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 18/547,851 filed on August 24, 2023 is a 371 of PCT/KR2022/019441 filed on December 2, 2022, which claims priority to, and the benefits of Foreign Application No.
IN202121009068 filed on December 2, 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Claims 1-8 are pending and under examination.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, the recitation of “the weight ratio of coconut husk and/or coir pith powder to at least one polyol compound” should read –the weight ratio of the coconut husk and/or coir pith powder to the at least one polyol compound”, such that an article “the” is used proceeding the phrases of “coconut husk and/or coir pith powder” and “at least one polyol compound” to clarify that this subject matter is the same as the one mentioned before. In addition, the recitation of “and combinations thereof “and the recitation of “wherein the weight ratio of” is missing a comma (,) in between.
Appropriate correction is required.
Claim Interpretation
The claimed term “co-processed”, when construed in light of the special definition recites on page 7, paragraph [45] shown below:
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, is taken to refer to the intended use of the excipient instantly claimed. Since the claim is interpreted to be a product, in this case, an excipient, the use of the product does not appear to further limit the structural components of the product.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-8, the recitation of “coir pith powder from the husk of coconut” and the recitation of “the fruit of Cocos nucifera” are missing a coordinating conjunction (e.g., or) to connect these two recitations. The lack of clarity can lead to various interpretations, for instance, it is not clear if applicant is intending to claim that (a) the natural coconut husk and/or coir pith powder is from the husk of coconut and the fruit of Cocos nucifera, such that “the fruit of Cocos nucifera” is a required feature of the claim; or (b) the natural coconut husk and/or coir pith powder is from the husk of coconut or the fruit of Cocos nucifera. In addition, to the extent that the claim is drawn to natural coconut husk and/or coir pith powder, the claim can also lead to various interpretations. For instance, it is not clear if applicant is intending to claim that (a) the natural coconut husk and/or coir pith powder are both from the husk of coconut, or (b) a coir pith powder from the husk of coconut with a natural coconut husk, such that only the coir pith powder has to be from the husk of coconut. In order to advance prosecution, the Examiner is examining the claims to the extent that the limitation of “the fruit of Cocos nucifera” is not a required feature of the claims; and the natural coconut husk is from the husk of coconut.
Regarding claim 1, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites “at least one polyol compound consisting of… combinations thereof”. It is noted that a combination of more than one polyol is no longer a single polyol compound/molecule, thus, the recitation of “combinations thereof” is broader than the limitation of “at least one polyol compound” proceeding said recitation. In addition, it is also not clear what is being referred to as the “combinations” given that the term is in the plural form rather than a singular form. Is applicant intending to refer to a combination that is composed of more than one combination, for instance, a combination that combines the combination of (glycerol and sorbitol) with the combination of (polyethylene glycol and propylene glycol) together? To the extent that the “combinations” pertains to more than one combination composed of more than one polyol, it is not clear which polyols contains therein is the essential polyol that meets the limitation of “at least one polyol compound”. The lack of clarity renders the claim indefinite as one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In order to advance prosecution, the Examiner is examining the claims to the extent that the at least one polyol compound is selected from the group consisting of glycerol, sorbitol, polyethylene glycol and propylene glycol.
Regarding claim 2, the claim recites the limitations of "the water holding capacity" and “the said ration” in line 4. There is insufficient antecedent basis for these limitations in the claim, because a water holding capacity and a ration is not mentioned prior to these limitations. It is not clear what “water holding capacity” and “ration” are being referred to by the applicant. In addition, the recitation of “its own weight” renders the claim indefinite, because it is not clear if applicant is referring to the weight of the natural coconut husk and/or coir pith powder, the weight of at least one polyol, or the weight of the whole co-processed multifunctional excipient. The lack of clarity renders the claim indefinite as one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claims 4 and 7, the recitation of “more polyols combinations” in the phrase of “the at least one polyol and/or more polyol combinations” renders the claim indefinite. There is insufficient antecedent basis for the limitation of “more polyols combinations” in the claim. It is not clear if applicant is intending to refer to another structurally distinct “combinations” composed of more than one combinations of polyols in addition to the “at least one polyol compound” previously sets forth in the claim it depends upon. If so, it is not clear what is being referred to as the “more polyols combinations”. The lack of clarity renders the claim indefinite as one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 5, the recitation of “like” in the phrase shown below:
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renders the claim(s) indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 8, the recitation of "like" in the phrase shown below:
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102
636
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renders the claim(s) indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more.
