DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1, 3-4, 6-8, 13, 15-16 and 18-24 are under consideration.
Status of Application
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/1/2025 has been entered.
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 1, 3-4, 6-8, 13, 15-16 and 18-24 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.
Claim 1 recites the term “about” in lines 6, 7, 8 and 9. While there is support for the recited amounts, there is no support in the specification for the amounts being present in terms of “about”.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claims 3 and 15 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.
Claims 3 and 15 each recite the terms “ultra-low”, “low”, “linear low”, “medium” and “high”. These are relative terms. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 3--4, 6-8, 13, 15-16, 18-19, and 23-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over United States Patent No. 7,374,753 (FARMER) in view of United States Patent Application Publication No. 2007/0160789 (MERICAL) (see IDS of 8/16/2023), Roos et al, Removal of Antibiotic Resistance Gene-Carrying Plasmids from Lactobacillus reuteri ATCC 55730 and Characterization of the Resulting Daughter Strain, L. reuteri DSM 17938, Applied and Environmental Microbiology, Oct 2008, p. 6032-6040 (ROOS), and ORAL REHYDRATION SALTS Production of the new ORS, Department of Child and Adolescent Health and Development (CAH) World Health Organization, 2006 (UNICEF) (see IDS of 8/16/2023).
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As to claim 1, FARMER discloses the use of a non-pathogenic lactic-acid bacteria for oral administration to the intestinal tract. At col. 6, lines 13-40, typical lactic acid producing bacteria useful as a probiotic of this invention which are L(+) lactic acid producers include Lactobacillus acidophilus, L. salivarius, L. g.g., L. plantenim, L. delbrueckiii, L. sporegenes (aka B. coagulans), L. rhamnosus, L. casei, Bifidobacterium longum, B. bifidum, B. infantus, Bacillus species, and the like.
In Example 5, it is taught that that bacteria can be freeze-dried and mixed with other powders (col. 17, lines 25-45). It would have been obvious to use freeze-dried bacteria as this allows the bacteria to be stored and mixed with other powders.
In Example 9, a powdered composition comprising an oral electrolyte maintenance powder with sodium chloride, potassium citrate, citric acid, glucose and powdered B. coagulans (see col. 18, line 60 to col. 19, line 35). The composition is used to treat diarrhea. Thus, it would have been obvious to use the composition of claim 9 and other probiotics disclosed by FARMER to treat diarrhea.
It would have been obvious to combine the bacteria with an oral rehydration solution as FARMER as does disclose the use of lactic acid bacterium at col. 6, lines 14-30.
FARMER does not disclose packaging the powder in an aluminum foil/ polyethylene material with a desiccant integrated in the foil.
MERICAL discloses that aluminum foil packaging [0058] helps prolong the storage of a variety of products including foods, pharmaceutical and nutraceuticals (See Example 11). Chemical desiccant materials are added to packing that includes foil [0107]. Chemical desiccant materials irreversibly bind water molecules within the crystalline product via a chemical reaction [0046]. This naturally further extends the shelf-life of the product when stored at the same temperature relative to using products without a desiccant. The package is sealed. The shelf life of a pharmaceutical or nutraceutical product in a package containing a desiccant film described above will be more than approximately 1 year [0102]. MERICAL also teaches storing product in packages formed with an outer layer of a polyester, e.g., polyethylene terephthalate, film or nylon film, a layer of aluminum foil up to 3.5 mils thick (0053].
It would have been obvious to one skilled in the art to use a packaging material that has a desiccant already incorporated in the packaging to prolong the storage of powders such as FARMER.
FARMER and MERICAL do not teach adding the claimed Lactobacillus bacteria.
ROOS teaches that Lactobacillus reuteri can be administered to patients as a probiotic. ROOS teaches that Lactobacillus reuteri ATCC 17938 is a probiotic which has been transformed so that unwanted antibiotic resistance traits have been removed but that the resultant strain maintains it is desirable probiotic characteristics (p. 6039, left column, last paragraph).
