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 .
This Office action is responsive to an amendment filed August 15, 2023. Claims 132-157 are pending. Claims 1-131 have been canceled. New claims 132-157 have been added.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 15, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 133-139, 141-142, 145, 149 & 157 is/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.
In regards to claim 133, the limitations “wherein each portion of the internally collapsed lumen of the tube-shaped body expands at different regions of the gastrointestinal tract” render the claim indefinite; for example, it is unclear whether or not the claim requires the step of expanding each portion of the internally collapsed lumen of the tube-shaped body at different regions of the gastrointestinal tract. For examination purposes, the limitations have been construed as mere device characteristics rather than an active method step.
In regards to claim 134, the limitations “wherein each segment of the tube-shaped body expands by unwinding” render the claim indefinite; for example, it is unclear whether the claim requires an active step of expanding each segment of the tube-shaped body by unwinding. For examination purposes, the limitations have been construed as mere device characteristics rather than an active method step.
In regards to claim 135, the limitations “wherein said tube-shaped body comprises a degradable material that degrades to enable the expansion of each portion of the internally collapsed lumen of the tube-shaped body at the different regions of the gastrointestinal tract” render the claim indefinite; for example, it is unclear whether the method requires an active step of degrading the degradable material and enabling the expansion of each portion of the internally collapsed lumen of the tube-shaped body at the different regions of the gastrointestinal tract. For examination purposes, the limitations have been construed as mere device characteristics rather than an active method step.
In regards to claim 136, the limitations “wherein each portion of the internally collapsed lumen of the tube-shaped body expands at different time points” render the claim indefinite; for example, it unclear whether the method claim requires the active step of expanding each portion of the internally collapsed lumen of the tube-shaped body at different time points. For examination purposes, the limitations have been construed as mere device characteristics rather than an active method step.
In regards to claim 137, the limitations “wherein the portions of the internally collapsed lumen of the tube-shaped body expand at the different time points by unwinding each segment of the tube-shaped body at the different time points” render the claim indefinite; for example, it is unclear whether the method claim requires the active step of expanding the portions of the internally collapsed lumen of the tube-shaped body at the different time points by unwinding each segment of the tube-shaped body at the different time points. For examination purposes, the limitations have been construed as mere device characteristics rather than an active method step.
In regards to claim 138, the limitations “wherein the tube-shaped body comprises a degradable material that degrades at the different time points to enable the expansion of the portions of the internally collapsed lumen of the tube-shaped body at the different time points” render the claim indefinite; for example, it unclear whether or not the method claim requires the step of degrading the degradable material at the different time points and enabling the expansion of the portions of the internally collapsed lumen of the tube-shaped body at the different time points.” For examination purposes, the limitations have been construed as a mere characteristic or property of the degradable material rather than an active method step.
In regards to claim 142, the limitations “wherein each of the discrete gastrointestinal samples is driven into the lumen by a pressure differential caused by radial expansion of the internally collapsed lumen” render the claim indefinite; for example, it is unclear whether the method claim requires the active step of driving each of the discrete gastrointestinal samples into the lumen by a pressure differential caused by radial expansion of the internally collapsed lumen or a step of radially expanding the internally collapsed lumen to drive each of the discrete gastrointestinal samples into the lumen by a pressure differential. For examination purposes, the limitations have been construed as a mere characteristic or property of the degradable material rather than an active method step.
In regards to claim 145, the limitations “wherein a rate of collecting of the series of discrete gastrointestinal samples is based on a rate of degradation of the degradable material” render the claim indefinite; for example, it is unclear whether the method claim requires a step of collecting the series of discrete gastrointestinal samples at a rate that is based on the degradation of the degradable material. For examination purposes, the limitations have been construed to mean mere device characteristic where the rate of collecting the series of gastrointestinal samples is connected to how well or how quickly the degradable material degrades and allows the tube-shaped body to expand at each time point rather than an active method step.
In regards to claim 149, the limitations “wherein collecting the series of discrete gastrointestinal sample occurs over 1 hour to 8 hours” render the claim indefinite; for example, it is unclear whether the method requires collecting the series of discrete gastrointestinal sample for a duration longer than 8 hours or merely between 1 hour and 8 hours.
