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 status
Claims 1-10 are pending in the amended claim set filed 04/17/2024. All claims are presently considered.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d), and receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The present application and all claims are being examined with the earliest effective filing date of 07/30/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 01/23/2024 has been considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: the claim recites the abbreviated terms “CMP”, “AMP”, “UMP” and “GMP”. Acronyms and abbreviations should be spelled out when they are first mentioned, with the acronym identified in parentheses which will be used in the remainder of the claims. For example, “cytidine monophosphate (CMP)”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: for clarity, please amend “a weight ratio of 1: 1-1: 2” in line 2 to recite “a weight ratio of 1:1 to 1:2”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: for clarity, please amend “1: 1.5-1: 2” in line 2 to recite “1:1.5 to 1:2”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-10 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.
Claim 1 recites the limitation “with a weight ratio of 45-75 parts of the nucleotide mixture and 20-30 parts of probiotics”. This renders the claim indefinite, because probiotics refer to living microorganisms which are conventionally quantified by their viability (CFUs), rather than their weight. As bacterial cells do not contribute substantial mass compared to other components in a mixture, it would not be apparent to a person of ordinary skill as to how to determine whether a prior art composition is within the metes and bounds of the claim.
In view of the specification as filed, there is no special definition for the term “probiotic”. In view of the prior art of record, probiotics are defined as “live microorganisms”, and quantification in a given sample is routinely achieved by counting the number of “colony forming units (CFUs)” expressed as “CFU per gram or mL” of the original sample to yield an estimate of the number of cells present (see Davis, C., cited on Form 892, at Abstract; pg. 11, col. 2, para. 2). Here, there is no standardized means found in the prior art to correlate or express the amount of live microorganisms in a composition (e.g., in CFUs or CFUs/g) by a “weight ratio” with the other components of the mixture (i.e., exogenous nucleotides) strictly in terms of the relative mass (e.g., in mg).
In view of Applicant’s Examples, the five probiotics were provided as a “lyophilized probiotic live bacteria powder” (see pg. 5, para. [0033]), and the probiotics and nucleotides loaded into the capsule were “uniformly mixed according to the ratios to obtain a mixed powder” (see pg. 4, para. [0029]). In view of the prior art, cryoprotectants and other excipients used during lyophilization contribute substantially to the overall mass of freeze-dried probiotic powders (see Shu, et al., cited on Form 892, at Abstract), and the dry mass of individual bacterial cells (e.g., at only 83 to 1,172 femtograms per cell) would be negligible even in at high concentrations of CFU/g (see Loferer- Krößbacher, et al., cited on Form 892, at Abstract). Hence, it would be expected that lyophilized samples would have varying amounts of other compounds, and the actual amount of bacteria (or live bacteria) in the samples may substantially vary even when the total weight of the compositions are the same.
Accordingly, the metes and bounds of the claim have not been clearly set forth.
In the interest of compact prosecution, claim 1 is interpreted as follows:
“A nucleotide probiotic capsule for delaying aging, comprising a capsule shell and contents, wherein the contents comprise a mixture of four exogenous nucleotides or sodium salts thereof and five probiotics.”
Claim 2 recites the limitation, “wherein weight percentages of the four exogenous nucleotides in the contents are as follows: 15-45% of CMP, 15-55% of AMP, 6-30% of UMP, and 14-35% of GMP” which renders the claim indefinite, because it is not clear if the weight percentages are in respect to the nucleotide mixture (i.e., the total nucleotides) or the total contents of the capsule (including probiotics). In the latter case, the claim is also indefinite for the reasons discussed for claim 1.
In the interest of compact prosecution, it is reasonably interpreted that the “weight percentages of the four exogenous nucleotides” is in respect to the weight of the nucleotide mixture.
Similarly, claim 3 recites the limitation, “wherein mass percentages of the various probiotics are as follows…” which renders the claim indefinite, because it is not clear whether the mass percentages are respective to the total mass of probiotics in the capsule or to the total contents of the capsule. In the latter case, the claim is also indefinite for the reasons discussed for claim 1.
