DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 30-71 are pending.
This action is Non-Final.
Election/Restrictions
The Requirement mailed 11/14/2025 is withdrawn.
The requirement mailed 8/22/2025 is in full effect, and applicant’s response filed 8/22/2025 is treated as fully responsive.
In the response filed 8/22/2025, applicant elected Species J of osmotic pressure with traverse, and stated all claims are readable on this election. As no other claims are pending, there is no need to discuss any traversal outside of what has already been discussed. As set forth in the requirement 5/22/2025, the invention lack a unity of invention in view of the art cited and as explained. In addition, see the rejections below which are further evidence of a lack of unity of invention.
Specification
The disclosure is objected to because of the following informalities:
PGPub paragraph 91 is clearly incorrect in its reference to Figure 8, this is clearly in reference to Figure 10.
PGPub paragraph 83 of makes no sense and needs to be amended “A first side of the semi-permeable membrane 52 faces the collection chamber 56. A second side of the semi-permeable membrane 52 faces the collection chamber 56.”
Rule 1.74 is not in compliance as Figure 5 is not discussed in the detailed description as is required.
Appropriate correction is required.
37 CFR 1.74 “When there are drawings, there shall be a brief description of the several views of the drawings and the detailed description of the invention shall refer to the different views by specifying the numbers of the figures and to the different parts by use of reference letters or numerals (preferably the latter).”
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 53-54 (same claim) means for controlling sampling by said gut rover while said gut rover is within said gut.
correspondence in PGPub: [0031]-[0032], [0037], [0093]-[0094] various different structures and equivalents
Claim 59 means for causing excess fluid in said brine reservoir to flow out of said gut rover at a fluid velocity that suppresses flow of gut fluid into said brine reservoir.
correspondence in PGPub: appears to be paragraph [0084]-[0085] outlet and equivalents
Claim 60 means for reducing a risk of clogging of said outlet by suspended particulates in gut fluid surrounding said gut rover.
correspondence in PGPub: appears to be paragraph [0084] outlet and equivalents
Claim 64 means for maintaining salinity of brine in said brine reservoir as water diffuses into said brine reservoir under osmotic pressure
correspondence in PGPub: appears to be paragraph [0087] but there is no clear corresponding structure
Claim 65 means for suppressing flow of said microbes back out of said inlet.
correspondence in PGPub: appears to be paragraph [0087] but there is no clear corresponding structure
Claim Objections
Applicant is advised that should claim 32 be found allowable, claim 33 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is advised that should claim 48 be found allowable, claim 49 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is advised that should claim 53 be found allowable, claim 54 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 63, 65 and 68 are objected to because of the following informalities: Each of claim 65 and 68 contain an extra “said” in “said said”. Claim 63 “wherein said sampler, which relies on osmotic pressure to collect said sampler” is clearly a typo and should collect said sample. Appropriate correction is required.
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 34, 37, 47-49, 60, 64-65 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.
Regarding claim 34, the limitations “further comprising providing a thread and nodes along said thread, wherein said thread has an end exposed to fluid within said gut” are rejected for being new matter. Claim 34 depend on claim 31, which requires “wherein obtaining samples of said gut microbiome comprises using osmotic pressure to collect said samples”. The embodiment of the thread and nodes is not the same embodiment as the osmotic pressure (diffusing across a membrane), but is a combination of originally disclosed mutually exclusive species being combined and thus is new matter. One of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed.
Regarding claim 37, the limitations “wherein obtaining said samples of said gut microbiome comprises causing an osmotic pressure differential that causes a first population of microbes to enter said gut rover and that causes a second population of microbes to exit said gut rover through an outlet in said gut rover, wherein said second population is smaller said first population” are rejected for being new matter. There is no express support for this limitation, and the closest passages in relation appear to be directed to the flow of gut fluids, but there is no discussion of microbes being expelled out the outlet as it appears the diffusion membrane stops the flow of the microbes from moving further into the brine reservoir. Applicant is invited to explain support. While there is no support for the microbes as claimed, there is support for gut fluid in general moving through the system from inlet to outlet, just not that such includes the microbes in the relationship being claimed. As such, one of skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed.
