FINAL 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 Claims
Receipt is acknowledged of the claim amendments filed on 29 August 2025.
Claims 1, 10 and 20 have been amended.
Claims 4-5, 9, 14-15 and 19 are cancelled.
Claims 1-3, 6-8, 10-13, 16-18 and 20 are 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 is 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 claim 6, 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. 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 that Greenspan reference does not teach or suggest that bioactive glass can be combined with low molecular weight collagen. Applicant argues that one of ordinary skill in the art would not know, without undue experimentation, that combining bioactive glass with low molecular weight collagen would achieve acceptable results for wound healing or tissue repair. Applicant argues that one of ordinary skill in the art would not be able to arrive specifically at 0.1%-10.5% by weight of bioactive glass because Greenspan reference teaches about 20% to about 80% bioactive glass.
Applicant's arguments filed on 29 August 2025 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]). 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). 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). Thus, from the disclosure of Petito and the teachings of Greenspan and Chang, one of ordinary skill in the art would have been motivated to add bioactive glass to the composition of Petito which comprises hydrolyzed collagen has a molecular weight of including from about 500 Daltons to about 10,000 Daltons that is used for treating wound to further improve scarring of a wound (e.g., same purpose of the composition of Petito) and 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 optimized 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%.
Applicant is reminded that obviousness does not require absolute predictability, however, at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). See MPEP 2143.02(II).
Further, "[i]t 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). In the instant case, it is prima facie obvious to add bioactive glass taught which is taught by Greenspan and Chang as being used for wound healing into the composition of Petito that is used for wound healing and contains hydrolyzed collagen has a molecular weight of including from about 500 Daltons to about 10,000 Daltons.
Thus, for the reasons of record and for the reasons presented above claims 1-3, 6-8, 10-13, 16-18 and 20 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are 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 extension fee 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 date of this final action.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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