The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 14 is canceled. Claims 1-13, 15-18 are pending and under consideration.
Priority: This application is a CON of U.S. Application 16497510, filed September 25, 2019, now U.S. patent 12139516, which is a 371 of PCT/EP2018/058294, filed March 30, 2018, which claims benefit to foreign application FR 1752674, filed March 30, 2017. A copy of the foreign priority document has been received in the parent application 16497510 on September 25, 2019, and is not in the English language.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code: see at least paragraph 0073 (of the application publication US 20250122249). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1, 10-11, 13, 15-18 are objected to because of the following informalities: claims 1, 10-11, 15-16, 18 should recite an indefinite article such as “a” or “an” at the beginning of the claims; in claims 13, 17, the sequences recited as “SEQ ID NO X” should be recited as “SEQ ID NO: X”. Appropriate correction is required.
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 10-13, 15-18 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. The instant claims recite a nature-based product, i.e. an acid-pH resistant phycocyanin comprising a mixture of c-phycocyanin (C-PC) and allophycocyanin (APC). The phycocyanin recited in the instant claims is not markedly different from naturally occurring phycocyanin.
Claims 10-13, 16-17 recite a nature-based product, i.e. a phycocyanin. Claims 15, 18 recite a food composition comprising the phycocyanin. The claims recite phycocyanin proteins that are structurally the same as naturally occurring phycocyanin proteins. The claims are directed to a statutory category, i.e. a composition of matter (step 1: YES).
Since the claims recite a nature-based product, i.e. phycocyanin, the claims are analyzed to determine whether it is directed to any judicial exception. The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. The recited phycocyanin protein is compared to its closest naturally occurring counterpart(s) to determine if it has markedly different characteristics. Here, the closest natural counterpart is naturally occurring phycocyanin protein. When the claimed phycocyanin is compared to this counterpart, the comparison indicates that there are no differences in structure, function, or other characteristics. Phycocyanin naturally comprises C-PC and APC and are found in algae and cyanobacteria (application publication paragraphs 0004, 0008). Phycocyanin isolated from algae and cyanobacteria to comprise different ratios of C-PC and APC does not have markedly different characteristics due to their purification or human manufacture. Therefore, the phycocyanin does not have markedly different characteristics from what occurs in nature and is a "product of nature" exception. Accordingly, the claim is directed to an exception (step 2A: YES). Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception(s). Claims 15, 18 recite a food composition comprising the phycocyanin. The composition does not comprise any additional components besides the phycocyanin. The incorporation of a protein into a composition is not only well-understood, routine and conventional activity already engaged in by the scientific community, it is also required for using the protein. The claims recite the composition at such a high level of generality that it merely tells a scientist to use whatever general buffer or excipient to form a composition comprising the protein. The claims do not recite anything significantly different than the natural product, i.e. the claims do not recite elements or features that demonstrate that the claimed phycocyanin is markedly different from what exists in nature. Therefore, the claims as a whole add nothing significantly more to the "product of nature" itself (Step 2B: NO), and thus, the claims do not qualify as eligible subject matter.
Therefore, the claimed phycocyanin comprising ratios of C-PC and APC does not have markedly different characteristics from what exists in nature and is a “product of nature” exception. See also Funk Brothers Seed Co., V. Kalo Inoculant Co., 333 U.S. 127, (1948) and Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ 2d. 1972 (2013).
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 1-10, 11-13, 15, 17-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, step b), recites the limitation "the supernatant" in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the phycocyanin" in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the culture medium" in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 is dependent on claim 1 and recites wherein the phycobiliproteins contained in the pellet are solubilized in an aqueous solution of acid pH and separated from the impurities and isolated by repeating steps b) and c). Claim 9 is confusing because step a) recites that organic matter other than the phycobiliproteins is precipitated or in other words, the precipitate contains organic matter and not the phycobiliproteins. Further clarification and/or correction is requested. Additionally, claim 9 recites the limitations “the pellet” and "the impurities" in the claim. There is insufficient antecedent basis for these limitations in the claim.