In the interest of compact prosecution, the recited percentages are interpreted as referring to the percentage of each probiotic respective to the total probiotics in the capsule.
Claims 4 and 5 recite weight ratios between the individual nucleotides of the mixture and the individual probiotics, which renders the claims indefinite for the same reason as claim 1.
In the interest of compact prosecution, the claims are interpreted such that the “parts” of each nucleotide is respective to the parts of the other nucleotides, and the “parts” of each probiotic is respective to the parts of the other probiotics.
Claims 6-9 are rejected for depending from an indefinite claim and for failing to rectify the indefiniteness of the base claim.
Claim 10 recites a use without any active, positive steps delimiting how the use is actually practiced which renders the claims indefinite. The broadest reasonable interpretation of “[a]n application of the nucleotide probiotic capsule according to claim 1” is a “use” of said nucleotide probiotic capsule. See rejection under 35 USC 101 below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed towards a “use” which is not one of the four categories of patent eligible matter. The broadest reasonable interpretation of “[a]n application of the nucleotide probiotic capsule according to claim 1” is a “use” of said nucleotide probiotic capsule.
In the interest of compact prosecution, claim 10 has been interpreted as a composition with an intended use as a health care food and/or drug for delaying aging.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klassen et al. (US 2013/0273015A1; cited on Form 892), hereafter, “Klassen”.
Regarding claim 1, Klassen teaches nutritional compositions designed to address the needs of infants and young children (see Abstract). Klassen teaches the health benefit provided by the nutritional compositions include the treatment or prevention of diarrhea, treatment or prevention of gut discomfort, weaning facilitation, maturation of the immune system, prevention or management of allergy, reducing cardiovascular diseases later in life, reducing risk of obesity, reducing risk of infections, ensuring a normal growth curve, improving or insuring optimal cognition, improved immune function and immune defenses, and prevention of upper respiratory tract infections like otitis media or common cold (see pg. 1, para. [0010]).
Klassen teaches that the nutritional compositions are packed into single dose units, preferably in the form of capsules (see pg. 5, para. [0072]). Klassen teaches that the nutritional composition may be packed into individual capsules, which may be equipped with an opening means to permit draining of the reconstituted formula (see pg. 5, para. [0073]). Hence, it is reasonably inferred from Klassen’s disclosure that the capsules comprise a “shell and contents”. Klassen teaches the composition comprises a mixture of probiotics, which may include Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus helveticus, Pediococcus pentosaceus, and Lactobacillus rhamnosus (see pg. 2, para. [0025] & [0028]). Klassen teaches the composition may further comprise nucleotides selected from cytidine monophosphate (CMP), uridine monophosphate (UMP), adenosine monophosphate (AMP), guanosine monophosphate (GMP) or any mixtures thereof (see pg. 5, para. [0068]).
Hence, Klassen teaches a nucleotide probiotic capsule, comprising a capsule shell and contents, wherein the contents comprise a mixture of four exogenous nucleotides or sodium salts thereof and five probiotics.
Regarding claim 6, Klassen teaches the probiotics are most preferably present in an amount of 107 to 109 cfu/g of composition (see pg. 3, para. [0033]).
Regarding claim 10, Klassen teaches that nutritional compositions are considered “food products” (see pg. 6, para. [0081]), and the nutritional compositions of the disclosure are administered to provide a “health benefit” (see pg. 1, para. [0010]). Therefore, Klassen teaches the nutritional composition to have an intended use as a “health care food”. Moreover, the claim does not recite any further structure to the claimed product, and there is no indication in Applicant’s disclosure that any further structure would be required for the nucleotide probiotic capsule to be used as a “health care food” or a “drug for delaying aging” (see, e.g., instant specification at pg. 3, paras. [0022]-[0024]). Hence, the claim, as interpreted, is not patentably distinct from claim 1 and is anticipated for the same reasons.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klassen as applied to claims 1 and 6 above, and further in view of Burgher (US 2005/0058690 A1; cited on Form 892), hereafter, “Burgher”
.
