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, filed 03/22/2022, is a 371 filing of PCT/IB2020/060572, filed 11/10/2020, which claims foreign priority to IN 201921046568, filed 11/15/2019. Receipt is acknowledged of certified copies of papers required by 37 CFR § 1.55.
Amendments and Claim Status
The amendment filed on 09/23/2025 is acknowledged and entered.
Claims 1, 7, 8, and 22 are amended;
Claims 13 and 14 are cancelled;
Claims 24 are added;
Claims 4, 5, 9-12, 15-21, and 23 remain withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species
Claims 1-12 and 15-24 are pending and are under prosecution.
Response to arguments
Applicant’s arguments filed 09/23/2025 with respect to the objections to the drawings and claims as well as the rejections under 35 U.S.C. § 101, and 103 have been fully considered.
With respect to the objection to the drawings the inclusion of replacement drawings is sufficient to overcome the objection.
With respect to the objection to claims 1-9, 11, 12, and 15-23 the inclusion of the status identifier to each claim is sufficient to overcome the objection.
With respect to the rejection of claims 1-3, 7, 8, and 22 under 35 U.S.C. § 101, the amendment of claim 7 to remove curcumin from the claim has rendered the objection directed to this claim moot. With respect to the remaining amendments directed to claims 1-3, 8, and 22, as well as new claim 24, the arguments made by Applicant have been fully considered but are not persuasive for the reasons set forth below.
Applicant argues that amended claim 1 is not directed to natural products because it recites nutrients, “such as lutein in an extract from the plant material selected for preparation of the composition, marigold flower,” where in the extract is obtained by saponification and thermal isomerization of marigold flower oleoresin and comprises about 60-85% lutein and 10-20% zeaxanthin isomers. Applicant contends that this processed marigold extract is not found in nature, and therefore claim 1 is not directed to a product of nature.
Applicant’s argument is found unpersuasive because, as set forth in MPEP § 2113, when a product is defined in terms of the process by which it is made, “patentability is based on the product itself. The patentability of the product does not depend on the method of its production.” The recitation that the marigold extract is obtained by “saponification and thermal isomerization” is therefore a product-by-process limitation that does not, by itself, confer patentability under 35 U.S.C. § 101. The 35 U.S.C. § 101 inquiry remains whether the final claimed composition comprising lutein, zeaxanthin, curcumin, and vitamin D3 and antioxidant is non-naturally occurring, and exhibits markedly different characteristics from its naturally occurring counterparts. Applicant has not identified any structural or functional characteristic of the final composition that differs from known, naturally occurring lutein, zeaxanthin, curcumin, and vitamin D3. That is, all of the components of the composition are known to occur in nature. Otherwise said, the “free-form” of lutein which results from the saponification of the extract is not a non-natural product—it exists in nature, as evidenced by the teachings of NutriScience (page 2, https://nutriscienceusa.com/insight/luteinestersfreelutein/, published December 30, 2021). In summary, the arguments focus only on how the naturally occurring extract is made, which is not determinative nor considered patentable under MPEP § 2113.
Applicant argues that the naturally occurring marigold flower oleoresin (MRO) does not contain free lutein, but only “lutein ester.” Relying on the specification, and the declaration by Padigaru, applicant states that saponification, “results in virtually complete conversion of the lutein asked to free ester,” such that free lutein is found only in the process extract, and not in the naturally occurring MRO starting material.
Applicant’s evidence shows only that within this particular plant oleoresin, lutein is initially present as an ester and is converted to free lutein by a routine hydrolysis (saponification) step. However, under the product-of-nature framework, (MPEP § 2106.04 (c)), the relevant “naturally occurring counterpart” is naturally occurring lutein itself, not just a specific chemical form of lutein in a single starting material. Free lutein is a well-known, naturally occurring carotenoid present in many plants and foods. Applicant has not provided evidence that the free lutein obtained after saponification is structurally or functionally different from naturally occurring free lutein. Thus, the process of hydrolyzing a naturally occurring lutein estimates are to yield the known “free lutein” does not create a nonnatural product; it is analogous to isolation or purification that does not, without more, confer patentability.
Applicant further argues that zeaxanthin is not present in the naturally occurring MRO prior to saponification, and that chromatographic analysis shows zeaxanthin peaks only in the process extract. Applicant therefore contends that the claimed composition includes components “that do not naturally occur in there only produced after processing MRO.”
