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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Group 1, claims 1-8 and 10 in the reply filed on 08/04/2025 is acknowledged.
Applicant argues the cited document does not describe any specific ranges or usable excipients for the compounds as required by instant newly amended claim 1. Applicant further argues that that the document fails to provide any defined compositional structure or specific quantitative ranges for these components as in instant newly amended claim 1.
Applicant is reminded that the instant case is a 371 of a PCT and thus subject to restriction under PCT rule 13.1, as the examiner provided prior art and broke unity showing the technical feature of the instant claims is ‘common’ and not special (see page 4 of the restriction for the explanation made of Kubo et al).
Per Annex B Unity of Invention, (b) technical feature, Rule 13.2 states:
The expression "special technical features" is defined in Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art.
As stated in the restriction/election requirement, the groups lack unity of invention because even though the inventions of these groups require the same technical feature, this technical feature is not a special technical feature as it does not make a contribution over the prior art. Therefore, the groups lack unity of invention.
Overall, Applicant’s argument is not found persuasive because unity was broken based off of the originally filed claims. Furthermore, over Kubo and additionally over Gao as evidenced by Schilling and Neavyn, the prior art below in the USC 103 rejections teaches the same issue with the amended claims, thus unity remains broken. Thus, the requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
In regards to claim 7, as to the following limitation:
“wherein the composition:
exhibits high stability at varied temperature range between 6-30 °C,
is semi-viscous form and retained for 2-3 minutes in the Buccal cavity,
mixes with the saliva in 5 to 6 minutes, flow rate of saliva is increased by 10-12 times and it remained higher 2.7 times more when compared to the control group,
the pH of the saliva is also dropped to 4.7 from 7.2 and remained at 4.7 for more than 96 hours.”
Applicant is reminded this is a composition claim and the prior art teaches the composition of instant claim 1 of which claim 7 is dependent upon, thereby since a product is not separable from its physical properties then it necessarily teaches the physical properties claimed by instant claim 7. Therefore, applicants observation that the composition ‘exhibits high stability at varied temperature ranges…’ as mentioned above, does not give it patentable weight, since it is the same composition, as adding a characterization to a prior art patented invention is not patentable.
In regards to claim 8, as to the limitation of 'for use in enhancing the conception rate in dairy animals' it is noted that the instant claims are composition claims and future intended use is not given patentable weight. Thus any composition meeting the limitations of instant claim 1, in which claim 8 is dependent upon, will meet this limitation.
In regards to claim 10, as to the limitation of ‘when orally administering to the bovine…’ it is noted that the instant claims are composition claims and future intended use, such as administering to bovine, is not given patentable weight. Thus any composition meeting the limitations of instant claim 1, in which claim 10 is dependent upon, will meet this limitation.
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 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.
Claim 1 is 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:
“A synergistic oral composition for enhancing chances of conception and female sex ratio in bovines, wherein the composition comprising curcuminoid or its derivative, polyhydric alcohol, amino acids, or its derivative, buffer agents and other pharmaceutically acceptable excipients,
wherein the composition comprises Demethoxycurcumin in the range of 5-10%, Sorbitol in the range of 10-30%, amino acids in the range of 2-4 %, buffering agent in the range of 12- 16% and other excipients including water in the range of 48-62%.”
This claim fails to outline the limitations of the claim as it is unclear if the first composition “comprising curcuminoid or its derivative, polyhydric alcohol…” or the second composition “composition comprises Demethoxycurcumin in the range of 5-10%..” or a combination of both compositions are the requirements of the claim.
For the purpose of moving prosecution forward, Examiner broadly interprets the claim to require either the first or second composition.
Claim 1 is further 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 “A synergistic oral composition for enhancing chances of conception and female sex ratio in bovines, wherein the composition comprising curcuminoid or its derivative, polyhydric alcohol, amino acids, or its derivative” which is unclear as to which chemical group it is modifying. For example does the claim include both polyhydric alcohol or its derivatives or is the limitation just polyhydric alcohols without their derivatives.
For the purposes of moving prosecution forward, Examiner broadly interprets the claims to include both ‘polyhydric alcohols and their derivatives’ and ‘amino acids and their derivatives’ in the list to be selected from.
Claims 3-5 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 3-5 utilize the phrases “preferably” and “most preferably" which render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purpose of moving prosecution forward, Examiner broadly interprets any limitation following these phrases to not be a required limitation of the claim.
Claim 3 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention
Claim 3 recites “wherein the polyhydric alcohol is selected from a group” then lists a group of polyhydric alcohols and then states preferably the polyhydric alcohol. Claim 3 is unclear as to whether this claim is defining the polyhydric alcohol of claim 1 or claiming the composition further comprises an additional polyhydric alcohol or if the claim is not further limiting/further expanding the limitation of claim 1 as the second composition listed in claim 1 already requires 10-30% sorbitol.
