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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Brazil on March 1, 2024. It is noted, however, that applicant has not filed a certified copy of the BR 10 2024 004249 2 application as required by 37 CFR 1.55.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Status of Claims
Claims 1 – 4 are pending.
Claims 1 -4 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1- 4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for formulations of palm oil and degummed soybean oil, as in Examples 1 and 3, does not reasonably provide enablement for formulations containing any monoglycerides, any diglycerides, any methyl esters of residual of any fatty acids, palm, palm kernel, soy, cotton, sunflower, canola and corn oils. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The test for enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the specification coupled with information known in the art without undue experimentation (United States v. Telectronice, 8, USPQ2D 1217 (Fed. Cir, 1988). Whether undue experimentation is needed is not based upon a single factor but rather in a conclusion reached by weighing many factors. The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). The Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’." (In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)). Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention. The nature of the claims are drawn to formulation characterized in that it contains monoglycerides, diglycerides, methyl esters of residual fatty acids, palm, palm kernel, soy, cotton, sunflower, canola and corn oils.
(2) the scope of the claims: The scope of the invention in the claims is that any combination of monoglycerides, diglycerides, methyl esters of residual fatty acids, palm, palm kernel, soy, cotton, sunflower, canola and corn oils will support a patentable formulation. Also, based in the disclosure the formulation will be cable of acting as an anti-dust and fluxing agent in civil construction and paving.
(3) The state of the prior art: the state of prior art formulations of plant based material is found in the teaching of Rehage (US 2014/0271928) and Bertin (US 2015/0197702). Example 32 of Rehage discloses a partially trans-esterified glycerides (PTEG) mixture comprising triglycerides, diglycerides, monoglycerides, and fatty acid methyl esters (FAMEs). 2 g of the PTEG solution was combined with 2 g of #6 oil, and the PTEG was observed to be miscible with the #6 oil.
Bertin discloses a grease composition comprising: (a) from 50 to 99 weight percent of a lubricating base oil, (b) from 1 to 30 weight percent of a thickener component comprising one or more of (i) one or more natural oil derivatives selected from the group consisting of triglycerides, diglycerides, monoglycerides, or oligomers therefrom, fatty acid methyl esters and corresponding fatty acids, salts, and dibasic esters therefrom, and C.sub.10-C.sub.15 esters, C.sub.15-C.sub.18 esters, or C.sub.18+ esters, or diesters therefrom, (ii) one or more carboxylic acids and/or derivatives thereof, and (iii) one or more of a metal base compound; and (c) from 1 to 15 weight percent of one or more optional additives.
(4) the predictability or unpredictability of the art: Chemistry is unpredictable. In reMarzocchi, 439 F2d 220, 169 USPQ 367 para. 3. However, the "predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or know results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. MPEP 2164.03.
(5) The relative skill of those in the art: One of ordinary skill is a practicing organic chemist.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided guidance for formulations of palm oil and degummed soybean oil, as in Examples 1 and 3. There is an Example 2, however, the origin of the residual fatty acid of Example 2 is not disclosed.
However, the specification does not provide guidance or the exact formulations comprised of any monoglycerides, any diglycerides, any methyl esters of residual of any fatty acids, palm, palm kernel, soy, cotton, sunflower, canola and corn oils.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to plant based compositions and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification for such large number of plant material being offered as a solution, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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.
Claims 2 – 4 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claim 2 recites the broad recitation “methyl esters is 90:10”, and the claim also recites “preferably between 40:60” which is the narrower statement of the range/limitation.
In the present instance, claim 3 recites the broad recitation “fatty amides” and the claim also recites “preferably alkalonamides” which is the narrower statement of the range/limitation.
In the present instance, claim 4 recites the broad recitation “short-chain methyl esters”, and the claim also recites “preferably methyl acetate,,,” which is the narrower statement of the range/limitation.
Regarding claims 3 and 4, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Rehage (US 2014/0271928).
The rejected claim covers, inter alia, a formulation characterized in that it contains monoglycerides, diglycerides, methyl esters of residual fatty acids, palm, palm kernel, soy, cotton, sunflower, canola and corn oils.
However, Rehage discloses in Example 32 a partially trans-esterified glycerides (PTEG) mixture comprising triglycerides, diglycerides, monoglycerides, and fatty acid methyl esters (FAMEs). 2 g of the PTEG solution was combined with 2 g of #6 oil, and the PTEG was observed to be miscible with the #6 oil. The vegetable oil in Rehage is a plant material that can include corn rice, wheat, spelt, quinoa, flax, or mixtures thereof; lentils (e.g., green, yellow, black), soybean, hemp seed, chia, grass, wheat grass and barley (e.g., pearl, groat) and cotton.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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 nonobviousness.
Claim(s) 1, 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Bertin (US 2015/0197702).
The rejected claim covers, inter alia, a formulation characterized in that it contains monoglycerides, diglycerides, methyl esters of residual fatty acids, palm, palm kernel, soy, cotton, sunflower, canola and corn oils.
Dependent clams 3 and 4 further limit the composition by includes additional compounds or compositions.
However, Bertin discloses Bertin discloses a grease composition comprising: (a) from 50 to 99 weight percent of a lubricating base oil, (b) from 1 to 30 weight percent of a thickener component comprising one or more of (i) one or more natural oil derivatives selected from the group consisting of triglycerides, diglycerides, monoglycerides, or oligomers therefrom, fatty acid methyl esters and corresponding fatty acids, salts, and dibasic esters therefrom, and C.sub.10-C.sub.15 esters, C.sub.15-C.sub.18 esters, or C.sub.18+ esters, or diesters therefrom, (ii) one or more carboxylic acids and/or derivatives thereof, and (iii) one or more of a metal base compound; and (c) from 1 to 15 weight percent of one or more optional additives.
Applicant is reminded that in the claims the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended."). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) ("The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps."); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts"). "The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended."
The difference between Bertin and the claimed invention is that it does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. §2131: "[t]he identical invention must be shown in as complete detail as is contained in the ...claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).).
However, based on the above, Bertin teaches the elements of the claimed invention with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. (see M.P.E.P. § 2143).
Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2013/131862 (IOI Lipid Enzymtec SDN. BHD.) discloses glyceride composition obtainable from shea oil. EP 2 917 199 (Bayarri et al.) discloses process for manufacturing several different compositions useful as biofuels.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YATE' K. CUTLIFF whose telephone number is (571)272-9067. The examiner can normally be reached Monday-Friday (8:30 - 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, Scarlett Y. Goon can be reached at (571) 270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YATE' K CUTLIFF/Primary Examiner, Art Unit 1692
Prosecution Insights