DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2 Applicant's amendment, filed on 01/08/2026, is acknowledged.
3. Claims 1-20 are pending.
4. Applicant’s election without traverse of Group II, claims 12-20 directed to an apparatus for treating a patient with renal anemia comprising a target compound reduction system configured to engage blood of the patient to reduce an amount of a target compound from the blood of the patient by selectively removing at least a portion of the target compound from the blood of the patient, filed on 01/08/2026, is acknowledged.
5. Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
6. Claims 12-20 are under examination as they read on an apparatus for treating a patient with renal anemia comprising a target compound reduction system configured to engage blood of the patient to reduce an amount of a target compound from the blood of the patient by selectively removing at least a portion of the target compound from the blood of the patient.
7. Applicant’s IDS, filed 12/03/2024 and 04/20/2023, is acknowledged.
Claim Interpretation
8. 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.
9. 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.
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:
“target compound reduction system” in claim 12. The phrase will be interpreted as any dialysis system or circuit.
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.
10. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
11. Claims 12-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12 encompasses a broad genus of target compounds.
Claim 13 encompasses a genus of uremic compounds.
Claim 20 encompasses a genus of chemical analogues of DTQ.
However, there does not appear to be an adequate written description in the specification as-filed of the essential structural feature that provides the recited function of increases a red blood cell lifespan of an RBC population of blood of the patient via reduction of a Piezo1 channel activation duration of at least a portion of the RBC population. The Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement make clear that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus.
The specification discloses that the target compound may be a uremic compound. the target compound may be 3-carboxy-4-methyl-5-propyl-2-furanpropionate (CMPF). [0011].
Besides CMPF, the specification fails to disclose other target/uremic compounds. Because the Specification fails to describe a genus of target/uremic compounds having any of the functions recited in the claims, it necessarily fails to describe a representative number of species within the claimed genera. In addition, the Specification fails to describe structural features common to members of the genus that would allow a skilled artisan to distinguish target compounds encompassed by the claim language from other target compound. Finally, the Specification fails to disclose any correlation between the structure and function of the target compounds encompassed by the claim language. Therefore, the Specification fails to describe the target compounds required to practice the claimed method in a manner that reasonably conveys to those skilled in the art that Appellant was in possession of the claimed method as of the filing date of the instant application.
A "sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) at 1350. "[ A ]n adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials."
"[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function." Id. "But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species." Id.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed.
12. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
13. Claims 12-20 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by US 10625241 B2.
The `241 patent teaches and claims a hemodiafiltration apparatus comprising: an extracorporeal circuit for receiving blood to be purified; at least one of a hemodialyzer or hemofilter connected to the blood circulation of a patient; and a hemocompatible adsorber for separating protein-bound uremic toxins contained in the blood or blood plasma of the patient and having a molecular mass of <500 g/mol regarding their carrier proteins; wherein the hemocompatible adsorber, which is disposed on a solid carrier component in at least one layer on a blood side within the hemodialyzer or hemofilter, comprises a polymer based on a cyclic oligosaccharide or a derivative thereof, wherein the polymer is disposed on the solid carrier component using a layer by layer (LBL) technology, wherein the polymer for a first layer of the LBL technology is an anionic polyelectrolyte, wherein the polymer for a second layer disposed on the first layer is a cationic counterpart, and wherein the hemocompatible adsorber is integrated as the solid carrier component coated with the polymer in a blood cap of the hemodialyzer, wherein the uremic toxins is 3-carboxy-4-methyl-5-propyl-2-furanopropionic acid (CMPF), wherein the carrier protein is human albumin (see issued claims 1-16).
The `241 patent further teaches different membranes are available for the elimination of uremic toxins by hemodialysis and hemo(dia)filtration. The membrane property plays an important role in ensuring efficient dialysis treatment. The efficiency of dialysis treatment can be assessed by determining the elimination capacity in terms of small molecules, usually water-soluble and not protein-bound. Recent clinical publications show, however, that the biochemical changes in uremia are triggered not only by water-soluble/non-protein-bound toxins, but also by protein-bound substances/toxins such as CMPF. These toxins are mainly bound to albumin (col. 5, lines 35+).
The claimed intended use of the apparatus “for treating a patient with renal anemia, “increases a red blood cell (RBC) lifespan . . . via reduction of a Piezo1 channel activation duration”, “the target compound having a form that prolongs the piezo 1 channel activation duration”, “target compound is a uremic compound” such as “CMPF”, “uses a ligand to adsorb CMPF, . . .”, “apheresis”, “displacer” such as “DTQ” recited in claims 12-20 are considered intended use of the apparatus.
