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 . Claims 28-30 and 33-34 (Group I) are examined herein.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 28 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims require: “wherein the pH of the beverage and hot fill packaging stabilizes the calcium therein”. Looking toward for related discussion on the topic in the pending Specification, this is what is found in the pending paragraphs:
On stability via pH
High acid environments help stabilize the calcium, including:
using an organic acid pH control composition so that calcium-containing components, for example, calcium phosphate, or magnesium-containing components, as well as other mineral components, do not precipitate from the hydration beverage at a pH of 4.0 or less (0104); and
heat treating at pH 3.6 or higher cause calcium and other mineral components to precipitate, leaving a thick sandy residue at the bottom of the container (0056, 0177).
Note: Although citric acid is claimed, calcium-containing components including: calcium phosphate are not, therefore one of skill in the art would not understand that Applicant had possession of the combination of a pH of less than 3.6 and hot fill packaging stabilizing it. Further, nothing discussed about a hot fill process indicates that this process step stabilizes calcium.
On stability via heat treatment
To create a shelf stable hydration beverage made from permeate, the beverage:
i) is heated to at least 175 degrees F for less than 5 minutes and filled into containers while hot (0008, 0010, 0057, 0068, 0188);
ii) undergoes an Ultra High Temperature (UHT) pasteurization process with aseptic fill (0188-0189); or
III) is sterilized by a retort heating process (after fill) (0189).
Note: Since calcium is not claimed, one of skill in the art would not understand that Applicant had possession of the combination of a pH of less than 3.6 and hot fill packaging stabilizing it. Further, nothing discussed about a hot fill process indicates that this process step stabilizes calcium.
Other forms of stabilizing the beverage
A shelf stable hydration beverage comprising dairy permeate can be made by hydrolyze the permeate with lactase enzymes to break down the disaccharide lactose into to its two monosaccharide components, glucose and galactose, wherein the lactose levels are < 0.1% in the finished product the hydrolysis is complete (0165).
Note: The discussion toward hydrolyzing the permeate with lactase enzymes indicates a step of hot filling or a required pH of the solution it will be mixed with thereafter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly cl
aiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 28, 34 and all claims dependent on them, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 28 and 34, it is unclear if the sodium salt is a first sodium and the sodium ion concentration is a second one; or the sodium salt is sodium chloride, comprising: a chloride concentration of about 20-40 mMol/L and a sodium ion concentration of about 10-50 mMol/L; or something else. Claim 34 has a similar problem.
It has been held that under 35 U.S.C. § 112(b), Appellant’s claims must particularly point out and distinctly claim the subject matter the applicant regards as the invention. The statutory language of particularity and distinctness indicates that claims must be cast in clear and not vague or ambiguous, terms. If, instead, “a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (precedential).
Further, the claims recite: “the pH of the beverage and hot fill packaging stabilizes the calcium therein”, which is indefinite, because:
“the calcium” lacks antecedent bases; and
calcium is not a claimed component of the beverage, therefore it is unclear as to how it can be stabilized, or how such a limitation further limits the claim.
Note: The only support found in the pending specification for calcium being stabilized is when in the form of calcium-containing components including: calcium phosphate, wherein it is stabilize via the used with enough organic acid (i.e. specifically citric acid) to lower the pH (0020, and 0104).
Claim Interpretation
With regard to the prior art, the phrase the pH of the beverage and hot fill packaging stabilizes the calcium therein, encompasses that the beverage is shelf stable.
With regard to the prior art, claim 28, encompasses:
A liquid hydration beverage comprising:
a liquid dairy permeate;
an acidification agent including citric acid;
zero to 6 wt% of carbohydrates, including: 0 to 0.1 wt% lactose (which imparts 0 to 0.1 wt% lactose in zero to 6 wt% of carbohydrates meaning zero to 0.006 wt% of lactose [0.1 / 6]);
a sodium salt (sodium chloride, per pending 00184), comprising:
about 20-40 mMol/L of chloride concentrations; and
about 10-50 mMol/L of sodium ions;
a pH of less than 3.60;
wherein the beverage is shelf stable.
