially connecting to the free end of the sweat collector tubing by joining the receptacles to the closure, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the system of Briscoe such that it comprises additional receptacles for sequentially connecting to closure because that would merely be a matter of duplication of parts. According to MPEP section 2144.04 VI. B. Duplication of Parts, the court has held that a mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
With respect to claims 12 & 14, Briscoe in view of Delente teaches the sweat collecting system of claim 1 and sweat collecting method of claim 7. Briscoe as modified by Delente further teaches the sweat collector tubing is joined to the closure at the hole in the closure (i.e., fluid is input into the container through one of the holes in the closure and cap via a fluid delivery means such as a tubing) (see Delente, figs. 5 & 6, Col. 6, lines 12-62).
With respect to claims 13 & 15, Briscoe in view of Delente teaches the method of Claim 12 and system of claim 14. Briscoe as modified by Delente fails to teach that the sweat collector tubing is joined to the closure at the hole in the closure by gluing, but does teach that glue can be used to affix an embodiment of the closure to the sample container (see Delente, figs. 2-4 & Col. 5, lines 31-52).
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to join the closure at the hole in the closure by gluing, since it is known in the art that glue can be used to join tubing to different devices (i.e., microfluidic devices, sample containers, etc.).
With respect to claims 16 & 17, Briscoe in view of Delente further teaches the closure is free from joinder to said main body and is displaced away from the outwardly-oriented surface of the main body (i.e., the closure is separate from the main body of the device and is capable of being placed away from the outwardly oriented surface of the main body) (see Delente, figs. 5 & 6, Col. 6, lines 12-62).
With respect to claims 18 & 19, Briscoe in view of Delente further teaches the closure is configured/operates to close the open end of the receptacle after sweat is collected in the receptacle (i.e., the cap closes the container after the sample has been received within the sampling container) (see Delente, figs. 5 & 6, Col. 6, lines 12-62).
Claim(s) 2-3, 8 & 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Briscoe in view of Delente as applied to claim 1 above, and further in view of US Patent Application Publication 20100268106 --as previously cited--, hereinafter referenced as "Johnson".
With respect to claim 2, Briscoe in view of Delente fails to teach the receptacle is a microfuge tube.
Johnson teaches a breath condensate sampler and detector that uses microfuge tubes to collect fluids that pass through the sampler/detector so as to permit later analysis of the fluids using sample analysis techniques (see Johnson, par 0020).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Briscoe in view of Delente such that it comprises a receptacle that is a microfuge tube because that would permit later analysis of the collected sweat since it is known in the art that samples can be collected in microfuge tubes for later analysis (i.e., storing the sample prior to analysis or for centrifuging a sample after collection) (see Johnson, par 0020).
With respect to claim 3, Briscoe in view of Delente and in further view of Johnson teaches the sweat collection system of claim 2. Briscoe as modified by Delente and Johnson further teaches the closure is a cap for a microfuge tube (i.e., it is known in the art that microfuge tubes have caps that close to store samples for later analysis) (see Johnson, par 0020).
With respect to claim 8, Briscoe in view of Delente teaches the method of claim 7. Briscoe in view of Delente fails to teach the receptacle is a microfuge tube.
Johnson teaches a breath condensate sampler and detector that uses microfuge tubes to collect fluids that pass through the sampler/detector so as to permit later analysis of the fluids using sample analysis techniques (see Johnson, par 0020).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Briscoe in view of Delente such that it comprises a receptacle that is a microfuge tube because that would permit later analysis of the collected sweat since it is known in the art that samples can be collected in microfuge tubes for later analysis (i.e., for storing the sample prior to analysis or for centrifuging a sample after collection) (see Johnson, par 0020).
With respect to claim 11, Briscoe in view of Delente teaches the method of claim 10. Briscoe as modified by Delente fails to teach that the sweat collection method of claim 10 comprises additional receptacles that are microfuge tubes which have lids joined to them.
As previously stated, Delente teaches an apparatus and method for collecting fluid (i.e., breath) samples comprising a container 1, cap 25, and closure 26, wherein the cap 25 and closure 26 respectively comprise holes 28, 39, 30 and holes 26a, 26b that permit the insertion of a sampling device (i.e., a tube or needle) through the cap 25 without having to remove the cap 25 after it has been secured in place on the container (see Delente, figs. 5 & 6, Col. 6, lines 12-31). During operation of the fluid collecting apparatus, the cap 25 is twisted loosely onto the container to open holes 28, 29, 30 that align with holes 26a, 26b of the closure, and fluid is input into the container through one of the holes in the cap and respective hole in the closure via a fluid delivery means 27 (i.e., via a tubing) (see Delente, figs. 5 & 6, Col. 6, lines 32-62). Therefore, the cap could be twisted such that container is removed and a new container is added.
Furthermore, Delente teaches an embodiment of the collection apparatus is part of a diagnostic kit 60, that contains a plurality of collection apparatuses for taking a plurality of fluid samples either at different times or under different conditions for subsequent analysis (see Delente, Col. 8, lines 29-46, fig. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Briscoe such that it comprises providing additional receptacles for sequentially connecting to the closure because using additional receptacles allows for large-batch sampling of sweat from an individual (see Delente, Col. 8, lines 29-46, fig. 10).
Moreover, even though Briscoe as modified by Delente discloses additional receptacles for sequentially connecting to the free end of the sweat collector tubing by joining the receptacles to the closure, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the system of Briscoe such that it comprises additional receptacles for sequentially connecting to closure because that would merely be a matter of duplication of parts. According to MPEP section 2144.04 VI. B. Duplication of Parts, the court has held that a mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Briscoe in view of Delente fails to teach the receptacle is a microfuge tube.
Johnson teaches a breath condensate sampler and detector that uses microfuge tubes to collect fluids that pass through the sampler/detector so as to permit later analysis of the fluids using sample analysis techniques (see Johnson, par 0020).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Briscoe in view of Delente such that it comprises a receptacle that is a microfuge tube because that would permit later analysis of the collected sweat since it is known in the art that samples can be collected in microfuge tubes for later analysis (i.e., for storing the sample prior to analysis or for centrifuging a sample after collection) (see Johnson, par 0020).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Briscoe in view of Delente as applied to claim 4 above, and further in view of US Patent 7,255,251 --as previously cited--, hereinafter referenced as "Smith".
With respect to claim 5, Briscoe in view of Delente teaches the sweat collection system of claim 4. Briscoe as modified by Delente fails to teach that the system further comprises a holder joined to the outwardly-oriented surface of the main body of the sweat collecting device, wherein the holder has a sleeve with an opening for receiving the receptacle, and the receptacle is removably joined to the main body of the sweat collecting device when it is inserted into the holder.
Smith teaches a holding appliance for facilitating a blood drawing process that comprises a holder 14 on a wristband 12 (see Smith, figs. 1 & 2, Col. 2, lines 4-17). The holder 14 is affixed to an outer surface of the wristband 12 so as to permit the successive insertion of multiple sampling tubes (see Smith, figs. 1 & 2, Col. 3, lines 1-10, Col. 3, lines 54-67 – Col. 4, lines 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Briscoe as modified by Delente such that the system further comprises a holder joined to the outwardly-oriented surface of the main body of the sweat collecting device, wherein the holder has a sleeve with an opening for receiving the receptacle, and the receptacle is removably joined to the main body of the sweat collecting device when it is inserted into the holder, because that would enable the successive insertion of multiple sampling tubes into the holder for collecting additional samples (see Smith, figs. 1 & 2, Col. 3, lines 1-10, Col. 3, lines 54-67 – Col. 4, lines 1-3).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791