Rate for DETAILED ACTION
The present application is a domestic application filed 24 April 2023, and claims foreign priority to CN202210449713.0, filed 24 April 2022.
Claims 1-4 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 § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The recitation “high embedding rate” and “rapid absorption” in claims 1-4 render the claims herein indefinite.
The term “high” in claims 1-4 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This has rendered the recitation “embedding rate” indefinite.
Furthermore, it is not clear what is meant by the term “embedding”. It suggests an additional unrecited component. According to the Specification, “the bifunctional dextrin is used for embedding some natural active substances, and can achieve an ideal embedding effect, strengthen product nutritions, and increase an absorption efficiency of the human body” (see para [0008] of the Specification).
The term “rapid” in claims 1-4 is a relative term which renders the claim indefinite. The term “rapid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This has rendered the recitation “absorption” indefinite.
It is not clear what is meant by the term “absorption”. It could be synonymous with embedding a natural active substance, or absorption of the embedded natural active substance in vivo. The Specification discloses “this is conducive to the digestion and absorption of the human body”…”accordingly, the novel beverage is suitable for rapid absorption in vivo” (see para [0005] of the Specification). The Specification also discloses “the bifunctional dextrin is used for embedding some natural active substances, and can achieve an ideal embedding effect, strength product nutritions, and increase an absorption efficiency of the human body” (para [0008]).
The term “high-pressure treatment” in claim 1 is a relative term which renders the claim and dependent claims 2 and 4 herein indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This has rendered the recitation “pressure” indefinite.
The recitation “conducting a treatment in a water bath for 1 h” in claim 1, step (1), line 5, renders the claim and dependent claims 2 and 3 herein indefinite. It is unclear if this recitation of “treatment” is the same, or different from the “alkali treatment” recited at the beginning of the step.
This rejection could be overcome by replacing ‘a’ with ‘the’, to recite “the treatment” or “the alkali treatment”.
The recitation “taking out, washing, and drying” in claim 1, step (3) renders the claim herein indefinite. It is not clear what material these steps are referencing.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The scope of step (3), conducting esterification and cross-linking claimed for preparing a bifunctional dextrin with a “high embedding rate” is much broader than what is disclosed in the present Specification.
The instant claims have been analyzed in accordance with the methodology for determining adequacy of written description, per MPEP 2163, section II: Section II 1) For each claim, determine what the claim as a whole covers; section II 2) Review the entire Application to understand how Applicant provides support for the claimed invention including each element and/or step; section II 3) Determine whether there is sufficient written description to inform a skilled artisan that Applicant was in possession of the claimed invention as a whole at the time the application was filed.
The analysis includes the following considerations: (1) actual reduction to practice, (2) disclosure of drawings or structural chemical formulas, (3) sufficient relevant identifying characteristics such as complete structure, partial structure, physical and/or chemical properties and functional characteristics when coupled with a known or disclosed correlation between function and structure, (4) method of making the claimed invention, (5) level of skill and knowledge in the art, and (6) predictability of the art
For each claim, determine what the claim as a whole covers
Claim 1 covers a method for preparing a bifunctional dextrin with a high embedding rate and rapid absorption. The method includes a step of esterifying and crosslinking highly-branched cyclodextrin with polyacrylic acid and β-CD in any amount.
Review the entire Application to understand how Applicant provides support for the claimed invention including each element and/or step:
(1) Actual reduction to practice: The only amounts found to produce a bifunctional dextrin with a “high embedding rate”, are when the polyacrylic acid and β-CD are used at a molar concentration ratio of 2:1.
(2) Disclosure of drawings or structural chemical formulas: figures 1-5 are drawn towards the overall synthetic process, and a macromolecular scale figure of the highly branched dextrin, its cross-link with β-CD, and guest molecules.
(3) Sufficient relevant identifying characteristics such as complete structure, partial structure, physical and/or chemical properties and functional characteristics when coupled with a known or disclosed correlation between function and structure: The state of the art is silent with respect to preparing a bifunctional dextrin from highly-branched dextrin and cyclodextrin. According to the Specification, highly branched dextrin not subjected to high-pressure treatment served as a control group. The subsequent grafting rate was low, and the tested cinnamaldehyde embedding rate was 48.3%. For the highly branched dextrin treated in the manner as claimed, the tested cinnamaldehyde embedding rate was 81.2%.
And as discussed below, according to the Specification, if the molar ratio of polyacrylic acid and β-CD are too low or too high, grafting is hindered resulting in low embedding rate.
