DETAILED ACTION
The present application is a national stage entry of PCT/JP2022/016403, filed 31 March 2022, which claims foreign priority to JP2021-061021, filed 31 March 2021.
The preliminary amendment filed 27 September 2023 is acknowledged. Claims 1-16 are pending in the current application and are examined on the merits herein.
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
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.
Claim(s) 10 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (Desalination, 2017, vol. 408, pp. 60-69, cited in PTO-892).
Wang et al. disclose a method for treating introducing an acidic group into starch, the method comprises treating starch having a weight average MW of 150,000 Da with monochloroacetic acid to obtain carboxymethyl starch (CMS), specifically a series of CMS(1)-(6) (p.61, 2.2. Preparation of CMS). Ultrasonic irradiation treatment of CMS(3) and CMS(5) was conducted to obtain two series of CMS samples having the same degree of carboxymethyl substitution, but lower molecular weight (p.61-62, 2.3. Ultrasonic degradation of CMS samples).
Thus, Wang et al. disclose introducing an acidic group into a starch, and reducing a molecular weight of the starch having the acidic group.
Thus, the disclosure of Wang et al. anticipates claims 10 and 16 of the present application.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10, 14, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (cited above) in view of Boonna et al. (Carbohydrate Polymers, 2019, vol. 205, pp. 143-150, cited in PTO-892).
Wang et al. teach as discussed above.
Wang et al. do not expressly disclose lowering the MW of starch using an enzyme (present claim 14), or the MW range recited in present claim 15.
Boonna et al. teach observed the effects of treating cassava starch (CS) with amylomaltase (AM) for various reaction times (abstract). Molar mass and polydispersity were lowered (abstract). The starting Mw of untreated starch was 216,000,000 g/mol, the starting Mn was 43,800,000 g/mol, and the starting polydispersity Mw/Mn was 4.93 (Table 2). After starch was treated with AM for 4 hours, the Mw was reduced to 85,600,000 g/mol, the Mn was reduced to 27,000,000 g/mol, and the polydispersity was reduced to 3.16. In another series of experiments, starch was first hydrolyzed with β-amylase, and then with AM. The Mw of B-CS (β-amylase treated starch) was 41,000,000 g/mol, the Mn of B-CS was 8,500,000 g/mol, and the polydispersity was 4.82. The Mw of B-AM5min (β-amylase and 5min AM-treated starch) was 21,700,000 g/mol, the Mn was 3,800,000 g/mol, and the polydispersity was 5.71. The Mw of B-AM4h (β-amylase and 4h AM-treated starch) was 69,500,000 g/mol, the Mn was 6,700,000 g/mol and the polydispersity was 10.37.
The ordinary artisan would have looked to the teaching of Boonna et al., because both Wang et al. and Boonna et al. are concerned with lowering the molecular weight of starch. In addition to, or alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an enzyme to lower the molar mass of starch, because Boonna et al. teach subjecting starch to two different enzymes for different periods of time could be optimized to lower the overall molar mass of the polysaccharide.
The molecular weight of starch obtained by the methods of Boonna et al. overlap with the range recited in present claim 15.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 8, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshimura et al. (Carbohydrate Polymers, 2006, vol. 64, pp. 345-349, cited in PTO-892) in view of Karim et al. (J. Agric. Food Chem., 2008, vol 56, pp. 10901-10907, cited in PTO-892).
Yoshimura et al. teach modifying starch with succinic anhydride, followed by neutralization (abstract). The obtained starch carboxylate is a superabsorbent hydrogel:
PNG
media_image1.png
84
316
media_image1.png
Greyscale
(p.346, 2.4. Preparation of superabsorbent hydrogels in water). The water absorbency of the product ranged from 50 g/g to 70 g/g (p.348, 3.2. Water absorbency and biodegradability). The maximum absorbency in pure water was about 120 g water/g dry gel (p.349, last para). Yoshimura et al. teach higher degree of substitution leads to higher absorbency (abstract).
Yoshimura et al. do not expressly disclose treating the starch with an enzyme before adding acidic groups (present claim 11).
Karim et al. teach modifying corn starch or mung bean starch by treating it with an enzyme to hydrolyze the polysaccharide (i.e. reduce the molecular weight of starch; also see p.10904, left column, third para). A hydroxypropyl group was introduced to enzyme-treated starch to give “Enzyme-hydrolyzed-HP”, or to native starch (untreated starch) to give “Native-HP” (p.10902, Materials and Methods). Karim et al. teach both types of modified starch showed a significant increase in swelling power compared to the corresponding native starch (p.10904-10905, bridging para). Karim et al. teach substituted starch is more easily hydrated. Karim et al. teach the degree of substitution can be increased by partial enzyme hydrolysis of starch (abstract; p.10906, last para). The pretreatment with an enzyme alters the surface and interior properties of the granules, allowing the hydroxypropylating agent to react more efficiently with the starch.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to partially hydrolyze starch with an enzyme and then introduce an acidic group into the partially hydrolyzed starch.
