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 Application
The Amendments and Remarks filed on 01/22/26 are acknowledged.
Claims 1-17 and 27-36 were cancelled.
Claims 18-20 and 25 were amended.
Claims 18-26 are pending and included in the prosecution.
Response to Amendments/Arguments
Objection to the Specification
In light of the amendment of the Specification to remove the embedded hyperlink and/or other form of browser-executable code, the objection to the Specification is withdrawn.
Claim Objections
In light of the amendment of claims 19 and 20, the objections to these claim are withdrawn. In light of the cancellation of claim 28, the objection to this claim is moot.
Claim Rejections - 35 USC § 112
In light of the amendment of claim 25 to remove the phrase “such as,” the rejection of this claim under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn. In light of the cancellation of claim 34, the rejection of this claim under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is moot.
New Objections & Rejections necessitated by Amendment
Claim Objections
Claim 25 is objected to because of the following informalities: In claim 25, line 2, the term “last” should be replaced with “least.” Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 18-25 are drawn to a polyphenol extract from cinnamon bark, comprising polyphenol from the cinnamon bark in a form of nanoparticles, wherein the polyphenol extract includes: a molecular weight of less than 10 KD when determined by aqueous Gel Permeation Chromatography (GPC); and an intrinsic viscosity in water of 0.1-1.0 when determined by Ubbelohde viscometer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons.
With regard to natural products, the MPEP states: “product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 11A F.3d at 760, 113 USPQ2d at 1244 (“Contrary to Myriads argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible."). Thus, a synthetic, artificial or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g. In re Roslin Institute (Edinburgh). 750 F.3d 1333, 1337. 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart.” (MPEP 2106.04(b)(II)).
The rationale for this determination is explained below:
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, a composition of matter.
Step 2a Prong 1: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
The claims are directed to a natural phenomenon, specifically nature-based products polyphenol from cinnamon bark. The instant specification discloses cinnamon cassia ground bark powder that is extracted (Example 1). Cinnamon and the polyphenols enclosed therein exists in nature and there is no evidence in the record that the claimed products impart new properties.
Step 2a Prong 2: Does the Claim recite additional elements that integrate the judicial exception into a Practical Application?
Yes, claim 25 recites that the polyphenol extract is formulated into at least one of lozenges, candy or foods.
Step 2b: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. With regards to claims 18-25, the recitation of a polyphenol extract (claim 18) and formulated into at least one of lozenges, candy or foods (claim 25) does not distinguish these claims from the judicial exception. The composition and oral preparation could be a natural product by itself which does not amount to significantly more than the judicial exception.
The claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception. Specifically, the claims do not include any elements in addition to the natural product. As such, claims 18-25 are drawn to a judicial exception.
Please note that this rejection is further corroborated by Applicant’s own admission that the nanoparticles of the claimed subject matter are 100% natural (Pages 5 and 7 of the Arguments filed on 01/22/26).
Notice for all US Patent Applications filed on or after March 16, 2013
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 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.
Maintained Rejections
Claim Rejections - 35 USC § 102
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.
Claims 18-26 are again rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helgeson et al. (WO 2018/209293 A2 – “Helgeson”).
The claimed invention is a polyphenol extract from cinnamon bark, comprising polyphenol from the cinnamon bark in a form of nanoparticles, wherein the polyphenol extract includes: a molecular weight of less than 10 KD when determined by aqueous Gel Permeation Chromatography (GPC); and an intrinsic viscosity in water of 0.1-1.0 when determined by Ubbelohde viscometer.
Helgeson teaches nanoparticles (Abstract and claims 1-17) comprising polyphenols (claim 19). Helgeson teaches essential oil from the bark of cinnamon (Page 47, lines 11-12). The nanoparticles have an average molecular weight of between 575 and 20,000 g/mol (0.5-20 KD) (Page 11, lines 20-24) can be determined by GPC (Page 72, line 17) and can be in the form of viscous liquid, gel or solid (Page 30, lines 28-29). Since it is well known in the art that low molecular weight decreases the viscosity of material, the viscosity of 0.1-1 is inherent. The limitations regarding antiviral activity are properties associated with the cinnamon extract and inseparable from it. Please see MPEP 2112.01. The diameter of the nanoparticles is between 1-100 nm and 160-1000 nm (Page 2, lines 26-28). Said nanoparticles comprise antiviral agents (Page 51, line 7). Helgeson also discloses that, the nanoparticles are food agents (Page 34, line 19) and may be compressed into tablets (Page 55, line 16).
