Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reissue: Final Office Action
Status of the Claims
On 4/26/2011 US Patent 7,932,365 issued to Lim et al. with claims 1-25.
The amendments and arguments filed 01/14/2026 are acknowledged and have been fully considered. Claims 13-16, 28-30, 32, and 34-39 are now pending. Claims 1-12, 17-27, 31, 33, and 40 are cancelled; claims 13-16 are amended relative to the ‘365 patent; claims 28-30, 32, and 34-39 are new relative to the ‘365 patent. Claims 13-16, 28-30, 32, and 34-39 are now under consideration.
OBJECTIONS/REJECTIONS WITHDRAWN
The rejection of claims 13-16, 28-30, 32, and 34-39 under 35 U.S.C. 251, is withdrawn in light of the new declaration filed 01/14/2026.
The rejection of claims 13-16, 28-30, 32, and 34-38 under 35 U.S.C. 101 is withdrawn, in light of the claim amendments.
OBJECTIONS/REJECTIONS MAINTAINED
The rejection of claims 13-16, 28-30, 32, and 34-39 under 35 U.S.C. 103(a) is maintained as discussed below.
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 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(a) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C 102(b)(2)(C) for any potential 35 U.S.C 102(a)(2) prior art against the later invention.
Claims 13, 14, 28-30, 32, and 34-39 are rejected under 35 U.S.C. 103(a) as being unpatentable over JOSIC (WO 02/30983; Pub. Apr. 18, 2002 or US 2003/0190732; Filed Oct. 11, 2001) and FISHER (US 2001/0006806; Pub. Jul. 5, 2001) as evidenced by JOYCE (Joyce, D. E., et al. Crit. Care Med. (2002), 30(5); S288-S293).
Since WO 02/30983 is in German, US patent application publication 2003/0190732 to Josic, which is the national stage entry of the international application, is relied upon as an English language equivalent for WO 02/30983. Paragraph numbers refer to the '732 publication.
Josic discloses a method of producing bikunin proteins from plasma (e.g., human plasma) (title; abstract; [0006], [0009]). The purified plasma fraction of Josic is employed as the base of a pharmaceutical formulation, which is obtainable by the optional further purification of the bikunin proteins and by formulation, and by measures for sterilization or sterile filtration and by inactivation of any pathogens present ([0027]). Josic teaches the formulation is suitable for intravenous administration (i.e., suitable for administration to a human) ([0027]). Josic teaches adding a stabilizer such as polyols, sugars, sugar alcohols, amino acids, or inorganic salts to the bikunin plasma fraction composition ([0027]-[0028]).
The purified plasma fraction contains bikunin-containing proteins of apparent molecular weight of 100 to 250 kDa, such as inter-α-inhibitor (IαI; MW 220 kDa) and pre-α-inhibitor (PαI; MW of at least 100 kDa) ([0002], [0006], [0026]). The purified IαI and PαI would be in physiological proportion when they are purified from plasma, where they occur naturally. While Josic is silent on the proportions of the two proteins in the composition, Josic teaches that these proteins can be isolated directly from plasma or from cryosupernatant ([0009]); therefore each contains the proteins in physiological proportions as it occurs naturally in human plasma. It is noted that the specification states that physiological proportions are usually between about 60-80% IαI and about 40-20% PαI, but that physiological proportions vary between subjects (col. 5, lines 8-12). The person of ordinary skill in the art would therefore have understood Josic’s teachings as disclosing the claimed proportions.
The process disclosed by Josic results in pure IαI and PαI proteins that do not have any additional substantial components, and are essentially free of unbound separate bikunin ([0006]; [0025]-[0026]). The purified plasma fraction of Josic contains at least 90% proteins that exhibit anti-trypsin activity, indicating that the proteins are within the scope of about 85% to 100% pure (i.e., about 90% pure) ([0023]; claim 7). This meets the purity limitations of instant claims 13 and 30.
Regarding the amount of the IαIp, Josic teaches the therapeutic dosage is in the range from 3-300 mg/kg ([0030]). This teaching overlaps the claimed amount of 500-1,000 mg. For example, a single unitary dosage form for treatment of an adult male (average weight approximately 90 kg) at a 10 mg/kg dosage would be prepared with 900 mg. Similarly, a single unitary dosage form for treatment of an adult female (average weight approximately 77 kg) at a 12 mg/kg dosage would be prepared with 924 mg. Both of these amounts fall squarely within the range taught by Josic.
