DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/23/2025 has been considered by the examiner.
Reference C4 has not been considered and has been crossed out on the IDS because a date of publication is not listed on the IDS.
Status of the Claims
The response filed 09/23/2025 is acknowledged.
Claims 1-15 are pending.
Claim 15 is new.
Claims 5-14 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2024.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Withdrawn
The rejection of claims 1-4 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subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention has been withdrawn because of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 09/23/2025 have been fully considered but they are not persuasive.
A. Claims 1-3 in view of Smith
Applicant has argued not all liquid electrolyte compositions should be used in all cases. Applicant argues Smith goes on to detail four "requirements" of electrolyte composition requirements (sodium concentration, agents that facilitate sodium absorption, alkalinizing agent to correct acidosis in calves with diarrhea, and energy) and factors to consider for appropriate selection of each "requirement." Applicant argues the Office's assertion that it would thus have been obvious to formulate a composition having any concentration of sodium ions, potassium ions, chloride ions, and alkalinizing agent within the broad ranges taught for each in Table 1 with a sugar and have a reasonable expectation of success of rehydrating calves suffering from neonatal diarrhea is therefore an oversimplification that improperly discounts Smith's teachings regarding the nuances and trials required in developing a liquid electrolyte composition to provide optimal rehydration.
These arguments are unpersuasive.
The claimed subject matter is directed to a liquid electrolyte composition. The claim is not a method claim requiring administration to any particular patient population. The compositions in Table 1 of Smith are all liquid electrolyte compositions having utility for electrolyte therapy. The ranges for sodium, potassium, potassium, chloride, strong ion difference, alkalinizing agent, and total osmolality in Table 1 of Smith were all taught as effective concentrations for electrolytes in electrolyte therapy for rehydration.
Applicant cannot find the Office's suggested teaching in Smith that liquid electrolyte compositions that are "roughly isotonic, e.g., 280-300 mOsm/L" should be used "to avoid worsening diarrhea and reduce the risk of abomasal bloat." Applicant argues the Office cites page 5 of Smith in making this assertion, but there is no page 5 in Smith. Applicant argues Smith teaches that "electrolyte solutions with high osmolalities (>650 mOsm/L) have been shown to significantly slow abomasal bloat in calves." Id., page 409, "Key Points." Applicant argues Smith teaches that "roughly isotonic" compositions of 280-300 mOsm/L are commercially available in North America. Id., page 413. Applicant argues Smith does not directly tie "roughly isotonic" liquid electrolyte compositions or liquid electrolyte compositions with osmolalities of 280-300 mOsm/L to treating diarrhea or reducing risk of abomasal bloat. Applicant argues that the Office's rationale that a person of ordinary skill in the art would have found it obvious to formulate a composition with an osmolality in the range of from 280-300 mOsm/kg misplaced since the purported motivation to do so, i.e., the alleged teaching in Smith, is not present.
This argument is unpersuasive.
The fifth page of the Smith reference (pg. 413) starts with the title Osmolality. The first range listed is roughly isotonic (280-300 mOsm/L). Smith clearly discloses electrolyte compositions having a roughly isotonic osmolality, e.g., 280-300 mOsm/L, as effective for electrolyte therapy.
Respectfully, Applicant’s quote from pg. 409 of Smith is incorrect. Key point three states electrolyte solutions with high osmolality (>650 mOsm/L) … can be a risk factor for abomasal bloat (emphasis added). Rather than slowing abomasal bloat as argued, the selected portion of Smith (pg. 409) cited by Applicant clearly indicates electrolyte compositions having an omolality of less than 650 mOsm/L will reduce the risk of abomasal bloat which agrees with Smith pg. 413 cited as “pg. 5” in the previous rejection. The claimed range is within this range suggested by Smith to reduce the risk of abomasal bloat as set forth in the rejection. The roughly isotonic range (280-300 mOsm/L) is clearly within the range of less than 650 mOsm/L which is suggested to avoid abomasal bloat (Smith, pg. 409). Abomasal bloat is a syndrome that is characterized by anorexia, abdominal distension, bloat, and often death in 6 to 48 hours (Smith, pg. 5/19 “pg. 413”, e.g., ¶ 3).
Smith, e.g., pg. 413, e.g., ¶ 2, cited as “pg. 5” in the rejection, also states electrolyte solutions with extremely high osmolality, e.g., greater than 700, and high glucose concentrations might cause problems, e.g., could worsen diarrhea. This is another reason the skilled artisan would have been led to select a lower osmolality for the electrolyte composition.
