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 .
Status of the Claims
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-20
Withdrawn claims: 8-15 and 17-20
Previously canceled claims: None
Newly canceled claims: None
Amended claims: 1, 3-15
New claims: 16-20
Claims currently under consideration: 1-7 and 16
Currently rejected claims: 1-7 and 16
Allowed claims: None
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7 and 16 in the reply filed on 13 January 2026 is acknowledged.
Claims 8-15 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 13 January 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on p. 5, line 2. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 c) (ii) should read, “(ii) an organic phase separation agent…”
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.
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 1-3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mach et al. (GB 1,073,738, cited on the IDS filed on 20 December 2023) in view of Kawahara et al. (US 2020/0367487 A1).
Regarding claim 1, Mach teaches a process for preparing a melanoidin product, the process comprising steps of:
a) treating coffee grounds with an extraction agent with a pH value greater than 7 to extract a melanoidin-containing solute in a fluid phase of the extraction agent – Mach teaches a process for recovery of melanoidins, comprising adding a solution of 0.1N sodium hydroxide to coffee grounds to a pH of 8.5 to produce a solution of melanoidins (see “Example 1”, p. 4, line 111 – p. 5, line 19).
b) separating the fluid phase from the coffee grounds – Mach teaches that the solution of the melanoidins is separated from the solid residue by filtration (p. 5, lines 11-14).
Mach does not discuss that the process comprises the steps of:
c) precipitating precipitates containing melanoidin by contacting the fluid phase with:
(i) an acid to obtain an acidic mixture with a pH value lower than 4 or
(ii) an organic phase separation agent and with an acid to obtain a mixture with a pH value in a range of from 4 to 8,
thereby forming precipitates containing melanoidin; and
d) separating the precipitates formed in step c) from the acidic mixture or the mixture with a pH value in the range of from 4 to 8.
However, Kawahara teaches a coffee extract containing coffee melanoidins ([0032]) obtained by extracting crushed roasted coffee beans with water at pH 6 to 8, and further subjecting the extract liquid to filtration, precipitation, centrifugation, and drying as needed ([0023] – [0025]). Kawahara teaches adjusting the pH of the fractionated liquid to 1 to 4 to reduce the water solubility of (i.e., precipitate) the extracted compounds ([0028]). Kawahara further teaches an organic solvent extraction step of the pH adjusted fraction liquid ([0029]). The extracted compounds are then subjected to a purification step ([0030]).
Therefore, Kawahara teaches c) precipitating precipitates containing melanoidin by contacting the fluid phase with:
(i) an acid to obtain an acidic mixture with a pH value lower than 4 (pH 1-4, see [0028]) or
(ii) an organic phase separation agent and with an acid to obtain a mixture with a pH value in a range of from 4 to 8 – Kawahara teaches that the pH adjusted fraction is extracted with an organic solvent ([0029]). Kawahara teaches a pH of 1-4, which touches the claimed range of pH 4-8.
thereby forming precipitates containing melanoidin; and
d) separating the precipitates formed in step c) from the acidic mixture or the mixture with a pH value in the range of from 4 to 8 – Kawahara teaches subjecting the extracted compounds to a purification step ([0030]) and centrifugation and drying as needed ([0025]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Mach with the teachings of Kawahara to improve the purity of the extracted melanoidins. First, Mach teaches a base method of and alkaline extraction melanoidins from coffee grounds, separating the extract from the coffee grounds, and drying the extract, but does not precipitate the melanoidins and separate the precipitates from the acidic mixture as claimed. However, Kawahara teaches extracting melanoidins from crushed coffee beans, separating the extracted liquid, acid precipitation of the extract, organic phase separation, and purification/separation of the melanoidins as claimed. Therefore, since both Mach and Kawahara extract melanoidins from coffee, one of ordinary skill in the art could have applied the precipitation and separation steps of Kawahara to the base method of Mach, resulting in the predictable result of improved purity of the coffee melanoidins. See MPEP § 2143(I)(C).