In regards to claim 157, the limitations “further comprising removing the first sample from the tube-shaped body before removing the second sample from the tube-shaped body for further analysis” render the claim indefinite; for example, since claim 132, from which the claim depends, requires a tubular-shaped body comprising an open end and a closed end, it is unclear how the first sample can be removed from the tube-shaped body before the second sample since the first sample would presumably be closest to the closed end of the tubular-shaped tube and therefore cannot be removed through the open-end before the second sample.
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.
Claim(s) 132-133, 135, 138-140 & 143-157 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wrigglesworth et al. (US 2016/0038086) (“Wrigglesworth” hereinafter) in view of Bell (US 2006/0024201).
In regards to claim 132, Wrigglesworth discloses a method of collecting gastrointestinal samples from a subject, the method comprising:
delivering a tube-shaped body (i.e., expandable wall) to a gastrointestinal tract, the tube-shaped body (i.e., expandable wall) comprising an open end, a closed end, and a lumen extending from the open end to the closed end, the lumen internally collapsed (i.e., closed compressed state, see par 0020-0021) during delivery (see at least figs. 1A, 2A-B & 4 and par 0020-0021, 0025 & 0027-0028);
collecting a series of discrete gastrointestinal samples (see at least par 0079);
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storing each of the series of discrete gastrointestinal samples in a corresponding portion of the lumen within a segment of the tube-shaped body (i.e., expandable wall) (see at least par 0079).
Wrigglesworth discloses a method, as described above, that fails to explicitly teach a method comprising collecting a series of discrete gastrointestinal samples through the open end.
However, Bell teaches that it is known to provide a method comprising collecting a series of discrete samples (i.e., in expandable sections 18, 19) through the open end of a tube-shaped body 12 (see at least abstract, figs. 1A & 3 and par 0025, 0027-0028, 0031-0032, 0036, 0039, 0042 & 0046).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth comprising collecting a series of discrete gastrointestinal samples through the open end as taught by Bell since such a modification would amount to applying a known technique (i.e., as taught by Bell) to a known device (i.e., as taught by Wrigglesworth) ready for improvement to achieve a predictable result such as an analytical system that can be simply and efficiently operated, with high sample throughput. Such a combined system would decrease operating expenditures such as labor costs, and the cost of training employees to operate complex analyzer systems, and would less likely to be subject to clinical errors and will result in higher accuracy of test results, thereby improving the quality of patient care (see at least par 0003 of Bell)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 133, Wrigglesworth discloses the method of claim 132, wherein each portion of the internally collapsed lumen of the tube-shaped body (i.e., expandable wall) expands at different regions of the gastrointestinal tract (see at least par 0079).
In regards to claim 135, Wrigglesworth discloses the method of claim 133, wherein said tube-shaped body (i.e., expandable wall) comprises a degradable material (i.e., coating) that degrades to enable the expansion of each portion of the internally collapsed lumen of the tube-shaped body (i.e., expandable wall) at the different regions of the gastrointestinal tract (see at least par 0017 & 0050-0056).
In regards to claim 138, Wrigglesworth discloses the method of claim 136, wherein the tube-shaped body comprises a degradable material that degrades at the different time points to enable the expansion of the portions of the internally collapsed lumen of the tube-shaped body at the different time points (see at least par 0079).
In regards to claim 139, Wrigglesworth discloses the method of claim 138, wherein the degradable material is a coating (see at least par 0017 & 0050-0056).
In regards to claim 140, Wrigglesworth discloses the method of claim 132, wherein delivering the tube-shaped body (i.e., expandable wall) to the gastrointestinal tract comprises delivering the tube-shaped body (i.e., expandable wall) in a capsule-shaped form (see at least fig. 1A and par 0033-0034).
In regards to claim 143, Wrigglesworth discloses the method of claim 132, wherein the tube-shaped body (i.e., expandable wall) comprises a degradable material (i.e., coating) restraining the tube-shaped body (i.e., expandable wall) during delivery (see at least par 0017 & 0050-0056).
In regards to claim 144, Wrigglesworth discloses the method of claim 143, further comprising gradually degrading the degradable material (i.e., coating) in the gastrointestinal tract over time to prevent the tube-shaped body (i.e., expandable wall) from expanding all at once (see at least par 0017 & 0050-0056).
