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 .
Applicants are advised that the Examiner of record has changed.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a composition for use in a preparation of a dialysis solution, species of phosphate as dihydrogen phosphate and species glycine as glycylglycine in the reply filed on September 6, 2023 and during the interview dated March 14, 2024 is acknowledged.
Claims 21, 22, and 29-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Priority
The present application claims status as a 371 (National Stage) of PCT/CN2019/086397 filed 05/10/2019.
Status of Claims
Claims 1-18 were originally filed and amended on 11/08/2021. The amendment cancelled claims 1-18 and added new claims 19-38.
The amendment filed on 07/15/2025, cancelled claims 37-38, added news claim 39-40, and amended claims 19, 23-28.
The amendment filed on 03/31/2025, cancelled claims 27-28, added new claim 41, and amended claims 19, 23-26, 39-40.
The amendment filed on 12/06/2025, amended claims 19 and 23-24.
Claims 21, 22, and 29-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) and Claims 19, 20, 23-26 and 39-41 are under examination.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
For claim 19, regarding the scope of “generate” it is noted that the instant specification does not define what constitutes to “generate phosphate” or to “generate a peptide”. Pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. Merriam-Webster Dictionary defines “generate” as to bring into existence or create by means of a defined process (see Merriam-Webster definition “generate” retrieved from https://www.merriam-webster.com/dictionary/generate on 05/26/2026). As such, the Examiner is interpreting the scope of “generate” in relation to the claimed solid composition as the ability of the solid composition to bring into existence or create phosphate, as well as the ability of the solid composition to bring into existence or create a peptide based on glycine.
Information Disclosure Statement
The IDS filed on 12/16/2025 has been considered by the Examiner.
Response to Arguments
1. Applicants’ arguments, see Remarks, filed 12/16/2025, with respect to the 35 U.S.C 112(b) rejection, have been fully considered and are persuasive. The 35 U.S.C 112(b) rejection of claims 23-26, 39 and 41 has been withdrawn.
2. Applicants’ arguments, see Remarks, filed 12/16/2025, with respect to the 35 U.S.C 102(a) rejection, have been fully considered and are persuasive. The 35 U.S.C 102(a) rejection of claims 19 and 40 has been withdrawn.
3. Applicants’ arguments, see Remarks, filed 12/16/2025, with respect to the 35 U.S.C 103 rejection, have been fully considered but are not persuasive. The 35 U.S.C 103 rejection of claims 19, 20, 23-26 and 39-41 has been maintained.
4. Applicants’ arguments, see Remarks, filed 12/16/2025, with respect to the nonstatutory double patenting rejection, have been fully considered but are not persuasive. The NSDP rejections have been maintained.
New Objection
Claim 19 is objected to because of the following informalities: unit of measurement abbreviation. The claim includes “mmol/l” as the abbreviated unit of measurement for concentration, the abbreviation should be “mmol/L”. Appropriate correction is required.
New Rejection
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.
1. Claims 19-20, 23-26 and 39-41 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. This is a new matter rejection.
In the instant case, claim 19 has been amended to recite that “the composition comprises an amount of phosphate or can generate an amount of phosphate such that the dialysis solution prepared from the composition comprises phosphate in a concentration of up to 0.2 mmol/l;
and the composition comprises an amount of the peptide or can generate an amount of the peptide such that the dialysis solution prepared from the composition comprises the peptide in a concentration of 5-100 mmol/l.”
Applicants stated in their remarks that “[s]upport for the amendments can be found throughout the original claims and specification as filed.” Further, Applicants stated that “[n]o new matter has been added.” (see Remarks filed on 12/16/2025, pg. 6 of 11). However, the evidence (i.e., specification as filed and the original claims) provided by Applicants fail to support that the newly added limitations to instant claim 19 were previously presented. As there is no mention of a solid composition that can generate an amount of phosphate such that the dialysis solution prepared from the composition comprises phosphate in a concentration of up to 0.2 mmol/L.
