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 .
Status of the Claims
Claims 1-11 have been cancelled. New claims 21-31have been added.
Claims 12-31 are currently under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12- rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
This is a new matter rejection. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The examiner was unable to locate explicit support nor any language which would infer that the limitation of “such that distinct physical-state characteristics are preserved prior to integration” recited in claim 12 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “maintaining a distinct phospholipid-associated complex state during integration with the micronized components” recited in claim 12 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “forming a coordinated micronized distribution architecture” recited in claim 12 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “wherein the encapsulated mixture comprises structurally distinct micronized domains arranged in a coordinated non-homogenous targeted-release delivery architecture” recited in claim 12 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “micronized bioactive subsystems are independently pre-processed prior to coordinated integration such that distinct physical-state characteristics of the respective subsystems are preserved during integration within the encapsulated delivery matrix” recited in claim 21 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “the coordinated integration preserves structurally distinct subsystem organization within the encapsulated delivery matrix” recited in claim 21 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “wherein the encapsulated delivery matrix comprises a coordinated non-homogeneous targeted-release delivery architecture configured to provide coordinated delivery behavior across the plurality of micronized bioactive subsystems” recited in claim 21 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “wherein the preserved physical-state characteristics comprise at least one characteristic chosen from micronized particle size characteristics, micronized dispersibility characteristics, or phospholipid-associated phytosome characteristics” recited in claim 22 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “the independently pre-processed micronized bioactive subsystems remain non-homogeneously organized, while preserving distinct physical-state characteristics, following encapsulation within the delivery matrix” recited in claim 23 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “ wherein the coordinated integration preserves structurally distinct phospholipid-associated phytosome characteristics following integration within the encapsulated delivery matrix ” recited in claim 24 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “ wherein the coordinated integration reduces interference between chemically distinct micronized bioactive subsystems during coordinated targeted release” recited in claim 25 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “ at least a portion of the micronized components are coordinated such that the micronized components exhibit substantially equalized particle-size distribution relationships forming a coordinated micronized distribution architecture” recited in claim 26 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “wherein the coordinated micronized distribution architecture maintains structurally distinct integrated subsystem organization within the encapsulated delivery matrix” recited in claim 26 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “the encapsulated delivery matrix comprises a coordinated non-homogeneous targeted-release delivery architecture configured to provide coordinated delivery behavior across the micronized components.” recited in claim 26 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “wherein the substantially equalized particle-size distribution relationships comprise overlapping micronized particle-size ranges across multiple micronized bioactive subsystems.” recited in claim 27 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “wherein the coordinated micronized distribution architecture preserves phospholipid-associated phytosome characteristics during integration with the micronized bioactive subsystems.” recited in claim 28 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “wherein the coordinated micronized distribution architecture provides coordinated targeted-release behavior across chemically distinct micronized bioactive subsystems.” recited in claim 29 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “wherein the preserved physical-state characteristics of the micronized bioactive subsystems are maintained through coordinated micronized particle-size distribution relationships configured to preserve structurally distinct subsystem organization within the encapsulated delivery matrix.” recited in claim 30 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
The examiner was unable to locate explicit support nor any language which would infer that the limitation of “wherein the coordinated micronized distribution architecture is characterized by measurable particle-size relationship distributions across multiple micronized bioactive subsystems sufficient to maintain coordinated distribution of the micronized bioactive subsystems within the encapsulated delivery matrix and coordinated targeted-release behavior following encapsulation.” recited in claim 31 was described in a way that one of ordinary skill in the art would understand in the originally filed specification.
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 12-31 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.
The term “substantially” in claims 12 and 26-27 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The examiner points out that Dictionary.com defines the term “substantially” as by an ample or considerable amount; quite a lot.