The reference hemodiafiltration apparatus meet the definition of apparatus comprising a target compound reduction system configured to engage blood of the patient to reduce an amount of a target compound from the blood of the patient by selectively removing at least a portion of the target compound from the blood of the patient.
The reference teachings anticipate the claimed invention.
13. Claims 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 2092944 A2.
The `944 publication teaches an electrosorption device for the purification of blood and other fluids such as artificial kidney, hemodialysis, peritoneal dialysis equipment, artificial liver, hemodialysis system for filtering or purification of blood of patient during kidney failure or renal failure of a human or animal for removing substance such as toxic substance including oxins such as albumin-bound toxin such as indoxyl sulfate, 3-carboxy-4-methyl-5-propyl-2-furanpropionic acid (CMPF) (i.e., uremic comound) (see published claims, [0015]).
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With respect to the recitation of “for treating a patient with renal anemia” and “increases a red blood cell (RBC) lifespan of an RBC population of blood of the patient via reduction of a Piezo1 cannel activation duration of at least a portion of the RBC population” is considered intended use of the claimed apparatus. “(T)he recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
It is well settled that the recitation of a new intended use for an old product does not make a claim to that old product patentable. See In re Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1657 (Fed.Cir.1990) ("The discovery of a new property or use of a previously known composition, even when that property and use are unobvious from prior art, cannot impart patentability to claims to the known composition.
While the reference is silence with respect to “the target compound (e.g., CMPF) having a form that prolongs the Piez1 channel activation duration”, it is noted that a compound and all of its properties are inseparable; they are one and the same thing (see In re Papesch, CCPA 137 USPQ 43; In re Swinehart and Sfiligoj, 169) USPQ 226 (CCPA 1971)). Therefore, in the absence of evidence to the contrary, the CMPF in the blood would inherently prolongs the Piezo1 channel activation duration.
The reference teachings anticipate the claimed invention.
14. Claims 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20100096329 (IDS).
The `329 publication blood flowing into hemodialysis machine 100 contains uremic toxin 10 bound to protein 20. Displacer substance 30 is infused from container 40 into the blood near the inlet of the blood flow into the hemodialysis machine 100. A fraction of displacer molecule 30 competitively binds to the protein 20, preferably albumin, thus freeing uremic toxin 10, which can then be removed by diffusion across dialyzer membrane 50, which also removes a fraction of displacer molecule 30. Displacer substance 30, preferably bilirubin, can be infused into the blood upstream of dialyzer membrane 50, to increase the serum bilirubin concentration in the blood at the point of infusion to about 15-20 mg/dL. That concentration of bilirubin can result in an increase in the concentration of free uremic toxin, such as, for example, CMPF, to be dialyzed and removed by dialysis membrane 50, which also removes about 50% to about 70% of the bilirubin, that is, the dialysis membrane removes a sufficient amount of the displacer substance to insure that the blood outflow returned to the patient has a non-toxic serum bilirubin concentration, that is, below about 10 mg/dL [0024]. For the current model calculations, bilirubin was used as the displacer molecule and 3-carboxy-4-methyl-5-propyl-2-furanpropanoic acid (CMPF) was the albumin-bound toxin; however, these calculations can be generalized to any displacer and any bound toxin if appropriate equilibrium constant information is provided. This model only considers these three molecules mentioned (albumin, bilirubin, and CMPF). Of course, there are expected to be a number of other species that bind to albumin in the plasma [0025] . From tables 5-8 it can be seen that the amount of available albumin also has a large effect on how much CMPF is unbound or free. These results suggest that even for the smallest (25%) fraction of available albumin sites, if the local concentration of bilirubin is increased in plasma containing CMPF bound to albumin then the CMPF will become displaced and able to be removed via dialysis.
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With respect to the recitation of “for treating a patient with renal anemia” and “increases a red blood cell (RBC) lifespan of an RBC population of blood of the patient via reduction of a Piezo1 cannel activation duration of at least a portion of the RBC population” is considered intended use of the claimed apparatus. “(T)he recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
It is well settled that the recitation of a new intended use for an old product does not make a claim to that old product patentable. See In re Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1657 (Fed.Cir.1990) ("The discovery of a new property or use of a previously known composition, even when that property and use are unobvious from prior art, can not impart patentability to claims to the known composition.
