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 .
Claim Status
Claims 1-29 are currently pending.
Claims 16-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 April 2026.
Claims 1-15 are under exam herein.
Priority
The instant Application is the National Stage filing of PCT/US2020/047408, filed 21 August 2020 which claims the benefit of priority to US provisional application 62/889,807, filed 21 August 2019. Each of claims 1-15 herein enjoy the priority to the EFD of 21 August 2019.
Information Disclosure Statement
The Information Disclosure Statements filed 2/17/2022; 4/4/2022; 9/29/2023; 10/3/2024; 2/26/2025; 7/24/2025; and 10/3/2025 are in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. Signed copies of the IDS documents are included with this Office Action.
Drawings
The Drawings filed 17 February 2022 have been accepted.
Specification
Note: All references to the Specification herein pertain to the PG publication: US20230044633A1.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 includes an incorrect “;” after the preamble, at line 2, reciting “effective against a microbial cell population in a subject comprising;”. The claim should be amended to include a colon and recite, “effective against a microbial cell population in a subject comprising:”.
Appropriate correction is required.
Claim Interpretation
In the interest of compact prosecution, the instant claims are examined to consider all claim limitations but the claims herein contain recitations of intended use, as recited below. The courts have stated that claims must be given their broadest reasonable interpretation consistent with the specification In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997); In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541,550-551 (CCPA 1969); and In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) (see MPEP § 2111). Thus the claims herein are given the broadest reasonable interpretation consistent with the indefinite claim language and specification wherein specific structures for the intended uses as recited in the claims are undefined. It is suggested that the claims be amended to recite active, positive limitations to avoid recitation of intended use in the claims.
Claims 5-6 and 13-14 recite the limitations “a method of treating a subject”, “a method of preventing a pathological disease”, respectively wherein the methods are performed by “using the antimicrobial dosing regimen” without any further steps as to implementation of the use herein.
Claim Rejections - 35 USC § 112(b)-Indefiniteness
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.
Claims 1-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1 and 8 recite, “and Kd is the death rate constant” wherein the formula (1) in in the instant claims fails to include the variable Kd and as such the recitation in the claim is unclear with respect to the instant formula. Clarification is requested.
Claims 1 and 8 include the formula (1) with e-at, which is not defined in the claim. As such, e is not clear with respect to formula (1) as recited. Clarification is requested.
Claims 1 and 8 recite, “based on the generated output value, correlating, at the end of the time period, an increase in microbe susceptibility in the presence of the antimicrobial agent with a likely clinical dosing regimen that is pharmacologically effective against the microbial cell population in the subject”, wherein the claim is unclear with respect to the susceptibility of the microbe cell population that is based on the mathematical modeling, as a particular indication value for a meaningful correlation is not clear. There are no parameters defined such that a particular value or range of values would indicate any increase in microbe susceptibility in the presence of a microbial agent and thus the correlation of such is indefinite. Clarification is requested through clearer claim language.
The dependent claims herein fail to remedy the above and are also included in the rejections herein.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1 Analysis: Are claims directed to process, machine, manufacture/composition of matter
With respect to step (1): yes, the claims are directed to a method for determining a clinical dosing regimen.
Step 2A, Prong 1 Analysis: Do claims recite abstract idea
With respect to step (2A)(1), the claims recite abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and in conjunction with mathematical concepts (in particular mathematical relationships and formulas).
The claim steps to abstract ideas are as follows:
Claim 1:
inputting said datasets into the mathematical modeling framework (1) for determining the susceptibility of the microbe cell population during contact with the one or more antimicrobial agents over the period of time (formula (1)); wherein Nlive is the bacterial population that is alive; Nmax is the maximum bacterial population; Kg is the growth rate constant; and Kd is the death rate constant; rmin is the kill rate of the most resistant sub-population; ℷ is the magnitude of adaptation; and a is the rate of adaptation; and (iii) generating an output value of the susceptibility of the microbe cell population based on the mathematical modeling frame work; and (iv) based on the generated output value, correlating, at the end of the time period, an increase in microbe susceptibility in the presence of the antimicrobial agent with a likely clinical dosing regimen that is pharmacologically effective against the microbial cell population in the subject, wherein steps directed to inputting data into a formula are mathematical processes and can be performed via pen and paper using said mathematical formula in the claims. Further, steps directed to generation of an output value are the outcomes from said input into the mathematical formula as written and making “correlations” between said output parameters and a microbe susceptibility are steps that are mental in nature whereby data are assessed to make said associations.
Claim 8 is directed to the same abstract steps as recited above.
Claims 2 and 11:
designing a dosing regimen that is pharmacologically effective against the microbial cell population based on the output values over the time period of the mathematical modeling framework, wherein the step of “design” is a mental operation whereby a clinician, for example, could plan a dosing regimen for a patient.