(5) Level of skill and knowledge in the art:
The level of skill in the art was low with respect to preparing a dextrin with a high embedding rate (and rapid absorption) from performing steps (1) and (2).
(6) Predictability of the art/(4) Method of making the claimed invention:
There is no prior art describing the claimed preparation method.
According to para [0019] of the Specification, “The polyacrylic acid and the β-cyclodextrin are at a concentration molar ratio of 2:1, which is an optimal addition ratio determined by measuring a cross-linking rate, and can achieve a better cyclodextrin grafting effect. When the concentration molar ratio is insufficient, the polyacrylic acid has a low concentration, while there are many active hydroxyl sites on the dextrin branch chains. Accordingly, the cross-linking agent directly cross-links the branched chains, and the grafting of β-cyclodextrin cannot be achieved. When the concentration molar ratio is excessive, the polyacrylic acid has an excess concentration. This makes the cross-linking agent intensively cross-link with the active sites on the branch chains, and also reduces the grafting effect of β-cyclodextrin and the embedding effect of a final product”.
III. Determine whether there is sufficient written description to inform a skilled artisan that Applicant was in possession of the claimed invention as a whole at the time the application was filed.
See MPEP 2163, II, A, 3(ii), “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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The claimed method was only performed successfully at a single heating temperature in step (1), a single pressure in step (2), and a single molar ratio of polyacrylic acid and β-CD in step (1).
Applicant has disclosed a method for preparing a dextrin that encapsulates cinnamaldehyde at 81.2%, at precise experimental conditions.
The scope of dextrins claimed is much broader than what is disclosed in the instant Specification.
The disclosed single method/experimental conditions is not a representative number of species that adequately describe the entire genus of dextrins with a “high embedding rate”.
Accordingly, it is deemed that the Specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Closest Prior Art
The following references represent the closest prior art.
Yao et al. (US Patent No. 10,653,784, cited in PTO-892) teach preparing a highly branched carbohydrate polymer linked to a polyalkylene glycol, and a hydrophobic or amphiphilic group linked to the highly branched carbohydrate polymer (abstract). In some embodiments, the highly branched carbohydrate can be dextrin, prepared from starch branching enzyme or glucan branching enzymes (col.3:39-46). In some embodiments, the highly branched carbohydrate polymer can be treated using high pressure processing, homogenization, hydrothermal processing, or a combination thereof (col. 12:25-29). The highly branched carbohydrate polymer can be further treated by conjugating with bioactive or functional groups or ligands such as a cyclodextrin (col.12:30-38).
However, Yao et al. do not expressly teach crosslinking a highly branched dextrin with beta-cyclodextrin as presently claimed.
Sun et al. (US Patent No. 6,689,378, cited in PTO-892) teach a method of grafting cyclodextrin to cellulose fibers, for odor absorbency or for release of complexed molecules (abstract). The cyclodextrin can be used for controlled delivery of pharmaceutical agents, or perfumes or other active ingredients (col.2:57-67). Sun et al. teach the use of polymeric anionic reactive compounds to covalently join cellulose with cyclodextrin as the crosslinking agent (col.8 to col.9, bridging para). An exemplary polymeric anion includes polyacrylic acid (col.7:16-23).
However, Sun et al. do not expressly teach crosslinking a highly branched dextrin with beta-cyclodextrin as presently claimed.
Ito et al. (JP 2008024608 A, cited in PTO-892) teach derivatizing a cluster dextrin (i.e. a highly branched dextrin), (para [0041]). The cluster dextrin may be esterified, grafted and/or crosslinked.
However, Ito et al. do not expressly teach crosslinking a highly branched dextrin with beta-cyclodextrin as presently claimed.
Zhang et al. (Carbohydrate Polymers, 2011, vol. 84, pp. 1419-1425, cited in PTO-892) teach a hyperbranched polyglycerol functionalized and grafted with β-CD, which functions as a carrier for insulin (title, abstract). Zhang et al. suggest the β-CD forms an inclusion complex with insulin (p.1419, last para). Zhang et al. also teach β-CD is advantageous as an absorption-promoting agent, because it is mild and has a reversible effect on the surface morphology of nasal mucosa and ciliary beating. Zhang et al. teach hyperbranched polyglycerol (HPG) was modified with an amine group, which then reacted with mono-tosylated β-CD (p.1420, section 2.2). Different ratios of HPG to CD were prepared, wherein the highest insulin loading was found to occur at a 1:5 mass ratio of HPG to CD (Table 2).
However, Zhang et al. do not expressly teach crosslinking a highly branched dextrin with beta-cyclodextrin as presently claimed.
Thus, the present claims are free of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699