In regards to claim 145, Wrigglesworth discloses the method of claim 143, wherein a rate of collecting of the series of discrete gastrointestinal samples is based on a rate of degradation of the degradable material (see at least par 0017, 0038 & 0052-0055, 0058 & 0079).
In regards to claim 146, Wrigglesworth discloses the method of claim 143, wherein degradation of the degradable material (i.e., coating) is time dependent (see at least par 0017 & 0050-0056).
In regards to claim 147, Wrigglesworth discloses the method of claim 143, wherein the degradable material (i.e., coating) is moisture sensitive (see at least par 0082-0083).
In regards to claim 148, Wrigglesworth discloses the method of claim 143, wherein the degradable material (i.e., coating) is pH sensitive (see at least par 0017, 0038 & 0052-0055 & 0058).
In regards to claim 149, Wrigglesworth discloses the method of claim 132, wherein collecting the series of discrete gastrointestinal sample occurs over 1 hour to 8 hours (i.e., due to capsule being recovered in the stool) (see at least abstract & 0079).
In regards to claim 150, while Wrigglesworth discloses the method of claim 132, wherein collecting the series of discrete gastrointestinal samples comprises:
collecting a first sample through the open end from a first region of the gastrointestinal tract; and collecting a second sample through the open end from a second region of the gastrointestinal tract different from the first region (see at least par 0079), Wrigglesworth as modified by Bell discloses a method that fails to explicitly teach a method wherein the first region and the second region of the gastrointestinal tract are selected from a stomach, a duodenum, a jejunum, an ileum, an ascending colon, a transverse colon, and a descending colon. However, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth as modified by Bell wherein the first region and the second region of the gastrointestinal tract are selected from a stomach, a duodenum, a jejunum, an ileum, an ascending colon, a transverse colon, and a descending colon as claimed in order to collect samples from different portions of the gastrointestinal tract.
In regards to claim 151, Wrigglesworth discloses the method of claim 132, wherein collecting the series of discrete gastrointestinal samples occurs as peristalsis moves the tube-shaped body (i.e., expandable wall) through the gastrointestinal tract (see at least par 0030).
In regards to claim 152, Wrigglesworth discloses the method of claim 132, further comprising recovering the tube-shaped body (i.e., expandable wall) with the series of discrete gastrointestinal samples from stool (see at least abstract and par 0019 & 0085).
In regards to claim 153, Wrigglesworth discloses the method of claim 132, that fails to explicitly teach a method wherein storing each of the discrete gastrointestinal samples comprises storing the series of gastrointestinal samples as a linear array in an order in which they were collected. However, Bell teaches that it is known to provide a method wherein storing each of the discrete samples comprises storing the series of gastrointestinal samples as a linear array in an order in which they were collected (see at least abstract, figs. 1A & 3 and par 0025, 0027-0028, 0031-0032, 0036, 0039, 0042 & 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth wherein storing each of the discrete gastrointestinal samples comprises storing the series of gastrointestinal samples as a linear array in an order in which they were collected as taught by Bell since such a modification would amount to applying a known technique (i.e., as taught by Bell) to a known device (i.e., as taught by Wrigglesworth) ready for improvement to achieve a predictable result such as an analytical system that can be simply and efficiently operated, with high sample throughput. Such a combined system would decrease operating expenditures such as labor costs, and the cost of training employees to operate complex analyzer systems, and would less likely to be subject to clinical errors and will result in higher accuracy of test results, thereby improving the quality of patient care (see at least par 0003 of Bell)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 154, Wrigglesworth as modified by Bell discloses the method of claim 152, that fails to explicitly teach a method wherein after recovering the tube-shaped body, a spatial resolution of the series of discrete gastrointestinal samples in the tube-shaped body is within 2 centimeters along the length of the tube-shaped body. However, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth as modified by Bell wherein after recovering the tube-shaped body, a spatial resolution of the series of discrete gastrointestinal samples in the tube-shaped body is within 2 centimeters along the length of the tube-shaped body as claimed since such a modification would amount to a mere optimization of the device of Bell to achieve the same goal of an analytical system that can be simply and efficiently operated, with high sample throughput. Such a combined system would decrease operating expenditures such as labor costs, and the cost of training employees to operate complex analyzer systems, and would less likely to be subject to clinical errors and will result in higher accuracy of test results, thereby improving the quality of patient care (see at least par 0003 of Bell). Moreover, it has previously been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art--See In re Aller, 105 USPQ 233.
