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 .
DETAILED ACTION
This Action is in response to the papers filed on August 11, 2025 for a Request for Continued Examination. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 11, 2025 has been entered.
Pursuant to the amendment filed on August 11, 2025, claims 1, 3, 7, 9, 11, 16, and 19 are pending in the application. Claims 1, 9, and 11 have been amended, claims 17-18 have been cancelled, and claim 19 is newly filed in Applicant' s amendment filed on August 11, 2025.
The examiner acknowledges receiving the Affidavit under 37 C.F.R. § 1.132 filed on 28 January 2025 and executed by Franck Zal (Zal Decl.).
Therefore, claims 1, 3, 7, 9, 11, 16, and 19 are currently under examination to which the following grounds of rejection are applicable.
Priority
The present application filed 15 October 2020, claims the benefit of PCT/EP2019/05968, filed on 15 April, 2019, which claims the benefit of FR 1853340, filed on 17 April, 2018.
Applicant has filed the translation of the Foreign Priority Documents on 28 January 2018.
Thus, the earliest effective priority for the instant application is 17 April 2018.
Maintained Objections/Rejections in response to Applicants' arguments or amendments:
Claim Rejection - 35 USC § 112(a) Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 7, 9, 11, and 16 , and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the Specification,
while being enabling for a graft that is for a kidney, providing the University of Wisconsin storage solution (wherein the formulation is provided by Paragraph [0034] of the as-Filed Specification), using the WTW Oxi 3205 as an O2 sensor that is not placed in contact with the graft, and a single oxygen carrier that is an extracellular hemoglobin from Arenicola marina that is a good carrier of oxygen for up to 55 hours.
it does not reasonably provide enablement for grafts of any tissue graft, any storage solutions, any oxygen probes, the extracellular hemoglobin from Arenicola marina able to maintain the percentage of dissolved O2 for any length of time at which the experiment is conducted.
The Specification does not enable any person skill in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The claims, when given the broadest possible interpretation, encompass a method of monitoring oxygenation of a graft, comprising immersing the graft in a composition, comprising an organ storage solution and an oxygen carrier, introducing a single oxygen probe in the composition, and monitoring the oxygenation of the graft. The Specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the patent coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is not based on a single factor but is rather a conclusion reached by weighing many factors (See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter, 1986) and In re Wands, 8USPQ2d 1400 (Fed. Cir. 1988); these factors include the following:
Nature of invention. The method encompasses a method of monitoring oxygenation of a graft, comprising immersing the graft in a composition, comprising an organ storage solution and an oxygen carrier, introducing a single oxygen probe in the composition, and monitoring the oxygenation of the dissolved oxygen of the graft.
Scope of the invention. The method encompasses a method of monitoring oxygenation of a kidney graft by measuring dissolved oxygen in a sealed container comprising the immersed kidney graft. .
Number of working examples and guidance. In the instant case, Applicant provides one working example in the as-Filed Specification (Paragraphs [0191] – [0221]). The Example teaches the storage of a PIA kidney in a preservative solution with or without annelid hemoglobin. Arenicola marina extracellular hemoglobin was used for formulating a commercial product, HEMO2life® (Hemarina SA). The kidneys were immersed in a tightly closed reservoir and filled with 800 mL of the solutions (UW and UW+HEMO2life) (Paragraph [0197]). Dissolved O2 was measured using an O2 sensor (WTW Oxi 3205) directly introduced into the composition wherein the graft is bathed(Paragraph [0206]). The pO2 was measured at t0 and does not decrease for 55 hours (Paragraph [0213]). The results clearly demonstrate the beneficial use of HEMO2life® at 1 g/L in addition to the low temperature storage solution, wherein HEMO2life® transfers oxygen 28 h more than the storage solution alone (Paragraph [0221]).
In this example, Applicant teaches that dissolved oxygen was measured, using a WTW Oxi3205,
for a kidney graft that was immersed in a composition comprising the organ-storage solution, UW, and an Arenicola marina extracellular hemoglobin, and wherein the oxygen level was maintained for up to 55 hours, and the experiment was conducted at 6° C. Applicant does not teach any other grafts, organ storage solutions, oxygen monitors, or temperatures wherein the oxygen level can be maintained.