While the reference is silence with respect to “the target compound (e.g., CMPF) having a form that prolongs the Piez1 channel activation duration”, it is noted that a compound and all of its properties are inseparable; they are one and the same thing (see In re Papesch, CCPA 137 USPQ 43; In re Swinehart and Sfiligoj, 169) USPQ 226 (CCPA 1971)). Therefore, in the absence of evidence to the contrary, the CMPF in the blood would inherently prolongs the Piezo1 channel activation duration.
The claimed intended use of the apparatus “for treating a patient with renal anemia, “increases a red blood cell (RBC) lifespan . . . via reduction of a Piezo1 channel activation duration”, “the target compound having a form that prolongs the piezo 1 channel activation duration”, “target compound is a uremic compound” such as “CMPF”, “uses a ligand to adsorb CMPF, . . .”, “apheresis”, “displacer” such as “DTQ” recited in claims 12-20 are considered intended use of the apparatus.
The reference dialysis system meets the definition of apparatus comprising a target compound reduction system configured to engage blood of the patient to reduce an amount of a target compound from the blood of the patient by selectively removing at least a portion of the target compound from the blood of the patient.
The reference teachings anticipate the claimed invention.
15. Claims 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niwa et al (Japanese Journal of Artificial Organs, (1995) Vol. 24, No. 3, pp. 694-696, abstract only).
Niwa et al teach that 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid (CMPF), which is
accumulated in uremic serum as a protein-bound uremic toxin, cannot be removed by conventional hemodialysis (HD) due to its strong albumin binding. To determine if HD using a large-pore membrane dialyzer can reduce the serum level of CMPF by its removal with a loss of albumin, eight patients with Ht values of less than 27%, who had been treated by HD with regenerated cellulose dialyzers, were treated with HD using large-pore membrane (BK-F) dialyzers for 4 months. The serum levels of CMPF markedly decreased after four months on HD using BK-F dialyzers. The values of Ht and Hb significantly increased after four months on HD using BK-F dialyzers. However, the levels of BUN and serum creatinine did not significantly change by HD using BK-F dialyzers. Each HD using a BK-F dialyzer could remove a certain amount of CMPF with a loss of albumin into dialysate, leading to the reduction of serum CMPF level. The decrease in the serum level of CMPF may account for the improvement of anemia by HD using BK-F dialyzers, because CMPF is an inhibitor of erythropoiesis (see English Abstract).
With respect to the recitation of “for treating a patient with renal anemia” and “increases a red blood cell (RBC) lifespan of an RBC population of blood of the patient via reduction of a Piezo1 cannel activation duration of at least a portion of the RBC population” is considered intended use of the claimed apparatus. “(T)he recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
It is well settled that the recitation of a new intended use for an old product does not make a claim to that old product patentable. See In re Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1657 (Fed.Cir.1990) ("The discovery of a new property or use of a previously known composition, even when that property and use are unobvious from prior art, can not impart patentability to claims to the known composition.
While the reference is silence with respect to “the target compound (e.g., CMPF) having a form that prolongs the Piez1 channel activation duration”, it is noted that a compound and all of its properties are inseparable; they are one and the same thing (see In re Papesch, CCPA 137 USPQ 43; In re Swinehart and Sfiligoj, 169) USPQ 226 (CCPA 1971)). Therefore, in the absence of evidence to the contrary, the CMPF in the blood would inherently prolongs the Piezo1 channel activation duration.
The reference teachings anticipate the claimed invention.
15. Claims 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niwa et al (Am J. Nephrol 1995, 15:463-467).
Niwa et al teach furancarboxylic acid (CMPF), an inhibitor of erythoopoiesis, cannot be removed by conventional hemodialysis dure to its strong albumin binding, resulting in its accumulation in uremic serum. Niwa et al used protein-leaking hemodialysis with BK-F dialyzes in 8 uremic patients for 4 months to determine its effect on the serum levels of CMPF. Pre-hemodialysis serum levels of CMPF significantly decreased to about 50% after 4 months by protein-leaking hemodalysis. Niwa et al teach that pre-hemodiaysis hematocrit and hemoglobin levels significanly increased by protein-leaking hemodialysis. Niwa et al concluded that protein leaking hemodialysis reduces serum levels of albumin-bound CMPF and improves anemia (abstract).
The protein-leaking hemodialysis wit BK-F dialyzes is considered an apparatus comprising a target compound reduction system configured to engage blood of the patient to reduce an anount of a targt compound from the blood of the patient by selectively removing at least a protein of the target compound from the blood of the patient.
