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 32, 35-44, 50-53, 55-73 are pending.
This action is FINAL.
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.
Claim 53 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
Claims 35, 38 are objected to because of the following informalities: The amendments to claim 35 and 38 introduce typos of unnecessary consecutive duplicate words and one of each duplicate should be deleted. 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 36-37, 42, 58-60, 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.
Applicant has amended the claims to all depend from features for the embodiment of Figures 8-9 which all commonly have an oil reservoir and a back channel (backchannel).
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As such, the current presentation of the following features are forms which were not supported by the application as originally filed and are new matter:
Claim 36:
wherein obtaining said samples of said gut microbiome comprises causing said osmotic pressure differential to drive flow of gut fluid from an inlet of said gut rover to an outlet of said gut rover.
There is no outlet with the backchannel.
Claim 37:
“wherein obtaining said samples of said gut microbiome comprises using said osmotic pressure differential to cause a first population of microbes to enter said gut rover and to cause a second population of microbes to exit said gut rover through an outlet in said gut rover, wherein said second population is smaller than said first population”
There is no outlet with the backchannel.
Claim 42
“wherein obtaining said samples of said gut microbiome comprises using a semi-permeable membrane to separate a collection chamber from said brine reservoir and providing an outlet to permit fluid that has been driven into said brine reservoir as a result of said osmotic pressure differential to exit said brine reservoir”
The embodiment of backchannel has no brine reservoir outlet.
Claim 58:
“wherein said sampler comprises an inlet, a collection channel connected to said inlet, and a stilling chamber between a beginning of said collection channel and an outer surface of said rover, whereby fluid from the gut passes through the inlet and into said stilling chamber before entering said collection channel”
These features do not appear in the backchannel embodiment nor fit with the requirements of connection in claim 69.
Claim 59:
“wherein said sampler comprises a brine reservoir into which fluid flows as a result of osmosis 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”
There is no outlet with the backchannel.
Claim 60:
“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”
There is no outlet with the backchannel.
Claim 64:
“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”
The embodiment of backchannel has no brine reservoir outlet so it is not clear what this means in view of the embodiment claimed.
Regarding claim 37, the limitations “wherein obtaining said samples of said gut microbiome comprises using said osmotic pressure differential to cause a first population of microbes to enter said gut rover and to cause 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. In addition, as above, the embodiment of the independent claims has no outlet. Applicant was invited to explain support and could not produce anything except hypotheticals. It is not the examiner’s role to explain what applicant desires, it is applicant’s role to explain how the disclosure as filed provides adequate implicit, inherent support for features which are never expressly mentioned. 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 in other embodiments, however, the backchannel has no outlet so it is clearly 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 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. This is in addition to the new matter raised above. 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 improperly structured 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. This is in addition to the new matter presented above. 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 43, 32, 35-42, 44, 51, 53, 55, 58, 60, 64, 65, 66, 70, 72-73 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 43, applicant has amended the claim creating antecedent basis issues including by addition and deletion. The terms “wherein increasing said level of oil in said back channel comprises causing deformation of said elastic membrane” find no proper antecedent basis. In addition, the deletion of terms now do not make sense as to what this final limitation of the method is setting forth. Applicant should consider amending some of the removed features back in to make these limitations make sense.
Claims 36-38, 41-42 limitation “said osmotic pressure differential” lacks proper antecedent basis.
Claim 39, the limitation “wherein a semi-permeable membrane separates said collection chamber from said brine reservoir” lacks proper antecedent basis as applicant deleted the term from claim 43.
Claim 41, the limitation “wherein obtaining said samples comprises using a semi-permeable membrane to separate a collection chamber from said brine reservoir, wherein a volume of said brine reservoir expands during sampling” lacks proper antecedent basis as applicant deleted the term from claim 43.
Claim 42, same as 39 and 41 as “said brine reservoir” lacks proper antecedent basis.
Claim 51 “an inlet of said gut rover… said inlet towards” renders the claim indefinite in view of claim 69 limitation “an inlet of said gut rover”. It is not clear whether these are the same or different and which is further limited. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Claim 53 is rejected similarly to claim 51 as it is unclear if “an inlet through which fluid within the gut can enter said gut rover” is the same or different component from claim 69 limitation “an inlet of said gut rover”. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Claim 55 recites the limitation “said back channel” which lacks proper antecedent basis. The claim has been amended to depend from the form presented in claim 69, which is one word not two. This makes the metes and bounds unclear which renders the claim indefinite.
