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 .
Priority
The instant application is a divisional of Application No. 17/245416 filed on 4/30/2021, which is a continuation of Application No. 16/646218 filed on 3/11/2020. The latter application is a national stage entry of PCT/US2018/050571 filed on 9/12/2018, which claims priority benefit of U.S. Provisional Application Nos. 62/635005 filed on 2/26/2018 and 62/557339 filed on 9/12/2017 under 35 U.S.C. 119(e).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/23/2024 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in the IDS have been fully considered.
Claim Objections
Claim 1 is objected to because of the following informality: the article before “process” in line 1 should be “a” instead of “the”.
Claim 13 is objected to because of lack space before “diisocyanate” in the following limitations: “2,4-toluenediisocyanate”, “2,6-toluenediisocyanate”, “2,4,4-trimethylhexamethylenediisocyanate”, “ethylidenediisocyanate”, “butylenediisocyanate”, “hexamethylenediisocyanate”, “p-phenylendiisocyanate”, and “tetramethyl-xylylenediisocyanate”. In addition, the term “p-phenylene” is misspelled in the limitation “p-phenylendiisocyanate” (i.e., letter “e” is missing at the end of said term) and “tetramethyl-xylylenediisocyanate” has an unnecessary hyphen.
Claim 15 is objected to due to the following informalities: lack of space before “diisocyanate” in the limitations “2,4-toluenediisocyanate” and “2,6-toluenediisocyanate”.
Appropriate corrections are required.
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.
Claims 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Cuero Rengifo et al. (Pub. No. US 2016/0168311 A1) in view of Zia et al. (International Journal of Biological Macromolecules 2014, Vol. 66, pages 26-32).
Cuero Rengifo et al. discloses polyurethane compositions based on natural materials, as well as biofoams made from said polyurethane compositions (Abstract, par. [0088]). The disclosed biofoams can be used in any application that employs synthetic polyurethane foams such as in upholstery, building products, automobiles, and aircraft (par. [0097]).
To prepare a polyurethane composition, Cuero Rengifo et al. teaches a process comprising: (a) admixing a polysaccharide, a surfactant, and a natural oil polyol in a solvent to produce a first admixture; and (b) reacting the first admixture with a polyisocyanate to produce the polyurethane composition (par. [0051]-[0053]). Isocyanate-reactive functional groups present in the polysaccharide, surfactant, and/or natural oil polyol react with the isocyanate groups in the polyisocyanate to form a polyurethane (par. [0084]). In an embodiment, the process further comprises adding a clay like bentonite and zeolite to the first admixture (par. [0077]).
A polysaccharide is a polymer composed of covalently-linked monosaccharides such as chitosan, chitin, cellulose, and guar (par. [0054], [0057]). Natural oil polyols are compounds derived from or present in natural oils that include at least one free hydroxyl group. Examples of applicable natural oil polyols include castor oil, chemically-modified vegetable oil, a carbohydrate, lignin, cork, cashew nutshell liquid, and/or Lesquerella oil (par. [0064]-[0065]). Polyisocyanates are compounds with two or more -N=C=O groups, which can be an aliphatic, cycloaliphatic, or aromatic diisocyanate such as 2,4-toluenediisocyanate alone or in combination with 2,6-toluenediisocyanate, and 4,4′-methylene diphenyl diisocyanate (MDI) (par. [0082]).
Cuero Rengifo et al. reads on the instant application as follows:
Regarding claim 1: the disclosed polyurethane composition is equivalent to “A polyurethane composition”.
The polyurethane composition is required to be “produced by a process comprising” steps (a) and (b), wherein the polyactive carbohydrate in step (a) is generated by fermenting a biological device comprising host cells. These are product-by-process limitations. As such, only the structural properties implied by the recited processes has patentable weight. MPEP § 2113 states “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”.
In this case, the polyactive carbohydrate is considered to comprise chitosan oligosaccharides since the host cells produce enzymes that catalyze production of chitin (by chitin synthase), conversion of chitin into chitosan (by chitin deacetylase), and degradation of chitosan into chitosan oligosaccharides (by chitosanase and optionally lipase). Moreover, having chitosan oligosaccharides in the first admixture extends and/or crosslinks the urethane chains being formed. Thus, the process comprising step (a) and step (b) is considered to produce a chitosan oligosaccharide-based polyurethane composition having a network of crosslinks between urethane chains. It is noted that Cuero Rengifo et al.’s process entails admixing a polysaccharide, a surfactant, and a natural oil polyol in a solvent and then reacting the resulting mixture with a polyisocyanate to produce a polyurethane composition (par. [0051]-[0053]).
