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 .
DETAILED ACTION
Applicant’s amendment filed on 04 August 2025 is entered. Claims 1-2 and 4-6. Claims 1-9 are pending. Claims 7-9 are withdrawn. Claims 1-6 are under examination.
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.
(New necessitated by amendment) Claims 1-6 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.
Claim 1 recites a product-by-process limitation, wherein the BMP powder is prepared through the steps comprising soaking, crushing and grinding, mixing with a buffer solution, temperature treatment, enzymatic hydrolysis sequentially with trypsin, pectinase and cellulase, filtration, concentration and vacuum freeze drying. It is unclear what is being soaked, crushed and ground, and mixed with a buffer solution.
Additionally, the soaking, crushing, grinding, and mixing steps are all verbs denoting an action to be performed during the step, but the temperature treatment, enzymatic hydrolysis, filtration, and concentration steps are all nouns, thus do not recite an action to be performed during the step. It is unclear what structural limitations, if any, are resulted from each of the temperature treatment, enzymatic hydrolysis, filtration, and concentration steps.
Claim 1 recites “1-2 parts by weight of nutritional yeast powder”. It is unclear what amount/concentration of yeast cells are the 1-2 parts by weight of nutritional yeast powder. Microorganisms such as yeast are measured in terms of colony forming units, and not by weight. The number of yeast cells could vary widely for any given weight due to differences in culturing techniques, culturing conditions, storage conditions, composition form, etc.
Regarding claims 1 and 3, claim 1 recites “2-5 parts by weight of a pancreatin” and claim 3 recites “wherein the pancreatin comprises trypsin, amylopsin, and pancreatic lipase with a weight ratio of 1:2:2”. It is unclear what the enzyme activities of the claimed pancreatin, trypsin, amylopsin, and pancreatic lipase are. Because each of these components are enzymatic proteins, the enzyme activity units of “2-5 parts by weight of a pancreatin” and “trypsin, amylopsin, and pancreatic lipase with a weight ratio of 1:2:2” could vary depending on the differences in sources of the pancreatin, trypsin, amylopsin, and pancreatic lipase raw materials.
Regarding claim 4, the numeration of step S11, S31, S32, and S33 is unclear. The first step recited in the claim is labeled as S11, which appears to be step 11 of the claimed process. Likewise, the steps labeled S31, S32, and S33 appear to recite steps 31, 32, and 33, but those steps are immediately following step 3 (S3) and immediately prior to step 4 (S4).
Regarding claims 4 and 6, claim 4 step S4 recites “wherein the trypsin is 5% by weight of the bitter melon extract”, “wherein the pectinase is 3% by weight of the first enzymatic hydrolysis system”, and “wherein the cellulase is 2% by weight of the second enzymatic hydrolysis system”. It is unclear what the enzyme activities of the claimed trypsin, pectinase, and cellulase are. Each of these components are enzymatic proteins, and so the enzyme activity of the 5 wt.% trypsin, 3 wt.% pectinase, and 2 wt.% cellulase could vary depending on the differences in sources of the trypsin, pectinase, and cellulase raw materials. Similarly, claim 6 step S2 recites “wherein the pectinase is 4% by weight of the first enzymatic hydrolysis system” and “wherein the cellulase is 3.5% by weight of the second enzymatic hydrolysis system”. As such, claim 6 is indefinite for the same reasons as described above.
Claims 2-6 are dependent on claim 1 and claim 5 is dependent on claim 4, so those claims are indefinite for the same reasons.
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.
(Maintained) Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a product of nature.
The claims recite a polysaccharide-peptide composite prepared from powdered dietary fiber isolated from oat, konjac powder, corn silk, bitter melon peptide (BMP) powder, soybean polypeptide powder, mulberry leaf extract, gardenia fruit oil, cocoa powder, L-arabinose, Poria cocos extract, hawthorn extract, nutritional yeast powder, pancreatin, and xylitol. Claim 2 limits the nutritional yeast powder to selenium-rich yeast, chromium-rich yeast, or a combination thereof. Claim 3 limits the pancreatin to comprise trypsin, amylopsin, and pancreatic lipase with a weight ratio of 1:2:2. Claims 4-6 are product-by-process claims, which seek to limit the process by which the bitter melon peptide powder of claim 1 is prepared (claim 4), or the process by which the gardenia fruit oil of claim 1 is prepared (claim 6). Claim 5 limits the buffer solution of claim 4 to be a phosphate buffer solution prepared from disodium hydrogen phosphate dodecahydrate and sodium dihydrogen phosphate dihydrate. Claims 1-3 recite a judicial exception of a product of nature in that each of the components of the claimed composition are all naturally derived components and/or compounds. Regarding claims 4-6, the determination of patentability of a product-by-process claim is based on the product itself, even though the claims are limited and defined by the process. MPEP §2113(I): "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Accordingly, the patentability of the resultant products of the processes claimed in claims 4-6 are the subjects of this analysis. The resultant products from the processes of claims 4-6, namely bitter melon peptide powder (claims 4-5) and gardenia fruit oil (claim 6), are drawn to the judicial exception of a product of nature because they are made from and contain naturally derived compounds.
