DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after May 16, 2023, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 05/16/2023 in the matter of Application N° 18/037,223. Said documents are entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after May 16, 2023, is being examined under the first inventor to file provisions of the AIA .
Thus, claims 1-21 represent all claims currently under consideration.
Withdrawn Rejections
The rejection of claims 2-4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of the amendments made thereto.
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 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Pinsky (US20090169615) in view of Loria (US9993578).
Regarding claims 1, and 22-24, Pinsky teaches use of bioactive collagen proteins, which serve as a dermal filler and also have beneficial biological activity, is the subject of other embodiments (See 0031). Making up the first silicone oil (See 0121-0122). There are several different types of carriers. Emulsion carriers, such as water in oil, water in water, oil in water in silicone emulsions, are a few examples (See 0121). According to the current invention, emulsions can include both an oil or lipid and the solution previously mentioned. Lipids and oils can be synthetic or natural, and they can come from petroleum, plants, or animals. Glycerin is one example of a humectant that is present in desired emulsions. Ideally, emulsions will also contain between 0.01% and 10% (See 0122). Transport medium. The unique property of HA to give highly swollen cross-linked gels can be used to effect modification of the properties of cross-linked gels made of mixtures of HA with other hydrophilic polymers. These polymers include other polysaccharides, such as carboxymethyl cellulose (See 0079). Nonlimiting classes of thickening agents for use in the compositions of the invention include those selected from the following: carboxylic acid polymers (See 0186). A surfactant. to prepare non-phospholipid paucilamellar lipid vesicles formed of non-phospholipid surfactant material and containing an aqueous-based collagen and/or HA material, any suitable method known in the art can be used (See 0112). In certain embodiments, oil-in-water emulsions that contain at least one hydrophilic surfactant which can disperse the hydrophobic materials in the water phase (percentages by weight of the topical carrier). The surfactant, at a minimum, must be hydrophilic enough to disperse in water (See 0131). The compositions of the present invention may also contain a safe and effective amount of a topical anesthetic. Examples of topical anesthetic drugs include lidocaine (See 0172). And optionally a second silicone oil. Anti-foaming agents include high molecular weight silicones and other materials well known in the art for such use (See 0123). Note: since silicones are utilized as both emulsion components and anti-foaming agents, several silicones are thought to be present, with the filler composition being an oil in water emulsion that is accepted by pharmaceuticals. The carrier can be in a wide variety of forms. For example, emulsion carriers, including, but not limited to, oil-in-water, water-in-oil, water-in-oil-in-water, and oil-in-water-in-silicone emulsions, are useful herein, and that the composition may deliver collagen to a human through the dermis of the skin (See Abstract). In one embodiment, the present invention provides a skin care composition with a safe and effective amount of one or more collagen fragments, and/or variants thereof, wherein the formulation facilitates the passage of the collagen protein through the epidermis and thus being delivered to the dermis of the skin (See 0030). However, it doesn’t go into detail about the filer’s composition, which includes optionally a second silicone oil with a second viscosity lower than the first, 15-98% water, 1-3wt.% of a transport medium, 0.05-10 vol.% of a surfactant, and 1-80 vol.% of a first silicone oil with a second viscosity. At the case where the initial viscosity is 30,000 cSt or less, the second silicone oil is supplied at a volume percentage of 0-80. At least one of the first and second silicone oils are distributed in the water as droplets with an average diameter of less than 30 microns when the initial viscosity is higher than 30,000 cSt. And when inserted intradermally or subcutaneously in a human, the transport medium is biodegradable and serves as a temporary scaffold for the formation of collagen between the droplets. But as Pinsky explains, the emulsions could contain droplets. In emulsion technology, the term “dispersed phase” is a term well-known to one skilled in the art that means that the phase exists as small particles or droplets that are suspended in and surrounded by a continuous phase (See 0126). Having 0.5-to-2-micron diameter. If an aqueous center is used, the paucilamellar lipid vesicles will normally range in diameter from about 0.5-2 μ, that the composition may comprise thickeners (See 0116). The compositions of the present invention can contain one or more thickening agents, preferably from about 0.1% to about 5%, that the composition may degrade in the living body slowly. Delivery of a drug from these systems occurs when the gel is degraded in the living body. The degradation process is usually slower than diffusion (See 0086). The rate of the degradation process can be controlled by several means.