With regard to the prior art, claim 34, encompasses: all of the limitations of claim 28, and further requires: wherein the liquid dairy permeate, includes: a liquid milk permeate, a liquid whey permeate, a liquid microfiltered milk a/k/a native whey, or a liquid milk co-product whey; and wherein the sodium salt, includes: sodium chloride, table salt, or sea salt.
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.
Claim(s) 28-30 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Mikkelson (US 20160255848) in view of Martyn.
Martyn: Nutritional Compositions; WO 2012/013975, published 2/02/2012.
Independent claim 28
Mikkelson teaches methods of making liquid food, including: beverages (0168), which encompasses a liquid beverage, as claimed.
A dairy permeate
Mikkelson teaches the beverages comprise a liquid dairy permeate, including: a liquid whey permeate, a liquid microfiltered milk a/k/a native whey or a liquid milk co-product whey (0048), which encompasses a liquid dairy permeate, as claimed.
However, it is noted that the matter of the form of ingredients in the composition, prior to their use is toward a product by process limitations, which makes no distinction over the composition being in a liquid form, because determination of patentability is based solely on the claimed product itself. The patentability of a product does not depend on its method of production. In this case, since the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
An acidification agent/pH
Mikkelson teaches the beverages comprise food acids, including: citric acid (0321), wherein the beverages are acidified, having a pH of at most 5.5, wherein even lower pH ranges are employed (0318), which encompasses an acidification agent including citric acid; and a pH of less than 3.6, as claimed.
A sodium salt (i.e. sodium/chloride ions)
Mikkelson teaches the beverages comprises minerals, including sodium (0196), including the optional use of sodium chloride (NaCl).
Mikkelson does not discuss the concentrations of chloride and sodium in the beverages.
Martyn also teaches methods of making beverages, including sports/rehydration types (ab.; and pg. 8, ln. 28+) and further provides the use of sodium chloride in an amount of from about 1 to 300 mmol/L (pg. 13, ln. 14+), a source of chloride, as claimed.
Since sodium chloride has a chloride ion concentration of about 61%, and a sodium ion concentration of about 40%, Martyn’s beverage would include:
about 0.6 to 183 mmol/L of chloride ions, and about 0.4 to 120 mmol/L of sodium ions, which encompasses the claimed chloride concentration of about 20-40 mMol/L, and sodium ion concentration of about 10-50 mMol/L.
Martyn further provides that salt comprising chloride provides the benefit of replenishing the electrolytes lost during exercise, facilitating intestinal reabsorption of fluids, and facilitating energy dependent processes (pg. 13, ln. 14+), this prior art provision shows advantages to its use, which presents a convincing line of reasoning to suggested motivation. See MPEP 2144.II that states: The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
Therefore, it would have been obvious to one of skill in the art, at the time of filing/the invention to modify the method of making beverages comprising sodium chloride, as the modified teaching above, to include the concentrations of sodium and chloride in the beverages, including: a chloride concentration of about 20-40 mMol/L, and sodium ion concentration of about 10-50 mMol/L, as claimed, because:
1) the prior art, in Martyn, provides multiple advantages from the use of sodium chloride, including that it replenishes electrolytes lost during exercise, facilitates intestinal reabsorption of fluids, and facilitates the energy dependent processes, wherein the strongest rationale for combining references because the advantages taught provide a recognition in the prior art from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination (see MPEP 2144.II that states: The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination: and
2) Martyn shows that it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select the claimed processing step of crushing when making beverage products, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use (see MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious).
A nutritional carbohydrate value
Mikkelson teaches the beverages comprises from 1 to 80 wt% of carbohydrates (0186), which encompasses the claim of zero to 6 wt% carbohydrates.
Lactose
Mikkelson teaches the beverages include: lactose free types (0150), which encompasses a lactose concentration of, which encompasses zero to 0.1% of lactose, in zero to 6 wt% of a carbohydrate, as claimed.
