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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 May 2026 has been entered.
Status of Claims
Receipt is acknowledged of claim amendments filed on 14 May 2026.
Claims 4-5, 9, 14-15 and 19 are cancelled.
Claim 21 has been added.
Claims 1-3, 6-8, 10-13, 16-18 and 20-21 are pending and presented for examination herein.
Rejections Maintained and Modified as Necessitated by the Claim Amendments
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over PETITO (US 2015/0216946 A1, publication date of 6 August 2015) in view of GREENSPAN (US 6,756,060; patent date of 29 June 2004) and CHANG (CN 106310347 B, publication date of 14 May 2019).
Petito is primarily directed towards a composition for reducing scar formation of wounds that includes hydrolyzed collagen and one or more supplemental ingredients (abstract).
Regarding claims 1 and 8, Petito discloses a composition for reduced scar formation of wounds (e.g., treating a wound) that include hydrolyzed collagen and one or more supplemental ingredients (paragraph [0008]). Petito discloses that the hydrolyzed collagen has a molecular weight of including from about 500 Daltons to about 10,000 Daltons (paragraph [0012]). The range of about 500 Daltons to about 10,000 Daltons overlaps ranges of “about 500-1,000 Daltons” (e.g., claims 1 and 20) and “about 500 Da” (e.g., claim 8). Thus, the claims are rendered prima facie obvious. See 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). See also MPEP 2144.05.
Petito does not specifically teach that the composition comprises bioactive glass. Petito does not specifically teach that the composition comprises about 0.1%-10.5% by weight bioactive glass, about 0.1%-2.0% by weight bioactive glass, or about 2.0% by weight bioactive glass. The deficiency is made up for by the teachings of Greenspan and Chang.
Greenspan is primarily directed treating wounds (abstract).
Regarding claim 1, Greenspan teaches compositions and method for treating wounds to significantly reduce the healing time, inflammation is greatly reduced around the wound site, the incidence of scar formation following a wound is reduced and the presence of bacteria is reduced (column 2, lines 31-39). Greenspan teaches compositions for treating wounds and teaches compositions that include particles of bioactive glass, alone or in combination with an additional anti-bacterial and/or anti-inflammatory agent, and optionally include other therapeutic agents (column 2, lines 40-43).
Regarding claim 7, Greenspan teaches that the glass (e.g., bioactive glass) includes between 40 and 86% by weight of silicon dioxide (SiO2), between about 0 and 35% by weight of sodium oxide (Na2O), between about 4 and 46% by weight calcium oxide (CaO), and between about1 and 15% by weight of phosphorus oxide (P2O5) (column 4, lines 27-31).
Chang is primarily directed towards a skin wound dressing and preparation method and application thereof (abstract of the English translation).
