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
1. Applicant’s election of Group II (claims 7, 66, 68-69, 73, 80-84 & 130-132) without traverse in the reply filed on 1/30/26 is acknowledged.
2. Claims withdrawn:
Claims 3-4, 106 & 125-129 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
3. Priority
Applicant’s claim for domestic priority under 35 U.S.C. 119(e), filed 11/12/20, is acknowledged.
4. Drawings
The drawings filed on 5/5/23 are acknowledged.
5. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
6. 35 U.S.C. § 112, first paragraph (Written Description)
Claims 7, 66, 68-69, 73, 80-84 & 130-132 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to the following genus claims.
7. (Currently Amended) A composition comprising a microbial oil and/or a derivative thereof produced by an oleaginous yeast, wherein the oil comprises a fatty acid profile comprising: at least 30% w/w saturated fatty acids; at least 30% w/w unsaturated fatty acids; and less than 30% w/w total polyunsaturated fatty acids.
8-65. (Cancelled)
66. (Currently Amended) The composition of claim [[63]]7, wherein the microbial oil derivative is a triglyceride, diglyceride, monoglyceride, free fatty acid, fatty acid salt, glycerin, ester, fatty alcohol, fatty amine, derivatives thereof, or combination thereof.
67. (Cancelled)
68. (Currently Amended) The composition of claim [[63]]7, wherein at least one of the oil derivatives functions as a surfactant, humectant, luxury soft oil, or biologically active ingredient in [[said]] a personal care composition.
69. (Original) The composition of claim 68, wherein the surfactant is an emulsifier, detergent, wetting agent, foaming agent, thickening agent, emollient, pearlescent, solubilizer, conditioning agent, co-surfactant or dispersant in said personal care composition.
70- 72. (Cancelled)
73. (Currently Amended) The composition of claim [[63]]7, further comprising a cleaning agent, a luxury soft oil, a polymer, an essential oil, a stabilizer, an emulsifier, a thickener, an antioxidant, a biologically active ingredient, or combinations thereof.
74. -79. (Cancelled)
80. (Currently Amended) The composition of claim [[63]]7, wherein the oleaginous yeast is Rhodosporidium toruloides.
81. (Currently Amended) The composition of claim [[63]]7, wherein the composition does not comprise palm oil or palm kernel oil or derivatives thereof.
82. (Currently Amended) The composition of claim [[63]]7, wherein the composition is a solid, liquid, cream, lotion, spray, gel, powder, or foam.
83. (Currently Amended) The composition of claim [[63]]7, wherein the composition is a skin repair serum, cleansing oil, a balm, a lotion, a cream, a makeup, a deodorant, a hair color, a baby wash, a baby shampoo, a shampoo, a conditioner, a liquid cleanser, a bar soap, a moisturizing oil, or a hair oil.
84. (Currently Amended) The composition of claim [[63]]83, wherein the composition is a cleansing-oil moisturizing oil comprising a microbial oil produced by an oleaginous yeast, wherein the microbial oil comprises the following amounts of fatty acids relative to the total fatty acids: between 25% and 37% w/w palmitic acid; between 40% and 55% w/w oleic acid; and between 5% and 15% w/w linoleic acid.
The claimed invention encompasses a genus of microbial oil composition from any oleaginous yeast and wherein the oil comprises a fatty acid profile comprising: at least 30% w/w saturated fatty acids; at least 30% w/w unsaturated fatty acids; and less than 30% w/w total polyunsaturated fatty acids, not adequately described.
The instant specification at most describes in Table 7, an oil composition from Rhodosporidium toruloides and from Palm oil (a plant). However, an analysis of Table 7 does not allow determination of various percentages of at least 30% w/w saturated fatty acids; at least 30% w/w unsaturated fatty acids; and less than 30% w/w total polyunsaturated fatty acids; or derivatives thereof.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe aninvention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what isclaimed."). Thus, an applicant complies with the written description requirement "bydescribing the invention, with all its claimed limitations, not that which makes it obvious,"and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966."Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents" of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case is discussed below.
Moreover, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
7. 35 U.S.C. § 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 therefore, subject to the conditions and requirements of this title".