Josic teaches a pharmaceutical composition comprising purified lal and Pal, which can be used to treat sepsis. Josic does not teach a composition further comprising an immunomodulator as an additional therapeutic agent as now recited in claim 13.
Fisher discloses methods for treating sepsis including combination therapy with protein C, which is taught to have anti-coagulant and anti-inflammatory properties (i.e., it is an anti-coagulant and an anti-inflammatory) (title; abstract; [0003], [0017]). Protein C also has immunomodulatory properties (i.e., it is an immunomodulator within the meaning of the instant claims) as evidenced by Joyce (see p. S292, middle col.).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to prepare a pharmaceutical composition comprising purified IαI and PαI in (in their physiological proportions) in combination with an anticoagulant/anti-inflammatory/immunomodulator such as protein C. One would have been motivated to do so since all of these compounds are known in the art to treat sepsis. The MPEP states: “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). See MPEP § 2144.06(I).
Regarding claims 14 and 35, Josic teaches the anti-trypsin specific activity, which is an intrinsic property of the bikunin-containing proteins, is much higher in the bikunin plasma fraction than the activity of human plasma. The anti-trypsin specific activity is preferably more than 200 times that in human plasma ([0023]-[0024]), which encompasses the claimed trypsin inhibitory specific activity of about 1000 to about 2000 IU/mg or about 1400 to about 2000 IU/mg ([0024]; claim 8). Furthermore, specific activity is simply a measure of protein purity, and the compositions of Josic are taught to have purity within the range instantly claimed ([0023]; claim 7).
Regarding claim 28, Josic teaches that the pharmaceutical formulations are suitable for intravenous administration (i.e., they are suitable for administration to a human) ([0027]-[0028]). The liquid base of said intravenous formulation that is necessarily present is within the broadest reasonable interpretation of a pharmaceutically acceptable carrier.
Regarding claim 29, the formulation comprising the purified plasma fraction itself or in combination with the commonplace components used for intravenous injection as taught by Josic discloses a kit. The claim does not limit the “instructions” to written or printed instructions, but even if it did, the mere recitation of printed matter is not afforded patentable weight since there is no evidence of a new and unobvious functional relationship between the printed matter and the composition in this case. See MPEP § 2111.05.
Regarding claim 32, Josic is silent on the proportions of the two proteins in the composition. However Josic teaches that these proteins can be isolated directly from plasma or from cryosupernatant ([0009]); therefore each contains the proteins in physiological proportions as it occurs naturally in human plasma. It is noted that the specification states that physiological proportions are usually between about 60-80% IαI and about 40-20% PαI, but that physiological proportions vary between subjects (col. 5, lines 8-12). The person of ordinary skill in the art would therefore have understood Josic’s teachings as disclosing the claimed proportions.
Regarding claim 34, Josic discloses adding a stabilizer such as polyols, sugars, sugar alcohols, amino acids, or inorganic salts to the bikunin plasma fraction composition ([0027]-[0028]).
Regarding claim 36, Josic teaches that the bikunin in the purified plasma fraction has a half-life of several hours in vivo ([0007]). This teaching is greater than one hour as recited in claim 36.
Regarding claims 37-38, Josic teaches the purified plasma fraction of bikunin (light chain), contains proteins associated with at least one heavy chain selected from H1, H2 and H3 ([0001], [0003], [0006]) as recited in claims 37 and 38.
Regarding claim 39, Josic teaches the use of the disclosed plasma fraction for treating sepsis or septic shock ([0008], [0031]; claim 13). The purified plasma fraction of Josic is employed as the base of a pharmaceutical formulation, which is obtainable by the optional further purification of the bikunin proteins and by formulation, and by measures for sterilization or sterile filtration and by inactivation of any pathogens present ([0027]). Josic teaches that the resulting pharmaceutical formulations are suitable for intravenous administration (i.e., they are suitable for administration to a human) ([0027]).
Claims 13, 14, 28-30, 32, and 34-39 are rejected under 35 U.S.C. 103(a) as being unpatentable over JOSIC (WO 02/30983; Pub. Apr. 18, 2002 or US 2003/0190732; Filed Oct. 11, 2001) and MacFARLANE (US 6,479,504; Pub. Nov. 12, 2002).