Claim 11 recites an acid pH-resistant phycocyanin…”characterized” in that the C-PC/APC molar ratio is at least 5. It is not clear what is meant by “characterized”, i.e. whether the acid pH-resistant phycocyanin actually comprises the recited features. Further clarification and/or correction is requested.
Claim 13 recites the limitations "the apoprotein of the α subunit" and “the apoprotein of the β subunit” in the claim. There is insufficient antecedent basis for these limitations in the claim.
Claim 17 recites the limitations "the apoprotein of the α subunit" and “the apoprotein of the β subunit” in the claim. There is insufficient antecedent basis for these limitations in the claim.
Claims 2, 5-8, 10, 12, 15, 18 are included in this rejection because they are dependent on the above claim(s).
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.
Claims 15, 18 are 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. Claims 15, 18 are product claims dependent on claims 10 and 11, respectively. The claims do not recite any additional components to the product that further limit the claims. The recitation of an intended use (i.e. food composition) in a product claim does not further limit the claim. 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 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.
(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 1-3, 10, 11-12, 15-16, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yan et al. (2011 J Appl Phycol 23: 1-6; IDS 12.12.24). Yan et al. teach a method comprising purifying phycobiliproteins (PBPs) from the cyanobacterium Spirulina (Arthrospira) platensis (p. 1). Yan et al. disclose suspending a crude extract comprising PBPs in sodium acetate buffer pH 5.0, centrifuging to remove debris and obtain a cell free extract (i.e. supernatant) and fractionating the supernatant with ammonium sulfate and dissolving in sodium acetate buffer and dialyzing overnight, where the dialyzed solution is loaded onto a DEAE-Sepharose Fast Flow column, washed, and eluted to obtain purified PBPs (p. 2). Therefore, Yan et al. can be deemed to teach a method comprising at least the steps of a) adjusting the pH of a crude extract of acid-pH resistant phycobiliproteins, b) recovering a supernatant comprising acid-pH resistant phycobiliproteins, and c) isolating acid-pH resistant phycobiliproteins, recited in instant claim 1.
Regarding instant claims 2-3, 10, 11-12, 16, Yan et al. teach the PBPs of Spirulina platensis comprise C-phycocyanin (C-PC) and allophycocyanin (APC), where the purified PHPs comprise a mixture of purified C-PC and APC (p. 2-3), the C-PC and APC were both stable at pH 4 (p. 3-5). Yan et al. teach obtaining different fractions comprising C-PC and APC having different ratios of purity and yield; including fractions containing 90.10 mg C-PC and 19.75 mg APC having low purity ratios of 0.97 and 0.37, fractions containing 144.48 mg C-PC and 33.78 mg APC having purity ratios of 2.11 and 0.83, and fractions containing 111.83 mg C-PC and 29.28 mg APC having purity ratios of 5.59 and 5.19 (at least p. 2-3, also Fig. 1). Therefore, Yan et al. can be deemed to teach the claimed phycocyanin mixtures and molar ratios (or purity ratios) since the PBPs in Yan et al. are obtained by the same method steps recited in the instant claims.
Regarding instant claims 15, 18, it is noted that the claim is still drawn to a composition comprising an acid-resistant phycocyanin, regardless of its intended use, i.e. food composition. See also MPEP 2111. As noted above, Yan et al. teach a composition comprising purified PHPs comprising a mixture of purified C-PC and APC (p. 2-3), the C-PC and APC both stable at pH 4 (p. 3-5), including fractions containing 111.83 mg C-PC and 29.28 mg APC having purity ratios of 5.59 and 5.19 (at least p. 2-3, also Fig. 1).
