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
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on 04/16/2025, wherein new claims 11-21 are added.
Status of Claims
Claims 1-6 and 8-21 are pending in instant application.
Claims 9-10 remain withdrawn.
Claims 1-6, 8 and 11-21 are currently under examination in this office action.
Action Summary/Response to Arguments
Applicant's Remarks filed on 04/16/2025 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 Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant' s remarks .The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-6, 8 and 11-21 under 35 U.S.C. 103 as being unpatentable over Wang’485 in view of Gao, Oliveira Varum and Zhong on the record is maintained and reiterated as necessitated by amendment.
Applicant argues about the stability problem of TBN (Remarks, pages 12-14), and “ incorporating specific alkalizing agents into the tablet core and adding an isolation layer could effectively address the stability issues of the enteric tablets… In summary, the present invention, through the tablet core composition including an alkalizing agent as claimed in claim 1, in combination with the isolation layer, effectively avoids the impact of the enteric coating on the stability of TBN, and successfully prepares stable enteric tablets. More importantly, the composition of the present invention rapidly disintegrates in the intestines, allowing the active substance TBN to be absorbed in the intestinal tract and exert its therapeutic effect, thereby effectively improving bioavailability (Remarks, page 16-18).
RESPONSE: Applicant’s argument about the stability problem solved by sodium bicarbonate and isolation layer have been fully considered, but are NOT persuasive. The technique feature of enteric formulation comprising sodium bicarbonate and isolation layer solving the stability problem of active ingredient (TBN) , are considered obvious based on the combined teachings of Gao, Oliveira Varum and Zhong, together with general knowledge of nitrone compounds and enteric formulation.
Regarding the alkylating agent sodium bicarbonate, Gao teaches embodiments of tablet core comprising sodium bicarbonate wherein the ratio of active ingredient TMPP (75mg) to sodium carbonate (30 or 40mg) in Example 2 and 6 is calculated to be 100: 40 (which is close to the ratio recited in new claims 16, 18 and 19). Although Applicant argues the use of sodium bicarbonate by Gao is different from that in the present invention (Remarks, bridging page 20-21), a skilled artisan would have known sodium carbonate is commonly used alkalizing /pH adjusting agent for pH sensitive active ingredients. Instant claimed TBN is derivative of TMP taught by Gao and both are pyrazines compounds. By adjusting the solubility of pyrazine compounds and dissolution rate thereof with sodium bicarbonate as taught by Gao, one would also be adjusting pH of the tablet core as needed that contribute to the alleged stability. Instant claims do not recite any amount/concentration of active ingredient TBN and the alkalizing agent. Independent claim 1 and other dependent claims DO NOT recite sodium bicarbonate as the specific alkalizing agent, while sodium bicarbonate is only recited in claims 4 and 17 in combination with vast variety of other pharmaceutical excipients. As such, the alleged stability result by undefined amount of sodium carbonate stabilizing undefined amount of active ingredient TBN does not commensurate with the vast scope of instant claimed alkalizing agent.
Regarding isolation layer, Oliveira Varum and Zhong already teach isolation layer and benefit of isolation layers, such as improving the stability of the formulations, avoid hydrolysis of water-sensitive drugs, accelerating initial drug release, etc.
Applicant’s argument about different use of isolation layer in Oliveira Varum and Zhong (Remarks, page 21-22) are NOT persuasive. Oliveira Varum explicitly teaches HPMC isolation layer improves the stability of the tablet during storage ( See [0266]), which read on the isolation layer in Table 4 (Remarks, page 16). An isolation layer is commonly used as a barrier between the tablet core and the outer enteric coating in an enteric tablet to prevent undesirable interactions between the tablet core and the outer coating. It would be logical and obvious to expect thick isolation layer would protect unstable active ingredient within the tablet core from outer detrimental factors, thus improve the stability of the active ingredient as alleged. Further, Oliveira Varum teaches embodiment of isolation layer for accelerating drug release at the small intestine at pH 5.5 to 7.2 (See [0049)], which read on Applicant’s alleged rapidly disintegration of TBN enteric tablet in the intestines.
In response to applicant's arguments against the references individually(Remarks, pages 18-22), one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although Wang’485 is silent about the stability problem of TBN, Wang’485 explicitly teaches TBN is synthesized from TMP with pyrazine formaldehyde as the intermediate (See Fig. 1 and 2). When faced with technical problem of improving property of TBN tablet (e.g. stability, bioavailability, etc.), it would be logical and obvious for a skilled artisan to explore TBN formulation based on the controlled release TMP tablet comprising a core and overcoat taught by Gao which also teaches sodium bicarbonate. Oliveira Varum and Zhong explicitly teach isolation layer in enteric formulation and benefit of isolation layer, e.g. improving the stability of the formulations, accelerating drug release, etc. It would be obvious for a skilled artisan to explore Wang’ 485 TBN tablet based on Gao’s teachings, together with further optimization based on Oliveira Varum and Zhong teachings of isolation layer and general knowledge of nitrone compounds and enteric pharmaceutical composition. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to further optimize combination of inactive ingredients and ratio thereof for desired dissolution/release and stability profile. 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.