Thus, there was motivation from Smith to formulate an electrolyte composition with an isotonic osmolality ranging from 280-300 mOsm/L since it is a clearly disclosed range in Smith which is effective for electrolyte delivery, and the range is within the range identified in Smith as effective to reduce the risk of abomasal bloat which may result in death in 6 to 48 hours.
Applicant has argued that liquid electrolyte compositions of claim 1 containing specific concentrations of sodium ions, potassium ions, chloride ions, and alkalinizing agent, and having specific osmolality and strong ion difference (SID), provided better rehydration and correction of metabolic acidosis in calves suffering from diarrhea. Applicant has argued that in Example 1 of Applicant's specification, the isotonic ("ISO") and hypotonic ("HYPO") liquid electrolyte compositions, which fall within the scope of claim 1, resulted in higher body weights (Table 2), higher fluid intake (Table 3), lower fecal loss (Table 3), and better blood acid-base balance (Table 4) than liquid electrolyte compositions falling outside of the claimed ranges, e.g., the control ("CON") or hypertonic ("HYPER") liquid electrolyte compositions.
These arguments are unpersuasive.
The claimed invention is directed to the compositions themselves rather than a method of treatment in which specific compositions were administered to a specific patient population using a specific protocol.
The claimed compositions are not limited to the specific concentrations of sodium ions, potassium ions, chloride ions, alkalinizing agent, specific osmolality, and strong ion difference reported in Tables 1, 2, 3, and 4.
Thus, the results are not commensurate in scope with the claimed invention.
Additionally, there is no statistical treatment of the data showing the results are statistically significant which would be indicative of a practical difference.
Additionally, the hypertonic solution results show an improvement in body weight, water balance, and blood acid-base balance in milk fed calves relative to the control. Thus, the data is insufficient to establish the ISO and HYPO compositions offer unexpected effects not seen in the HYER formulations.
Applicant has argued the finding in the specification that liquid electrolyte compositions with an osmolality ranging from 200-315 mOsm/kg provide superior weight gain is entirely contrary to teachings of Smith. Applicant argues Smith teaches that treatment with liquid electrolyte compositions with high osmolality, i.e., greater than 350 mOsm/L, prevented more weight loss in calves than treatment with liquid electrolyte compositions with low osmolality: "Research has also shown that when calves were deprived of milk, those fed low- osmolality oral electrolyte solutions had significantly greater weight loss than calves fed high-osmolality oral electrolytes." Smith, page 413.
This argument is unpersuasive.
Smith, pg. 413, notes that in calves deprived of milk, those fed low osmolality oral electrolyte solutions had significantly greater weight loss than calves fed high-osmolality oral electrolytes. The examples in the specification were not performed on calves deprived of milk. Each of the calves were fed milk replacer twice a day (Specification, e.g., pg. 8, Example 1, ¶ 2). It is unclear where the Specification shows increased weight gain in calves deprived of milk.
It was understood that higher osmolality compositions offer higher energy levels because the primary difference between higher and lower tonicity composition is the amount of glucose added to the composition, i.e., higher tonicity contains higher energy because they contain an increased glucose concentration (Smith, e.g., pg. 413, e.g., ¶ 1, cited as “pg. 5” in the previous Office action).
Applicant argues Smith teaches away-that is, in an opposite direction-from Applicant's claimed range of 60-88 mM sodium ions, stating that "...most research suggests it should be between 90 and 130 mM/L. Products containing sodium at lower concentrations are not able to adequately correct dehydration." Smith, page 412.
This argument is unpersuasive when Smith and the cited art are considered as a whole.
Smith, e.g., pg. 412 states the ideal sodium concentration is not completely known but most research suggests it should be between 90 and 130 mM/L Thus, the skilled artisan would have understood that the ideal sodium concentration may be around or below 90 mM. This is close to the upper limit of 88 mMol encompassed by the claimed invention.
Further, Smith, e.g., Table 1, reports a number of available oral electrolyte compositions known at the time had a sodium concentration less than 90 mM, e.g., 46 mM, 59 mM, 67 mM, and 75 mM. From Smith, Table 1, the skilled artisan would have concluded a number of available compositions for electrolyte therapy actually have a concentration lower than 90 mM.