Regarding claim 2, Klassen teaches nutritional compositions for infants and young children comprising nucleotides and probiotics (beneficial gut bacteria) which confer health benefits, such as improved immune function and multiple benefits to the gut, as discussed above. Klassen further discloses an exemplified composition, wherein the nucleotides were present in the amounts of 1.1 mg of CMP (40.7%), 0.7 mg of UMP (25.9%), 0.7 mg of AMP (25.9%) and 0.2 mg of GMP (7.4%) (see pg. 7, para. [0095]). Hence, Klassen teaches CMP, UMP and AMP were in amounts that are within the claimed ranges as a weight percentage.
Klassen does not teach wherein the GMP is present in a weight percentage of 14-35%.
Burgher teaches that nucleotides obtained from the diet may be essential to the preterm infant playing an important role in cell growth, energy transfer, and promotion of gut maturation and development. Nucleotides may also provide benefits relating to biological effects,
including increasing beneficial gut microflora, improving lipid metabolism and enhancing immunity (see pg. 1, para. [0011]). Burgher teaches infant formula compositions are provided which comprise 3.2 mg/L to 15.4 mg/L of CMP (30-34%); 1.8 mg/L to 11.0 mg/L of UMP (19-22%); 1.8 mg/L to 8.0 mg/L of GMP (16-19%); 0.1 mg/L to 2.2 mg/L of IMP (0.1- 4%); and 2.5 mg/L to 13.2 mg/L of AMP (26%) (see Abstract). Hence, Burgher teaches CMP, AMP, UMP and GMP are within the same weight percentages as the claim.
It would have been obvious at the time of filing for a person of ordinary skill to have arrived at the claimed invention by combining the teachings of Klassen and Burgher, because both references teach compositions comprising nucleotides having a range of beneficial effects, including enhanced immunity. Further, Burgher teaches the nucleotides of the composition to increase beneficial gut microflora, while Klassen teaches a similar composition that includes beneficial bacteria. Hence, a person of ordinary skill would have recognized that the elements taught by each disclosure could be combined in order to arrive at a nutritional formula useful for increasing beneficial bacteria and maintaining proper immune function in developing children. Hence, the combination would have been readily apparent and deemed to be a mere (A) combining of prior art elements according to known methods to yield predictable results (see MPEP 2143(I): Rationales to support rejections under 35 U.S.C. 103).
Claim(s) 3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klassen as applied to claims 1 and 6 above, and further in view of Olmstead (US 9,579,353 B2; cited on Form 892), hereafter, “Olmstead”.
Regarding claim 3, Klassen teaches a nucleotide probiotic capsule, comprising a nutritional composition for infants and young children, wherein the contents comprise a mixture of four exogenous nucleotides or sodium salts thereof and five probiotics, as discussed above. Klassen teaches the nutritional composition comprises nucleotides and probiotics conferring health benefits, such as improved immune function and multiple benefits to the gut, as discussed above. Klassen teaches the composition comprises a mixture of probiotics, which may include Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus helveticus, Pediococcus pentosaceus, and Lactobacillus rhamnosus (see pg. 2, para. [0025] & [0028]).
Klassen does not teach the composition comprising Lactobacillus plantarum.
Olmstead teaches prophylactic and therapeutic compositions comprising probiotics for preventing and treating diseases or conditions associated with gastrointestinal diseases, such as IBD (see col. 1, lines 12-16, 25). Olmstead teaches that IBD is believed to be caused by an alteration of the body’s immune response, triggering an inflammatory reaction in the intestinal wall (see col. 2, lines 22-25) and, like other gastrointestinal disorders, IBD is associated with an imbalance (dysbiosis) between protective and harmful gastrointestinal organisms (see col. 1, lines 44-47). Olmstead teaches that probiotics are widely applied as nutritional supplements in animals and humans, and lactic acid bacteria of Lactobacillus are associated with multiple properties such as enhanced barrier effects, immune modulatory effects, and alterations in intestinal mobility or function, making them an effective type of alternative medicine (see col. 3, lines 8-24). Olmstead teaches that Lactobacillus are among the best studied probiotics, and the use of Lactobacillus in human studies, such as L. acidophilus, L. casei, and L. plantarum, has been extensively reviewed in the scientific literature (see col. 6, lines 21-22, 29-34), and, among other benefits, these organisms are thought to restore and maintain immune system function (see col. 6, lines 52-54). Olmstead teaches the compositions of the disclosure may be administered as dietary supplements (see col. 8, lines 1-2).