Regarding claims 1-3, Chang teaches bioactive glass containing CaO, P2O5, SiO2, and Na2O (third page, second paragraph of the English translation). Chang teaches that the mass percent content of bioactive glass in a wound dressing is 1 to 20% (page 4, ninth paragraph of the English translation). Chang teaches bioactive glass promotes wound healing (sixth page, seventh paragraph of the English translation). It is prima facie obvious for one of ordinary skill in the art to determine the optimum amount of bioactive glass to include in a composition for treating a wound to obtain a desired treatment of the wound, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition for treating wounds that comprises hydrolyzed collagen with a molecular weight of including from about 500 Daltons to about 10,000 Daltons and particles of bioactive glass; wherein the particles of bioactive glass includes between 40 and 86% by weight of silicon dioxide (SiO2), between about 0 and 35% by weight of sodium oxide (Na2O), between about 4 and 46% by weight calcium oxide (CaO), and between about1 and 15% by weight of phosphorus oxide (P2O5); and wherein the mass percent content of the bioactive glass is optimized using including a range of 1 to 20%. The person of ordinary skill in the art would have been motivated to make those modifications to obtain a composition that while adding to improving scarring of a wound (e.g., same purpose of the composition of Petito) additionally provide other benefits including significantly reduce the healing time, greatly reduce inflammation around the wound site, and reduce the presence of bacteria, by adding the bioactive glass taught by Greenspan and Chang; and optimize the amount of the bioactive glass to obtain the desired wound promoting effects of bioactive glass by using including the amount range taught by Chang of 1 to 20%. The person of ordinary skill in the art would have reasonably expected success because Petito discloses a composition for reduced scar formation of wounds (e.g., treating a wound) that include hydrolyzed collagen and one or more supplemental ingredients (paragraph [0008]). Petito discloses that the hydrolyzed collagen has a molecular weight of including from about 500 Daltons to about 10,000 Daltons (paragraph [0012]). Greenspan teaches compositions and method for treating wounds to significantly reduce the healing time, inflammation is greatly reduced around the wound site, the incidence of scar formation following a wound is reduced and the presence of bacteria is reduced (column 2, lines 31-39). Greenspan teaches a compositions and methods for treating wounds and teaches compositions that include particles of bioactive glass (column 2, lines 40-43). Chang teaches that the mass percent content of bioactive glass in a wound dressing is 1 to 20% (page 4, ninth paragraph of the English translation). Chang teaches bioactive glass promotes wound healing (sixth page, seventh paragraph of the English translation).
Claim 6 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Petito in view of Greenspan and Chang as applied to claims 1-3 and 7-8 above, and further in view of KESSLER (US 2004/0065228 A1, publication date of 8 April 2004).
Regarding claims 6 and 21, the composition of claim 1 is described above in section 5.
Petito and Greenspan do not specifically teach that the bioactive glass has an average particle size between about 10 µm and about 90 µm (e.g., claim 6) or between about 35 µm and about 45 µm (e.g., claim 21). The deficiency is made up for by the teachings of Kessler.
Kessler is primarily directed towards a mixture of bioactive glass and dental glass for producing an agent for a permanent dental filling (abstract).
Regarding claim 6, Kessler teaches bioactive glass particles with an average particle size of <50 µm. Kessler teaches that a higher ratio of surface area to weight or volume brings about a higher sterilizing biocidal action than with larger particles (paragraph [0032]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition for treating wounds that comprises hydrolyzed collagen with a molecular weight of including from about 500 Daltons to about 10,000 Daltons and particles of bioactive glass; wherein the particles of bioactive glass includes between 40 and 86% by weight of silicon dioxide (SiO2), between about 0 and 35% by weight of sodium oxide (Na2O), between about 4 and 46% by weight calcium oxide (CaO), and between about1 and 15% by weight of phosphorus oxide (P2O5); wherein the mass percent content of the bioactive glass is optimized using including a range of 1 to 20%; and wherein the bioactive glass have an average particle size of <50 µm. The person of ordinary skill in the art would have been motivated to make those modifications to obtain a composition with a higher sterilizing biocidal action by including bioactive glass particles with an average particle size of <50 µm, as taught by Kessler. The person of ordinary skill in the art would have reasonably expected success because Kessler teaches bioactive glass particles with an average particle size of <50 µm. Kessler teaches that a higher ratio of surface area to weight or volume brings about a higher sterilizing biocidal action than with larger particles (paragraph [0032]).
Claims 10-13, 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over PETITO (US 2015/0216946 A1, publication date of 6 August 2015) in view of PETITO (US 2016/0220645 A1, publication date of 4 August 2016, hereafter Petito2), GREENSPAN (US 6,756,060; patent date of 29 June 2004) and CHANG (CN 106310347 B, publication date of 14 May 2019).
Petito is primarily directed towards a composition for reducing scar formation of wounds that includes hydrolyzed collagen and one or more supplemental ingredients (abstract).