Instant claim 1 recites “[a] co-processed multifunctional excipient comprising: a) natural coconut husk and/or coir pith powder from the husk of coconut, the fruit of Cocos nucifera; and b) at least one polyol compound consisting of glycerol, sorbitol, polyethylene glycol (PEG), propylene glycol (PG), and combinations thereof wherein the weight ratio of coconut husk and/or coir pith powder to at least one polyol compound is in the range of 1:1 to 6:4”.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. In the present case, applicant’s claims are directed to a product, in this case, a co-processed multifunctional excipient; therefore, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In the present case, applicant’s claims recite a nature-based product, in this case, a combination of naturally occurring substances such as natural coconut husk and sorbitol. First, natural coconut husk is the outer layer of the fruits of coconut tree (species Cocos Nucifera), as evidenced by Chand et al. (Woodhead Publishing Series in Composites Science and Engineering, 2008: 1-58) (see e.g., p. 9, “Coir” section). Second, sorbitol is a type of carbohydrate called a sugar alcohol or polyol, which are water-soluble compounds that occur naturally in many fruits and vegetables, as evidenced by Dumitrescu (“What is Sorbitol?” [Online]. International Food Information Council. Published on April 18, 2019) (see e.g., “the basics of sorbitol” section). Each of these cited references demonstrate these individual components are found together in nature. Therefore, the claims do recite a judicial exception, i.e., products of nature, which require further eligibility analysis.
MPEP § 2106.04(b) states that “[w]hen a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A”. MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”. In the instant case, the closest counterpart to the claimed invention is the combination of naturally components found in the fruit of Cocos Nucifera. Specifically, according to Chair et al. (“Safety Assessment of Cocos nucifera (Coconut)-Derived Ingredients as Used in Cosmetics” [Online]. Published online on September 25, 2020.), the aqueous part of the coconut (Cocos Nucifera) endosperm is known to contain sugar alcohols including sorbitol (see e.g., p. 4, “Cocos Nucifera (Coconut) Liquid Endosperm” section); and the exocarp (smooth outside skin of the coconut fruit) and mesocarp (hard, fibrous reddish-brown husk) make up the husk of the coconut. Since there is no indication in the specification that combining natural coconut husk and sorbitol changes the structural, functional, or other properties of these individual components in any marked way in comparison with the closest naturally occurring counterpart from natural plant. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2), this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, the claimed co-processed multifunctional excipient does not further comprise additional elements other than the product of natures. Thus, the answer to Step 2A, Prong Two, is No. Therefore, the additional element is not sufficient to integrate anything beyond the judicial exception. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself”. In the instant case, the claims recites the intended use of each individual components found in nature (see claims 3, 5, 6 and 8) and its functional characteristics (see claims 2, 4 and 7). Said limitation(s) does not introduce anything markedly different characteristics because each components retain the same physical and chemical structure as their naturally occurring counterpart and that does not introduce any markedly different characteristics to the claimed co-processed multifunctional excipient as a whole. In addition, the limitation of “wherein the weight ratio of coconut husk and/or coir pith powder to at least one polyol compound is in the range of 1:1 to 6:4” in claim 1 do not constitute additional elements that amounts significantly more than the judicial exception as mixing components are insignificant extra-solution activities that add nothing more than an efforts to combine the naturally occurring components. The claims recite a co-processed multifunctional excipient at a high level of generality of simply combining each naturally occurring component together, and combining individual components in various amount and ratio is well-understood, routine, and conventional activities known to the industry. Given that each naturally occurring component retains its naturally occurring structure and properties as their natural state, instant claims do not provide any limitations beyond the judicial exception or provide anything that adds significantly more to the judicial exceptions. Thus, the answer to Step 2B is No.
Therefore, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosa et al. (Journal of Applied Polymer Science, 2009. Vol. 111: 612-618), as evidenced by Hutten (Handbook of Nonwoven Filter Media, 2007: 103-194).
Rosa et al. teaches biodegradable composites based on starch/ethylene vinyl alcohol/glycerol blends and coconut fibers (see e.g., title). Rosa et al. further teaches the blends of thermoplastic starch (50 wt%), EVOH (30 wt%), water (10 wt %), and glycerol (10 wt %), as plasticizer, were melt-extruded with different amounts of unripe coconut fiber; and the fiber was added in varying proportions, i.e., 5, 10, and 15% of the total weight of the polymer (starch + EVOH) (see e.g., p. 613, left column, “Blend extrusion” section). Rosa et al. further teaches the unripe coconut fiber (coir) is used as a filler in a biodegradable polymer matrix of starch/EVOH/glycerol (see e.g., p. 613, left column, line 1-4). Rosa et al. further teaches the incorporation of coconut fibers into biocomposites as fillers can provide substantial cost saving without critically compromising the properties of the composites (see e.g., p. 618, left column, last line to right column, line 2).