Applicant’s arguments are found unpersuasive because the argument focuses on the contents of a particular starting oleoresin rather than whether or not the claimed molecules are themselves natural products. Zeaxanthin, like lutein is a naturally occurring xanthophyll. Applicant has not provided evidence that is the zeaxanthin in the process extract has a structure or function distinct from naturally occurring zeaxanthin and found in other natural sources. Under MPEP § 2113, the fact that the process step (saponification) is needed to generate the zeaxanthin and from the specific starting material does not change that the end product is a naturally-occurring carotenoid, as evidenced by NutriScience (page 2). Thus, the presence of zeaxanthin in the final composition which results through the process of saponification does not remove the claim from the product of nature exception under 35 U.S.C. § 101.
Finally, applicant concludes that, “the composition of claim 1 is not simply a combination of naturally occurring products,” and that it “includes components that do not occur naturally and are only produced after processing MRO.”
As explained above, the claimed composition remains a combination of natural products— lutein, zeaxanthin, curcumin, vitamin D3, and an antioxidant— each of which is a nature-based product, and applicant has not demonstrated that any of these individual components, or their combination, possess markedly different structural or functional characteristic relative to their natural counterparts, or the combination thereof. Under the Step 2A analysis, the claim therefore remains directed to a product-of-nature exception; and because the additional elements merely reflect the conventional combination of natural ingredients in a composition, they do not integrate the exception into a practical application, or add an “inventive concept.”
Accordingly, the rejection of claims 1-3, 8, and 22 under 35 U.S.C. § 101 is maintained and is included hereinafter.
With respect to the rejection of claims 1-3, 6-8, and 22 under 35 U.S.C. § 103 as being unpatentable over OMNIACTIVE HEALTH TECHNOLOGIES LIMITED (IN201721006792, December 7 2018, included in IDS filed 03/22/2022) hereinafter OHTL, and further in view of and Lee et al. (Neurobiology of Aging Volume 33, Issue 10, pages 2382-2389), hereinafter Lee, the claim amendments made by Applicant have necessitated the inclusion of a new reference. The arguments made by applicant are herein addressed as follows.
Applicant argues that OHTL merely provides a long list of possible lipophilic nutrients (vitamins, carotenoids, tocopherols, fatty acids, etc” and that out of this list OHTL “is silent as to using the specific combination of lutein, zeaxanthin, and curcumin.
Applicant’s argument is found unpersuasive because, according to MPEP § 2143 I (A), a rationale that supports the conclusion of obviousness includes, “combining prior art elements according to known methods to yield predictable results.” That is, the mere fact that the elements are taught within the prior art within the context of the shared common and predictable result of treating eye diseases supports their combination in a conclusion of obviousness. Furthermore, the inclusion of the new reference Deshpande and Jeyakodi (WO 2015145389 A2, published October 1, 2015) now provides the primary teaching of a composition comprising lutein, zeaxanthin, and curcumin (claim 13), as well as the new limitation of the isolation of the xanthophyll components from saponified marigold flower oleoresin (page 24, lines 7-9). OHTL is now relied upon as a secondary reference to provide teachings regarding particle dispersion size reductions, and typical antioxidant excipients, as well as the inclusion of vitamin D. To the extent that applicant’s argument is directed to OHTL alone, it is not sufficient to overcome the rejection included hereinafter directed to the instant claims.
Applicant argues that OHTL teaches lutein and zeaxanthin provided as “a concentrate manufactured from purified crystals consisting of lutein and zeaxanthin obtained from extract of dried flowers of Marigold,” with a concentrate comprising 20% lutein and 4% zeaxanthin isomers. Applicant contrasts this with amended claims 1 and 22, which recite and extract of saponified marigold flower oleoresin comprising 60-85% free lutein, and 10-20% zeaxanthin isomers.
