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 .
Amendment Entered
In response to the amendment filed on July 13th, 2026, amended claims 1-2 are entered. Claims 3-6 and 9 are canceled.
Response to Arguments
Applicant's remarks and amendments with respect to the specification objection have been fully considered. The objection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the claim objection have been fully considered. The objection is withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 102 have been considered but are not persuasive. The rejections have been maintained, and further clarified, in view of the amendment.
At Pgs. 6-7 of the Reply, Applicant argues wherein Shalon fails to describe “1. A membrane arranged in the plurality of inlet holes”, specifically arguing that “amended claim 1 recites a membrane (a filter that passes fluid while blocking solids) and a film (which degrades in the small and large intestine to control the timing of sample inflow) as two distinct elements”. Examiner respectfully disagrees. Applicant seems to be arguing more than what is actually being claimed. Claim 1 currently recites “a membrane arranged in the plurality of inlet holes”, “a meltable film having a pH of 6 to 6.5”, and “wherein the meltable film is formed in one selected inlet hole among the plurality of inlet holes”. Thus, there is no recitation of a filter that passes fluid while blocking solids, a film which degrades in the small and large intestine to control the timing of sample inflow, and wherein the filter and film are two distinct elements. Furthermore, the Examiner would like to clarify that although the covering element 30 is being used to satisfy the membrane and meltable film, these two elements are being considered separately. Shalon clearly teaches wherein “each opening 42 of collecting member 18 is covered by a distinct covering element 30” (Shalon [0137]) and “multiple layers of moisture degradable materials can be designed into covering element 30 so that the final layer degrades at a set time after a series of pH levels is encountered in the layers, leading to anatomically distinct and predictable sampling locations” (Shalon [0138]). There is no claim limitation that precludes the membrane and the meltable film from both being part of covering element 30, but as different layers of covering element 30.
At Pgs. 7-8 of the Reply, Applicant argues wherein Shalon fails to describe “2. The arrangement of inlet holes and divided arrangement space”. The Examiner would like to clarify that a different embodiment of Shalon is being relied upon in view of the amendment. Therefore, Shalon clearly teaches the current claim limitations in this current embodiment: “In some embodiments, device 10 comprises a plurality of collecting members 18 separately enclosed with separate opening 42, seal 38 and/or actuator 24. Each opening 42 of collecting member 18 is covered by a distinct covering element 30. Each covering element 30 degrades at a preset pH or dissolution time. In this manner, one device 30 can collect multiple discrete samples of gastrointestinal fluids from different regions of the GI tract without cross talk or cross contamination between the samples” (Shalon [0137]).
At Pgs. 8-9 of the Reply, Applicant argues wherein Shalon fails to describe “3. The structure of inlet holes”, citing the Applicant’s Specification to describe specific functional purposes of the “inlet holes” of the current invention. Examiner respectfully disagrees and would once again like to point out that the Applicant seems to be arguing more than what is actually being claimed. Furthermore, the Examiner notes wherein the limitations “so as to absorb a microbiome flowing in through the inlet holes” and “so as to connect a corresponding one of the plurality of divided arrangement spaces with an outside of the casing” are recitations of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1 recites “space so as to absorb” in line 4, but should read “space configured to absorb”
Claim 1 recites “the inlet holes” in line 5, but should read “the plurality of inlet holes”
Claim 1 recites “casing so as to divide” in line 8, but should read “casing configured to divide”
Claim 1 recites “casing so as to connect” in lines 12-13, but should read “casing configured to connect”
Claim 7 recites “casing so as to pressurize” in line 2, but should read “casing configured to pressurize”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 and 7-8 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 absorption member is independently arranged in each of the plurality of divided arrangement spaces” in lines 10-11. It is unclear as to how the “absorption member” can be “independently arranged in each of the plurality of divided arrangement spaces”, if the “absorption member” is a singular element. Clarification is requested.
Claim 1 recites “an outside of the casing” in line 14. It is unclear as to whether this limitation is referring to the external surface of the casing or the external environment outside of the casing. Clarification is requested.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shalon (U.S. Publication No. 2020/138416; previously cited).