Regarding claims 10, 18 and 20, Petito discloses a composition for reduced scar formation of wounds (e.g., treating a wound) that include hydrolyzed collagen and one or more supplemental ingredients (paragraph [0008]). Petito discloses that the hydrolyzed collagen has a molecular weight of including from about 500 Daltons to about 10,000 Daltons (paragraph [0012]). The range of about 500 Daltons to about 10,000 Daltons overlaps ranges of “about 500-1,000 Daltons” (e.g., claims 1 and 20) and “about 500 Da” (e.g., claim 8). Thus, the claims are rendered prima facie obvious. See 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). See also MPEP 2144.05.
Petito does not specifically teach that the hydrolyzed collagen with a molecular weight of including from about 500 Daltons to about 10,000 Daltons is hydrolyzed collagen comprising bovine sourced hydrolyzed collagen, marine sourced hydrolyzed collagen, and hydrolyzed whey. Petito does not specifically teach that the composition comprises bioactive glass. Petito does not specifically teach that the composition comprises about 0.1%-10.5% by weight bioactive glass, about 0.1%-2.0% by weight bioactive glass, or about 2.0% by weight bioactive glass. The deficiencies are made up for by the teachings of Petito2, Greenspan and Chang.
Petito2 is primarily directed towards composition for tissue/cell repair facilitates healing of damaged tissues, promoting tissue and cell growth, protecting cells and tissues, and reducing scar tissue (abstract).
Regarding claims 10 and 11, Petito2 teaches composition for tissue/cell repair including proteinaceous amino acids including hydrolyzed collagen (paragraph [0012]). Petito2 teaches mixtures of collagen from different collagen sources including bovine sourced collagen, marine sourced collagen, and why protein (paragraph [0024]). Petito2 teaches that varying the source of the hydrolyzed collagen can control the chemotactic, hydrophilic, and cell proliferative properties of the composition (paragraph [0025]). Petito2 teaches for a heavily exudative or wet wound can be treated with a highly hydrophilic composition, including at least about 50% by weight bovine sourced hydrolyzed collagen (e.g., about 50% to about 60% by weight bovine sourced hydrolyzed collagen), at least about 20% by weight marine sourced hydrolyzed collagen (e.g., about 20% to about 30% by weight marine sourced hydrolyzed collagen), and up to about 30% by weight hydrolyzed whey protein (e.g., about 5% to about 30% by weight hydrolyzed whey protein) (paragraph [0026]).
Greenspan is primarily directed treating wounds (abstract).
Regarding claims 10 and 20, Greenspan teaches compositions and method for treating wounds to significantly reduce the healing time, inflammation is greatly reduced around the wound site, the incidence of scar formation following a wound is reduced and the presence of bacteria is reduced (column 2, lines 31-39). Greenspan teaches a compositions and methods for treating wounds and teaches compositions that include particles of bioactive glass, alone or in combination with an additional anti-bacterial and/or anti-inflammatory agent, and optionally include other therapeutic agents (column 2, lines 40-43).
Regarding claim 17, Greenspan teaches that the glass (e.g., bioactive glass) includes between 40 and 86% by weight of silicon dioxide (SiO2), between about 0 and 35% by weight of sodium oxide (Na2O), between about 4 and 46% by weight calcium oxide (CaO), and between about1 and 15% by weight of phosphorus oxide (P2O5) (column 4, lines 27-31).
Chang is primarily directed towards a skin wound dressing and preparation method and application thereof (abstract of the English translation).
