DETAILED ACTION
This office action is in response to applicant’s filing dated March 17, 2026.
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 .
Status of Claims
Claims 1-8 are pending in the instant application.
Election/Restrictions
Applicant’s election of a formulation comprising aloe polysaccharide and gardenia polysaccharide as the plant polysaccharide; berberine hydrochloride, oryzanol, and tea polyphenol as the formulation species in the reply filed on March 17, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-8 are presently under examination as they relate to the elected species:
a formulation comprising aloe polysaccharide and gardenia polysaccharide as the plant polysaccharide; berberine hydrochloride, oryzanol, and tea polyphenol.
Priority
The present application is a CON of PCT/CN2023/121033 filed on September 25, 2023, which claims benefit of foreign priority to CHINA 202310442156.4 filed on April 23, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 15, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
Drawings
Acknowledgement is made of the drawings received on December 19, 2023. These drawings are accepted.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
In the instant case, the abstract does not include a general use of the composition.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
Claim 1 contains a comma (“,” ) between the terms composition and comprising. This should be deleted.
Claim 5 contains a comma (“,” ) between the terms composition and comprising. This should be deleted.
Appropriate correction is 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2020/0069806 A1) in view of Hikino et al (US 4,598,069, cited in the IDS filed March 15, 2024).
Regarding claims 1 and 5, Li teaches an anti-diabetic pharmaceutical composition, characterized in that the composition comprises a pharmaceutical carrier consisting of well-mixed sesame oil and beeswax as well as oryzanol and berberine hydrochloride as active ingredients (claim 1). Thus, Li teaches a composition comprising a drug carrier composition comprising sesame oil and beeswax, and an active agent, oryzanol and berberine hydrochloride.
Li does not explicitly teach the carrier composition or the composition comprises a plant polysaccharide, aloe polysaccharide.
However, Hikino teaches a hypoglycemic composition comprising as its effective component a polysaccharide which has hypoglycemic activity and is a water-soluble component of aloes of the family Liliaceae, and a method of treating diabetes comprising administering to a patient afflicted with diabetes a therapeutically effective amount of the above composition (col 1, lines 40-46) and the hypoglycemic composition of the present invention comprises one or a mixture of polysaccharides and a solid or liquid excipient (col 2, lines 47-49).
Thus, it would be prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the references so as to produce composition comprising sesame oil, beeswax, oryzanol, and berberine hydrochloride taught by Li to further comprise aloe polysaccharide taught by Hikino. One would have been motivated to do so because of each of the compositions have been individually taught in the prior art to be useful in treating diabetes. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining composition comprising sesame oil, beeswax, oryzanol, and berberine hydrochloride taught with aloe polysaccharide, one would have achieved a pharmaceutical composition useful for treating diabetes.
Regarding the claimed amounts of sesame oil, beeswax and aloe polysaccharide of instant claims 1 and 2, Li teaches the beeswax is present in an amount of 1 -20% by weight, and the sesame oil is present in an amount of 40-85% by weight (claim 8). Moreover, Hikino teaches Aloe arborescens Mill. in Example was orally administered continuously at a daily dosage of 300 mg in 3 separate doses over three months (col 4, lines 56-59). Regarding the weight ratio of active ingredient and drug carrier compositions of instant claim 7, Li teaches the oryzanol is present in an amount of 1 -5% by weight, the berberine hydrochloride is present in an amount of 5-50% by weight, the beeswax is present in an amount of 1 -20% by weight, and the sesame oil is present in an amount of 40-85% by weight (claim 8). It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of beeswax, sesame oil, berberine hydrochloride, and oryzanol taught by Li and the amount of aloe saccharides taught by Hikino as a starting point for optimizing the amounts and ratios of beeswax, sesame oil, berberine hydrochloride, oryzanol, and aloe polysaccharides utilized to treat diabetes since the cited art teaches beeswax, sesame oil, berberine hydrochloride, oryzanol, and aloe saccharides are useful for treating diabetes and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosage and ratio given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Regarding claim 8, Li teaches the pharmaceutical composition according to the present invention can be formulated depending on the particular mode of administration into various formulations well known in the art, such as a tablet, hard capsule, syrup, elixir, sachet, granule, emulsion, ointment, gel, balm, plaster, paste, suppository, cream [0042]. Hikino teaches the hypoglycemic composition of the present invention comprises one or a mixture of polysaccharides and a solid or liquid excipient (col 2, lines 47-49).
Taken together, all this would result in the composition of claims 1, 2, 5, 7, and 8 with a reasonable expectation of success.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2020/0069806 A1) in view of Hikino et al (US 4,598,069, cited in the IDS filed March 15, 2024) as applied to claims 1, 2, 5, 7, and 8 above, and further in view of Meng et al (Journal of the Science of Food and Agriculture, 2021; 101(9):3723-3731, published December 10, 2020).