Since WO 02/30983 is in German, US patent application publication 2003/0190732 to Josic, which is the national stage entry of the international application, is relied upon as an English language equivalent for WO 02/30983. Paragraph numbers refer to the '732 publication.
Josic discloses a method of producing bikunin proteins from plasma (e.g., human plasma) (title; abstract; [0006], [0009]). The purified plasma fraction of Josic is employed as the base of a pharmaceutical formulation, which is obtainable by the optional further purification of the bikunin proteins and by formulation, and by measures for sterilization or sterile filtration and by inactivation of any pathogens present ([0027]). Josic teaches the formulation is suitable for intravenous administration (i.e., suitable for administration to a human) ([0027]). Josic teaches adding a stabilizer such as polyols, sugars, sugar alcohols, amino acids, or inorganic salts to the bikunin plasma fraction composition ([0027]-[0028]).
The purified plasma fraction contains bikunin-containing proteins of apparent molecular weight of 100 to 250 kDa, such as inter-α-inhibitor (IαI; MW 220 kDa) and pre-α-inhibitor (PαI; MW of at least 100 kDa) ([0002], [0006], [0026]). The purified IαI and PαI would be in physiological proportion when they are purified from plasma, where they occur naturally. While Josic is silent on the proportions of the two proteins in the composition, Josic teaches that these proteins can be isolated directly from plasma or from cryosupernatant ([0009]); therefore each contains the proteins in physiological proportions as it occurs naturally in human plasma. It is noted that the specification states that physiological proportions are usually between about 60-80% IαI and about 40-20% PαI, but that physiological proportions vary between subjects (col. 5, lines 8-12). The person of ordinary skill in the art would therefore have understood Josic’s teachings as disclosing the claimed proportions.
The process disclosed by Josic results in pure IαI and PαI proteins that do not have any additional substantial components, and are essentially free of unbound separate bikunin ([0006]; [0025]-[0026]). The purified plasma fraction of Josic contains at least 90% proteins that exhibit anti-trypsin activity, indicating that the proteins are within the scope of about 85% to 100% pure (i.e., about 90% pure) ([0023]; claim 7). This meets the purity limitations of instant claims 13 and 30.
Regarding the amount of the IαIp, Josic teaches the therapeutic dosage is in the range from 3-300 mg/kg ([0030]). This teaching overlaps the claimed amount of 500-1,000 mg. For example, a single unitary dosage form for treatment of an adult male (average weight approximately 90 kg) at a 10 mg/kg dosage would comprise 900 mg. Similarly, a single unitary dosage form for treatment of an adult female (average weight approximately 77 kg) at a 12 mg/kg dosage would comprise 924 mg. Both of these amounts fall squarely within the range taught by Josic.
Josic teaches a pharmaceutical composition comprising purified lal and Pal, which can be used to treat sepsis. Josic does not teach a composition further comprising an immunomodulator as an additional therapeutic agent as now recited in claim 13.
MacFarlane discloses methods inhibiting stimulation of the immune system with 4-aminoquinoline chloroquine analogues (title, abstract). MacFarlane teaches excessive stimulation of the immune system can have adverse effects in autoimmune diseases, rejection during transplantation, and invasions by pathogens. Inhibition of this stimulation can have beneficial therapeutic results (col. 1, lines 19-27). MacFarlane teaches sepsis is the primary cause of death in intensive care units in the United States annually. It can be caused by infection by a pathogen, such as viruses, bacteria, fungi, and parasites, which triggers host defenses. This may result in activation of innate immunity, particularly, an inflammatory response, which consequently promotes deleterious effects (collectively termed "sepsis") including shock, respiratory distress, capillary leaks, renal failure, jaundice, bleeding, coma and death (col. 2, lines 14-22). MacFarlane teaches use of the disclosed 4-aminoquinolines for the treatment of sepsis (col. 2, lines 37-41; col. 12, lines 16-20; col. 13, lines 47-53; col. 14, lines 40-52). Because the compounds of MacFarlane affect the immune response (i.e., they suppress excessive immune stimulation), they are immunomodulators within the meaning of the instant claims.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to prepare a pharmaceutical composition comprising IαI and PαI (in their physiological proportions) in combination with an immunomodulator. One would have been motivated to do so since all of these compounds are known in the art to treat sepsis and septic shock. The MPEP states: “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). See MPEP § 2144.06(I).