Therefore, it would have been obvious to one of ordinary skill in the art before the instant effective filing date to create the filler composition comprising: 1-80 vol.% of a first silicone oil having a first viscosity; 15-98 vol.% of water; 1-3 wt% of a transport medium. 0.05-10 vol% of a surfactant; and optionally a second silicone oil having a second viscosity lower than the first viscosity. Wherein the second silicone oil is provided in an amount of 1-80 vol.% when the fist viscosity is 30,000 cSt or less; the second silicone oil is provided in an amount of 0-80 vol.%. when the first viscosity is greater than 30,000 cSt; at least one of the first silicone oil and the second silicone oil is dispersed in the water as droplets having an average diameter of less than 30 microns; and the transport medium is sufficiently biodegradable when implanted intradermally or subcutaneously in a human to provide a temporary scaffold for collagen growth between the droplets, through routine experimentation.
Regarding claim 2, Pinsky teaches the filler composition of claim 1, as previously mentioned, but the composition, which consists of 3 vol.% of the second silicone oil and 27 vol.% of the first silicone oil, with the first viscosity being 12,500 cSt and the second viscosity being 1,000 cSt, is not specifically disclosed. But as pinsky reveals, several silicones are used. The carrier can be in a wide variety of forms. For example, emulsion carriers, including, but not limited to, oil-in-water, water-in-oil, water-in-oil-in-water, and oil-in-water-in-silicone emulsions (See 0121). High molecular weight silicones and other compounds that are well-known in the field for their usage as anti-foaming agents are examples. And that thickeners might be included in the composition (See 0123). The compositions of the present invention can contain one or more thickening agents, preferably from about 0.1% to about 5% (See 0185).
Therefore, it would have been obvious to one of ordinary skill in the art before the instant effective filing date to create the filler composition which comprises 3 vol.% of the second silicon oil and 27 vol% of the first silicone oil, wherein the second viscosity is 1,000 cSt and the first viscosity is 12,500 cSt, through routine experimentation.
Regarding claim 3, Pinsky teaches the filler composition of claim 1, as previously mentioned, but the composition, which consists of 5 vol.% of the second silicone oil and 25 vol.% of the first silicone oil, with the first viscosity being 100,000 cSt and the second viscosity being 12,500 cSt, is not specifically disclosed. However, as Pinsky discloses the use of multiple silicones, the carrier can be in a wide variety of forms. For example, emulsion carriers, including, but not limited to oil in water in silicone emulsions (See 0122). Anti-foaming agents include high molecular weight silicones and other materials well known in the art for such use (See 0123). And that the composition may comprise thickeners. The compositions of the present invention can contain one or more thickening agents, preferably from about 0.1% to about 5%.
Therefore, it would have been obvious to one of ordinary skill in the art before the instant effective filing date to create the filler composition which comprises 5 vol.% of the second silicon oil and 25 vol.% of the first silicone oil, wherein the second viscosity is 12,500 cSt and the first viscosity is 100,000 cSt, through routine experimentation.
Regarding claim 4, Pinsky teaches the filler composition of claim 1, as disclosed above, but does not further specifically disclose the composition which comprises 30 vol% of the first silicon oil and none of the second silicone oil, wherein the first viscosity is 100,000 cSt. However, as Pinsky discloses the use of multiple silicones. The carrier can be in a wide variety of forms. For example, emulsion carriers, including, but not limited to, oil in water in silicone emulsions (See 0122). Anti-foaming agents include high molecular weight silicones and other materials well known in the art for such use (See 0123). And that the composition may comprise thickeners. The compositions of the present invention can contain one or more thickening agents, preferably from about 0.1% to about 5%. It would have been obvious to one of ordinary skill in the art to create the filler composition which comprises 30 vol.% of the first silicon oil and none of the second silicone oil, wherein the first viscosity is 100,000cSt, through routine experimentation.
