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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5, 17 - 19, 26, 30, & 34 are rejected under 35 U.S.C. 103 as being unpatentable over Heseltine (WO 2021219891 A1 - cited by applicant as Enteromics LTD.)
In regard to claims 1 & 26, Heseltine discloses a device and method of manufacturing a device for passive sampling of a gastrointestinal (GI) tract, where the device comprises a capsule (FIG. 2, component 100) with a housing (FIG. 2, component 106) that bounds a cavity (FIG. 2, component 108) with a sampling aperture (FIG. 5B, component 156; FIG. 5B shows fluid, component “F” entering sampling aperture; paragraph [0080])) formed in the capsule housing (FIG. 2, component 106) and a sampling hydrogel (paragraph [0058]; FIG. 2, component 112) configured to absorb sample fluid, expand within the cavity, and store the fluid for analysis (paragraphs [0059] - [0060]). Heseltine further discloses a sealing member (paragraph [0049]; FIG. 2, component 120) such as a plunger or sealing assembly where the plunger assembly is activated by the sampling hydrogel that expands in response to exposure to liquids such that a sample can be collected and the capsule then sealed (paragraph [0058]). Heseltine additionally discloses that the device includes a biodegradable coating (FIG. 2, component 104) fully enclosing the sample collection vessel (FIG. 2, component 102; paragraph [0056]) including the sample aperture (FIG. 2, component 110) where the coating works as a cover to prevent the collection vessel from capturing samples until a determined location (paragraph [0056]). Heseltine discloses a secondary embodiment where the biodegradable coating comprises a plurality of biodegradable layers (FIG 17H, component 502 & 504) where the layers are an enteric coating that selectively dissolves based on time, location, pH, or other characteristics and the coatings are applied as a single layer over the entire capsule (paragraph [0124]). It would have been obvious to one of ordinary skill in the art to have modified the first embodiment of Heseltine with the teaching of the additional embodiment of Heseltine that includes the use of multiple coating layers because Heseltine indicates that the capsule (FIGs. 15 - 17, component 500) is substantially similar to the other embodiments described in the disclosure (paragraph [0124]) such as the capsule (FIG. 1, component 100) discussed above. Heseltine additionally discloses that different attributes of the coating can be used to control the time and/or location where the coating is fully dissolved (paragraph [0057]) such that incorporating multiple coatings would allow for more control over the location that samples are collected.
In regard to claims 17 - 19, Heseltine discloses that the capsule housing (FIG. 16, component 500) includes a top portion (FIG. 16, component 506) and a bottom (FIG. 16, component 508) that are removably attachable to one another via a screw interface (paragraph [0124], see “threading”). The top portion (FIG. 16, component 506) defines an inlet (FIG. 16, component 550) that acts as a sampling aperture.
In regard to claim 30, Heseltine discloses the invention of claim 26 and additionally discloses that the biodegradable coating is disposed over only a portion of the capsule housing (paragraph [0003]).
In regard to claim 34, Heseltine discloses the invention of claim 26 and further discloses providing a sampling hydrogel (FIG. 1, component 112) configured to absorb a sample fluid, expand within the cavity, and store the sample fluid for subsequent analysis upon exposure to a sample fluid (paragraphs [0061] - [0063]).
Claims 5 - 9 are rejected under 35 U.S.C. 103 as being unpatentable over Heseltine (WO 2021219891 A1 - cited by applicant as Enteromics LTD.) as applied to claim 1 above, and further in view of Shalon (US 20200138416 A1 - Cited by Applicant)
In regard to claims 5 - 9, Heseltine discloses the invention of claim 1 above. While Heseltine discloses that the capsule includes a plurality of coating layer that can be selectively dissolved based on a pH level (paragraph [0124]; FIG 17H, component 502 & 504) in order to dissolve when exposed to particular locations in the body (paragraph [0057]), they do not specify that the plurality of coating layers comprise first biodegradable coating layer and second biodegradable coating layer where the first and second biodegradable coating layers are configured to degrade at a first and second predetermined location in the gastrointestinal tract, where the first and second predetermined locations are different from one another.