Claim 12 recites “maintaining a structurally distinct phospholipid-associated complex state during integration with the micronized components”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 12 recites “such that the micronized components exhibit a substantially equalized particle size distribution forming a coordinated micronized distribution architecture”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 12 recites “wherein the encapsulated mixture comprises structurally distinct micronized domains arranged in a coordinated non-homogenous targeted-release delivery architecture”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 21 recites “micronized bioactive subsystems are independently pre-processed prior to coordinated integration such that distinct physical-state characteristics of the respective subsystems are preserved during integration within the encapsulated delivery matrix”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 21 recites “the coordinated integration preserves structurally distinct subsystem organization within the encapsulated delivery matrix”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 21 recites “wherein the encapsulated delivery matrix comprises a coordinated non-homogeneous targeted-release delivery architecture configured to provide coordinated delivery behavior across the plurality of micronized bioactive subsystems”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 21 recites “coordinated integration” in line 6. This language renders the claim indefinite as it is unclear the meaning of a coordinated integration. Does a coordinated integration mean that the micronized bioactive subsystems are all in one dosage unit, must have a chemical interaction such as covalent or ionic bonding amongst the bioactive subsystems, or no barriers between the micronized bioactive subsystems.
Claim 22 recites “wherein the preserved physical-state characteristics comprise at least one characteristic chosen from micronized particle size characteristics, micronized dispersibility characteristics, or phospholipid-associated phytosome characteristics”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 23 recites “the independently pre-processed micronized bioactive subsystems remain non-homogeneously organized, while preserving distinct physical-state characteristics, following encapsulation within the delivery matrix”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 24 recites “wherein the coordinated integration preserves structurally distinct phospholipid-associated phytosome characteristics following integration within the encapsulated delivery matrix”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 25 recites “wherein the coordinated integration reduces interference between chemically distinct micronized bioactive subsystems during coordinated targeted release”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 26 recites “at least a portion of the micronized components are coordinated such that the micronized components exhibit substantially equalized particle-size distribution relationships forming a coordinated micronized distribution architecture”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 26 recites “wherein the coordinated micronized distribution architecture maintains structurally distinct integrated subsystem organization within the encapsulated delivery matrix”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 27 recites “wherein the substantially equalized particle-size distribution relationships comprise overlapping micronized particle-size ranges across multiple micronized bioactive subsystems”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 28 recites “wherein the substantially equalized particle-size distribution relationships comprise overlapping micronized particle-size ranges across multiple micronized bioactive subsystems”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 29 recites “wherein the coordinated micronized distribution architecture provides coordinated targeted-release behavior across chemically distinct micronized bioactive subsystems”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 30 recites “wherein the preserved physical-state characteristics of the micronized bioactive subsystems are maintained through coordinated micronized particle-size distribution relationships configured to preserve structurally distinct subsystem organization within the encapsulated delivery matrix”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claim 31 recites “wherein the coordinated micronized distribution architecture is characterized by measurable particle-size relationship distributions across multiple micronized bioactive subsystems sufficient to maintain coordinated distribution of the micronized bioactive subsystems within the encapsulated delivery matrix and coordinated targeted-release behavior following encapsulation”. This language is indefinite as it is not clear what is meant by the limitation and is also not defined in the instant specification.
Claims depending from rejected claims have also been rejected because they incorporate
all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness
concerns outlined above.
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.
Claims 12-31 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US20050008690A1, Published 01/13/2005) in view of Mora et al. (Journal of Pharmaceutical Sciences, Published 11/2003 Volume 92, Issue 11, Pages 2177-2184) further in view of Technology Scientific (Biopolymer Technologies Green and Smart, Published 07/16/2024).