The amendments to the instant claims have necessitated the inclusion of a new reference wherein the teachings by Deshpande and Jeyakodi wherein the instantly claimed percentages of xanthophylls overlap with the ranges of the instant claims. The disclosure teaches a composition wherein composition comprises 80-95% w/w lutein; (R,R)-zeaxanthin at 14-20% w/w and (R,S)-zeaxanthin at 0.01-1% (claim 13). Furthermore, as noted the xanthophylls are isolated from saponified marigold flower oleoresin (page 24, lines 7-9). As such, the teachings of the new reference encompass that of the instant claims. It is well-established that claimed ranges which overlap with those taught by the prior art are rendered prima facie obvious, absent evidence of criticality or unexpected results. Thus, even if the ranges taught by OHTL differ numerically from those instantly claimed, applicant has not provided evidence that the claimed ranges are critical or yield unexpected properties, relative to the overlapping ranges taught by OHTL or those taught by Deshpande and Jeyakodi.
Applicant asserts that Lee “fails to remedy the shortcomings of PHTL” because Lee is silent as to using a combination of lutein, zeaxanthin, and curcumin in a composition, and is also silent to using saponified marigold oleoresin for the claimed percentages of the xanthophyll extracts.
Applicant’s argument is deemed unpersuasive, for the reasons set forth above. The newly included rejection now shows that Deshpande and Jeyakodi teach the saponified marigold oleoresin extract, and combination with curcumin, while OHTL provides teachings on particle sizes, and Lee provides the motivation or teaching to include vitamin D3.
Applicant argues that neither OHTL nor Lee teach suggested compositions wherein the “extract is present in the composition by an amount 2% - 10% by weight, the curcumin is present in the composition in an amount 20% - 50% by weight, and the vitamin D3 is present in the composition by an amount 0.01% - 2% by weight.”
Applicant’s argument is deemed unpersuasive because the newly added claim limitations are sufficiently addressed by the inclusion of the new reference Deshpande and Jeyakodi, whose ranges encompass and overlap the relative proportions of extract and curcumin recited in claim 24 when formulated a practical dosage levels. Likewise, Lee teaches effective amounts of vitamin D for improving visual function in humans, and OHTL teaches typical antioxidant and excipient loadings and oil dispersion compositions.
Selecting particular sub ranges within overlapping prior art ranges has been held to be prima facie obvious in the absence of criticality or unexpected results. Applicant has not provided evidence that the specific ranges recited achieve any unexpected or critical effect relative to the ranges and teachings of OHTL or Lee. Rather, the claimed ranges represent a routine optimization of nor formulation parameters to provide a workable dosage form for eye health applications. Accordingly, claims 24 is deemed unpatentable for the reasons set forth hereinafter.
For the reasons discussed above, applicant’s amendments and arguments do not overcome the rejection of the instant claims, now based on the teachings of Deshpande and Jeyakodi in view of OHTL and Lee. Deshpande and Jeyakodi teach treatment of eye disease with compositions comprising saponified marigold oleoresin, liberation of free lutein and zeaxanthin by saponification and isomerization of lutein to zeaxanthin, carotenoids compositions having overlapping ranges of lutein and zeaxanthin within those claimed, and inclusion of curcumin and antioxidant excipients. OHTL teaches formulations of lipophilic nutrients into oil dispersions with reduced particle size in the claimed micron range, and Lee teaches the use and benefit of vitamin D3 and improving visual function retinal health. The combined teachings render a prima facie obvious to arrive at the presently claimed compositions, including the extract characteristics, curcumin, vitamin D3, antioxidants, oil suspension dosage form, and particle size limitations as instantly claimed.
Thus, the references meet all the claim limitations, and the rejection is not overcome by amendment. Therefore, the obviousness of the claimed invention by the references herein stands. Accordingly, the rejection of claims 1-3, 6-8, and 22 under 35 U.S.C. § 103 is hereby maintained.
With respect to the rejection of claims 1-3, 6-8, and 22 under 35 U.S.C. § 103 as being unpatentable over Lang (WO 2011057183 A1, published May 12, 2011), in view of Massimino et al. (Industrial Crops and Products, Volume 109, pages 493-497, published September 11, 2017), hereinafter Massimino; Baganu et al. (Oxidative Medicine and Cellular Longevity Volume 2019, published February 12, 2019), hereinafter Baganu; Roberts and Dennison (J ophthalmology, Volume 2015, published December 20, 2015); and Lee et al. (Neurobiology of Aging Volume 33, Issue 10, pages 2382-2389), hereinafter Lee.
Applicant has amended the claim to include percentages of xanthophylls lying outside of the ranges taught by Lang, thereby removing the disclosure from consideration as a prior art rejection. Furthermore, the amendment of claim 7 to remove curcumin has removed the disclosure by Massimino from consideration as a prior art rejection. However, the teachings of Deshpande and Jeyakodi as set forth above, as well as in the rejection below meets all the of the instant claims limitations, and the rejection not overcome by amendment.