It would have been obvious to one skilled in the art to use Lactobacillus reuteri 17938 in the product of FARMER and MERICAL, because ROOS teaches that Lactobacillus reuteri ATCC 17938 is a probiotic which has been transformed so that unwanted antibiotic resistance traits have been removed but that the resultant strain maintains it is desirable probiotic characteristics.
The references above are silent as to adding certain oral rehydration components.
UNICEF teaches that it is desirable to package anhydrous glucose (i.e., an anhydrous sugar) and anhydrous sodium citrate (i.e., and anhydrous salt such as potassium and sodium salts) in such products to prolong shelf life. For example, in the case of glucose it is only form of glucose that can be used as glucose as non-anhydrous glucose will liquefy with other compounds when stored in humid conditions (see pg. 14).
As to the claimed amounts, UNICEF teaches a composition comprising 65.854% of anhydrous glucose, 14.146% of trisodium citrate, 7.317% potassium chloride, and 12.683% sodium chloride are present (see pgs. 38-39). Potassium and sodium are minerals. However, at page 5 it is taught that additional ingredients may increase the total and individual substance concentration of a solution. The ingredients must be considered when the total substance concentration of a product is calculated for comparison with the criteria mentioned in this document. A clear distinction should also be made between products recommended for treating/preventing dehydration caused by diarrhea and preparations with compositions that are designed for replacing water and salt losses during exercise (sport drinks). Thus, it would have been obvious to vary the amounts based on what additional ingredients are added and the purpose of the oral rehydration solution.
Thus, it would have been obvious to add anhydrous sugar; an anhydrous salt comprising one or more of sodium, chloride, potassium, bicarbonate or citrate; and minerals the product of the references above to prolong shelf life.
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MERICAL also teaches storing product in packages formed with an outer layer of a polyester, e.g., polyethylene terephthalate, film or nylon film, a layer of aluminum foil up to 3.5 mils thick ([0053]). This includes ultra-low, low, linear low, medium or high density polyethylene [0044].
It would have been obvious to one skilled in the art to use a polyethylene layer to prolong the storage of powders such as FARMER.
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FARMER does not disclose packaging the powder in a foil material having a desiccant integrated in the foil.
MERICAL discloses packaging that already contains desiccants such as calcium oxide within the packaging. MERICAL also teaches storing product in packages formed with an outer layer of a polyester, e.g., polyethylene terephthalate, film or nylon film, a layer of aluminum foil up to 3.5 mils thick [0035].
It would have been obvious to one skilled in the art to use desiccants such a calcium oxide and packaging such as polyethylene as they are taught to prolong storage of materials such as food, pharmaceuticals and nutraceuticals.
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As to claims 6-8, FARMER teaches that a typical therapeutic composition will contain in a one gram dosage formulation from 1013 to 1012 colony forming units (CFU) of viable lactic acid bacterium.
FARMER does not disclose the shelf life. (see col. 12, lines 60-68).
However, MERICAL discloses that aluminum foil packaging [0058] helps prolong the storage of a variety of products including foods, pharmaceutical and nutraceuticals (See Example 11). The package is sealed. The shelf life of a pharmaceutical or nutraceutical product in a package containing a desiccant film described above will be more than approximately 1 year [0102].
It would have been obvious to one skilled in the art to use a packaging material of MERICAL with FARMER, as MERICAL teaches that the packaging allows the storage of powders for more than a year.
Moreover, as the applicant is aware, the patent office does not have the abilities to measure shelf life. In this regard, applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. 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, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
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As to claim 13, FARMER discloses the use of a non-pathogenic lactic-acid bacteria for oral administration to the intestinal tract. At col. 6, lines 13-40, typical lactic acid producing bacteria useful as a probiotic of this invention which are L(+) lactic acid producers include Lactobacillus acidophilus, L. salivarius, L. g.g., L. plantenim, L. delbrueckii, L. sporegenes (aka B. coagulans), L. rhamnosus, L. casei, Bifidobacterium longum, B. bifidum, B. infantus, Bacillus species, and the like.