Regarding claims 10 and 12-13, Chang teaches bioactive glass containing CaO, P2O5, SiO2, and Na2O (third page, second paragraph of the English translation). Chang teaches that the mass percent content of bioactive glass in a wound dressing is 1 to 20% (page 4, ninth paragraph of the English translation). Chang teaches bioactive glass promotes wound healing (sixth page, seventh paragraph of the English translation). It is prima facie obvious for one of ordinary skill in the art to determine the optimum amount of bioactive glass to include in a composition for treating a wound to obtain a desired treatment of the wound, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition for treating wounds that comprises hydrolyzed collagen with a molecular weight of including from about 500 Daltons to about 10,000 Daltons and particles of bioactive glass; wherein the hydrolyzed collagen with a molecular weight of including from about 500 Daltons to about 10,000 Daltons comprises at least about 50% by weight bovine sourced hydrolyzed collagen (e.g., about 50% to about 60% by weight bovine sourced hydrolyzed collagen), at least about 20% by weight marine sourced hydrolyzed collagen (e.g., about 20% to about 30% by weight marine sourced hydrolyzed collagen), and up to about 30% by weight hydrolyzed whey protein (e.g., about 5% to about 30% by weight hydrolyzed whey protein); wherein the particles of bioactive glass includes between 40 and 86% by weight of silicon dioxide (SiO2), between about 0 and 35% by weight of sodium oxide (Na2O), between about 4 and 46% by weight calcium oxide (CaO), and between about 1 and 15% by weight of phosphorus oxide (P2O5); and wherein the mass percent content of the bioactive glass is optimized using including a range of 1 to 20%; and administered the composition to a subject in need of treatment for a wound. The person of ordinary skill in the art would have been motivated to make those modifications to obtain: 1) a composition that is highly hydrophilic to treat heavily exudative or wet wound by including as the hydrolyzed collagen at least about 50% by weight bovine sourced hydrolyzed collagen (e.g., about 50% to about 60% by weight bovine sourced hydrolyzed collagen), at least about 20% by weight marine sourced hydrolyzed collagen (e.g., about 20% to about 30% by weight marine sourced hydrolyzed collagen), and up to about 30% by weight hydrolyzed whey protein (e.g., about 5% to about 30% by weight hydrolyzed whey protein); and 2) a composition that while adding improvement to scarring of a wound (e.g., same purpose of the composition of Petito), additionally provide other benefits including significantly reduce the healing time, greatly reduce inflammation around the wound site, and reduce the presence of bacteria, by adding the bioactive glass taught by Greenspan and Chang; and optimize the amount of the bioactive glass to obtain the desired wound promoting effects of bioactive glass by using including the amount range taught by Chang of 1 to 20%. The person of ordinary skill in the art would have reasonably expected success because Petito discloses a composition for reduced scar formation of wounds (e.g., treating a wound) that include hydrolyzed collagen and one or more supplemental ingredients (paragraph [0008]). Petito discloses that the hydrolyzed collagen has a molecular weight of including from about 500 Daltons to about 10,000 Daltons (paragraph [0012]). Petito2 teaches composition for tissue/cell repair including proteinaceous amino acids including hydrolyzed collagen (paragraph [0012]). Petito2 teaches mixtures of collagen from different collagen sources including bovine sourced collagen, marine sourced collagen, and why protein (paragraph [0024]). Petito2 teaches that varying the source of the hydrolyzed collagen can control the chemotactic, hydrophilic, and cell proliferative properties of the composition (paragraph [0025]). Petito2 teaches for a heavily exudative or wet wound can be treated with a highly hydrophilic composition, including at least about 50% by weight bovine sourced hydrolyzed collagen (e.g., about 50% to about 60% by weight bovine sourced hydrolyzed collagen), at least about 20% by weight marine sourced hydrolyzed collagen (e.g., about 20% to about 30% by weight marine sourced hydrolyzed collagen), and up to about 30% by weight hydrolyzed whey protein (e.g., about 5% to about 30% by weight hydrolyzed whey protein) (paragraph [0026]). Greenspan teaches compositions and method for treating wounds to significantly reduce the healing time, inflammation is greatly reduced around the wound site, the incidence of scar formation following a wound is reduced and the presence of bacteria is reduced (column 2, lines 31-39). Greenspan teaches a compositions and methods for treating wounds and teaches compositions that include particles of bioactive glass (column 2, lines 40-43). Chang teaches bioactive glass containing CaO, P2O5, SiO2, and Na2O (third page, second paragraph of the English translation). Chang teaches that the mass percent content of bioactive glass in a wound dressing is 1 to 20% (page 4, ninth paragraph of the English translation). Chang teaches bioactive glass promotes wound healing (sixth page, seventh paragraph of the English translation).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Petito in view of Petito2, Greenspan and Chang as applied to claims 10-13, 17-18 and 20 above, and further in view of KESSLER (US 2004/0065228 A1, publication date of 8 April 2004).