State of the art. Although the field of measuring oxygen levels is highly developed, the method of monitoring oxygenation levels by immersing the graft in a composition comprising organ storage solution and an extracellular hemoglobin from Arenicola maria is not highly developed for any graft (organs). The art must therefore be considered to be poorly developed.
Unpredictability of the art. Before the effective filing date of the claimed invention, it was
known in the art that the UW solution was the standard for abdominal organ preservation fluid but has been replaced with the HTK solution for use in kidney and liver preservation, as evidenced by Stewart et al. (Stewart ZA. Et al. Histidine-tryptophan-ketoglutarate (HTK) is associated with reduced graft survival in pancreas transplantation. Am J Transplant. 2009 Jan;9(1):217-21. Epub 2008 Nov 4. PMID: 18986383; of record) (pg. 217, right column, first paragraph). Stewart teaches that the HTK solution is more advantageous due to lower dose, reduced risk of perfusion hyperkalemia, better tissue perfusion and cell preservation over a wider range of temperatures (pg. 217, right column, first paragraph). Thus, for graft storage solution, HTK might be the more optimal choice.
Further, it was known in the art that short term ex vivo storage of kidneys in UW solution at 4 C causes progressive nuclear ploidy changes of renal tubular epitheliocytes, as evidenced by Sun et al. (Sun, H. et al. Short term ex vivo storage of kidneys cause progressive nuclear ploidy changes of renal tubular epitheliocytes. Sci Rep 5, 10341 (2015); of record) (Abstract and Title).
Additionally, the best storage temperature for liver grafts, wherein the graft is stored in the UW solution, is 1°C, as evidenced by Charrueau et al. (Charrueau C. et al. Best temperature for static liver graft storage is 1°C. J Surg Res. 2013 Apr;180(2):322-9. Epub 2012 May 12. PMID: 22607696; of record) (Abstract). Charrueau et al. also teaches the static storage at +1°C improved liver function compared with +4°C or −0.5°C (Abstract). However, the applicant is on record as stating that the addition of Arenicola marina hemoglobin to a kidney graft immerse in the kidney storage solution maintains O2 concentration in the perfusion solution up to 30h in this experimental condition relative to the storage solution without Arenicola marina hemoglobin (Zal Decl. page 1, para. 3). Thus, it is not clear how the Arenicola marina hemoglobin functions to maintain the dissolved O2 concertation in the perfusion solution of the instant invention.
It is known in the art that the specific concentration of 1.25 g/l of the hemoglobin of Arenicola Marina totally protects the renal cells from the cell death induced by 24 hrs of cold storage in the UW solution but not any organ storage solution, as evidenced by Zal et al. (US 2010/0209902 A1, published 19 August, 2010; of record) (Paragraph [0130]). Thus, there is an optimal concentration at which the hemoglobin will be effective.
Amount of Experimentation Required. Given the unpredictability of the art, the poorly
developed state of the art with regard to research on the UW solution for graft storage, the discrepancy of optimal temperature and concentration for organ storage using the hemoglobin from Arenicola marina, and the functionality of the hemoglobin with the specific UW carrier, the skilled artisan would have to conduct undue, and unpredictable experimentation to practice the claimed invention and monitor the oxygenation in the kidney graft in the storage solution. Further, due to the lack of specific guidance in the specification for making, using and administering the graft and the UW solution, it would require undue experimentation to practice the breadth of the instant methods as claimed.
New Grounds of Objection/ Rejection:
Claim Objections
Claims 1, 3, 7, 9, 11, and 19 are objected to because of the following informalities:
Claims 1, 3, 7, 9, and 11 are objected to because they are not written in proper form, in particular there is no proper introduction of the method claims. The claims are not being rejected under 112(b) for the lack of antecedence, but there should be the proper article that begins each claim. For example with claim being written as, “A method of monitoring oxygenation of a graft,…” and then the dependent claims reciting “The method of claim __, …” (as is currently recited in claims 16 and 19).