In Example 5, it is taught that that bacteria can be freeze-dried and mixed with other powders (col. 17, lines 25-45). It would have been obvious to use freeze-dried bacteria as this allows the bacteria to be stored and mixed with other powders.
In Example 9, a powdered composition comprising an oral electrolyte maintenance powder with sodium chloride, potassium citrate, citric acid, glucose is mixed with probiotic microorganisms (see col. 18, line 60 to col. 19, line 35).
It would have been obvious to combine the bacteria with an oral rehydration solution as FARMER as does disclose the use of lactic acid bacterium at col. 6, lines 14-30.
FARMER does not disclose packaging the powder in a foil material having a desiccant integrated in the foil.
MERICAL discloses that aluminum foil packaging [0058] helps prolong the storage of a variety of products including foods, pharmaceutical and nutraceuticals (See Example 11). Chemical desiccant materials are added to packing that includes foil [0107]. Chemical desiccant materials irreversibly bind water molecules within the crystalline product via a chemical reaction [0046]. This naturally further extends the shelf-life of the product when stored at the same temperature relative to using products without a desiccant. The package is sealed. The shelf life of a pharmaceutical or nutraceutical product in a package containing a desiccant film described above will be more than approximately 1 year [0102]. MERICAL also teaches storing product in packages formed with an outer layer of a polyester, e.g., polyethylene terephthalate, film or nylon film, a layer of aluminum foil up to 3.5 mils thick [0053].
It would have been obvious to one skilled in the art to use a packaging material that has a desiccant already incorporated in the packaging to prolong the storage of powders such as FARMER.
FARMER and MERICAL do not teach adding the claimed Lactobacillus bacteria.
ROOS teaches that Lactobacillus reuteri can be administered to patients as a probiotic. ROOS teaches that Lactobacillus reuteri ATCC 17938 is a probiotic which has been transformed so that unwanted antibiotic resistance traits have been removed but that the resultant strain maintains it is desirable probiotic characteristics (p. 6039, left column, last paragraph).
It would have been obvious to one skilled in the art to use Lactobacillus reuteri 1798 in the product of FARMER and MERICAL, because ROOS teaches that Lactobacillus reuteri ATCC 17938 is a probiotic which has been transformed so that unwanted antibiotic resistance traits have been removed but that the resultant strain maintains it is desirable probiotic characteristics.
The references above are silent as to adding certain oral rehydration components.
UNICEF teaches that it is desirable to package anhydrous glucose (i.e., an anhydrous sugar) and anhydrous sodium citrate (i.e., and anhydrous salt) in such products to prolong shelf life. For example, in the case of glucose it is only form of glucose that can be used as glucose as non-anhydrous glucose will liquefy with other compounds when stored in humid conditions (see pg. 14).
As to the claimed amounts, UNICEF teaches a composition comprising 65.854% of anhydrous glucose, 14.146% of trisodium citrate, 7.317% potassium chloride, and 12.683% sodium chloride are present (see pgs. 38-39). Potassium and sodium are minerals. However, at page 5 it is taught that additional ingredients may increase the total and individual substance concentration of a solution. The ingredients must be considered when the total substance concentration of a product is calculated for comparison with the criteria mentioned in this document. A clear distinction should also be made between products recommended for treating/preventing dehydration caused by diarrhea and preparations with compositions that are designed for replacing water and salt losses during exercise (sport drinks). Thus, it would have been obvious to vary the amounts based on what additional ingredients are added and the purpose of the oral rehydration solution.
Thus, it would have been obvious to add anhydrous sugar; an anhydrous salt comprising one or more of sodium, chloride, potassium, bicarbonate or citrate; and minerals the product of the references above to prolong shelf life.
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FARMER is silent as to using aluminum foil.
MERICAL also teaches storing product in packages formed with an outer layer of a polyester, e.g., polyethylene terephthalate, film or nylon film, a layer of aluminum foil up to 3.5 mils thick ([0053]). This includes ultra-low, low, linear low, medium or high density polyethylene [0044].
