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 .
DETAILED ACTION
Summary
This is a Final Office action based on the 17/420801 application response filed on 10/09/2025.
Claims 1-2, 9-11,15, 17-18 & 20 are pending and have been fully considered.
Claims 3-8, 12-14, 16 & 19 are cancelled.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 9-11,15, 17-18 & 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12, 139,516 in view of SCHOLTEN in WO 2017132407 in view of RAHMAN in Thermostable phycocyanin from the red microalga Cyanidioschyzon merolae, a new natural blue food colorant and in further view of in view of LEPINE in US 20200140496.
U.S. Patent No. 12, 139,516 teaches a method for purifying acid-pH-resistant phycocyanins from a crude extract of acid-pH-resistant phycocyanins from cells of a phycocyanin-producing microorganism, said microorganism being of the genus Galdieria, said acid-pH-resistant phycocyanins being phycocyanins stable at a pH less than 5, and wherein the method comprises the steps of: a) adjusting the pH of the crude extract of acid-pH-resistant phycocyanins to a pH below 5 so as to precipitate organic matter other than acid-pH-resistant phycocyanins, b) recovering the supernatant comprising acid-pH-resistant phycocyanins obtained in step a) and c) isolating acid-pH-resistant phycocyanins from the supernatant of step b).
The patent further teaches wherein the acid-pH-resistant phycocyanin comprises a mixture of C-phycocyanin (C-PC) and allophycocyanin (APC), the C-PC/APC molar ratio being at least 5; wherein the acid-pH-resistant phycocyanins comprise at least 95 mol % acid-pH-resistant C-PC and less than 5 mol % APC, the percentages being expressed in relation to the total sum of APC and C-PC; wherein the recovery of the supernatant is carried out by filtration; wherein the microorganism is of the strain Galdieria sulphuraria; and wherein the residual acid-pH resistant phycocyanins contained in the precipitate of step a) are solubilized in an aqueous solution of acid pH and separated from organic matter other than acid-pH-resistant phycocyanins and isolated by repeating steps b) and c).
U.S. Patent No. 12, 139,516 does not specifically call out “tangential,” filtration or lysis, however these are taught by SCHOLTEN in WO 2017132407 in view of RAHMAN in Thermostable phycocyanin from the red microalga Cyanidioschyzon merolae, a new natural blue food colorant and in further view of in view of HARRISON in US 20200255473.
SCHOLTEN teaches a process for producing a protein material and/or food source from a cellular biomass, wherein the biomass can be an algal biomass (abstract). SCHOLTEN teaches that the algae used can be Galdieria (0039). This genus of algae accumulates water soluble glycogen.
SCHOLTEN teaches a method of extracting proteins the biomass (0070, 0073,0075), and of lysing (lysol (0077)) an algae or microalgae culture which can result in a suspension (step a, b1) (0075), followed by an acid wash step (step b2) (0076). This acid washing step can lower the pH to 4.5 or less (0080). The acid washing step can be followed by centrifugation to achieve a pellet (recovering the lysed biomass fraction insoluble, proteinaceous product, step c) followed by resuspension in a solvent ((0073 and 0077]). SCHOLTEN teaches than any of the steps can be done in any order and that one or more of the steps described can be eliminated ((0073]).
It would have been obvious extract proteins from algae as is done in SCHOLTEN in the patent, due to the many potential advantages algael proteins have for human and animal nutrition and needs (SCHOLTEN, paragraph 0005-0006).
SCHOLTEN focus is on extracting proteins, which phycocyanin is one of, but does not teach of specifically extracting phycocyanin. SCHOLTEN also does not call out specifically adjusting the pH specifically to a pH range in which the phycocyanins are less soluble and specifically 4.5 to 5.5.
RAHMAN is used to remedy this and teaches of methods of investigating phycocyanins from red microalga(abstract). This includes extraction of pycocyanins from an initial pycocyanin solution (stock culture-Page 1234, first column, last paragraph and second column, first paragraph) or the biomass in water (Page 1234, column 2, purification of phycocyanin).
