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 .
Response to Arguments
Applicant’s arguments, filed September 11, 2025 have been fully considered. Therefore, the previous rejections have been withdrawn, such as the objections to the Specification and previous 112 rejections. However, upon further consideration, new ground(s) of 112 rejections are made in view of the amendments added to the current set of claims.
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 1, 9, 11 and their dependent claims 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.
Claim 1 recites the following newly added limitations to the claims that do not have clear and explicit support in the instant Specification and thus would constitute new matter:
“the gases are at least partially bound to corpuscular gas carrier molecules”, in particular the phrase “at least partially bound” on line 3
“a pore size gradient with smaller pores oriented toward the liquid composition and larger pores oriented toward a dialysate” on lines 7-9
“the dialysate is continuously regenerated” on line 23
“to maintain gas exchange capacity” on line 24
“transport of the gas occurs in both directions across the asymmetric, semipermeable membrane” on lines 25-26
Claim 9 recites the limitation “bicarbonate buffered dialysate” on line 2 but it is not clear that bicarbonate is in the buffer of the dialysate of the actual claimed invention.
Claim 11 recites the following newly added limitations to the claims that do not have clear and explicit support in the instant Specification and thus would constitute new matter:
“the gases are at least partially bound to corpuscular gas carrier molecules”, in particular the phrase “at least partially bound” on line 3
“a pore size gradient with smaller pores oriented toward the liquid composition and larger pores oriented toward a dialysate” on lines 8-9
“a second pool” on line 10
“the dialysate is continuously regenerated” on line 34
“to maintain gas exchange capacity” on line 35
“transport of the gas occurs in both directions” on line 36
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 1-4, 7, 9, 11-16, 18, 22 and their dependent claims 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 the limitation “the concentration” on line 1. There is insufficient antecedent basis for this limitation in the claim. It is not necessarily inherent based on the construction of the claim to this point that there are “gases” with an inherent “concentration” in a “composition”.
Claim 1 recites the limitation “the composition” on line 13. It is not clear if this limitation is the same limitation as the previously recited limitations “a/the liquid composition” earlier in the claim, or not. Examiner interprets them to be the same.
Claim 1 recites the limitation “the dialysate side” on line 16. There is insufficient antecedent basis for this limitation in the claim. Claims 3, 4 recite this limitation too.
Claim 1 recites the limitation “the liquid composition side” on line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the phrase “close proximity” on lines 19-20. The term “close proximity” is a relative term which renders the claim indefinite. The term “close proximity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what clearly defines “close proximity” from “normal proximity” or “no proximity” in a quantitative or comparative sense.
Claim 1 recites the limitation “the addition” on line 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the gas” on line 25. It is not clear if this limitation is the same limitation as the previously recited limitations “the gases” earlier in the claim, or not. Examiner interprets them to be the same.
Claim 2 recites the limitation “the gas carrier”. There is insufficient antecedent basis for this limitation in the claim. It is also not clear if this limitation is the same limitation as the previously recited limitations “the molecular gas carrier molecules” as in Claim 1 or not.
Claim 3 recites the limitation “the open pores” on line 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the gas carrier”. There is insufficient antecedent basis for this limitation in the claim. It is also not clear if this limitation is the same limitation as the previously recited limitations “the molecular gas carrier molecules” as in Claim 1 or not.
Claim 3 recites the limitation “the membrane”. There is insufficient antecedent basis for this limitation in the claim. It is also not clear if this limitation is the same limitation as the previously recited limitations “the asymmetric, semipermeable membrane” as in Claim 1 or not.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 4 recites the limitation “the composition” twice in the claim. There is insufficient antecedent basis for this limitation in the claim. It is also not clear if this limitation is the same limitation as the previously recited limitations “the liquid composition” as in Claim 1 or not.
Claim 4 recites the limitation “the gas carrier”. There is insufficient antecedent basis for this limitation in the claim. It is also not clear if this limitation is the same limitation as the previously recited limitations “the molecular gas carrier molecules” as in Claim 1 or not.
Claim 7 recites the limitation “the membrane”. There is insufficient antecedent basis for this limitation in the claim. It is also not clear if this limitation is the same limitation as the previously recited limitations “the asymmetric, semipermeable membrane” as in Claim 1 or not.
Claim 9 recites the limitation “the hemoglobin” on line 4. It is not clear if this limitation is the same as “molecular hemoglobin” as in Claim 2, or not.
Claim 9 recites the limitation “the hemoglobin solubility limit” and “the albumin solubility limit”. There is insufficient antecedent basis for these limitations in the claim.
Claim 11 recites the limitation “the gases” on line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the liquid composition” on lines 8-9. There is insufficient antecedent basis for this limitation in the claim. It is also unclear if this limitation is supposed to be the same as “a/the fluid composition” already recited or not.
Claim 11 recites the limitation “larger pores” on line 23. It is not clear if this limitation is the same as “larger pores” on line 9, or not.
Claim 11 recites the limitation “smaller pores” on line 24. It is not clear if this limitation is the same as “smaller pores” on line 8, or not.
Claim 11 recites the phrase “close proximity” on line 30. The term “close proximity” is a relative term which renders the claim indefinite. The term “close proximity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what clearly defines “close proximity” from “normal proximity” or “no proximity” in a quantitative or comparative sense.
Claim 11 recites the phrase “said liquid composition” on line 31. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the addition” on line 34. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the pumps”. It is not clear if both “a pump” and “second pump” of Claim 11 are included as part of this limitation or not. Examiner suggests stating “the pump and second pump” if so.
Claim 13 recites the limitation “the pores” and “the membrane”. It is not clear if these limitations are the same as “the larger pores” and “the asymmetric, semipermeable membrane”, respectively, already recited in Claim 11, or not.
Claim 14 recites the limitation “the device for regeneration”. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “the composition”. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “a dialyzer”. It is not clear if this limitation is the same as “a dialyzer” already recited in Claim 11, or not.
Claim 16 recites the limitation “the device for regeneration”. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation “the device for regeneration”. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation “the molecular gas carrier molecules”. It is not clear if it is the same as “a/the molecular gas carrier molecule” as recited earlier in Claim 11, or not, since it is plural, not singular as originally stated.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: after conducting a thorough search in the closest fields of endeavor, the Examiner has determined that the limitations “wherein the dialysate comprises molecular gas carrier molecules for at least one of the gases” and “without allowing the molecular gas carrier molecule to cross the asymmetric, semipermeable membrane” in combination with the other claimed features for independent Claims 1 & 11 would be allowable over the closest prior art including Kreymann et al., (“Kreymann”, US 2019/0030232), and Ash et al., (“Ash”, WO 98/17333), once the 112 rejection issues as indicated above are addressed.
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 JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at 571-270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779