Furthermore, no additional data has been provided or discussed by Applicant to demonstrate any unexpected results. According to MPEP §716.02 (b) (I)
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c)
Thus, the burden is on the applicant to demonstrate that any asserted unexpected results are both significant and unexpected, and that they are directly attributable to the claimed invention. Importantly, the applicant must provide a comparison with the closest prior art. Mere attorney argument or conclusory statements without adequate supporting evidence or insufficient to rebut a prima facie case of obviousness.
Thus, all arguments presented by Applicants have been addressed and are found unpersuasive for the reasons presented herein and in the previous non-final rejection. Applicants are reminded that “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 8, 22, and 24 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to natural products, without significantly more.
Natural products that are excluded from eligibility include naturally occurring products and non-naturally occurring products that are not markedly different from naturally occurring products. To be patent eligible, a claimed product must be both non-naturally occurring and markedly different from naturally occurring products. The cited claims of the instant application fail to satisfy the non-naturally occurring requirement because the no structural difference occurs by the mere isolation or purification of lutein and zeaxanthin to form a combination product. Even though the claims require the combination of lutein, zeaxanthin, curcumin and vitamin D3, as well as the isolation of free lutein from zeaxanthin from an extract of saponified marigold flower oleoresin, the claims fail to satisfy the non-naturally occurring requirement because all the claimed components exist in nature, and no structural difference occurs by merely combining the naturally-occurring components in a composition as claimed. Combining the components does not change the structure of any of the components and thus the product as claimed is neither non-naturally occurring nor markedly different in structure. That is, both free lutein and zeaxanthin occur in nature, as evidenced by NutriScience (page 2).
According to MPEP §2106 I-III, a determination of subject matter eligibility is herein made, including a rejection based on the subject matter eligibility test flowchart in MPEP § 2106.03 and 2106.04.
Step 1: Claims 1-3, 8, 22, and 24 recite a combination composition comprising an extract comprising lutein and zeaxanthin, curcumin, vitamin D3, and an antioxidant such as ascorbic acid, all of which are natural products. Thus, the claims fall into a statutory category of invention under 35 U.S.C. § 101, i.e., composition of matter.
Step 2A1: Claims 1-3, 8, 22, and 24 require a combination of lutein, zeaxanthin, curcumin, vitamin D3, and an antioxidant such as ascorbic acid. These components are natural products. Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied (see MPEP § 2106.04(c)(I)(A)). Because the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state, the first step in the analysis is to select the appropriate counterpart(s) to the nature-based product. Markedly different characteristics can be expressed in terms of structure, function, and/or other properties, and are evaluated on what is recited in the claim. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception (see MPEP § 2106.04(c)(II)). When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. The recitation that the marigold extract is obtained by “saponified marigold flower oleoresin” is therefore a product-by-process limitation that does not, by itself, confer patentability under 35 U.S.C. § 101. The 35 U.S.C. § 101 inquiry remains whether the final claimed composition comprising lutein, zeaxanthin, curcumin, and vitamin D3 and antioxidant is non-naturally occurring, and exhibits markedly different characteristics from its naturally occurring counterparts.
In this case, the combination of the of lutein, zeaxanthin, curcumin, vitamin D3, and an antioxidant such as ascorbic acid do not have a natural counterpart. When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. In this case, the counterparts would be the of lutein, zeaxanthin, curcumin, vitamin D3, and ascorbic acid found in nature. Because the markedly different characteristics analysis is based on comparing the characteristics of the claimed nature-based product and its counterpart, the second step in the analysis is to identify appropriate characteristics to compare (see MPEP § 2106.04(c)(I)(B)). The appropriate characteristics of the extract to be compared are the structure and chemical constituency of the extract.
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart (see Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75). Thus, in order to be markedly different, the applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart (see MPEP § 2106.04(c)(II)(C)). In this case, there is no evidence to suggest that the combination of the extract comprising lutein and zeaxanthin, curcumin, vitamin D3 and an antioxidant such as ascorbic acid, which are expected to retain their individual structure or chemical constituency upon combining, would have different characteristics leading to a markedly different product. Because there is no change in any characteristic, the claimed natural product lacks markedly different characteristics and represents a product of nature exception. It is noted that claim 8 is included in this analysis, since the claimed formulation’s form as an oil suspension is essentially the natural state of lutein and zeaxanthin, curcumin, vitamin D3, and ascorbic acid.