Further, Hardin, US 20110245171 teaches oral rehydration solutions wherein sodium may be added at 20-100 mEq/L with a preferred level of from 40-60 mEq/L for formulations for treatment of acute dehydration and 75-90 mEq/L for formulations for prevention of dehydration or maintenance of hydration (Hardin, e.g., 0064). The teachings of Hardin clearly suggest sodium concentrations less than 90 mM and within the claimed range were known and effective for hydration.
Further, Remesy (US 6616839) teaches rehydration fluid for young animals having a sodium ion concentration less than 90 mM (Remesy, e.g., c7, tables).
Further, as of 2020, Washio, US 10869492 reported oral rehydration solutions containing electrolytes effective for treating dehydration in subjects when the sodium concentration ranges from 60- 90 mM (mEq/L). See Washio, e.g., c1:24-40. Thus, even after Smith’s publication, there was art suggesting oral rehydration compositions having a sodium concentration of less than 90 mM, e.g., 60-90mM as effective for hydration. This range overlaps significantly with the claimed range of 60-88 mM.
Thus, when considered as a whole, the prior art of record does not teach away from the invention as claimed.
Applicant has argued that Smith teaches away from Applicant's claimed osmolality range of 200-315 mOsm/kg. Applicant argues Smith teaches that low osmolality liquid electrolyte compositions result in "significantly greater weight loss" (an undesirable outcome) compared to high osmolality liquid electrolyte compositions. Smith also describes that high osmolality liquid electrolyte compositions provide more nutritional support and better blood balance while preventing more weight loss compared to low osmolality electrolyte compositions.
This is unpersuasive.
Smith teaches low osmolality liquid electrolyte compositions result in "significantly greater weight loss" only when milk is withheld from calves. Additionally, Smith teaches lower osmolality solutions may be appropriate for calves that are still suckling or in conjunction with a milk replacer in calves which maintained a good appetite (Smith, e.g., pg. 414, ¶ 1).
B. Claims 1-3 in view of Washio, US 10869492
Applicant argues Washio does not teach a composition that overlaps with the liquid electrolyte composition of amended claim 1. Applicant argues Washio, e.g., claim 1, contains 10-30 mM trisodium citrate, an amount well below the claimed 50-99 mM of alkalinizing agent specified in claim 1. Applicant argues a prima facie case of obviousness has not been established.
This argument is unpersuasive.
The specification indicates the term alkalinizing agent encompasses, e.g., citrate (Specification, e.g., pg. 6:6-8). Wahio, e.g., claim 1 teaches the solution comprises citric acid and trisodium citrate at a total concentration of 80 mM or lower (Washio, e.g., claim 1). Thus, Washio, e.g., claim 1, teaches a composition having a citrate concentration of 80 mM or lower.
When citric acid dissolves in water it releases protons to form a citrate ion. See the citric acid document, pp. 2-3 (Citric acid, brainly.com, 2025).
Hardin, US 20110245171 (of record) teaches citric acid is a source of citrate (Hardin, e.g., 0070).
Smith teaches acetate, propionate, bicarbonate, and citrate were all considered alkalinizing agents (Smith, e.g., pg. 414, Alkalinizing Ability, ¶ 2).
The combination of citrate salt with citric acid was a known alkalinizing agent. See Steer, e.g., 20100136113, pg. 63, Table 2 (BICITRA (sodium citrate and citric acid – alkalinizing agent used in those conditions where long term maintenance of alkaline urine is desirable)).
Thus, Washio teaches a composition having citrate (alkalinizing agent as claimed) which is present at a concentration of less than 80 mM (Washio, e.g., claim 1). Wahsio’s concentration overlaps with the claimed limitation of 50-90 mM of an alkalinizing agent.
C. Claims 1-4 in view of Washio and Morgan
Applicant argues claims 1-3 are non-obvious over Washio as evidenced by "How are Osmolarity and Osmolality Different". Claim 4 depends from claim 1 and therefore is also non-obvious over Washio and "How are Osmolarity and Osmolality Different" for at least the same reason. The Office cites Morgan for teaching "lactose was a known carbohydrate equivalent for glucose." Id., page 8. Thus, Morgan fails to impact the above analysis.
This argument is unpersuasive. As enumerated above, Washio teaches compositions having a citrate (citric acid/potassium citrate) concentration of less than 80 mM, which concentration overlaps with the claimed limitation of 50-90 mM of an alkalinizing agent.
