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 .
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 4-7, 9-10, and 13 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by Tuduri et al (EP 0511932) as evidenced by Roopa et al (2008).
Tuduri sets forth processes of obtaining polymers with activity on the hematopoietic system. Said polymers are polysaccharides such alginic acid, Arabic gum or tragacanth gum and the method includes exposing aqueous containing solutions to ultrasonic radiation.
The process set forth by Tuduri involves in the first stage preparing an aqueous suspension of said polysaccharides in quantities between 5 and 25 mg/mL in a final volume distilled water, wherein the final volume may range from 10 to 200 mL of distilled water and in a second stage the previously described suspension is subjected to ultrasound having an amplitude of 5-15 mm, a frequency of 23 KHz for a time period between 0.5 to 8 hours, wherein the temperature is maintained within the range of 0 deg. C to 15 deg. C.
Tuduri sets forth in example 1 preparing an alginic acid (a polycarboxylate polysaccharide) suspension having between 5 and 25 mg/ml of alginic acid in a volume of distilled water ranging from 10 to 200 mL with stirring. The obtained alginic acid suspension is subjected to ultrasound having a frequency of 23 kHz and amplitude between 5 and 15 mm for 1 hour at a temperature range between 0 deg. C to 15 deg. C. Once irradiated the obtained samples are purified by dialysis using distilled water and dehydrated or spray-dried to obtain a powdery product—see stages 1-4 in example 1 on page 4, lines 20-40. It is deemed this method appears to anticipate claim 1 since the alginic acid is utilized in a liquid suspension during the ultrasonic exposure step, thus inherently not in gel form.
Said suspension comprises from 0.5 to 2.5 w/v%, wherein 2.5 w/v% is deemed to be approximately/about 3 w/v% as set forth as the lower limit in claim 2.
The exposure to ultrasonic radiation in step 2 is deemed to anticipate claim 4.
Regarding claims 5-6: Tuduri sets forth the temperature during ultrasonic radiation is maintained within a range of 0 to 15 deg. C—see page 3 The gelation temperature of alginic acid is 37.6 deg. C, as evidenced by Roopa—see abstract of Roopa. Therefore, it is deemed the method set forth by Tudor applies ultrasonic waves at a temperature range that includes at least 22 deg. C lower than the gelation temperature of alginic acid.
Regarding claim 7: the frequency set forth in the method of Tuduri is 23 kHz—see example 1 page 4, line 32.
Regarding claim 9: Tuduri sets forth in the overall teachings of the reference the ultrasonic irradiation step is preformed from 0.5 hours to 8 hours, therefore, the claimed upper limit of 30 min is anticipated by the reference—see page 2, line 57.
Regarding claim 10: Tuduri sets forth the suspension of alginic acid in water is obtained by stirring the mixture—see lines 26-27 on page 4.
Regarding claim 13: The method set forth by Tuduri comprising suspending said polysaccharides in distilled water only, thus the mixtures/suspensions comprises less than 10% v/v of organic solvent.
Claim(s) 1-2, 4-6, 9-10, 12-14, 16-17 and 21-22 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by Monroy et al (Ultrasonics-Sonochemistry, 2018).
Monroy sets forth microstructural and techno-functional properties of cassava starch modified by ultrasound. It is deemed cassava starch is a specific type of polysaccharide that is composed of two polymers of glucose: a linear polymer called amylose and a highly branched polymer called amylopectin, wherein amylose and amylopectin are both polysaccharides—evidenced by claims 12 and 16.
Monroy sets forth cassava starch ultrasound treatment comprising creating an 5 % w/v concentration of an aqueous suspension of cassava starch having 17 % amylose. Said suspension is subjected to ultrasound at a power of 750 W and 40 % amplitude for time periods 5, 10, and 20 min) with an ice bath—see page 796, section 2.1 and Table 1.
Regarding claims 1-2, 4, 6, 9 and 12-13: Per table 1, Monroy subjects a suspension of cassava starch in distilled water having a concentration of 5 % w/v of cassava starch to ultrasound radiation in an ice bath wherein the initial processing temperature is 22 deg. C and the final temperature is 21 deg. C to obtain the ultrasound modified cassava starch U5—see table 1 on page 796.
Regarding claim 10: Monroy sets forth the samples (5 % w/v cassava starch suspensions) where centrifuged at 2500 rpm—see section 2.1 on page 796.
Regarding claim 12: Monroy sets forth said treated cassava starch samples comprise at least 17 % amylose.
Regarding claim 13: The suspensions set forth by Monroy comprise suspending said starch in distilled water; therefore, said suspension comprises less than 10 % (v/v) organic solvent.
Regarding claim 14 and 16-17: The 5 % w/v concentration of the ultrasonic irradiated cassava starch comprising 17 % amylose does not appear to change after irradiation and the viscosity of the irradiated U5 sample is 0.513 Pa*s—see Table 3 on page 802 (apparent viscosity).
Regarding claims 21: Monroy sets forth cassava starch is known for its use in applications in food processing—first full paragraph in section 1 (introduction) on page 795.
Claim Rejections - 35 USC § 103
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroy (cited above).
Monroy is set forth above as anticipating the instantly claimed method of claims 1-2, 4-6, 9-10, 12-14, 16-17 and 21-22 for the reason above. Monroy does not expressly set forth the mixture is between about 3% and about 25% (w/v) of polysaccharides in the method. However, it is within the skill level of an ordinary artisan to scale up or scale down the methods as set forth by Monroy. The court have upheld, “mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In absence of evidence to the contrary and/or unexpected results, a skilled artisan would have found it obvious to use any concentration of polysaccharides to use the methods set forth by Monroy with a reasonable expectation of successfully modifying cassava starch using ultrasonic radiation.
Claim(s) 20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroy et al as applied to claims 1-2, 4-6, 9-10, 12-14, 16-17 and 21-22 above, and further in view of Toukai et al (Am. J. of Plant Sciences, 2015).
Monroy is set forth above as anticipating claims 1-2, 4-6, 9-10, 12-18 and 21-22. Monroy does not expressly set forth said modified cassava starch is useful as a pharmaceutical ingredient, a nutritional supplement or a cosmetic or cosmeceutical ingredient. However, cassava starch is a known ingredient in the pharmaceutical and supplement industries, as a filler material and/or bonding agent. Cassava starch is also a known ingredient in the cosmetics industry as an absorbent, as set forth by Toukai. Toukai sets forth the use of cassava as an industrial base. Thus, it is deemed it would have been within the skill level of an ordinary artisan to use the modified cassava starch as set forth by Monroy in known applications, such as absorbents in the cosmetic industry and filler and/or binding materials in the pharmaceutical and supplement industrial, as set forth by Tokara in absence of evidence to the contrary and/or unexpected results. The courts have upheld it is prima facie obvious to use a known additive for its known function—see In re Dial et al 140 USPQ 244 and In re Linder 173 USPQ 356.
Allowable Subject Matter
Claims 8, 11, 15, and 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the overall teachings of Monroy and Tuduri do not set forth the parameters found in claims 8, 11, and 18-19. Tudor sets forth because of the use of the low temperature during irradiation the need for bubbling N2 through the samples is not necessary. Tuduri and Monroy both set forth temperatures ranges outside of the 1 to 25 deg. C below the gelation temperature as the temperatures during irradiation using ultrasound. Both set forth depolymerization of the polysaccharides in the overall teachings.
Conclusion
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/SANZA L. McCLENDON/Primary Examiner, Art Unit 1765
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