RAHMAN further teach of harvesting the cultures (Page 1234, column 2, paragraph 1). RAHMAN et al. further discuss that algeal stability changes with respect to pH, for example merolae phycocyanin is relatively stable at pH 4 to 5 (which reads on adjustment into a range of 4.5 to 5.5 as instantly claimed). RAHMAN also teaches of investigating the phycocyanin of another red microalgae, Galdieria sulphuraria(Page 1234, column 1, paragraph 2, line 12). RAHMAN et al. further teach that in their method they specifically adjust the pH to a pH of 2 to grow the bio-organsim (adjusting the pH to grow,) the phycocyanin and then of using a pH of 5 to store the precipitate (Page 1234, column 2, first paragraph 1, lines 9-11). RAHMAN further teach of exposing the phycocyanin to water to precipitate and extract water (this adjusts the pH of the biomass since the sample grew at pH of 2 and water has a pH of 7) (Page 1234, column 2, purification of phycocyanin).
It would have been obvious to one of ordinary skill to extract phycocyanin from Galdieria sulphuraria and to adjust the pH of the solution to precipitate out the phycocyanins as done in RAHMAN in the method of SCHOLTEN due to the interesting alternatives the different stabilities of different algaes and different pH’s offer (RAHMAN, abstract) and due to the advantage the phycocyanin extraction of and the species of Galdieria sulphuria has in that it grows at relatively high temperatures and low pH(Page 1234, column 1, paragraph 2, line 12).
SCHOLTEN and RAHMAN teach of the claimed invention as shown above. They do not call out tangential or cross flow filtration/ the concentration of the phycocyanin.
LEPINE is used to remedy this and further teaches of a method of extracting phycocyanin (abstract), in which tangential filtration is used with a cut-off (paragraph 0024, 0027, 0048, 0049), and further in which the phycocyanin is concentrated to greater than 10g/L which reads on the claimed 20g/L(paragraph 0029, 0033, 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use tangential filtration and to extract to a high concentration as is done on LEPINE in the methods of SCHOLTEN and RAHMAN due to the advantages of phycocyanins (in spirulina) can have for expanding uses in food and therapeutic fields due to them being rich in essential amino acids and due toteh advantage tangential microfiltration offers for complete clarification of the solutions (paragraphs 0003, & 0024-0025).
Claims 1-2, 9-11,15, 17-18 & 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-15, 18-20, 22-25, & 7-11 of copending Application No. 17/273678 in view of SCHOLTEN in WO 2017132407 in view of RAHMAN in Thermostable phycocyanin from the red microalga Cyanidioschyzon merolae, a new natural blue food colorant and in further view of in view of LEPINE in US 20200140496.
This is a provisional nonstatutory double patenting rejection.
U.S. Application 17/273678 teaches a process for producing a protein-rich biomass and removing glycogen from a biomass of lysed microorganisms that accumulate water-soluble glycogen during their growth (wherein Galdieria is one of the potential microorganisms); including the steps of lysis, acidifying the biomass to a pH of 5 or less or 4.5.
U.S. Application 17/273678 does not specifically call out “tangential,” filtration, however these are taught by SCHOLTEN in WO 2017132407 in view of RAHMAN in Thermostable phycocyanin from the red microalga Cyanidioschyzon merolae, a new natural blue food colorant and in further view of in view of HARRISON in US 20200255473.
SCHOLTEN teaches a process for producing a protein material and/or food source from a cellular biomass, wherein the biomass can be an algal biomass (abstract). SCHOLTEN teaches that the algae used can be Galdieria (0039). This genus of algae accumulates water soluble glycogen.
SCHOLTEN teaches a method of extracting proteins the biomass (0070, 0073,0075), and of lysing (lysol (0077)) an algae or microalgae culture which can result in a suspension (step a, b1) (0075), followed by an acid wash step (step b2) (0076). This acid washing step can lower the pH to 4.5 or less (0080). The acid washing step can be followed by centrifugation to achieve a pellet (recovering the lysed biomass fraction insoluble, proteinaceous product, step c) followed by resuspension in a solvent ((0073 and 0077]). SCHOLTEN teaches than any of the steps can be done in any order and that one or more of the steps described can be eliminated ((0073]).