For the purpose of moving prosecution forward, Examiner broadly interprets the limitations of claim 3 to be any composition comprising any of listed polyhydric alcohols at any concentration.
Claim 4 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 4 recites “the percentage of 1-2% individually and together 2-4%” which further broadens the optionally concentration limitation of claim 1 of “amino acids in the range of 2-4%” thus rendering the claim indefinite.
For the purpose of moving prosecution forward, as mentioned in the above 112(b) rejections, the statement “the percentage of 1-2% individually and together 2-4%” follows the phrase “preferably” and is interpreted as not being a requirement of the claim.
Claim 4 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 4 recites “the composition comprises stabilizers selected from a group” which lists numerous amino acids. It is unclear if these are defining the amino acids of claim 1 or if the composition further comprises additional amino acids as stabilizers.
For the purpose of moving prosecution forward, Examiner broadly interprets claim 4 to be defining the amino acids of claim 1.
Claim 6 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 6 recites the limitation of “the excipients….which is not disturbing the pH of the resulted final composition of material” which is indefinitely as the pH of the composition of instant claim 1 is not defined, nor are the components of claim 1. Therefore, since it is unclear what the pH of the composition of claim one is, it is unclear what excipient might alter the pH, thus rendering the claim indefinite.
For the purpose of moving prosecution forward, Examiner broadly interprets this to mean any pH of any excipient.
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. Claims 1, 3-8 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claims recite a composition comprising curcuminoid or its derivative or desmethoxycurcumin, a polyhydric alcohol or sorbitol, amino acids, buffer such as a citrate buffer, and water. This judicial exception is not integrated into a practical application because the claims only recite natural products (i.e. curcuminoid), without any additional elements recited that are sufficient to amount to significantly more than the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims either only recite natural products, without any additional elements recited. A detailed analysis follows.
The claimed invention is directed to a composition comprising: (a) curcuminoid or its derivative or desmethoxycurcumin;(b) a polyhydric alcohol or sorbitol; (c) amino acids; (d) buffer such as a citrate buffer; and (e) excipient - water. These compositions are not markedly different from their closest naturally occurring counterpart because there is no indication that extraction has caused the curcuminoid, sorbitol, amino acid, or citrate that comprise the claimed compositions to have any characteristics that are markedly different from the naturally occurring plants or animals. For example, amino acid supplements have been known to increase production of eggs in livestock, specifically during early ovulation and the intake of methionine and lysine have a strong effect throughout the fertility cycle (e.g., see Amino Acids for Animal Health. (2019, January 30). Kemin Compelled by Curiosity. https://www.kemin.com/ap/en/blog/animal/amino-acids-for-animal-health). Therefore, the extracted components are not markedly different from the plants as they are the same active component(s) as the plant or animal itself. Furthermore, since the natural products are known to have the above properties, the ratios of the components to one another do not amount to material changes that would alter the physical characteristics.
Under the 101 analysis for patent eligibility:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
The claims are drawn to a composition of matter.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claims are drawn to a product of nature, a product of extraction (curcuminoid, sorbitol, etc.), because there is no indication that extraction/separation has caused the components of a product of extraction, that comprise the claimed composition, to have any characteristics that are different from the naturally occurring components in a turmeric, fruit, or animals. Natural products/extracts used for drug development and medicines are isolations of bioactive natural products (abstract - Zhang QW, Lin LG, Ye WC. Techniques for extraction and isolation of natural products: a comprehensive review. Chin Med. 2018 Apr 17;13:20. doi: 10.1186/s13020-018-0177-x. PMID: 29692864; PMCID: PMC5905184.). The MPEP 2112.01(II) states that “products of identical chemical composition cannot have mutually exclusive properties”. Thus, the components recited in the claims are natural products that would occur naturally. There is no indication in the record of any markedly different characteristics (either structural or functional) of the composition as broadly claimed. For example, there is no evidence of record that the components present have any structural differences in the extract(s) instantly claimed as compared to their nature-based counterparts. Additionally, the nature-based counterparts (i.e. demethoxycurcumin, sorbitol, amino acids, citrate, and water) are already known to have fertility increasing properties in livestock (see references cited above), which function is also cited for the instantly claimed extracts (e.g., claim 8).
Step 2A, Prong 2: Does the claim recite additional elements that integrate the Judicial Exception into a practical application?
No. As stated above, claims 1, 3-8, and 10 do not recite additional elements outside the natural elements of instant claim 1.
When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. See MPEP 2016.04(c)(II)(A). As reiterated above, the naturally occurring composition, to include amino acids, are already known to have fertility increasing properties in livestock (see references cited above). Therefore, the instantly claimed combinations do not possess “markedly different characteristics” from that of the prior art (i.e., having a property not found in the prior art). Inherent or innate characteristic of the naturally occurring counterpart cannot show a marked difference; see MPEP 2106.04(c)(II).