This judicial exception is not integrated into a practical application because the claims are drawn to a compositions of matter, and the claims do not recite any practical applications of the compositions.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
The claimed composites of claims 1-3 comprise a combination of naturally derived components. MPEP 2106.04(c)(II)(A) 3rd paragraph: “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.” Each of these components in the claimed composites are either found in nature, or wholly comprise naturally derived compounds. In the case of oat dietary fiber, konjac powder, corn silk, bitter melon peptide powder, soybean polypeptide powder, mulberry leaf extract, cocoa powder, Poria cocos extract, and hawthorn extract, the components are either natural plants themselves, or otherwise comprise natural compounds or proteins from natural plants. As such, each of these components of the whole claimed composite would be compared to their closest natural counterparts, the plants themselves in their natural environment, or the compounds or proteins from plants in their natural environment. There is no evidence that these naturally derived components have been modified in any way such that they would comprise any markedly different characteristics as compared to their closest natural counterparts. L-arabinose and xylitol are chemical compounds that exist in nature, but there is also no evidence that these chemical compounds in the claimed composite comprise any markedly different characteristics as compared to their closest natural counterparts (L-arabinose and xylitol as they occur in nature). The nutritional yeast component is just yeast cells, which are naturally occurring organisms. There is no evidence that these nutritional yeast cells comprise any markedly different characteristics as compared to their closest natural counterpart (those same yeast cells in their natural environment). As such, claims 1-3 are directed to the judicial exception of a product of nature.
In the case of claims 4-6, the chemical and biological compositions of the end products of the product-by-process claims do not contain any unnatural compounds or elements and are wholly derived from nature, and so they are compared to their closest natural counterparts, the chemical and biological compounds as found in their natural environment. There is no evidence that the processes as claimed have changed any characteristics of the naturally derived end products, and there is no evidence that the naturally derived end products have any markedly different characteristics as compared to their closest natural counterparts, and as such claims 4-6 are also directed to the judicial exception of products of nature.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
(Maintained) Claims 1-2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Feng et al. (CN 106983052 A, published 28 July 2017), Hu et al. (CN 104187611 A, published 10 December 2014), Li et al. (CN 103861086 A, published 18 June 2014), Boltri et al. (CA 2812862 A1, published 05 April 2012), Cao et al. (CN 107136278 A, published 08 September 2017), and Xiang et al. (CN 108130185 A, published 08 June 2018), and as evidenced by Merriam-Webster (Definition of “amylopsin”, https://www.merriam-webster.com/dictionary/amylopsin, accessed on 27 March 2025).
Feng teaches a solid beverage for helping reduce blood sugar comprising 0-85 wt.% mulberry leaf extract, 0-85 wt.% balsam pear extract, 0-85 wt.% corn stigma (corn silk), 0-90 wt.% soybean protein powder, 0-85 wt.% powdered dietary oat fiber, 0-90 wt.% konjak powder, and 0.01-90 wt.% xylitol (Feng claims 1-2). Feng teaches that balsam pear is another name for bitter melon (Feng pg. 4 para. 8). Feng teaches that the solid beverage is in a powder form (Feng pg. 3 para. 12 second to last sent.), and so the balsam pear extract within the solid beverage must be in a powdered form.
However, Feng does not teach the solid beverage to comprise a peptide extract form of the bitter melon extract, nor that it further comprises gardenia fruit oil, cocoa powder, Poria cocos extract, hawthorn extract, nutritional yeast, pancreatin, and L-arabinose.
Hu teaches a nutritional food for gastrointestinal absorption disorders comprising 10-16 g of hawthorn extract, 4-10g of gardenia fruit, and 1-10 g Poria cocos (Hu specification embodiments 1-8 and claims 1-5). Hu also teaches that diabetes is a gastrointestinal malabsorption disorder classified under a absorption mechanism disorder (Hu pgs. 1-2 bridging para.).