Therefore, the limitations of claims 18-26 are anticipated by Helgeson.
Response to Arguments
Applicant’s arguments (Pages 5-6, filed 01/22/26) with respect to the rejection of claims 18-36 under 35 U.S.C. 102(a)(1) as being anticipated by Helgeson have been fully considered but are not persuasive.
In light of the cancellation of claims 27-36 the rejection of these claims is moot.
Applicant argues that the “PTO has not demonstrated that Helgeson discloses the features required by claim 18, including a cinnamon bark extract that includes "[a] polyphenol in the form of nanoparticles" that comprise the cinnamon-derived polyphenols, with the polyphenol of the cinnamon bark extract having "a molecular weight of less than 10 KD" and "an intrinsic viscosity in water of 0.1-1.0," as recited in independent claim 18. (Emphasis added).
This is not persuasive because Helgeson teaches nanoparticles (Abstract and claims 1-17) comprising polyphenols (claim 19). Helgeson teaches essential oil from the bark of cinnamon (Page 47, lines 11-12). The nanoparticles have an average molecular weight of between 575 and 20,000 g/mol (0.5-20 KD) (Page 11, lines 20-24). Since the same nanoparticles comprising the same polyphenols from the bark of cinnamon are disclosed by Helgeson, the corresponding molecular weight and intrinsic viscosity in water, which are inherent properties of the polyphenol extract, are also present. Please see MPEP 2112.01. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
Applicant argues that “In Helgeson, cinnamon appears only as an optional essential oil among many other oils and is never presented as a polyphenol-based extract, let alone one having the properties recited in claim 18.”
This is not persuasive because even if Helgeson lists cinnamon as an optional essential oil it is still clearly disclosed. According to MPEP § 2123, “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” and “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure of preferred embodiments.” The polyphenols in the cinnamon bark are inherently present. This is corroborated by Applicant’s own admission that the nanoparticles of the claimed subject matter are 100% natural, they are the natural extract of the cinnamon without any additives. Instant claims do not recite any specific polyphenol to distinguish over the prior art.
Applicant argues that Helgeson describes a delivery system that contain various essential oils (one may be from cinnamon) where the delivery system is made of polymers and surfactants that form the nanoparticles, and in contrast, the nanoparticles of claim 18 are formed in nature, isolated, and identified.
This is not persuasive because instant claims recite the transitional phrase “comprising” which is considered open language and allows the inclusion of additional components, such as other essential oils, polymers, and surfactants.
Therefore, the rejection of 09/23/25 is maintained.
Claim Rejections - 35 USC § 102
Claims 18-19 and 21-24 are again rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guen et al. (KR 2004 0046309 A – English Espacenet Translation - “Guen”).
Guen teaches nanoparticulated cinnamon extract (Abstract) and a composition containing a nanoparticle-formed cinnamon extract ([8]). The nanoparticles have a particle size distribution of 200 to 300 nm ([38], [48], Fig. 1).
Regarding instant claim 18, the limitation of the polyphenol extract from cinnamon bark in a form of nanoparticles is anticipated by the nanoparticulated cinnamon extract (Abstract), as taught by Guen.
Regarding instant claims 18 and 21-24, the limitations of the molecular weight, intrinsic viscosity, and antiviral activity are inherent properties of the nanoparticulated cinnamon extract taught by Guen. Please see MPEP 2112.01. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.). The burden is shifted to Applicant to show that the prior art product does not possess or render obvious the same properties as the instantly claimed product.
Regarding instant claim 19, the limitation of the nanoparticle size of 100-500 nanometers (nm) is anticipated by the nanoparticulated cinnamon extract having a particle size distribution of 200 to 300 nm ([38], [48], Fig. 1), as taught by Guen. According to MPEP 2131.03(I), a specific example in the prior art which is within a claimed range anticipates the range. In the present case, the range of 200 to 300 nm taught by Guen lies within the claimed range of 100-500 nm, thereby anticipating the claimed range.