Claim 10:
further comprising compiling a library of antimicrobial agents and dosing regimens effective to suppress an emergence of acquired resistance in microbial cell populations, wherein the step of compiling a library is a mental step of collecting pertinent data in a set.
Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined herein to each cover performance either in the mind (calculations by hand or pen and paper or computer as a tool) and performance by mathematical operation (normalization; curve fitting; etc.). There are no specifics as to the methodology involved in “measureing” or in “selecting” and thus, under the BRI, one could simply, for example, perform said operation with pen and paper, or, alternatively with the aid of a generic computer as a tool to perform said operations. These recitations are similar to the concepts of collecting information, analyzing it and providing certain results from the collection and analysis (Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations (Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in (Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind with pen and paper, and can include mathematical concepts.
Further, see MPEP § 2106.04(a)(2), subsection III. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674: noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016): holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind" (see Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016): holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Step 2A, Prong 2 Analysis: Integration to a Practical Application
Because the claims do recite judicial exceptions, direction under (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim is said to fail to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements:
Claims 1 and 8:
collecting information-rich datasets that indicate microbe cell population growth response in the presence of one or more antimicrobial agents over a period of time at fixed concentrations, which is a step directed to pre-solution activity that includes data gathering.
Claims 3 and 11:
the microbial cell population is a cell population of Gram-negative bacteria, Gram-positive bacteria, yeast, mold, mycobacteria, virus, or infectious agents, which is a step that further defines the type of data in the claims and further is limited to data gathering.
Claims 4 and 12:
the antimicrobial agent is an antibiotic, an anti- fungal or anti-viral agent, which is a step that further defines the type of data in the claims and further is limited to data gathering.
Claims 5 and 13:
method of treating a subject having a pathological condition caused by infection with a microbial cell population using the antimicrobial dosing regimen determined by the method of claim 1, which is a step of extra-solution activity akin to “apply it” in the claim as there are no specific treatment steps provided.
Claims 6 and 14:
method of preventing a pathological condition caused by exposure of a subject to a microbial cell population using the antimicrobial dosing regimen determined by the method of claim 1, which is a step of extra-solution activity akin to “apply it” in the claim as there are no specific prevention steps provided.
Claims 7 and 15:
the information-rich datasets that indicate microbe cell population growth response in the presence of one or more antimicrobial agents are optically derived, which is a step that further defines the data in the claims and is akin to pre-solution data gathering.
Data gathering does not impose any meaningful limitation on the abstract idea, or on how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Further, the Supreme Court has explained that the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). In Flook, the Court reasoned that "[t]he notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula". 437 U.S. at 590; 198 USPQ at 197; Id. (holding that step of adjusting an alarm limit variable to a figure computed according to a mathematical formula was "post-solution activity"). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 79, 101 USPQ2d 1961, 1968 (2012) (additional element of measuring metabolites of a drug administered to a patient was insignificant extra-solution activity).
Step 2B Analysis: Do Claims Provide an Inventive Concept
The claims are lastly evaluated using the (2B) analysis, wherein it is determined that because the claims recite abstract ideas, and do not integrate that abstract ideas into a practical application, the claims also lack a specific inventive concept. Applicant is reminded that the judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering and extra-solution activity described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the claim elements directed to collecting information-rich datasets that indicate bacterial population growth are steps that are defined by the instant Specification as performed using “any” optically based instrument or device [0036] and that may include, for example, the BacterioScan 216Dx laser microbial growth monitor which was well-known in the art for laboratory data gathering. See, for example, Roberts et al. (Laboratory Medicine (2018) Vol. 49:35-40) describing the BacterioScan 216Dx. Other well-known devices include routine benchtop spectrophotometers and microplate readers.
Further, the courts have recognized the application of routine laboratory techniques including the following as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)II.): determining the level of a biomarker in blood by any means (Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017)); detecting DNA or enzymes in a sample (Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017)).
The dependent claims have been analyzed with respect to step 2B and none of these claims provide a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception.
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
1. Claims 1-9 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhagunde et al. (AIChE Journal (2015) Vol. 61, No.8:2385-2393; IDS reference).