It would have been obvious extract proteins from algae as is done in SCHOLTEN in the patent, due to the many potential advantages algael proteins have for human and animal nutrition and needs (SCHOLTEN, paragraph 0005-0006).
SCHOLTEN focus is on extracting proteins, which phycocyanin is one of, but does not teach of specifically extracting phycocyanin.
SCHOLTEN also does not call out specifically adjusting the pH specifically to a pH range in which the phycocyanins are less soluble and specifically 4.5 to 5.5.
RAHMAN is used to remedy this and teaches of methods of investigating phycocyanins from red microalga(abstract). This includes extraction of pycocyanins from an initial pycocyanin solution (stock culture-Page 1234, first column, last paragraph and second column, first paragraph) or the biomass in water (Page 1234, column 2, purification of phycocyanin).
RAHMAN further teach of harvesting the cultures (Page 1234, column 2, paragraph 1). RAHMAN et al. further discuss that algeal stability changes with respect to pH, for example merolae phycocyanin is relatively stable at pH 4 to 5 (which reads on adjustment into a range of 4.5 to 5.5 as instantly claimed). RAHMAN also teaches of investigating the phycocyanin of another red microalgae, Galdieria sulphuraria(Page 1234, column 1, paragraph 2, line 12). RAHMAN et al. further teach that in their method they specifically adjust the pH to a pH of 2 to grow the bio-organsim (adjusting the pH to grow,) the phycocyanin and then of using a pH of 5 to store the precipitate (Page 1234, column 2, first paragraph 1, lines 9-11). RAHMAN further teach of exposing the phycocyanin to water to precipitate and extract water (this adjusts the pH of the biomass since the sample grew at pH of 2 and water has a pH of 7) (Page 1234, column 2, purification of phycocyanin).
It would have been obvious to one of ordinary skill to extract phycocyanin from Galdieria sulphuraria and to adjust the pH of the solution to precipitate out the phycocyanins as done in RAHMAN in the method of SCHOLTEN due to the interesting alternatives the different stabilities of different algaes and different pH’s offer (RAHMAN, abstract) and due to the advantage the phycocyanin extraction of and the species of Galdieria sulphuria has in that it grows at relatively high temperatures and low pH(Page 1234, column 1, paragraph 2, line 12).
SCHOLTEN and RAHMAN teach of the claimed invention as shown above. They do not call out tangential or cross flow filtration/ the claimed concentration of phycocyanin.
LEPINE is used to remedy this and further teaches of a method of extracting phycocyanin (abstract), in which tangential filtration is used with a cut-off (paragraph 0024, 0027, 0048, 0049), and further in which the phycocyanin is concentrated to greater than 10g/L which reads on the claimed 20g/L(paragraph 0029, 0033, 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use tangential filtration and to extract to a high concentration as is done on LEPINE in the methods of SCHOLTEN and RAHMAN due to the advantages of phycocyanins (in spirulina) can have for expanding uses in food and therapeutic fields due to them being rich in essential amino acids and due toteh advantage tangential microfiltration offers for complete clarification of the solutions (paragraphs 0003, & 0024-0025).
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 ofmatter, or any new and useful improvement thereof, may obtain a patent therefor, subject to theconditions and requirements of this title.
The claimed invention of Claims 1-2, 9-11,15, 17-18 & 20 are directed to non-statutory subject matter.
The invention of instant independent claim 1, are drawn towards a process for extracting and purifying phycocyanin.
Through 101, inquiry analysis:
Are the claims directed to a statutory category of invention?
Yes, the claims, all dependent on independent Claim 1 are drawn towards a statutory category of a method.
Do the claims involve a Judicial Exception?
Yes. The claims involve the judicial exception which is—a product of nature. Phycocyanin is a natural product, present in algae and other materials. Even when extracted and purified, it is still a product of nature.
Analysis of other factors to determine if the claim qualifies as eligible and ismore than the natural product.
There are no features instantly claimed which make the natural product markedly different from its natural state, nor which add in significantly more than the judicial exception to the product of nature.
