DETAILED ACTION
Background
The amendment dated February 23, 2024 (amendment) adding new claims 55-81 and canceling claims 1-54 has been entered. Claims 55-80 as filed with the amendment have been examined. Claim 81 is withdrawn from consideration.
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 .
Election/Restrictions
Applicant’s election of the invention of Group I, claims 55-80 in the reply filed on March 05, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 81 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Specification
The disclosure is objected to because of the following informalities:
At [00139] on page 25, at line 18 after “glutathione,” correct the spelling of --metallothcapto-1-propanesulfonic--.
Appropriate correction is required.
Claim Objections
Claims 58 and 74 are objected to because of the following informalities:
In claim 58, at line 4 after “glutathione,” correct the spelling of --metallotheionein-- and correct the spelling of --2,3-dimercapto-1-propanesulfonic--; and,
In claim 74 at line 4 after “glutathione,” correct the spelling of --metallotheionein-- and correct the spelling of --2,3-dimercapto-1-propanesulfonic--. Appropriate correction is required.
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.
Claims 55-80 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 55, at line 2 (one instance) and line 3 (one instance) the “wt%” of the recited phycocyanin is indefinite for lacking a basis or denominator. Is the amount of the recited phycocyanin based on the weight of the claimed acidic composition, the weight of composition solids, or some other weight basis?
The Office interprets the wt% of the recited phycocyanin as being based on the total weight of the acidic composition.
In claim 60, at lines 3-5 (8 instances in 4 alternative ranges in total) the “wt%” of the recited phycocyanin is indefinite for lacking a basis or denominator. Is the amount of the recited phycocyanin based on the weight of the claimed acidic composition, the weight of composition solids, or some other weight basis?
The Office interprets the wt% of the recited phycocyanin as being based on the total weight of the acidic composition.
In claim 66, at lines 2-4, the recited ratio (4 instances in total) is indefinite for lacking units. Is the recited ratio of phycocyanins to sulphated polysaccharide a weight ratio, a volume ratio or some other unitary ratio?
The Office interprets the recited ratio of phycocyanins to sulphated polysaccharide as being a weight ratio.
In claim 70, at lines 3-5, the recited ratio (4 instances in total) is indefinite for lacking units. Is the recited ratio of phycocyanins to sulphated polysaccharide a weight ratio, a volume ratio or some other unitary ratio?
The Office interprets the recited ratio of phycocyanins to sulphated polysaccharide as being a weight ratio.
In claim 72, at line 2 (one instance) and line 3 (one instance) the “wt%” of the recited Galdieria extract is indefinite for lacking a basis or denominator. Is the amount of the recited Galdieria extract based on the weight of the claimed acidic composition, the weight of composition solids, the weight of the Galdieria extract plus the weight of the chelating agent or some other weight basis?
The Office interprets the wt% of the recited Galdieria extract as being based on the total weight of the acidic composition.
In each of claims 78-80, at lines 3 and 4 (one pair in each line) the amount in “mg/L” of the recited phycocyanin is indefinite for lacking a basis or denominator. Is the amount of the recited phycocyanin based on the weight of the claimed total liquid composition, or some other liquid weight basis?
The Office interprets the recited mg/L of phycocyanin as being total mg phycocyanin based on a liter of the total acidic composition.
Claims 56-59, 61-65, 67-69, 71 and 73-77 are rejected as depending from a rejected base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 79 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 79 recites a sulphated polysaccharide as optional and is in this sense, therefore broader than claim 70, from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
OR
(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.
Claims 55-58, 60-64, 67-69, 72-74, 76 and 78 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2018/0271119 A1 to Cagnac (Cagnac), of record.
The Office considers a food product to include a food or a beverage or an additive or ingredient for use in a food or beverage.
Regarding instant claim 55, 60, 64, 67 and 69, Cagnac at [0119] discloses in Example 6, Beverage 2 a health drink for athletes (“acidic composition” as a liquid as in claim 67 and a “food product” in claim 69) comprising 150 mg phycocyanin per liter of the health drink (0.015 wt%, based on the total weight of the acidic composition as in claims 55 and 60) and having a pH of 3.5 (claim 64).
Also regarding claims 55, 60, 64, 67 and 69, and regarding claims 56, 58 and 68, Cagnac at [0118] discloses a soda beverage (“carbonated beverage” in claim 68 as a liquid in claim 67 and a food product in claim 69) as an acidic composition (claim 55) comprising 100 mg/L phycocyanins (0.01 wt% based on the total weight of the acidic composition as in claims 55 and 60) and sodium citrate (“chelating agents” in claim 56 as citrates in claim 58) and having a pH of 2.95 (a “pH of about 4 or less” as in claim 64).