Regarding claim 16, the composition of claim 10 is described above in section 7.
Petito, Petito2, Greenspan and Chang do not specifically teach that the bioactive glass has an average particle size between about 10 µm and about 90 µm. The deficiency is made up for by the teachings of Kessler.
Kessler is primarily directed towards a mixture of bioactive glass and dental glass for producing an agent for a permanent dental filling (abstract).
Regarding claim 16, Kessler teaches bioactive glass particles with an average particle size of <50 µm. Kessler teaches that a higher ratio of surface area to weight or volume brings about a higher sterilizing biocidal action than with larger particles (paragraph [0032]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition for treating wounds that comprises hydrolyzed collagen with a molecular weight of including from about 500 Daltons to about 10,000 Daltons and particles of bioactive glass; wherein the hydrolyzed collagen with a molecular weight of including from about 500 Daltons to about 10,000 Daltons comprises at least about 50% by weight bovine sourced hydrolyzed collagen (e.g., about 50% to about 60% by weight bovine sourced hydrolyzed collagen), at least about 20% by weight marine sourced hydrolyzed collagen (e.g., about 20% to about 30% by weight marine sourced hydrolyzed collagen), and up to about 30% by weight hydrolyzed whey protein (e.g., about 5% to about 30% by weight hydrolyzed whey protein); wherein the particles of bioactive glass includes between 40 and 86% by weight of silicon dioxide (SiO2), between about 0 and 35% by weight of sodium oxide (Na2O), between about 4 and 46% by weight calcium oxide (CaO), and between about 1 and 15% by weight of phosphorus oxide (P2O5); wherein the mass percent content of the bioactive glass is optimized using including a range of 1 to 20%; and wherein the bioactive glass have an average particle size of <50 µm; and administered the composition to a subject in need of treatment for a wound. The person of ordinary skill in the art would have been motivated to make those modifications to obtain a composition with a higher sterilizing biocidal action by including bioactive glass particles with an average particle size of <50 µm, as taught by Kessler. The person of ordinary skill in the art would have reasonably expected success because Kessler teaches bioactive glass particles with an average particle size of <50 µm. Kessler teaches that a higher ratio of surface area to weight or volume brings about a higher sterilizing biocidal action than with larger particles (paragraph [0032]).