There is also a lack of mention of a solid composition that can generate an amount of the peptide such that the dialysis solution prepared from the composition comprises the peptide in a concentration of 5-100 mmol/L.
The details pertaining to the claimed solid composition for use in preparation of a dialysis solution, read as follows: “the composition has an amount of phosphate such that the dialysis solution prepared from the composition contains phosphate having a concentration in a range from up to 0.4 mmol/L, preferably in a range from up to 0.375 mmol/L, or in a range from up to 0.25 mmol/L, and particularly preferably in a range from up to 0.2 mmol/L” (see instant specification, pg. 5, third paragraph). It is also noted that the specification emphasizes that “the dialysis solution contains phosphate in a range from 0.05 mmol/L to 0.25 mmol/L, in particular up to 0.20 mmol/L. The lower limit of the concentration of phosphate in the dialysis solution preferably lies at 0.05 mmol/L.” (see instant specification, pg. 5, fourth paragraph).
With respect to the amount of the peptide, the instant specification recites that “the dialysis solution contains 5-100 mmol/l of the peptide” (see instant specification, pg. 5, seventh paragraph).
Therefore, examination of the instant support shows that the envisioned dialysis solution comprises a phosphate concentration and a peptide concentration ranging from preferably 0.05 mmol/L up to 0.2 mmol/L, and from 5-100 mmol/L, respectively. In other words, a dialysis solution prepared from the claimed solid composition includes a concentration of phosphate and a concentration of a peptide based on glycine. However, the instant support does not show any evidence of wherein the composition can generate, as in bring to existence, an amount of phosphate so that the concentration of the dialysis solution prepared from it comprises phosphate in a concentration of up to 0.2 mmol/L. The same is true for the claim limitation that refers to wherein the composition can generate an amount of the peptide; the instant support does not show any evidence of the generation of an amount of peptide such that the dialysis solution prepared from the composition comprises the peptide in a concentration of 5-100 mmol/L.
Although, the specification teaches that the first substance comprises or can generate phosphate and that the second substance comprises or can generate a peptide based on glycine (see instant specification, pg. 1, last paragraph). Positive recitation of the generation of phosphate or the generation of a peptide based on glycine, without evidence of the generated (i.e., brought into existence) phosphate and peptide based on glycine, does not provide support in claiming that the solid composition can generate an amount of phosphate and an amount of the peptide, such that the dialysis solution prepared from the claimed solid composition comprises the generated phosphate in a concentration of up to 0.2 mmol/L; and the generated peptide in a concentration of 5-100 mmol/L.
Accordingly, the generation of an amount of phosphate and an amount of peptide by the claimed solid composition such that the dialysis solution comprises a concentration of phosphate ranging from up to 0.2 mmol/L, and of peptide from 5-100 mmol/L, respectively is not expressly described. Thus, parent claim 19, and dependent claims 20, 23-26 and 39-41 fail to comply with the written description requirement.
Maintained/Modified Rejections in light of Amendments
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
2. Claims 19, 20, 23-26, and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Sternby et al. (WO 2014/177656; published 2014) (herein after “Sternby et al.”), in view of Yatzidis et al. (“On the Usefulness of Glycylglycine in Hemodialysis and Peritoneal Dialysis Solutions”, ASAIO Journal, 1996, 984-992) (here in after “Yatzidis et al.”).
Regarding claim 19, Sternby et al. teach dialysis fluids also referred therein as treatment fluids. Sternby et al. teach dialysis fluids comprising phosphate (first substance), bicarbonate, lactate, citrate, glucose, sodium (electrolyte), calcium, potassium (electrolyte), magnesium (electrolyte) (see pp. 28-39, Examples A-O). Thereby constituting wherein the composition comprises a first substance, wherein the first substance comprises phosphate, and also constituting wherein the composition further comprises bicarbonate and/or lactate, and electrolytes.