Cuero Rengifo et al. is different from the claimed invention in that it only teaches using chitosan and not chitosan oligosaccharides as the polysaccharide.
It is known in the art, however, that chitosan has lower solubility in water at neutral or basic pH due to its basic nature as substantiated by Zia et al.. Zia et al. states that chitosan’s low solubility is a barrier for chemical reactions (third par., left col., page 27). Chitosan oligomers are therefore preferred over chitosan and can be generated via hydrolysis by acid at high temperature or hydrogen peroxide. Accordingly, Zia et al. teaches treating chitosan with hydrogen peroxide to prepare chitosan oligosaccharides and employing the prepared chitosan oligosaccharides to synthesize polyurethane.
Since chitosan oligosaccharides are highly water soluble and have looser structure which make the functional groups (i.e., hydroxyl and amino groups) more accessible than chitosan, and given that the polysaccharide can be chemically modified according to Cuero Rengifo et al. (par. [0054]), a person with ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cuero Rengifo et al. by utilizing chitosan oligosaccharides instead of chitosan as the polysaccharide. Such modification would provide more readily available functional groups that can form crosslinks with urethane chains. It can be predicted that chitosan oligosaccharides would yield the benefits of making a stronger and more biodegradable polyurethane composition. Obviousness is based on the rationale that some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Hence, claim 1 is obvious over Cuero Rengifo et al. in view of Zia et al..
Regarding claims 2-6: the genes expressing chitin deacetylase, chitin synthase, chitosanase, or lipase having the recited sequences do not confer structural features to the claimed polyurethane composition because chitosan oligosaccharides are the same whether they are produced enzymatically or chemically.
Regarding claims 7-8: the host cells are further defined as being “transformed with a vector comprising the DNA construct” and “comprise yeast or bacteria”, which do not impart any structure to the polyurethane composition.
Regarding claim 9: Cuero Rengifo et al. teaches that the surfactant is used to a form a stable emulsion of the polysaccharide and natural oil polyol, wherein the surfactant can be ethoxylated fatty alcohol surfactants (also known as “alcohol ethoxylates”) and polyoxyethylene oxide C12-C18 sorbitan monoesters (also known as “polysorbates) (par. [0071]-[0072]). This teaching meets the limitation “wherein step (a) further comprises admixing a surfactant, wherein the surfactant is a polysorbate, a lecithin, an alcohol ethoxylate, or PEG-40 hydrogenated castor oil”.
Regarding claim 10: polyoxyethylene oxide C18 sorbitan monoester is identical to polysorbate 80, which is used in working examples (Tables 4-8, pages 10-12) and satisfies “wherein the polysorbate is polysorbate 20 or polysorbate 80”.
Regarding claim 11: the natural oil polyols can be or is derived from soy, castor oil, chemically-modified vegetable oil, a carbohydrate, lignin, cork, cashew nutshell liquid, and/or Lesquerella oil (par. [0064]-[0065]), which is the same as “wherein the natural oil polyol comprises or is derived from soy oil, castor oil, a chemically-modified vegetable oil, a carbohydrate, lignin, cork, cashew nutshell liquid, Lesquerella oil, or a combination thereof”.
Regarding claim 12: castor oil fulfills “wherein the natural oil polyol comprises castor oil, ricinoleic acid, or a combination thereof”.
Regarding claim 13: suitable polyisocyanates include 2,4-toluenediisocyanate alone or in combination with 2,6-toluenediisocyanate, and 4,4′-methylene diphenyl diisocyanate (MDI) (par. [0082]), which correspond to “wherein the polyisocyanate comprises 2,4-toluenediisocyanate, 2,6-toluenediisocyanate, 4,4'-methylene diphenyl diisocyanate (MDI)…”.
Regarding claim 14: Cuero Rengifo et al.’s teaching that the polyisocyanate can be added to the first admixture at different ratios such as about 1:1, to about 1:8 relative to the total emulsion volume (par. [0083]) meets “wherein the ratio of polyisocyanate to the first admixture formed is from 1:1 to 1:8”.
Regarding claim 15: the embodiment of using MDI or 2,4-toluenediisocyanate in combination with 2,6-toluenediisocyanate as the polyisocyanate satisfies “wherein the polyisocyanate comprises (i) 2,4-toluenediisocyanate and 2,6-toluenediisocyanate or (ii) 4,4'-methylene diphenyl diisocyanate”.
Regarding claim 16: the process further comprising adding a clay like bentonite and zeolite to the first admixture (par. [0077]) is analogous to “wherein step (a) further comprises admixing a clay selected from the group consisting of bentonite, montmorillonite, kaolinite, and a zeolite”.
