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 Non-Final Office action based on the 17/420801 application RCE filed on 04/01/2026.
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/01/2026 has been entered.
Double Patenting
The prior double patenting rejection has been overcome due to terminal disclaimers with U.S. Patent No. 12, 139,516 and co-pending Application No. 17/273678, which were approved on 04/02/2026.
Claim Rejections - 35 USC § 101
The prior 101 rejection has been overcome due to amendments made 04/01/2026. The claims now fully encompass a method and process for extracting and purifying phycocyanins, and not solely the purified version of phycocyanins themselves.
Claim Objections
Claim 1 is objected to because of the following informalities:
With respect to Claim 1, the preamble is drawn towards “extracting and purifying,” however the claim body itself does not mention “extracting and purifying,” at all. It is understood that precipitation and filtration lead to “extracting and purifying,” however applicant should note this in the claim body to prevent confusion. Appropriate correction is required.
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 (red algae) (0039)---though SCHOLTEN does not call out that this contains the claimed phycocyanin, it is a material property/part of the make-up of Galdieria. This genus of algae accumulates water soluble glycogen.
SCHOLTEN teaches a method of extracting proteins from the biomass (0070, 0073,0075), and of lysing (paragraph 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 further teaches of reducing the biomass by centrifugation (paragraph 0044, 0075, 0077, 0084, 0103, 0114-0117). SCHOLEN even further teaches of “retrieval,” of proteinaceous product material, which reads on the claimed “recovery,” of protein/s (including phycocyanin, which is a protein in Galdieria).
SCHOLTEN notes that these steps are done to “maximize protein extraction.” 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), so this teaches that the claimed order, of lysing, centrifuging, recovering is obvious, since all of these steps are taught in a slightly different order.
SCHOLTEN’s focus is on extracting proteins, which phycocyanin is one of and which is a protein found in Galdieria, which is taught by SCHOLTEN, but does not call out 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 to precipitate.
RAHMAN is used to remedy this and teaches of methods of investigating phycocyanins from red microalga(abstract). This includes extraction of phycocyanins from an initial phycocyanin 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, such as the claimed 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.
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 to the 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 04/01/2026 have been fully considered but they are not persuasive.
The prior Double Patenting and 101 rejections are overcome due to amendments made 04/01/2026.
With respect to the prior art, in response to applicant's arguments against the references individually, one cannot show non-obviousness 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 SCHOLTEN does not teach of specifically phycocyanin precipitation or recovery, which the instant invention is drawn to. With respect to this, the examiner notes that SCHOLTEN does in fact teach of protein extraction and recovery from Galdieria genus microorganism biomass. The examiner notes the phycocyanin is a protein in Galdieria genus microorganisms biomass. Therefore, though SCHOLTEN doesn’t call out the phycocyanin specifically, it would be included in the recovery and extraction of protein/s as taught by SCHOLTEN.
Further- with respect to this, the examiner notes that applicant’s claimed process which supposedly allows for just extracting a purifying phycocyanin, and not other proteins from Galdieria, is claimed very very broadly, only including very general steps of “mechanical or enzymatic lysis,” “centrifuging,” “recovering,” “adjusting the pH to 4.5 to 5.5,” and “concentrating…by tangential filtration with a cut-off threshold.” Most of these claimed steps (lysis, centrifuging, recovery, and acid adjustment,” are in fact taught by SCHOLTEN for the proteins in Galdieria, which again due to the material properties of Galdieria, would include phycocyanin.
RAHMAN teaches of why one would want to use acid in the claimed range of 4.5- 5.5, and LUPINE teaches of the claimed tangential filtration, which therefore, make the instant claims obvious.
If applicant would like to overcome the instant prior art rejection, it is suggested that they add more specific steps with respect to the claimed “mechanical or enzymatic lysis,” “centrifuging,” “recovering,” “adjusting the pH to 4.5 to 5.5,” and “concentrating…by tangential filtration with a cut-off threshold,” which make the method specific to phycocyanin. For example, what specific lysing agents are used, what speeds are used for centrifugation, how exactly is the phycocyanin recovered, what is used to adjust the pH, and what is the cut off threshold for the tangential filtration?
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. Notably, if the instant invention does in fact allow for low residual sugar contents, it is not clear that what exactly is responsible for the low residual sugar content is claimed.
Further, with respect to the phycocyanin content concentration of 20g/L being “surprising,” this is really not convincing, since the final concentration of a product is dependent on what is in the initial compound of the product and different compounds would result in different final concentrations. Therefore, a final concentration after purification is not “surprising,” but instead is a material property of the compound and the source itself.
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 can be used 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.
With respect to the LUPINE reference, applicant argues that LUPINE does not teach of s precipitation step. The examiner points out that as claimed, applicants precipitation step comprises only the acid adjustment and tangential filtration. Therefore, since LUPINE does in fact teach of tangential filtration as claimed, it does in fact teach of the claimed precipitation. The acid adjustment part of this step was already taught by the other references as shown above, as was the recovery of proteins (which would include phycocyanin), by SCHOLTEN.
Therefore LUPINE teaching of tangential filtration in solution does not teach away from the instant claims.
Again, if applicant would like to overcome the instant prior art rejection, they should add details to the claims with respect to the “mechanical or enzymatic lysis,” “centrifuging,” “recovering,” “adjusting the pH to 4.5 to 5.5,” and “concentrating…by tangential filtration with a cut-off threshold,” which make the method specific to phycocyanin.
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).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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