Sternby et al. also teach that the patients in need of dialysis are often hyperphosphatemic when starting the dialysis treatment; however, during the dialysis treatment phosphate is removed from the patient and if no counteraction is taken the patients may become hypophosphatemic (see pg. 3, last paragraph). In order to counteract this loss of phosphate during the treatment, phosphate containing dialysis fluids have been developed and as a consequence the variability of patient serum phosphate levels as well as the incidences of hypophosphatemia have been significantly reduced (see pp. 3, last para and pg. 4, 1st para).
Sternby et al. add that phosphate can be added to treatment fluids and that the impact by variations in the treatment fluid flow rates on the phosphate level in the blood returned to the patient will therefore be rather small (see pg. 6, 3rd para). It is thus possible to vary the treatment dose by varying the treatment flow rates without affecting the phosphate balance too much (see pg. 6, 3rd para).
Sternby et al. teach the treatment fluids (dialysis fluids) may be prepared from dry powder concentrates (see pg. 3, 5th para); thereby constituting a solid composition for use in preparation of dialysis solution. Sternby et al. also teach the dry powder concentrates can be dissolved and diluted into determined concentrations (see pg. 3, 5th para).
With respect to phosphate concentration of up to 0.2 mmol/L comprised by the dialysis solution prepared from the composition, as recited in instant claim 19:
Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of phosphate comprised by the solid composition needed to achieve the desired dialysis solution, prepared from the solid composition, comprising phosphate concentration of up to 0.2 mmol/L. Thus, an ordinary skilled artisan would have been motivated to dissolve and dilute the dry powder concentrates as taught by Sternby et al. thereby resulting in a dialysis solution comprising phosphate in a concentration of up to 0.2 mmol/L, because an ordinary skilled artisan would have been able to utilize the teachings of Sternby et al. to obtain various dialysis solutions prepared from the dry powder concentrates with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the phosphate concentration of up to 0.2 mmol/L of the dialysis solution prepared from the claimed solid composition would have been obvious at the time of Applicants invention. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, because the combined teachings of the prior art are fairly suggestive of the claimed invention.
With respect to the claimed container which contains the solid composition, although Sternby et al. do not expressly teach a container wherein the dry powder concentrates (solid composition for use in preparation of dialysis solution) are contained.
The Examiner would like to remind Applicants that the preamble is the introductory phrase in a claim that establishes what the invention is (i.e., identifies the category of the invention), provides context and does not limit the scope of the claim. In the instant case the preamble of claim 19, has been amended to include a container (i.e., a product), and while descriptive clause, i.e., “contained in the container” when referring to the contemplated use (i.e. “intended use”) of a claimed product is proper, it is not a limitation that changes the structure of the claimed solid composition, and thus of no significance in determining the patentability thereof over the prior art.
MPEP 2111.02 (I) states that any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation. See, e.g., Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989) (The determination of whether preamble recitations are structural limitations can be resolved only on review of the entirety of the application "to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification."). In view of the entirety of the instant specification, the terms “container” and “contained in the container” have been imported from the specification and do not limit the structure of the solid composition. In other words, inclusion of a “container” does not change or alter the interrelation of the first substance, the second substance, the bicarbonate and/or lactate, and the electrolytes.
Furthermore, the clause “for use in preparation of a dialysis solution” constitutes a recitation of the intended use of the claimed invention, therefore it does not limit the scope of the claim because it does not constitute a structural difference between the claimed invention and the solid composition taught by the prior art. If the prior art structure is capable of performing the intended use, then it meets the limitations recited in instant claim 19. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP §2111.02 (II). In the instant case, the preamble recites the intended use of the claim composition without a distinct definition of any of the claimed inventions’ limitations.
Additionally, MPEP 2112.01 states that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not inherently possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. In the instant case, the teachings of Sternby et al. read on the claim limitations recited in claim 19, wherein a solid composition (i.e., dry powder concentrate) comprises a first substance (i.e., phosphate), bicarbonate, lactate, citrate, glucose, sodium (electrolyte), calcium, potassium (electrolyte), magnesium (electrolyte). Therefore, the claimed solid composition contained in a container would have been obvious to one skilled in the art.
