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 .
Examiner of Record
The examiner of record is now Christopher Babic.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1 and 8, in the reply filed on 6/11/2026 is acknowledged. Claims 2-7 and 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1 and 8 are currently under examination.
Claim Rejections - 35 USC § 112 – Indefiniteness
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.
Claims 1 and 8 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 and 8 recite a “highly active and highly safe” refined rubber seed oil. The terms “highly active” and “highly safe” are relative terms that do not provide clear boundaries for the claimed subject matter. See MPEP § 2173.05(b).
The claims do not recite an objective standard, test method, numerical threshold, comparison point, or measurable property for determining when a refined rubber seed oil is “highly active” or “highly safe.” For example, the claims do not specify a required level of biological activity, atherosclerotic plaque inhibition or reduction, dosage-response result, toxicity level, impurity level, acid value, compliance with any safety standard, or other measurable criterion.
Although the specification describes testing under the GB 2716-2018 food safety standardand reports biological activity in animal models, Claims 1 and 8 do not incorporate those standards, assays, or thresholds. Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed “highly active and highly safe” refined rubber seed oil.
Accordingly, Claims 1 and 8 are indefinite under 35 U.S.C. § 112(b).
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 1 and 8 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception, i.e., a nature-based product/product of nature, without reciting markedly different characteristics or additional elements sufficient to amount to significantly more than the judicial exception.
Under MPEP § 2106, Step 1, Claims 1 and 8 nominally fall within a statutory category. Claim 1 recites a refined rubber seed oil, and Claim 8 recites a pharmaceutical composition comprising the refined rubber seed oil of Claim 1 and a pharmaceutically acceptable carrier.
Under MPEP § 2106, Step 2A, Claims 1 and 8 appear to be directed to a nature-based product. The specification indicates that rubber seed oil is obtained from rubber seeds and states that the rubber seed oil used in prior medical studies “should be the crude oil of rubber seeds in food science, that is, the crude extract of lipid-soluble components of rubber seeds in Plant chemistry” (see Spec [0006]). The specification further states that “rubber seed crude oil has significant medicinal activity of reversing and ablating atherosclerosis,” but contains harmful or toxic ingredients (see Spec [0007]). Thus, the claimed refined rubber seed oil appears to be derived from naturally occurring rubber seeds and therefore implicates the nature-based product analysis (see Spec [0006]–[0007]).
Pursuant to MPEP § 2106.04(b), a nature-based product is patent eligible only if the claimed product has markedly different characteristics from its naturally occurring counterpart. Claim 1 does not recite any objective structural, compositional, chemical, impurity-level, safety-threshold, or biological-activity limitation requiring the claimed refined rubber seed oil to be markedly different from naturally occurring rubber seed oil or rubber seed crude oil (see Spec [0006]–[0007], [0032]–[0037]). Claim 1 does not require a fatty acid profile, triglyceride profile, acid value, cyanogenic glycoside content, resin/rubber content, purity threshold, pesticide level, heavy-metal level, plaque-reduction threshold, or any particular assay result (see Spec [0032]–[0037]).
Although the specification alleges that the refined oil of the invention meets edible-oil safety requirements and has biological activity that can reach or exceed crude oil, those characteristics are not recited in Claim 1 with objective boundaries (see Spec [0028], [0042], [0055]–[0059], [0094], [0107], [0127]). The claim language “highly active and highly safe” is relative and does not define a measurable markedly different characteristic (see Spec [0028], [0032], [0042]).
The product-by-process recitation in Claim 1—preparation from rubber seed crude oil through alkali neutralization, centrifugal separation, adsorption filtration, and deodorization—does not itself establish that the claimed product has markedly different characteristics (see Spec [0032]–[0037]). The specification identifies those steps as the preparation method for the alleged substance, but Claim 1 does not require any resulting structural or compositional characteristic that distinguishes the oil from its naturally occurring counterpart (see Spec [0032]–[0037], [0054]–[0059]).
Claim 8 does not cure the deficiency. Claim 8 recites a pharmaceutical composition comprising a therapeutically effective amount of the refined rubber seed oil of Claim 1 and a pharmaceutically acceptable carrier (see Spec [0038]). The specification discloses conventional pharmaceutical dosage forms and excipients, including tablets, soft capsules, injection emulsions, starch, corn syrup, magnesium stearate, gelatin, glycerol, lecithin, sodium chloride, and water (see Spec [0131]–[0158]). Claim 8 does not recite any particular carrier, formulation structure, interaction, or new functional relationship that imparts markedly different characteristics to the rubber seed oil or to the claimed composition as a whole (see Spec [0038], [0131]–[0158]).
Under MPEP § 2106, Step 2B, the additional elements do not amount to significantly more than the judicial exception. In Claim 1, the refining-process descriptors are generic oil-processing steps applied to a naturally derived plant oil (see Spec [0032]–[0037]). In Claim 8, the pharmaceutically acceptable carrier is recited generically and performs its ordinary carrier function (see Spec [0038], [0131]–[0158]). The claimed subject matter therefore does not transform the nature-based product into patent-eligible subject matter (see Spec [0006]–[0007], [0032]–[0038], [0131]–[0158]).