Claim 58 recites the limitations “an inlet, a collection channel connected to said inlet, and a stilling chamber between a beginning of said collection channel and an outer surface of said rover, whereby fluid from the gut passes through the inlet” which like claim 51 is rejected in view of claim 69 limitation “an inlet of said gut rover”. It is not clear whether these are the same or different and which is further limited. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Regarding claim 66, the limitations “an oil reservoir… and said oil reservoir” renders the claim indefinite in view of claim 69 requirement that “said sampler comprises an oil reservoir”. It is not clear whether these are the same or different and which is further limited. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Regarding claim 70. the limitation “said sampler comprises an inlet” is rejected in view of claim 69 limitation “an inlet of said gut rover”. It is not clear whether these are the same or different. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Claims 65, 72-73 are dependent on a canceled claim and by definition are indefinite.
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.
The dependent claims are rejected for depending on a rejected claim.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims and specification filed 7/22/2026.
Applicant’s arguments regarding the claim objections have been fully considered and are partially persuasive due to the amendments to the claims. However, the amendments necessitated new objections as presented above.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112(a) have been fully considered and are partially persuasive due to cancelation of claims.
Regarding claim 37, applicant’s arguments do not make sense and in any case appear irrelevant as claim 37 now depends from claim 43, which is to an embodiment of using Figures 8-9, the included features with claim 37 are new matter to that embodiment as a back channel prevents microbe leakage and there is only an inlet so whatever point was trying to be made is categorically irrelevant. It is unclear if applicant is taking the position that the claimed invention is inoperable as claimed because the position taken seems to make it seem such, and should the arguments be repeated, the fact that not all semipermeable membranes only have nanopores seems like it may be essential or microbes can get through as the attorney argues. But as these arguments seem meaningless, they will be ignored at this time. Thus, the claim is rejected for being new matter combination of embodiments not present at the time the application was filed. In addition, the prior rejection is maintained as new features cannot be added to the disclosure.
Regarding claim 60, applicant’s arguments do not make sense and in any case appear irrelevant as claim 60 now depends from claim 69, which is to an embodiment of using Figures 8-9, the included features with claim 60 are new matter to that embodiment as the back channel provides for only an inlet. Thus, the claim is rejected for being new matter combination of embodiments not present at the time the application was filed. In addition, the prior rejection is maintained as new features cannot be added to the disclosure and placing structure for the inlet at the outlet does not satisfy the written requirement.
Regarding claim 64, the arguments do not specifically identify what structure amounts to the means for, but generally cites to paragraphs. This is improper. If applicant is basing support on these passages, then applicant needs to specifically identify what the “means for” are as the disclosure does not do this as filed and presented. As the Figure 8-9 brine reservoir has no outlet, but only an expanding membrane, the maintaining of salinity is not a function as brine begins to be diluted and only causes stopping when expansion is completed, there is no structure to maintain salinity. Its new matter and not supported for the embodiment.
Regarding claim 65, the arguments do not specifically identify what structure amounts to the means for, but generally cites to paragraphs explaining the function. This is improper. If applicant is basing support on these passages, then applicant needs to specifically identify what the “means for” are as the disclosure does not do this as filed and presented. As claim 65 depends on a canceled claim, other issues could be present which would require further consideration.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112(b) have been fully considered but are not persuasive as the issues were not directly addressed (applicant may want to review 112(f) discussed in MPEP 2181 “If one employs means plus function language in a claim, one must set forth in the specification an adequate disclosure showing what is meant by that language. If an applicant fails to set forth an adequate disclosure, the applicant has in effect failed to particularly point out and distinctly claim the invention as required by the 35 U.S.C. 112(b) [or the second paragraph of pre-AIA section 112].” In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc)…The proper test for meeting the definiteness requirement is that the corresponding structure (or material or acts) of a means- (or step-) plus-function limitation must be disclosed in the specification itself in a way that one skilled in the art will understand what structure (or material or acts) will perform the recited function. See Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1381, 53 USPQ2d 1225, 1230 (Fed. Cir. 1999).”); in addition, the amendments have necessitated new grounds of rejection.
Applicant’s arguments regarding the claim rejections in view of prior art have been fully considered and are persuasive due to the inclusion of allowable features in independent form the rejections are withdrawn.
Allowable Subject Matter
Claims 69, 50, 52, 56-57, 61-63, 67-68, 71 are allowed.
Claims 43, 32, 35, 38-41, 44, 51, 53, 55, 66, 70 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
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 features explained in the previous action, when considered with all limitations and as a whole.
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.
No prior art rejections have been applied to claims 65, 72-73 as each are dependent on a canceled claim and by definition are indefinite.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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