However, Sternby et al. do not teach that the dialysis fluids or dry powder concentrates comprise glycine and do not expressly teach the composition exemplified in Examples A-O as dry powder concentrates.
The article of Yatzidis et al. is a review the usefulness of glycylglycine dialysis solutions that contain bicarbonate. Yatzidis et al. teach glycylglycine (glycine; elected species) is useful in preparing stable hemodialysis solutions containing bicarbonate (see pg. 984, abstract). Yatzidis et al. teach the coexistence of bicarbonate and glycylglycine in a dialysis solution renders it a potent, stable buffer in which the well-known reaction between bicarbonate and calcium and magnesium and the subsequence formation of insoluble neutral calcium and magnesium carbonate salts are avoided (see pg. 984, abstract). Yatzidis et al. also disclose Table 1, which depicts three bicarbonate-glycylglycine (BiGG) solutions which include 10 mmol/L of glycylglycine (see pg. 985, right column, Table 1). Thereby corresponding to wherein the composition comprises an amount of the peptide such that the dialysis solution prepared from the composition comprises the peptide in a concentration of 5-100mmol/L.
Yatzidis et al. also teach that the BiGG solution for hemodialysis contains a very low concentration of GG (glycylglycine) to avoid its purposeless entry into the patient through the artificial dialyzer membrane during each treatment session (see pg. 985, right column, 1st full paragraph). The effective buffering capacity of peritoneal dialysis solutions is due to the presence of Bi and GG, both of which remain undegraded, thus protecting each other, and achieving a constant pH of 7.35 and stability for long periods (see pg. 985, right column, 1st full paragraph). Therefore, the successive reactions leading to insoluble neutral calcium and magnesium salts are avoided (see pg. 985, right column, 1st full paragraph and Fig. 1).
It would have been obvious to the artisan of ordinary skill to add glycylglycine before the effective filing date of the claimed invention to avoid the formation of insoluble neutral calcium and magnesium carbonate salts. There would have been a reasonable expectation of success because the combination of bicarbonate and glycylglycine in a dialysis solution renders it a stable and a potent buffer; and because it was known that glycylglycine significantly prolongs the stability of bicarbonate-glycylglycine solutions even at pH 7.65; and because bicarbonate and glycylglycine protect each other as taught by Yatzidis et al.
It would have been obvious to provide the dialysis fluids of Sternby et al., with the obvious addition of glycylglycine as taught by Yatzidis et al., as a dry powder concentrate. The artisan would have been motivated to do so with a reasonable expectation of success given that is was known that the loss of phosphate during dialysis treatments can be counteracted by including phosphate in treatment fluids; and to allow making the dialysis solution into determined concentrations.
Regarding claim 20, Sternby et al. teach the term phosphate means phosphoric acid or any salt thereof (see pg. 9, 5th para). Sternby et al. further teach the component of phosphate may be added as dihydrogen phosphate (i.e., Applicants’ elected species) (see pg. 9, 5th para).
As previously mentioned, Yatzidis et al. teach glycylglycine (i.e., Applicant’ elected species) (see pg. 984, abstract).
Regarding claims 23 and 24, Sternby et al. teach that the composition comprise citrate and glucose (see pp. 28-39, Examples A-O).
Regarding claims 25 and 41, Sternby et al. teach that the composition comprise bicarbonate (see pp. 28-39, Examples A-O).
Regarding claims 26 and 39, Sternby et al. teach the composition comprise lactate (see pp. 28-39, Examples A-O).
Therefore, the presently claimed invention was prima facie obvious to the artisan of ordinary skill at the time before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
3. Claims 19, 20 and 40 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, 20, 21, 22-26, 28, and 30-35 of copending Application No. 16/610,614 (Publication Number US20200061272A1) in view of Yatzidis et al. (“On the Usefulness of Glycylglycine in Hemodialysis and Peritoneal Dialysis Solutions”, ASAIO Journal, 1996, 984-992) and Huppert et al. (US 2017/0296729 A1; published 2017).