Li and Hikino teach all the limitations of claims 3 and 4, except wherein the plant polysaccharide further comprises gardenia polysaccharide.
However, Meng teaches dietary fiber is mainly composed of cell wall polysaccharides that are resistant to digestion in the small intestine but fermented partially or fully in the large intestine; it provides beneficial health effects on the gastrointestinal tract and carbohydrate and lipid metabolism, thus lowering the risk of some diseases such as colorectal cancer, diabetes mellitus, obesity and cardiovascular diseases in humans (page 3723, left, last paragraph). Meng teaches a sequential fractionation scheme allows the separation of cell wall polysaccharides into their major components. W-SF, Ac-SF, Al-SF and IRF from gardenia (Gardenia jasminoides Ellis) husk were fractionated using sequential extraction; all the fibers exhibited acceptable hypoglycemic effects such as adsorbing glucose, retarding glucose diffusion and hindering the digestion of starch; thus, dietary fiber from gardenia husk may be a promising hypoglycemic ingredient for diabetic functional food; the modification of gardenia husk fiber should be further studied to promote its glucose-lowering property (page 3731, left, las paragraph).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the references so as to produce composition comprising sesame oil, beeswax, oryzanol, and berberine hydrochloride taught by Li to further comprise aloe polysaccharide taught by Hikino and gardenia polysaccharide taught by Meng. One would have been motivated to do so because of each of the compositions have been individually taught in the prior art to be useful in treating diabetes. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining composition comprising sesame oil, beeswax, oryzanol, and berberine hydrochloride taught with aloe polysaccharide and gardenia polysaccharide, one would have achieved a pharmaceutical composition useful for treating diabetes.
Regarding the claimed ratio of aloe polysaccharide and gardenia polysaccharide of instant claim 4, it would have been prima facie obvious to one of ordinary skill in the art to utilize the same amounts of aloe polysaccharide and gardenia amount (i.e. a 1:1 ratio) as a starting point for optimizing the ratio of aloe polysaccharide and gardenia polysaccharide utilized to treat diabetes since the cited art teaches both are useful for treating diabetes and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosage and ratio given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the composition of claims 3 and 4 with a reasonable expectation of success.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2020/0069806 A1) in view of Hikino et al (US 4,598,069, cited in the IDS filed March 15, 2024) and Meng et al (Journal of the Science of Food and Agriculture, 2021; 101(9):3723-3731, published December 10, 2020) as applied to claims 1-5, 7, and 8 above, and further in view of Lin-Shiau (US 2019/0224266 A1).
Li, Hikino, and Meng teach all the limitations of claim 6 (see above 103), except wherein the active ingredient comprises further comprises tea polyphenol.
However, Lin-Shiau teaches a pharmaceutical composition for use in therapy of diabetes comprising a polyphenol (claim 1) wherein the polyphenol is tea polyphenols and berberin (claim 2).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the references so as to produce composition comprising sesame oil, beeswax, oryzanol, and berberine hydrochloride taught by Li to further comprise aloe polysaccharide taught by Hikino, gardenia polysaccharide taught by Meng, and tea polyphenol taught by Lin-Shiau. One would have been motivated to do so because of each of the compositions have been individually taught in the prior art to be useful in treating diabetes. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining composition comprising sesame oil, beeswax, oryzanol, and berberine hydrochloride taught with aloe polysaccharide, gardenia polysaccharide, and tea polyphenol, one would have achieved a pharmaceutical composition useful for treating diabetes.
Regarding the claimed amounts of berberine hydrochloride, oryzanol, and tea phenol of instant claim 6, Li teaches the oryzanol is present in an amount of 1 -5% by weight and the berberine hydrochloride is present in an amount of 5-50% by weight (claim 8). Moreover, Lin-Shiau teaches the proportion between the concentration of the polyphenols and the clinical drug is 1:0.1-3. It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of berberine hydrochloride and oryzanol taught by Li and the ratio of tea polyphenol to drug taught by Lin-Shiau as a starting point for optimizing the amounts of berberine hydrochloride, oryzanol, and tea polyphenols utilized to treat diabetes since the cited art teaches berberine hydrochloride, oryzanol, and polyphenols are useful for treating diabetes and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosage and ratio given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the composition of claim 6 with a reasonable expectation of success.
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 13, 14, 17-21, and 23 of U.S. Patent No. 11,623,010 B2 in view of Hikino et al (US 4,598,069, cited in the IDS filed March 15, 2024), Meng et al (Journal of the Science of Food and Agriculture, 2021; 101(9):3723-3731, published December 10, 2020), and Lin-Shiau (US 2019/0224266 A1).
The instant claims are directed to a drug carrier composition, comprising the following components in parts by weight: 10-25 parts of sesame oil, 2-8 parts of beeswax, and 0.6-1.4 parts of plant polysaccharide; wherein the plant polysaccharide is one or more selected from the group consisting of aloe polysaccharide, gardenia polysaccharide, and trametes robiniophia murr polysaccharide and a hypoglycemic drug comprising the drug carrier and an active agent.