D. Claims 1-4 in view of Smith and Remesy
Applicant argues that as described above in Section A., claims 1-3 are non-obvious over Smith as evidenced by "How are Osmolarity and Osmolality Different". Applicant argues Claim 4 depends from claim 1 and therefore is also non-obvious over Smith as evidenced by "How are Osmolarity and Osmolality Different"
This argument is unpersuasive.
For the reasons outlined under section A above, it is not agreed claims 1-3 are non-obvious over Smith as evidenced by "How are Osmolarity and Osmolality Different."
E. Claims 1-3 in view of Hardin and Smith
Applicant disagrees with the Office's obviousness rationale, and submits that a person of ordinary skill in the art would not have been motivated to combine Hardin and Smith as posited by the Office. Applicant argues Smith teaches away from Applicant's claimed osmolality range of 200-315 mOsm/kg. Applicant argues Smith describes that calves treated with liquid electrolyte solutions of low osmolality (<350 mOsm/L) led to greater weight loss, poorer nutritional support, and poorer blood balance compared to treatment with liquid electrolyte solutions of higher osmolality. Applicant argues a person of ordinary skill in the art would have been motivated to "optimize the osmolality" of Hardin's oral rehydration composition to the high osmolality ranges taught in Smith as favored, i.e., in the opposite direction of Applicant's claimed osmolality range.
This argument is unpersuasive.
For the reasons set forth in section A above, it is not agreed that Smith teaches away from the claimed osmolality ranging from 200-315 mOsm/Kg. Smith as evidenced by How are Osmolarity and Osmolality Different teaches electrolyte solutions having an osmolality which are roughly isotonic, e.g., 280-300 mOsm/L as effective for hydration, reduce the risk of abomasal bloat, and avoid worsening diarrhea. Smith teaches lower osmolality solutions may be appropriate for calves that are still suckling or in conjunction with a milk replacer in calves which maintained a good appetite (Smith, e.g., pg. 414, ¶ 1). Thus, Smith as evidenced by How are Osmolarity and Osmolality Different cures any deficiency in Hardin with respect to the claimed osmolality range.
F. Claims 1-4 in view of Hardin, Smith, and Remesy
Applicant argues that as set forth in Section E., claims 1-3 are non-obvious over Hardin in view of Smith. Claim 4 depends from claim 1 and therefore is also non-obvious over Hardin in view of Smith for at least the same reason. Applicant argues the Office cites Remesy for teaching "lactose was a known carbohydrate equivalent for glucose." Id., page 12. Applicant argues Remesy fails to impact the above analysis.
This argument is unpersuasive. It is not agreed that claims 1-3 are non-obvious over Hardin in view of Smith. Remesy cures any deficiency in the combined teachings of Hardin and Smith with respect to lactose as recited in claim 4.
Rejections Addressing Applicant’s Amendment
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 of this title, 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 1-3, and new claim 15, are rejected under 35 U.S.C. 103 as being unpatentable over Smith, Vet Clin Food Anim 30, 2014 (cited on Applicant’s IDS dated 21 March, 2022) as evidenced by How are Osmolarity and Osmolality Different, 2014.
Smith teaches oral rehydration solutions and electrolyte therapy (Smith, e.g., title, pp. 409-410).
Smith teaches a number of known formulations containing sodium, potassium, and an alkalinizing agent, which formulations are also characterized by strong ion difference (SID) and osmolality (Smith, e.g., pg. 411, e.g., table 1).
Smith reports osmolality in units of mOsm/L while the claimed unit is mOsm/Kg. However, Smith’s mmol/L overlaps significantly with the claimed range of 200-315 mosm/kg. Osmolarity and osmolality are practically the same value at the claimed concentrations. See How are Osmolarity and Osmolality Different, 2014. Dilute solutions, e.g., osmolarity of 291 mOsm/L is almost numerically the same as the osmolality 292 mOsm/kg.
Applicable to claim 15: Smith teaches wherein the alkalinizing agent is propionate.
None of the compositions in Table 1 of Smith have a combination of values within each of the claimed ranges.