Applicant’s invention
Applicant’s claims are drawn to a targeted release dietary supplement delivery system comprising: a predetermined quantity of micronized bioactive agents selected from the group consisting of DHEA derivatives, HMB free acid, and free fatty acids in a dry, free-flowing powder form of less than ten microns, wherein a quality control of the DHEA derivative has determined that no chemical degradation has occurred, and wherein the DHEA derivative is un-esterified and free of any ester or acyl substitution at its hydroxyl positions, and encompasses both saturated and unsaturated androstane and androstene analogs, including dione, diol, triol, hydroxy-keto, and dehydrogenated variants having optional double bonds at positions 1, 4, or 5 of the carbon backbone; wherein the DHEA derivatives are pre-processed independently of the HMB free acid and free fatty acids prior to blending with other components such that distinct physical-state characteristics are preserved prior to integration; a predetermined quantity of micronized cyclodextrin; a predetermined quantity of micronized Siberian ginseng extract; a predetermined quantity of micronized omega-3 fatty acids; a predetermined quantity of micronized vitamin B6; a predetermined quantity of micronized trans-resveratrol; a phytosome complex formed from poorly soluble herbals selected from the group consisting of ashwagandha and ginseng, the phytosome complex being pre-formed prior to blending with other formulation components and maintaining a structurally distinct phospholipid- associated complex state during integration with the micronized components; wherein the pre-processed group consisting of DHEA derivatives, HMB free acid, and free fatty acids are blended after micronization with the cyclodextrin such that the micronized components exhibit a substantially equalized particle size distribution forming a coordinated micronized distribution architecture; wherein the phytosome complex is integrated with the pre-processed DHEA derivatives, cyclodextrin, Siberian ginseng extract, omega-3 fatty acids, vitamin B6, trans-resveratrol, and HMB free acid; wherein the resulting mixture is encapsulated; and wherein the encapsulated mixture comprises structurally distinct micronized domains arranged in a coordinated non-homogenous targeted-release delivery architecture.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 12, 21 and 26, Miller teaches a novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments such as a dietary supplement in the form of a single dosage, multi-compartment capsule having one or more active ingredients in a primary capsule and one or more active ingredients introduced into a secondary smaller capsule having a size (paragraph [0039]). Miller further teaches active ingredients or medicaments may take the physical form of a powder (i.e., free-flowing) (paragraph [0021]). Miller also teaches the present invention will use one or more of the below ingredients in a multi-compartment capsule, combinable as would be recognized in view of the teachings of the present application in combination with the knowledge available to one of ordinary skill in the art (paragraph [0376]), such as Androstenedione (i.e., DHEA derivative encompassing androstane analogs including dione) (paragraph [0377]), Siberian ginseng (paragraph [0377]), Fish Oil 30% EPA/20% DHA (i.e., omega-3 fatty acids) (paragraph [0382]), Pyridoxine Hydrochloride (Vitamin B6) (paragraph [0384]), trans-resveratrol (paragraph [0377]), HMB (Hydroxyl Methyl Butyrate) (paragraph [0380]), and phospholipids (paragraph [0379]). The Examiner points out that in combining the phospholipids with phytochemicals (i.e., Siberian ginseng powder, ashwagandha, ginseng (Korean) powder), the formation of a phytosome complex will inherently occur. With regards to the limitations wherein the DHEA derivatives are pre-processed independently on the HMB free acid and free fatty acids prior to blending with other components; wherein a phytosome complex is being pre-formed prior to blending with other formulation components; wherein the pre-processed group consisting of DHEA derivatives, HMB free acid, and free fatty acids are blended after micronization with the cyclodextrin until both have the same particle size; wherein the phytosome complex is added to the pre-processed DHEA derivatives, with the cyclodextrin, Siberian ginseng extract, omega-3 fatty acids, vitamin B6, trans-resveratrol, and HMB free acids, these limitations are all product-by-process language. "[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). See MPEP 2113 (I).
Regarding claims 13-18, Miller teaches the specific mg of each product is not included due to the amounts of each material is typically based upon the formulators opinions, however there are some (RDA) recommended daily allowances that could be used to determine the formulation (paragraph [1549]).
Regarding claims 19-20, Miller teaches the present invention can be utilized with a variety of excipients. Categories of excipients include, but are not limited to, Binders, Disintegrants Fillers (diluents), and Lubricants, such as microcrystalline cellulose, and hydroxypropyl methylcellulose (i.e., Hypromellose) (paragraph [1548]).
Regarding claim 23, the limitation wherein the independently pre-processed micronized bioactive subsystems remain non-homogeneously organized, while preserving physical state characteristics, following encapsulation within the delivery matrix is an inherent property of Miller’s multi-compartment capsule, as Miller teaches a novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments multi-compartment capsule having one or more active ingredients in a primary capsule and one or more active ingredients introduced into a secondary smaller capsule having a size (paragraph [0039]). Miller also teaches the present invention will use one or more of the below ingredients in a multi-compartment capsule, combinable as would be recognized in view of the teachings of the present application in combination with the knowledge available to one of ordinary skill in the art (paragraph [0376]), such as Androstenedione (i.e., DHEA derivative encompassing androstane analogs including dione) (paragraph [0377]), Siberian ginseng (paragraph [0377]), Fish Oil 30% EPA/20% DHA (i.e., omega-3 fatty acids) (paragraph [0382]), Pyridoxine Hydrochloride (Vitamin B6) (paragraph [0384]), trans-resveratrol (paragraph [0377]), HMB (Hydroxyl Methyl Butyrate) (paragraph [0380]), and phospholipids (paragraph [0379]). The Examiner points out that in combining the phospholipids with phytochemicals (i.e., Siberian ginseng powder, ashwagandha, ginseng (Korean) powder).