Regarding instant claim 57, the Office considers the claimed synthetic or natural compounds to include the citrates as in Example 6, Beverage 1 of Cagnac.
Regarding instant claim 61, the Office considers the recited phycobiliprotein of which the apoprotein comprises the protein of SEQ ID NO. 1 or SEQ ID NO. 2, or variants thereof to include the phycobiliprotein in the Galdieria extract used in Example 6 of Cagnac. See especially SEQ ID No.2 which comes from Galdieria sulphararia and has 172 units. See Cagnac at pages 8-9.
Regarding instant claims 62-63 and 72, the phycocyanins in the Example 6, Beverage 1 and 2 of Cagnac comprise acidic compositions of phycocyanins comprising the phycocyanins extracted from an alga of the genera Galdieria and Cyanidioschyzon (claim 62), including Galdieria sulphararia and Cyanidioschyzon merolae (claim 63), which is a Galdieria extract in the amount of 0.015 wt% of the total weight of the acidic composition in Beverage 1 and 0.01 wt% in Beverage 2 (claim 72).
Regarding instant claims 73-74, the Office considers the claimed synthetic or natural compounds to include the citrates (claim 74) as in Example 6, Beverage 1 of Cagnac.
Regarding instant claim 76, the Office considers the recited phycobiliprotein of which the apoprotein comprises the protein of SEQ ID NO. 1 or SEQ ID NO. 2, or variants thereof to include the phycobiliprotein in the Galdieria extract used in Example 6 of Cagnac. See especially SEQ ID No.2 which comes from Galdieria sulphararia and has 172 units. See Cagnac at pages 8-9.
Regarding instant claim 78, Cagnac at [0075] discloses a concentrated liquid composition as an acidic composition comprising from 500 to 1000 mg/L of its composition wherein. Further and regarding the sulphated polysaccharide, while the Office considers optional limitations the claims themselves do not require them.
Claims 55, 60, 64, 67 and 69-71 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US2022/0015398 A1 to Leeb et al. (Leeb).
The Office considers a food product to include a food or a beverage or an additive or ingredient for use in a food or beverage.
Regarding instant claim 55, 60, 64, 67 and 69-71, Leeb at [0148] and Table 11 discloses a beverage having a pH of 2.9 (“acidic composition”) comprising 0.012 wt% of phycocyanin, based on the total weight of the beverage as an acidic composition (claims 55 and 60) and having a “pH of about 4 or less” as in claim 64. The Office considers the beverage as a liquid as in claim 67 and a “food product” in claims 69 and 71. The acidic composition further comprises fucoidan (at [0075]) a sulphated polysaccharide in a weight ratio of the phycocyanin and sulphated polysaccharide of 1:4 (claims 70-71).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 59, 65-66, 75 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over US2018/0271119 A1 to Cagnac (Cagnac) as applied to claims 55, 58, 72 and 74 above, and further in view of EP3692806 A1 to MacDonald et al. (MacDonald).
As applied to claims 55, 58, 72 and 74, Cagnac discloses in Example 6, Beverage 2 a liquid or solid acidic composition comprising from between about 0.001 wt% and about 0.1 wt% of a phycocyanin, based on the total weight of acidic composition, the composition further comprising a chelating agent selected from the group consisting of ethylene diamine tetra acetic acid and/or its Na, K, Ca salts (EDTA), L- glutamic acid N,N-diacetic acid tetrasodium salt (GLDA), sodium hexametaphosphate, glutathione, metallotheionein, 2,3-dimerapto-1-propanesulfonic acid, chlorella, garlic, cilantro, selenium, milk thistle, vitamin C, vitamin E, citrates, grape seed extract, quercetin, lipoic acid and mixtures thereof. Further, Cagnac at Example 6 discloses its phycocyanins as comprising a Galdieria extract in the amount of from 0.004 to 0.4 wt% of the acidic composition.
Regarding instant claims 59, 65-66, 75 and 77, Cagnac does not disclose an acidic composition wherein the chelating agent is vitamin C and/or EDTA as in claims 59 and 75; does not disclose an acidic composition further comprising an amount of at least one sulphated polysaccharide, wherein the at least one sulphated polysaccharide is carrageenan as in claim 65; further, Cagnac does not disclose an acidic composition wherein the phycocyanins and at least one sulphated polysaccharide as in claim 77, or disclose a composition wherein the sulphated polysaccharide is present in the composition in a ratio selected from the group consisting of a ratio of between about 0.20:1 and about 20:1, a ratio between about 0.25:1 and about 10:1, a ratio between about 1:1 to about 10:1, and a ratio between about 0.3:1 and about 1.5:1 as in claim 66.