Regarding claims 5, Pinsky teaches the filler composition of claim 1, but does not further specifically disclose the composition wherein the first viscosity is from 12,500 cSt to 20,000,000 cSt and the second viscosity is from 65 cSt to 5,000 cSt. However, as pinsky teaches the use of multiple silicones, the carrier can be in a wide variety of forms. For example, emulsion carriers, including, but not limited to oil in water in silicone emulsions (See 0122). Anti-foaming agents include high molecular weight silicones and other materials well known in the art for such use and that the composition may comprise thickeners. The compositions of the present invention can contain one or more thickening agents, preferably from about 0.1% to about 5%. It would have been obvious to one of ordinary skill in the art to create the filler composition wherein the first viscosity is from 12,500 cSt to 20, 000,000 cSt and the second viscosity is from 65 cSt to 5000 cSt, through routine experimentation (See 0185).
Regarding claims 6, and 22-24, Pinsky teaches the filler composition of any one of claims 1-5, as described above, but does not further describe wherein the first silicone oil and the second silicone oil are polydimethylsiloxane. The filler composition that Lora teaches is similar. The present invention relates to compositions in the form of oil-in-water dispersions comprising a silicone oil (See Abstract). This invention pertains to compositions that contain silicone oil-in-water emulsions, as well as techniques for creating and applying such composition as dermal fillers (col 1 lines 10-12). polydimethylsiloxane may be a component of the composition. In certain embodiments of the filler composition, the silicone oil comprises at least one member selected from the group consisting of polydimethylsiloxane. In certain embodiments of the filler composition, the silicone oil comprises polydimethylsiloxane with a viscosity of 5000 cSt (See col 4 lines 49-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the instant effective filing date to combine these references, and to create the filler composition wherein the first silicone oil and the second silicone oil are polydimethylsiloxane, because PDMS is a known lubricant with personal care uses as skin conditions that provide a smooth feel (See col 2 lines 46-61).
Regarding claim 7, Pinsky teaches the filler composition of any of claims 1-5, wherein the transport medium may be a water-soluble. The unique property of HA to give highly swollen cross-linked gels can be used to effect modification of the properties of cross-linked gels made of mixtures of HA with other hydrophilic polymers. These polymers include carboxymethyl cellulose (See 0079). Nonlimiting classes of thickening agents for use in the compositions of the invention include those selected from the following carboxymethyl cellulose (See 0186).
Regarding claim 8, Pinsky teaches the filler composition of any one of claims 1-5, wherein the transport medium may be at least one member selected from the group consisting of carboxymethylcellulose he unique property of HA to give highly swollen cross-linked gels can be used to effect modification of the properties of cross-linked gels made of mixtures of HA with other hydrophilic polymers (See 0079). Nonlimiting classes of thickening agents for use in the compositions of the invention include those selected from the following: carboxymethyl cellulose, hyaluronic acid, hydroxyethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, polyvinylalcohol, guar gum, hydroxypropyl guar gum, xanthan gum, croscarmellose sodium, and alginic acid (See 0186).
Regarding claim 9, Pinsky teaches the filler composition of claim 8, wherein the transport medium may be CMC. The unique property of HA to give highly swollen cross-linked gels can be used to effect modification of the properties of cross-linked gels made of mixtures of HA with other hydrophilic polymers. These polymers include carboxymethyl cellulose (See 0079). Nonlimiting classes of thickening agents for use in the compositions of the invention include those selected from the following carboxymethyl cellulose (See 0186).
Regarding claim 10, Pinsky teaches the filler composition of claim 9, but does not further specifically disclose wherein the CMC is cross-linked. However, as Pinsky discloses that cross-linking takes place. The swelling ratio depends upon the degree of cross-linking of the gel (See 0076). And the use of cross-linking agents. An even more preferred cross-linking agent is 1,4-butanediol diglycidyl ether (BDDE) (See 0077). It would have been obvious to one of ordinary skill in the art to create the filler composition wherein the CMC is crossed linked, through routine experimentation.