Claim 1 is therefore rendered obvious.
Regarding claim 2, Mach also teaches that the extraction agent is aqueous and comprises sodium hydroxide or potassium hydroxide – Mach teaches that the extraction agent is “roughly 0.1 N aqueous solution of sodium hydroxide” (p. 4, lines 1-2).
Claim 2 is therefore rendered obvious.
Regarding claim 3, Mach does not discuss that the organic phase separation agent is selected from the group consisting of ethanol, ethyl acetate, tetrahydrofuran, and 2-methyltetrahydrofuran.
However, Kawahara teaches organic phase separation, wherein the organic solvent may be ethyl acetate ([0029]).
Therefore, where it would have been obvious to modify the method of Mach with the teachings of Kawahara to include an organic solvent extraction step as described regarding claim 1, and since Kawahara teaches ethyl acetate as an organic solvent for the extraction step, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used ethyl acetate as the organic solvent in the modified method.
Claim 3 is therefore rendered obvious.
Regarding claim 16, Mach and Kawahara teach the method of claim 2.
Mach does not discuss that the organic phase separation agent is selected from the group consisting of ethanol, ethyl acetate, tetrahydrofuran, and 2-methyltetrahydrofuran.
However, Kawahara teaches organic phase separation, wherein the organic solvent may be ethyl acetate ([0029]).
Therefore, where it would have been obvious to modify the method of Mach with the teachings of Kawahara to include an organic solvent extraction step as described regarding claim 1, and since Mach teaches the limitations of claim 2 and Kawahara teaches ethyl acetate as an organic solvent for the extraction step, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used ethyl acetate as the organic solvent in the modified method.
Claim 16 is therefore rendered obvious.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Mach et al. and Kawahara et al. as applied to claim 1 above, and further in view of Lee et al. (Lee, M. Y., Lee, C., Jung, H. S., Jeon, M., Kim, K. S., Yun, S. H., ... & Hahn, S. K. (2016). Biodegradable photonic melanoidin for theranostic applications. ACS nano, 10(1), 822-831. https://doi.org/10.1021/acsnano.5b05931, cited on the IDS filed on 20 December 2023).
Regarding claim 4, Mach does not discuss that the step d) comprises a step of fractionating the precipitates formed in the step c) to obtain a low-molecular weight fraction of the precipitates formed in the step c) with an average molecular weight of less than 10 kDa, and wherein the step d) is followed by a step e) of producing nanoparticles from the low-molecular weight fraction obtained in the step d).
However, Kawahara teaches, “As needed, the coffee extract may be subjected to a fractionation step of performing a fractionation treatment according to a molecular weight” ([0026]). Kawahara teaches a fractionation step using an ultrafiltration membrane to separate components into components having a molecular weight above 10,000 (i.e., 10 kDa) and components having a molecular weight below 10,000 ([0027]).
Lee teaches preparing melanoidins as nanoparticles for use in theranostic nanomedicines (Abstract). In preparing the melanoidin particles, the size was controlled by changing reaction time, resulting in particles with molecular weights of 5.6 ± 0.3 kDa after reaction for 4 days, to 7.7 ± 0.5 kDa after 1 week, and to 10.3 ± 0.8 kDa after 2 weeks (p. 823, cols. 1-2, bridging ¶). Therefore, Lee teaches melanoidin nanoparticles with a size of under 10 kDa are useful in applications such as theranostic nanomedicines.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Mach with the teachings of Kawahara and Lee to fractionate the precipitated melanoidins by ultrafiltration with a 10 kDa molecular weight cutoff, and prepare melanoidin nanoparticles from a low-molecular weight melanoidin fraction of less than 10 kDa. One of ordinary skill in the art would have been motivated to do so in order to provide melanoidin nanoparticles for applications such as theranostic nanomedicine. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Kawahara teaches filtration, including fractionation into components having a molecular weight above 10,000 and those having a molecular weight below 10,000 as needed, and Lee teaches preparing melanoidin nanoparticles with a molecular weight of less than 10 kDa.