Olmstead teaches a composition comprising a mixture of at least one strain of Pediococcus and at least one strain of Lactobacillus (see col. 5, lines 1-8), provided in the form of a capsule, each capsule comprising at least 1 million CFUs of the Pediococcus strain and at least 1 million CFUs of each additional microorganism (see col. 5, lines 9-15). Olmstead teaches the composition, wherein the Pediococcus strain is Pedioccocus pentosaceus (see col. 5, lines 18-19). Olmstead teaches an embodiment wherein the selected species of Pedioccocus is combined with Lactobacillus acidophilus, L. casei, L. helveticus, and L. plantarum (see col. 5, lines 24-31), wherein the probiotics can be present in a range of more than 10% or less than 10% relative to the CFU content of the composition (see col. 8, lines 34-35; col. 9, lines 17-18). Olmstead teaches an embodiment wherein the capsule comprises 1.5 billion CFU of the Pediococcus strain, 2.5 billion CFU of L. casei and L. plantarum, and 3.0 billion CFU of Lactobacillus acidophilus (see col. 9, lines 24-35) which was used in Olmstead’s Examples to treat an 8 year-old boy with complete resolution of symptoms after 3 weeks. However, Olmstead also teaches that a variety of different mixtures of Lactobacillus and other probiotic organisms can be combined with Pediococcus in various % compositions that produce efficacious results, and the invention is not limited to the exact formulation described above (see col. 9, lines 38-43).
Thus, Olmstead’s disclosure reasonably encompasses probiotic compositions comprising 3.0 billion CFUs of Lactobacillus acidophilus (25%), 2.5 billion CFUs of L. plantarum (20%), 2.5 billion CFUs of L. casei (20%), 2.5 billion CFUs of Lactobacillus helveticus (20%), and 1.5 billion CFUs of Pediococcus pentosaceus (12%), which meets the further limitation of the claim.
It would have been obvious at the time of filing for a person of ordinary skill to have arrived at the claimed invention by combining the teachings of Klassen and Olmstead, because both references teach compositions comprising probiotics having a range of beneficial effects, including restoring and maintaining immune function. Further, Olmstead teaches various combinations of beneficial bacteria for inclusion in a dietary supplement, while Klassen teaches nutritional compositions that includes many of the same beneficial bacteria, as well as exogenous nucleotides, that are disclosed to have similar benefits. Hence, a person of ordinary skill would have recognized that the elements taught by each disclosure could be combined in order to arrive at a composition useful for restoring a balanced gut microflora and maintaining proper immune system function. Hence, the combination would have been readily apparent and deemed to be a mere (A) combining of prior art elements according to known methods to yield predictable results (see MPEP 2143(I): Rationales to support rejections under 35 U.S.C. 103).
Regarding claim 9, Klassen teaches the probiotics may be added to the powdered nutritional composition by dry mixing, and a skilled person would be able to determine when the incorporation of the probiotics should occur (see pg. 6, para. [0083]). Klassen teaches the compositions are packed into individual capsules (see pg. 5, paras. [0072]-[0073]), and the nutritional compositions may be manufactured by blending and freeze-drying the mixture into a homogenized powder (see pg. 5, col. [0077]). Hence, it would have been obvious to have weighed and/or measured the nucleotides and probiotics according to the ratios taught by Klassen and Olmstead, to have uniformly mixed (“blended”) them to obtain a mixed powder, and to have loaded (“packed”) the mixed powder into a capsule shell.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klassen and Burgher as applied to claims 1, 2 and 6 above, and further in view of Olmstead.