Instant claim 1 is directed to:
A method for determining a clinical dosing regimen that is pharmacologically effective against a microbial cell population in a subject comprising [Bhagunde et al. discloses development of formulas used in estimation and subsequent dosing schedules under pharmacokinetic conditions, p. 2385 at abstract]
(i) collecting information-rich datasets that indicate microbe cell population growth response in the presence of one or more antimicrobial agents over a period of time at fixed concentrations [Bhagunde et al. disclose collection of datasets that indicate cell population growth response in presence of antimicrobial agents over time at Figures 4 and 5 at pp. 2389 and 2390, respectively];
(ii) inputting said datasets into the mathematical modeling framework (1) for determining the susceptibility of the microbe cell population during contact with the one or more antimicrobial agents over the period of time
PNG
media_image1.png
102
876
media_image1.png
Greyscale
wherein Nlive is the bacterial population that is alive; Nmax is the maximum bacterial population; Kg is the growth rate constant; and Kd is the death rate constant; rmin is the kill rate of the most resistant sub-population; ℷ is the magnitude of adaptation; and a is the rate of adaptation [Bhagunde et al. disclose the mathematical modeling framework at Equations (1), (6), (33), and (34)]; and
(iii) generating an output value of the susceptibility of the microbe cell population based on the mathematical modeling frame work [Bhagunde et al. disclose parameter estimates at pp. 2390-2391 wherein the outcome includes an estimate of the antibiotic concentration that can be established to ensure eradication of the bacterial population including those most resistant]; and
(iv) based on the generated output value, correlating, at the end of the time period, an increase in microbe susceptibility in the presence of the antimicrobial agent with a likely clinical dosing regimen that is pharmacologically effective against the microbial cell population in the subject [Bhagunde et al. disclose correlations at Figure 6, p. 2390 and further Equation 939) and Table 2 which calculate the estimate of the antibiotic concentration as disclosed at p. 2391; it is noted herein that the derivation of the equation in the instant claims would be inherently performed by one of skill in the art and does not distinguish between instant claims as they are capable of achieving the same outcome].
With respect to claim 8, Bhagunde et al. disclose the above limitations which are he same as present in claim 8. Claim 8 also includes doing so for populations that have acquired resistance. Bhagunde et al. disclose such as described in the above limitations.
With respect to claims 2 and 9, Bhagunde et al. disclose that the methodology is used for design of agents effective against a microbial cell population [abstract; data used to build models suitable for dosing regimen design].
With respect to claims 3 and 11, Bhagunde et al. disclose the bacteria, E. coli, which is a gram-negative bacteria [p. 2391].
With respect to claims 4 and 12, Bhagunde et al. disclose moxifloxacin, which is an antibiotic [p.2391].
With respect to claims 5 and 13, the prior art to Bhagunde et al. disclose use of the model for dosing regimens, which would inherently include that of using a dosing regimen to treat. The claims are not limited by any particular treatment or step rather than the use of the model.
With respect to claims 6 and 14, the prior art to Bhagunde et al. disclose use of the model for dosing regimens, which would inherently include that of using a dosing regimen to prevent a condition. The claims are not limited by any particular step rather than the use of the model.
With respect to claims 7 and 15, Bhagunde et al. disclose that the data are optically derived [p. 2391, bacterial density enumerated visually].
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.
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 as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention 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.
1. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bhagunde et al. (AIChE Journal (2015) Vol. 61, No.8:2385-2393; IDS reference), as pertains to claim 8 above, in further view of US2010/0292964A1 to Tam et al. (IDS reference with different inventive entity; 102(a)(1) reference).
With respect to claim 10, the prior art to Bhagunde et al. disclose limitations as pertain to claim 8 recited above. Bhagunde et al. do not specifically disclose compiling a library of agents and dosing regimens based on the mathematical mode. However, the prior art to Tam et al. disclose steps of compiling a library of agents and dosing regimens effective to suppress emergence of acquired resistance in a cell population at least at [0013]; [0053].
It would have been prima facei obvious to one of skill in the art before the effective filing date of the claimed invention to have including the library of Tam et al. with the methodology as disclosed by Bhagunde et al., as both references are directed to provide method to predict agents effective to supress acquisition of bacterial resistance (Tam et al. at abstract; Bhagunde et al. at abstract). Inclusion of a library as the result of the models of Bhagunde et al. would have been an obvious output of said modeling and one would have had a reasonable expectation of success in so doing by compilation of the data as derived from said models therein.
2. Claims 1-9 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bhagunde et al. (AIChE Journal (2015) Vol. 61, No.8:2385-2393; IDS reference), in further view of US2010/0292964A1 to Tam et al. (IDS reference with different inventive entity; 102(a)(1) reference).
The prior art to Bhagunde et al. disclose the limitations of claims 1-9 and 11-15 as disclosed above.
Insomuch as the derivation of the equation in the instant claims would not be inherently performed by one of skill in the art in practicing the exact disclosure of Bhagunde et al., claims 1-9 and 11-15 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as each of the disclosed parameters exist in the prior art and the technological solutions to provide the output value as claimed are disclosed. One of skill in the art of mathematics (calculus) could have readily derived the magnitude adaptation as provided herein from the disclosure at p. 2390, Equations 35-36 of Bhagunde et al. As such, said operations are obvious herein.
Conclusion
No claims are allowed.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-273-8300): PTO/SB/439. Applicant is encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lori A. Clow, whose telephone number is (571) 272-0715. The examiner can normally be reached on Monday-Thursday from 12:00PM to 10:00PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached on (571) 272-9047.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
/Lori A. Clow/Primary Examiner, Art Unit 1687
Prosecution Insights