Claims 1-5, 7-9, 10, 11-13, 15-17, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rahman et al. (2017 J Appl Phycol 29: 1233-1239, published online November 21, 2016; IDS 12.12.24). Rahman et al. teach compositions comprising thermostable phycocyanin from Cyanidioschyzon merolae (C. merolae), a new natural blue food colorant (p. 1233). Rahman et al. teach extracts and/or fractions containing C-PC and APC (p. 1234). It is taught that phycocyanin solutions with a purity index of at least 0.7 are considered to be food grade, while a purity of index of at least 4 is considered to be analytical grade; the phycocyanin extracted from C. merolae has a high purity index (p. 1236). Rahman et al. teach compositions comprising C. merolae C-PC and APC having purity indexes of at least 5 and less than 5 (p. 1236, also Table 1), and where the phycocyanin is stable at acidic pH < 5 (p. 1237). Therefore, Rahman et al. can be deemed to anticipate at least instant claims 10, 11-12, 15-16, 18.
Regarding instant claims 13, 17, it is disclosed in the instant specification that instant SEQ ID NOS: 1-2 are the alpha and beta subunits, respectively, of C-PC from Galdieria sulphuraria (G. sulphuraria) and instant SEQ ID NO: 3-4 are the alpha and beta subunits, respectively, of APC from G. sulphuraria. In this instance, since Rahman et al. teach extracts and/or fractions containing C-PC and APC, the alpha and beta subunits of C-PC and APC would necessarily be present. Therefore, Rahman et al. can be deemed to teach variants of the claimed SEQ ID NOS (instant claims 13, 17).
Regarding instant claims 1, 4, 7-8, Rahman et al. teach a method of extracting phycocyanin from C. merolae comprising adjusting a crude extract comprising C. merolae expressing phycocyanin to a pH 2.0, recovering the blue colored supernatant, isolating or purifying phycocyanin from the supernatant (at least p. 1234, 1236).
Regarding instant claims 2-3, 5, as noted above, Rahman et al. teach compositions comprising C. merolae C-PC and APC having purity indexes of at least 5 and less than 5 (p. 1236, also Table 1), and where the phycocyanin is stable at acidic pH < 5 (p. 1237).
Regarding instant claim 9, Rahman et al. teach further purification of the blue colored supernatants (or crude phycocyanin extracts) comprising precipitation in ammonium sulfate, solubilizing in buffer pH 5.0, recovery of supernatant, and obtaining phycocyanin (at least p. 1234, 1236).
Claims 10, 11-13, 15-17, 18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Van Der Maarel et al. (WO 2016099261; IDS 12.12.24). Van Der Maarel et al. teach compositions comprising thermostable phycocyanin from Cyanidioschyzon merolae (C. merolae) (at least p. 12). Van Der Maarel et al. teach extracts and/or fractions containing C-PC and APC (at least p. 12). It is taught that phycocyanin solutions with a purity index of 1 or higher are considered to be food grade, where the blue pigment (C. merolae phycocyanin) is easily purified to a purity index of 5 or higher (p. 4) and compositions comprising the thermostable C. merolae blue pigment (at least p. 5). Van Der Maarel et al. teach compositions comprising C. merolae C-PC and APC having purity indexes of at least 5 and less than 5 (at least p. 12 Table 1), and where the phycocyanin is stable at acidic pH < 5 (p. 13). Therefore, Van Der Maarel et al. can be deemed to anticipate at least instant claims 10, 11-12, 15-16, 18.
Regarding instant claims 13, 17, it is disclosed in the instant specification that instant SEQ ID NOS: 1-2 are the alpha and beta subunits, respectively, of C-PC from Galdieria sulphuraria (G. sulphuraria) and instant SEQ ID NO: 3-4 are the alpha and beta subunits, respectively, of APC from G. sulphuraria. In this instance, since Van Der Maarel et al. teach extracts and/or fractions containing C-PC and APC, the alpha and beta subunits of C-PC and APC would necessarily be present. Therefore, Van Der Maarel et al. can be deemed to teach variants of the claimed SEQ ID NOS (instant claims 13, 17).
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.