Shelf stable
When looking for light in the pending specification, it is disclosed, that:
the pH of the beverage stabilizes the calcium therein to keep it soluble therein (pending 00170); or
shelf stability is due to aseptic packaging (pending 00181), a hot fill packaging method (0007).
Mikkelson provides:
1) the composition has a pH which encompasses the claimed pH, as discussed above therefore, given Mikkelson provides an encompassing range for pH, it would be reasonable to expect (i.e. obvious), that the beverage is shelf stable, as claimed.
2) Mikkelson teaches the type of packaging used, include: aseptic packaging (0401), therefore, given the shelf stability of the product is due to aseptic packaging and Mikkelson provides this, it would be reasonable to expect (i.e. obvious), that the beverage is shelf stable, as claimed.
Therefore, it would have been obvious to one of skill in the art, at the time of filing/the invention to modify the method of making liquid food compositions, including beverages, as the modified teaching above, to include that said beverage will function to have shelf stability, as claimed, because the composition established through the applied teachings provides a sufficiently close relationship between the ingredients, the pH of the beverage, and the method of packaging used, to create an expectation that such a similar compositions would have similar utility, properties or functionality because the claims are not physically or structurally distinguishable over the prior art compositions.
Intended use: hydration
When looking for light in the pending Specification, it is noted that it is the compositional formulation that encourages and stimulates hydration (p. 0084), therefore the matter of the beverage having the intended use of a hydration beverage, is dependent on the scope of the ingredients claimed.
Therefore, since the modified teaching provides a similar composition comprising similar amounts of similar ingredients, which reflects the breadth of the claim composition, it would be reasonable to expect that it would function to hydrate and have the intended use of a hydration beverage, absent a showing of criticality, because the teaching of a similar composition imparts a suggestion in or expectation that the composition taught will have the same or a similar utility.
Therefore, it would have been obvious to one of skill in the art, at the time of filing/the invention to modify the method of making liquid food compositions, including beverages, as the modified teaching above, to include that said beverage will function to hydrate, therefore have the intended use of a hydration beverage, as claimed, because the composition established through the applied teachings provides a sufficiently close relationship between the ingredients to create an expectation that such a similar compositions would have similar utility, properties or functionality because the claims are not physically or structurally distinguishable over the prior art compositions.
Independent claim 34
With regard to the prior art, claim 34, encompasses: all of the limitations of claim 28, and further requires:
wherein the liquid dairy permeate, includes:
a liquid whey permeate, a liquid microfiltered milk a/k/a native whey, or a liquid milk co-product whey; and
wherein the sodium salt, includes: sodium chloride, table salt, or sea salt.
On the liquid milk permeate: As discussed above, Mikkelson teaches the beverages comprise a liquid dairy permeate, including: a liquid whey permeate, a liquid microfiltered milk a/k/a native whey or a liquid milk co-product whey (0048), which encompasses the specifically claimed types of liquid dairy permeate.
On the sodium salt: As discussed above, Mikkelson teaches the beverages comprises minerals, including sodium (0196), including the optional use of sodium chloride (NaCl), as claimed.
Dependent claims (29-30 and 33)
As for claim 29, the modified teaching, in Martyn, provides the use of sodium chloride, as an electrolytes used in beverages for the benefits of: replenishing electrolytes lost during exercise, facilitating intestinal reabsorption of fluids, and for facilitating energy dependent processes.
As for claims 30 and 33, Mikkelson provides a liquid permeate from microfiltered milk is provided that comprises native whey proteins, and is further referred to as ideal whey, serum or milk serum (0048), which imparts: a liquid milk permeate, a liquid whey permeate, a liquid microfiltered milk, a native whey, or liquid milk co-product whey, as claimed.
Response to Arguments
Claim status
It was asserted, that Claims 1-7, 10-15 and 28-34 are pending. Claims 28 and 34 have been amended for clarification. Support for the amendments can be found throughout the specification, and original claims. No new matter has been added.
In response, it is noted that claims 1-7 and 10-15 were previously withdrawn and 31-32 were previously canceled.
