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 office action is response to communication filed on 12/18/2025.
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on 12/18/2025, wherein claims 28, 29, 31, 44 and 82 are cancelled, new claim 91-93 are added.
Election/Restrictions
Applicant elected , without traverse, Group I, claims 27-31 and 37-47 in the reply filed on 08/20/2025.
Status of Claims
Claims 27, 30, 37-43, 45-47, 67, 75-81, 83-86 and 91-93 are pending.
Claims 67, 75-81 and 83-86 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention/species.
Claims 27, 30, 37-43, 45-47, and 91-93 are currently under examination in this office action.
Action Summary/Response to Arguments
Applicant's remarks filed 12/18/2025 have been fully considered. Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant’s persuasive arguments .The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office action.
US application No. 18/701,841 is abandoned on 01/06/2026. The provisional rejection on the ground of double patenting over US application No.18/701,841 is withdrawn.
It’s noted claim 27 is amended to recite Alzheimer’s disease. Applicant’s argument have been fully considered, but NOT persuasive to overcome rejections under 35 USC § 112 Scope of enablement and rejections over Dreyfus ‘299 under 35 USC § 103. Please see response to arguments in following section, respectively.
Priority
This application 18/005,245 filed 01/12/2023 is a 371 of PCT/US2021/042877 filed 07/23/2021
which claims the benefit of U.S. Provisional App. No 63/055,362 filed 07/23/2020.
Claim Interpretation
According to Pubchem database (CID#135260636, retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/ly3372689), instant claimed compound of formula, N-[4-fluoro-5-[[(2S,4S)-2-methyl-4-[(5-methyl-1,2,4- oxadiazol-3-yl)methoxy]-1-piperidyl]methyl]thiazol-2-yl]acetamide (CAS# 2241514-56-5) is an O-GlcNAcase OGA inhibitor, also known as LY3372689, ceperognastat.
Claim Rejections - 35 USC § 112
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.
Claims 27, 30, 37-43, 45-47, and 91-93 are rejected under 35 U.S.C. 112(a) because the specification, while be enabling for a method of treating Alzheimer’s disease in a patient in need thereof, with orally administering certain dose of compound of N-[4-fluoro-5-[[(2S,4S)-2-methyl-4-[(5-methyl-1,2,4- oxadiazol-3-yl)methoxy]-1-piperidyl]methyl]thiazol-2-yl]acetamide (i.e. LY3372689) (which still needs more data support ), does not reasonably provide enablement for 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 without undue experimentation (maintained and reiterated as necessitated by amendment).
To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). The determination that "undue experimentation" would have been needed to practice the claimed invention in full scope is not a single, simple factual determination.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. Keeping that in mind, the Wands factors are relevant to the instant application for the following reasons:
The Breadth of The Claims/ Nature of The Invention
Independent claim 27 and its dependent claims are amended to recite a method for treating Alzheimer’s disease in a patient in need thereof, comprising orally administering a compound of formula, N-[4-fluoro-5-[[(2S,4S)-2-methyl-4-[(5-methyl-1,2,4- oxadiazol-3-yl)methoxy]-1-piperidyl]methyl]thiazol-2-yl]acetamide (i.e. LY3372689) or a pharmaceutically acceptable salt thereof, at a total dose of 0.5 mg/kg to 5mg/day. The dependent claims are further directed low dose amount (e.g. 0.5 mg/day, etc. ). The efficacy of instantly claimed low dose ranging from 0.5 mg to 5mg/day (especially the lower dose 0.5mg) for treating Alzheimer’s disease lacks sufficient support by instant specification at the time the application was filed.
The State of the Prior Art and the Predictability or Lack Thereof in the Art
It is well known in the prior art that treatment of neurodegenerative disease/disorder (e.g. Alzheimer ) is highly unpredictable and very challenging. O-GlcNAcase inhibition targeting at tau pathology of tau-mediated neurodegeneration disorders (e.g. Alzheimer) has been documented and thousands of OGA inhibitors have been studied (See Bartolomé-Nebreda 2021 review, Applicant’s IDS dated 04/18/2024). However, due to high unpredictable factors (e.g. unfavorable toxicity and pharmacokinetic profile for brain penetration, etc. ), only two OGA inhibitors, MK-8719 by Merck (See Selnick 2019) and ASN-120,290 by Asceneuron (See Asceneuron 2019 news release) advanced to human clinical trial as of July 2020 but no clinical data was released at the time instant application was filed.