Claims 13, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Van Der Maarel et al. (WO 2016099261; IDS 12.12.24). The teachings of Van Der Maarel et al. over at least instant claims 11, 16, 18 are noted above. As noted above, Van Der Maarel et al. disclose compositions comprising thermostable phycocyanin from Cyanidioschyzon merolae (C. merolae) (at least p. 12). It is disclosed that other natural blue pigments are available from other sources, including G. sulphuraria (p. 2, 4, 14-15).
As noted above, it is disclosed in the instant specification that instant SEQ ID NOS: 1-2 are the alpha and beta subunits, respectively, of C-PC from G. sulphuraria and instant SEQ ID NO: 3-4 are the alpha and beta subunits, respectively, of APC from G. sulphuraria.
Therefore, regarding instant claims 13, 17, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to arrive at the claimed C-PC and APC subunits comprising the instant SEQ ID NOS. because it is disclosed phycocyanin (natural blue pigments) are available from rhodophytes and have been isolated from G. sulphuraria (Van Der Maarel et al. p. 2, 4) because there was interest in isolating natural blue pigments for commercial purposes. One of ordinary skill would have a reasonable expectation of success because methods of purifying phycocyanin were known in the prior art.
Claims 1, 6 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. or Rahman et al. in view of WO 2005065697 (IDS 12.12.24; translated copy provided by EPO is provided and cited herein) (WO ‘697). The teachings of Yan et al. or Rahman et al. over at least instant claim 1 are noted above. The cited art references do not explicitly teach filtration.
WO ‘697 also discloses extracting phycobiliproteins from algae and cyanobacteria (p. 1). WO ‘697 discloses clarifying an aqueous extract comprising the phycobiliproteins by tangential microfiltration (p. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a filtration step as suggested in WO ‘697 to recover the supernatants and/or clarify the extracts containing phycobiliproteins in the method of Yan et al. or Rahman et al. (instant claim 6). The motivation to do so is given by WO ‘697 which disclose in extracts containing debris and phycobiliproteins, the extracts can be clarified by filtration. One of ordinary skill would have a reasonable expectation of success because methods of purifying phycocyanin were known in the prior art.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 10, 11-13, 15-17, 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, 11, 16-17, 19, 23-24, 26 of copending Application No. 15762659 (‘659) (reference application) in view of Van Der Maarel et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘659 claims are drawn to G. sulphuraria phycobiliproteins comprising C-PC and APC and compositions comprising said G. sulphuraria phycobiliproteins. As noted above, it is disclosed in the instant specification that instant SEQ ID NOS: 1-2 are the alpha and beta subunits, respectively, of C-PC from Galdieria sulphuraria (G. sulphuraria) and instant SEQ ID NO: 3-4 are the alpha and beta subunits, respectively, of APC from G. sulphuraria. Therefore, the instant claims (i.e. 10, 11-13, 16-17, 18) and the ‘659 application claims recite the same proteins and SEQ ID NOS. While the ‘659 application claims may not explicitly recite the purity ratio of the phycocyanin, it would have been obvious to arrive at the claimed purity in view of the teachings of Van Der Maarel et al. noted above. It is taught that phycocyanin solutions with a purity index of at least 0.7 are considered to be food grade, while a purity of index of at least 4 is considered to be analytical grade (Van Der Maarel et al. p. 1236). Therefore, it would have been obvious that the phycocyanin of the ‘659 application claims can be purified to the claimed ratio because methods of purifying phycocyanin were known in the prior art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12139516 (‘516). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘516 patent claims are drawn to a method for purifying acid-pH-resistant phycocyanin 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, comprising the steps a), b), and c). The method steps recited in instant claim 1 and claim 1 of the ‘516 patent comprise the same steps and/or similar steps. The ‘516 patent claims also recite obtaining the same phycocyanin proteins recited in the instant claims.
No claim is allowed.
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/Marsha Tsay/Primary Examiner, Art Unit 1656
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