Claims 1, 9 and 19 are objected to because of the improper use of the Markush groups by reciting “chosen from…” as opposed to the proper Markush grouping by reciting “selected from the group consisting of…”, and use of the conjunction "and" before the final members of the groups The recitation of “chosen from…”is in lines 9, 11, 14, and 16 of claim 1; lines 9, 11, 14, and 16 of claim 9; and line 1 of claim 19.
Claim 1 is objected because the indentations of steps (d) and (e) are shifted further than previous steps, and it is unclear if this is a layout mistake or rather these steps are to be understood as subcombinations. MPEP 608.01 states “Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). There may be plural indentations to further segregate subcombinations or related steps…”. In the instant case, clarification is required. Moreover, it is unclear as to why the method steps of claim 1 employ letters, and the similar method of claim 9, another independent claim, employs roman numerals.
Claims 1 and 9 appear to have misspelled “potassium” in lines 9 in the recitation of “jarassium.”
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 7, 9, 11, 16, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, 9 and 19 contains the trademark/trade names:
Claims 1 and 9: ProfiLine Oxi 3205 model from WTW.
Claim 19: IGL-1®, Celsior®, Custodiol®, HTK Solution, Euro-Collins®, Soltran®, Perfadex®.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe organ storage solutions and, accordingly, the identification/description is indefinite. Furthermore, the solutions are indefinite because is unclear if the claimed compositions that are listed are the standard compositions for these trademarked solutions or different compositions based on the claimed chemicals and/or concentrations.
Additionally, in view of the storage solutions claimed in claim 19, it is unclear if the claimed compounds are in addition to the salts, sugar, glutathione, active agent, and colloid recited in claim 1 or rather are the specific compounds being further described.
Regarding claim 19, the recitation of “Solution from Hopital Edouard Henriot,..” is indefinite because it is unclear if the solution if physically from the claimed “Hopital Edouard Henriot.
Claims 1 and 9 recite in reference to the single oxygen probe “is a sensor for measuring dissolved oxygen in the composition by luminescence, and is of the type ProfiLine Oxi 3205 model from WTW”, however Oxi 3205 is the pocket meter as opposed to the sensor itself. The manufacturer’s website describes the sensors that can be used with this model as galvanic dissolved oxygen (DO) sensors, and does not include optical DO sensors, despite these sensors being available by the manufacturer, e.g. FDO® 925 (Optical IDS). The lab catalogue is attached herein, and the dissolved oxygen sensors are listed on page 64, and the claimed meter is described on page 61. Altogether, the claim is indefinite as it is appearing to be claiming the meter as opposed to the sensor, and furthermore it is unclear if the meter claimed has any compatible optical DO sensors.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 7, 9, 11, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zal et al. (US 2014/0113274 A1; citations taken from published patent US 9,861,095 B2) in view of Gao et al. (Biotechnology and bioengineering 86.4 (2004): 425-433), Anderson et al. (US Patent US 2014/0045167 A1, Published February 13, 2014), and Geotech (Geotech Environmental Equipment, Inc, Water Quality Meters: WTW ProfiLine 3110 Series and 3205 Single Parameter Handheld Meters).