Regarding claim 11, Pinsky teaches the filler composition of any of claims 1-5, but does not further teach wherein the temporary scaffold dissolves in 7 to 35 days. However, Pinsky reveals that the composition may gradually deteriorate in a living body. Delivery of a drug from these systems occurs when the gel is degraded in the living body. The degradation process is usually slower than diffusion. The rate of the degradation process can be controlled by several means (See 0086). It would have been obvious to one of ordinary skill in the art to create the filler composition wherein the temporary scaffold in 7 to 35 days, through routine experimentation.
Regarding claim 12, Pinsky teaches the filler composition of any one of claims 1-5, wherein, the surfactant may be lidocaine. The compositions of the present invention may also contain a safe and effective amount of a topical anesthetic. Examples of topical anesthetic drugs include lidocaine (See 0172).
Regarding claim 13, Pinsky teaches the filler composition of any one of claims 1-5, as described above, but does not further specifically teach wherein the average diameter of the droplets is from 1 nanometer to 1 micron. However, as pinsky teaches the use of droplets having 0.5-to-2-micron diameter. If an aqueous center is used, the paucilamellar lipid vesicles will normally range in diameter from about 0.5-2 μ. It would have been obvious to one of ordinary skill in the art to create the filler composition wherein the average diameter of the droplets is from 1 nanometer to 1 micron, through routine experimentation (See 0116).
Regarding claim 14, Pinsky teaches the first silicone oil and the second silicone oil are polydimethylsiloxane; the transport medium may be an optionally cross-linked water-soluble polymer selected from the group consisting of carboxymethylcellulose. The unique property of HA to give highly swollen cross-linked gels can be used to effect modification of the properties of cross-linked gels made of mixtures of HA with other hydrophilic polymers (See 0079). These polymers include carboxymethylcellulose. Nonlimiting classes of thickening agents for use in the compositions of the invention include those selected from the following carboxymethyl cellulose. Nonlimiting classes of thickening agents for use in the compositions of the invention include those selected from the following carboxymethylcellulose, hyaluronic acid, hydroxyethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone, polyvinylalcohol, guar gum, hydroxypropyl guar gum, xanthan gum, croscarmellose sodium, and alginic acid; the surfactant is lidocaine; and/or the average diameter of the droplets may be from 1 nanometer to 1 micron (See 0186). If an aqueous center is used, the paucilamellar lipid vesicles will normally range in diameter from about 0.5-2 μ (See 0116).
Regarding claim 15, Loria teaches a similar filler composition. The present invention relates to compositions in the form of oil in water dispersions comprising a silicone oil (See Abstract). This invention relates to compositions comprising silicone oil-in-water emulsions and to methods of making and using such compositions as a dermal filler, wherein a method for preparing the filler composition comprising the steps of (I) preparing an oil phase comprising the steps of: (a) providing an active ingredient that is substantially sterile and substantially free of pyrogen, wherein the active ingredient is the second silicone oil or the first silicone oil when there is no second silicone oil (See col 1 lines 10-12). The processes comprise the general steps of (i) preparing a silicone oil phase comprising the steps of: (a) sterilizing and depyrogenizing a sample of silicone oil until essentially sterile and pyrogen-free; (b) mixing the active ingredient with 1-5 volumes of sterile injectable water for 4 to 6 minutes at 1200 to 1500 rpm (See col 11 lines 21-25). Mixing the resultant sterile and pyrogen-free silicone oil sample with from about an equal volume to about four to five volumes of sterile injectable water, for approximately 5 minutes at about 1200 to 1500 rpm (See col 11 lines 26-29). (c) allowing the active ingredient and water mixture to separate into a lower water layer and an upper layer containing the active ingredient. Allowing the silicone oil and water mixture to separate into two layers (col 11 lines 30-31). (d) removing the