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 .
Claim status
Claims 1-4, 9, 11, 14-22, and 25 are pending in the current application. Claims 18-22 are withdrawn from consideration. Claims 5-8, 10, 12-13, and 23-24 have been cancelled.
Claim Rejections - 35 USC § 103
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 1-4, 7-9, 11, 14-15, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. (herein referred to as Yoon, US 20180339006 A1) in view of Ferreira et al. (herein referred to as Ferreira, “Chemical features of Ganoderma polysaccharides with antioxidant, antitumor and antimicrobial activities”) and Politi et al. (herein referred to as Politi, US 20170281470 A1)
With regard to Claim 1, Yoon teaches a method for making a composition, said method teaches preparing a granule or a pill containing a plant, medicinal herb or traditional oriental medicine decoction extract (abstract). Yoon teaches herbal medicine includes Ganodermae Polyporus ([0028]). Ganodermae Polyporus is not a species of fungi but rather Ganderma (i.e, Ganodermae) is a genus of polypore fungi. This is evidenced by Ferreira who additionally teaches Ganoderma genus comprises one of the most commonly studied species worldwide, Ganoderma lucidum (abstract). Ganoderma lucidum is widely studied regarding its bioactive properties including antibacterial, antioxidant, antitumor and other effects (1.1. Bioactivity of Ganoderma). Thus, because Yoon only broadly teaches the genus, one with ordinary skill in the art would be motivated to look to the art to find specific species to use. One would be motivated to use Ganoderma lucidum, as evidenced by Ferreira, because it is one of the most common studies species and its advantageous bioactive properties such as antibacterial, antioxidant, antitumor and other effects.
Continuing, Yoon teaches granulating a powder comprising one or more extracts to form granulates ([0016] –[0017]) and applying a coating material on the granulates ([0031], Claim 15) The coating material comprising the one or more extracts; wherein the composition is substantially free of materials that are not derived from the one or more extracts ([0031]-[0032]). Yoon teaches applying a solution comprising a solute and a solvent to the granules ([0017], [0042], [0096] Yoon reads such that in example two a binder, of the corresponding extract was sprayed, and of purified water was sprayed), Yoon teaches the solute is the second sample of the extract ([0017], [0096]). As stated above, the extract includes medicinal herb such as Ganderma lucidum. Yoon teaches an embodiment wherein 1500g of the corresponding extract was sprayed on to a base seed (table 1). By using the word “spray” Yoon is clearly teaching the 1500g of corresponding extract is in a liquid form. Thus, one with ordinary skill in the art would be able to modify the amount of corresponding extract (i.e, second sample) in the spray (i.e, solution) to achieve the desired spray conditions such as feeding rate and spray pressure and thus achieving the desired coating through routine optimization ([0096]). See MPEP 2144.05(II) "[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).
However, Yoon is silent to the granulating comprising dry granulating the powdered first sample.
Politi teaches a method and apparatus for dry granulation ([0002]). Politi teaches because of the manufacturing and process validation issues related to wet granulation and direct compression methods, it is desirable, particularly in the pharmaceutical industry, to use dry granulation techniques whenever possible ([0020]). Specifically in wet granulation the liquids needed in the granule and tablet manufacturing process often have an adverse effect on the characteristics of the active pharmaceutical ingredients (APIs) and/or on the end product such as a tablet ([0006]). Politi teaches because substantially no liquids are used in the dry granulation process, the issues related to wet granulation are avoided.
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yoon to use a dry granulation method as taught by Politi because the method using substantially no liquid therefore issues such as the liquids needed in the granule and tablet manufacturing process having an adverse effect on the characteristics of the active pharmaceutical ingredients and/or end product can be entirely avoided.
With regard to Claim 2, Yoon teaches the granulating is performed without using non-extract (i.e., non-Ganderma lucidum) derived materials ([0016]-[0017], [0031]-[0032]).
With regard to Claim 3, Yoon teaches the applying of the coating material is performed without using non-extract (i.e., non-Ganderma lucidum) derived materials ([0016]-[0017], [0031]-[0032]).
With regard to Claim 4, Yoon teaches the granules and the coating are substantially free of auxiliary excipients or additives ([0016]-[0017], [0019], [0031]-[0032]).
With regard to Claim 9, Yoon teaches the solvent is water ([0017], [0096]).
With regard to Claim 11, Yoon teaches spraying a solution of the extract while fluidizing the same thereby growing the microgranules to a predetermined size of granule (abstract). In one embodiment, Yoon teaches spraying a liquid sample as small droplets with a size of several tens to several hundreds of micrometers 10-200 μm (i.e, 0.00039 - 0.0079 in). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. 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).
With regard to Claim 14, Yoon teaches the applying step comprises using a spray fluidized bed ([0017], [0033]).
With regard to Claim 15, Yoon teaches the powder is obtained by subjecting the herbal medicine to water extraction and then spray drying (Example 1 [0079]-[0095]).
With regard to Claim 25, Yoon teaches a method for making a composition, said method teaches preparing a granule or a pill containing a plant, medicinal herb or traditional oriental medicine decoction extract (abstract). Yoon teaches herbal medicine includes Ganodermae Polyporus ([0028]). Ganodermae Polyporus is not a species of fungi but rather Ganderma (i.e, Ganodermae) is a genus of polypore fungi. This is evidenced by Ferreira who additionally teaches Ganoderma genus comprises one of the most commonly studied species worldwide, Ganoderma lucidum (abstract). Ganoderma lucidum is widely studied regarding its bioactive properties including antibacterial, antioxidant, antitumor and other effects (1.1. Bioactivity of Ganoderma). Thus, because Yoon only broadly teaches the genus, one with ordinary skill in the art would be motivated to look to the art to find specific species to use. One would be motivated to use Ganoderma lucidum, as evidenced by Ferreira, because it is one of the most common studies species and its advantageous bioactive properties such as antibacterial, antioxidant, antitumor and other effects.