Regarding claim 17: the polysaccharide in the admixture can amount to from about 0.01 to about 10% by weight (par. [0061]) and renders obvious the limitation “wherein the polyactive carbohydrate is from 0.1 to 1% by weight of the first admixture”.
MPEP 2144.05 states that a prima facie case of obviousness exists when the claimed ranges "overlap or lie inside ranges disclosed by the prior art" In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). And in this case, the disclosed amount overlaps with the claimed concentration range of the polyactive carbohydrate.
Regarding claim 18: the natural oil polyol can be present in the amount of 25% to 70% v/v of the first admixture (par. [0075]), which fulfills “wherein the natural oil polyol is from 20 to 80 vol% of the first admixture”.
Regarding claim 19: the natural oil polyol being castor oil meets the additional limitation “(ii) the natural oil is castor oil”.
Although Cuero Rengifo et al. does not teach the producing the polysaccharide with the aid of enzymes expressed by host cells, limitation (i) is deemed a product-by-process limitation that does not confer structural limitations as discussed above (see rejection for claim 1).
Regarding claim 20: the biofoam being derived from the disclosed polyurethane compositions is equivalent to “A biofoam comprising the polyurethane composition of claim 1”.
Regarding claim 21: the biofoam of claim 20 is further required to be formed via “(1) the polyurethane composition is poured into a mold, and (2) the polyurethane composition is dried to remove residual solvent”, which is also a product-by-process limitation that implies the claimed biofoam has a shape and is dry/solvent-free. The prior art teaches that the disclosed bofoam can be produced in any desired shape or size such as by pouring the polyurethane composition into a mold and placed in an oven to remove the residual solvent (par. [0091]).
Regarding claim 22: the embodiment of the biofoam containing additives including flame retardants, color additives, release agents, and biocides (par. [0092]) is the same as “wherein the biofoam further comprises a flame retardant, a color additive, a release agent, a biocide, another additive, or a combination thereof”.
Regarding claim 23: the prior art teaches that one or more blowing agents can be incorporated into the polyurethane compositions to form the biofoams (par. [0089]) and therefore meets the requirement “wherein the biofoam further comprises a physical blowing agent or a chemical blowing agent”.
Regarding claim 24: suitable blowing agents include physical blowing agents like hydrofluorocarbons, hydrocarbons, hydrofluoroolefins, liquid CO2, and other low boiling point liquids (par. [0089]), thereby satisfying “wherein the physical blowing agent is a hydrofluorocarbon, a hydrocarbon, a hydrofluoroolefin, liquid carbon dioxide, or another low boiling point liquid”.
Regarding claim 25: the disclosed biofoam can be used in upholstery such as cushions, pillows, and mattresses, which is analogous to “An article comprising the biofoam of claim 20”.
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 1-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,868,811 in view of Zia et al. (International Journal of Biological Macromolecules 2014, Vol. 66, pages 26-32).
The U.S. patent is drawn to a polyurethane composition, as well as a biofoam or molded article comprising said polyurethane composition. The polyurethane composition is produced by a process comprising: (a) admixing chitosan and a natural oil polyol in a solvent to produce a first admixture, wherein the chitosan is from 60% to 100% acetylated and the natural oil polyol comprises a hydroxy fatty acid; and (b) reacting the first admixture with a polyisocyanate to produce the polyurethane composition. The natural oil polyol can comprise castor oil, ricinoleic acid, or a combination thereof.
In an embodiment, step (a) further comprises admixing a surfactant and said surfactant is limited to a polysorbate, a lecithin, or an alcohol ethoxylate. In another embodiment, the first admixture further comprises a clay or clay mineral, wherein the clay or clay mineral is a bentonite, a zeolite, or a combination thereof.
The recited processes are considered product-by-process limitations. A product-by-process limitation is evaluated insofar as the method of production imparts distinct structural properties to the product. See MPEP § 2113. Accordingly, the U.S. patent’s polyurethane composition differs from the claimed invention in that it comprises chitosan instead of chitosan oligosaccharides.
But as explained above, it would have been obvious to use chitosan oligosaccharides rather than chitosan because chitosan’s low aqueous solubility is a barrier for chemical reactions as taught by Zia et al. (third par., left col., page 27). Zia et al. teaches treating making chitosan oligosaccharides and utilizing them to generate polyurethane. Compared to the higher molecular weight chitosan that has a more rigid and compact structure, it can be expected that chitosan oligosaccharides would provide more readily available hydroxyl and amino groups that promote formation of intramolecular crosslinks, thereby making the polyurethane more structurally stable and more biodegradable. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Thus, the claims of the instant application are obvious over U.S. 9,868,811 in view of Zia et al..
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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