However, considering the tabulated known formulations from Smith table 1, the skilled artisan sees that Smith teaches compositions comprising 45-150 mM sodium including values within the claimed range, 7-50 mM potassium including values within the claimed range, 20-112 chloride including values within the claimed range, SID 20-136 including values within the claimed range, an alkalinizing agent, and an osmolality ranging from 245-731 including values within the claimed range. See Smith, e.g., Table 1). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05
None of the compositions Table 1 expressly recite one or more sugars. However, Smith teaches sugar is routinely included in oral electrolyte products to promote sodium absorption (Smith, e.g., pg. 412: sodium absorption).
Smith teaches compositions may be roughly isotonic, e.g., 280-300 mOsm/L to avoid worsening diarrhea and reduce the risk of abomasal bloat (Smith, e.g., pg. 5).
It would have been obvious before the effective filing date of the presently claimed invention to prepare a composition comprising 45-150 mM sodium, 7-50 mM potassium, 20-112 chloride, an SID 20-136, an alkalinizing agent, an osmolality ranging from 245-731 e.g., 280-300, and a sugar for improving sodium absorption with a reasonable expectation of success. Each of the claimed ranges overlap with the ranges suggested by Smith, table 1. The skilled artisan would have been motivated to further modify the composition with a sugar to activate transport of sodium in the intestine for improved electrolyte replacement in the same way suggested by Smith. The skilled artisan would have been motivated to formulate the osmolality of in the range of from 280-300 to avoid worsening diarrhea and/or to prevent abomasal bloat. The skilled artisan would have had a reasonable expectation of success because Smith suggests nearly all oral electrolyte formulations contain a mixture of sodium and glucose.
Accordingly, the subject matter of claims 1-3 and new claim 15 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Washio, US 10869492 as evidenced by How are Osmolarity and Osmolality Different, 2014.
Washio teaches a Ready-To-Drink Oral Rehydration Solution product comprising an Oral Rehydration Solution in a sealed container, the Oral Rehydration Solution comprising, in an electrolyzed acidic water: a combination of buffering components consisting of: 40 to 80 mM citric acid and 10 to 30 mM trisodium citrate; and glucose and sodium chloride, wherein the Oral Rehydration Solution has a pH of 3.0 or higher but lower than 4.0, wherein the Oral Rehydration Solution comprises sodium at 50 to 90 mEq/L, potassium at 15 to 25 mEq/L, chloride at 50 to 80 mEq/L, glucose at a molar concentration at least equal to that of sodium but not exceeding 111 mmol/L, and no phosphorus, and has an osmolarity of 200 to 310 mmol/L, provided that the Oral Rehydration Solution comprises: citric acid and trisodium citrate at a total concentration of 80 mM or lower; 70 to 111 mM glucose, and 35 to 50 mM sodium chloride, the method comprising: a step of electrolyzing a water containing an electrolyte to obtain the electrolyzed acidic water; a step of adding: the combination of buffering components consisting of citric acid and trisodium citrate; and glucose and sodium chloride to the electrolyzed acidic water to obtain the Oral Rehydration Solution; and a step of sealing the Oral Rehydration Solution into a container, wherein the electrolyte contained in the water during the electrolysis comprises: citric acid; or trisodium citrate; or citric acid and trisodium citrate (Washio, e.g., claim 1).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
The composition contains sodium ions, potassium ions, chloride ions and alkalinizing agent (citrate) in amounts overlapping with the claimed amounts. The compositions further comprise a sugar (glucose). The osmolarity of 200 to 310 mmol/L overlaps significantly with the claimed range of 200-315 mosm/kg. Osmolarity and osmolality are practically the same value at the claimed concentrations. See How are Osmolarity and Osmolality Different, 2014. Dilute solutions, e.g., osmolarity of 291 mOsm/L is almost numerically the same as the osmolality 292 mOsm/kg.
Washio does not expressly teach the strong ion difference as defined by SID=[Na+]+[K+]-[Cl−] and expressed in mEq/L or mM. However, Washio’s compositions have a sodium ion concentration [Na+] of 50 to 90 mEq/L, a potassium ion concentration [K+] of 15 to 25 mEq/L, and a chloride ion concentration [Cl−] of 50 to 80 mEq/L. Therefore, Washio’s compositions necessarily have a strong ion difference and it may be calculated as ranging from 50+15-80 = -15 to 90+25-50 = 65. The claimed range overlaps with this SID range for Wahsio’s compositions and there does not appear to be any criticality or unexpected result shown for the claimed range which is commensurate in scope with the claimed invention. IN the specification, the compositions: ISO, HYPO, and HYPER all have the same SID [76].