Regarding claim 4, Klassen teaches a nucleotide probiotic capsule, comprising a nutritional composition comprising a mixture of four exogenous nucleotides or sodium salts thereof and five probiotics, as discussed above. Klassen teaches the nutritional composition comprises nucleotides and probiotics conferring health benefits, such as improved immune function and multiple benefits to the gut, as discussed above. Klassen teaches the composition comprises a mixture of probiotics, which may include Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus helveticus, Pediococcus pentosaceus, and Lactobacillus rhamnosus (see pg. 2, para. [0025] & [0028]).
Klassen does not explicitly teach the weight ratios of the composition are 10-20 parts of 5'-CMP, 20-30 parts of 5'-AMP, 5-10 parts of 5'-UMPNa2, 10-15 parts of 5'-GMPNa2, 5-7 parts of Lactobacillus acidophilus, 5-7 parts of Lactobacillus plantarum, 5-7 parts of Lactobacillus casei, 3-5 parts of Lactobacillus helveticus, and 2-4 parts of Pediococcus pentosaceus.
Examiner notes that in view of Applicant’s disclosure (see, e.g., pg. 2, para. [0011]), it is understood that CMP and AMP are equivalent to 5’-CMP and 5’-AMP, respectively, while 5’-UMPNa2 and 5’-GMPNa2 are the disodium salts of UMP and GMP, respectively.
Burgher teaches that exogenous nucleotides provide benefits relating to biological effects, including increasing beneficial gut microflora and enhancing immunity, as discussed above. Burgher teaches the exogenous nucleotides are present in the amounts of 3.2 mg/L to 15.4 mg/L of CMP, 1.8 mg/L to 11.0 mg/L of UMP, 1.8 mg/L to 8.0 mg/L of GMP, and 2.5 mg/L to 13.2 mg/L of AMP (see Abstract). These ranges would necessarily include embodiments wherein the nucleotides are present in the amounts of 6 mg/mL CMP (10 parts), 12 mg/L AMP (20 parts), 3 mg/L UMP (5 parts) and 6 mg/L GMP (10 parts) which are all within the claimed ranges. Burgher also discloses an exemplified embodiment wherein the UMP and GMP are in the form of disodium salts (see pg. 3, para. [0036]) which meets the limitation of “5’-UMPNa2” and “5’-GMPNa2”, as discussed above.
Olmstead teaches prophylactic and therapeutic compositions comprising probiotics associated with immune modulatory effects which are useful for preventing and treating diseases or conditions caused by an alteration of the body’s immune response, as discussed above. Olmstead’s disclosure includes compositions comprising 3.0 billion CFUs of Lactobacillus acidophilus, 2.5 billion CFUs of L. plantarum, 2.5 billion CFUs of L. casei, 2.5 billion CFUs of Lactobacillus helveticus, and 1.5 billion CFUs of Pediococcus pentosaceus, as discussed above. These amounts are equivalent to 5-6 parts Lactobacillus acidophilus, 4-5 parts L. plantarum, 4-5 parts L. casei, 4-5 parts Lactobacillus helveticus, and 2-3 parts Pediococcus pentosaceus, which are all within or at least overlap with the claimed ranges.
In view of Applicant’s disclosure, particularly Applicant’s Examples, there is no evidence to show that the claimed ranges were critical to the effects disclosed in the specification. See MPEP 2143 (II) which states that, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In the instant case, the prior art combination would have necessarily led a person of ordinary skill to embodiments which are within or overlap with the claimed ranges, even though they are not disclosed using the same units of measure. Hence, it would have been prima facie obvious to have provided the probiotics in a ratio which meet the claim, because the prior art ranges necessarily include ratios of the claimed probiotics that are within the claimed ranges.