Response to Arguments
Applicant argues pages 6-7 that while different components have been identified in the cited references, the Office Action has failed to take into effect the underlying bioactivity of bioglass, the interaction of bioglass with low molecular weight hydrolyzed collagen, and the potential for the deactivation of bioglass from encapsulation with hydrolyzed collagen, such that a person of ordinary skill in the art would not have sought to combine hydrolyzed collagen and bioglass to arrive at the instantly claimed composition and the references taken individually, or in combination, do not lead a person of ordinary skill in the art to the instantly claimed composition. Applicant argues on page 7 that bioglass bonds to tissue through the formation of hydroxyapatite on its surface when in contact with biological fluids and that bioglass’ ability to form hydroxyapatite is its bioactivity, which occurs through dissolution of surface cations followed by biomineralization on the resulting cation-diminished, silica gel surface of the bioglass and points to Zheng in Exhibit A. Applicant argues that dissolution of bioglass releases calcium, silica, sodium and phosphate ions, which increase the local pH and osmotic pressure and leaves a silica gel on the glass surface and upon reaction of the released ions with physiological ions, calcium phosphate is produced, which deposits on and reacts with the silica gel surface to form first amorphous then crystalline hydroxyapatite and points Cannio in Exhibit B. Applicant argues that ionic bonding would be expected to occur between the bioglass surface cation such as calcium cations (positively charged, electron withdrawing) and the low molecular weight hydrolyzed collagen’s pendant and end group carboxylate groups (negatively charged, electron donating). Which results in surface decoration (encapsulation) of the bioglass with low molecular weight hydrolyzed collagen (oligomers and monomers). Applicant argues that the calcium oxide is a strong basic oxide that reacts vigorously with acids to form calcium salt. Applicant argues that calcium ions and amino acids form complexes and that the interaction of calcium ions with amino acids can affect tissue viability or tissue destruction and points to Tomashevisiy in Exhibit C. Applicant argues that based on Tomashevskiy, a person of ordinary skill in the art would expect that Ca ion- amino acid complexes to be stable under normal physiological conditions at normal pH levels and with a wide range of pH and, thus, inhibit the bioglass Ca ions from interacting with hydronium ions (H+, H3O+) in physiological medium which is the first step in bioglass bioactivity and points to Rabiee in Exhibit D and Yu in Exhibit E. Applicant argues on page 10 that from the reaction of low molecular weight hydrolyzed collagen (LHC) with bioglass surface cations, the surface pI changes, the formation of silanol surface is inhibited, and the protein as well as calcium phosphate deposition is inhibited. Applicant argues that decreased availability of calcium ions through ionic bonding with LHC would inhibit protein adsorption, protein complexation with calcium ions, and hydroxyapatite formation. Applicant argues that changing the bioglass surface charge, through amino acid, such as with LHC, surface decoration, would negatively impact adsorption of proteins with similar charges. Applicant argues on page 11 that release of calcium ions from the bioglass is critical to signaling within the extracellular matrix and points to Kirkness in Exhibit F. Applicant argues that a person of ordinary skill in the art would not seek to combine LHC with bioglass due to the recognition that the dissolution of cations from the bioglass surface would be inhibited and thus mineralization (bioactivity) diminished as well as decrease in coordination of calcium ions with proteins in the extracellular matrix.
Applicant's arguments filed on 14 May 2026 have been fully considered but they are not persuasive. In response, Petito discloses a composition for reduced scar formation of wounds (e.g., treating a wound) that include hydrolyzed collagen and one or more supplemental ingredients (paragraph [0008]). Petito discloses that the hydrolyzed collagen has a molecular weight of including from about 500 Daltons to about 10,000 Daltons (paragraph [0012]). Petito discloses that hydrolyzed collagen can be combined with therapeutics including antimicrobials (paragraph [0014]). Greenspan teaches compositions and method for treating wounds to significantly reduce the healing time, inflammation is greatly reduced around the wound site, the incidence of scar formation following a wound is reduced and the presence of bacteria is reduced (column 2, lines 31-39). Greenspan teaches compositions for treating wounds and teaches compositions that include particles of bioactive glass, alone or in combination with an additional anti-bacterial and/or anti-inflammatory agent, and optionally include other therapeutic agents (column 2, lines 40-43). Greenspan teaches that bioactive glass can be combined with treatments including collagen (column 7, lines 31-33). Chang teaches bioactive glass promotes wound healing (sixth page, seventh paragraph of the English translation). Chang teaches that the mass percent content of bioactive glass in a wound dressing is 1 to 20% (page 4, ninth paragraph of the English translation). Thus, in light of the disclosure of Petito and the teachings of Greenspan and Chang, one of ordinary skill in the art would have been motivated to produce a composition by combining hydrolyzed collagen including from about 500 Daltons to about 10,000 Daltons with bioactive glass, wherein the amount of bioactive glass includes 1 to 20% because one of ordinary skill in the art would expect that the combination would also be effective for treating a wound. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose ....[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Exparte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).
