DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
The rejection under section 112(a) is maintained, below:
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1, 2, 4, 5, 7, 12 and 13-17 remain 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 those particular impurities in an amount providing the required electrical conductivity does not reasonably provide enablement for any biomass-resource derived minor substance in any amount that can provide the recited electrical conductivity. 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 the invention commensurate in scope with these claims.
“The standard for determining whether the specification meets the enablement requirement [in accordance with the statute] was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988). See also United States v. Telectronics, Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988) ("The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation."). A patent need not teach, and preferably omits, what is well known in the art. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384, 231 USPQ 81, 94 (Fed. Cir. 1986), cert. denied, 480 U.S. 947 (1987); and Lindemann Maschinenfabrik GMBH v. American Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984). Determining enablement is a question of law based on underlying factual findings. In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991); Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984).” See M.P.E.P. § 2164.
First the claim is broad, namely, compositions covering a diol and biomass-resource substances adjusted to provide the recite electrical conductivity.
As Applicant admitted, purification of biomass-resourced diols does not result in a diol composition with impurities that provide the required electrical conductivity: “Conventionally, biomass-resource derived minor substances obtained by manufacturing diol from a biomass resource were considered to cause coloration of polyester and, thus, inclusion of these minor components in diol compositions for polyester material was avoided. Indeed, as noted in para. [0015] of Aoshima [applied in the last Office Action], biomass-resource-derived dicarboxylic acid or diol is typically used only after being subjected to purification treatment to reduce its impurity content. As Aoshima teaches reducing the amount of biomass-derived impurities, the diol composition of Aoshima would not reasonably be expected to have a biomass-resource derived minor substance “in an amount to cause the diol composition to have an electrical conductivity of 0.6 to 30 mS/m.”.
See Applicant’s remarks dated 12/16/2022.
Other references also demonstrate purification sequences of biomass-resource derived diols, see U.S. Patent No. 7919658 to Adkesson et al. (Adkesson):
Methods of biologically-preparing diols from biologically-derived sources are known.
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Adkesson, col. 1.
The process of purifying the propane diol is substantially the same as that of Applicant:
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The purified propane diol solution has substantially the same physical characteristics:
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see col. 4
In this manner those of ordinary skill would expect that the propanediol of Adkesson to be substantially the same as that covered in the rejected claims, and possessing the same characteristics, such as electrical conductivity, see MPEP 2112.01 (“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”).
However, Applicant’s remarks that “[a]s Aoshima [which is a prior art references that also] teaches reducing the amount of biomass-derived impurities, the diol composition of Aoshima would not reasonably be expected to have a biomass-resource derived minor substance “in an amount to cause the diol composition to have an electrical conductivity of 0.6 to 30 mS/m”. See reply dated 12/16/2022.
Therefore, based upon Applicant’s remarks, efforts to purify the propane diol in a manner similar to the prior art, i.e., Aoshima and Adkesson, would not result in a diol composition with the recited electrical conductivity, and moreover, the prior art fails to show which impurities, or their respective amounts, will impart the recited electrical conductivity.
In this manner, it is unpredictable whether purification of a biomass-resource derived diol will provide an impurity level imparting the required electrical conductivity. In this relation, determining how a particular chemical impurity will impact a biomass composition, such as the recited diol compositions, not routine and the level of ordinary skill is high, as an ordinary artisan in this art needs specialized knowledge of the complex nature of biomass-derived compositions.
Also, Applicant is reminded of the heightened enablement for chemical inventions. Specifically, the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. [I]n the field of chemistry generally, there may be times when the well-known unpredictability of chemical reactions will alone be enough to create a reasonable doubt as to the accuracy of a particular broad statement put forward as enabling support for a claim. This will especially be the case where the statement is, on its face, contrary to generally accepted scientific principles. Most often, additional factors, such as the teachings in pertinent references, will be available to substantiate any doubts that the asserted scope of objective enablement is in fact commensurate with the scope of protection sought and to support any demands based thereon for proof. [Footnote omitted.]
Therefore, if:
the prior art does not identify how the composition is adjusted to provide the claimed electrical conductivity; and
the prior art does not identify the amounts of impurities that provide the claimed electrical conductivity; and
the prior art purification processes do not result in those impurities in amounts the provide the electrical conductivity; and
it is unpredictable whether purification of a biomass-resource derived diol will provide an impurity level imparting the required electrical conductivity;
Then: the specification must remedy the state of the art.
However, the instant specification does not identify those impurities or the required amounts of impurities that provide the claimed electrical conductivity.
At most the specification provides an example of a single purification method. However, Applicant is not claiming a method of purifying a diol purification, but the diol composition itself, and is required to identify how the diol composition can be prepared for the full scope of those impurities claimed. However, the specification does not provide any additional examples or guidance on how to make the claimed composition with the recited electrical conductivity for the full scope of impurities and amounts of impurities claimed.
The claims were amended to limit the one or more minor substances selected from ammonia and carbon dioxide, to limit the electrical conductivity within 0.6 to 30 mS/m.
Again, it would require undue experimentation to practice the invention as broadly claimed. One cannot predict how a given “minor substance” will affect the physical characteristics of a given diol composition, including electrical conductivity. The references cited above demonstrate that conductivity values for individual minor substances vary greatly. Therefore, the amount of experimentation would be undue because it would require determining which impurities, and amounts thereof, would provide the necessary electrical conductivity for the array of diols recited.
Specifically, the electrical conductivity of a diol solution may be adjusted with ammonia, as ammonia (or ammonium compounds) can act as an electrolyte or ion source in polar organic solvents like diols. Diols (such as ethylene glycol, 1,2-propanediol, and 1,3-propanediol) are frequently used to increase the solubility of ammonia, allowing for controllable ionic conductivity. See: Singh et al., Microchemical Journal 208 (2025) 11244 and Saeed et al., Membranes 2020, 10, 262; (“The electrical conductivity of PVA was enhanced by some researchers upon the addition of different ammonium salts to prepare proton (H+)-conducting SPEs. Radha et al. reported the highest ionic conductivity at ambient temperature in the order of 10−6 S/cm for PVA/NH4F proton-conducting SPEs. Hema et al. [18] reported the enhancement in ionic conductivity value in the order of 10−3 S/cm for PVA/NH4I, 10−4 S/cm for PVA/NH4Br, and 10−5 S/cm for PVA/NH4Cl proton-conducting SPEs. In this work, series of proton-conducting SPEs are prepared from PVA as the host matrix, and the low-cost ammonium nitrate (NH4NO3) is used as a proton source for improving the ionic conductivity of the system. The structural, electrical, and transport properties of the prepared samples are studied as a function of salt concentrations, frequency, and temperature to expect the possible applications of the system.”).
However, the prior art emphasizes the concentration of ammonia and the specific type of diol must be identified to achieve the desired ionic strength. For example, high concentrations of certain ammonium salts can cause significant shifts in pH., see Langenfeld et al., HORTSCIENCE 60(9):1555–1560. 2025 and Mohamed et al., Phys. Scr. 100 (2025) 015940.
In this manner, the amount of experimentation would be undue because it would require determining which diols and impurities, such as ammonia and carbon dioxide, and amounts thereof, would provide the necessary electrical conductivity for the array of diols recited. Therefore, the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Janet Epps-Smith, can be reached at telephone number (571)272-0757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646