One having ordinary skill in the art would have been motivated to partially hydrolyze starch with an enzyme and then introduce an acidic group into the partially hydrolyzed starch, because Karim et al. found partially hydrolyzing starch increases the subsequent degree of substitution of the starch, and Yoshimura et al. teach increasing the degree of substitution increases the water absorbency of starch.
While Karim et al. was concerned with substituting starch with a hydroxypropyl group, one having ordinary skill in the art would have had a reasonable expectation of success in pretreating starch with an enzyme to increase substitution with succinic anhydride, because Karim et al. teach pretreatment with an enzyme alters the surface and interior properties of the granules, allowing the modification reagent to react more efficiently with the starch.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshimura et al. and Karim et al. as applied to claims 8, 11 and 13 above, and further in view of Boonna et al. (Carbohydrate Polymers, 2019, vol. 205, pp. 143-150, cited in PTO-892).
Yoshimura et al. teach as discussed above.
Yoshimura et al. do not expressly disclose the molecular weight or polydispersity of enzyme-treated starch (present claims 9 and 12).
Karim et al. teach as discussed above.
Boonna et al. teach as discussed above.
One having ordinary skill in the art would have been motivated to partially hydrolyze starch with an enzyme and then introduce an acidic group into the partially hydrolyzed starch, because Karim et al. found partially hydrolyzing starch increases the degree of substitution of the starch, and Yoshimura et al. teach increasing the degree of substitution increases the water absorbency of starch.
Like Karim et al., Boonna et al. found treating starch with an enzyme generally reduces the overall molar mass of the polysaccharide. One having ordinary skill in the art would have known the Mw, Mn and polydispersity are result-effective variables that depend on the enzyme used, and amount of time the starch is treated with said enzyme. One having ordinary skill in the art would have known the longer starch is treated with AM, the lower the Mw. Additionally, one of ordinary skill in the art would have known β-amylase treatment of starch increases the molecule’s polydispersity. Thus, one having ordinary skill in the art would have been motivated to prepare enzymatically treated starch because it affords various starch structures.
According to Karim et al., partially hydrolyzing starch increases alters the surface and interior properties of the granules, allowing the modification reagent to react more efficiently with the starch. Thus, one having ordinary skill in the art would have been motivated to optimize the conditions for pre-treating starch with an enzyme, and subsequently chemically modifying it with an acidic group because it leads to starch having higher water absorbency properties.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 1-4, 7, 8, 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshimura et al. and Karim et al. as applied to claims 8, 11, and 13 above, and further in view of Lawal et al. (European Polymer Journal, 2009, vol. 45, pp. 3399-3408, cited in PTO-892).
Yoshimura et al. teach as discussed above.
Yoshimura et al. do not expressly disclose crosslinking one water-soluble polymer with another (present claim 1, step c3).
Karim et al. teach as discussed above.
Lawal et al. teach crosslinking carboxymethyl starch to prepare hydrogels that have a large water absorption capacity (title, abstract, p.3399, first para). The hydrogels can be used in personal care products, including diapers, incontinence articles, sanitary products for fluid absorption, etc. (p.3399, first para). Lawal et al. teach substituting starch with anionic carboxymethyl groups improves hydrophilicity, thus facilitating water absorbance (p.3400, second para). Lawal et al. teach while epichlorohydrin has been reported as a crosslinker, they explored the use of non-toxic di- or polyfunctional carboxylic acids as cross-linkers to prepare cross-linked carboxymethyl cassava starch to be used as a biodegradable absorbent (p.3400). The cross-linked carboxymethyl starch had a number-average molar mass of Mn = 4.6 x 106- g/mol, and a weight average molar mass as Mw = 5.6 x 106 g/mol (p.3404, first para). This gives a polydispersity of Mw/Mn of 1.2. The crosslinked carboxymethyl starch had an absorption under load of 16-28 g/g in deionized water, and 12-20 g/g in saline (figs. 6 and 7, respectively). It also had a free swelling capacity of 50-80 g/g in deionized water, and 40-70 g/g in saline (fig. 9 and 10, respectively). Thus, Lawal et al. was able to prepare a hydrogel using cheap, readily available and renewable resource, having diverse technical applications, particularly where moderate swelling/water absorption is required (p.3408).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further crosslink an acid modified starch derivative because it allows for the preparation of hydrogels using cheap, readily available and renewable resource, having diverse technical applications, particularly where moderate swelling/water absorption is required.
Modifying starch with anionic groups was already a known technique for the preparation of starch derivatives with water absorption properties. Dicarboxylic acids can further be used as a non-toxic agent to further crosslink two starch derivatives together, to give a hydrogel with moderate swelling/water absorption.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshimura et al., Karim et al. and Lawal et al. as applied to claims 1-4, 7, 8, 11 and 13 above, and further in view of Mohamood et al. (Chemistry Central Journal, 2018, vol. 12, 10 pages, cited in PTO-892).
Yoshimura et al. teach as discussed above.
Yoshimura et al. do not expressly disclose “wherein no crosslinking agent is used in the step (c3)”, (present claim 5), or further subjecting the resin obtained from claim 1 to alkali treatment (present claim 6).
Karim et al. and Lawal et al. teach as discussed above.