It would have been obvious to one skilled in the art to use a polyethylene layer to prolong the storage of powders such as FARMER.
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FARMER does not disclose packaging the powder in a foil material having a desiccant integrated in the foil.
MERICAL discloses packaging that already contains desiccants such as calcium oxide within the packaging. MERICAL also teaches storing product in packages formed with an outer layer of a polyester, e.g., polyethylene terephthalate, film or nylon film, a layer of aluminum foil up to 3.5 mils thick [0035].
It would have been obvious to one skilled in the art to use desiccants such a calcium oxide and packaging such as polyethylene as they are taught to prolong storage of materials such as food, pharmaceuticals and nutraceuticals.
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As to claims 18-19, UNICEF teaches that it is desirable to package anhydrous glucose (i.e., an anhydrous sugar) and anhydrous sodium citrate (i.e., an anhydrous salt) in such products to prolong shelf life. For example, in the case of glucose it is only form of glucose that can be used as glucose as non-anhydrous glucose will liquefy with other compounds when stored in humid conditions (see pg. 14).
Thus, it would have been obvious to add anhydrous sugar; an anhydrous salt comprising one or more of sodium, chloride, potassium, bicarbonate or citrate; and minerals the product of the references above to prolong shelf life.
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As noted above, FARMER discloses the use of a non-pathogenic lactic-acid bacteria for oral administration to the intestinal tract. At col. 6, lines 13-40, typical lactic acid producing bacteria useful as a probiotic of this invention which are L(+) lactic acid producers include Lactobacillus acidophilus, L. salivarius, L. g.g., L. plantenim, L. delbrueckii, L. sporegenes (aka B. coagulans), L. rhamnosus, L. casei, Bifidobacterium longum, B. bifidum, B. infantus, Bacillus species, and the like.
MERICAL discloses that aluminum foil packaging [0058] helps prolong the storage of a variety of products including foods, pharmaceutical and nutraceuticals (See Example 11). Chemical desiccant materials are added to packing that includes foil [0107]. Chemical desiccant materials irreversibly bind water molecules within the crystalline product via a chemical reaction [0046]. This naturally further extends the shelf-life of the product when stored at the same temperature relative to using products without a desiccant. The package is sealed. The shelf life of a pharmaceutical or nutraceutical product in a package containing a desiccant film described above will be more than approximately 1 year [0102].
UNICEF teaches that it is desirable to package anhydrous glucose (i.e., an anhydrous sugar) and anhydrous sodium citrate (i.e., an anhydrous salt) in such products to prolong shelf life. For example, in the case of glucose it is only form of glucose that can be used as glucose as non-anhydrous glucose will liquefy with other compounds when stored in humid conditions (see pg. 14).
Given the references above teach the use of anhydrous materials and desiccants for prolonging storage, it would have been obvious that the use of materials that eliminate moisture/humidity would prolong storage.
Applicant is also reminded that the patent office does not have the abilities to measure shelf life. In this regard, applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. 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, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
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FARMER, MERICAL, ROOS and UNICEF teach the product of claim 1 for the reasons noted above. It would have been obvious to administer the product to a patient given FARMER discloses the use of a non-pathogenic lactic-acid bacteria for oral administration to the intestinal tract. At col. 6, lines 13-40, FARMER teaches typical lactic acid producing bacteria useful as a probiotic of this invention which are L(+) lactic acid producers include Lactobacillus acidophilus, L. salivarius, L. g.g., L. plantenim, L. delbrueckii, L. sporegenes (aka B. coagulans), L. rhamnosus, L. casei, Bifidobacterium longum, B. bifidum, B. infantus, Bacillus species, and the like.
Claims 20-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Farmer, Merical, Roos and UNICEF as applied to claim 1 above, and further in view of United States Patent Application Publication No. 2003/0077333 (PHILLIPS).