Applicant argues on page 14 that the instant specification discloses that the bioglass chemical composition is selected to enhance bonding to soft tissue and stimulate fibroblasts and points to paragraph [0042]. Applicant argues that there is no teaching in the instant specification that bioglass is used for microbial growth control.
In response, “[t]he fact that appellant 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.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979) (Claims were directed to grooved carbon disc brakes wherein the grooves were provided to vent steam or vapor during a braking action. A prior art reference taught noncarbon disc brakes which were grooved for the purpose of cooling the faces of the braking members and eliminating dust. The court held the prior art references when combined would overcome the problems of dust and overheating solved by the prior art and would inherently overcome the steam or vapor cause of the problem relied upon for patentability by applicants. Granting a patent on the discovery of an unknown but inherent function (here venting steam or vapor) “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991). In the instant case, in light of the disclosure of Petito and the teachings of Greenspan and Chang, one of ordinary skill in the art would have been motivated to produce a composition by combining hydrolyzed collagen including from about 500 Daltons to about 10,000 Daltons with bioactive glass, wherein the amount of bioactive glass includes 1 to 20% because one of ordinary skill in the art would expect that the combination would also be effective for treating a wound by providing including antimicrobial and anti-inflammatory from the bioactive glass (as taught by Greenspan) and providing wound healing from the bioactive glass as taught by Chang.
Applicant argues that low molecular weight hydrolyzed collagen by itself for wound healing is not taught in Petito or Petito2. Applicant argues that Petito2 teaches high molecular weight hydrolyzed collagen may provide exceptional bacteriostatic and cellular repair properties in which the molecular weight far exceeds that of low molecular weight hydrolyzed collagen, which would be expected by a person of ordinary skill in the art to facilitate reduction of scar tissue. Petito does not teach hydrolyzed collagen of any molecular weight range by itself for scar prevention nor does it teach the requirement of including collagen and an antioxidant or including lipoic acid for wound healing.
In response, Petito discloses that the hydrolyzed collagen has a molecular weight of including from about 500 Daltons to about 10,000 Daltons to reduce scar formation of wounds (paragraph [0012] and claim 1). While Petito2 teaches that high molecular weight hydrolyzed collagen may provide exceptional bacteriostatis and cellular repair properties (paragraph [0015] of Petito2). It would have been prima facie obvious for one of ordinary skill in the art to use hydrolyzed collagen having a molecular weight of including from about 500 Daltons to about 10,000 Daltons taught by Petito to obtain a composition to reduce scar formation of wounds and not have the exceptional bacteriostatis and cellular repair properties if not desired which is the same composition as the composition of claim 1 of Petito. Applicant is reminded that omission of an element and its function is obvious if the function of the element is not desired. Ex parte Wu, 10 USPQ 2031 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a method for inhibiting corrosion on metal surfaces using a composition consisting of epoxy resin, petroleum sulfonate, and hydrocarbon diluent. The claims were rejected over a primary reference which disclosed an anticorrosion composition of epoxy resin, hydrocarbon diluent, and polybasic acid salts wherein said salts were taught to be beneficial when employed in a freshwater environment, in view of secondary references which clearly suggested the addition of petroleum sulfonate to corrosion inhibiting compositions. The Board affirmed the rejection, holding that it would have been obvious to omit the polybasic acid salts of the primary reference where the function attributed to such salt is not desired or required, such as in compositions for providing corrosion resistance in environments which do not encounter fresh water.). See also In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965) (Omission of additional framework and axle which served to increase the cargo carrying capacity of prior art mobile fluid carrying unit would have been obvious if this feature was not desired.); and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (deleting a prior art switch member and thereby eliminating its function was an obvious expedient). See MPEP 2144.04(II)
Thus, for the reasons of record and for the reasons presented above claims 1-3, 6-8, 10-13, 16-18 and 20-21 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are allowed.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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