DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/30/2025 has been entered.
Status of claims
Claims 17-39 as amended on 6/30/2025 are pending.
Claims 24-35 were withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 8/01/2024.
Claims 17-23 and 36-39 as amended on 6/30/2025 are under examination in the instant office action.
Claim Rejections - 35 USC § 102
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.
Claims 17-20 and 36-39 as amended are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Gerloff-Elias et al (FEMS Microbiol Ecol, 2006, 56, pages 345-354) in the light of evidence by Borges et al (Front Immunol. 2012 May, Vol. 3, article 95, pages 1-2).
The cited reference by Gerloff-Elias discloses a protein or peptide extract derived from Chlamydomonas acidophila, wherein the protein or peptide extracts are purified heat-shock proteins or HSP (see entire document including abstract). The HSPs are obtained by extraction from aqueous dispersions of Chlamydomonas acidophila, followed by heating, centrifugation and fractionation by electrophoresis (see page 347, col. 1, section “protein extraction”). Thus, the final pure protein product contains nearly 100% amount of proteins or peptides in the final extract. There are no free amino acids as evidenced by molecular weights (figure 5).
With regard to claimed limitations drawn to enzymatic hydrolysis of algal biomass with alkaline protease, it is noted that a product-by-process claim is not limited to recited manipulations of the recited steps but only the structure implied by the steps. Thus, the final structure is the same as claimed and as disclosed, both being a protein or peptide extract derived from Chlamydomonas acidophila.
With regard to claimed limitations drawn to “antioxidant, antiaging or anti-inflammatory” effects of the claimed peptide extract derived from Chlamydomonas acidophila, it is noted that the cited reference by Gerloff-Elias identify the extracted peptides are as heat-shock proteins or HSP. The HSP are knonw to provide for anti-inflammatory effects upon administration as evidenced by Borges (see abstract).
Thus, the cited reference by Gerloff-Elias is considered to anticipate the claimed invention.
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 17-23 and 36-39 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over BR 102014023096 (Lisboa et al), Samarakoon et al (Food Research International, 2012, 48, pages 948-960) and Morris et al (Bioresource Technology, 2008, 99, pages 7723-7729).
The cited document BR 102014023096 (Lisboa et al) teaches that peptide extract obtained by enzymatic hydrolysis of microalga biomass including microalga belonging to Chlamydomonas or Chlorella are suitable for pharmaceuticals and cosmetics and they provide for antioxidant, immunomodulatory and antimicrobial effects (see English abstract).
The cited document BR 102014023096 (Lisboa et al) is silent about molecular weight (MW) of microalgal protein hydrolysates being less than 3500Da and at least about 20% of microalgal protein hydrolysates in the extract.
However, the cited prior art reference by Samarakoon teaches that the beneficial and bio-active microalgal protein hydrolysates are obtained by enzymatic hydrolysis and by further ultra-membrane separation to provide for small molecular weight peptides with MW 3000 Da (page 949, col. 2, par. 2-3). The cited reference by Samarakoon teaches and demonstrates that bio-active properties of enzymatic hydrolysates are common features for whole group of marine alga (abstract) including representatives of taxonomic unit Chlorophyceae (page 949, col.1, par. 2); and the marine microalga Chlamydomonas and Chlorella of BR 102014023096 (Lisboa et al) are representatives of the taxonomic unit Chlorophyceae. The cited reference by Samarakoon also teaches that microalgal peptides range in sizes from 2 to 20 amino acids and are harvested depending of specific enzyme used and combination of conditions of enzymatic hydrolysis used (page 949, col. 2, par. 2). The cited reference by Samarakoon teaches that bioactive properties of enzymatically digested small molecular weight algal proteins provide for antioxidative, antihypertensive, anticoagulative, antitumor and immune-stimulating properties (abstract; section 3.1; section 3.5; page 957, col. 2, last par.). The cited reference by Samarakoon also recognizes that specific bioactivities of proteolytic enzyme extracts are based on specific amino acid sequences (page 949, col.1, last paragraph lines 6-8).
Further, the cited reference by Morris clearly recognizes that microalgal enzymatic protein hydrolysates are more effective than intact proteins for clinical applications (page 7723, col. 2, par. 2). The cited reference by Morris demonstrates that enzymatic hydrolysis of microalgal biomass of representatives of taxonomic unit Chlorophyceae (to which claimed Chlamydomonas belongs) provide for a peptide extract or a protein hydrolysate with about 53% of peptides depending on concentrations of algal cell slurries (table 3) as well as depending on specific enzymes, pH, time and other conditions (figures 1-4). The major and most abundant peptides obtained by enzymatic hydrolysis have MW below 3500 Da or 2000 Da (figure 6).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to provide and/or to modify an enzymatic peptide extract of representatives of genus of Chlamydomonas taught/suggested by BR 102014023096 (Lisboa et al) including peptide extract of Chlamydomonas acidophilus species, which is representative of the genus Chlamydomonas, with a reasonable expectation of success in providing peptide extract containing at least 20% and more of peptide hydrolysates including low MW peptides because prior art clearly teaches and demonstrates that microalgal bio-active protein hydrolysates are obtained by enzymatic hydrolysis and ultra-membrane separation provide and they contain small molecular weight peptides with MW 3000 Da and lower, that peptide extract or a protein hydrolysate with about 53% of peptides are obtainable depending on concentrations of algal cell slurries, specific enzymes and other conditions used. One of skill in the art would have been motivated to provide peptide extracts or enzymatic protein hydrolysates and/or to optimize microalgal biomass enzymatic treatment conditions because microalgal small MW peptide extracts are recognized as being more effective than intact proteins for clinical applications (Morris and Samarakoon) and because peptide extract obtained by enzymatic hydrolysis of representatives of the genus Chlamydomonas are recognized as suitable for pharmaceuticals and cosmetics for their antioxidant, immun0-stimulatory and antimicrobial effects (by BR 102014023096 (Lisboa et al)).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
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 17-23 and 36-39 remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite a peptide extract of Chlamydomonas acidophilus. The microalga Chlamydomonas acidophilus is a naturally occurring microorganisms and so are peptides thereof. Microbial peptides would be found in nature as result of degradation or autolysis which is enzymatic hydrolysis. Moreover, enzymatic hydrolysis as claimed does not change structure and function of natural peptides. Further, with regard to peptide amounts and MW, it is noted that concentration and separation of peptides is a common, routine and conventional practice.
This judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed product, and the claimed product as a whole is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Response to Arguments
Applicant's arguments filed on 6/30/2025 have been fully considered but they are not persuasive.
With regard to claim rejection under 35 U.S.C. 102 (a) (1) as being anticipated by Gerloff-Elias et al (FEMS Microbiol Ecol, 2006, 56, pages 345-354) Applicants argue that the cited refence does not teach the use of alkaline protease to provide for protein extract of lower molecular weight that would have biological properties including anti-inflammatory effects such as demonstrated in the specification examples (response pages 7-9 of 15).
This argument is not found persuasive because a product-by-process claim is not limited to manipulations of the recited steps but only the final structure implied by the steps. Thus, the final structure is the same as claimed and as disclosed, both being a protein or peptide extract derived from Chlamydomonas acidophila. The rejected claims are not limited by a particular low MW peptide distribution in final preparation as argued.
Moreover, the cited reference by Gerloff-Elias clearly recognizes that peptide extract derived from Chlamydomonas acidophila contains eat-shock proteins or HSP; and the HSP are knonw to provide for anti-inflammatory effects upon administration as evidenced by Borges (see abstract).
With regard to claim rejection under 35 U.S.C. 103 as being unpatentable over BR 102014023096 (Lisboa et al), Samarakoon et al (Food Research International, 2012, 48, pages 948-960) and Morris et al (Bioresource Technology, 2008, 99, pages 7723-7729) Applicant’s main argument is that none of the cited references teaches and/or suggests to provide a peptide extract from Chlamydomonas acidophila by enzymatic hydrolysis (response pages 9-12 of 15).
This argument is not found persuasive because the prior art clearly recognizes that microalgal enzymatic protein hydrolysates are more effective than intact proteins for clinical applications (see reference by Morris at page 7723, col. 2, par. 2). The cited BR 102014023096 (Lisboa et al) teaches that enzymatic protein hydrolysates with biological activities are obtained from a large variety of microalga across several genera including the genus Chlamydomonas (abstract). Thus, regardless the fact as argued by Applicants that the genus Chlamydomonas contains 500 species (as based on IDS reference by Bellido), one of skill in the art would obviously expect that enzymatic hydrolysates of all marine microalga are bioactive and/or bio-functional. The prior art references including BR 102014023096 (Lisboa et al) and Samarakoon teach that peptide extracts obtained by enzymatic hydrolysis of microalga biomass including microalga belonging to the genus Chlamydomonas are suitable for pharmaceuticals and cosmetics and they provide for antioxidant, immunostimulatory and antimicrobial effects. The cited reference by Samarakoon teaches that the beneficial and bio-active microalgal protein hydrolysates are obtained by enzymatic hydrolysis and by further ultra-membrane separation to provide for small molecular weight peptides.
Thus, the prior art as a whole teaches that beneficial small MW peptides are extracted from a large variety of alga of various genera including representatives of genus Chlamydomonas. Moreover, the cited reference by Morris clearly recognizes that microalgal enzymatic protein hydrolysates are more effective than intact proteins for clinical applications (page 7723, col. 2, par. 2).
The presently claimed peptide extract, as being a small MW peptide, is not structurally and functionally different from any of the beneficial small MW peptides enzymatically extracted from a large variety of alga of various genera including representatives of genus Chlamydomonas. The peptide as disclosed in the as-filed specification is not characterized by any specific amino acid sequence. But the state of the art, for example: the cited reference by Samarakoon, recognizes that specific bioactivities of proteolytic enzyme extracts are based on specific amino acid sequences (page 949, col.1, last paragraph lines 6-8).
Thus, regardless specific algal source, the claimed peptide is an obvious variant of prior art small MW algal peptides. The cited prior art clearly recognizes that microalgal enzymatic hydrolysates provides for biological activities such as antioxidant, anti-aging and anti-inflammatory effects. One of ordinary skill in the art would obviously expect that enzymatic hydrolysates of all marine microalga including representatives of genus Chlamydomonas are bioactive and/or bio-functional.
With regard to claim rejection under 35 U.S.C. 101 Applicants appear to argue that claimed peptide extract cannot provide for claim-recited features such as “antioxidant, antiaging and/or anti-inflammatory” unless enzymatic hydrolysis is performed (response page 13 of 15).
This argument is not found persuasive for the very least reason that although enzymatic hydrolysates are more bio-effective, the intact or native proteins are also bio-effective to more or less degree as clearly stated by prior art (the cited reference by Morris at page 7723, col. 2, par. 2). Proteins derived from marine microalga provide for claim-recited features such as “antioxidant, antiaging and/or anti-inflammatory” effects (see the cited BR 102014023096 (Lisboa et al) and Samarakoon as explained above).
No claims are allowed.
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Vera Afremova
December 8, 2025
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653