Regarding claims 14 and 35, Josic teaches the anti-trypsin specific activity, which is an intrinsic property of the bikunin-containing proteins, is much higher in the bikunin plasma fraction than the activity of human plasma. The anti-trypsin specific activity is preferably more than 200 times that in human plasma ([0023]-[0024]), which encompasses the claimed trypsin inhibitory specific activity of about 1000 to about 2000 IU/mg or about 1400 to about 2000 IU/mg ([0024]; claim 8). Furthermore, specific activity is simply a measure of protein purity, and the compositions of Josic are taught to have purity within the range instantly claimed ([0023]; claim 7).
Regarding claim 28, Josic teaches that the pharmaceutical formulations are suitable for intravenous administration (i.e., they are suitable for administration to a human) ([0027]-[0028]). The liquid base of said intravenous formulation that is necessarily present is within the broadest reasonable interpretation of a pharmaceutically acceptable carrier.
Regarding claim 29, the formulation comprising the purified plasma fraction itself or in combination with the commonplace components used for intravenous injection as taught by Josic discloses a kit. The claim does not limit the “instructions” to written or printed instructions, but even if it did, the mere recitation of printed matter is not afforded patentable weight since there is no evidence of a new and unobvious functional relationship between the printed matter and the composition in this case. See MPEP § 2111.05.
Regarding claim 32, Josic is silent on the proportions of the two proteins in the composition. However Josic teaches that these proteins can be isolated directly from plasma or from cryosupernatant ([0009]); therefore each contains the proteins in physiological proportions as it occurs naturally in human plasma. It is noted that the specification states that physiological proportions are usually between about 60-80% IαI and about 40-20% PαI, but that physiological proportions vary between subjects (col. 5, lines 8-12). The person of ordinary skill in the art would therefore have understood Josic’s teachings as disclosing the claimed proportions.
Regarding claim 34, Josic discloses adding a stabilizer such as polyols, sugars, sugar alcohols, amino acids, or inorganic salts to the bikunin plasma fraction composition ([0027]-[0028]).
Regarding claim 36, Josic teaches that the bikunin in the purified plasma fraction has a half-life of several hours in vivo ([0007]). This teaching is greater than one hour as recited in claim 36.
Regarding claims 37-38, Josic teaches the purified plasma fraction of bikunin (light chain), contains proteins associated with at least one heavy chain selected from H1, H2 and H3 ([0001], [0003], [0006]) as recited in claims 37 and 38.
Regarding claim 39, Josic teaches the use of the disclosed plasma fraction for treating sepsis or septic shock ([0008], [0031]; claim 13). The purified plasma fraction of Josic is employed as the base of a pharmaceutical formulation, which is obtainable by the optional further purification of the bikunin proteins and by formulation, and by measures for sterilization or sterile filtration and by inactivation of any pathogens present ([0027]). Josic teaches that the resulting pharmaceutical formulations are suitable for intravenous administration (i.e., they are suitable for administration to a human) ([0027]).
Claims 15 and 16 are rejected under 35 U.S.C. 103(a) as being unpatentable over JOSIC and either of Fisher or MacFarlane as applied to claims 13, 14, 28-30, 32, and 34-39 above, and further in view of FDA Guidance for Industry (FDA).
The teachings of Josic are presented above. It is further noted that the mere purity of a product, by itself, does not render the product unobvious (see MPEP 2144.04(VII)).
Regarding claims 15 and 16, these claims require that the half-life of the composition is at least 5 hours or at least 10 hours, respectively. Josic teaches that the bikunin in the purified plasma fraction has a half-life of several hours in vivo ([0007]), and renders obvious the half-lives recited in claims 15 and 16. Although the specification does not limit the term “several hours,” the person of ordinary skill in the art would have interpreted it as reasonably encompassing times such as 5-10 hours. Thus, “several hours” is reasonably considered to disclose a half-life of “at least 5 hours” and “at least 10 hours.”
In the alternative, however, if “several hours” does not render obvious these time ranges directly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (MPEP 2144.05). In this case, there is no indication that there are any structural differences between the compositions of Josic and those of the instant claims.