Regarding claim 47, the limitation “wherein said sampler relies on osmotic pressure to collect said samples and wherein said sampler comprises a capillary pump” are rejected for being new matter. The embodiment of the capillary pump is not the same embodiment as the osmotic pressure (diffusing across a membrane), but is a combination of originally disclosed mutually exclusive species being combined and thus is new matter. One of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed.
Regarding claim 48, the limitations “wherein said sampler relies on osmotic pressure to collect said samples and wherein said apparatus further comprises a thread and nodes along said thread, wherein said thread comprises an end and wherein said end is exposed to fluid” are rejected for being new matter. The embodiment of the thread and nodes is not the same embodiment as the osmotic pressure (diffusing across a membrane), but is a combination of originally disclosed mutually exclusive species being combined and thus is new matter. One of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed.
Regarding claim 49, the limitations “wherein said sampler relies on osmotic pressure to collect said samples and wherein said apparatus further comprises a thread and nodes along said thread, wherein said thread comprises an end and wherein said end is exposed to fluid within said gut” are rejected for being new matter. The embodiment of the thread and nodes is not the same embodiment as the osmotic pressure (diffusing across a membrane), but is a combination of originally disclosed mutually exclusive species being combined and thus is new matter. One of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed.
Regarding claim 60, the limitations “wherein said sampler comprises an outlet and means for reducing a risk of clogging of said outlet by suspended particulates in gut fluid surrounding said gut rover” are rejected for lack of adequate written description. The claim invokes 35 U.S.C. 112(f), but in review of the disclosure as filed, the correspondence structure for the claimed functions is an outlet. However, an outlet is already structure in the claim, thus the inclusion of two outlet structures is not supported and must be new matter. As such, one of skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed.
Regarding claim 64, the limitations “means for maintaining salinity of brine in said brine reservoir as water diffuses into said brine reservoir under osmotic pressure” are rejected for lack of adequate written description. The claim invokes 35 U.S.C. 112(f), but in review of the disclosure as filed, there is not a clear correspondence to the structure for performing said function in the disclosure PGPub paragraph 87 and thus the claims are both indefinite and not adequately described (MPEP 2181). As such, one of skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed.
Regarding claim 65, the limitations “means for suppressing flow of said microbes back out of said inlet” are rejected for lack of adequate written description. The claim invokes 35 U.S.C. 112(f), but in review of the disclosure as filed, there is not a clear correspondence to the structure for performing said function in the disclosure PGPub paragraph 87 and thus the claims are both indefinite and not adequately described (MPEP 2181). As such, one of skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed.
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 60, 64-65 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 60, the limitations “wherein said sampler comprises an outlet and means for reducing a risk of clogging of said outlet by suspended particulates in gut fluid surrounding said gut rover” are rejected for being indefinite for lack of correspondence to the specification (MPEP 2173.03). The claim invokes 35 U.S.C. 112(f), but in review of the disclosure as filed, the correspondence structure for the claimed functions is an outlet. However, an outlet is already structure in the claim, thus the inclusion of two outlet structures is not consistent with the disclosure as filed and in addition to being new matter renders the claim indefinite. As such, the metes and bounds of the claim are unclear which renders the claim indefinite.
Regarding claim 64, the limitations “means for maintaining salinity of brine in said brine reservoir as water diffuses into said brine reservoir under osmotic pressure” are rejected for being indefinite. The claim invokes 35 U.S.C. 112(f), but in review of the disclosure as filed, there is not a clear correspondence to the structure for performing said function in the disclosure PGPub paragraph 87 and thus the claims are both indefinite and not adequately described (MPEP 2181). As such, the metes and bounds of the claim are unclear which renders the claim indefinite.
