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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11 September 2026 has been entered.
Status of the claims
Claims 18, 20, 22, 24 and 26 have been cancelled.
Claims 1-17, 19, 21, 23 and 25 are presented for examination on the merits.
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 1-17, 21, and 25 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.
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).
In Ariad Pharm. Inc. v. Eli Lily & Co. 598 F ad 1336 (Fed. Cir. 2010) en banc}, the Federal Circuit noted the importance of an application's disclosure, stating, “the hallmark of written description is disclosure.” A disclosure adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1354. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbot Labs, 636 F.3d 1341, 1948 (Fed. Cir. 2011)
Satisfying the written description requirement “varies with the nature and scape of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F. 3d 1349, 1357 (Fed. Cir. 2005). The Federal Circuit explained what is required to meet the written description requirement in Ariad Pharm., Inc. v. Eli Lilly & Co:
This inquiry, as we have long held, is a question of fact. Ralston Purina, 772 F.2d at 575. Thus, we have recognized that determining whether a patent complies with the written description requirement will necessarily vary depending on the context. Capon v Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir. 2005). Specifically, the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Id. For generic claims, we have set forth a number of factors for evaluating the adequacy of the disclosure, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, [and] the predictability of the aspect at issue." Id. at 1359.
A written description of a genus in biotechnological arts “requires a precise definition, such as by structure, formula, [or] chemical name” of the claimed subject matter sufficient to distinguish it from other materials. Regents of the Univ. of Cal. v. Eli Lilly & Co., 199 F.3d 1559, 1568 (Fed. Cir. 1997). The Federal Circuit reflected on Eli Lilly in Ariad while explaining how to sufficiently describe a genus in biotechnological applications:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species fitting within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. at 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. at 1568 (quoting Fiers v. Revel 984 F.2d 1164, 1171 (Fed. Cir. 1993). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
A “representative number of species” must typify the entire claimed genus and account for variation between the species of the genus:
[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictably in the results obtained from species other than those specifically enumerated. Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Or. 2004).
In Ariad, the Court also addressed the presence of a genus within a method claim, in Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme. Id. at 918. We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification’s function description, the specification did not provide an adequate written description of the claimed invention. Id. at 927-28. Ariad, at 1373.
The MPEP states that the purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention 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 is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, no 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.
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 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.
Level of Skill and Knowledge in the Art:
The MPEP indicates:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
What constitutes a “representative number” is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
Applicant has provided evidence of only a single example of a method of producing a product with antiviral functionality. That is – mixing barley flour with water without yeast or malt; keeping the solution at a temperature range of 27 ± 3°C for 16 hours to form another solution; distilling at 80-140 °C to form a distillate; covering and keeping at temperature of 10 ±2 °C for one hour to form a crude product; distilling, lyophilizing, and diluting to a desired concentration and treating with basic solution to the pH 7.4. This method produces a product which shows efficacy in treating viral infections.
There is well-known unpredictability regarding natural product extracts and their e.g., pharmaceutical capabilities. The resulting compositions and thus functional properties of an extraction process are highly dependent on the particular steps of the extraction and the extraction solvent employed
Raskin et al. clearly establish the grave unpredictability of elucidating active ingredients from natural sources:
Multi-component botanical therapeutics also present unique challenges in identifying their active ingredients and in validating their clinical effects. Activity-guided fractionation and reconstitution experiments currently used to characterize compound interferences within a mixture are cumbersome and time consuming…..While chromatographic analysis is often employed to produce biochemical fingerprints used for product comparison…..in the absence of information about the identity of active ingredients, such analysis is hardly reliable, since chromatography provides an incomplete picture of the qualitative and quantitative comparison of a complex extract (p. 3426, col. 2 – p. 3427, col. 1) emphasis added.
There is no known means for predicting the capability of other products, besides the products specifically described in the Instant disclosure, with regard to e.g., anti-viral effect. The skilled artisan could not even relatively predict other conditions of preparation would result in a product that would perform this function. Absent any discussion regarding correlation between structure and function, even the most skilled of artisans would need to guess what other products could potentially have the effect(s) listed in the claim(s).
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 1-17, 19, 21, 23 and 25 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 is rendered vague and indefinite by the phrase “further distilling, lyophilizing, and diluting the crude product, to different concentrations to obtain a final pharmaceutical preparation”.