However, Shalon teaches a device for collecting GI samples, that includes a capsule with external and internal pH sensitive degradable covering elements (paragraph [0031]) such as enteric degradable coatings (paragraphs [0077] - [0080]) that comprise first and second biodegradable coating layers. Shalon further teaches that the first and second biodegradable coating layers are configured to degrade at different areas of the GI tract such that the external coating or first biodegradable coating layer degrades at a pH of about 6.4 or above such that the first biodegradable coating layer dissolves in the small intestines, and the internal coating or second biodegradable coating layer degrades at a pH of 6.4 or below such that the second biodegradable coating layer dissolves in the right colon of the large intestines (paragraph [0029]). Shalon additionally teaches that the internal coating or second biodegradable coating layer, can be configured to dissolve in a different location than the right colon such as the duodenum, where the pH is around 5 (paragraph [0304]) to target GI tract fluids in that specific region such that the biodegradable coating layer would degrade at a pH of 5.5 or below.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system disclosed by Heseltine, which includes a capsule for sampling liquid at a predictable location within the GI tract (paragraph [0048]) with multiple biodegradable coatings (FIG 17H, component 502 & 504; paragraph [0124]), with the teaching of Shalon that a capsule for sampling liquid can include first and second biodegradable coatings configured to degrade at different pH levels to target specific locations in the GI tract during liquid sampling, because Heseltine already discusses controlling a sampling location based on degradation of a coating at a specific pH (paragraph [0057]) such that modifying the system disclosed by Heseltine with the teaching of Shalon would be considered simple substitution of one known element, in this case the biodegradable coatings disclosed by Heseltine, for another, in this case the biodegradable coatings disclosed by Shalon, to obtain the predictable results of targeting a specific location in the GI tract for sample collection.
Claims 13 - 14 are rejected under 35 U.S.C. 103 as being unpatentable over Heseltine (WO 2021219891 A1 - cited by applicant as Enteromics LTD.) as applied to claim 1 above, and further in view of Kopecek (US 5415864 A)
In regard to claims 13 - 14, Heseltine discloses the invention of claim 1 above, including a sampling hydrogel (paragraph [0058]; FIG. 2, component 112) configured to absorb sample fluid, expand within the cavity, and store the fluid for analysis (paragraphs [0059] - [0060]) where the sampling hydrogel is composed of hydrophilic polymers or hydrogels such as acrylamide (paragraph [0058]). However, Heseltine does not specify that the sampling hydrogel is synthesized from acrylic acid and acrylamide monomers.
However, Kopecek teaches a hydrogel used in a colonic-targeted oral drug dosage form where the hydrogel exhibits pH-dependent swelling in the colon (Abstract; Column 3, lines 41 - 47). While Kopecek is directed towards drug release when the hydrogel swells, one of ordinary skill in the art would recognize that the ability of the hydrogel to retain liquid from a specific part of the colon during swelling would be relevant to the sampling hydrogel disclosed by Heseltine which also swells or expands to capture a sample (Heseltine, paragraph [0058]; FIG. 2, component 112). The hydrogel is composed of acrylic acid and acrylamide monomers (Column 8, lines 45 - 53) where the ratio of acrylic acid to acrylamide monomers are about 10% acrylic acid (Column 8, line 45 indicates a formulation with 10% acrylic acid) and about 90% acrylamide (Column 8, lines 41 - 47 indicate that a correspondingly greater amount of acrylamide makes up the hydrogel composition, which would equate to about 90% acrylamide when 10% acrylic acid is used as specified in the formulation of the hydrogel composition).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the system disclosed by Heseltine, which includes a sampling hydrogel disclosed by Heseltine which also swells or expands to capture a sample (Heseltine, paragraph [0058]; FIG. 2, component 112), with the teaching of Kopecek that a hydrogel capable of swelling during liquid absorption in the colon comprises acrylic acid and acrylamide monomers with a ratio of about 10% acrylic acid to about 90% acrylamide because both Heseltine and Kopecek disclose details of a hydrogel that captures a liquid sample in the GI tract such that modifying Heseltine with the teachings of Kopecek would be considered simple substitution of one known element for another, in this case the sampling hydrogel disclosed by Heseltine with the hydrogel taught by Kopecek, to yield the predictable result of absorbing or capturing a liquid sample from the GI tract using a hydrogel.