lower water layer and collecting the upper silicone layer (See col 11 lines 32-33) and (e) repeating steps (b) through (d) on the active ingredient at least once to obtain the oil phase. Repeating steps b through d on the silicone oil one or more additional times (ii) preparing a water phase solution comprising the sequential steps of (a) dissolving with stirring a transport medium in a sterile solvent selected from the group consisting of injectable water, normal saline, Ringer’s solution, and lactated Ringer’s solution, to form a preliminary water phase solution (See col 11 lines 38-39). Dissolving a thickening agent in sterile injectable water or a sterile solution selected from normal saline, Ringer’s solution, or lactated Ringer’s solution, solution with stirring to form a thickened water phase solution (See col 11 lines 41-44) (b) sterilizing the preliminary water phase solution to form a sterilized water phase solution (See col 11 line 45). Sterilizing the thickened water phase solution, and (c) Optionally freezing and thawing the sterilized thickened water phase solution; and (iii) preparing an oil in water emulsion by combining 35-45 parts by volume of the oil phase with 55-65 parts by volume of the water phase solution with agitation to form an emulsion of the active ingredient within the water (See col 11 lines 46-47). Adding approximately 40 parts by volume of the silicone oil phase to approximately 60 parts by volume of the thickened water phase with agitation to form a dispersion of the silicone oil within the water (See col 11 lines 51-54)
Therefore, it would have been obvious to one of ordinary skill in the art prior to the instant effective filing date to combine these references, and to create a method for preparing the filler composition according to any one of claims 1-5, comprising the steps of: (a) providing at least one silicone oil that is substantially sterile and substantially free of pyrogen, wherein the at least one silicone oil comprises the first silicone oil and optionally the second silicone oil;(b) mixing the at least one silicone oil with 1-5 volumes of sterile injectable water for 4 to 6 minutes at 1200 to 1500 rpm; (c) allowing the at least one silicone oil and water mixture to separate into a lower water layer and an upper layer containing the at least one silicone oil; (d) removing the lower water layer and collecting the upper layer; and (e) repeating steps (b) through (d) on the at least one silicone oil at least once to obtain the oil phase; (ii) preparing a water phase solution comprising the sequential steps of: (a) dissolving with stirring a transport medium in a sterile solvent selected from the group consisting of injectable water, normal saline, Ringer's solution, and lactated Ringer's solution, to form a preliminary water phase solution; (b) sterilizing the preliminary water phase solution to form a sterilized water phase solution; and (c) optionally freezing and thawing the sterilized water phase solution; and (iii) preparing an oil-in-water emulsion by combining 35-45 parts by volume of the oil phase with 55-65 parts by volume of the water phase solution with agitation to form an emulsion of the at least one silicone oil within the water, because the procedure can readily be modified to incorporate further cross-linking agents to aid in thickening (See Loria, col 5 lines 29-31; col 11 lines 55-67).
Regarding claim 16, Pinsky in view of Loria describes the method of claim 15, as described above. Pinsky further describes wherein the sterile solvent may contain a cross-linking agent which forms cross-links in the transport medium. An even more preferred cross-linking agent is 1,4-butanediol diglycidyl ether (BDDE) (see 0077).
Regarding claim 17, Pinsky in view of Loria teaches the method of claim 16, as described above. Pinsky further describes wherein the cross-linking agent may be 1,4-butanediol diglycidyl ether. An even more preferred cross-linking agent is 1,4-butanedioldiglycidyl ether (BDDE), but does not further specifically disclose wherein it is present in an amount from 0.01 to 10% by weight of the composition. However, it would have been obvious to one of ordinary skill in the art to create the method wherein the cross-linking agent may be 1,4-butanediol diglycidyl ether present in an amount from 0.01 to 10% by weight of the composition, through routine experimentation (See 0077).