However, Feng and Hu do not teach a peptide extract form of a bitter melon extract, nor do they teach gardenia fruit in the form of an oil, L-arabinose, chromium-rich yeast, cocoa powder, or pancreatin.
Li teaches a composition comprising balsam pear peptide extract, 15-25 parts of L-arabinose and 0.1 to 0.3 parts yeast, and when compared to a composition just comprising balsam pear peptide extract, the combined effect of the composition of Li is better for glycemic control and lipid metabolism in type II diabetes patients, improving insulin sensitivity (symptom of type II diabetes), and reduction of total cholesterol in type II diabetic patients (Li Abstract). Li also teaches that balsam pear peptide extract has a blood sugar adjustment effect (Li Pg. 3 [0014]). Li also teaches that the yeast is chromium-rich yeast (Li Embodiment 1 [0011]), which is commensurate in scope with instant claim 2.
However, Li does not teach the exact range of concentrations for L-arabinose and chromium-rich yeast claimed in the instant composition.
MPEP §2144.05(II)(A) states “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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)”.
It would have been prima facie obvious to one of ordinary skill in the art to have optimized the concentrations of L-arabinose and chromium rich yeast in the instant composition in order to optimize the diabetic treatment effect of the components in a diabetes treating composition. One of ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success, because Li teaches that chromium-rich yeast is good for reducing and regulating blood sugar and reducing blood fat (Li Embodiment 1 [0011]), and Li also teaches that L-arabinose containing compositions are suitable for diabetes and sucrose disabled people (Li [0003]).
However, Feng, Hu, and Li do not teach gardenia fruit in the form of an oil, cocoa powder, or pancreatin.
Boltri teaches a composition that treats disorders in which a patient has no or low levels of digestive enzymes or those who need supplementation, and such disorders include side effects of drugs such as metformin used to treat diabetes in which the pancreas may be compromised (Boltri Pg. 23 last para.). Boltri teaches that the composition comprises pancrelipase enzymes including a mixture of lipases, amylases, and proteases in different combinations and ratios (Boltri Pg. 8 last para.). Boltri teaches pancrelipase is an alternative name to the term pancreatin (Boltri Pg. 7 para. 3), and that it also comprises trypsin (a protease) (Boltri Pg. 2 last para.). Since Boltri teaches that the pancrelipase is of pancreatic origin, the enzymes contained therein are interpreted to be pancreatic enzymes. Furthermore, the instantly claimed term “amylopsin” is an equivalent term to “pancreatic amylase”, as evidenced by (Merriam-Webster pg. 1). Boltri teaches that the pancrelipase enzymes are present in the composition in an amount of 4-20 wt.% (Boltri claim 1). Examiner mathematically determined the weight percentage of pancreatin in the instant composition is from 1.22–4.59 wt.%, and so the ranges of Boltri overlaps with the concentration of pancreatin in instant claim 1. Examiner calculated the weight percentages from 1) the composition that comprises the minimal amount of pancreatin listed in the claim 1 (2 parts by weight) in combination with the maximum amounts of all other ingredients, resulting in the minimum weight percentage of pancreatin in a composition of the instant claim 1 (1.22 wt.%), and 2) the composition that comprises the maximum amount of pancreatin listed in the instant claim 1 (5 parts by weight) in combination with the minimal amounts of all other ingredients, resulting in the maximum weight percentage of pancreatin in a composition of the instant claim 1 (4.59 wt.%).
However, Feng, Hu, Li, and Boltri do not teach gardenia fruit in the form of an oil or cocoa powder.
Cao teaches a chocolate flavored composition comprising 8-12 parts cocoa powder by weight (Cao Abstract), and that its composition can treat diabetes mellitus (Cao pg. 3 last para. last sent.). Although the cocoa powder does not appear to be the active ingredient in the composition of Cao, the cocoa powder is nonetheless taught by Cao to be safe in compositions administered to patients with diabetes, and is also taught to be a constituent ingredient in the chocolate flavor, which Cao teaches has an exquisite and mellow taste that is greatly popular with people of every age, and has great market scale and development potential (Cao pg. 2 para. 2. sent. 1).
However, Feng, Hu, Li, Boltri, and Cao do not teach gardenia fruit in the form of an oil.