Finally regarding claims 15 and 16, the instant specification teaches that half-life is an inherent property of the composition and fluctuations of the half-life are not based on the structure of the composition itself, but rather on the state of sepsis (i.e., the rate of clearance) in the patient to which the composition is administered (see col. 20, lines 1-6; col. 20, line 60 to col. 21, line 12; col. 21, lines 37-41; Fig. 4 of the '365 patent). Thus, in the absence of any structural difference between the compositions of Josic and those instantly claimed, the half-life is considered a property of the composition that depends upon the state of sepsis at a given time.
Response to Arguments
Applicants' arguments have been fully considered but are not persuasive. Applicants argue that Josic does not teach a physiological proportion of IαI and PαI (response, pgs. 7-9).
At the outset, it is noted that the specification states that physiological proportions are usually between about 60-80% IαI and about 40-20% PαI, but that physiological proportions vary between subjects (col. 5, lines 8-12). Throughout the response (and in the Lim declaration; e.g., par. 5), applicants mention a 2:1 ratio when referring to physiological proportions. However, according to the specification, a “physiological proportion” can range from at least 1.5:1 to 4:1. Thus, applicants’ arguments are not commensurate in scope with the instant claims, even if they were otherwise persuasive (which they are not).
Josic teaches the same starting materials (plasma, cryosupernatant; see Josic at par. [0009] and claim 1) that are taught to be preferred in the instant invention (see col. 5, line 63 to col. 6, line 7; col. 6, lines 62-67; and claims 4-5 of the ‘365 patent; see also pars. 4-6 of the declaration). Josic also teaches the same chromatographic processes (e.g., DEAE and hydroxyapatite chromatography; see Josic at pars. [0018]-[0019]) that are taught to be capable of producing the claimed composition (see col. 9, lines 33-52 and Example 3 of the ‘365 patent), as well as the same methods of using the composition (i.e., to treat sepsis). The claimed composition has the same utility as Josic’s, and Josic suggests suitable methods of obtaining the claimed composition, factors which lead to a determination of obviousness. MPEP 2144.04(VIl).
Applicants continue to focus on Examples 1 and 2 of Josic while ignoring the other teachings of the reference. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. MPEP 2123(l). For example, the declaration by Dr. Lim filed on 7/17/2025 states that anion exchange chromatography and affinity chromatography that does not require the use of an antibody can be used to prepare the claimed pharmaceutical composition, including IαI and PαI in physiological proportions (declaration, par. 4). Josic teaches a method of purifying IαI and PαI using anion exchange chromatography followed by size exclusion chromatography (neither of which utilize antibodies) ([0010]-[0019], [0034]).
Notwithstanding the fact that Josic teaches methods of purifying IαI and PαI that have been established on the record to be capable of purifying the proteins in the claimed (physiological) proportions, Josic teaches the process provided according to the invention provides a bikunin plasma fraction obtained substantially contains native bound bikunin or native IαI ([0006], [0016], [0024]). The description of the purified proteins as “native” suggests the proteins are in the same state, including amounts (proportions) thereof, to those of skill in this field. Applicants have failed to provide evidence that the methods described in Josic could not achieve the physiological proportions as claimed. Applicants have also failed to provide evidence that using the same purification techniques taught by Josic would alter the proportions of purified IαI and PαI from that in plasma, where they occur naturally.
Applicants argue that the FDA Guidance document does not remedy the alleged deficiency of Josic (response, p. 9).
However, as discussed above, Josic is not deficient. The Lim declaration filed on 7/17/2025 states that anion exchange chromatography and affinity chromatography that does not require the use of an antibody can be used to prepare the claimed pharmaceutical composition, including IαI and PαI in physiological proportions (declaration, par. 4). Josic teaches the same chromatographic processes (e.g., DEAE (a type of anion exchange) and hydroxyapatite chromatography; see Josic at pars. [0018]-[0019]) that are taught to be capable of producing the claimed composition (see col. 9, lines 33-52 and Example 3 of the ‘365 patent, as well as par. 4 of the Lim declaration).
Summary/Conclusion
Claim 13-16, 28-30, 32, and 34-39 are rejected; claims 1-12, 17-27, 31, 33, and 40 are cancelled.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin S Orwig whose telephone number is (571)270-5869. The examiner can normally be reached Mon.-Fri. 8AM-5PM.
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/Kevin S Orwig/ Patent Reexamination Specialist, Art Unit 3991
Conferees:
/LBD/ Patent Reexamination Specialist, Art Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991