Response to Arguments
Applicant’s arguments (Page 6, filed 01/22/26) with respect to the rejection of claims 18-19, 21-24, 27-28, 30-33, and 36 under 35 U.S.C. 102(a)(1) as being anticipated by Guen have been fully considered but are not persuasive.
In light of the cancellation of claims 27-28, 30-33, and 36, the rejection of these claims is moot.
Applicant reiterated the same arguments for Helgeson in this section relating to Guen. The anticipation rejection over Guen is maintained because this reference teaches nanoparticulated cinnamon extract (Abstract), a composition containing a nanoparticle-formed cinnamon extract ([8]), and nanoparticles having a particle size distribution of 200 to 300 nm ([38], [48], Fig. 1). The rejected claims are addressed in detail above.
Therefore, the rejection of 09/23/25 is maintained.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 20 is again rejected under 35 U.S.C. 103 as being unpatentable over Guen et al. (KR 2004 0046309 A – English Espacenet Translation - “Guen”), as applied to claims 18-19 and 21-24 above.
Instant claim 20 is drawn to the polyphenol extract according to claim 19, wherein the nanoparticle size is 100-170 nanometers.
The teaching of Guen is discussed above.
Although Guen teaches that the nanoparticles have a particle size distribution of 200 to 300 nm ([38], [48], Fig. 1), Guen does not expressly teach the nanoparticle size of 100-170 nm as recited in instant claim 20.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a nanoparticulated cinnamon extract having a particle size distribution of 200 to 300 nm, as taught by Guen, modify the nanoparticles based on the desired particle size, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the particle size is a result effective parameter that can be modified to produce a final product having the desired release, uniformity, and stability of the cinnamon extract. Guen teaches that the particle size is similar to intercellular lipid spacing, and can selectively promote absorption of physiologically active substances into the skin and oral mucosa, thereby increasing the bioavailability of active ingredients and enhancing the effect of preventing and treating oral diseases ([38]). The upper limit of the claimed range, i.e., 170 nm, is close to the lower limit of the range taught by Guen. According to MPEP 2144.05(I), “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).”
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 20, the limitations of the nanoparticle size of 100-170 nanometers would have been obvious over the particle size distribution of 200 to 300 nm ([38], [48], Fig. 1), as taught by Guen. Please see MPEP 2144.05(I).
Response to Arguments
Applicant’s arguments (Page 7, filed 01/22/26) with respect to the rejection of claims 20 and 29 under 35 U.S.C. 103 as being unpatentable over Guen have been fully considered but are not persuasive.
In light of the cancellation of claim 29, the rejection of this claim is moot.
Applicant argues that Guen does not disclose a nanoparticulated cinnamon extract, that it discloses nanoparticles containing a mixture of active ingredients, in which cinnamon extract is dissolved or dispersed but is not itself nanoparticles, nor a polyphenolic fraction. Applicant argues that Guen appears to describe nanoparticles that are artificially made using surfactants and work-up while in the subject matter of the claims, nanoparticles are not made but instead isolated natural nanoparticles that are 100% natural.
This is not persuasive because Guen teaches nanoparticulated cinnamon extract (Abstract), a composition containing a nanoparticle-formed cinnamon extract ([8]), and nanoparticles having a particle size distribution of 200 to 300 nm ([38], [48], Fig. 1). According to MPEP § 2123, “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” and “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure of preferred embodiments.” The polyphenols in the cinnamon extract are inherently present. This is corroborated by Applicant’s own admission that the nanoparticles of the claimed subject matter are 100% natural. Instant claims do not recite any specific polyphenol to distinguish over Guen.
Furthermore, instant claims recite the transitional phrase “comprising” which is considered open language and allows the inclusion of additional components, such as surfactants.
Therefore, the rejection of 09/23/25 is maintained.
Claim Rejections - 35 USC § 103
Claims 25-26 are again rejected under 35 U.S.C. 103 as being unpatentable over Guen et al. (KR 2004 0046309 A – English Espacenet Translation - “Guen”), as applied to claims 18-19 and 21-24 above, in view of Daugherty et al. (US 2006/0073220 A1 – “Daugherty”).