Regarding claim 18, as previously mentioned, Pinsky describes the filler composition of any one of claims 1-5, but it makes no explicit mention of a soft tissue augmentation technique that involves injecting the filler composition of any one of claims 1-5 into a patient intradermally or subcutaneously. A comparable filler content is revealed by Loria. The present invention relates to compositions in the form of oil-in-water dispersions comprising a silicone oil (See abstract). This invention relates to compositions comprising silicone oil-in water emulsions and to methods of making and using such compositions as a dermal filler, wherein the composition may be used in a soft tissue augmentation method comprising intradermally and/or subcutaneously injecting into a patient the filler composition (See col 1 lines 10-12). A third aspect of the invention is directed to a soft tissue augmentation method comprising subcutaneously injecting into a patient the filler composition of the invention.
Therefore, it would have been obvious to one of ordinary skill in the art before the instant effective filing date to combine these references, and to create a soft tissue augmentation method comprising intradermally and/or subcutaneously injecting into a patient the filler composition of any one of claims 1-5, because liquid injectable silicone is a known soft tissue filler and is both versatile and cost-effective (See Loria, col 7 lines 25-32).
Regarding claim 19, Pinsky in view of Loria describes the soft tissue augmentation method of claim 18, as described above. Loria further describes wherein a volume of 20 to 60 ml of the filler composition is injected into a single injection site. In certain embodiments of the soft tissue augmentation method, a volume of 20 to 60 ml is injected into a single injection site (col 5 lines 39-41).
Regarding claim 20, Pinsky in view of Loria teaches the soft tissue augmentation method of claim 18, as described above. Loria further describes wherein: the filler composition stimulates collagen growth; the transport medium forms a temporary scaffold for collagen growth between active ingredient droplets. In certain embodiments of the filler composition, the thickening agent is carboxymethyl cellulose (col 4 lines 37-38). The filler composition stimulates collagen growth between silicone oil droplets and a collagen matrix anchors the active ingredient droplets in place as the temporary scaffold dissolves within 7-35 days (See col 5 lines 44-45). A collagen matrix anchors the silicone oil droplets in place as the temporary scaffold dissolves within 14-28 days (See col 5 lines 45-47).
Regarding claim 21, Pinsky in view of Loria teaches the soft tissue augmentation method of claim 18, as described above. Loria further teaches wherein the filler composition is injected into a penis or a scrotum for penis or scrotum enhancement. In certain embodiments of the soft tissue augmentation method, the filler composition is injected into a penis or a scrotum for penis or scrotum enhancement (See col 5 lines 48-50).
Response to Arguments
Applicant's arguments filed September 28, 2025 have been fully considered but they are not persuasive. Pinsky is analogous art. Under controlling precedent, a reference is analogous art if it is either: (1) from the same field of endeavor, regardless of the problem addressed, or (2) reasonably pertinent to the particular problem with which the inventor was concerned (MPEP 2141.01 (a)). Pinsky is directed to injectable dermal filler compositions, including formulations intended for soft tissue augmentation, tissue support, and long-lasting dermal effects. The present application is likewise directed to injectable filler compositions intended to achieve tissue anchoring and collagen matrix formation in the dermis.
Accordingly, both Pinsky and the claimed invention fall within the same field of endeavor, namely dermal filler formulations and injectable cosmetic/medical compositions. Pinsky is reasonably pertinent to the problem addressed: Even assuming arguendo that the field of endeavor were construed narrowly, Pinsky remains reasonably pertinent to the problem addressed by the present application. The problem addressed by the claimed invention concerns: filler retention and anchoring within tissue, and interaction between injectable materials and the dermal environment, including stimulation of tissue response. Pinsky expressly teaches injectable compositions that interact with dermal tissue, including embodiments in which bioactive components promote tissue response and integration. Pinsky further discloses multiple carrier systems, including, silicone oil-based systems, emulsion carriers (e.g., water-in-oil, oil-in-water, oil-in-silicone emulsions), and combinations of oils, lipids, and aqueous phases. These teachings directly relate to the delivery, retention, and biological interaction of dermal fillers, which are the same general considerations implicated by the claimed invention, even if the biological mechanism differs.