In addition to the natural product, “preparing an initial phycocyanin solution as a crude solution obtained from a lysis of a Galdieria genus microorganisms biomass,”
“selective precipitation which consists of,” “adjusting the pH of the initial solution to” a pH of 4.5 to 5.5,
and “concentrating,” “using tangential filtration with cutoff threshold,” … and “recovery of the precipitated phycocyanin,” is claimed.
With respect to the limitation, “obtained from a lysis of Galdieria genus microorganism,” even if the microorganism is broken up through lysis, it still results in a natural product/product of nature. Further—it seems in this limitation that applicant is just claiming that they, “obtained,” the natural compound in a slightly smaller state that an un-lysed sample. Given this is this case, does not change the fact that a lysed sample is still a natural sample/product of nature. Nothing has been added here which shows that the compound is changed to being markedly different from what is found in nature. Samples can be lysed in nature.
Further- with respect to the claiming of “Galdieria genus microorganism biomass,” this is merely stating the origin of the product of nature, so is still is a product of nature.
Adjusting the pH to the range of 4.5 to 5.5 is something can occur naturally or be present in the initial sample. As shown in Claim 5, Cyanidioschyzon, Cyanidium or Galdieria are the microorganisms the sample is taken from. Particularly, Cyanidium or Galdieria commonly exist at pH’s in the claimed range, in which case—there might not even be the claimed adjustment with an outside solution to arrive at this pH. In any event, no specific solution which changes or reacts with the natural product to make it something markedly different is claimed.
The claimed extracting a purification- “using tangential filtration with cutoff threshold,” is separating the phycocyanin from it’s surrounding compound (Cyanidioschyzon, Cyanidium or Galdieria- which are algae type microorganisms).
As disclosed, and especially as claimed--there is no indication that purified phycocyanin has any characteristics (structural, functional, or otherwise) that are different from naturally occurring phycocyanin. The claim therefore encompasses phycocyanin that is structurally and functionally identical to naturally occurring phycocyanin. Because there is no difference between the claimed and naturally occurring phycocyanin, the claimed acid does not have markedly different characteristics from what occurs in nature, and thus is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A, Prong 1: YES). The claim doesn’t add anything to practically apply the judicial exceptions. The claimed general lysis, adjusting of pH, and concentrating of phycocyanins, at least as generally claimed does not change the natural product to something markedly different and also at the level of generality claimed does nothing to practically apply (Step 2A, Prong 2: NO). Because the claim does not include any additional features that could add significantly more to the exception (Step 2B: NO), the claim does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
Since tangential flow filtration is well understood, routine and conventional in the art for separation of substances, it does not add significantly more to the claimed method. It also does nothing to practically apply as claimed. Claiming the concentration that the phycocyanin is concentrated to by the filtration does not change these matters as again the phycocyanins are still not markedly different from what is found in nature.
See MPEP 2106, and specifically, the part with respect to Products of Nature 2106.04(b). See MPEP 2106.05(d) which deals with what is considered “Well-Understood, Routine and Conventional.”
Claim 2 does not change matters as it merely states that the routine and conventional steps are carried out sequentially or simultaneously.
Claims 15 & 20 does not change matters as it claims removing water/ “concentration,” and this is something that can happen naturally as is also routine and conventional in the art and does not change the natural product to something markedly different from what is found in nature.
Claim 9 does not change matters as it states the product of nature is dehydrated and ground, which does not make it markedly different from what is found in nature, and drying and grinding compounds is also routine and conventional in the art.
Claims 10, 11 & 18 do not change matters as they state a material property which is part of the product of nature.
Claim 17 does not change matters. Claim states that 17 that the phycocyanin has a phycocyanin/glycogen ratio. This is a material property (naturally occurring property) of the product of nature, so is part of the judicial exception itself.
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 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 non-obviousness.
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.
Claims 1-2, 9-11,15, 18 & 20 are rejected under 35 U.S.C. 103 as being obvious over SCHOLTEN in WO 2017132407 in view of RAHMAN in Thermostable phycocyanin from the red microalga Cyanidioschyzon merolae, a new natural blue food colorant and in further view of in view of LEPINE in US 20200140496.