Accordingly, Claims 1 and 8 appear to be directed to a nature-based rubber seed oil product, or a pharmaceutical composition comprising that product with a generic carrier, without reciting markedly different characteristics or additional elements sufficient to amount to significantly more than the judicial exception (see Spec [0006]–[0007], [0032]–[0038], [0131]–[0158]). Therefore, Claims 1 and 8 are not patent eligible under 35 U.S.C. § 101.
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.
Claim 1 is rejected under 35 U.S.C. § 102(a)(1) as anticipated by CN 104130856 A (published Nov. 5, 2014 – translation provided).
Claim 1 is directed to a refined rubber seed oil prepared from rubber seed crude oil through alkali neutralization, centrifugal separation, adsorption filtration, and deodorization.
Wang et al. discloses a grease-processing method for retaining nutrient components in oils (see [0001] – all citations reference the translation). Wang et al. teaches that the grease may be a vegetable oil and expressly lists rubber seed oil among suitable oils (see [0027], [0060]). Wang et al. further teaches that the grease to be deacidified may be crude oil that has not undergone chemical refining (see [0072]).
Wang et al. discloses alkali neutralization because it teaches that free fatty acids in oil react with alkali in an acid-base neutralization reaction to form soapstock, which is then removed to deacidify the oil (see [0002]–[0005]). Wang et al. further discloses that deacidification may be alkali-refining deacidification and that the alkali may be sodium hydroxide, potassium hydroxide, or calcium hydroxide (see [0024], [0032], [0081]–[0082]).
Wang et al. discloses centrifugal separation because it teaches that, after crude oil is mixed with alkali liquid and enters a neutralization tank, the generated soapstock is removed by centrifuge (see [0003]). Wang et al. also teaches separating oil and soapstock by centrifugation after neutralization-tank treatment (see [0139]–[0140], [0162], [0245]).
Wang et al. discloses adsorption filtration because it teaches decoloring by adsorption bleaching and also teaches conventional filtration for removing impurities (see [0066], [0069]). Wang et al. further discloses decoloring using carclazyte/clay in an amount of 0.5–5%, which is an adsorbent used in oil decoloring (see [0152]–[0153], [0187]).
Wang et al. discloses deodorization because it teaches that after deacidification the oil may undergo conventional post-processing steps including deodorizing and decoloring (see [0148]–[0150]). Wang et al. further provides deodorizing conditions including elevated temperature, vacuum, and steam treatment (see [0152], [0154], [0188]).
Thus, Wang et al. discloses treating crude vegetable oils, including rubber seed oil, by alkali-refining deacidification, centrifugal separation, adsorption/decoloring filtration, and deodorization, thereby disclosing the refined rubber seed oil of Claim 1.
Claim 1 is in product-by-process form. Under MPEP § 2113, patentability of a product-by-process claim is based on the product itself, not on the process by which it is made. See In re Thorpe, 777 F.2d 695, 697, 227 USPQ 964, 966 (Fed. Cir. 1985). Claim 1 does not recite any objective structural, compositional, impurity-level, safety-threshold, or pharmacological-activity limitation that distinguishes the claimed refined rubber seed oil from the refined rubber seed oil disclosed by Wang et al.
Further, where the claimed and prior-art products appear to be the same or substantially the same, or are produced by the same or substantially similar processes, the burden shifts to Applicant to show that the prior-art product does not necessarily or inherently possess the characteristics of the claimed product. See MPEP § 2112.01; In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433–34 (CCPA 1977). Here, Wang et al. discloses rubber seed oil as a suitable oil and discloses substantially the same oil-refining operations recited in Claim 1, including alkali neutralization, centrifugal separation, adsorption/decoloring treatment, and deodorization (see [0027], [0031]–[0032], [0060], [0069], [0072], [0139]–[0140], [0148]–[0154], [0162], [0187]–[0188], [0245]). Therefore, absent evidence to the contrary, the refined rubber seed oil disclosed or necessarily produced by Wang et al. is presumed to possess the same inherent properties as the claimed refined rubber seed oil.
Accordingly, Wang et al. discloses each limitation of Claim 1, expressly or inherently, and Claim 1 is anticipated under 35 U.S.C. § 102(a)(1).
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, 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.
Claim 1 is rejected under 35 U.S.C. § 103 as being unpatentable over Wang et al. (CN 104130856 A, published November 5, 2014).
To the extent Wang et al. is not considered to expressly anticipate Claim 1 because rubber seed oil is selected from a disclosed list of vegetable oils, Claim 1 would nevertheless have been obvious over Wang et al.
Wang et al. discloses a grease-processing method for retaining nutrient components in oils (see [0001] – all citations reference the translation). Wang et al. teaches that suitable greases include vegetable oils and expressly identifies rubber seed oil as one such oil (see [0027], [0060]). Wang et al. also teaches that the grease to be deacidified may be crude oil that has not undergone chemical refining (see [0072]).