Claims 20 - 21 are rejected under 35 U.S.C. 103 as being unpatentable over Heseltine (WO 2021219891 A1 - cited by applicant as Enteromics LTD.) as applied to claim 1 above, and further in view of Huang (US 20180021452 A1).
In regard to claims 20 and 21, Heseltine discloses the invention of claim 1. While Heseltine discloses that the sampling hydrogel is used to collect bacteria which is captured within the hydrogel where the bacteria is captured and maintained within the hydrogel in the same condition and with the same characteristics as they existed when captured (paragraph [0079]), Heseltine does not specify that the hydrogel is constructed and arranged to maintain live bacteria for at least one hour or up to 24 hours after the cavity is sealed.
However, Huang teaches a hydrogel that is constructed and arranged to maintain live bacteria (FIG. 1B) where the live bacteria can be maintained for over 24 hours (paragraphs [0048] - [0049]).
It would have been obvious to one of ordinary skill prior to the effective filing date to have modified the system disclosed by Heseltine, which includes a sampling hydrogel for collecting bacteria, with the teaching of Huang that a hydrogel that is that is constructed and arranged to maintain live bacteria (FIG. 1B) for over 24 hours (paragraphs [0048] - [0049]) because it would be considered combining prior art elements according to known methods to yield the predictable result of maintain bacteria within a hydrogel.
Claims 27 - 28 are rejected under 35 U.S.C. 103 as being unpatentable over Heseltine (WO 2021219891 A1 - cited by applicant as Enteromics LTD.) as applied to claim 26 above, and further in view of Eisaman (US 20220119941 A1 - Cited by Applicant).
In regard to claim 27, Heseltine discloses the method of claim 26 and further discloses that the biodegradable coatings can comprise a variety of materials including polymer coatings such hypromellose (paragraph [0057]; FIG 17H, component 502 & 504). Heseltine does not specify that the coatings are deposited using a drop casting technique within the sampling aperture.
However, Eisaman teaches a method for coating a substrate with a polymer solution to form a coated substrate where the coating method is carried out using a drop casting technique (paragraph [0036]).
It would have been obvious to one of ordinary skill in the art to have modified the method disclosed by Heseltine, which includes the manufacturing of a capsule with a biodegradable coating that can comprise a variety of materials including polymer coatings, with the teaching of Eisaman that includes a method for coating a substrate with a polymer solution using a drop casting method because it would be considered combining prior art elements according to known methods to yield the predictable result of coating a substrate with a polymer coating.
In regard to claim 28, Heseltine as modified discloses the invention of claim 27. Heseltine further discloses that that method includes placing a first portion of the capsule housing (FIG. 4, component 134) on a sealing plate (paragraph [0070]; FIG. 4, component 114), the first portion of the capsule housing including the sampling aperture (FIG. 5, component 156), where the sealing plate is configured to provide a liquid-tight seal with the sampling aperture (paragraph [0072], plunger assembly moves sealing plate (FIG. 2, component 116) to prevent fluid or debris from entering into the cavity of the capsule). Eisaman teaches depositing coating layers using a drop casting technique and Heseltine further discloses that the coatings are layered over only the sampling aperture (FIG. 3B, component 110; paragraph [0003]). Heseltine additionally discloses that the first portion of the capsule housing (FIG. 3B, component 134) is coupled to the second portion of the capsule housing (FIG. 3B, component 136) using mating elements (paragraph [0069]) including press-fit connections, threading, and fasteners (paragraphs [0069] & [0125]) such that the first portion of the capsule housing can be removed from the sealing plate and other capsule elements (paragraph [0101]).
Claims 29 & 35 are rejected under 35 U.S.C. 103 as being unpatentable over Heseltine (WO 2021219891 A1 - cited by applicant as Enteromics LTD.) as applied to claim 26 above, and further in view of Prausnitz (US 20200238065 A1).