Regarding claim 24, the limitation wherein the coordinated integration preserves structurally distinct phospholipid-associated phytosome characteristics following integration within the encapsulated delivery matrix is an inherent property of Miller’s multi-compartment capsule.
Regarding claim 28, the limitation wherein the coordinated micronized distribution architecture preserves phospholipid-associated phytosome characteristics during integration with the micronized bioactive subsystems, is an inherent property of Miller’s multi-compartment capsule.
Regarding claim 29, the limitation wherein the coordinated micronized distribution architecture provides coordinated targeted-release behavior across chemically distinct micronized bioactive subsystems is an intended use of dietary supplement delivery system.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Miller does not teach cyclodextrin. Miller also does not teach micronizing the bioactive agents. However these deficiencies are cured by Mora et al. and Technology Scientific.
Mora teaches improving dehydroepiandrosterone (DHEA) solubility and bioavailability by high‐energy cogrinding (i.e., micronizing) with α‐cyclodextrin (α‐Cd) (abstract), wherein Cyclodextrin (Cd) complexation is known as an effective method for enhancing dissolution properties and bioavailability of poorly water‐soluble drugs, including several steroids. In particular, techniques of mechanochemical activation by roll mixing or cogrinding with Cds have been successfully employed for improving dissolution properties of drugs (Introduction section, second paragraph). 25 mg of native DHEA or an equivalent amount of DHEA–α‐CD–glycine multicomponent system (GR 1:2:3)( i.e., mixture) was administered orally as a tablet (In vivo studies section).
Technology Scientific teaches that micronization is the process of reducing the average particle size of a solid ingredient used in the production of a dietary supplement. Micronization intervenes by reducing their size to the micron scale, imparting new geometric properties to the particles and new physical and biological features to the supplement: Increased surface-to-volume ratio; Enhanced solubility; Increased bioavailability; and General enhancement of product performance (first paragraph).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to add cyclodextrin to Androstenedione (i.e., DHEA derivative encompassing androstane analogs including dione) in Miller’s multicompartment capsular delivery apparatus. The artisan of ordinary skill would have been motivated to do so because Mora teaches improving dehydroepiandrosterone (DHEA) solubility and bioavailability by high‐energy cogrinding (i.e., micronizing) with α‐cyclodextrin (α‐Cd) (abstract), wherein Cyclodextrin (Cd) complexation is known as an effective method for enhancing dissolution properties and bioavailability of poorly water‐soluble drugs, including several steroids. The skilled artisan would have had a reasonable expectation of success because Mora teaches techniques of mechanochemical activation by roll mixing or cogrinding with Cds have been successfully employed for improving dissolution properties of drugs (Introduction section, second paragraph), wherein 25 mg of native DHEA or an equivalent amount of DHEA–α‐CD–glycine multicomponent system (GR 1:2:3)( i.e., mixture) was administered orally as a tablet (In vivo studies section), wherein the Multicomponent DHEA–α‐Cd–glycine systems significantly improved the drug solubility and dissolution properties (Conclusion paragraph) and Miller teaches the use of one or more of the below ingredients in a multi-compartment capsule, combinable as would be recognized in view of the teachings of the present application in combination with the knowledge available to one of ordinary skill in the art (paragraph [0376]), such as Androstenedione (i.e., DHEA derivative encompassing androstane analogs including dione) (paragraph [0377]), therefore adding cyclodextrin to Miller’s DHEA derivative for the purpose of improving DHEA solubility and dissolution properties.