With respect to Claim 1, SCHOLTEN teaches a process for producing a protein material and/or food source from a cellular biomass, wherein the biomass can be an algal biomass (abstract). SCHOLTEN teaches that the algae used can be Galdieria (0039). This genus of algae accumulates water soluble glycogen.
SCHOLTEN teaches a method of extracting proteins the biomass (0070, 0073,0075), and of lysing (lysol (0077)) an algae or microalgae culture which can result in a suspension (step a, b1) (0075), followed by an acid wash step (step b2) (0076). This acid washing step can lower the pH to 4.5 or less (0080). The acid washing step can be followed by centrifugation to achieve a pellet (recovering the lysed biomass fraction insoluble, proteinaceous product, step c) followed by resuspension in a solvent ((0073 and 0077]). SCHOLTEN teaches than any of the steps can be done in any order and that one or more of the steps described can be eliminated ((0073]).
SCHOLTEN’s focus is on extracting proteins, which phycocyanin is one of, but does not teach of specifically extracting phycocyanin. SCHOLTEN also does not call out specifically adjusting the pH specifically to a pH range in which the phycocyanins are less soluble and specifically 4.5 to 5.5.
RAHMAN is used to remedy this and teaches of methods of investigating phycocyanins from red microalga(abstract). This includes extraction of pycocyanins from an initial pycocyanin solution (stock culture-Page 1234, first column, last paragraph and second column, first paragraph) or the biomass in water (Page 1234, column 2, purification of phycocyanin).
RAHMAN further teach of harvesting the cultures (Page 1234, column 2, paragraph 1). RAHMAN et al. further discuss that algael stability changes with respect to pH, for example merolae phycocyanin is relatively stable at pH 4 to 5 (which reads on adjustment into a range of 4.5 to 5.5 as instantly claimed). RAHMAN also teaches of investigating the phycocyanin of another red microalgae, Galdieria sulphuraria(Page 1234, column 1, paragraph 2, line 12). RAHMAN et al. further teach that in their method they specifically adjust the pH to a pH of 2 to grow the bio-organsim (adjusting the pH to grow,) the phycocyanin and then of using a pH of 5 to store the precipitate (Page 1234, column 2, first paragraph 1, lines 9-11). RAHMAN further teach of exposing the phycocyanin to water to precipitate and extract water (this adjusts the pH of the biomass since the sample grew at pH of 2 and water has a pH of 7) (Page 1234, column 2, purification of phycocyanin).
RAHMAN also teaches of determination of the concentration of the phycocyanin content in mg/mL (Page 1235, column 2, last paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to extract phycocyanin from Galdieria sulphuraria and to adjust the pH of the solution to precipitate out the phycocyanins as done in RAHMAN in the method of SCHOLTEN due to the interesting alternatives the different stabilities of different algaes and different pH’s offer (RAHMAN, abstract) and due to the advantage the phycocyanin extraction of and the species of Galdieria sulphuria has in that it grows at relatively high temperatures and low pH(Page 1234, column 1, paragraph 2, line 12).
SCHOLTEN and RAHMAN teach of the claimed invention as shown above. They do not call out tangential or cross flow filtration and concentrating the phycocyanin to 20g/L. Further, if the claimed “lysis,” is unclear clear, LEPINE is used to remedy this.
LEPINE is used to remedy this and further teaches of a method of extracting phycocyanin (abstract), in which tangential filtration is used with a cut-off (paragraph 0024, 0027, 0048, 0049), and further in which the phycocyanin is concentrated to greater than 10g/L which reads on the claimed 20g/L (paragraph 0029, 0033, 0050). LEPINE also teaches of preparing the sample by performing cellular lysis (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use tangential filtration and to extract to a high concentration as is done on LEPINE in the methods of SCHOLTEN and RAHMAN due to the advantages of phycocyanins (in spirulina) can have for expanding uses in food and therapeutic fields due to them being rich in essential amino acids and due toteh advantage tangential microfiltration offers for complete clarification of the solutions (paragraphs 0003, & 0024-0025).