Continuing, Yoon teaches granulating a powder comprising one or more extracts to form granulates ([0016] –[0017]) and applying a coating material on the granulates ([0031], Claim 15) The coating material comprising the one or more extracts; wherein the composition is substantially free of materials that are not derived from the one or more extracts ([0031]-[0032]). Yoon teaches applying a solution comprising a solute and a solvent to the granules ([0017], [0042], [0096] Yoon reads such that in example two a binder, of the corresponding extract was sprayed, and of purified water was sprayed), Yoon teaches the solute is the second sample of the extract ([0017], [0096]). As stated above, the extract includes medicinal herb such as Ganderma lucidum. Yoon teaches an embodiment wherein 1500g of the corresponding extract was sprayed on to a base seed (table 1). By using the word “spray” Yoon is clearly teaching the 1500g of corresponding extract is in a liquid form. Thus, one with ordinary skill in the art would be able to modify the amount of corresponding extract (i.e, second sample) in the spray (i.e, solution) to achieve the desired spray conditions such as feeding rate and spray pressure and thus achieving the desired coating through routine optimization ([0096]). See MPEP 2144.05(II) "[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).
However, Yoon is silent to the granulating comprising dry granulating the powdered first sample.
Politi teaches a method and apparatus for dry granulation ([0002]). Politi teaches because of the manufacturing and process validation issues related to wet granulation and direct compression methods, it is desirable, particularly in the pharmaceutical industry, to use dry granulation techniques whenever possible ([0020]). Specifically in wet granulation the liquids needed in the granule and tablet manufacturing process often have an adverse effect on the characteristics of the active pharmaceutical ingredients (APIs) and/or on the end product such as a tablet ([0006]). Politi teaches because substantially no liquids are used in the dry granulation process, the issues related to wet granulation are avoided.
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yoon to use a dry granulation method as taught by Politi because the method using substantially no liquid therefore issues such as the liquids needed in the granule and tablet manufacturing process having an adverse effect on the characteristics of the active pharmaceutical ingredients and/or end product can be entirely avoided.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US 20180339006 A1) in view of Ferreira. (“Chemical features of Ganoderma polysaccharides with antioxidant, antitumor and antimicrobial activities”), Politi (US 20170281470 A1) and Verkoeijen et al. (herein referred to as Verkoeijen, “Determining granule strength as a function of moisture content”).
With regard to Claim 16, Yoon is silent to the moisture content of the composition.
Verkoeijen teaches granulation is a process in which granules are produced from a liquid or particulate feed. It is an important process in various industries and employs a number of different types of equipment (1. Introduction). Verkoeijen teaches moisture content has a direct relationship to the granules strength (1.2. Strength of Granules).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yoon in view of Verkoeijen to modify the moisture content in the granules to achieved the desired granule strength though routine optimization. See MPEP 2144.05(II) Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
With regard to Claim 17, Yoon is silent to the porosity of the granules.
Verkoeijen teaches granulation is a process in which granules are produced from a liquid or particulate feed. It is an important process in various industries and employs a number of different types of equipment (1. Introduction). Verkoeijen teaches granule strength increases with decreasing porosity (1.2. Strength of granules).
Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Yoon in view of Verkoeijen to modify the porosity of the granule to achieve the desired strength through routine optimization. See MPEP 2144.05(II) Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In this case, the applicant argues that Shanamugam does not overcome the deficiencies of Yoon with regard to teaching the dry granulation process. This argument is moot because Shanamugam is no longer relied upon in the rejection and Politi is now relied upon to teach the dry granulation process. Specifically applicant argues that with Shanamugam, one with ordinary skill in the art would not have been motivated to use dry granulation over a wet granulation method. However, with Politi, the reference specifically discusses the benefit of dry granulation over wet granulation (Politi [0006], [0020]). Therefore the argument is moot in view of the new grounds of rejection and the new reference clearly overcome applicant’s argument with regard to dry vs. wet granulation. AS a result the applicants argument is not found to be persuasive.
Next, applicant argues that Yoon contains no teaching or suggestion that the 1500g of extract should be contained within a solute at any particular concentration, much less 1% w/w to 12% w/w as required by the applicant’s claims. This argument is not found to be persuasive because Yoon teaches “spraying the solution of the extract onto the microgranules” (Yoon [0017]-[0018]). In addition, in example 2 Yoon is specific to the extract being sprayed with water which is a solute that is limited by claim 9. Therefore one with ordinary skill in the art would recognize that the extract is contained within a solute and applicants argument is nit persuasive. With regard to the amount, the examiner first wants to highlight MPEP 2144.05(II)(A) which states, Generally, 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). In this case the applicant does not provide data or results that would indicate that the range would be critical. In addition, Yoon provides ample motivation for one with ordinary skill in the art to modify the concentration of the extract the desired coating through routine optimization ([0096]). Therefore, applicant’s argument is not found to be persuasive.
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.
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/K.I.D./ Examiner, Art Unit 1792
/ERIK KASHNIKOW/ Supervisory Patent Examiner, Art Unit 1792
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