The applied reference (“Zal”) has a common inventor with the instant application, whose earliest filing date is April 2018. Based upon the earlier effectively filed date of the reference (2008), it constitutes prior art under 35 U.S.C. 102(a)(1), which is well beyond the provisions of 102(a)(2). Therefore the prior art is excluded from the provisions under 35 U.S.C. 103, and CANNOT be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1 and claim 9, that are similar methods directed to monitoring oxygenation of a graft and method of determining viability of a graft, respectively, Zal teaches providing an organ storage solution and mixing the organ storage solution with at least one oxygen carrier that is an extracellular hemoglobin from Arenicola marina, to obtain a composition, in a container, (“The present invention relates to the use of a composition comprising at least one globin, one globin protomer or one extracellular hemoglobin of annelids, a stabilizing solution and/or a clinically used organ preservation solution, said composition having a temperature of between 0° C. and 37° C (col 1, ln 19-25); “Even more preferentially, the extracellular hemoglobin of annelids is chosen from the extracellular hemoglobin of Arenicola marina and the extracellular hemoglobin of Nereis, more preferentially the extracellular hemoglobin of Arenicola marina.” (col 4, ln 20-24); “preparation was then hermetically sealed” (col 11, ln 30-31) wherein the extracellular hemoglobin from Arenicola marina is at a concentration relative to a final volume of the composition between 0.5 mg/ml and 5 mg/ml, wherein the organ storage solution is an aqueous solution having a pH between 6.5 and 7.5 and an osmolality between 250 and 350 mOsm/1 (“Typically, the extracellular hemoglobin of annelids, globin protomers thereof and/or globins thereof is present at a concentration, relative to the final volume of composition, of between 0.001 mg/ml and 100 mg/ml, preferentially between 0.005 mg/ml and 20 mg/ml and more preferentially between 1 mg/ml and 5 mg/ml, in particular 1 mg/ml.” (col 7, ln 65- col 8, ln 3); “said aqueous solution having a pH of between 6.5 and 7.6, preferably equal to 7.1±0.5, preferably of approximately 7.35,” (col 3, ln 5-7); “Typically, the composition according to the invention has an osmolarity of between 250 and 350 mOsm/l,” (col 8, ln 4-7)) salts chosen from chloride, sulfate, sodium, calcium, jarassium [interpreted as potassium, see objection above] and magnesium ions; at least one sugar chosen from mannitol, raffinose, sucrose, glucose, fructose, lactobionate and gluconate; optionally glutathione; optionally at least one active agent chosen from allopurinol, lactates and amino acids: and optionally at least one colloid chosen from hydroxyethyl starch, polyethylene glycol and dextran; (col 5-7), and the preservation being conducted at around 4° C, but can be conducted between 0° C. and 37° C allowing for both hypothermic conditions and under normothermic condition (col 8, ln 15-23). The composition is taught as being used with various organs, e.g “(heart, lung, liver, kidneys, pancreas, intestine, cornea, etc.)”, and describes using a composition of UW storage solution with M101 (“M101 (HEMO2Life®, Hemarina SA, France) is a buffered solution of Arenicola marina hemoglobin,” (col 9, ln 11-13)) for kidney preservation, wherein recovery of renal function was preserved, tissue integrity was maintained, inflammation/ immune response was reduced (col 2, ln 49-52; col 11-13). Zal does teach using an oxygen sensor to measure the amount of dissolved oxygen in the solution with M101 and UW storage solution.
Zal does not teach including a “single oxygen probe”, and therefore the claim limitations in reference to it, i.e. step (c) through step (e), as recited in claim 1, and the related step (iii) through (v) recited in claim 9.
The use of optical dissolved oxygen sensors is known in the art, and can be seen with cell culture systems that include such sensors. Gao describes that “For long-term growth of mammalian cells in perfused bioreactors, it is essential to monitor the concentration of dissolved oxygen (DO) present in the culture medium to ascertain the health of the cells. An optical oxygen sensor based on dynamic fluorescent quenching was developed for long-term continuous measurement of DO for NASA-designed rotating perfused bioreactors (abstract). Gao does not teach these DO sensors for organ storage solutions.