The previously allowed claims are directed to an anti-diabetic pharmaceutical composition in capsule or tablet form for oral administration, consisting of: oryzanol and berberine hydrochloride as active ingredients; and a pharmaceutical carrier consisting of well-mixed sesame oil and beeswax; wherein, the oryzanol is present in an amount of 1-5% by weight relative to the total weight of the pharmaceutical composition, the berberine hydrochloride is present in an amount of 5-50% by weight relative to the total weight of the pharmaceutical composition, the beeswax is present in an amount of 1-20% by weight relative to the total weight of the pharmaceutical composition, and the sesame oil is present in an amount of 40-85% by weight, relative to the total weight of the pharmaceutical composition within the capsule or tablet; and the beeswax forms microcrystals which are homogeneously dispersed in the sesame oil.
The previously allowed claims differ from the instant claims in that the instant claims further require a plant polysaccharide, aloe polysaccharide and gardenia saccharide and further require a tea polyphenol.
However, Hikino teaches a hypoglycemic composition comprising as its effective component a polysaccharide which has hypoglycemic activity and is a water-soluble component of aloes of the family Liliaceae, and a method of treating diabetes comprising administering to a patient afflicted with diabetes a therapeutically effective amount of the above composition (col 1, lines 40-46) and the hypoglycemic composition of the present invention comprises one or a mixture of polysaccharides and a solid or liquid excipient (col 2, lines 47-49).
Meng teaches dietary fiber is mainly composed of cell wall polysaccharides that are resistant to digestion in the small intestine but fermented partially or fully in the large intestine; it provides beneficial health effects on the gastrointestinal tract and carbohydrate and lipid metabolism, thus lowering the risk of some diseases such as colorectal cancer, diabetes mellitus, obesity and cardiovascular diseases in humans (page 3723, left, last paragraph). Meng teaches a sequential fractionation scheme allows the separation of cell wall polysaccharides into their major components. W-SF, Ac-SF, Al-SF and IRF from gardenia (Gardenia jasminoides Ellis) husk were fractionated using sequential extraction; all the fibers exhibited acceptable hypoglycemic effects such as adsorbing glucose, retarding glucose diffusion and hindering the digestion of starch; thus, dietary fiber from gardenia husk may be a promising hypoglycemic ingredient for diabetic functional food; the modification of gardenia husk fiber should be further studied to promote its glucose-lowering property (page 3731, left, las paragraph).
Lin-Shiau teaches a pharmaceutical composition for use in therapy of diabetes comprising a polyphenol (claim 1) wherein the polyphenol is tea polyphenols and berberin (claim 2).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the teachings of the references so as to produce composition comprising sesame oil, beeswax, oryzanol, and berberine hydrochloride of the previously allowed claims to further comprise aloe polysaccharide taught by Hikino, gardenia polysaccharide taught by Meng, and tea polyphenol taught by Lin-Shiau. One would have been motivated to do so because of each of the compositions have been individually taught in the prior art to be useful in treating diabetes. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining composition comprising sesame oil, beeswax, oryzanol, and berberine hydrochloride taught with aloe polysaccharide, gardenia polysaccharide, and tea polyphenol, one would have achieved a pharmaceutical composition useful for treating diabetes.
Regarding the amount of oryzanol, berberine hydrochloride, beeswax, and sesame of oil of the instant claims, the previously allowed claims teach the oryzanol is present in an amount of 2-4% by weight, the berberine hydrochloride is present in an amount of 15-30% by weight, the beeswax is present in an amount of 3-6% by weight, and the sesame oil is present in an amount of 60-75% by weight. Regarding the amount of plant polysaccharide, Hikino teaches Aloe arborescens Mill. in Example was orally administered continuously at a daily dosage of 300 mg in 3 separate doses over three months (col 4, lines 56-59). Regarding the amount of tea polyphenol, Lin-Shiau teaches the proportion between the concentration of the polyphenols and the clinical drug is 1:0.1-3. It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of sesame oil, beeswax, berberine hydrochloride and oryzanol of the previously allowed claims, and the amount of aloe saccharides taught by Hikino, and the ratio of tea polyphenol to drug taught by Lin-Shiau as a starting point for optimizing the amounts of sesame oil, beeswax, aloe polysaccharide, gardenia polysaccharide, berberine hydrochloride, oryzanol, and tea polyphenols utilized to treat diabetes since the cited art teaches compositions comprising sesame oil, beeswax, aloe polysaccharide, gardenia polysaccharide, berberine hydrochloride, oryzanol, and tea polyphenols are useful for treating diabetes and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosage and ratio given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Thus, resulting in the composition of the instant claims.
Conclusion
Claims 1-8 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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