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As to claims 20-22, the references above are silent as to using zinc sulphate in oral rehydration solutions. PHILIPPS teaches in [0012] and [0022] that zinc is a beneficial and needed supplement for people suffering from diarrhea and it is preferred that zinc be delivered in the form of zinc sulphate. The quantity of zinc contained within the ORS can vary widely. However, as a general guideline, the Zinc will typically be present in a quantity of from about 0.3 mEq to about 95 mEq per liter. Thus, it would have been obvious to one skilled in the art vary the amount of zinc sulphate given the amounts can vary widely [0015].
It would have been obvious to one skilled in the art to add zinc sulphate as part of an oral rehydration solution to the references above, as PHILLIPS teaches zinc is a beneficial and needed supplement for people suffering from diarrhea and it is preferred that zinc be delivered in the form of zinc sulphate.
As to potassium and sodium chloride, UNICEF teaches that it is desirable to package anhydrous glucose (i.e., an anhydrous sugar) and anhydrous sodium citrate (i.e., an anhydrous salt such as potassium and sodium salts) in such products to prolong shelf life. For example, in the case of glucose it is only form of glucose that can be used as glucose as non-anhydrous glucose will liquefy with other compounds when stored in humid conditions (see pg. 14).
As to the claimed amounts, UNICEF teaches a composition comprising 65.854% of anhydrous glucose, 14.146% of trisodium citrate, 7.317% potassium chloride, and 12.683% sodium chloride are present (see pgs. 38-39). Potassium and sodium are minerals. However, at page 5 it is taught that additional ingredients may increase the total and individual substance concentration of a solution. The ingredients must be considered when the total substance concentration of a product is calculated for comparison with the criteria mentioned in this document. A clear distinction should also be made between products recommended for treating/preventing dehydration caused by diarrhea and preparations with compositions that are designed for replacing water and salt losses during exercise (sport drinks). Thus, it would have been obvious to vary the amounts based on what additional ingredients are added and the purpose of the oral rehydration solution.
Thus, it would have been obvious to add anhydrous sugar; an anhydrous salt comprising one or more of sodium, chloride, potassium, bicarbonate or citrate; and minerals to the product of the references above to prolong shelf life.
Given the ingredients are known to those skilled in the art and there is no evidence that the claimed amounts provide an unexpected amount, it would have been obvious to provide a composition that ”consists of” the claimed ingredients.
Response to Arguments
Applicant's arguments filed 8/1/2025 have been fully considered but they are not persuasive.
The Declaration under 37 CFR 1.132 filed 12/20/2023 is insufficient to overcome the rejection of claims 1, 3, 4, 6-18, 13, 15, 16 and 18-24 based upon 35 USC 103 as set forth in the last Office action in light of the reasons set forth below.
The Second Declaration under 37 CFR 1.132 filed 12/20/2023 is insufficient to overcome the rejection of claims 1, 3, 4, 6-18, 13, 15, 16 and 18-24 based upon 35 USC 103 as set forth in the last Office action in light of the reasons set forth below.
The applicant argues that the changes to the claims are now commensurate in scope with arguments (see pg. 5 of applicant’s response). In support of this position, the applicant cites to the First and Second Declarations by Christopher Lundqvist (filed on parent application 12/804,758, now abandoned and in the present application on 12/20/2023).
However, an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential). While it is understood that the present specification provides examples of using a desiccant and not using a desiccant, there is no comparison of how the amount of ingredients impact the composition.
Moreover, in view of the prior art, there does not appear to be any unexpected effect or benefit by using the claimed amounts. PHILIPPS teaches in [0012] and [0022] that zinc is a beneficial and needed supplement for people suffering from diarrhea and it is preferred that zinc be delivered in the form of zinc sulphate. The quantity of zinc contained within the ORS can vary widely. However, as a general guideline, the Zinc will typically be present in a quantity of from about 0.3 mEq to about 95 mEq per liter. Thus, it would have been obvious to one skilled in the art vary the amount of zinc sulphate given the amounts can vary widely [0015].