In regards to claim 155, Wrigglesworth as modified by Bell discloses the method of claim 154, that fails to explicitly teach a method wherein the discrete gastrointestinal samples in the tube-shaped body have distinct biomolecular composition at a spatial resolution within 2 centimeters along the length of the tube-shaped body. However, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth as modified by Bell wherein the discrete gastrointestinal samples in the tube-shaped body have distinct biomolecular composition at a spatial resolution within 2 centimeters along the length of the tube-shaped body as claimed since such a modification would amount to a mere optimization of the device of Bell to achieve the same goal of an analytical system that can be simply and efficiently operated, with high sample throughput. Such a combined system would decrease operating expenditures such as labor costs, and the cost of training employees to operate complex analyzer systems, and would less likely to be subject to clinical errors and will result in higher accuracy of test results, thereby improving the quality of patient care (see at least par 0003 of Bell). Moreover, it has previously been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art--See In re Aller, 105 USPQ 233.
In regards to claim 156, while Wrigglesworth discloses the method of claim 132, wherein collecting the series of discrete gastrointestinal samples comprises:
collecting a first sample through the open end; and collecting a second sample through the open end (see at least par 0079), Wrigglesworth discloses a method that fails to explicitly teach a method wherein the second sample flows through the segment of tube-shaped body previously occupied by the first sample from an open end. However, Bell teaches that it is known to provide a method wherein the second sample flows through the segment of tube-shaped body 12 previously occupied by the first sample from an open end (see at least abstract, figs. 1A & 3 and par 0025, 0027-0028, 0031-0032, 0036, 0039, 0042 & 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth method wherein the second sample flows through the segment of tube-shaped body previously occupied by the first sample from an open end as taught by Bell since such a modification would amount to applying a known technique (i.e., as taught by Bell) to a known device (i.e., as taught by Wrigglesworth) ready for improvement to achieve a predictable result such as an analytical system that can be simply and efficiently operated, with high sample throughput. Such a combined system would decrease operating expenditures such as labor costs, and the cost of training employees to operate complex analyzer systems, and would less likely to be subject to clinical errors and will result in higher accuracy of test results, thereby improving the quality of patient care (see at least par 0003 of Bell)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 157, Wrigglesworth discloses the method of claim 156, that fails to explicitly teach a method further comprising removing the first sample from the tube-shaped body before removing the second sample from the tube-shaped body for further analysis. However, Bell teaches that it is known to provide a method (see at least abstract, figs. 1A & 3 and par 0025, 0027-0028, 0031-0032, 0036, 0039, 0042 & 0046). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth further comprising removing the first sample from the tube-shaped body before removing the second sample from the tube-shaped body for further analysis as taught by Bell since such a modification would amount to applying a known technique (i.e., as taught by Bell) to a known device (i.e., as taught by Wrigglesworth) ready for improvement to achieve a predictable result such as an analytical system that can be simply and efficiently operated, with high sample throughput. Such a combined system would decrease operating expenditures such as labor costs, and the cost of training employees to operate complex analyzer systems, and would less likely to be subject to clinical errors and will result in higher accuracy of test results, thereby improving the quality of patient care (see at least par 0003 of Bell)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 134, 136-137 & 141-142 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wrigglesworth et al. (US 2016/0038086) (“Wrigglesworth” hereinafter) in view Bell (US 2006/0024201) further in view of Villari (US 4,187,860).