MacDonald discloses at Abstract a liquid foodstuff comprising spirulina-extract comprising phycocyanin, at least one multi-sulphated carrageenan and a chelating agent, wherein the amount of multi-sulphated carrageenan is between 0.003 and 0.6 wt, wherein the weight ratio between multi-sulphated carrageenan and phycocyanin ranges between 1:1 and 100:1, wherein the chelating agent is present between 1 - 2000 ppm. At [0009], MacDonald discloses that its liquid foodstuff has increased color stability upon heating. At [0022], MacDonald discloses a ratio of sulphated polysaccharide and phycocyanin of between 4:1 and 15:1. Further, at [0030]-[0031] MacDonald discloses that chelating agents work with its sulphated polysaccharide to improve color retention; and, at [0031] MacDonald discloses EDTA or its Na, K or Ca salts, L- glutamic acid N,N-diacetic acid tetrasodium salt (GLDA), sodium hexametaphosphate, glutathione, metallothionein, 2,3-dimercapto-1-propanesulfonic acid, chlorella, garlic, cilantro, selenium, milk thistle, vitamin C, vitamin E, citrates, grape seed extract, quercetin and lipoic acid. Still further, MacDonald in Experiment 1.1 at [0049]-[0050[ and Table 1 discloses that multi-sulphated polysaccharide prevents aggregation of phycocyanins from solution at a pH of 4.0.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of MacDonald for Cagnac to include in its acidic compositions a carrageenan as a sulphated polysaccharide as well as EDTA as a chelating agent, wherein further the phycocyanins and at least one sulphated polysaccharide are present in the composition in a ratio selected from the group consisting of a ratio of between about 0.20:1 and about 20:1, a ratio between about 0.25:1 and about 10:1, a ratio between about 1:1 to about 10:1, and a ratio between about 0.3:1 and about 1.5:1. Both references disclose stable phycocyanin liquid compositions for use in food or beverage. The ordinary skilled artisan in Cagnac would have desired to include the EDTA and the carrageenan of MacDonald in the claimed amounts relative to a phycocyanin to improve the heat and color stability of the resulting liquid product in food or beverage applications
Claims 70-71 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over US2018/0271119 A1 to Cagnac (Cagnac) in view of EP3692806 A1 to MacDonald et al. (MacDonald).
The Office considers a food product to include a food or a beverage or an additive or ingredient for use in a food or beverage.
Regarding instant claims 70-71 and 79, Cagnac at [0075] discloses a concentrated liquid composition as an acidic composition comprising from 500 to 1000 mg/L of a phycocyanin. At [0064] Cagnac discloses food compositions (“food products”) and uses therefor as in claim 71.
Further, Cagnac does not disclose an acidic composition further comprising an amount of at least one sulphated polysaccharide as in claims 70-71 and 79.
MacDonald discloses at Abstract a liquid foodstuff comprising spirulina-extract comprising phycocyanin, at least one multi-sulphated carrageenan and a chelating agent, wherein the amount of multi-sulphated carrageenan is between 0.003 and 0.6 wt, wherein the weight ratio between multi-sulphated carrageenan and phycocyanin ranges between 1:1 and 100:1. At [0009], MacDonald discloses that its liquid foodstuff has increased color stability upon heating. At [0022], MacDonald discloses a ratio of sulphated polysaccharide and phycocyanin of between 4:1 and 15:1. Further, MacDonald in Experiment 1.1 at [0049]-[0050[ and Table 1 discloses that multi-sulphated polysaccharide prevents aggregation of phycocyanins from solution at a pH of 4.0.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of MacDonald for Cagnac to include in its acidic compositions a sulphated polysaccharide. Both references disclose stable phycocyanin liquid compositions for use in food or beverage. The ordinary skilled artisan in Cagnac would have desired to include the sulphated polysaccharide of MacDonald in its acidic composition to improve the heat and color stability of the resulting liquid product in food or beverage applications
Further regarding instant claim 79, Cagnac at [0075] discloses a concentrated liquid composition as an acidic composition comprising from 500 to 1000 mg/L, based on the total weight of its composition.