Step 2B: Does the claim recite additional elements that amount to significantly more than the Judicial Exception?
Each of the elements recited in the claims are natural products which do not integrate the judicial exception into a practical application. No other limitations are recited in instant claims 1, 3-8, and 10 that would add significantly more to the Judicial Exception.
Accordingly, the claimed composition recites a natural product that is not markedly different in structure from naturally occurring elements and hence reads on patent ineligible subject matter under the above guidelines. See MPEP 2106.07.
To transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature. Essentially, appending conventional steps specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible. The Court provides long standing exceptions (laws of nature, natural phenomena, and abstract ideas) to categories of patent eligibility defined in 35 U .S.C.§ 101. A claim that recites a law of nature or natural correlation, with additional steps that involve well- understood, routine, conventional activity previously engaged in by researchers in the field is not patent-eligible, regardless of whether the steps result in a transformation for the reasons cited above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kubo et al. (WO200704356A1, published 01/08/2007, translation via google, hereafter Kubo).
Kubo teaches a functional masticatory material comprising functional ingredients (title and claim 1; according to the claim limitations of the instant claim 1). Kubo teaches the functional component having a physiological effect useful for maintaining or restoring health and a therapeutic effect for ([0001]; according to the claim limitations of the instant claim 1). Kubo claims the function ingredients to include xylitol, and the functional chew is obtained by using more than one species (claim 8; according to the claim limitations of the instant claim 1). Furthermore, Kubo claims the composition comprises a polyphenols, specifically curcumins (claims 3 and 10; according to the claim limitations of the instant claim 1). Furthermore, claim 20 of Kubo claims the concentration of the polyphenol to be about 1-20% based on the total amount of prolamins and wheat dartene (according to the claim limitations of the instant claim 1). Kubo claims the composition further comprises an organic buffer and teaches the buffer to be at least one selected from a list to include citrate, malic acid, tartaric acid, succinic acid, darconic acid, lactic acid, and acetic acid (claims 30 and 33; according to the claim limitations of the instant claims 1 and 5). Kubo teaches the functional material may also include cysteine ([0015]; according to the claim limitations of the instant claims 1, 4, and 6). Furthermore, Kubo teaches the functional materials to be curcumin, tetrahydrocurcumin, functional amino acids, xylitol ([0035]; according to the claim limitations of the instant claims 1 and 3-6). Lastly, Kubo teaches the composition further comprising sweeteners, flavors, and a binder ([0059]; according to the claim limitations of the instant claim 6).
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5].
“[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. Therefore, as outlined by Kubo is would be obvious to claim the instantly claimed invention of claims 1, 3-8, and 10.
Claims 1, 3-4, 6-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (US20140141082A1, published 05/22/2014, hereafter Gao), as evidenced by Schilling et al. (Schilling, S.U., Shah, N.H., Malick, A.W., Infeld, M.H. and McGinity, J.W. (2007), Citric acid as a solid-state plasticizer for Eudragit RS PO. Journal of Pharmacy and Pharmacology, 59: 1493-1500. https://doi.org/10.1211/jpp.59.11.0005, hereafter Schilling), and as evidenced by Neavyn et al. (Neavyn, M.J., Boyer, E.W., Bird, S.B. et al. Sodium Acetate as a Replacement for Sodium Bicarbonate in Medical Toxicology: a Review. J. Med. Toxicol. 9, 250–254 (2013). https://doi.org/10.1007/s13181-013-0304-0, hereafter Neavyn).
As evidenced by Schilling, citric acid is a widely used excipient in pharmaceutical formulations (page 1494, paragraph 3).
As evidenced by Neavyn, sodium bicarbonate is a buffer (page 251, paragraph 2).