UNICEF teaches a composition comprising 65.854% of anhydrous glucose, 14.146% of trisodium citrate, 7.317% potassium chloride, and 12.683% sodium chloride are present (see pgs. 38-39). Potassium and sodium are minerals. However, at page 5 it is taught that additional ingredients may increase the total and individual substance concentration of a solution. The ingredients must be considered when the total substance concentration of a product is calculated for comparison with the criteria mentioned in this document. A clear distinction should also be made between products recommended for treating/preventing dehydration caused by diarrhea and preparations with compositions that are designed for replacing water and salt losses during exercise (sport drinks). Thus, it would have been obvious to vary the amounts based on what additional ingredients are added and the purpose of the oral rehydration solution.
Thus, there is no evidence that the claimed amounts provide an unexpected result. Neither declaration remedies this deficiency. Indeed, in inventor Lundqvist's Second Declaration Under CFR § 1.132 (filed February 28, 2021, in parent Application No. 12/803,758 (signed January 8, 2021) and filed 12/20/2023 in present application), it is stated that
In the previous declaration, I discussed how, although the probiotic product of 4. Example 1 contained a specific anhydrous ORS (glucose as a sugar and sodium citrate, potassium chloride, sodium chloride, and zinc sulfate as salts), different anhydrous sugars and salts can be present in the ORS and could have been substituted and produced similar stability results”.
The applicant also argues that the addition of a desiccant provide an unexpected result.
However, the desiccant only appears to be working as a desiccant should.
MERICAL discloses that aluminum foil packaging [0058] helps prolong the storage of a variety of products including foods, pharmaceutical and nutraceuticals (See Example 11). Chemical desiccant materials are added to packing that includes foil [0107]. Chemical desiccant materials irreversibly bind water molecules within the crystalline product via a chemical reaction [0046]. This naturally further extends the shelf-life of the product when stored at the same temperature relative to using products without a desiccant. The package is sealed. The shelf life of a pharmaceutical or nutraceutical product in a package containing a desiccant film described above will be more than approximately 1 year [0102].
The applicant also argues that one of ordinary skill in the art would not combine Farmer, Merical, Unicef, and Roos.
However, it remains the Examiner’s position that one skilled in the art would have been motivated to combine the references. ROOS teaches that Lactobacillus reuteri can be administered to patients as a probiotic. ROOS teaches that Lactobacillus reuteri ATCC 17938 is a probiotic which has been transformed so that unwanted antibiotic resistance traits have been removed but that the resultant strain maintains it is desirable probiotic characteristics (p. 6039, left column, last paragraph). Thus, ROOS teaches the use of a particularly desirable probiotic. While the applicant argues that the desirable traits of the ROOS Lactobacillus reuteri ATCC 17938 are not elements of the claims, The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below) (see MPEP 2144).
As to why one skilled in the art would combine ROOS with the other references, it is noted that FARMER discloses the use of a non-pathogenic lactic-acid bacteria for oral administration to the intestinal tract. At col. 6, lines 13-40, typical lactic acid producing bacteria useful as a probiotic of this invention which are L(+) lactic acid producers include Lactobacillus acidophilus, L. salivarius, L. g.g., L. plantenim, L. delbrueckii, L. sporegenes (aka B. coagulans), L. rhamnosus, L. casei, Bifidobacterium longum, B. bifidum, B. infantus, Bacillus species, and the like.
As to MERICAL and UNICEF, MERICAL discloses that aluminum foil packaging [0058] helps prolong the storage of a variety of products including foods, pharmaceutical and nutraceuticals (See Example 11). Chemical desiccant materials are added to packing that includes foil [0107]. Chemical desiccant materials irreversibly bind water molecules within the crystalline product via a chemical reaction [0046]. This naturally further extends the shelf-life of the product when stored at the same temperature relative to using products without a desiccant. The package is sealed. The shelf life of a pharmaceutical or nutraceutical product in a package containing a desiccant film described above will be more than approximately 1 year [0102].