Regarding claim 65, the limitations “means for suppressing flow of said microbes back out of said inlet” are rejected for being indefinite. The claim invokes 35 U.S.C. 112(f), but in review of the disclosure as filed, there is not a clear correspondence to the structure for performing said function in the disclosure PGPub paragraph 87 and thus the claims are both indefinite and not adequately described (MPEP 2181). As such, the metes and bounds of the claim are unclear which renders the claim indefinite.
Claim Rejections - 35 USC § 102
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.
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 30-33, 35-37, 39-42, 44-46, 52-54, 56-60, 64-65, 68, 71 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jones et al. (Jones, US 2018/0049725).
Regarding claim 30, Jones teaches a method comprising providing a gut rover to a patient, said gut rover being configured to traverse a gut of said patient (see at least Figures 2-5, [0005], [0254]) and comprising a sampler for obtaining samples of a gut microbiome at a selected location within said gut (see at least Figures 2-5, [0431], [0267]), said method comprising, using said gut rover (see at least Figures 2-5, [0431]): obtaining samples of gut microbiome at selected locations within said patient’s gastrointestinal system (see at least Figures 1-6, [0431], [0267], [0270], [0282], [0295], [0304], [0319], [0359], [0360], [0374], [0383], [0435]-[0436]), after said gut rover has traversed said patient’s gut, recovering said gut rover, and recovering, from said gut rover, microbes that have been collected from within said gut (see at least [0005], [0383], [0430]-[0431]).
Regarding claim 31, Jones teaches wherein obtaining samples of said gut microbiome comprises using osmotic pressure to collect said samples (see at least Figures 3, [0271]-[0293]).
Regarding claims 32-33, Jones teaches wherein obtaining samples of said gut microbiome comprises using passive osmotic pressure to collect said samples (see at least Figures 3, [0271]-[0293]).
Regarding claim 35, Jones teaches wherein obtaining said samples of said gut microbiome comprises using an osmotic pressure differential across a membrane in said gut rover to drive sampling of gut fluid into said gut rover-during an interval (see at least Figure 3 318, [0275], [0277]).
Regarding claim 36, Jones teaches wherein obtaining said samples of said gut microbiome comprises causing an osmotic pressure differential that drives flow of gut fluid from an inlet of said gut rover to an outlet of said gut rover (see at least Figure 3 , [0271]-[0293]).
Regarding claim 37, Jones teaches wherein obtaining said samples of said gut microbiome comprises causing an osmotic pressure differential that causes a first population of microbes to enter said gut rover (see at least Figure 3 , [0271]-[0293]) and that causes a second population of microbes to exit said gut rover through an outlet in said gut rover, wherein said second population is smaller said first population (implied through usage of outlet and lack of specificity into size of semi-permeable membrane 318 as smaller microbes passed are possible to passed through to the outlet where larger microbes remain on the first side of the membrane and the populations will be naturally less than those trapped; see at least Figures 3 and 6, [0283] and [0511] where the valve of 3 is taught to be included in the structures of Figures 1-2, 6, such that the inclusion with any of these also includes an exit port to allow for fluid to be removed. Such combination is explicitly taught, or in the alternative, the suggestion would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine an osmotic valve with an exit port in an ingestible device in order to allow for fluid venting).
Regarding claim 39, Jones teaches wherein obtaining said samples of said gut microbiome comprises collecting gut fluid that enters an inlet in said gut rover while said gut rover is within said gut (see at least Figures 2-5, [0431], [0267], [0270], [0282], [0295], [0304], [0319], [0359], [0360], [0374], [0383], [0435]-[0436]), wherein said inlet leads to a collection chamber that is in fluid communication with said inlet (see at least Figure 3, inlet 302, collection chamber interpreted as 304 on top of 318 connected to 302), wherein a semi-permeable membrane separates said collection chamber from a brine reservoir (see at least Figure 3 318 where bottom of 318 of 304 is interpreted as brine reservoir), thereby causing an osmotic pressure differential that promotes diffusion of water into said brine reservoir (see at least Figure 3 , [0271]-[0293]).