In regard to claim 29, Heseltine discloses the invention of claim 26. While Heseltine further discloses that the capsule includes biodegradable coatings that comprise a variety of materials including polymer coatings such hypromellose (paragraph [0057]; FIG 17H, component 502 & 504), Heseltine does not specify that the coatings are layers are dried using near infrared radiation.
However, Prausnitz teaches that polymer constructs can be dried using radiation such as NIR light (paragraph [0146]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method disclosed by Heseltine with the teaching of Prausnitz that polymer constructs can be dried using radiation such as NIR light because Heseltine already discloses coating a capsule in biodegradable coatings such that modifying the method disclosed by Heseltine with the teaching of Prausnitz would be considered combining prior art elements according to known methods to yield the predictable result of drying a polymeric layer.
In regard to claim 35, Heseltine discloses the invention of claim 26 and further discloses closing the sampling aperture with a plurality of biodegradable coatings (FIG 17H, component 502 & 504) where closing the first and second biodegradable coatings close the sample aperture.
While Heseltine further discloses that the capsule includes biodegradable coatings that comprise a variety of materials including polymer coatings such hypromellose (paragraph [0057]; FIG 17H, component 502 & 504), Heseltine does not specify that the coatings are layers are dried using near infrared radiation.
However, Prausnitz teaches that polymer constructs can be dried using radiation such as NIR light (paragraph [0146]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method disclosed by Heseltine with the teaching of Prausnitz that polymer constructs can be dried using radiation such as NIR light because Heseltine already discloses coating a capsule in biodegradable coatings such that modifying the method disclosed by Heseltine with the teaching of Prausnitz would be considered combining prior art elements according to known methods to yield the predictable result of drying a polymer layer.
Claims 31 - 33 are rejected under 35 U.S.C. 103 as being unpatentable over Heseltine (WO 2021219891 A1 - cited by applicant as Enteromics LTD.) as applied to claim 26 above, and further in view of Shalon ‘326 (WO 2020185326 A1 - Cited by Applicant).
In regard to claims 31 & 32, Heseltine discloses the invention of claim 26. While Heseltine additionally discloses that the biodegradable coating is disposed such that it covers one or more of the sampling apertures (FIG. 5, component 156; paragraph [0003]) in order to seal the sampling aperture (paragraph [0078]), they do not specify that the biodegradable coating is disposed within or constrained within the sampling aperture.
However, Shalon ‘326 teaches a method for manufacturing a device for collecting GI samples that includes a biodegradable coating (FIG. 5B, component 30) that is disposed within and constrained within a sampling aperture (FIG. 5B, component 42; paragraph [0117]).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the method disclosed by Heseltine with the teaching of Shalon ‘326 that a biodegradable coating can be disposed within a sampling aperture of a collection capsule because it would be considered a simple rearrangement of parts, in this case the biodegradable coating, to seal a sampling aperture.
In regard to claim 33, Heseltine discloses the invention of claim 26. While Heseltine additionally discloses that the biodegradable coating is disposed such that it covers one or more of the sampling apertures (FIG. 1, component 110; paragraph [0003]) in order to seal the sampling aperture (paragraph [0078]), they do not specify that the biodegradable coating is formed as plane.
However, Shalon ‘326 teaches a method for manufacturing a device for collecting GI samples that includes a biodegradable coating (FIG. 5B, component 30) that is formed as a plane to seal or cover a sampling aperture (FIG. 5B, component 42).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the method disclosed by Heseltine with the teaching of Shalon ‘326 that a biodegradable coating can be formed as a plane because Heseltine and Shalon ‘326 are both interested in sealing a sampling aperture until the sampling capsule reaches a specific location such that modifying the coating of Heseltine with the teaching of Shalon would be considered simple substitution of one known element, in this case the biodegradable coating disclosed by Heseltine, for another, in this case the biodegradable coating taught by Shalon, to obtain the predictable result of sealing a sampling aperture.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791
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