Claim 4 is therefore rendered obvious.
Regarding claim 5, Mach, Kawahara, and Lee teach the process according to claim 4.
Mach also teaches that the weakly acidic melanoidin solution may be turned into a dry product by evaporation (p. 4, lines 22-23), spray drying or vacuum drying (p. 2, lines 72-75).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have dried the low-molecular weight fraction obtained as described regarding claim 4 by spray drying or vacuum drying as disclosed by Mach, thereby producing nanoparticles as claimed, with the same motivation, and with the same expectation of success as described regarding claim 4.
Claim 5 is therefore rendered obvious.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mach et al. and Kawahara et al. as applied to claim 1 above, and further in view of Jin et al. (Jin, G., Prabhakaran, M. P., Kai, D., Annamalai, S. K., Arunachalam, K. D., & Ramakrishna, S. (2013). Tissue engineered plant extracts as nanofibrous wound dressing. Biomaterials, 34(3), 724-734. https://doi.org/10.1016/j.biomaterials.2012.10.026).
Regarding claims 6-7, Mach does not discuss that the step d) comprises a step of fractionating the precipitates formed in the step c) to obtain a high molecular weight fraction with an average molecular weight of at least 10 kDa, and wherein the step d) is followed by a step e) of producing nanofibers from the high-molecular weight fraction (re: claim 6), wherein the step e) comprises electrospinning (re: claim 7).
However, Kawahara teaches, “As needed, the coffee extract may be subjected to a fractionation step of performing a fractionation treatment according to a molecular weight” ([0026]). Kawahara teaches a fractionation step using an ultrafiltration membrane to separate components into components having a molecular weight above 10,000 (i.e., 10 kDa) and components having a molecular weight below 10,000 ([0027]). Kawahara also teaches production and isolation of coffee melanoidins having a molecular weight of 10,000 or more ([0040]). Kawahara further teaches that coffee melanoidins support cell viability and reduce low-temperature damage and inhibit necrosis ([0049], [0051]). Kawahara concludes that “an organ, a tissue, or cells of a living body can be preserved without damaging the organ, the tissue or the cells by using a medium comprising a coffee extract” ([0052]). Therefore, Kawahara teaches that a high-molecular weight fraction (over 10 kDa) of coffee melanoidins has desirable properties with regard to cell and tissue biology.
Jin teaches that the use of plant extracts in treating other forms of tissue damage, namely burns and wounds, is a common practice, and that electrospun nanofibers provide a high porosity with large surface area-to-volume ratio and are more appropriate for cell accommodation, nutrition infiltration, gas exchange, and waste excretion (Abstract). Jin teaches the preparation of nanofibrous mats to serve as skin graft substitutes that support the proliferation of human dermal fibroblasts, and the differentiation of adipose derived stem cells into epidermal cells (Abstract). Jin teaches dissolving polycaprolactone (PCL) and powdery extracts of plants and electrospinning into nanofibers (p. 725, col. 2, ¶ 3). Therefore, Jin teaches that plant extracts with desirable properties with regard to cell and tissue biology were known to be formed into nanofibers by electrospinning.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Mach with the teachings of Kawahara and Jin to fractionate the precipitated melanoidins by ultrafiltration with a 10 kDa molecular weight cutoff, and prepare melanoidin nanofibers from a high-molecular weight melanoidin fraction of greater than 10 kDa. One of ordinary skill in the art would have been motivated to do so in order to provide melanoidin nanofibers for applications in cell and tissue biology. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Kawahara teaches filtration, including fractionation into components having a molecular weight above 10,000 and those having a molecular weight below 10,000 as needed, as well as production and isolation of coffee melanoidins having a molecular weight of 10,000 or more, and Jin teaches preparing nanofibers from plant extracts by electrospinning.
Claims 6-7 are therefore rendered obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Shellhammer whose telephone number is (703)756-5525. The examiner can normally be reached Monday - Thursday 7:30 am - 5:00 pm ET.
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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