Regarding claim 40, Jones teaches wherein obtaining said samples of said gut microbiome comprises using osmotic pressure to collect said samples (see at least Figures 3, [0271]-[0293]) and wherein recovering microbes from said gut rover comprises recovering said microbes from a semi-permeable membrane in said gut rover upon which said microbes have been deposited as a result of flow driven by an osmotic pressure differential across said semi-permeable membrane in said gut rover (see at least [0005], Figure 3, sample analyzed after recovery without specificity of what aspects are analyzed by assay [0279] which necessarily includes the sample in 304 of large microbes that did not pass 318).
Regarding claim 41, Jones teaches wherein obtaining said samples comprises using a semi-permeable membrane to separate a collection chamber from a brine reservoir having a volume that expands during sampling of gut fluid that enters said collection chamber via an inlet (see at least Figure 3, 318 semipermeable membrane with above and below of 304 interpreted as the chamber and reservoir with inlet 302), wherein an osmotic pressure difference exists across said semi-permeable membrane while said gut rover is within said gut (see at least [0271]-[0293]).
Regarding claim 42, Jones teaches wherein obtaining said samples of said gut microbiome comprises using a semi-permeable membrane to separate a collection chamber from a brine reservoir (see at least Figure 3, 318 semipermeable membrane with above and below of 304 interpreted as the chamber and reservoir with inlet 302) and providing an outlet to permit fluid that has been driven into said brine reservoir (see at least Figures 3 and 6, [0283] and [0511] where the valve of 3 is taught to be included in the structures of Figures 1-2, 6, such that the inclusion with any of these also includes an exit port to allow for fluid to be removed. Such combination is explicitly taught, or in the alternative, the suggestion would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine an osmotic valve with an exit port in an ingestible device in order to allow for fluid venting) as a result of an osmotic pressure differential across said semi-permeable membrane to exit said brine reservoir (see at least [0271]-[0293]).
Regarding claim 44, Jones teaches wherein obtaining samples of said gut microbiome comprises using osmotic pressure to obtain said samples at said selected locations (see at least Figure 3, [0271]-[0293]) and tracking said gut rover while said gut rover is traversing said gut (see at least [0267], [0274]).
Regarding claim 45, Jones teaches an apparatus comprising a gut rover that is configured to traverse a gut of a patient (see at least Figures 2-5, [0005], [0254]), said gut rover comprising a sampler for obtaining samples of a microbiome at a selected location within said gut (see at least Figures 1-6, [0431], [0267], [0270], [0282], [0295], [0304], [0319], [0359], [0360], [0374], [0383], [0435]-[0436]).
Regarding claim 46 Jones teaches wherein said sampler relies on osmotic pressure to collect said samples (see at least Figures 3, [0271]-[0293]).
Regarding claim 52, Jones teaches wherein said sampler comprises a semi-permeable membrane that maintains an osmotic pressure differential to drive sampling by said gut rover while said gut rover is within said gut (see at least Figure 3 318, [0275], [0277]).
Regarding claims 53-54, Jones teaches wherein said sampler, which relies on osmotic pressure to collect said samples (see at least Figure 3), comprises a brine reservoir (see at least Figure 3, interpreted as bottom portion of element 304 on bottom side of 318 containing hydrophilic material [0257]-[0258], [0262]), a collection chamber that is in fluid communication with an inlet through which fluid within the gut can enter said gut rover (see at least Figure 3, interpreted as top portion of element 304 on top side of 318 which connects to 302) and means for controlling sampling by said gut rover while said gut rover is within said gut (see at least Figure 3 306).
Regarding claim 56, Jones teaches wherein said sampler, which relies on osmotic pressure to collect said samples (see at least Figures 3, [0271]-[0293]), comprises a brine reservoir that expands in volume during sampling (see at least Figure 3, interpreted as bottom portion of element 304 on bottom side of 318 containing hydrophilic material [0257]-[0258], [0262]).