It would have been prima face obvious to one of ordinary skill in the art at the time of filing to micronize the ingredients for the formation of the capsule. The artisan of ordinary skill would have been motivated to do so because Technology Scientific teaches that micronization is the process of reducing the average particle size of a solid ingredient used in the production of a dietary supplement. Micronization intervenes by reducing their size to the micron scale, imparting new geometric properties to the particles and new physical and biological features to the supplement: Increased surface-to-volume ratio; Enhanced solubility; Increased bioavailability; and General enhancement of product performance (first paragraph). The skilled artisan would have had a reasonable expectation of success because Technology Scientific teaches that micronization has the benefits of enhancing solubility, increasing bioavailability and the enhancement of product performance, wherein a micronized product, with a high surface-to-volume ratio increasing radically the number of molecules dissolving in the glycocalyx, ready to cross the enteric mucosae, and increasing the bioavailability can unleash the whole therapeutic potential of the product and improve the patient’s well-being (The Science behind Micronization, seventh paragraph).
With regards to claims 13-18, wherein the DHEA derivative, Siberian ginseng, omega-3 fatty acids, vitamin B6, trans-resveratrol, and HMB free acids are in mg per capsule, it would have been obvious to one of ordinary skill at the time of filing to optimize the amounts of each ingredient in the capsule. One would have understood in view of Miller that the amounts of each material is typically based upon the formulator’s opinion, and that there are some recommended daily allowances that could be used to determine the amounts in the formulation. It would have been obvious to optimize the amounts of the ingredients in the capsule because Miller teaches that the amounts of the materials are based upon the formulator’s opinions to achieve desired results. "[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). See MPEP 2144.05 (II) (A).
With regards to the limitation of claim 22, wherein the preserved physical-state characteristics comprise at least one characteristic chosen from micronized particle-size characteristics, micronized dispersibility characteristics or phospholipid-associated phytosome characteristics, the examiner points out that Miller and Technology scientific do not suggest that once the ingredients are encapsulated, the physical-state characteristics will change, as there is no further modification of the particle size once encapsulated, therefore the preponderance of the evidence supports the conclusion that the physical state characteristics are preserved.
With regards to the limitations of claims 25, 27, and 30-31, wherein the coordinated integration reduces interference between chemically distinct micronized bioactive subsystems during coordinated targeted release; wherein the substantially equalized particle-size distribution relationships comprise overlapping micronized particle-size ranges across multiple micronized bioactive subsystems; wherein the preserved physical-state characteristics of the micronized bioactive subsystems are maintained through coordinated micronized particle-size distribution relationships configured to preserve structurally distinct subsystem organization within the encapsulated delivery matrix; and wherein the coordinated micronized distribution architecture is characterized by measurable particle-size relationship distributions across multiple micronized bioactive subsystems sufficient to maintain coordinated distribution of the micronized bioactive subsystems within the encapsulated delivery matrix and coordinated targeted-release behavior following encapsulation, the examiner points out that these limitations are inherent properties of Miller’s multi-compartment capsule which teaches the combination of ingredients with the knowledge available to one of ordinary skill in the art (paragraph [0376]), such as Androstenedione (i.e., DHEA derivative encompassing androstane analogs including dione) (paragraph [0377]), Siberian ginseng (paragraph [0377]), Fish Oil 30% EPA/20% DHA (i.e., omega-3 fatty acids) (paragraph [0382]), Pyridoxine Hydrochloride (Vitamin B6) (paragraph [0384]), trans-resveratrol (paragraph [0377]), HMB (Hydroxyl Methyl Butyrate) (paragraph [0380]), and phospholipids (paragraph [0379]). in view of the teachings of Technology scientific wherein micronization has the benefits of enhancing solubility, increasing bioavailability and the enhancement of product performance, wherein a micronized product, with a high surface-to-volume ratio increasing radically the number of molecules dissolving in the glycocalyx, ready to cross the enteric mucosae, and increasing the bioavailability can unleash the whole therapeutic potential of the product and improve the patient’s well-being (The Science behind Micronization, seventh paragraph).
Response to Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive.