Firstly, it is unclear how a single pharmaceutical preparation can have multiple different concentrations. Perhaps, Applicant means that the crude product is diluted to the desired concentration.
Secondly, since this is not the final step of the claimed method of preparing a pharmaceutical preparation for treating viral infection, it is unclear how the product of the step can be considered a final pharmaceutical preparation. Is the final pharmaceutical preparation of the method the product of step (e) or (f)?
Regarding claims 16, 17, 21 and 25, the phrase "such as" renders the claim 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 § 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.
Claim(s) 19 and 23 stand rejected under 35 U.S.C. 103 as being unpatentable over Whisky Advocate, "How Whisky is Made" (March 22, 2017) in view of Fusté, et al., "Barley ß-glucan accelerates wound healing by favoring migration versus proliferation of human dermal fibroblasts," Carbohydrate Polymers, Vol. 210, 2019, pages 389-398, and Sharma, et al., "Extraction of starch from hulled and hull-less barley with papain and aqueous sodium hydroxide." J Food Sci Technol. 2014 Dec;51(12):3870-7.
The instant claim(s) is/are of record, drawn to the following: processes of preparing a pharmaceutical preparation comprising the steps of (a) mixing barley flour .
with water and stirring vigorously to form a solution; (b) keeping the solution of step (a) at an appropriate temperature range of 20 to 40 degrees Celsius for adequate time ranging 10 to 20 hours to form another solution; (c) the solution of step (b) is subjected to distillation at 80-140 degrees Celsius to form a distillate; (d) the distillate formed in step (c) is covered and keeping at temperature of 10 +/- 2 degrees for one hour to form a crude product; and (e) the crude product is further distilled, lyophilized, and diluted to different concentrations to obtain a final pharmaceutical preparation; and (f) the pharmaceutical preparation of step (e) is treated with basic solvent to make the pH to alkaline levels, and in some embodiments, further comprising a method of treating viral infections or the inventions caused by related RNA viruses such as COVID-19 disease using Hordeum or Barley or Barley extracts; and/or a pharmaceutical preparation for the treatment of viral infections or the infections caused by related RNA viruses such as COVID-19 disease.
Whisky Advocate broadly teaches the method steps for making whisky from barley comprising malting, mashing, fermentation, distillation, maturation and bottling. Whisky Advocate teaches the steps for: malting, comprising moistening the barley; mashing, comprising grinding the grain and putting it into a large tank with hot water and agitating the mixture to for a resulting mixture that resembles a porridge (broadly teaching instant claim(s) 1, 2, 5-12, 19, and 23) mixing barley flour with water and stirring vigorously to form a solution; wherein barley flour is obtained by grinding Barley grains); fermentation, comprising keeping the resulting mash solution in tank with yeast for 48 to 96 hours (noting that fermentation time will differ depending on the yeast strain and flavor intended) (broadly teaching instant claim(s) 1, 8-9, 12, 19, and 23, keeping solution of step (a) at an appropriate temperature range for adequate time to form another solution); distillation, comprising pot still distillation and/or column still distillation (broadly teaching instant claim 1, 19 and 23, the solution of step (b) is subjected to distillation to form a distillate; (d) the distillate formed in step (c) is covered and keeping at temperature for one hour to form a crude product); maturation, comprising storing the distillate into wood barrels; and bottling of the resultant solution (broadly teaching the resultant composition as required in instant claim(s) 1(f), 18, 19(e), 22, 23(e), and 26).
Whisky Advocate is silent as to: the crude product is lyophilized, and diluted to different concentrations to obtain a final pharmaceutical preparation (instant claim 1); the pharmaceutical preparation of step (e) is treated with basic solvent (i.e. 1N NaOH) to make the pH to alkaline levels (instant claim(s) 1, 13 and 19); wherein the water is distilled/double distilled water (instant claim(s) 3-4); and treating viral infections or the inventions caused by related RNA viruses such as COVID-19 disease using Hordeum or Barley or Barley extracts (instant claim(s) 16-17, 20-21 and 24-25).