Although Washio does not teach a single embodiment having values for each recited component in the claimed ranges, the ranges for each of the recited elements overlap with the claimed ranges.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
It would have been obvious before the effective filing date of the presently claimed invention to combine a sugar, sodium ions, potassium ions, chloride ions, and alkalinizing agent in amounts suggested in Washio to arrive at a composition characterized as having an mOsm/L and strong ion difference in the claimed ranges with a reasonable expectation of success. The skilled artisan would have been motivated to formulate a sugar with sodium ions, potassium ions, chloride ions, and alkalinizing agent in amounts suggested in Washio to arrive at a beverage product for rehydration with a reasonable expectation of success. Washio provides an express teaching which would have prompted the skilled artisan to combine the recited ingredients in similar, overlapping, amounts to arrive at a beverage useful for rehydration with a reasonable expectation of success.
Accordingly, the subject matter of claims 1-3 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Washio, US 10869492 as evidenced by How are Osmolarity and Osmolality Different, 2014 and Morgan, US 20210169115.
The teachings of Washio as evidenced by How are Osmolarity and Osmolality Different, 2014 enumerated above apply here.
The teachings of Washio teach the composition comprising a sugar, e.g., glucose but do not expressly teach wherein the composition comprises lactose.
However, lactose was a known carbohydrate equivalent for glucose. See Morgan, e.g., 0057.
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions suggested by Washio by substituting lactose for glucose with a reasonable expectation of success. Lactose was a known carbohydrate alternative for glucose as employed by Washio. The skilled artisan would have seen this modification as the substitution of one known carbohydrate for another to achieve predictable results. The skilled artisan would have had a reasonable expectation of success because each document teaches compositions for maintenance of health.
Accordingly, the subject matter of claims 1-4 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
New claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Washio, US 10869492 as evidenced by How are Osmolarity and Osmolality Different, 2014 as applied to claims 1-3 above, and further in view of Smith, Vet Clin Food Anim 30, 2014 (cited on Applicant’s IDS dated 21 March, 2022).
Washio teaches compositions including an alkalinizing agent, e.g., citrate (Washio, e.g., claim 1). However, Washio does not expressly teach compositions comprising propionate.
Smith teaches citrate and propionate were both known and used as alkalinizing agents for electrolyte compositions effective at correcting acidosis (Smith, e.g., pp. 414-415).
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions known from Washio by incorporating propionate with a reasonable expectation of success. The skilled artisan would have seen this modification as a combination of two known agents, each known from the art as alkalinizing agents, and useful for correcting acidosis into a single composition useful for the same purpose. See MPEP 2144.06, I.
Accordingly, the subject matter of claim 15 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-4 and new claim 15 are rejected under 35 U.S.C. 103 as being unpatentable over Smith, Vet Clin Food Anim 30, 2014 (cited on Applicant’s IDS dated 21 March, 2022) as evidenced by How are Osmolarity and Osmolality Different, 2014 in view of Remesy, US 6616939.
The teachings of Smith enumerated above apply here with respect to claims 1-3 and new claim 15.
Smith teaches compositions comprising a sugar such as glucose but does not expressly teach lactose.
However, lactose was a known carbohydrate equivalent for glucose. Remesy teaches the sugar lactose may be used in rehydration and suggests lactose participates in sodium cotransport like glucose (Remesy, e.g., c2:45-52). Remesy teaches compositions similar to those of Smith, e.g., including 87.5 mM sodium, 25 mM potassium, 55.5 mM chloride, lactose, and alkalinizing agents (Remesy, e.g., c7, Tables).
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions suggested by Smith by substituting lactose for glucose with a reasonable expectation of success. Lactose was a known carbohydrate alternative for glucose seen from the teachings of Remesy. The skilled artisan would have seen this modification as the substitution of one known carbohydrate for another to achieve predictable results. The skilled artisan would have had a reasonable expectation of success because each document teaches compositions for maintenance of health and hydration.
Accordingly, the subject matter of claims 1-4 and 15 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-3 and new claim 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hardin, US 20110245171 in view of Smith, Vet Clin Food Anim 30, 2014 (cited on Applicant’s IDS dated 21 March, 2022) as evidenced by How are Osmolarity and Osmolality Different, 2014.