Instant claim 25 is drawn to the polyphenol extract according to claim 18, which is further formulated into lozenges, candy, foods such as ice cream and beverages.
The teaching of Guen is discussed above.
Guen does not expressly teach lozenges, candy, foods such as ice cream and beverages.
Daugherty teaches a cinnamon extract enriched for polyphenols (Abstract, claims 1, 14-19). Phenolic enriched compositions include plant extracts prepared from various parts of the plant, such as bark ([0099]), and may be formulated as pills, capsules, or liquids ([0138]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a nanoparticulated cinnamon extract having a particle size distribution of 200 to 300 nm, as taught by Guen, use the nanoparticulated cinnamon extract in formulations such as pills, capsules, or liquids, as taught by Daugherty, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because both references are drawn to compositions containing cinnamon extract, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A).
Regarding instant claims 25-26, the limitations of the lozenges and capsules would have been obvious over the compositions containing cinnamon extract (Abstract) formulated as pills (reads on lozenges), capsules, or liquids ([0138]), as taught by Daugherty.
Response to Arguments & 132 Declaration
Applicant’s arguments (Pages 7-9, filed 01/22/26) and the Declaration of Abraham J. Domb under 37 C.F.R. § 1.132 (filed 01/22/26 – “the Declaration” hereinafter) with respect to the rejection of claims 25-26 and 34-35 under 35 USC § 103 as being unpatentable over Guen in view of Daugherty have been fully considered but are not persuasive.
Applicant argues that Daugherty appears to relate to polyphenol enrichment, but never teaches producing nanoparticles composed solely of cinnamon polyphenols, nor achieving the specific molecular weight (<10 kDa) and intrinsic viscosity (0.1-1.0) recited in independent claim 18. Applicant argues that the present claims require a low-molecular-weight cinnamon polyphenol fraction (<10 kDa) with intrinsic viscosity 0.1-1.0, and these properties are non obvious to achieve and could not have been obtained from the teaching of the cited references.
This is not persuasive because instant claims recite the transitional phrase “comprising” which is considered open language and allows the inclusion of additional components, such as other polyphenols along with cinnamon polyphenols. The properties of low molecular weight and intrinsic viscosity are intrinsic or natural properties of the polyphenol extract, which is taught by the prior art. The reason Daugherty is combined with Guen is to cure the deficiency regarding lozenges, candy, or foods. The teachings of Guen and Daugherty are properly combined because both references are drawn to compositions containing cinnamon extract, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A).
Applicant argues that the specification demonstrates that these nanoparticles:
Form stable aqueous nano-dispersions with no sedimentation forming over time (Applicant refers to Examples 6 and 7 in the instant specification);
Possess defined rheology, including intrinsic viscosity 0.1-1.0 (Applicant refers to Example 10 in the instant specification);
Retain and demonstrate broad antiviral activity (Applicant refers to Examples 12 and 13 and the Declaration by inventor Abraham Domb); and
Are obtainable only when the cinnamon fraction is reduced to <10 kDa through the disclosed membrane process (Applicant refers to Examples 2, 4, and 11).
The Examples in the Specification and the Declaration (including Figures 1-5) have been fully considered but are not persuasive because the unexpected results are due to using the extract produced by the specific steps enumerated in the examples but are not recited in the instant claims. Since all the limitations currently recited in the instant claims are taught by the prior art, the same results would have been expected. For example, in point (4) Applicant states that the unexpected results are obtainable only when the cinnamon fraction is reduced to <10 kDa through the disclosed membrane process. The prior art which teaches the same indistinguishable cinnamon fraction would be expected to have the same results.
Applicant’s statements regarding the process steps appear to be for preparing the polyphenol extract nanoparticles, and these steps possibly giving patentable weight to the claims. However, no such steps are recited in the instant claims. Applicant has not compared the claimed invention with the closest prior art which shows that only by using the product-by-process steps can the results listed above be achieved.
As such, the evidence is not commensurate in scope with the claimed invention. Please see MPEP 2145. Furthermore, MPEP 716.02(d) states: “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.””
Therefore, the rejection of 09/23/25 is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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