Gao teaches a composition for therapeutic or nutraceutical uses that is used as a functional food, drink, dietary supplement or therapeutic dosage orally (title and abstract; according to the claim limitations of the instant claim 1). Gao claims the composition protects/improves/enhances the function/condition of at least one of the following list to include ovaries, prostate, breast, and/or any other organ (claim 37; according to the claim limitations of the instant claim 1). Furthermore, Gao teaches the use of similar compositions for animals ([0010], [0013], and [0015]; according to the claim limitations of the instant claim 1). Gao claims the nutraceutical or therapeutic composition comprises a phytochemicals selected from a group to include curcumin, demethoxycurcumin, and bis-demethoxycurcumin (claim 19; according to the claim limitations of the instant claim 1). Claim 22 of Gao claims the concentration of the curcumin to be 1-40% (according to the claim limitations of the instant claim 1). Claim 19 of Gao further claims the composition comprises amino acids or peptides including arginine, lysine, methionine, histidine, leucine, isoleucine, alanine, phenylalanine, asparagine, aspartic acid, tryptophane, proline, threonine, cysteine, selenocysteine, serine, taurine, tyrosine, valine, glycine, glutamine, glutamic acid, ornithine, carnosine, and L-carnitine (according to the claim limitations of the instant claims 1, 4, and 6). Gao claims the concentration of L-carnitine (a listed amino acid/peptide) to be 0.1-20% (claim 22; according to the claim limitations of the instant claims 1 and 4). Gao teaches that the composition further comprises water soluble binders to include starches, natural gums, cellulose gums, microcrystalline cellulose, methylcellulose, cellulose ethers, ethyl cellulose, sodium carboxymethylcellulose, gelatin, dextrose, lactose, sucrose, sorbitol, mannitol, polyethylene glycol, polyvinylpyrrolidone, pectins, alginates, polyacrylamides, polyvinyloxoazolidone, polyvinylalcohols and mixtures thereof (according to the claim limitations of the instant claims 1, 3, and 6). Gao claims the concentration of polyethylene glycol (water-soluble binder) to be 0.2-10% of the composition (claim 24; according to the claim limitations of the instant claims 1 and 3). Gao teaches the composition may comprise other ingredients such as flavor agents, fillers, surfactants, color agents, and sweetener which are well known useful excipients in the art ([0090]; according to the claim limitations of the instant claims 1 and 6). Gao claims the composition comprising 10-60% of citric acid (claim 24; according to the claim limitations of the instant claims 1 and 6). Gao further teaches the composition to comprise 5-40% of sodium bicarbonate (claim 24; according to the claim limitations of the instant claim 1). Lastly, Gao teaches the absorption is faster and active ingredients are delivered to the stomach at a pH that is just right for absorption ([0110]; according to the claim limitations of the instant claim 5).
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5].
“[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. Therefore, as outlined by Kubo is would be obvious to claim the instantly claimed invention of claims 1, 3-4, 6-8, and 10.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gao (US20140141082A1, published 05/22/2014, hereafter Gao), in view of Neavyn et al. (Neavyn, M.J., Boyer, E.W., Bird, S.B. et al. Sodium Acetate as a Replacement for Sodium Bicarbonate in Medical Toxicology: a Review. J. Med. Toxicol. 9, 250–254 (2013). https://doi.org/10.1007/s13181-013-0304-0, hereafter Neavyn), as evidenced by AAT Bioquest (Acetate Buffer (pH 3.6-5.6) Preparation and Recipe. AAT Bioquest. (2019, August 8) https://www.aatbio.com/resources/buffer-preparations-and-recipes/acetate-buffer-ph-3-6-to-5-6, via wayback machine, hereafter Bioquest), and as evidenced by Schilling et al. (Schilling, S.U., Shah, N.H., Malick, A.W., Infeld, M.H. and McGinity, J.W. (2007), Citric acid as a solid-state plasticizer for Eudragit RS PO. Journal of Pharmacy and Pharmacology, 59: 1493-1500. https://doi.org/10.1211/jpp.59.11.0005, hereafter Schilling).
As evidenced by Bioquest, an acetate buffer, specifically a sodium acetate buffer, has a pH of 3.6-5.5 (title and first paragraph).
As outlined above, Gao as evidenced by Neavyn, Bioquest, and Schilling teach an oral composition comprising demethoxycurcumin, sorbitol, amino acids, a buffering agent and excipients in ranges that overlap or lie within the claimed composition of instant claim 1.
Gao fails to teach the buffer to be a citrate or acetate buffer and the desired pH of the composition as in instant claim 5.
Neavyn teaches sodium acetate as a replacement for sodium bicarbonate (title). Neavyn further teaches that there are several lines of evidence to suggest comparable efficacy of sodium acetate with that of sodium bicarbonate as a buffer (page 251, paragraph 2).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a composition comprising demethoxycurcumin, sorbitol, amino acids, sodium bicarbonate and excipients at the desired concentrations as outlined by Gao as evidenced by Schilling and AAT Bioquest with the simple substitution of sodium acetate for sodium bicarbonate, both buffers, as outlined by Neavyn. Simple substitution of one buffer for another is within the purview of the skilled artisan and would yield predictable results. Furthermore, as evidenced by Bioquest, sodium acetate has a pH of 3.6-5.5, therefore it would be obvious to claim the pH at that range as it is a property of sodium acetate. Additionally, it is noted these are composition/product claims and the prior art teaches the composition of claims 1 and 5, thereby since a product is not separable from its physical properties then it necessarily teaches the composition having a pH of 3.5-5.5. Applicant’s observation that it also has a pH of 3.5-5.5 does not give it patentable weight, since it is the same composition, as adding a characterization to a prior art patented invention is not patentable.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611