Copending Application No. 16/610,614, claim set filed 05/21/2025, claims an all-in-one dialysis concentrate configured to be diluted or dissolved by a diluting solution comprising at least one electrolyte salt where the electrolyte salt comprise one or more electrolyte salts selected from salts of sodium, calcium, and magnesium, sodium lactate and at least one osmosis agent. See claims 1, 7-9, 20, 21, 22-26, 28, and 30-35.
Copending Application No. 16/610,614 further claims the concentrate comprises bicarbonate. See claim 7. The limitation directed to the electrolyte salt comprising one or more electrolyte salts selected from salt of sodium, salt of calcium and salt of magnesium encompasses any combination of the listed electrolytes in the concentrate; thus encompasses multiple electrolytes. With regard to the limitation “configured to be diluted or dissolved by a diluting solution”, see claim 1 in Copending Application No. 16/610,614, the specification of Copending Application No. 16/610,614, discloses that concentrate that are configured to be diluted can be liquid or powder (solid). See p. 9, 3rd paragraph. Thus, the reference to concentrate includes both liquids and powders (solid). T specification of the reference application can be relied upon to properly construe the scope of the claim. MPEP §804.
Copending Application No. 16/610,614 does not claim the concentrate comprises phosphate and glycine as claimed.
The article of Yatzidis et al. is a review the usefulness of glycylglycine dialysis solutions that contain bicarbonate. Yatzidis et al. teach glycylglycine (glycine; elected species) is useful in preparing stable hemodialysis solutions containing bicarbonate. See the abstract. Yatzidis et al. teach the coexistence of bicarbonate and glycylglycine in a dialysis solution renders it a potent, stable buffer in which the well-known reaction between bicarbonate and calcium and magnesium and the subsequence formation of insoluble neutral calcium and magnesium carbonate salts are avoided. See abstract. It would have been obvious to the artisan of ordinary skill to add glycylglycine to the claimed concentrate of Copending Application No. 16/610,614 to avoid the formation of insoluble neutral calcium and magnesium carbonate salts are avoided. There would have been a reasonable expectation of success because the combination of bicarbonate and glycylglycine in a dialysis solution renders it a stable and potent buffer as taught by Yatzidis et al.
Huppert et al. teach precipitation as an issue related to dialysis solutions with bicarbonate and calcium/magnesium See para.[0001-0009]. Huppert et al. teach including phosphate in the dialysis solutions impedes the precipitation and increases the stability of the solution. See paras. [0011-0012]. Huppert et al. teach phosphate encompasses orthophosphate and dihydrogen phosphate (elected species). See paras. [0014, 0024]. It would have been obvious to the artisan of ordinary skill to add phosphate to the claimed concentrate of Copending Application No. 16/610,614 to impede precipitation of the dialysis solution and increase stability.
This is a provisional nonstatutory double patenting rejection.
4. Claims 19, 20, 23-26 and 39-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, 20, 21, 22-26, 28, and 30-35 of copending Application No. 16/610,614 in view of Yatzidis et al. (“On the Usefulness of Glycylglycine in Hemodialysis and Peritoneal Dialysis Solutions”, ASAIO Journal, 1996, 984-992) and Huppert et al. (US 2017/0296729 A1; published 2017) as applied claims 19, 20 and 40 above, and in further view of Ahmad et al. (“Dialysate Made From Dry Chemicals Using Citric Acid Increases Dialysis Dose”, American Journal of Kidney Diseases, 2000, pp.493-499).
The disclosures of claims 1, 7-9, 20, 21, 22-26, 28, and 30-35 of Copending Application No. 16/610,614, Yatzidis et al. and Huppert et al. are discussed above.