Claims 7, 66, 68-69, 73, 80-84 & 130-132 are rejected under 35 U.S.C. § 101 because the claimed invention is directed toward non-statutory subject matter.
Claims 7, 66, 68-69, 73, 80-84 & 130-132 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because the claimed invention is directed to a naturally-occurring compound, a tetra-glycosylated steviol compound, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., --U.S.—(June 13, 2013).
Claims 7, 66, 68-69, 73, 80-84 & 130-132 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 7, 66, 68-69, 73, 80-84 & 130-132 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
Claims 7, 66, 68-69, 73, 80-84 & 130-132 are directed to a naturally-occurring fatty acid compound(s) which are naturally saturated, unsaturated or polyunsaturated of oil produced by yeast whether isolated, synthetic or recombinant or not, that are not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 106 USPQ2d 1972 (June 13, 2013), as they are not markedly different than the fatty acid compound(s) as it occurs in nature. It is noted that the instant specification discloses the isolation of these compounds in Table 7 (See US 20240000697 A1, Applicants’ PGPub); however, the occurrence of fatty acid compound(s)-producing and/or the derivatives thereof occur in nature and mere isolation does not change its content that can be varied depending on the how it is concentrated or not or have a particular use – for example in cosmetics.
In view of the evidence of record, the compound of claims encompasses a naturally occurring product(s) that is not markedly different from a corresponding product that occurs in nature. As such, the claimed compound is considered to be a law of nature and a judicial exception.
In this case, the composition of claims does not include an additional element or elements that is/are sufficient to amount to significantly more than the judicial exception itself.
There is no indication in the specification that the claimed fatty acid compound(s) which are naturally saturated, unsaturated or polyunsaturated compound has any characteristics (structural, functional, or otherwise) that are different from the individual fatty acid compound(s) which are naturally saturated, unsaturated or polyunsaturated as they occur in nature. Thus, the fatty acid compound(s) which are naturally saturated, unsaturated or polyunsaturated do not have markedly different characteristics from what occurs in nature, and is considered to be a “product of nature” exception. Accordingly, claims 7, 66, 68-69, 73, 80-84 & 130-132 are directed to a judicial exception. Because the claim does not include any additional features that could add significantly more to the exception, the claim does not qualify as eligible subject matter.
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
8. Double Patenting Rejection
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 7 is provisionally rejected under the judicially created doctrine of double patenting over claims 7 and 74 of co-pending Application No. 18035594. This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
The subject matter claimed in the instant application is fully disclosed in the referenced co-pending application and would be covered by any patent granted on that co-pending application since the referenced co-pending application and the instant application are claiming common subject matter, as follows:
Instant claim 7 is drawn to: A composition comprising a microbial oil and/or a derivative thereof produced by an oleaginous yeast, wherein the oil comprises a fatty acid profile comprising: at least 30% w/w saturated fatty acids; at least 30% w/w unsaturated fatty acids; and less than 30% w/w total polyunsaturated fatty acids.
Co-pending application claims 7 and 74 are drawn to as follows:
Claim 7 - An edible microbial oil produced by an oleaginous yeast, wherein the edible oil comprises a fatty acid profile comprising: at least 30% w/w saturated fatty acids; at least 30% w/w unsaturated fatty acids; and less than 30% w/w total polyunsaturated fatty acids.
Claim 74 - A food product comprising the an edible microbial oil produced by an oleaginous yeast of claim 7, or a derivative thereof, wherein the edible oil comprises a fatty acid profile comprising: at least 30% w/w saturated fatty acids; at least 30% w/w unsaturated fatty acids; and less than 30% w/w total polyunsaturated fatty acids.
Given the fact pattern of the instant case as well as the co-pending application the claims of the 2 application are obvious variation of each other, where instant application claiming a composition versus the co-pending application claiming “An edible microbial oil” or “A food product” comprising a fatty acid profile comprising: at least 30% w/w saturated fatty acids; at least 30% w/w unsaturated fatty acids; and less than 30% w/w total polyunsaturated fatty acids.
9. No claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. 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, Robert B Mondesi can be reached on 408 918 7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940