Regarding Claim 1, Shalon discloses a microbiome collection device (devices and methods for collecting gastrointestinal samples using a capsule-shaped device that is swallowed; Abstract; device 10) comprising:
a casing (body 12) having an arrangement space (cavity 16) and a plurality of inlet holes (opening 42) formed therein (device 10 comprises a plurality of collecting members 18 separately enclosed with separate opening 42, seal 38 and/or actuator 24; [0137]), and
an absorption member (collecting members 18; [0124-0125]) arranged in the arrangement space so as to absorb a microbiome flowing in through the inlet holes ([0129, 0132, 0137, 0174, 0182, 0233]);
a membrane arranged in the plurality of inlet holes (Each opening 42 of collecting member 18 is covered by a distinct covering element 30; [0137]);
a meltable film having a pH of 6 to 6.5 (Each opening 42 of collecting member 18 is covered by a distinct covering element 30. Each covering element 30 degrades at a preset pH or dissolution time. In this manner, one device 30 can collect multiple discrete samples of gastrointestinal fluids from different regions of the GI tract without cross talk or cross contamination between the samples. In some embodiments, covering element 30 is made from a moisture degradable material that is pH sensitive…covering element 30 uncovers a fourth set of opening (e.g., similar to opening 42 and 22) at a pH of 6 to 7 after a set time delay, leading to a colon sampling location. Multiple layers of moisture degradable materials can be designed into covering element 30 so that the final layer degrades at a set time after a series of pH levels is encountered in the layers, leading to anatomically distinct and predictable sampling locations; [0138]); and
at least one partition wall arranged inside the casing so as to divide the arrangement space into a plurality of divided arrangement spaces (device 10 comprises a plurality of collecting members 18 separately enclosed with separate opening 42, seal 38 and/or actuator 24; [0137]),
wherein the absorption member is independently arranged in each of the plurality of divided arrangement spaces (Collecting members 18 are shown as a series of spaces between thin disks 20 made of fluid impervious material mounted on a central stem in the form of a spindle; [0117]),
wherein each of the plurality of inlet holes is formed in the casing so as to connect a corresponding one of the plurality of divided arrangement spaces with an outside of the casing (device 10 comprises a plurality of collecting members 18 separately enclosed with separate opening 42, seal 38 and/or actuator 24; [0137]), and
wherein the meltable film is formed in one selected inlet hole among the plurality of inlet holes
(Each opening 42 of collecting member 18 is covered by a distinct covering element 30. Each covering element 30 degrades at a preset pH or dissolution time. In this manner, one device 30 can collect multiple discrete samples of gastrointestinal fluids from different regions of the GI tract without cross talk or cross contamination between the samples…multiple layers of moisture degradable materials can be designed into covering element 30 so that the final layer degrades at a set time after a series of pH levels is encountered in the layers, leading to anatomically distinct and predictable sampling locations; [0137-0138]).
Regarding Claim 2, Shalon discloses wherein the absorption member is any one selected from the group consisting of a bio-sponge, a bio-organoid, bio pulp, fabric, and a combination thereof (the term “porous” means any open cell structure. Such materials comprise open cell foams, fibers, channeled materials, papers, cellulosics, acetates, cotton, cloth, gauze, sponges and the like; [0081]; collecting member 18 is a porous or water soluble material that fits at least partially within the hollow volume of piston 26 and causes the gastrointestinal samples to flow, wick or diffuse into collecting member 18…a porous collecting member 18 that has structural rigidity in the form of open-cell foam or dehydrated hydrogel; [0124-0125]).
Regarding Claim 7, Shalon discloses a piston (piston 26) that is movably arranged inside the casing so as to pressurize the absorption member (actuator 24, which is material that expands when wet, starts to push piston 26 axially due to the fluids in the GI tract flowing through hole 22 and wetting actuator 24. FIG. 10 shows device 10 in isometric view after the collection of a gastrointestinal sample with body 12 in section view to expose the components therein. Piston 26 has been displaced axially to the left side of body 12 by actuator 24, which is at its fully expanded state; [0121-0122]; Figures 9-10),
wherein a rod hole into which a rod is inserted is formed in the casing (hole 22; Examiner’s Note: The Examiner notes wherein the limitation “into which a rod is inserted” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations), and
wherein a circumferential diameter of the rod hole is smaller than a circumferential diameter of the piston (Examiner’s Note: The circumferential diameter of the hole 22 is smaller than a circumferential diameter of the piston 26, as shown in Figures 6 and 8-10).
Regarding Claim 8, Shalon discloses a lens arranged in an open part of the casing, a camera module arranged inside the casing, and a controller arranged inside the casing and connected to the camera module (device 10 contains within it a camera and power source, together with on-board image storage capabilities or wireless transmission capabilities to an external image storage device; [0273]).
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 CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J YOON/Examiner, Art Unit 3791
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