With respect to Claims 2 & 15, SCHOLTEN teaches a method of extracting proteins the biomass (0070, 0073,0075), and of lysing (lysol (0077)) an algae or microalgae culture which can result in a suspension (step a, b1) (0075), followed by an acid wash step (step b2) (0076). This acid washing step can lower the pH to 4.5 or less (0080). The acid washing step can be followed by centrifugation to achieve a pellet (recovering the lysed biomass fraction insoluble, proteinaceous product, step c) followed by resuspension in a solvent ((0073 and 0077]). SCHOLTEN teaches than any of the steps can be done in any order and that one or more of the steps described can be eliminated ((0073]). Further, even if SCHOLTEN didn’t teach the ability to adjust the order of performing the steps in the claimed order or reversing the order, it has been found that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results; See In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) & MPEP 2144.
With respect to Claim 20, SCHOLTEN teaches in table 6 that there is a total solids % of 12.15-15.15.5% (Table 6). Further SCHOLTEN teaches of determining the concentration of phycocyanin (Page 1234, column 2, last 2 paragraphs). Also- see Page 1235, column 1, results and discussion, paragraph 1). The concentration of the concentrated sample would be dependent on the sample taken. Therefore, from what is taught in SCHOLTEN, it would have been obvious to one of ordinary skill in the art to determine the concentration of phycocyanin present in any sample taken (and making it obvious to determine the claimed concentrations), since this would be no more than routine experimentation. See MPEP 2144, Routine Optimization.
Further, LEPINE teaches of a method of extracting phycocyanin (abstract), in which tangential filtration is used with a cut-off (paragraph 0024, 0027, 0048, 0049), and further in which the phycocyanin is concentrated to greater than 10g/L which reads on the claimed 20g/L, and of up to 50g/L which reads on the claimed at least 30g/l (paragraph 0029, 0033, 0050). LEPINE also teaches of preparing the sample by performing cellular lysis (abstract).
With respect to Claim 9, SCHOLTEN refers to the dry weight mass of the biomass (which is algae) (Page 1235, column 1, Figure 1 description).
With respect to Claims 10-11, & 18 RAHMAN teach of a purified phycocyanin and of the purity index being 18.07 which reads on the instant claim language of at least 2 and higher than 4 and at least 3(Page 1236, column 2, second paragraph).
Claims 17 is rejected under 35 U.S.C. 103 as being obvious over SCHOLTEN in WO 2017132407 in view of RAHMAN in Thermostable phycocyanin from the red microalga Cyanidioschyzon merolae, a new natural blue food colorant in further view of LEPINE in US 20200140496 and further in view of Wang in Effects of the different nitrogen, phosphorus and carbon source on the growth and glycogen reserves in Synechocystis and Anabaena.
With respect to Claim 17, SCHOLTEN and RAHMAN and LEPINE teach of the claimed invention as shown above. They do not call out that the organism also produces glycogen. This would be a material property of the organism used, however if this is not apparent to one of ordinary skill in the art, WANG is used to remedy this.
WANG et al. teach of analysis of two different cyanobacteria and that the cyanobacteria have both a glycogen content and a phycocyanin content and further teach that the content of glycogen and phycocyanin is dependent on the nutrient sources(abstract). It would have been obvious to one of ordinary skill in the art to analyze the content of the algeal or biomass components as is done in WANG in the methods of SCHOLTEN and RAHMAN and LEPINE due to the need in the art for better understanding of biomass content based on nutrient sources to better control algeal blooms (Page 2821, column 1, paragraphs 1-2). WANG et al. do not teach of the exact claimed weight ratio of glycogen/ phycocyanin, but from the teachings in WANG it would be obvious to one of ordinary skill that one could adjust this by adjusting nutrient sources(abstract).
Response to Arguments
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
The prior claim objections are overcome due to amendments made 10/09/2025.
With respect to the Double Patenting rejections, applicant argues that a Terminal Disclaimer has been filed. This is not seen in the file for the application. Therefore- the rejections are maintained until Terminal Disclaimers are filed and approved.
The 101 rejections are maintained and further explained in the rejection above for the amended claims. Applicant argues that Claim 1 is not directed to a law of nature, natural phenomena, or to an abstract idea. The examiner notes that the judicial exception the claims currently encompass is a product of nature.