Regarding claims 23-26 and 39 and 41, Copending Application No. 16/610,614 claim set filed 05/21/2025, claims the concentrate includes glucose. Copending Application No. 16/610,614, Yatzidis et al. and Huppert et al. do not claim or teach the addition of citrate in the dialysis concentrate.
Ahmad et al. teach the addition of citrate to dialysate concentrates as anti-coagulant. See p. 493, right/left col.-bridging paragraph and p.499, col.1, 1st paragraph Ahmad et al. postulates the addition of citrate as an anti-coagulant improves dialysis efficiency. See p.499, cols. Right/left, bridging paragraph and col.-left, 1st paragraph. It would have been obvious to add citrate as an anti-coagulate. The motivation would be to increased dialysis efficiency as suggested by Ahmad et al.
Response to Arguments
Applicants’ arguments filed 12/16/2025, with respect to the 35 U.S.C 103 rejection, have been fully considered but they are not persuasive.
Applicants contend that one of ordinary skill would not have sought to prepare, in a single container, a dry composition for use in preparing a dialysis solution including no more than 0.2 mmol/L of phosphate and 5-100mmol/L of peptide, based on Sternby and Yatzidis, alone or in combination (see Remarks, filed 12/16/2025, pg. 8-11, 1st full paragraph). This argument has been fully considered but it is not persuasive.
In response to Applicants’ argument, it is acknowledged that there is not a single reference that teaches and/or suggests every claim limitation recited in instant claim 19 and the dependent claims. However, Applicants are respectfully reminded that the rejections supra are based on obviousness, and pursuant to MPEP 2142, 35 USC 103 authorizes a rejection where, to meet the claim, it is necessary to modify a single reference or to combine it with one or more other references (emphasis added). Additionally, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, as discussed above in the 35 U.S.C 103 rejection, Sternby teaches dialysis fluids that comprise phosphate, bicarbonate and/or lactate and electrolytes. Sternby also teaches that the dialysis fluids can be prepared from dry powder concentrates which can be dissolved and diluted into determined concentrations. With respect to the claimed container, it has been determined that the container does not change or alter the structure of the claimed solid composition (i.e., the interrelation of the first substance, the second substance, the bicarbonate and/or lactate, and the electrolytes).
Furthermore, Yatzidis teaches dialysis solutions comprising bicarbonate and glycylglycine and adds that the effective buffering capacity of the peritoneal dialysis solutions is due to the presence of bicarbonate and glycylglycine solutions, both of which remain undegraded, thus protecting each other, and achieving a constant pH of 7.35 and stability for long periods.
As such, the question is whether (1) a person of ordinary skill in the art would be motivated and/or expected to incorporate a peptide based on glycine (i.e., glycylglycine) to dry powder concentrates that can be dissolved and diluted into determined concentrations as taught by Sternby, and (2) whether a person of ordinary skill in the art would be motivated and/or expected that the dialysis solution prepared from the composition comprises phosphate in a concentration of up to 0.2 mmol/L; and the peptide in a concentration of 5-100 mmol/L. The Examiner maintains that the answers to these questions are yes in light of the teachings of Sternby and Yatzidis for questions 1 and 2.
Applicants also contend that one of ordinary skill in the art would not have sought to prepare a dialysis solution including, in combination, 0.2 mmol/L or less of phosphate and 5-100 mmol/L of peptide, as required by amended claim 19 (see Remarks, filed 12/16/2025, pg. 8 of 11, last paragraph). This argument has been fully considered but it is not persuasive.
It is the Examiner’s understanding that Applicants are suggesting that an one of ordinary skill in the art would not have been successful at achieving the claimed invention after reading Sternby and Yatzidis. Pursuant to MPEP 2143.02(II), obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). In the instant case, one of ordinary skill in the art would have been successful at achieving the claimed invention because dialysis solutions were known to include phosphate and a peptide based on glycine and because an ordinary skilled artisan would have been motivated to optimize the amount of the first substance and the amount of the second substance in order to achieve the desired concentrations of phosphate and glycylglycine present in the dialysis solution prepared from the solid composition.