Regarding claim 57, Jones teaches wherein said sampler relies on osmotic pressure to collect said samples (see at least Figures 3, [0271]-[0293]) and wherein said sampler comprises a collection channel having a rectangular cross section (see at least Figure 3, interpreted as top and/or bottom portion of element 304).
Regarding claim 58, Jones teaches wherein said sampler relies on osmotic pressure to collect said samples (see at least Figures 3, [0271]-[0293]) and wherein said sampler comprises an inlet (see at least Figure 3 302), a collection channel connected to said inlet (see at least Figure 3, interpreted as the bottom portion of 104 connected to 102 via top portion of 104), and a stilling chamber between a beginning of said collection channel and an outer surface of said rover (see at least Figure 3, interpreted as top portion of 104), whereby fluid from the gut passes through the inlet and into said stilling chamber before entering said collection channel (see at least Figure 3).
Regarding claim 59, Jones teaches wherein said sampler comprises a brine reservoir into which fluid flows as a result of osmosis (see at least Figure 3) and means for causing excess fluid in said brine reservoir to flow out of said gut rover at a fluid velocity that suppresses flow of gut fluid into said brine reservoir (see at least Figure 1 second opening 108, Figure 3, [0283] and [0511] where the valve of 3 is taught to be included in the structures of Figures 1-2, 6, such that the inclusion with any of these also includes an exit port to allow for fluid to be removed [0165]-[0167], [0257]. Such combination is explicitly taught, or in the alternative, the suggestion would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine an osmotic valve with an exit port in an ingestible device in order to allow for fluid venting).
Regarding claim 60, Jones teaches wherein said sampler relies on osmotic pressure to collect said samples (see at least Figures 3, [0271]-[0293]) and wherein said sampler comprises an outlet (see at least Figure 1 108 and Figure 6 622, Figure 3, [0283] and [0511] where the valve of 3 is taught to be included in the structures of Figures 1-2, 6, such that the inclusion with any of these also includes an exit port to allow for fluid to be removed [0165]-[0167], [0257], [0030]. Such combination is explicitly taught, or in the alternative, the suggestion would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine an osmotic valve with an exit port in an ingestible device in order to allow for fluid venting) and means for reducing a risk of clogging of said outlet by suspended particulates in gut fluid surrounding said gut rover (see at least [0300] In some embodiments, the outlet port 622 may contain a gas permeable membrane, a one-way valve, a hydrophobic channel, or some other mechanism to avoid unwanted material, (e.g., fluids and solid particulates from within the GI tract), from entering the ingestible device 600 through the outlet port 622.).
Regarding claim 64, Jones teaches wherein said sampler comprises a brine reservoir and means for maintaining salinity of brine in said brine reservoir as water diffuses into said brine reservoir under osmotic pressure (see at least Figure 3 314).
Regarding claim 65, Jones teaches wherein said said sampler relies on osmotic pressure to obtain said samples (see at least Figures 3, [0271]-[0293]) and wherein said sampler comprises a collection chamber, an inlet through which microbes suspended in gut fluid enter said collection chamber (see at least Figure 3 302 and 304) and means for suppressing flow of said microbes back out of said inlet (see at least Figure 3 314).
Regarding claim 68, Jones teaches wherein said said sampler comprises an osmotic pump (see at least Figures 3, [0271]-[0293]).
Regarding claim 71, Jones teaches wherein said sampler relies on osmotic pressure to collect said samples (see at least Figures 3, [0271]-[0293]) and wherein said apparatus further comprising a shield that prevents fluid from contacting said sampler (see at least Figure 3, 306), wherein said shield is configured to dissolve upon occurrence of a condition indicative of entry into region from which samples are to be acquired (see at least [0274] while in relation to 306 discussion is in to melting or destruction, dissolving is not directly suggested. however, in [0340] instead of melting using a dissolvable coating for actuation is suggested. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that in place of meltable structure a dissolvable structure could be substituted for 306 to obtain predicable results of 306 being destroyed when preset or desired to be removed from plugin entry).