Regarding assessment of OGA inhibitor on tau topography, Paul (J. Nucl. Med. 2019, Applicant’s IDS dated 04/18/2024) teaches evaluation of PET radioligand to image O-GlcNAcase brain and periphery of rhesus monkey and knock-out mouse, for OGA inhibitor LSN3316612 parent ligand (LSN3316612, 1 mg/kg intravenously) or the prototypic inhibitor thiamet-G (10 mg/kg intravenously). Paul teaches the limitation of activity/efficacy measurement: “Although 18F-LSN3316612 has exemplary properties for imaging and quantifying its target enzyme in monkey brain, its extension to humans may have limitations. The current study suggests that the most worrisome characteristic of 18F-LSN3316612 is that VT measurements did not stabilize; instead, they increased by 5%-10% in the last 40 min of a 2-h scan. Such a relatively small increase in humans would be acceptable, but greater increases may be problematic. Such instability over time could reflect that equilibrium binding has not been achieved (e.g., because of high density of the enzyme or high affinity of the radioligand) or that radiometabolites accumulate in brain” (See page 133). Instantly claimed low-dose of compound N-[4-fluoro-5-[[(2S,4S)-2-methyl-4-[(5-methyl-1,2,4- oxadiazol-3-yl)methoxy]-1-piperidyl]methyl]thiazol-2-yl]acetamide (i.e. LY3372689) might not have passed through blood-brain barrier and accumulate enough amount in the brain to stabilize the VT measurements for the assay.
More generally, the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity (e.g., cancer prevention) is generally considered an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The level of one of ordinary skill in the art
The level of skill required to make and/or use the instant invention would likely require many years of professional experience conducting research in the art (e.g., medicine, pharmaceutical science, biology, biochemistry, medicinal chemistry, etc.) as well as an advanced educational degree (e.g., M.D. and/or Ph.D.) commensurate in level with the advanced techniques involved in the preparation and/or use of the instant invention.
The Amount of Direction Present and Presence or Absence of Working Examples
Instant specification discloses pharmacokinetic assay of compound of Formula I in healthy subjects (See page 9-) and a clinical study design to evaluate/ assess brain o-GlcNAcase enzyme occupancy after single oral doses of the compound of formula I as measured by positron emission tomography with the radioligand [18F]LSN3316612 in healthy subjects (See page 14 ). Instant specification does NOT disclose assay/study wherein instantly claimed low dose of compound of Formula I ( e.g. 0.5mg/day) was administered and evaluated in patients with Alzheimer's disease. However, plasma level of compound of Formula I does not necessarily correlate with the amount of compound of Formula I in the brain that need to pass through blood-brain barrier, especially at low dose (See instant Table 5a). Because hyperphosphorylated tau in human AD brains contains noticeably lower levels of O-GlcNAc than the levels found in healthy brains, OGA occupancy in the brain of healthy subjects would be different from OGA of pathological tau in the brain of patients with neurodegenerative disease, thus could not be used to predict the efficacy of compound of Formula I in patients with pathological tau for treating neurodegenerative disease.
It’s noted clinal study design for NCT05063539, a study of LY3372689 to assess the safety, tolerability, and efficacy in participants with Alzheimer's disease was first posted on 09/29/2021(retrieved from https://clinicaltrials.gov/study/NCT05063539) and no clinical data has been disclosed in instant specification as filed on 07/23/2021. It’s well known that animal study does not necessarily translate into efficacy in humans, the efficacy of instantly claimed low dose for treating Alzheimer’s disease has not been fully established at the time the application was filed due to the high unpredictability of neurodegenerative disease treatment .