On pages 8-9 of Applicant’s remarks, Applicants argue that Miller does not disclose or suggest coordinated integration of independently pre-processed micronized bioactive subsystems within a common encapsulated delivery matrix while preserving distinct subsystem characteristics following integration. Nor does Miller teach coordinated particle-size distribution relationships, pre-formed phytosome architectures, or structurally distinct micronized domain organization after encapsulation. Applicant further argues that the cited references fail to teach or suggest (i) independently pre-processing specified bioactive groups prior to integration, (ii) blending the micronized components until coordinated particle-size equalization is achieved, (iii) integrating a pre-formed phytosome complex that maintains structurally distinct phospholipid-associated organization during integration; and (iv) producing a coordinated non-homogeneous targeted-release delivery architecture.
This argument is not persuasive. The examiner points out that the broadest reasonable interpretation of coordinated integration of independently pre-processed micronized bioactive subsystems within a common encapsulated delivery matrix while preserving distinct subsystem characteristics following integration, coordinated particle-size distribution relationships, pre-formed phytosome architectures, or structurally distinct micronized domain organization after encapsulation encompasses a capsule that comprises compartments that are separated and Applicant has not defined these terms. The examiner further points out that Miller teaches a novel integrated capsule delivery apparatus and methods for delivering one or more active ingredients or medicaments such as a dietary supplement in the form of a single dosage, multi-compartment capsule having one or more active ingredients in a primary capsule and one or more active ingredients introduced into a secondary smaller capsule having a size (paragraph [0039]), therefore Miller teaches that more than one active ingredient can be in one targeted-release delivery system. With regards to the arguments wherein the cited references fail to teach or suggest (i) independently pre-processing specified bioactive groups prior to integration, (ii) blending the micronized components until coordinated particle-size equalization is achieved, (iii) integrating a pre-formed phytosome complex that maintains structurally distinct phospholipid-associated organization during integration; and (iv) producing a coordinated non-homogeneous targeted-release delivery architecture, the Examiner points out that these limitations are all new matter as stated above wherein no explicit support for these limitations are found in the instant specification.
On page 10 of Applicants remarks, Applicant argues that the presently claimed processing limitations define resulting structural and physical-state relationships within the claimed delivery system itself, such as i) independently pre-processed bioactive groups; ii) the preservation of distinct physical-state characteristics; iii) coordinated particle-size equalization architecture; iv) coordinated micronized distribution relationships; v) pre-formed phytosome architectures; vi) preserved subsystem characteristics; vii) structurally distinct micronized domains; and viii) coordinated non-homogeneous targeted-release organization. These limitations define affirmative structural organization within the encapsulated delivery system itself rather than merely reciting manufacturing steps or intended use.
This argument is not persuasive. The Examiner points out that the means by which one arrives at the structure of the claimed invention is a product by process. The Examiner contends that the end product falls within the broadly interpreted claims. Within a reasonable broad interpretation of what the claims encompass, the prior art fits the same structure as the claimed invention. The Examiner further points out that that the structural and physical-state relationships within the claimed delivery system itself are not defined in the instant specification.
On page 11 of Applicants remarks, Applicants argue that among other disclosures lacking in the cited references, they fail to disclose: i) deliberate phytosome pre-formation; ii) preservation of phytosome structural organization during integration; iii) coordinated subsystem perseveration; or iv) any inevitable formation of the claimed phytosome architecture, therefore the inherency position is unsupported.
This argument is not persuasive. In response to applicant's argument that in the cited references, they fail to disclose: i) deliberate phytosome pre-formation, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The Examiner reiterates that Miller teaches the present invention will use one or more of the below ingredients in a multi-compartment capsule, combinable as would be recognized in view of the teachings of the present application in combination with the knowledge available to one of ordinary skill in the art (paragraph [0376]), such Siberian ginseng (paragraph [0377]), ashwagandha (paragraph [0377]), and phospholipids (paragraph [0379]). The Examiner points out that in combining the phospholipids with phytochemicals (i.e., Siberian ginseng powder, ashwagandha, ginseng (Korean) powder), the formation of a phytosome complex will inherently occur. The Examiner further points out with regards to the deliberate phytosome pre-formulation, one need not know that they are making a phytosome complex in order for a phytosome complex to occur. Secondarily, a phytosome complex occurs because all the ingredients needed in the method steps to form a phytosome complex are present. With regards to the arguments wherein the references fail to disclose the preservation of phytosome structural organization during integration and coordinated subsystem preservation, these limitations are not relevant to the formation of the phytosome complex but rather what happens after the phytosome complex occurs.