Please note the coconut fiber taught by Rosa et al., commonly known as coir, is obtained from the fibrous husk of the coconut, as evidenced by Hutten et al. (see e.g., p. 143, “4.3.5.1.3.8 Coconut fiber”); and that is a natural coconut husk from the husk of coconut.
According to MPEP § 2131.02, “[a] reference disclosure can anticipate a claim when the reference describes the limitations but "’d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962))”. In the instant case, even though Rosa et al. does not expressly spell out the weight ratio of the coconut fiber to the glycerol, one would at once envisage the weight ratio from the weight-by-weight percentage of the coconut fiber and the glycerol taught by Rosa et al. For instance, Rosa et al. clearly teaches the blends of thermoplastic starch (50 wt%), EVOH (30 wt%), water (10 wt %), and glycerol (10 wt %) were melt-extruded with different amounts of unripe coconut fiber, and the fiber was added in varying proportions, i.e., 5, 10, and 15% of the total weight of the polymer (starch + EVOH). Accordingly, the weight of coconut fiber can be calculated as follows:
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; and the weight of glycerol can be calculated as follows:
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. Taken together, the weight ratio of the coconut fiber to the glycerol can be determined by joining the formulae noted above as follows:
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, which can be further simplified as follows:
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. Using the formula noted above, the composite with 15% of coconut fiber with respect to the weight of the polymer, which when calculated by
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=
1.2
, gives a ratio of 1.2. According to MPEP § 2131.03, "[w]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). The fact that the weight ratio of coconut fiber to glycerol calculated from the composite with 15% coconut fiber content, i.e., 1.2, falls within the range of 1:1 to 6:4 (equivalent to the range of 1 to 1.5), said composition anticipates the co-processed multifunctional excipient instantly claimed.
Regarding the limitation of “wherein the water holding capacity of the said ration was found in the range of 6 to 10 times of its own weight” in claim 2, said limitation is drawn to the functional characteristics of the co-processed multifunctional excipient instantly claimed. According to MPEP §2112.01, “’[p]roducts of identical chemical composition cannot have mutually exclusive properties.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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. Id.”. In the instant case, the composite with 15% coconut fiber content taught by Rosa et al. meets the structural limitation of the co-processed multifunctional excipient instantly claimed. Therefore, the claimed limitation would necessarily be presented in said composite of Rosa et al. sets forth above.
Regarding the limitation of “wherein the coconut husk and/or coir pith powder is used as absorbent” in claims 3 and 6, said limitation is drawn to the intended use of the coconut husk and/or coir pith powder contains within the co-processed multifunctional excipient instantly claimed. The intended use of the coconut husk and/or coir pith powder within the claimed co-processed multifunctional excipient does not patentably distinguish the coconut husk and/or coir pith powder, per se, since such undisclosed use is inherent in the unripe coconut fiber taught by Rosa et al. sets forth above. In order to be limiting, the intended use must create a structural difference between the claimed natural coconut husk and the prior art’s unripe coconut fiber. In the instant case, the intended use of the coconut husk and/or coir pith powder does not create a structural difference, thus, the intended use is not limiting. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims.
Regarding the limitation of “wherein the at least one polyol and/or more polyols combinations thereof increase the bulk density of particle” in claims 4 and 7, said limitation is drawn to the intended use of the at least one polyol and/or more polyols combinations thereof contains within the co-processed multifunctional excipient instantly claimed. The intended use of the at least one polyol and/or more polyols combinations thereof within the claimed co-processed multifunctional excipient does not patentably distinguish the polyol(s), per se, since such undisclosed use is inherent in the glycerol taught by Rosa et al. sets forth above. In order to be limiting, the intended use must create a structural difference between the claimed polyol and the prior art polyol. In the instant case, the intended use of the polyol(s) does not create a structural difference, thus, the intended use is not limiting. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims.
Regarding the limitation of “wherein the excipient is used as a multifunctional component like absorbent, scavenging agent, flow property improver, thickening agent, and/or viscosity enhancer” in claims 5 and 8, said limitation is drawn to the intended use of the co-processed multifunctional excipient instantly claimed. The intended use of the co-processed multifunctional excipient does not patentably distinguish the excipient, per se, since such undisclosed use is inherent in the composite taught by Rosa et al. sets forth above. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use of the claimed co-processed multifunctional excipient does not create a structural difference, thus, the intended use is not limiting. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims.
Therefore, the claimed invention is being anticipated by Rosa et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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