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 .
The amendment filed 29 January 2026 is acknowledged and 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 § 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) 1-2, 5-15, 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.
Claim(s) 3-4 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, as applied to claim(s) 1-2, 5-15, 18-19, 22-23 and 26 above, and in further view of Prikhod'ko, et al., "Methods of Water Preparation and Conditioning for Pharmaceutical Purposes," Pharmaceutical Chemistry Journal, Vol. 36, pages 548-556 (2002).
The instant claim(s) and teachings of Whisky Advocate, Fusté, et al., and Sharma, et al is/are of record.
The references is/are silent as to: 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).
Prikhod 'ko, et al. further teaches the quality of water used for pharmaceutical purposes is a key element ensuring the safety of manufactured preparations (see page 548). Prikhod 'ko further teaches distillation is a traditional, effective and reliable method of ensuring a high degree or purification, which is very important for drug preparation (see page 554-555) (broadly teaching instant claim(s) 3-4).
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, pH adjustment and/or the use of distilled water/double distilled water as taught by Fusté, et al. and Sharma, et al., and Prikhod'ko, et al., respectively, to obtain the instantly claimed composition(s). 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, pH adjustment, and/or use of distilled water/double distilled water in a method of processing barley, as instantly claimed. 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.
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. .
Claim(s) 16-17, 21 and 25 stand rejected under 35 U.S.C. 103 as being unpatentable over Whisky Advocate, "How Whisky is Made" (March 22, 2017), 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, as applied to claim(s) 1-2, 5-15, 18-19, 22-23 and 26 above, and in further view of Prikhod'ko, et al., "Methods of Water Preparation and Conditioning for Pharmaceutical Purposes," Pharmaceutical Chemistry Journal, Vol. 36, pages 548-556 (2002), as applied to claim(s) 1-15, 18-19, 22-23 and 26 above, and in further view of Idehen, et al., "Bioactive phytochemicals in barley.", J Food Drug Anal., 2017 Jan;25(1):148-161.
The instant claims and teachings of Whiskey Advocate, Fusté, et al., Sharma, et al and Prikhod'k is/are of record.
The references is/are silent as to: 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).
Idehen, et al. further teaches bioactive phytochemicals in barley. Idehen, et al. teaches the major phytochemicals found in barley include phenolic acids, flavonoids, lignans, vitamin E (tocols), sterols, and folates (page 149). Idehen, et al. teaches phenolic compounds act as defense mechanisms against pathogens, parasites and predictors (page 149). Idehen, et al. teaches lignans found in barley are known to induce a wide range of biological effects including antiviral, antibacterial and fungistatic activities (page 152) (broadly teaching application in the treatment of viral infections (i.e. RNA viruses/COVID-19 disease, as required in claim(s) 16-17, 20-21 and 24-25).
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, pH adjustment and/or the use of distilled water/double distilled water as taught by Fusté, et al. and Sharma, et al., and Prikhod'ko, et al., respectively, to obtain the instantly claimed composition(s). Moreover, 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 use the instantly claimed composition(s) for treating viral infections, particularly where it was known in the art that barley contained phytochemicals with antiviral/ antibacterial/ antifungal activities as taught by Idehen, et al.
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.). Similarly, a person of ordinary skill in the art would have been motivated to apply the instantly claimed composition(s) to treat viral infections, particularly where it was known in the art that barley had antiviral/antibacterial/antifungal properties. A person of ordinary skill in the art would have had a reasonable expectation of success for using the method of processing barley and/or the use of the resultant composition to treat viral infections, as instantly claimed. 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.
The references is/are relied upon for the reasons discussed above. If not expressly taught by the references, based on the overall beneficial teaching provided by the references with respect to the ingredients of the composition(s) and/or method(s) of making and/or using disclosed therein, the adjustments of particular conventional working conditions (E.g. the duration of keeping barley solution (i.e. instant claim(s) 1,8, 9, 19 and 23 at step (b)); ratio of barley flour: water (instant claim 5), temperatures (instant claims 1, 6, 7 10, 11, 19, and 23); solvent (instant claim(s) 13 and 19), and pH range (instant claims 14 and 15)) in which to perform such method is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. (see Zhang, et al. "Techniques for extraction and isolation of natural products: a comprehensive review." Chin Med. 2018 Apr 17;13:20.). Thus, absent some demonstration of unexpected results or criticality from the claimed parameters, this optimization would have been obvious before the effective filing date of applicant's claimed invention.
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 112(b) rejections have been fully considered and are persuasive. The 35 USC 112(b) rejection of the previous Office action has been withdrawn.
Applicant’s cancellation of claims makes the 35 USC 101 rejection moot and has been withdrawn.
Applicant's amendments/arguments filed with respect to the 35 USC 103 rejection have been fully considered but they are not persuasive.
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 1. 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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/ Examiner, Art Unit 1655
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