On pages 11-12 of Applicant’s remarks, Applicant argues that Miller primarily discloses ingredient combinations and generalized supplement systems, and Miller fails to teach or suggest: 1) independently preserving physical-state characteristics prior to subsystem integration; 2) coordinated particle-size equalization architecture; 3) pre-formed phytosome integration architecture; 4) structurally distinct micronized domain organization, or 5) coordinated non-homogeneous targeted-released architecture. Mora fails to disclose the multi-component coordinated architecture, structurally preserved subsystem integration, or coordinated targeted-release organization as presented in the currently amended claims. Technology Scientific merely provides generalized teachings regarding micronization and bioavailability enhancement. Therefore the cited references fail to disclose or suggest preservation of coordinated subsystem-state relationships or coordinated micronized distribution architectures as presently recited in newly added claims 21-30.
These arguments are not persuasive. The Examiner points out that the limitations 1) independently preserving physical-state characteristics prior to subsystem integration; 2) coordinated particle-size equalization architecture; 3) pre-formed phytosome integration architecture; 4) structurally distinct micronized domain organization, or 5) coordinated non-homogeneous targeted-released architecture, are not defined in the instant specification. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references…[The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
On pages 12-13 of Applicant’s remarks, Applicant argues the Office action has not established that the claimed coordinated particle size equalization architecture, independently preserved subsystem states, structurally distinct phytosome integration architecture, or coordinated non-homogeneous delivery organization represented recognized result-effective variables subject to routine optimization.
This argument is not persuasive. The Examiner is not asserting that the routine optimization would arrive at the limitations of the claimed coordinated particle size equalization architecture, independently preserved subsystem states, structurally distinct phytosome integration architecture, or coordinated non-homogeneous delivery organization. However, the Examiner asserts that one would arrive through routine optimization the amounts of each ingredient in the capsule. One would have understood in view of Miller that the amounts of each material is typically based upon the formulator’s opinion, and that there are some recommended daily allowances that could be used to determine the amounts in the formulation. It would have been obvious to optimize the amounts of the ingredients in the capsule because Miller teaches that the amounts of the materials are based upon the formulator’s opinions to achieve desired results. "[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). See MPEP 2144.05 (II) (A).
On page 13 of Applicants remarks, Applicant argues the prior art teaches away from combining chemically and physical diverse bioactive compounds into a coordinated integrated system due to risks of incompatibility, instability, absorption competition, and subsystem interference.
This argument is not persuasive. The Examiner reads Miller’s multi-compartment capsule as being a coordinated integrated system, wherein Miller has found a solution for risks of incompatibility, instability, absorption competition, and subsystem interference by using a multi-compartment capsule wherein one or more active ingredients are in a primary capsule, and one or more active ingredients are introduced into a secondary smaller capsule having a size sufficient for being selectively positionable within the primary capsule (paragraph [0039]).
On page 14 of Applicant’s remarks, Applicants argue that the Examiner has not demonstrated that the presently claimed coordinated structural architecture as a whole would have been obvious. Applicant’s invention, as presently claimed, recites a coordinated subsystem integration framework in which: 1) there is a preprocessing sequence; 2) there is coordinated subsystem-state preservation; 3) there is particle-state equalization; 4) there is coordinated micronized distribution architecture; 5) there is phytosome pre-formation; 6) there is coordinated micronized integration; and 7) there is coordinated non-homogenous targeted-release architecture.
This argument is not persuasive. The Examiner reiterates that the limitations of 1) there is a preprocessing sequence; 2) there is coordinated subsystem-state preservation; 3) there is particle-state equalization; 4) there is coordinated micronized distribution architecture; 5) there is phytosome pre-formation; 6) there is coordinated micronized integration; and 7) there is coordinated non-homogenous targeted-release architecture are not defined in the instant specification.
On page 14 of Applicant’s remarks, Applicants argue unexpected and non-obvious results wherein the presently claimed coordinated targeted-release delivery architecture achieves structural and functional coordination not predictable from the isolated teachings of the cited references.
This argument is not persuasive. The Examiner points out that Applicants assertion of unexpected and non-obvious results need to be supported by evidence. Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
Conclusion
No claims are allowed.
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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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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