Hardin teaches an ORS solution containing water, carbohydrate, sodium ions, potassium ions, chloride ions and citrate ions. Sodium can be added at 20-100 mEq/L with a preferred level of from 40-60 mEq/L for formulations for treatment of acute dehydration and 75-90 mEq/L for formulations for prevention of dehydration or maintenance of hydration. Preferred potassium levels are from 20-30 mEq/L with a broad range of 10-100 mEq/L operable. The chloride anion is normally added at 30-80 mEq/L with a broad range of 25-100 mEq/L operable. The source of base is generally selected from the group consisting of acetate, lactate, citrate or bicarbonate and is normally added at a range of 25-40 mEq/L with a broad range of 10-50 mEq/L operable. See Hardin, e.g., 0064-0070. The claimed amounts overlap with or are within the ranges for sodium, potassium, chloride, base (alkalinizing agent) suggested by Hardin.
Hardin does not expressly teach the osmolality in the range of 200-315 or strong ion difference in the range of 60-80 mM.
However, Smith teaches compositions for rehydration may be roughly isotonic, e.g., 280-300 mOsm/L to avoid worsening diarrhea and reduce the risk of abomasal bloat (Smith, e.g., pg. 5). Smith further teaches strong ion difference ranging from 60-80 meq/L for oral electrolyte products effective to maintain hydration in patients with diarrhea (Smith, e.g., pp. 414-416, Alkalinizing ability).
Smith reports osmolality in units of mOsm/L while the claimed unit is mOsm/Kg. However, Smith’s mmol/L overlaps significantly with the claimed range of 200-315 mosm/kg. Osmolarity and osmolality are practically the same value at the claimed concentrations. See How are Osmolarity and Osmolality Different, 2014. Dilute solutions, e.g., osmolarity of 291 mOsm/L is almost numerically the same as the osmolality 292 mOsm/kg.
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions for hydration known from Hardin by optimizing the osmolality in the range of from 280-300 and the strong ion difference ranging from 60-80 as suggested by Smith with a reasonable expectation of success. The skilled artisan would have been motivated to optimize the osmolality and strong ion difference of the composition in the ranges suggested by Smith for improved hydration and possibly correcting acidosis in the same way. The skilled artisan would have had a reasonable expectation of success because each reference teaches compositions for improved hydration.
Applicable to claim 2: The claimed chloride ion concentration overlaps with the range suggested by Hardin. Moreover, as evident from Smith, e.g., Table 1, pg. 411, hydrating compositions were known having chloride concentrations in the claimed range, e.g., 20 mM and 30 mM.
Applicable to claims 3 and 15: Hardin teaches acetate (Hardin, e.g., 0064). Smith teaches acetate and propionate show several similar advantages (Smith, e.g., pp. 414-415).
Applicable to new claim 15: It would have been obvious before the effective filing date of the presently claimed invention to modify compositions of Hardin with a propionate alkalinizing agent with a reasonable expectation of success. The skilled artisan would have seen this modification as a combination of two known agents each recognized by the art as alkalinizing agents useful for correcting acidosis, and which offer a number of similar advantages, into a single composition useful for the same purpose. See MPEP 2144.06, I.
Accordingly, the subject matter of claims 1-3 and 15 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hardin, US 20110245171 in view of Smith, Vet Clin Food Anim 30, 2014 (cited on Applicant’s IDS dated 21 March, 2022) and Remesy, US 6616939 as evidenced by How are Osmolarity and Osmolality Different, 2014.
The combined teachings of Hardin and Smith teach compositions comprising a sugar such as glucose but does not expressly teach lactose.
However, lactose was a known carbohydrate equivalent for glucose. Remesy teaches the sugar lactose may be used in rehydration and suggests lactose participates in sodium cotransport like glucose (Remesy, e.g., c2:45-52). Remesy teaches compositions similar to those of Hardin and Smith, e.g., including 87.5 mM sodium, 25 mM potassium, 55.5 mM chloride, lactose, and alkalinizing agents (Remesy, e.g., c7, Tables).
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions suggested by Hardin and Smith by substituting lactose for glucose with a reasonable expectation of success. Lactose was a known carbohydrate alternative for glucose seen from the teachings of Remesy. The skilled artisan would have seen this modification as the substitution of one known carbohydrate for another to achieve predictable results. The skilled artisan would have had a reasonable expectation of success because each document teaches compositions for maintenance of health and hydration.
Accordingly, the subject matter of claims 1-4 and 15 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is 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.
Correspondence
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615