Thus, a person of ordinary skill in the art seeking to improve dermal filler anchoring, stability, and tissue interaction would reasonably have consulted Pinsky.
Exclusion of collagen does not render pinsky non-analogous. Applicant’s argument improperly conflates differences in clamed limitations with non-analogous art. The fact that the present claims exclude collagen does not negate the relevance of Pinsky, which teaches: filler compositions, carrier systems, emulsion structures, and dermal tissue interaction principles. It is well established that a reference need not disclose every claimed feature to be analogous art. Differences in mechanism of action (exogenous collagen replacement versus stimulation of endogenous collagen formation) do not preclude a reference from being reasonably pertinent, particularly where both references address how injectable fillers are formulated, delivered, and retained in tissue.
A person of ordinary skill in the art would have been motivated to consider Pinsky in order to select suitable carrier systems (e.g. silicone oils and emulsions), optimize injectability and tissue compatibility, and improve filler persistence and integration within dermal tissue. The motivation arises from the shared goal of achieving effective, stable dermal fillers, not from identical biological mechanisms.
Pinsky is analogous art, as it is from the same field of endeavor and is reasonably pertinent to the problem addressed. Applicant’s exclusion of collagen does not render Pinsky non-analogous.
Pinsky does not teach away from high-viscosity silicone oils. A reference teaches away only if it criticizes, discredits, or otherwise discourages the claimed solution (In re Gurley, 27 F.3d 551 (Fed. Cir. 1994)). Mere disclosure of preferred embodiments or examples using lower viscosities does not constitute teaching away. While Pinsky discloses embodiments in which certain emulsions may exhibit viscosities of approximately 50 cSt or less, Pinsky does not state or suggest that higher-viscosity silicone oils are unsuitable, undesirable, or inoperable for dermal filler compositions. To the contrary, Pinsky expressly teaches that, multiple silicone oils may be used, the carrier can be in a wide variety of forms, including oil-in-water, water-in-oil, oil-in-water-in-silicone, and other emulsion systems, and higher molecular weight silicones are known and suitable for use in such compositions. Accordingly, Pinsky does not discourage the use of higher-viscosity silicone oils, but instead provides broad flexibility in carrier selection and formulation design.
The absence of explicit disclosure of the claimed viscosities does not constitute teaching away. Applicant’s argument improperly equates lack of explicit disclosure with teaching away. Pinsky’s failure to expressly disclose a composition comprising, for example, 27 vol.% of a first silicone oil having a viscosity of 12,500 cSt and 3 vol.% of a second silicone oil having a viscosity of 1,000 cSt, does not amount to a teaching away. It is well established that prior art need not disclose the exact claimed values to render them obvious, and overlapping or adjacent ranges and routine optimization of result-effective variables, such as viscosity and relative component amounts, are considered obvious absent a showing of criticality (MPEP 2144; In re Aller, 220 F.2d 454 (CCPA 1955)).
Pinsky further teaches that the disclosed compositions may include thickening agents, preferably in amounts ranging from about 0.1% to about 5%, to adjust the rheological properties of the formulation. The express inclusion of thickening agents demonstrates that viscosity is a design parameter intended to be adjusted, not a fixed or limiting characteristic. This teaching directly undermines applicant’s assertion that pinsky would dissuade the use of higher-viscosity systems.
A person of ordinary skill in the art would have been motivated to modify the viscosity of Pinsky’s filler compositions by: selecting higher-viscosity silicone oils, combining silicone oils of differing viscosities, and/or incorporating known thickening agents, in order to optimize injectability, tissue retention, and in vivo performance, with a reasonable expectation of success, given Pinsky’s broad disclosures regarding carriers, silicone materials, and rheology control. The differences in viscosity reflect routine formulation choices, not a fundamental incompatibility.
Pinsky does not teach away from the claimed viscosities. The claimed viscosity ranges represent obvious variations of known formulation parameters. Applicant has not demonstrated that the claimed viscosities yield unexpected results commensurate in scope with the claims.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615