However, Fusté, et al., teaches barley beta-glucan extraction comprising the steps of milling whole barley and suspending the barley flour in warm distilled water to reach a 1:5 flour/solvent ratio; stirring the mixture for 1 hour at a constant temperature of 55 degrees, and centrifuging the resultant mixture (page 390). Fusté, et al. further teaches the supernatant is frozen for 24 hours then thawed, filtered, rinsed with ultrapure water and freeze-dried (i.e. lyophilized) (page 390). Fusté, et al further teaches the dry powder extracts is filtered in a medium at different final concentrations (broadly teaching the instant claim 1, crude product is lyophilized, and diluted to different concentrations).
Sharma, et al., teaches extraction of starch from hulled and hull-less barley with papain and aqueous sodium hydroxide. Sharma, et al. teaches methods for enzyme- assisted extraction of starch and other components comprising the steps of steeping barley in water, grinding the barley, pH adjustment of the resultant slurry and enzyme incubation (page 3871, "Enzyme-assisted extraction of starch and other components"). Sharma, et al. further teaches the step of raising the pH of a "barley slurry", comprising barley milled with water, using 1N sodium hydroxide solution (page 3871, "Enzyme- assisted extraction of starch and other components") (broadly teaching instant claim(s) 1, 13 and 19).
It would have been obvious to one of person of ordinary skill in the art at the time of the instant invention effective filing to have modified the method of processing barley as taught by Whisky Advocate with the routine and conventional steps of lyophilization/dilution and pH adjustment as taught by Fusté, et al. and Sharma, et al., respectively, to obtain the instantly claimed composition(s)
A person of ordinary skill in the art would have been motivated to modify the method of processing barley, particularly where the steps of lyophilization/dilution and pH adjustment were known technique(s) recognized as part of the ordinary capabilities of one skilled in the art (as evidenced by Fusté, et al. and Sharma, et al.). A person of ordinary skill in the art would have had a reasonable expectation of success for applying the routine and/or conventional steps of lyophilization/dilution and/or pH adjustment in a method of processing barley, as instantly claimed. Thus, it would have been obvious to person of ordinary skill in the art to combine the teachings of the references to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
A person of ordinary skill in the art would have been motivated to modify the method of processing barley, particularly where the steps of lyophilization/dilution, pH adjustment and use of distilled water/double distilled water were known technique(s) recognized as part of the ordinary capabilities of one skilled in the art (as evidenced by Fusté, et al. and Sharma, et al., and Prikhod'ko, et al.). Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the references to arrive at the instantly claimed invention(s) with a reasonable expectation of success. .
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants' composition with the composition of the prior art (including compositions within recited processes), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and "as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Response to Arguments
Applicant’s amendments/arguments, with respect to the 35 USC 103 rejection of claim 1 and claims dependent thereon have been fully considered and are persuasive. Claim 1 has been amended to include the limitation “mixing barley flour with water and stirred vigorously to form a solution consisting of barley flour and water”. The 35 USC 103 rejection of the previous Office action of claim 1 and dependent claims has been withdrawn.
Applicant's amendments/arguments filed with respect to the 35 USC 103 rejection of claims 19 and 23 have been fully considered but they are not persuasive.
The amendments made to independent claim 1 have not been made to independent claims 19 or 23, thus the claims remain rejected for all of the reasons previously stated.
Applicant asserts that the cited reference Whisky Advocate does not disclose steps where just barley flour is mixed with water then kept for adequate time (without addition of malt or yeast) before distillation and Advocate does not teach or suggest every steps of the method of claim 19. Applicant further asserts that modification to arrive at the steps where just barley flour is mixed with water then kept for adequate time (without addition of malt or yeast, which are essential elements in Whisky Advocate's process) before distillation, would not result in fermentation, and would render the process of Whisky Advocate unsatisfactory for its intended purpose.
This is unpersuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., just barley flour mixed with water without addition of malt or yeast]) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40oC and 80oC and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100oC and an acid concentration of 10%); See also, Peterson, 315 F.3d at 1330, 65 USPQ 2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references where held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ 2d 1843 (Fed. Cir.), cert denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ 2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ 2d 1362 (Fed. Cir. 1997).
Accordingly, the instant claims, where no unexpected results are observed (e.g, the criticality of the specifically recited variables in the claimed method produced some surprising/unexpected results), would have been obvious to one of ordinary skill having the above cited references before him/her.
Prosecution Insights