The quantity of experimentation needed
Although instant specification provide some guidance/protocols in the clinical study design, an ordinary skilled artisan would not be able to practice the method of treating Alzheimer's disease in human patients with instantly claimed low dose of compound of Formula I (i.e. LY3372689) without unduly experimentation to validate the efficacy of low dose of compound of Formula I. In addition to the PET scan, the efficacy of OGA inhibitor at low dose might need to be validated through other clinical index/criteria of Alzheimer disease (e.g. cognitive subscale ADAS-Cog13, functional decline , etc.). Therefore, it would be a great burden for one of ordinary skill in the art to carry out undue experimentation to use the claimed invention for treating Alzheimer's disease in full scope.
Conclusion
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562,27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here with respect to the claimed method of treating Alzheimer with orally administering low dose of compound of Formula I, in view of the analysis above pursuant to In re Wands. In other words, one skilled in the art could not practice the claimed invention in full scope without undue experimentation.
Response to Arguments
Applicant argues claim 27 is amended to recite Alzheimer's disease, claims 27, 30, and 67 lower bound of the claimed range amended from 0.1 mg/day to 0.5 mg/day and there is sufficient data supporting the 0.5 mg/day dose in the application.
RESPONSE: Applicant’s argument is NOT persuasive. Instant specification only disclose pharmacokinetic data and Positron Emission Tomography essay on HEALTHY subjects which could not be used to validate efficacy of instant claimed low-dose regimen for treating subjects having Alzheimer’s. The plasma level of compound of Formula I does not necessarily correlate with the amount of compound of Formula I in the brain that need to pass through blood-brain barrier, especially at low dose. Due to the high unpredictability of treating Alzheimer, the efficacy of instantly claimed low dose of LY3372689 for treating Alzheimer’s disease has not been fully established at the time the application was filed.
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 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 non-obviousness.
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.
Claims 27, 30, 37-43, 45-47, and 91-93 are rejected under 35 U.S.C. 103 as being unpatentable over Dreyfus ‘299 ( WO2018140299A1, hereafter “Dreyfus ‘299 ”, family member of US 10,081,625 B2, Applicant’s IDS dated 04/17/2024) (maintained and reiterated as necessitated by amendment).
Dreyfus ‘299 teaches 5-methyl-1,2,4- oxadiazol-3-yl compounds, e.g. compound of Formula I and Ia, N-[4-fluoro-5-[[(2S,4S)-2-methyl-4-[(5-methyl-1,2,4- oxadiazol-3-yl)methoxy]-1-piperidyl]methyl]thiazol-2-yl]acetamide (i.e. instant claimed compound), or a pharmaceutically acceptable salt thereof, and method of treating neurodegenerative diseases and disorders, such as Alzheimer's disease or other tau-mediated neurodegenerative disorders (e.g. progressive supranuclear palsy PSP), comprising administering to the patient an effective amount of compound of Formulas I or Ia (See abstract; page 2, lines 7-26; page 3, lines 1-32; enzyme assay from page 22-25 ; claims 1-15).
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Dreyfus ‘299 teaches the activity of compound of Formula I or Ia, in-vitro and cellular assay, e.g. IC50 of 21.9 nM ± 7.3 (See page 25, line 21; enzyme assay from page 22-25). Dreyfus ‘299 teaches compound of Formula I or Ia are preferably formulated into pharmaceutical compositions for oral administration following general knowledge in the art (See page 4 , lines 26-29). Dreyfus ‘299 teaches dosages per day normally fall within the range of about 0.1 to about 15 mg/kg of body weight. In some instances dosage levels below the lower limit of the aforesaid range may be more than adequate (See page 4, lines 20-23). For a person with average weight of 60kg, the dosage range is calculated to be about 6-900 mg total daily dose/day. As indicated by Dreyfus ‘299 (See page 4, lines 11-49), an effective amount can be readily determined by one skilled in the art by the use of known techniques and by observing results obtained under analogous circumstances. Dose adjustment including titrating down dose amount, adjusting administration times and frequency, etc. based on evaluation of treatment outcome/assessment of patient’s response is within the knowledge of a skilled artisan in the art. It would have been obvious to one of the ordinary skilled in the art to explore the dosage regimen of Formula I or Ia based on the teachings of Dreyfus ‘299, together with experimentation and optimization based on the general knowledge of neurodegenerative diseases and disorders (e.g. Alzheimer's disease) and arrive the range claimed in instant invention. Since Dreyfus ‘299 teaches dose below 6mg (corresponding to 0.1 mg/kg of body weight for 60kg adult) might be adequate for intended treatment outcome, a skilled artisan would be motivated to explore administering lower dose of compound of Formula I or Ia to avoid adverse event commonly associated with higher dose. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and exploration/optimization of administration regimen (e.g. dose amount) for intended treatment outcome based on the general knowledge of treating neurogenerative disease (e.g. Alzheimer’s). Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues high end of the claimed total daily dose range (5 mg) is lower than the low end of Dreyfus's disclosed range... a person of ordinary skill in the art would not have been motivated, based on Dreyfus, to adjust the total daily dose to a value within the presently claimed range.