Therefore, it would have been obvious at the time of filing for a person of ordinary skill to have arrived at the claimed invention by combining the teachings of Klassen, Burgher and Olmstead for at least the following reasons: (1) All references disclose compositions useful as dietary supplements or nutritional formulations that are beneficial to the immune system and gastrointestinal system for the prevention and treatment of disorders thereof; (2) Klassen and Burgher teach the compositions comprising exogenous nucleotides and each disclose similar and overlapping amounts of said nucleotides; (3) Klassen and Olmstead both teach the compositions comprising the probiotics P. pentosaceus and several species of Lactobacillus; (4) Klassen teaches compositions comprising both the exogenous nucleotides and the probiotics; and (5) Burgher teaches that the administration of exogenous nucleotides helps to increase the number of beneficial microflora. Hence, all three references are in the same field of endeavor, are relevant to solving the same problem(s), and further provide some suggestion for a person of ordinary skill to have combined their teachings. Hence, the combination would have been readily apparent and deemed to be a mere (A) combining of prior art elements according to known methods to yield predictable results (see MPEP 2143(I): Rationales to support rejections under 35 U.S.C. 103).
Regarding claim 5, as discussed above, Burger teaches the exogenous nucleotides are present in the amounts of 6 mg/mL CMP (10 parts), 12 mg/L AMP (20 parts), 3 mg/L UMP (5 parts) and 6 mg/L GMP (10 parts) which are within the claimed ranges.
Olmstead teaches the probiotics are present in amounts that are equivalent to 5-6 parts Lactobacillus acidophilus, 4-5 parts L. plantarum, 4-5 parts L. casei, 4-5 parts Lactobacillus helveticus, and 2-3 parts Pediococcus pentosaceus, as discussed above.
Here, 4-5 parts L. helveticus is outside (above) the claimed range.
However, Olmstead teaches that a variety of different mixtures of Lactobacillus can be combined with Pediococcus in various % compositions (see col. 9, lines 38-41). In the capsule composition previously discussed, the probiotics were present in the amounts of 3.0 billion CFUs Lactobacillus acidophilus, 2.5 billion CFUs L. plantarum, 2.5 billion CFUs L. casei, and 1.5 billion CFUs Pediococcus pentosaceus. However, additional Lactobacillus strains are also disclosed in amounts ranging from 0.5-3.5 billion CFUs (see col. 9, lines 25-32), and Olmstead discloses Lactobacillus helveticus several times as a species that may also be selected for the composition (see col. 5, line 30; col. 8, line 56; claim 7), as does Klassen (see Klassen at pg. 3, para. [0039]; claim 11).
In view of the instant claim, the second and third embodiments alternatively recite Lactobacillus helveticus in 4 parts and 5 parts, respectively. This results in a slightly higher percentage of L. helveticus relative to the other strains, about 16.7% of the total probiotics, whereas the prior art composition comprising 5-6 parts L. acidophilus, 4-5 parts L. plantarum, 4-5 parts L. casei, 4-5 parts L. helveticus, and 2-3 parts P. pentosaceus (as previously presented) comprises about 16% to 20% L. helveticus relative to the total probiotics.
In view of Applicant’s Examples, all three embodiments (Test groups 1-3) achieved similar results (see Table 5). The examiner also notes that the control groups, comprising either the nucleotides or the probiotics, also achieved significant results compared to the blank control group. Hence, Applicant’s Examples do not include any comparative evidence to demonstrate that the specific amounts of probiotics included in the composition were critical to the effects that were achieved, and these effects are presumed to be achievable using various amounts of the probiotics and/or nucleotides. Furthermore, the specification states:
For those skilled in the art, without departing from the scope of the technical solution of the present invention, many possible changes and modifications can be made to the technical solution of the present invention by using the technical contents above… Therefore, any simple modification… made to the above embodiments according to the technical essence of the present disclosure without departing from the technical solution of the present invention shall still belong to the protection scope of the technical solution of the present invention. (see pgs. 11-12, para. [0060]; Emphasis added)
Therefore, the examiner submits that there is no sufficient showing that the claimed ranges, which include “3 parts of Lactobacillus helveticus” was in any way critical to achieving unexpected results, and the prior art ranges would inherently achieve the same results without departing from the “technical essence” of Applicant’s disclosure. See MPEP 2143(II) which states that, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” Thus, for the reasons set forth above, as well as the reasons discussed regarding claim 4, the instant claim would have been obvious.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klassen as applied to claims 1 and 6 above, and further in view of Porras-Saavedra, et al. (Cited on Form 892), hereafter “Porras”.