Xiang teaches a method of extracting gardenia oil from gardenia and that gardenia oil can be used to treat diabetes (Xiang pg. 2 paras. 1-2). Xiang teaches a method of extracting gardenia oil including steps for drying and crushing gardenia, heating, settling, treating with enzymes, filtering, and vacuum drying to obtain gardenia oil (Xiang Abstract).
MPEP § 2113(I) states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966. Examiner notes that the final product of Xiang is a gardenia oil product extracted from gardenia, which Examiner interprets to be commensurate in scope with the final product of the product-by-process recited in instant claim 6.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to create a composition comprising 20-25 parts by weight of powdered oat dietary fiber, 10-15 parts by weight of konjac powder, 10-15 parts by weight of a corn silk, 20-30 parts by weight of bitter melon peptide (BMP) powder, 10-12 parts by weight of soybean polypeptide powder, 5-10 parts by weight of a mulberry leaf extract, 5-10 parts by weight of a gardenia fruit oil, 5-10 parts by weight of cocoa powder, 5-10 parts by weight of L-arabinose, 3-5 parts by weight of a Poria cocos extract, 5-10 parts by weight of a hawthorn extract, 1-2 parts by weight of nutritional yeast, 2-5 parts by weight of a pancreatin, and 5-8 parts by weight of xylitol. One of ordinary skill in the art would have been motivated to do so in order to produce a new composition suitable for treating diabetes and its symptoms. One of ordinary skill in the art would have had a reasonable expectation of success because cited references Feng, Hu, Li, Boltri, Cao, and Xiang all teach their compositions to be suitable to treat diabetes, hyperglycemia, insulin sensitivity, and other conditions associated with diabetes. One of ordinary skill in the art would have been motivated to use the cocoa powder taught by Cao to be a chocolate flavoring agent in their composition because Cao taught that cocoa powder is a constituent ingredient in the chocolate flavor, which has an exquisite and mellow taste that is greatly popular with people of every age, and has great market scale and development potential (Cao pg. 2 para. 2. sent. 1). One of ordinary skill in the art would have had reasonable expectations of success because Cao teaches its compositions are safe to be administered to patients with diabetes.
(Maintained) Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Feng in view of Hu, Li, Boltri, Cao, and Xiang as applied to claims 1-2 and 6 above, and further in view of Efthymiopoulos et al. (AU 2014253526 A1, published 13 November 2013).
Feng, Hu, Li, Boltri, Cao, and Xiang do not teach pancreatin to comprise a ratio of trypsin, amylopsin, and pancreatic lipase that is 1:2:2.
Efthymiopoulos teaches compositions which treat diabetes which comprise pancreatin enzymes trypsin (a protease), lipase, and amylase (Efthymiopoulos pg. 27 lns. 12-13, and pg. 6 lns. 28-31), and that the ratio of lipase, protease, and amylase ranges from 1:10:10 to about 10:1:1 (Efthymiopoulos pg. 8 lns. 11-14), which is interpreted to mean that each component in the ratio can be any value ranging from 1-10, such that the ratio range of Efthymiopoulos includes a ratio of trypsin, amylopsin, and pancreatic lipase that is 1:2:2.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to adjust the ratio of trypsin, amylopsin, and pancreatic lipase to 1:2:2 in the pancreatin ingredient of the obvious method of Feng in view of Hu, Li, Boltri, Cao, and Xiang. One of ordinary skill in the art would have been motivated to do so in order to enhance the antidiabetic effect of the obvious diabetes treating composition of Feng, Hu, Li, Boltri, Cao, and Xiang. One of ordinary skill in the art would have had a reasonable expectation of success because Efthymiopoulos teaches a ratio range of trypsin, amylopsin, and pancreatic lipase that includes the ratio recited in instant claim 3, and that compositions comprising said ratio are suitable for treating diabetes.
(Maintained) Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Feng in view of Hu, Li, Boltri, Cao, and Xiang as applied to claims 1-2 and 6 above, and further in view of Han et al. (CN 101461514 A, published 24 June 2009).
Feng, Hu, Li, Boltri, Cao, and Xiang do not teach an extraction of bitter melon peptide to result in a bitter melon peptide powder.
Han teaches a method of preparing a bitter melon peptide powder, comprising steps of drying, crushing a balsam pear fruit (also named bitter melon), adding water, adjusting pH, heating for extraction, reducing to room temperature, adjusting pH and heating for extraction again, adding cellulase and pectinase for a enzymatic treatment, heating to high temperatures to inactivate the enzymes, performing ultrasonic treatment, reducing to room temperature again, centrifuging, filtering, and drying in to a solid powder (Han pg. 2 paras. 4-7). The resulting product of Han, the balsam pear peptide powder, (bitter melon peptide powder) is commensurate in scope with the final product of claim 4-5.