UNICEF teaches that it is desirable to package anhydrous glucose (i.e., an anhydrous sugar) and anhydrous sodium citrate (i.e., and anhydrous salt) in such products to prolong shelf life. For example, in the case of glucose it is only form of glucose that can be used as glucose as non-anhydrous glucose will liquefy with other compounds when stored in humid conditions (see pg. 14). Thus, MERICAL and UNICEF teach the need to avoid moisture.
Indeed, ALL of the reference discuss the need for a dry environment or need to avoid moisture. FARMER teaches that the powders must be dry ingredients (see col 7, lines 52-61 and col. 12, lines 15-25). MERICAL discloses that aluminum foil packaging [0058] helps prolong the storage of a variety of products including foods, pharmaceutical and nutraceuticals (See Example 11). Chemical desiccant materials are added to packing that includes foil [0107]. Chemical desiccant materials irreversibly bind water molecules within the crystalline product via a chemical reaction [0046]. This naturally further extends the shelf-life of the product when stored at the same temperature relative to using products without a desiccant. The package is sealed. The shelf life of a pharmaceutical or nutraceutical product in a package containing a desiccant film described above will be more than approximately 1 year [0102].
Given the references above teach the use of anhydrous materials and desiccants for prolonging storage, it would have been obvious that the use of materials that eliminate moisture/humidity would prolong storage.
As to claims 6-8, it is argued that the Examiner has failed to point to anything in the combination of references describing the stability of a L. reuteri DSM 17938- ORS product, much less the specific parameters of after 12 months of storage of the probiotic product at 30°C there being at least 1OE+07 CFU/gram (claim 6), at least 1OE+08 CFU/gram (claim 7), and 1OE+09 CFU/gram (claim 8) of Lactobacillus reuteri DSM 17938 when starting with 5x10E+09 CFU/gram of Lactobacillus reuteri DSM 17938, which Applicant submits are non-obvious over the cited references.
FARMER teaches that a typical therapeutic composition will contain in a one gram dosage formulation from 1013 to 1012 colony forming units (CFU) of viable lactic acid bacterium.
FARMER does not disclose the shelf life. (see col. 12, lines 60-68).
As to the 12 month storage, it is noted above that the references discuss the need for a dry environment or need to avoid moisture otherwise this destroys the viability of the ingredients. the packaging and dry powders set forth in the claims appear to function as intended (i.e., maintaining a moisture free environment for storage purposes). "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) (resultant decrease of dental enamel solubility accomplished by adding an acidic buffering agent to a fluoride containing dentifrice was expected based on the teaching of the prior art); Ex parte Blanc, 13 USPQ2d It would have been obvious to use ingredients to extend the shelf life. Moreover, the Patent Office does not have the facilities to conduct shelf life tests. Applicant has chosen to use parameters that cannot be measured by the Office, for the purpose of prior art comparison, because the office is not equipped to manufacture prior art products and compare them for patentability. 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, 911F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, as a prima facia case of obviousness has been properly established, the burden is shifted to the applicant to show that the prior art product is different.
It is also noted that the Declarations argue that the Inventor's First Declaration at paragraphs 12-13 and Second Declaration at paragraph 10 indicate that as of the priority date of the instant invention, it was not possible to mix the claimed freeze dried L. reuteri DSM 17938 strain with ORS powder and keep the bacteria viable during ambient storage for a longer period of time due to the extremely hygroscopic nature of ORS powders, despite the assertions in the instant Office Action.
However, as noted above, all of the claimed elements as intended AND the references discuss the need for a dry environment or need to avoid moisture otherwise this destroys the viability of the ingredients. the packaging and dry powders set forth in the claims appear to function as intended (i.e., maintaining a moisture free environment for storage purposes).
As to Farmer, Merical, Roos, Unicef and PHILIPS, the applicant argues that PHILIPS does not remedy the deficiencies of Merical, Roos, and Unicef. However, the references are proper for the reasons noted above.
Conclusion
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/PHILIP A DUBOIS/Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791