RESPONSE: As explained in last office action and reiterated above, dose adjustment including titrating down dose amount, adjusting administration times and frequency, etc. based on evaluation of treatment outcome/assessment of patient’s response is within the knowledge of a skilled artisan in the art. A skilled artisan would be motivated to use low-dose of compound of Formula I (i.e. LY3372689) to minimize/ reduce adverse effect. As such, instant low dose regimen compared with 7 mg per taught by Dreyfus is considered as routine optimization in treating Alzheimer’s disease .
Applicant argues Dreyfus does not disclose how low the dose can be adjusted while retaining efficacy.
RESPONSE: As explained in preceding rejection under 35 USC § 112, the alleged efficacy of low-dose regimen of compound of Formula I (i.e. LY3372689) for treating Alzheimer’s disease is NOT fully supported/validated by instant specification at the time of filing.
As MPEP 2143.02.I. stated : “Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute"))”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 27, 30, 37-43, 45-47, and 91-93 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. patent No.10,081,625 B2, in view of Dreyfus ‘299 et al. (WO2018140299A1, Applicant’s IDS dated 04/17/2024) (maintained and reiterated as necessitated by amendment).
Reference claims are directed to compound of formula N-[4-fluoro-5-[[(2S,4S)-2-methyl-4-[(5-methyl-1,2,4- oxadiazol-3-yl)methoxy]-1-piperidyl]methyl]thiazol-2-yl]acetamide that’s instantly claimed compound (i.e. LY3372689) and pharmaceutical composition thereof.
Reference claims are silent about method of treating Alzheimer's disease with N-[4-fluoro-5-[[(2S,4S)-2-methyl-4-[(5-methyl-1,2,4- oxadiazol-3-yl)methoxy]-1-piperidyl]methyl]thiazol-2-yl]acetamide (i.e. LY3372689) and dose thereof. The collective teachings of Dreyfus ‘299 is elaborated in preceding 103 rejection and applied as before. Dreyfus ‘299 teaches a method of treating neurodegenerative diseases and disorders (e. g. Alzheimer's disease, progressive supranuclear palsy PSP, etc.),comprising administering to a patient in need thereof, an effective amount of a compound of formula I or Ia , e.g. 0.1 to about 15 mg/kg of body weight which is equivalent to about 6-900 mg total daily dose/day for a person with average 60 kg weight.
Dose adjustment including titrating down dose amount, adjusting administration times and frequency, etc. based on evaluation of treatment outcome/assessment of patient’s response is within the knowledge of a skilled artisan in the art. It would have been obvious to one of the ordinary skilled in the art to explore the dosage regimen of Formula I or Ia based on the teachings of Dreyfus ‘299, together with experimentation and optimization based on the general knowledge of neurodegenerative diseases and disorders (e.g. Alzheimer's disease) and arrive the range claimed in instant invention. Since Dreyfus ‘299 teaches dose below 6mg (corresponding to 0.1 mg/kg of body weight for 60kg adult) might be adequate for intended treatment outcome, a skilled artisan would be motivated to explore administering lower dose of compound of Formula I or Ia to avoid adverse event commonly associated with higher dose. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05.
The instant application shares at least one common inventor/applicant with the reference patent. Further, the continuing data of instant application is not related to the reference patent and thus no 35 USC 121 shield exists. See MPEP 804.01.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628