Wang et al. teaches oil-refining operations including alkali-refining deacidification, centrifugal separation of soapstock, decoloring by adsorption bleaching, filtration, and deodorization (see [0002]–[0005], [0024], [0031]–[0032], [0066], [0069], [0139]–[0140], [0148]–[0154], [0162], [0187]–[0188], [0245]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to apply the disclosed oil-refining process of Wang et al. to rubber seed oil, because Wang et al. expressly identifies rubber seed oil as a suitable vegetable oil for the disclosed process (see [0027], [0060]). The motivation would have been to deacidify the oil, remove free fatty acids, remove soapstock, reduce impurity content, improve oil quality, retain beneficial components, and obtain a refined oil product (see [0011]–[0012], [0034]–[0039], [0050], [0078]–[0080], [0136]–[0142], [0172]–[0177]).
Applying alkali neutralization, centrifugal separation, adsorption/decoloring filtration, and deodorization to rubber seed oil would have been the predictable use of known oil-processing steps for their established purposes. Wang et al. expressly teaches alkali neutralization of free fatty acids (see [0002], [0005], [0024], [0032], [0081]–[0082]), centrifugation to separate oil from soapstock (see [0003], [0139]–[0140], [0162], [0245]), adsorption bleaching/decoloring and filtration (see [0066], [0069], [0152]–[0153], [0187]), and deodorization (see [0148]–[0154], [0188]).
Claim 1 does not recite any objective structural, compositional, impurity-level, safety-threshold, or pharmacological-activity limitation that distinguishes the claimed refined rubber seed oil from refined rubber seed oil produced by applying the process of Wang et al. to rubber seed oil. The relative language “highly active and highly safe” does not define a measurable product limitation sufficient to patentably distinguish the product.
Accordingly, even if Wang et al. does not disclose every limitation of Claim 1 arranged in a single express embodiment, it would have been obvious to prepare refined rubber seed oil using the disclosed oil-refining steps, and Claim 1 is unpatentable under 35 U.S.C. § 103.
Claim 8 is rejected under 35 U.S.C. § 103 as being unpatentable over Wang et al. (CN 104130856 A, published November 5, 2014) in view of He et al. (CN 102586000 A, published July 18, 2012), and further in view of Singh (WO 2019/069096 A1, published April 11, 2019).
Claim 8 recites a pharmaceutical composition comprising a therapeutically effective amount of the refined rubber seed oil of Claim 1 and a pharmaceutically acceptable carrier.
The teaching of Wang et al. have been discussed above. Wang et al. does not teach a pharmaceutical composition comprising a therapeutically effective amount of refined rubber seed oil and a pharmaceutically acceptable carrier.
He et al. teaches rubber seed oil and its edible and medical development value (see He [0002]–[0004], [0094]). He et al. discloses that rubber seed oil studies showed no adverse effects, blood lipid-lowering effects, and clinical reductions in cholesterol and triglycerides (see He [0004]). He et al. further discloses that rubber seed oil can be used as an excellent edible or medical oil source (see He [0094]). He et al. therefore provides a reason to use rubber seed oil, including refined rubber seed oil suggested by Wang et al., in a medically useful or therapeutically effective amount.
Singh discloses oil-containing pharmaceutical, nutraceutical, and food supplement compositions comprising an oil component and a lipid component/carrier. Singh teaches that the oil-containing product may be an oral dosage form selected from a pharmaceutical, nutraceutical, or food supplement dosage form and that the solid composition may be used as a medicament or in therapy. Singh also identifies vegetable oils, including rubber seed oil, as suitable oil components (see Singh [0015]–[0017], [0019]–[0020], [0072], [0079], [0104], [0178]–[0179], [0202]–[0207]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to formulate the refined rubber seed oil taught or suggested by Wang et al. in a therapeutically effective amount, based on the medical-use teachings of He et al., with a pharmaceutically acceptable carrier as taught by Singh. The motivation would have been to provide an orally administrable pharmaceutical oil composition with improved handling, stability, palatability, dosage uniformity, and suitability for therapeutic administration (see He [0004], [0094]; Singh [0002]–[0007], [0064]–[0070], [0178]–[0179], [0202]–[0207]).
The combination represents the predictable use of known oil-refining and pharmaceutical formulation techniques applied to a known rubber seed oil having disclosed edible and medical utility. Claim 8 does not recite any particular carrier, dosage form, concentration, structural formulation feature, or unexpected property that distinguishes the claimed pharmaceutical composition from the composition rendered obvious by the combined teachings.
Accordingly, Claim 8 is unpatentable under 35 U.S.C. § 103 over Wang et al. in view of He et al. and Singh.
Conclusion
No claims are allowed.
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/CHRISTOPHER M BABIC/ Supervisory Patent Examiner, Art Unit 1633