Claim 80 is rejected under 35 U.S.C. 103 as being unpatentable over US2018/0271119 A1 to Cagnac (Cagnac) as applied to claim 72 above.
As applied to claim 72, Cagnac discloses in Example 6, Beverage 2 a liquid or solid acidic composition comprising from between about 0.001 wt% and about 0.1 wt% of a phycocyanin, based on the total weight of acidic composition, wherein the phycocyanins of Cagnac comprise a Galdieria extract in the amount of from 0.004 to 0.4 wt% of the acidic composition.
Cagnac does not disclose an acidic composition that is a concentrated liquid composition comprising phycocyanins that comprise a Galdieria extract. However, Cagnac at [0075] discloses a concentrated liquid composition as an acidic composition comprising from 500 to 1000 mg/L of its composition wherein.
Further and regarding the sulphated polysaccharide in claim 80, while the Office considers optional limitations the claims themselves do not require them.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Cagnac to make its concentrated liquid acidic composition comprising a Galdieria extract as its phycocyanin. Cagnac discloses in Example 6 and at [0047]-[0051] that Galdieria extracts provide a desirable acidic-pH -resistant phycocyanin to make its acidic compositions
Claims 56-59, 68 and 78-79 are rejected under 35 U.S.C. 103 as being unpatentable over US2022/0015398 A1 to Leeb et al. (Leeb) as applied to claims 55 and 67, above.
As applied to claims 55 and 67, Leeb at [0148] and Table 11 discloses a liquid or solid acidic composition comprising from between about 0.001 wt% and about 0.1 wt% of phycocyanin, based on the total weight of acidic composition.
Regarding instant claim 56, at [0082] Leeb discloses a liquid foodstuff comprising a phycocyanin with a pH of 4.7-8, which the claimed acidic composition pH overlaps wherein the liquid foodstuff further contains a chelating agent (claim 56). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. It would have been obvious in view of Leeb for the ordinary skilled artisan to make an acidic composition comprising the phycocyanin and chelating agent because Leeb discloses that it is desirable to make acidic compositions from its food and beverage compositions.
Regarding instant claims 57-59, Leeb at [0082] discloses chelating agents selected from the group consisting of ethylene diamine tetra acetic acid (EDTA) (claims 58 and 59) and sodium, potassium and calcium salts thereof, and L-glutamic acid N, N-diacetic acid tetrasodium salt (GLDA) (claim 58). The Office considers the claimed synthetic or natural compounds to include the EDTA and salts and the GLDA of Leeb.
Regarding instant claim 68, Leeb discloses a carbonated beverage as liquid composition.
Regarding instant claims 78-79, Leeb does not disclose an example of a concentrated liquid composition wherein the phycocyanins are present in the concentrated liquid composition in an amount ranging between about 50 mg/L and about 2500 mg/L or in an amount ranging between about 500 mg/L and about 1000 mg/L, the composition optionally further comprising at least one sulphated polysaccharide. However, Leeb at [0084] discloses syrups as its liquid acidic compositions. And, at [0145]-[0146] Leeb discloses concentrated liquid compositions comprising 34.3 wt% water and having a Brix of about 65° and wherein the ratio of the phycocyanin to sulphated polysaccharide is about 1:4. The Office considers the disclosed concentrated liquid composition at [0084] of Leeb to comprise about 99.3 wt% water and sugar, and about 0.7 wt% of a 1:4 mixture of phycocyanin and sulphated polysaccharide, or about 0.14 wt% which is 1400 mg/L of phycocyanin. In addition, at [0147] Leeb discloses further reducing phycocyanin content by adding additional sugar.
Further, in claims 78-79 and regarding the sulphated polysaccharide, while the Office considers optional limitations the claims themselves do not require them.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
WO 2005112667 A1 to Takashi (Clarivate machine translation, copy included herewith) discloses at Abstract on page 1 discloses a health food that chelates harmful minerals comprising (in Example 8 at [0059] methylsulfonylmethane (60) mg, citric acid (100) mg, L-cystine (2.5) mg, linoleic acid (100) mg, L-parin (50) mg, L-isoleucine (50) mg, phycocyanin (2.5) mg, phytic acid (0) mg, L-cystine (0) mg, L-methionine (5) mg, ethylenediamine (0) mg, EDTA (0) mg, α —Lipoic acid (0) mg, peach juice (50 mg) and 1500 mg of oligosaccharide.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki H Dees can be reached at (571) 270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW E MERRIAM/Examiner, Art Unit 1791