All the other limitations recited in claims 12-20 are considered intended used of the apparatus.
“(T)he recitation of a new intended use for an old product does not make a claim to that old product patentable.” In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997).
The reference teachings anticipate the claimed invention.
16. Claims 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rifai, K (Liver International 2011: 31(Suppl. 3): 13–15 ).
Rifai teaches fractionated plasma separation and adsorption (FPSA) is a method of albumin dialysis that is integrated into an extracorporeal liver support device (Prometheuss). This concept allows the effective removal of both protein bound and water-soluble substances without the need for external albumin. Several studies comparing the in vivo extraction capacities of FPSA and molecular adsorbent recirculating system (MARS) concluded that detoxification by FPSA seems to be more effective than by MARS. Overall, FPSA therapy has been shown to be safe. Survival after 1 and 3 months was evaluated in 145 patients with acute-on-chronic liver failure comparing FPSA therapy with standard medical treatment versus standard medical treatment alone. There was no statistically significant survival benefit for patients undergoing FPSA therapy. However, patients with hepatorenal syndrome type I or MELD score >30 showed a significant survival benefit under FPSA in a predefined subgroup analysis. Furthermore, there have been promising results with FPSA in the treatment of refractory cholestatic pruritus (abstract).
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Fig. 1. Scheme of the FPSA method. The fractionated plasma separation and adsorption system (Prometheuss) consists of a primary and a secondary circuit. Both circuits are separated by an albumin-permeable polysulphone membrane (AlbuFlows). There, the patient’s albumin fraction is filtered into the secondary circuit, where direct purification from albumin-bound toxins (target compound) by different adsorbers takes place. Afterwards, conventional high flux is performed inside the primary circuit.
Rafai teaches the removal of both water soluble and water-insoluble albumin-bound toxins (target compound) is important to support detoxification. FPSA allows the patient’s own albumin to be regenerated via passage through two adsorption matrixes in a secondary circuit (Fig. 1), wherein an albumin-permeable polysulphone membrane (AlbuFlows, Fresenius Medical Care, Bad Homburg, Germany) is used and there is no need for external albumin. This concept was implemented into a commercially available device. This device also includes a high-flux haemodialyser inside the primary circuit (see page 13, under Method of Prometheus). Rafai teaches that FPSA, as an established method of albumin dialysis, offers safe extracorporeal liver support. The concept allows an effective and safe removal of both protein-bound and water-soluble substances without the need for external albumin. The detoxification by FPSA seems to be more effective than by MARS. FPSA is a promising treatment option in subgroups of patients (see page 14-15, under conclusions and future options).
The claimed intended use of the apparatus “for treating a patient with renal anemia, “increases a red blood cell (RBC) lifespan . . . via reduction of a Piezo1 channel activation duration”, “the target compound having a form that prolongs the piezo 1 channel activation duration”, “target compound is a uremic compound” such as “CMPF”, “uses a ligand to adsorb CMPF, . . .”, “apheresis”, “displacer” such as “DTQ” recited in claims 12-20 are considered intended use of the apparatus.
The reference fractionated plasma separation and adsorption system meet the definition of apparatus comprising a target compound reduction system configured to engage blood of the patient to reduce an amount of a target compound from the blood of the patient by selectively removing at least a portion of the target compound from the blood of the patient.
The reference teachings anticipate the claimed invention.
17. 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.
18. Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20100096329 in view of Faiza, M. (23 Jul 2017, IDS).
The teachings of US 20100096329 have been discussed, supra.
The `329 publication claims A method of removing a deleterious substance bound to a protein in blood of a patient comprising: a) introducing a displacer substance into the blood under conditions in which the displacer substance replaces deleterious substance bound to the protein, thereby resulting in additional unbound deleterious substance in the blood; and
b) removing unbound deleterious substance from the blood by extracorporeal renal replacement treatment, wherein the deleterious substance comprises a uremic toxin, wherein the extracorporeal renal replacement treatment includes dialysis, adsorption, and filtration, wherein the protein comprises albumin, wherein the displacer substance has a higher binding affinity to the protein than the deleterious substance, wherein the extracorporeal renal replacement treatment is hemodialysis, wherein the extracorporeal renal replacement treatment is peritoneal dialysis, wherein displacer substance is returned to the patient and provides the patient with a benefit, wherein the displacer substance comprises bilirubin.