MPEP § 2113(I) states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to create a bitter melon peptide powder using the method of Han, and then use that powder in the obvious composition of Feng in view of Hu, Li, Boltri, Cao, and Xiang that is useful for treating diabetes and symptoms thereof. One of ordinary skill in the art would have been motivated to do so because Li teaches bitter melon peptide extract is useful in compositions for treating diabetes (Li Pg. 3 [0014]). One of ordinary skill in the art would have had a reasonable expectation of success because Han teaches how to make a bitter melon peptide powder, and Li teaches that bitter melon peptide is suitable for treating diabetes.
Response to Arguments
Applicant's arguments filed 04 August 2025 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that claim has amended the “nutritional yeast” to “nutritional yeast powder”, which is a commercially available product that is commonly measured by weight in the practical application and plays a role as an auxiliary ingredient in the claimed composite (Remarks pg. 11 para. 3), the BRI of the new claim term “nutritional yeast powder” includes yeast cells that are in a powdered physical form. The composition itself is what is being examined, not any application or use of said composition. Thus any argument about the significance of the role of the nutritional yeast powder in the claimed composition is not convincing to overcome the indefiniteness. The actual amount of yeast within the nutritional yeast powder is not distinctly pointed out within the claim language, and any variances in the amount of yeast cells within the nutritional yeast powder does change the content of the claimed composition.
Regarding Applicant’s arguments that the pancreatin, trypsin, and amylopsin enzymes are merely auxiliary ingredients in the claimed composite, and the enzyme activities are used to evaluate catalysis efficiency of those enzymes, which will not significantly affect the efficacy of the claimed composition (Remarks pgs. 12 and 17), the composition itself is what is being examined, not any application or use of said composition. Thus any argument about the significance of the role of pancreatin, trypsin, and amylopsin in the efficacy of the claimed composition is not convincing to overcome the indefiniteness. Furthermore, the enzyme activities describe the amount of active enzyme present in the claimed composition. It is still unclear what amounts of active pancreatin, trypsin, and amylopsin are present in the claimed composition.
Regarding Applicant’s arguments that the enumeration labels of the steps of claim 4 has been amended to overcome the clearness (Remarks pg. 12), the steps labeled S31, S32, and S33 have not been amended, so those steps appear to be labeled as steps 31, 32, and 33, but are then followed by a step 4, which is unclear.
Regarding Applicant’s arguments that the newly added limitation to claim involves enzymatic hydrolysis with trypsin in preparation of the BMP powder which significantly alters the molecular weight distribution of the BMP powder according to table 1 of the specification, thereby imparting a material modification of the structure and function of the BMP powder with respect to its natural counterpart (Remarks pgs. 21-22 and 24), the claims recite product-by-process language which describe how the claimed products are produced. MPEP §2113(I) states that product-by-process claims are not limited by the manipulations of the process, only by the implied structure of the steps. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Applicant’s digestion of the bitter melon peptides does not impart any special structures or functional abilities of the digested BMP that amount to a markedly different composition as compared to the BMP of nature, or over the BMP powder taught by prior art Han. When the claimed composition is considered as a whole, the digestion of the BMP does not add any markedly different structures or functions which were not already present in the natural BMP or the BMP taught by Han. A simple redistribution of molecular weights in the composition does not necessarily impart any markedly different characteristics that amount to significantly more than the natural counterpart, nor does it differentiate the instant BMP powder from the BMP powder of Han, because the BMPs themselves within the BMP powder, and each of their cleaved parts as a result of the enzymatic digestion, are all still naturally occurring proteins present in the bitter melon, and are also present in the BMP powder of Han. Furthermore, the non-digested bitter melon peptide power itself is taught to have antidiabetic properties like blood sugar and lipid control (Han abstract), so Applicant's claim that the claimed composition would exhibit blood sugar-regulating functions is insufficient to differentiate it from the art, or the natural counterpart based on its function. Accordingly, the claims are still directed to a product of nature without significantly more, and are also still not patentable under 103 because the BMP powder component in the claimed is taught by Han.
Conclusion
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER M DURYEE whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/ Supervisory Patent Examiner, Art Unit 1657