Applicant argues that the claims are directed to a process and not the product of nature. Though the examiner understands that it is applicant’s intent to claim a method/process for extraction and purification, as claimed it is not done so in a way which makes one sure applicant is not just trying to claim a naturally occurring phycocyanin, as outside of the phycocyanin all that is claimed is very general lysis, extracting, filtration, and precipitation by adjusting of pH. As stated in the rejection above, both the claimed lysis, which it is noted from the claim language occurs outside the boundary of the claim due to the “obtained,” language, and the precipitation- which as claimed only occurs by pH “adjustment,” are things which happen to natural products naturally in nature. Applicant is not claiming anything specific which changes the product of nature to something markedly different. Further--- nothing specific is claimed with respect to the tangential filtration. Claiming the concentration of the phycocyanin does not change this matter. Applicant doesn’t claim what the cutoff is exactly or how it is used, nor does applicant claim how the particles are recovered. Applicant also does not claim any specific reagents or instruments used and notably does not claim any specific enzyme that is used to lysis nor do they claim a specific reagent for adjustment of pH. Therefore—due to the level of generality of the claims, the claims still encompass the product of nature judicial exception. If applicant adds more detail to the claims, this can likely be overcome.
The examiner disagrees with applicant’s analysis of the instant claims with respect to steps 2A and 2 B, and maintains their analysis as shown in the 101 rejection above.
Applicant argues that the “by lysis,” limitation and “phycocyanin content of at least 20g/l,” involve specific parameters and a specific method and that tangential filtration involves deliberate and controlled application of mechanical forces to separate components of a solution based on size. With respect to this, the examiner is not convinced, at least for how generally the claims read as instantly claimed. No cut-off size for the filter is claimed. No specific reagent used for lysing is claimed, nor are any other reagents of instrumentation. Therefore as instantly claimed, applicant does seem to be trying to tie up phycocyanin at a concentration of 20g/L or more. The pH adjustment as claimed is something that can happen naturally in nature as is the lysis and concentration. Again--- if applicant adds more detail to the claims, it is likely they can overcome this rejection.
The examiner agrees that a process is a statutory category of invention, however it is unclear as to why applicant is arguing about this, since the examiner never argued that it wasn’t.
With respect to the prior art, applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Notably, a new reference LEPINE is used instead of the priorly used HARRISON reference for the claims which were amended 10/09/2025.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Specifically, applicant argues about the SCHOLTEN reference separately though, it is the combination of the prior art that makes the instant invention obvious. Therefore, these arguments are not convincing.
Applicant argues that the invention of the instant invention have surprisingly discovered the instant invention which allows for phycocyanin concentration with low residual sugar contents, and that this surprisingly allows phycocyanin content concentration to 20g/L. The examiner does not find the convincing. The newly used LUPINE reference teaches of phycocyanin concentration at this level, so this does not seem surprising. Further--- as claimed, all that is claimed is very very generalized either sample processing or observation. As claimed, the lysis and adjusting of concentration are things that can o cur naturally. Though the examine assumes that applicant involves more things in a laboratory setting to reach that claimed concentration, as generally claimed this is not the case.
Applicant argues that the secondary reference RAHMAN teaches away from using the specifically claimed Galdieria. The examiner disagrees as RAHMAN also teaches of advantages of using Galdieria in that it has for being a compound to extract phycocyanin from since Galdieria sulphuria cab grow at relatively high temperatures and low pH (Page 1234, column 1, paragraph 2, line 12). Therefore, this does not teach away.
Applicant further argues about the HARRISON reference, but this reference is no longer used. LUPINE reference was used since multiple different amendments were made to Claim 1 which result in the changing of scope of claim 1.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
HARRISON in US 20200255473
HARRISON teaches of methods of purifying phycocyanins (abstract). HARRISON further teach of clarifying the crude mixture starting from a biomass of algae through tangential filtration (paragraphs 0033-0037 & 0042).
HARRISON even further teaches that the process involves multiple rounds of redissolving pellets in water, and then removal (concentration) or the clear supernatant. Removal of the supernatant concentrates the sample and yields highly purified phycocyanin product (paragraph 0046).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758