Claims 38, 50, 61 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (Jones, US 2018/0049725) as applied to claims 31 and 45 above, and further in view of Robertson et al. (Robertson, US 2010/0185055).
Regarding claim 38, Jones teaches wherein obtaining said samples of said gut microbiome comprises using an osmotic pressure differential to drive gut fluid laden with microbes towards a semi-permeable membrane in said gut rover (see at least Figure 3, [0271]-[0293]), wherein said semi-permeable membrane is permeable to water (see ay least Figure 3, [0271]-[0293] inherent or implied by osmosis using semi permeable membrane), whereby microbes in said gut fluid are entrapped on said semi-permeable membrane, wherein recovering microbes from said gut rover comprises recovering said microbes from said semi-permeable membrane (see at least [0005], Figure 3, sample analyzed after recovery without specificity of what aspects are analyzed by assay [0279] which necessarily includes the sample in 304 of large microbes that did not pass 318).
However, the reference is silent to the size of pore in the semipermeable membrane such that it is not clear that the semi permeable membrane is impermeable to microbes in said gut fluid is taught.
Robertson teaches a related system for ingestible devices (see title and abstract), and teaches that semi-permeable membrane pore sizes can be designed as desired and to include configurations were the membrane is only permeable to water (see at least [0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to change the pore sizes in a semi-permeable membrane as desired in order to allow for selective passing of water and not other components in an osmotic system as taught in Robertson in [0068].
Regarding claim 50. Jones teaches wherein said sampler comprises a semipermeable membrane (see at least Figure 3, 318), a collection chamber (see at least Figure 3, interpreted as top portion of element 304 on top side of 318), and a brine reservoir (see at least Figure 3, interpreted as bottom portion of element 304 on bottom side of 318 containing hydrophilic material [0257]-[0258], [0262]), wherein said semipermeable membrane separates said collection chamber and said brine reservoir (see at least Figure 3), wherein said semipermeable membrane is permeable to water, wherein, as a result of brine in said brine reservoir, an osmotic pressure differential exists across said semi-permeable membrane (intended result, see at least Figure 3, [0271]-[0293]).
However, the reference is silent to the size of pore in the semipermeable membrane such that it is not clear that the semi permeable membrane is impermeable to said microbes is taught.
Robertson teaches a related system for ingestible devices (see title and abstract), and teaches that semi-permeable membrane pore sizes can be designed as desired and to include configurations were the membrane is only permeable to water (see at least [0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to change the pore sizes in a semi-permeable membrane as desired in order to allow for selective passing of water and no other components in an osmotic system as taught in Robertson in [0068].
Regarding claim 61, Jones teaches wherein said sampler comprises a semi-permeable membrane across which an osmotic pressure difference exists during operation thereof (see at least Figure 3, [0271]-[0293]); however, the limitations of wherein said semi-permeable membrane comprises a material selected from the group consisting of cellulose acetate, a thin film coating of polyimide, and a thermoplastic polyurethane are not directly taught.
Robertson teaches a related system for ingestible devices (see title and abstract), and teaches that semi-permeable membrane made be made of different materials including polyurethane, or cellulose acetate (see at least [0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a known material known for semipermeable membranes in order to pass material semi-selectively through a membrane in an osmotic system. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious).
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (Jones, US 2018/0049725) as applied to claim 45 above, and further in view of Shalon (US 2020/0138416).
Regarding claim 51, Jones teaches wherein said sampler comprises an osmotic pump (see at least Figure 3, [0271]-[0293]) that comprises a collection channel coupled to an inlet of said gut rover (see at least Figure 3 interpreted as 304 connected to 302 above 318, where there is teaching that the form of the osmotic valve can be changed from the illustrated embodiment, [0271]-[0293]), wherein said collection channel traverses a path from said inlet towards a brine reservoir (see at least Figure 3, interpreted as 304 on top of 318 where brine reservoir interpreted as bottom of 318).