Regarding claim 7, Klassen teaches that the nutritional compositions are packed into single dose units, preferably in the form of capsules (see pg. 5, para. [0072]). Klassen teaches that suitable capsule constructions are disclosed in the prior art (see pg. 5, para. [0073]). Klassen teaches the compositions may also comprise carbohydrates, such as maltodextrin (see pg. 3, para. [0050]). Klassen teaches the compositions may also comprise proteins, such as soy protein (see pg. 4, para. [0055]).
Klassen does not teach the capsule, wherein a material of the capsule shell is maltodextrin and soy protein isolate with a weight ratio of 1:1 to 1:2.
Porras teaches that the encapsulation process is widely used in the chemical, pharmaceutical and food industry as a method to conserve sensible materials that can be degraded by environmental agents, and some encapsulated products include aromatic compounds and microorganisms (see pg. 105, col. 1). Porras teaches that while the principal objective of encapsulation is to protect the active agent against environmental factors, this also improves stability and nutritional value of the encapsulated agent (see pg. 105, cols. 1-2). The objective of Porras’ study was to examine the effect of wall materials such as maltodextrin, gum Arabic and soy protein isolates (see pg. 106, col. 1, para. 1). Porras teaches wall materials to increase process efficiency can be achieved due to the synergetic effect of each material used, including carbohydrates and proteins (see pg. 106, col. 2). Porras teaches compositions of different blends of wall materials, including wall material comprising 10% maltodextrin and 10% soy protein isolate in a 1:1 ratio (see pg. 107, Table 1).
It would have been obvious at the time of filing for a person of ordinary skill in the art to have arrived at the claimed invention by combining the teachings of Klassen and Porras, because Porras teaches that the nutritional ingredients of Klassen’s disclosure can be useful for pharmaceutical encapsulation processes for the protection of active agents. One would have also recognized from Klassen that maltodextrin and soy protein are digestible nutritional ingredients that would naturally serve the purpose of dissolving when ingested to release the contents of the capsule. Furthermore, Porras teaches that carbohydrates and proteins are typically used in encapsulation processes for pharmaceutical applications and teaches result-effective variables using maltodextrin and soy protein isolate. Hence, the components of the capsule shell and their functions were known in the art, and one would have recognized there to be a reasonable expectation of success when using the ratio taught by Porras. Hence, the combination would have been readily apparent and deemed to be a mere (B) simple substitution of one known element for another to obtain predictable results (see MPEP 2143(I): Rationales to support rejections under 35 U.S.C. 103).
Regarding claim 8, Porras teaches various compositions of different blends of wall materials, including compositions which exclude maltodextrin (10-20% soy protein isolate), compositions which exclude soy protein isolate (10-20% maltodextrin), and those with a 4:1 ratio (13.33% maltodextrin and 3.33% soy protein isolate) or a 1:4 ratio (3.33% maltodextrin and 13.33% soy protein isolate) (see pg. 107, Table 1). Hence, Porras teaches compositions for encapsulation comprising maltodextrin and soy protein isolate in ratios from 1:1 to 1:4, which includes the claimed range of 1:1.5 to 1:2.
In view of Applicant’s Examples, there is no evidence that any of the capsule shell ratios that were used for the invention were any more or less effective for administering than any of the other ratios (see Examples 1-3 on pgs. 4-5). As previously discussed, Test Groups 1-3 (which used the capsules of Examples 1-3) all achieved similar results, and there is no evidence or even discussion to suggest these results were influenced by the shell content of the capsules. See MPEP 2143(II) which states that, “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” Hence, Porras teaches encapsulation materials comprising the same components of the claim in a range which includes the claimed range, and the claim would have been prima facie obvious to a person of ordinary skill for the reasons set forth above, as well as the reasons discussed regarding claim 7.
Conclusion
No claims are allowed.
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/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651