Claims 2 and 3 require the same combination of lutein and zeaxanthin, curcumin, vitamin D3 as claims 1, 22, and 24, but require an antioxidant such as ascorbic acid. Again, there is no natural counterpart to the combination of components, and the closest counterparts are the individual nature-based components of the combination. The appropriate characteristics of the instantly claimed combination to be compared are the chemicals making up the combination. In this case, the structural nature of the claimed plant based compounds is identical, whether found in the plant or the claimed combination resulting from the saponification of marigold flower oleoresin to obtain the components, and there is no evidence of any markedly different characteristic.
Claim 8 is drawn to a form of the composition elected to be an oil suspension, which is the natural state of lutein, zeaxanthin, and vitamin D. The combination of curcumin and ascorbic acid with the aforementioned components would naturally result in an oil suspension form.
Applicant has not identified any structural or functional characteristic of the final composition that differs from known, naturally occurring lutein, zeaxanthin, curcumin, and vitamin D3. Accordingly, claims 1-3, 8, and 22 are drawn to judicial exceptions.
Step 2A2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.
The elements in claims 1, 22, and 24 lie in the combination of natural products. However, these are product claims, and this combination does not impose or result in any application of the judicial exception natural products and does not, therefore, integrate the judicial exceptions into a practical application. Contrast product claims to, for example, a method of therapeutic treatment using the claimed combination, which would not be subject to this rejection under 35 U.S.C. § 101.
The additional elements of claim 2 and 3 lie in the combination, as well as the inclusion of an antioxidant, such as ascorbic acid, which itself is a natural product. The combination with the additional component does not, therefore, integrate the judicial exceptions into a practical application.
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim.
The additional elements in claims 2 and 3 lie in the combination of natural products. However, combining the natural products is not an inventive concept and represents well-understood, routine, and conventional practice in plant extracts and phytopharmacology.
Accordingly, the additional elements in claims 2 and 3 do not amount to something more than the judicial exceptions claimed and do not transform the claims into patent eligible subject matter.
This rejection is based on the recent court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013) (Myriad) on the Supreme Court' s long-standing “rule against patents on naturally occurring things”, as expressed in its earlier precedent including Diamond v. Chakrabarty, 447 U.S. 303 (1980) (Chakrabarty), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (Mayo). Myriad relied on Chakrabarty as “central” to the eligibility inquiry, and re-affirmed the Office' s reliance on Chakrabarty' s criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products). Id. at 2116-17. Myriad also clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman' s art”). Thus, while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.
Thus, since the claimed products are not markedly different from what exists in nature, the claims are patent ineligible under 35 U.S.C. § 101 and thus are properly rejected.
Claim Rejections – 35 U.S.C. § 103
The text of those sections of title 35, U.S. Code not included in this action can be found in the prior Office action.
Claims 1-3, 6-8, 22, and 24 are rejected under 35 U.S.C. § 103 as being unpatentable over Deshpande and Jeyakodi (WO 2015145389 A2, published October 1, 2015), in view of OMNIACTIVE HEALTH TECHNOLOGIES LIMITED (IN201721006792, December 7 2018, included in IDS filed 03/22/2022) hereinafter OHTL, and further in view of and Lee et al. (Neurobiology of Aging Volume 33, Issue 10, pages 2382-2389), hereinafter Lee.
The amended claims are drawn to a composition comprising a) an extract of saponified marigold flower oleoresin comprising 60- 85% lutein and 10-20% zeaxanthin, b) curcumin, c) vitamin D3, and d) at least one excipient, elected in the reply filed on 05/12/2025 by Applicant to be an antioxidant. The claims are further drawn to specific particle sizes for both the extract, and curcumin. Finally, the claims are drawn to a form of the composition, elected by applicant in the reply filed 05/12/2025 to be an oil suspension.
