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 .
DETAILED ACTION
Election/Restriction
Applicant’s election without traverse of claims 1-7 in the reply filed on 5/29/24 is acknowledged.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “using the internal filtration rate IFR to configure the membrane for increasing convective transport of solutes across the membrane” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-7 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.
How the location of the inversion point, or the value of xi, is determined is unclear.
The following expression in claim 1 is unclear (an equal sign missing?):
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The step (vii) is indefinite: (vii) using the hemodialyzer to treat blood to remove toxins. MPEP 2173.05(q).
Applicant appears to have attempted to correct the issue, but did not result in crossing out the wrong equation. Correction is required.
Claim limitation “using the internal filtration rate IFR to configure the membrane for increasing convective transport of solutes across the membrane” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The term “configured to” means shape or put together in a particular form or configuration. Therefore, “to configure the membrane …” connotes an actual physical change in the membrane or membrane cartridge, which does not appear to be the case form applicant’s disclosure. First, making a physical change to the dialysis membrane is not possible during dialysis. Second, if applicant uses the IFR to control the blood flow rate or dialysate flow rate to maintain a specific IFR, there is no disclosure for it. The disclosure provides (1) IFR is determined in examples 1 and 2 for constant QD and variable QB, and (2) in acquiring real time IFR from blood and dialysate flow rate. This data is transmitted, but nowhere in the disclosure does
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-7 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.
The limitation, “using the internal filtration rate IFR to configure the membrane for increasing convective transport of solutes across the membrane” appears to be new matter, because no disclosure could be found in support of this element.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a Judicial exception without significantly more.
The claim(s) recite(s) a computer-implemented method for determining an internal filtration rate (IFR) within a dialyzer. This judicial exception is not integrated into a practical application because they simply recite acquiring data using a computer and solving mathematical equation using a computer to obtain the IFR rate, which in itself is only a time-dependent variable, and which needs further integration (as in claim 2) to obtain the total IFR during dialysis. The IFR thus determined is not being used for any practical or tangible process step, such as to operate the dialysis system for a usable end result. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements.
Step 2A, Prong 1: Acquiring data and calculating using mathematical expressions are abstract ideas that can be done by hand. Acquiring data on physical properties of the hemodialyzer and of hollow fiber membranes (step i) appears to be something that could be done mentally. This step appears to be looking up the data in a database for the hemodialyzer used. Step iii – determining the internal filtration rate (IFR) of the hemodialyzer definitely appears to be math which is an abstract idea.
Step 2A, Prong 2: has the abstract idea been integrated into a particular practical application? Once the IFR is determined, no action is taken. Step (ii) appears to be a step of gathering data – blood flow rate QB and dialysis flow rate QD through the hemodialyzer during operation (but claim 1 just says that this data is acquired during operation). Note that data gathering to be used in the abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g).
Also, the steps of claim 1 all appear to be done by using a computer. Note that a general purpose computer is not a particular machine. See MPEP 2106.05(b), I.
Step 2B: does the claim recite any elements which are significantly more than the abstract idea? There are no additional steps or elements.
The newly added steps (iv) and (v) do not further add to “integration into a practical application” as in Step 2A, or “significantly more” as in Step 2B, because calculating the IFR would automatically output (provide) its value; step (iv) is only a result of the calculation. Step (v) is only a mental step to decide whether to use (reuse) or not to use the hemodialyzer based on the output. Also, the hemodialyzer has already been used for the same function to which this decision making step is being employed according to the amended step (ii), which, kind of, questions the usefulness of the procedure. (The procedure appears to be about deciding whether to reuse the dialyzer, or determine its usefulness after using it.)
The newly added limitations of obtaining real-time blood and dialysate flow rates, updating the IFR, controlling dialyzer using the real-time flow rates, and operating the dialyzer do not change the abstract idea into a practical application or add significantly more to the claim. The step of “using the hemodialyzer to treat blood to remove toxins” do not add to significantly more.