Rejections under 35 U.S.C. §112
It is asserted, that Claims 28 and 34 and all claims dependent on them were rejected under 35 U.S.C. §112(b) or 35 U.S.C. §112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. § 112, the applicant), regards as the invention.
Claims 28 and 24 have been amended to clarify and address the Examiner's
comments at pages 3-4 of the Office Action, largely consistent with the Examiner's Claim Interpretation at page 4 of the Office Action.
Regarding the sodium concentration and chloride concentration, Applicant
contends the claims are clear as drafted. The sodium concentration of the beverage does not arise exclusively from the sodium salt. The chloride concentration of the beverage does not arise exclusively from the sodium salt. Each of sodium and chloride can have other counterions sourced, for example, as part of the liquid dairy permeate, or other non- specified components of the composition. As such, the amended claims are clear and comply with 35 U.S.C. §112(b) or 35 U.S.C. §112 (pre-AIA ), second paragraph. Reconsideration and withdrawal of the rejection is respectfully requested.
In response, the claim does not clearly set forth that the sodium and chloride ions are further to the sodium chloride salt, therefore this rejection stands as the claim remains unclear because under 35 U.S.C. § 112(b), Appellant’s claims must particularly point out and distinctly claim the subject matter the applicant regards as the invention. The statutory language of particularity and distinctness indicates that claims must be cast in clear and not vague or ambiguous, terms. If, instead, “a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (precedential).
Rejections under 35 U.S.C.§103
Claim(s) 28-30 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160255848 ("Mikkelson") in view of WO 2012/013975 ("Martyn"). Claims 28-30 and 33-34 were rejected under 35 U.S.C. §103 as being
unpatentable over the U.S. DAIRY PROTEINS AND PERMEATES IN READY-TO- DRINK BEVERAGES; copyright 2017. ("US Dairy") in view of Iso Pure Company: Isopure® Zero Carb; copyright 2015. ("IPC"), Martyn and Sports Dietitians Australia: fact Sheet: Sports Drink; published June 2007 ("SDA").
Without acquiescence to these rejections, claims 28 and 34 have been amended to clarify that the beverage is shelf stable, wherein the pH of the beverage wherein the pH of the beverage and hot fill packaging stabilizes the calcium therein. This feature is neither taught or suggested by the cited references. Thus, claims 28 and 34, and claims that depend therefrom, are patentable over the cited references.
Reconsideration and withdrawal of these rejections is respectfully requested.
In response, Applicant’s timely response is appreciated. Please see the modified grounds of rejection above, necessitated by said amendments.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
The references as applied in the 2nd obviousness rejection, of 2/25/2025, including:
US Dairy Export Council: U.S. DAIRY PROTEINS AND PERMEATES IN READY-TO-DRINK BEVERAGES; copyright 2017.
IPC: Iso Pure Company: Isopure® Zero Carb; copyright 2015.
Martyn: Nutritional Compositions; WO 2012/013975, published 2/02/2012.
SDA: Sports Dietitians Australia: fact Sheet: Sports Drink; published June 2007.
MSI Express provides evidence that aseptic exceeds standards of hot fill packaging, there provides encompassing properties for shelf stability.
MSI Express: Deciding Between Aseptic and Hot Fill Processing: Choosing the Best Method for Your Product; 26 Apr 2023
Iwasaki (US 2006/0099318) provides that packaged sports beverages, comprising: sodium ions (0023), no lactose which is an encompassing amount (see throughout), citric acid (0056), an encompassing pH (0024) include carbohydrates in encompassing amounts (0068), including sugar alcohols (0061).
Olson provides the use of: sodium (pg. 16), low carbohydrates (bottom of pg. 18) and milk permeates (pg. 33) in sports drinks (ti.), all for specific health benefits.
Olson: Efficacy of Whey Permeate Based Sports Drink; University of Wisconsin-Stout; Aug 2003
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA ANN GEORGE whose telephone number is (571)272-5955. The examiner can normally be reached T-TH 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571)272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Patricia George
Primary Examiner
Art Unit 1793
/PATRICIA A GEORGE/ Primary Examiner, Art Unit 1793
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