Deshpande and Jeyakodi teach the administration of a composition comprising lipophilic nutrients derived from plant extract/oleoresin containing xanthophylls/xanthophylls ester aimed at treating eye diseases (Abstract), including dry eye disease (page 9, line 9). The disclosure further teaches that the preferred source of xanthophylls oleoresin is marigold (page 23, lines 4-11). It is taught that marigold flower is considered to be the best possible commercial source for trans-lutein as it contains lutein mono -and diesters as the major carotenoid constituents (page 24, lines 19 and 20) The disclosure teaches the saponification of an extract/oleoresin resulting in the liberation of xanthophylls in free form, in which an isomerization reaction converts part of the lutein from marigold into (R,S)-zeaxanthin (page 24, lines 7-9). The composition taught by Deshpande and Jeyakodi contains trans-lutein at 80-95% w/w; (R,R)-zeaxanthin at 14-20% w/w; and (R,S)-zeaxanthin at 0.01-1% w/w, in addition to curcumin at 5-95% (claim 13), as well as a range of excipients (claims 12 and 15). The disclosure further teaches a range of antioxidant excipients such as ascorbic acid, ascorbyl palmitate, rosemary extract, mixed natural tocopherols, alpha tocopheryl acetate, and sodium ascorbate (page 19, lines 1-4) (see instant claims 1-3, 22, and 24). Deshpande and Jeyakodi further teach that the bioavailability of lipophilic nutrients is limited view to the limited solubility in the gastrointestinal tract. The solubility of the components as well as the composition is enhanced by reducing the particle size, which will in turn enhance the efficacy of micellization (page 5, lines 22-31, see instant claims 6 and 7). The disclosure further teaches wherein which the composition is in the form of an oil suspension (page 11, line 18, see instant claim 8).
Deshpande and Jeyakodi fail to teach vitamin D3 within their composition (see instant claim 1). Furthermore, Deshpande and Jeyakodi failed to teach the specific particle size for both the extract, as well as the composition (see instant claims 6 and 7).
The deficiencies of Deshpande and Jeyakodi are remedied by the disclosure of OHTL, which teaches oil dispersion compositions for oral administration comprising lipophilic nutrient, oil vehicle and at least one pharmaceutically or nutraceutically acceptable excipient for eye health benefit (page 2). OHTL teaches suitable lipophilic nutrients include vitamins such as vitamin D, carotenoids such as lutein and zeaxanthin, curcumin, and combinations thereof (pages 9-10). OHTL teaches that the lipophilic nutrient used in the oil dispersion of the present invention is reduced to a desirable particle size by the process of milling wherein the desired particle size range of micronized lipophilic nutrient before adding in the oil vehicle is 1- 10 microns and the desired particle size of the lipophilic nutrient in oil dispersion composition is in the range 0.1 nanometer to 10 microns, preferably 0.5 nanometer to 5 microns and most preferably 0.1 nanometer to 4 microns (page 10). OHTL further teaches that the composition can further contain excipients such as antioxidants, wherein the antioxidant used in the oil dispersion of the present invention is selected from but not limited to the commonly used antioxidants such as a-Tocopherol, b-Tocopherol, g-Tocopherol, mix Tocopherol, synthetic d,l a-Tocopherol, citric acid, Rosemary extract, ascorbyl palmitate, sodium ascorbate or the like and the combinations thereof, in the range of 1 to 5% preferably 2 to 4% by weight of the oil dispersion (page 12). OHTL specifically teaches the use of lipophilic nutrients including lutein, zeaxanthin, curcumin and combinations thereof (pages 15-16). Example 1 specifically discloses an oil dispersion composition comprising lutein and zeaxanthin wherein the lutein and zeaxanthin was obtained from an extract of dried flowers of marigold (Tagetes erecta) and was micronized to achieve particle size below 10 micron (page 17). Example 3 specifically discloses an oil dispersion composition comprising micronized curcumin (pages 18-19). Claims 1-3 of OHTL claim a composition that can be used for eye health benefits comprising among other lipophilic nutrients lutein, zeaxanthin, curcumin, vitamin D and mixtures thereof. Claim 6 of OHTL claims the composition further comprising at least one excipient such as antioxidants. Tocopherols, rosemary extract, ascorbyl palmitate and Sodium ascorbate are claimed as specific antioxidants, wherein sodium ascorbate is the conjugate base of ascorbic acid (claim 9). Acidic conditions, such as those found in the human stomach, would produce ascorbic acid through a simple acid-base reaction.