Anderson teaches the methods for evaluating the viability of an organ that is used for transplant by monitory the oxygen consumption rate of the organ (Paragraph [0008]) (interpreted as monitoring oxygenation of a graft and determining the viability of a graft). Anderson teaches that the methods and systems are applicable to the heart, lung, liver, kidney, and pancreas (Paragraph [0011]). Anderson teaches that the system will allow an organ to be viable longer, and allow user to monitor the health of the organ during transport (Paragraph [0009]) (interpreted as transporting the graft to the recipient, instant claim 3). Anderson teaches that by monitoring the oxygen, the health of the tissues can be monitored (Paragraph [0011]) (interpreted as monitoring the dissolved oxygen, indicating the viability of the graft, instant claim 9). Anderson teaches that an organ chamber is configured to receive that transplant organ (T) and a fluid (Paragraph [0043]) (interpreted as providing an organ storage solution and immersing the graft in the solution, instant claim 1 and 9). Anderson teaches that oxygen is introduced into the first portion of the pumping chamber (Paragraph [0047]). Anderson teaches that throughout the process, the partial pressure of oxygen is measured with oxygen sensors, which can be optical (light absorbance of oxygen-binding molecules) or electrical (Clark-type electrode) (Paragraph [0050]) (interpreted as introducing an oxygen probe in the composition and monitoring is carried out in real time, instant claim 1 and 9). Anderson teaches that the organ chamber is hermetically sealed (Paragraph [0046]) (interpreted as hermetically closing the sealed container, instant claims 1 (in part) and 9 (in part)). Anderson teaches that the oxygen consumption rate (OCR) was calculated by: (1) multiplying the difference between the pO2 of the delivered UWS (University of Wisconsin Solution) and the pO2 of the organ outflow by 0.00006 the oxygen solubility factor per ml of solution at 4° C., (2) multiplying the result by the organ perfusion in ml/min, (3) normalizing this result by the weight of the organ (Paragraph [0143]) (interpreted as establishing a calibration curve representing pO2 of the composition in which the graft is immersed, normalized to the weight of the graft, instant claim 7 and 16).
The combined references of Zal, Gao, and Anderson do not specifically exemplify that the single oxygen probe is portable.
Geotech teaches several dissolved oxygen meters that are handheld (portable), one of which being the Oxi3205 meter that has a capacity for measuring DO at 0.00 – 20.00 mg/l ±0.5% of value, 0 – 90 mg/L ±0.5 % of value (dependent) (p 2).
It would have been prima facia obvious for one ordinary skill in the art to combine prior art elements according to known methods to yield predictable results, in particular to have combined an optical dissolved oxygen sensor with the organ storage solution taught by Zal that comprises a standard storage solution, i.e. UW, with M101 oxygen carrier, based on it being known that oxygenation is required for preservation, and lack thereof is harmful for the organ potentially leading to transplant failure (Zal col 1-2). M101 was used by Zal as the oxygen carrier to effectively oxygenate organs to prevent conditions of oxygen deprivation during organ storage. Zal teaches using a dissolved oxygen sensor to measure dO2 levels in solution to monitor M101 function in binding of oxygen (Zal col 9). The composition comprising M101, was shown to provide improved protection against cold storage damage, cellular function of the transplant returned more quickly, tissue integrity was better preserved, and less inflammation or immune response after transplantation (Zal col 11-12). Altogether, it would be obvious to monitor DO in the transport of organs in preservation solution based on it being known in view of Zal that low oxygen conditions are dangerous for the transplant, and the M101 molecule that is comprises in the storage solution is functioning by binding to oxygen to prevent such condition as occurring. In further support of this, Zal teaches measuring dissolved oxygen, Anderson teaches monitoring of oxygen levels in a transplant container to monitor the health of the organ (Anderson par 0035), Gao teaching optical dissolved oxygen sensors for monitoring health of cell cultures, and therefore usage outside of monitoring water quality (Gao abstract), and Geotech the specific meters claimed herein.
Regarding claim 3, Zal teaches transplantation of the preserved kidney that has been hermetically sealed (col 9, 12), additionally Anderson teaches the oxygenation of an organ for transplant in a hermetically sealed container prior to delivery to a patient for transplant (0008-10, 0046).
Regarding claims 7 and 16, the rejection above for claim 1 and 9 makes obvious the limitations recited.
Regarding claim 11, the rejection above for claim 1 and 9 makes obvious the limitations recited.
Regarding claim 19, the rejection above for claim 1 and 9 makes obvious the limitations recited wherein Zal teaches several of the organ storage solutions (col 10, ln 4-10).
Conclusion
Claims 1,3,7,9,11,16 and 19 are rejected. No claims are allowed.
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/MICHAEL ANGELO RIGA/ Examiner, Art Unit 1634
/TERESA E KNIGHT/ Primary Examiner, Art Unit 1634