The reference teachings differ from the claimed invention only in the recitation that the adsorption process comprises FPSA in claim 16, using a ligand to adsorb CMPF, the ligand having a binding affinity to CMPF in the range of about K1= 106 to 108 in claim 17, the target compound reduction system operative to perform aphaeresis to selectively remove the target compound in claim 18, wherein the apheresis is performed with a displacer targeting a RBC binding site of the at least one target compound in claim 19, the displacer comprising DTQ or chemical analogues thereof.
Faiza teaches dithymoquinone as a novel inhibitor for 3-carboxy-4 methyl- 5-propyl-2-furanpropanoic acid (CMPF) to prevent renal Failure (see title). Faiza teaches CMPF is a major endogenous ligand found in the human serum albumin (HSA) of renal failure patients. It gets accumulated in the HSA and its concentration in sera of patients may reflect the chronicity of renal failure. It is considered uremic toxin due to its damaging effect to the renal cells. The high concentrations of CMPF inhibit the binding of other ligands to HSA. Removal of CMPF is difficult through conventional hemodialysis due to its strong binding affinity. Faiza hypothesized that the competitive inhibition may be helpful in removal of CMPF binding to HSA. A compound with higher HSA binding affinity than CMPF could be useful to prevent CMPF from binding so that CMPF could be excreted by the body through the urine. She studied an active compound dihydrothymoquinone/ dithymoquinone (DTQ) found in black cumin seed (Nigella sativa), which has higher binding affinity for HSA. Molecular docking simulations were performed to find the binding affinity of CMPF and DTQ with HSA. DTQ was found to have higher binding affinity possessing more interactions with the binding residues than the CMPF. She studied the binding pocket flexibility of CMPF and DTQ to analyze the binding abilities of both the compounds. She predicted the ADME properties for DTQ which shows higher lipophilicity, higher gastrointestinal (GI) absorption, and blood-brain barrier (BBB) permeability. she discovered that DTQ has potential to act as an inhibitor of CMPF and can be considered as a candidate for the formation of the therapeutic drug against CMPF (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the displacer taught by the `329 publication with the DTQ displacer taught by Faiza in a dialysis aparature taught by the `329 publication because DTQ is capable to bind more strongly to HSA than the CMPF and shows inhibitory effects, making DTQ the best possible solution for inhibition of CMPF binding to HSA.
The claimed intended use of the apparatus “for treating a patient with renal anemia, “increases a red blood cell (RBC) lifespan . . . via reduction of a Piezo1 channel activation duration”, “the target compound having a form that prolongs the piezo 1 channel activation duration”, “target compound is a uremic compound” such as “CMPF”, “uses a ligand to adsorb CMPF, . . .”, “apheresis”, “displacer” such as “DTQ” recited in claims 12-20 are considered intended use of the apparatus.
The reference dialysis, adsorption, and filtration meet the definition of apparatus comprising a target compound reduction system configured to engage blood of the patient to reduce an amount of a target compound from the blood of the patient by selectively removing at least a portion of the target compound from the blood of the patient.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
19. No claim is allowed.
20. The art made of record and not relied upon is considered pertinent to applicant's disclosure:
(i) Luce et al. Is 3-Carboxy-4-methyl-5-propyl-2-furanpropionate (CMPF) a Clinically Relevant Uremic Toxin in Haemodialysis Patients? Toxins (Basel). 2018 May 18;10(5):205. doi: 10.3390/toxins10050205
Luce et al teach that Chronic kidney disease (CKD) is characterized by accumulation of uremic toxins especially, some protein-bound uremic toxins as p-cresyl sulfate and indoxyl sulfate. The clinical manifestations of these uremic toxins are rather nonspecific and may include neurologic disorders, protein energy wasting (PEW), cardiovascular (CV) diseases, progression of CKD and mortalit. In CKD, CMPF is described as a deleterious uremic toxin because CMPF directly interacts with free oxygen radicals, which can induce cell damages [14]. Therefore, in experimental studies, CMPF has been reported to inhibit erythropoiesis [15], contributes to the development of thyroid abnormalities [16], impairs neurological function [17] and leads to renal cellular damage [14]. Given its role in oxidative stress [18], CMPF is associated as an uremic retention toxins with CV relevance [19]. The uncertainties concerning CMPF toxicity also results from the wide range of values reported for plasma CMPF concentration and difficulties to interpret and compare studies. Surprisingly, the clinical consequences of CMPF accumulation in HD patients have up to now never been explored.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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February 17, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644