With respect to the particle size of the extract as claimed (see instant claims 6 and 7), which ranges from 0.1 to 10 micron, OHTL specifically teaches that the lipophilic nutrient used in the oil dispersion of the present invention is reduced to a desirable particle size by the process of milling wherein the desired particle size range of micronized lipophilic nutrient before adding in the oil vehicle is 1- 10 micron and the desired particle size of the lipophilic nutrient in oil dispersion composition is in the range 0.1 nanometer to 10 microns, preferably 0.5 nanometer to 5 microns and most preferably 0.1 nanometer to 4 microns (page 10). Moreover, example 3 of OHTL specifically exemplifies an oil dispersion composition that has been micronized (page 19). Thus, OHTL specifically teaches that the lipophilic nutrient, has a particle size which overlaps with the particle size as claimed.
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art following the teachings of Deshpande and Jeyakodi in creating a composition for use of eye diseases, to reduce the particle sizes of the extract and composition following the teachings of OHTL in order to improve the absorption of the composition in the intestinal tract, specifically motivated by the teachings of Deshpande and Jeyakodi (page 5, lines 22-31).
Neither Deshpande and Jeyakodi nor OHTL, specifically teach vitamin D3 as the specific form of vitamin D as instantly claimed, nor do they teach a specific percentage of vitamin D3 (as recited in instant claim 24). Furthermore, neither Deshpande and Jeyakodi nor OHTL specifically teach combining an extract comprising lutein and zeaxanthin, curcumin, vitamin D3, and an antioxidant as claimed.
The deficiencies of Deshpande and Jeyakodi as well as OHTL are remedied by Lee, who teaches vitamin D3, and its vital role in immune regulation and improving visual function (Title). The disclosure by Lee demonstrates a market reduction in inflammation in the retina and improved retinal function with the use of vitamin D3 (page 2387).
Accordingly, prior to the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to use vitamin D3 as the specific form of vitamin D for use in the formulation of Deshpande and Jeyakodi and OHTL since Lee teaches that vitamin D3 is known in the art for improving visual function. Since both Deshpande and Jeyakodi and OHTL teach similar compositions that can be used for eye health benefits, one would have been motivated to add vitamin D3 as the specific form of vitamin D since vitamin D3 is specifically known for improving visual function. Thus the use of vitamin D3 as the specific form of vitamin D in the formulation of Deshpande and Jeyakodi as well as OHTL is rendered obvious.
Although neither Deshpande and Jeyakodi, nor OHTL, nor Lee specifically teach combining an extract comprising lutein and zeaxanthin, curcumin, vitamin D3, and an antioxidant as claimed, both Deshpande and Jeyakodi and OHTL teach that the claimed components and combinations thereof can be formulated into a composition for eye health benefits. Moreover, the prior art teaches that all components of the composition are used for the common purpose of improving visual function. According to MPEP § 2144.06 (I), combining equivalents known for the same purpose is rendered obvious. The courts have said,
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.).
Accordingly, prior to the effective filing date of claimed invention, it would have been obvious to a person of ordinary skill in the art to combine an extract comprising lutein and zeaxanthin with curcumin, vitamin D3 and antioxidants based on the teachings of Deshpande and Jeyakodi, OHTL and Lee, for the common purpose of improving visual function. According to the prior art cited, all components are very well known in the art for treating dry eye disease, as well as eye diseases related to aging and improving visual function. Therefore, the combination of said components as claimed is found to be prima facie obvious.
Furthermore, with respect to the specific percentages of each component as recited in the instant claims (see instant claims 1, 22, and 24), as well as specific sizes of the particles (see instant claims 6 and 7), the teachings of Deshpande and Jeyakodi and OHTL recite components and particle sizes whose ranges within the taught compositions overlap with those of the instant claims. The courts have determined that ranges which overlap are considered to be prima facie obvious. It is noted that the courts have stated,
where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP § 2144.05.01).
Furthermore, although neither Deshpande and Jeyakodi, OHTL, nor Lee teach a specific percentage by weight of vitamin D3, the courts have also found that,
“where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP § 2144.05 II).
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art. Applicant is advised that MPEP § 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel's arguments in place of evidence in the record. Accordingly, the cited claims of the instant application stand rejected.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new grounds 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 nonprovisional extension fee (37 CFR § 1.17(a)) 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call +1 (800) 786-9199 (IN USA OR CANADA) or +1 (571) 272-1000.
/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
Prosecution Insights