In response to Applicants’ argument that the present application demonstrates that the phosphate and glycine-based peptide of the presently claimed compositions “can achieve a synergetic effect to obtain a more stable, more effective dialysis solution.” (see Remarks, filed 12/16/2025, pg. 9 of 11), have been fully considered but are not persuasive.
Pursuant to MPEP 716.02(c)(II), expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967). As previously discussed, Yatzidis et al. teach solutions for peritoneal dialysis which include glycylglycine, bicarbonate and electrolytes (i.e., sodium, chloride, potassium, calcium). Yatzidis et al. add that the effective buffering capacity of peritoneal dialysis solutions is due to the presence of bicarbonate and glycylglycine, both of which remain undegraded, thus protecting each other, and achieving a constant pH of 7.35 and stability for long periods. As such, Applicants’ results are expected and thus obvious, because prior to the effective filing date of the claimed invention it was known that dialysis solutions comprising glycylglycine, bicarbonate and electrolytes were stable for long periods, maintained a constant pH of 7.35 and the glycylglycine and bicarbonate remained undegraded.
Applicants assert that the compositions of Table 4 “need to be diluted 8-9 times, for example 8.8 times to obtain the dialysis solution” yielding a solution including about 0.04-0.1 mmol/L of phosphate and about 10.6-9.4 mmol/L of glycylglycine (see Remarks, filed 12/16/2025, pg. 9 of 11, and instant specification at pg. 8). This argument has been fully considered, but it is not persuasive.
Pursuant to MPEP 716.02(b)(I), the evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practically significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength “are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.”). See MPEP 716.02(b)(I).
In the instant case, the data depicted in Tables 3 and 4 of the instant specification fails to include the claimed concentration ranges of phosphate (i.e., up to 0.2 mmol/L) and the peptide (i.e., 5-100 mmol/L) of the dialysis solution prepared from the claimed solid composition. Thus, the data disclosed in Table 3 and Table 4 pertains to the amount of first component, second component and further components (i.e., bicarbonate and electrolytes) present in the claimed solid composition. Therefore, until statistical significance is given a determination of unexpected results cannot be made with respect to the “synergetic” effect of phosphate and glycine-based peptide in relation to a more stable, more effective dialysis solution.
Furthermore, the scope of claim 19 encompasses a dialysis solution prepared from the solid composition, wherein the dialysis solution comprises phosphate in a concentration of up to 0.2 mmol/L and comprises the peptide in a concentration of 5-100 mmol/L. The instant specification is silent about details pertaining to the specific concentration ranges of phosphate and the peptide in dialysis solutions prepared from the claimed solid composition, exhibiting improved stability (i.e., more stable) and improved function (i.e., more effective dialysis solution). Instead, the evidence provided in the specification, i.e., Table 3 and Table 4, shows the components present in the solid composition and their respective amounts.
MPEP 716.02(d)(I), states that [t]he nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979). MPEP 716.02(d)(II) also states that [t]o establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
As such, an ordinary skilled artisan would not be able to extend the unexpectedly improved stability and improved function attributed to the synergetic effect of phosphate and glycine-based peptide present in the solid composition to the scope of the dialysis solution prepared from the solid composition because a two compositions (see Table 4) that need to be diluted 8-9 times to obtain a dialysis solution including about 0.04-0.1 mmol/L of phosphate and about 10.6-9.4 mmol/L of glycylglycine are not sufficient to establish a reasonable expectation of unexpected results over the entire claimed genera and ranges. Thus, contrary to Applicants’ argument, the Office has set forth a proper prima facie showing of obviousness, thereby the rejection of claims 20, 23-26 and 39-41 has been maintained.
Applicant’s request to hold the present double-patenting rejections be held in abeyance until the claims are otherwise in condition for allowance is acknowledged. As such, the double-patenting rejections are maintained.
Conclusion
No claims are allowed.
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.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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