Mohamood et al. teach preparing carboxymethyl starch, and crosslinking it with acetic acid (abstract). However, Mohamood et al. also teach crosslinking can be established by change in pH, radiation, heat or pressure (p.2, first para). Crosslinking increases chemical bond strength and thermal stability. Carboxymethyl starch is known to have water absorption properties. Carboxylic acid groups are added to starch to enable the starch to increase its absorption capacity (p.2, second para). The degree of swelling increased the most when the crosslinked carboxymethyl starch was treated with 1.0 M NaOH, to a value of 23.64 g/g in PBS (i.e. subjected to alkali treatment), (see fig. 7). The optimum crosslinking temperature was 60 °C.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to crosslink carboxymethyl starch using heat; and subject crosslinked carboxymethyl starch to alkali treatment.
One having ordinary skill in the art would have been motivated to crosslink carboxymethyl starch using heat because Mohamood et al. teach crosslinking can be induced by heat. Thus, it is a known alternative to using a chemical crosslinking agent.
One having ordinary skill in the art would have been motivated to treat crosslinked carboxymethyl starch with 1.0 M NaOH, because it resulted in a starch hydrogel having the highest observed water absorption capacity.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 1-4, 7, 8, 9, 11, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshimura et al. and Karim et al. as applied to claims 8, 11, and 13 above, and further in view of Boonna et al. and Lawal et al. (European Polymer Journal, 2009, vol. 45, pp. 3399-3408, cited in PTO-892).
Yoshimura et al. teach as discussed above.
Yoshimura et al. do not expressly disclose crosslinking one water-soluble polymer with another (present claim 1, step c3). Yoshimura et al. do not expressly disclose the molecular weight or polydispersity of enzyme-treated starch (present claims 9 and 12).
Karim et al., Boonna et al. and Lawal et al. teach as discussed above.
One having ordinary skill in the art would have been motivated to partially hydrolyze starch with an enzyme and then introduce an acidic group into the partially hydrolyzed starch, because Karim et al. found partially hydrolyzing starch increases the degree of substitution of the starch, and Yoshimura et al. teach increasing the degree of substitution increases the water absorbency of starch.
Like Karim et al., Boonna et al. found treating starch with an enzyme generally reduces the overall molar mass of the polysaccharide. One having ordinary skill in the art would have known the Mw, Mn and polydispersity are result-effective variables that depend on the enzyme used, and amount of time the starch is treated with said enzyme. One having ordinary skill in the art would have known the longer starch is treated with AM, the lower the Mw. Additionally, one of ordinary skill in the art would have known β-amylase treatment of starch increases the molecule’s polydispersity. Thus, one having ordinary skill in the art would have been motivated to prepare enzymatically treated starch because it affords various starch structures.
According to Karim et al., partially hydrolyzing starch increases alters the surface and interior properties of the granules, allowing the modification reagent to react more efficiently with the starch. Thus, one having ordinary skill in the art would have been motivated to optimize the conditions for pre-treating starch with an enzyme, and subsequently chemically modifying it with an acidic group because it leads to starch having higher water absorbency properties.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further crosslink an acid modified starch derivative because it allows for the preparation of hydrogels using cheap, readily available and renewable resource, having diverse technical applications, particularly where moderate swelling/water absorption is required.
Modifying starch with anionic groups was already a known technique for the preparation of starch derivatives with water absorption properties. Dicarboxylic acids can further be used as a non-toxic agent to further crosslink two starch derivatives together, to give a hydrogel with moderate swelling/water absorption.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/553,129 in view of Karim et al.
The claims of the reference Application are directed towards a water-absorbing resin, which is a crosslinked product of starch or a partially degraded starch, with an acidic group introduced therein. The acidic group has a carboxyl group. And claim 11 recites degrading the water-absorbing resin by subjecting it to alkali treatment.
The claims of the reference application do not expressly disclose using an enzyme to degrade starch.
Karim et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to partially hydrolyze starch with an enzyme and then introduce an acidic group into the partially hydrolyzed starch.
One having ordinary skill in the art would have been motivated to partially hydrolyze starch with an enzyme and then introduce an acidic group into the partially hydrolyzed starch, because Karim et al. found partially hydrolyzing starch increases the subsequent degree of substitution of the starch, and Yoshimura et al. teach increasing the degree of substitution increases the water absorbency of starch.
While Karim et al. was concerned with substituting starch with a hydroxypropyl group, one having ordinary skill in the art would have had a reasonable expectation of success in pretreating starch with an enzyme to increase substitution with succinic anhydride, because Karim et al. teach pretreatment with an enzyme alters the surface and interior properties of the granules, allowing the modification reagent to react more efficiently with the starch.
Alternatively, claim 10 is no more than a selective combination of prior art teachings done in a manner obvious to one of ordinary skill in the art since each step of the process appears to be relatively complete in itself and there is no indication of an interaction between steps of such a type that would lead one of ordinary skill in the art to doubt that a substitution of alternative steps known to the art could be made. In re Mostovych, 144 USPQ 38 (1964).
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET.
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, Fereydoun Sajjadi can be reached at 571-272-3311. 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.
/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699