In regards to claim 134, Wrigglesworth as modified by Bell discloses the method of claim 133, that fails to explicitly teach a method wherein each segment of the tube-shaped body expands by unwinding. However, Villari teaches that it is known to provide a method wherein each segment of the tube-shaped body 16 expands by unwinding (see at least abstract and figs. 1 & 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth as modified by Bell wherein each segment of the tube-shaped body expands by unwinding as taught by Villari since such a modification would amount to a simple substitution of one known element (i.e. Wrigglesworth) for another (i.e., as taught by Villari) to obtain predictable results such as providing an expansible collection bag defining a collection chamber movable between a first configuration of reduced dimensions with air substantially removed from the chamber, and a second configuration of extended dimensions with the chamber enlarged to receive a sample (see at least abstract of Villari)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 136, Wrigglesworth as modified by Bell discloses the method of claim 132, that fails to explicitly teach a method wherein each portion of the internally collapsed lumen of the tube-shaped body expands at different time points. However, Villari teaches that it is known to provide a method wherein each portion of the internally collapsed lumen of the tube-shaped body 16 expands at different time points (see at least abstract and figs. 1 & 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth as modified by Bell wherein each portion of the internally collapsed lumen of the tube-shaped body expands at different time points as taught by Villari since such a modification would amount to a simple substitution of one known element (i.e. Wrigglesworth) for another (i.e., as taught by Villari) to obtain predictable results such as providing an expansible collection bag defining a collection chamber movable between a first configuration of reduced dimensions with air substantially removed from the chamber, and a second configuration of extended dimensions with the chamber enlarged to receive a sample (see at least abstract of Villari)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 137, Wrigglesworth as modified by Bell discloses the method of claim 136, that fails to explicitly teach a method wherein the portions of the internally collapsed lumen of the tube-shaped body expand at the different time points by unwinding each segment of the tube-shaped body at the different time points. However, Villari teaches that it is known to provide a method wherein the portions of the internally collapsed lumen of the tube-shaped body 16 expand at the different time points by unwinding each segment of the tube-shaped body at the different time points (see at least abstract and figs. 1 & 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth as modified by Bell wherein the portions of the internally collapsed lumen of the tube-shaped body expand at the different time points by unwinding each segment of the tube-shaped body at the different time points as taught by Villari since such a modification would amount to a simple substitution of one known element (i.e. Wrigglesworth) for another (i.e., as taught by Villari) to obtain predictable results such as providing an expansible collection bag defining a collection chamber movable between a first configuration of reduced dimensions with air substantially removed from the chamber, and a second configuration of extended dimensions with the chamber enlarged to receive a sample (see at least abstract of Villari)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 141, Wrigglesworth as modified by Bell discloses the method of claim 134, that fails to explicitly teach a method wherein the unwinding of the tube-shaped body in the gastrointestinal tract occurs gradually to prevent the tube-shaped body from unwinding all at once. However, Villari teaches that it is known to provide a method wherein the unwinding of the tube-shaped body 16 occurs gradually to prevent the tube-shaped body from unwinding all at once (see at least abstract and figs. 1 & 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth as modified by Bell wherein the unwinding of the tube-shaped body occurs gradually to prevent the tube-shaped body from unwinding all at once as taught by Villari since such a modification would amount to a simple substitution of one known element (i.e. Wrigglesworth) for another (i.e., as taught by Villari) to obtain predictable results such as providing an expansible collection bag defining a collection chamber movable between a first configuration of reduced dimensions with air substantially removed from the chamber, and a second configuration of extended dimensions with the chamber enlarged to receive a sample (see at least abstract of Villari)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 142, Wrigglesworth as modified by Bell discloses the method of claim 132, that fails to explicitly teach a method wherein each of the discrete gastrointestinal samples is driven into the lumen by a pressure differential caused by radial expansion of the internally collapsed lumen. However, Villari teaches that it is known to provide a method wherein each of the discrete samples is driven into the lumen by a pressure differential caused by radial expansion of the internally collapsed lumen (see at least abstract and figs. 1 & 3). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Wrigglesworth as modified by Bell wherein each of the discrete samples is driven into the lumen by a pressure differential caused by radial expansion of the internally collapsed lumen as taught by Villari since such a modification would amount to a simple substitution of one known element (i.e. Wrigglesworth) for another (i.e., as taught by Villari) to obtain predictable results such as providing an expansible collection bag defining a collection chamber movable between a first configuration of reduced dimensions with air substantially removed from the chamber, and a second configuration of extended dimensions with the chamber enlarged to receive a sample (see at least abstract of Villari)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Conclusion
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/RENE T TOWA/Primary Examiner, Art Unit 3791