However, the limitation of a helical path is not directly taught.
Shalon teaches a related system for collecting samples, and teaches that a collecting chamber can be helical shaped from an inlet which reasonably teaches a helical path (see at least Figure 30, [0009], [0183]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to change the shape of the path as desired as a change of shape is prima facie obvious. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Claims 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. (Jones, US 2018/0049725) as applied to claim 45 above, and further in view of Hughes (US 2003/0196955).
Regarding claim 62, Jones teaches a membrane (see at least Figure 3 318), but does not directly teach such membrane is a reverse osmosis membrane.
Hughes teaches a related system that discusses filtering materials from samples containing water and organic material which is related to the compounds found in a GI system (see at least [0008]), and teaches that many different types of filters are known for filtering such materials from water based fluids, including reverse osmosis and nanopore membranes (see at least [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a known material known for semipermeable membranes in order to pass material semi-selectively through a membrane in an osmotic system. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious).
Regarding claim 63, Jones teaches wherein said sampler, which relies on osmotic pressure to collect said sampler (see at least Figure 3, [0271]-[0293]), but does not directly teach comprises a nanopore membrane.
Hughes teaches a related system that discusses filtering materials from samples containing water and organic material which is related to the compounds found in a GI system (see at least [0008]), and teaches that many different types of filters are known for filtering such materials from water based fluids, including reverse osmosis and nanopore membranes (see at least [0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a known material known for semipermeable membranes in order to pass material semi-selectively through a membrane in an osmotic system. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious).
Allowable Subject Matter
Claims 43, 55, 66-67, 69-70 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The art of record teaches similar collection systems involving osmotic systems for collecting sample, but fails to teach, suggest, or make reasonably obvious the following features when considered with all limitations and the limitations upon which they depend as a whole:
Claim 43 increasing a level of oil in a back channel, wherein increasing said level of oil in said back channel comprises causing deformation of an elastic membrane that separates an oil reservoir from a brine reservoir, wherein a high concentration of salt in said brine reservoir causes an osmotic pressure differential that drives flow of gut fluid through said gut rover.
Claim 55 wherein said sampler, which relies on osmotic pressure to collect said samples, comprises a brine reservoir, an oil reservoir, a back channel, and an elastic membrane that separates said brine reservoir from said oil reservoir and that, wherein deformation of said elastic membrane controls a level of oil in said oil reservoir via said back channel.
Claim 66 wherein said sampler, which relies on osmotic pressure to collect said samples, comprises a brine reservoir, an oil reservoir, and a polydimethylsiloxane membrane that faces said brine reservoir and said oil reservoir.
Claim 67 wherein said sampler, which relies on osmotic pressure to collect said samples, comprises an elastic membrane, an oil reservoir, and a backflow channel that leads to a collection channel through which fluid laden with microbes enters said gut rover, wherein said oil reservoir connects to said backflow channel, wherein said elastic membrane faces said oil reservoir, and wherein deformation of said elastic membrane causes entry of said fluid into said collection channel to cease.
Claim 69 wherein said sampler relies on osmotic pressure to collect said samples and wherein said sampler comprises an oil reservoir and a backchannel that connects said oil reservoir to an inlet of said gut rover.
Claim 70 wherein said sampler relies on osmotic pressure to collect said samples and wherein said sampler comprises an inlet, a collection channel connected to said inlet, an oil reservoir in fluid communication with said collection channel, and a pump that pumps oil from said oil reservoir into said collection channel, wherein said pump comprises a brine reservoir having a variable volume and an elastic membrane that deforms in response to changes in said variable volume of said brine reservoir.
Conclusion
No prior art rejections have been applied to claims 34, 47-49 but the claims are not allowable due to the 112(a) rejections.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791