Particularly, the abstract idea of determining the IFR in step (ii) and updating in the IFR in step (v) are only acquiring IFR for the dialyzer. Such acquisition is not further used in any tangible process step of hemodialysis. It is not significantly more than simply collecting information about IFR. Thus, the abstract idea is not changed into a practical application.
Applicant’s disclosure also sheds no more light in to any further adaptation of the IFR data in hemodialysis. The disclosure and the working examples only show how the mathematical model applicant developed compares to the results of the experimental method of Lorenzin, et. al. to determine the IFR. There is no disclosure showing how the calculated IFR can be used to further improve or control the hemodialysis process.
Dependent claims do not add any further or significantly more to the Judicial exception. Claim 2 acquires the time duration and determined the total volume, claim 3 recites the data as acquired from a database, and claim 4-6 recites data as acquired through an input device, the input device being an optical device, a user interface or an extracorporeal treatment apparatus disclosed in -page 6-7 as something that provides data.
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.
Claims 1-7 are rejected under 35 USC 103 as unpatentable over Lee et al, “Mathematical analysis for internal filtration of convection-enhanced high-flux hemodialyzer,” Computer methods and programs in biomedicine 108(2012) 68-79.
Lee teaches the fundamental equations and a mathematical model for determining the IFR as claimed – see the appendix B. Particularly, the equation (A16) is the same as applicant’s disclosed equation for IFR on page 8 at line 5. Lee solves this equation by numerical methods using a computer to arrive at the same results of determining the IFR or the global forward filtration rate (and backward filtration rate). As argued by the applicant (11/25/24), Lee uses previously reported (or obtained) data (experimental results,) including blood and dialysate flow rates (se section 2.4.1.) Applicant uses the same “previous” results in step (ii.), like applicant does in the working examples. The Lee model also is useful in calculating the IFR and BFR using real-time Qb and Qd data, which would have been obvious to one of ordinary skill in the art.
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It is noted that the point xi is the location of net zero flow rate, which is the same as x0 in Lee. The equation in claim 1 and in the disclosure at line 20, page 8, appears to be a numerical solution to the equation at line 5, Id. While Lee does not elaborate the numerical analysis for the integration, such would have been within the capability of one of ordinary skill in this art of mathematical modeling and numerical integration.
Regarding the use of the data developed by the reference as in step (v), see the ‘convection enhanced high flux dialyzer’ for clearance of middle molecular weight toxins. The model determines whether the dialyzer is convention enhanced – see abstract, introduction and results sections. While applicant does not define what the wide range molecular weights include, from the disclosure (pages 1 and 2), it appears it includes middle and lower range molecular weight.
Regarding configuring the membrane, Lee teaches in page 69, left column, “By controlling the balance between the forward filtration volume and back filtration volume, the net ultra filtration volume can be adjusted theoretically to zero or to a target volume.” Lee also alludes to structural modification of the dialyzer to improve internal filtration. Id.
Use of dialyzers for blood treatment is well-known, and is not patentable.
Claim 2 is only a summation of the IFR for the duration of dialysis, which would have been obvious and within the capability of one of ordinary skill in the art to calculate. Claims 3-6 only recite obtaining the data required from databases using input devices (user interface, computer terminal, optical reader, etc.), which are also obvious to one of ordinary skill, unless otherwise shown. Claim 7 simply recite an extracorporeal treatment apparatus, without any further details. Such an apparatus is implied in Lee, because Lee does same or similar work.
Response to Arguments
Applicant's arguments filed 11/20/25 have been fully considered but they are not persuasive. They are addressed in the rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 KRISHNAN S MENON whose telephone number is (571)272-1143. The examiner can normally be reached Flexible, but generally Monday-Friday: 8:00AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Prem C Singh can be reached on 571-272-6381. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISHNAN S MENON/ Primary Examiner, Art Unit 1777