As stated in MPEP 716.02(d): “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”.
It’s noted embodiments in Table 4 and 5 with alleged stability (Remarks, page 16-17) comprise TBN, sodium bicarbonate with specific combination of excipients at specific ratio in tablet core, isolation layer (hydroxypropyl cellulose, Tac), moisture barrier Opadry, and enteric layer (HPMCAS, titania, tac, triethyl citrate). However, the scope of instant claims comprising active ingredient TBN with vast variety combinations of inactive ingredients as alternative alkalizing agent, binders, fillers, disintegrant, lubricant, plasticizers, coating material, anti-sticking agent, opaquer, etc. at various ratio that might not comprise isolation layer as recited in claims 1- 2 and their dependent claims are extremely broad. As such, Applicant’s alleged stability/dissolution result based on sodium bicarbonate as alkalizing agent and specific combination of pharmaceutical excipients in the tablet core, isolation layer and enteric layer, does not commensurate with the scope of instant claimed composition comprising active ingredient TBN and vast variety of pharmaceutical excipients at different combination, different amount and ratio thereof.
Applicant is advised to amend claims with limitation that are critical/essential to achieve the alleged stability and dissolution profile, for example, concentration/amount of active ingredient TBN, amount/concentration of specific alkylating agent (sodium carbonate), in combination with pharmaceutical excipients in tablet core(as recited in claim 20), enteric layer and isolation layer (as recited in claims 3, 5, 8 and 21 ) that have sufficient support by instant specification. Please note the trademark/trade name, e.g. Opadry, Eudragit L30D-55, Eudragit L100 and Eudragit NE30D, etc. recited in instant claims also need to be amended.
Priority
This application 17/434,624 filed on 08/27/2021 is 371 of PCT/CN2019/098709 filed on 07/31/2019 and claims benefit of CHINA 201910143739.0 filed on 02/27/2019.
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 8 and new claim 21 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 (maintained and reapplied as necessitated by amendment)
Claim 8 refer to composition comprising multiple inactive ingredients with ratio limitation as alternative plasticizers, anti-sticking agent, coating material. Claim 8 recites coating material and anti-sticking agent in the isolation layer which has insufficient antecedent basis in claim 2 from which claim 8 depends from. Anti-sticking agents in both enteric layer and isolation layer are confusing. Claim 8 also recites “ the moisture barrier is Opadry” which has insufficient antecedent basis in claim 2 . 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 Opadry is used to identify/describe a film coating system comprising variety of polymer/copolymers, plasticizers and pigments, etc. ( See https://www.colorcon.com/products/film-coatings/pharmaceuticals/opadry) , the identification/description of film coating system is indefinite. An ordinary skilled in the art would not be apprised of the scope of alternative combinations of plasticizers, anti-sticking agent, coating material. The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 21 is rejected due to its dependency on claim 8.
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.
Claims 1-6, 8 and 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 2011/0034485 A1, hereafter Wang ’485, corresponding to US 8404688 B2,), in view of GAO et al. (CN 101269049 A, Applicant’s IDS dated 08/27/2021 under “Foreign Patent Documents”, Cite #4, machine translated by Google), Oliveira Varum et al.( US 20140056980 A1) and Zhong et al. (CN 101987081B, Applicant’s IDS dated 08/27/2021 under “Foreign Patent Documents”, Cite #5)(maintained and reiterated as necessitated by amendment).
Claim interpretation: As disclosed by instant Spec(page 1), TBN is a nitrone derivative of tetramethylpyrazine (TMP).
PNG
media_image1.png
246
666
media_image1.png
Greyscale
Pharmaceutical excipients is a catch-all term which refers to various sub-groups such as binders, fillers, disintegrants, lubricants, plasticizer, etc. The terms of binders, fillers etc. are construed as intended use of inactive ingredients which might have different names/synonyms and can be used interchangeably wherein one chemical can be categorized in different category of excipient by different application. For example, titania is also known as titanium(IV) oxide or titanium dioxide and can be used as pigment.
Regarding the active ingredient TBN recited in instant claims, Wang ’485 discloses preparation of nitrone derivative of pyrazine compounds, pharmaceutical composition comprising nitrone derivatives, and use thereof (See abstract, claims 1-2, 5, 8-18). Wang ’485 explicitly discloses compound of formula (II) (i.e. TBN) and TBN is the nitrone derivative of TMP ( See Figure 1, [0019], claim 5)
PNG
media_image2.png
309
1255
media_image2.png
Greyscale
Wang ’485 discloses method of treating and/or preventing diseases that result from over production of ROS and/or formation of blood clot, comprising administering to a patient an effective amount of the compound of formula (II) (i.e. TBN), and a pharmaceutically acceptable carrier (See [0021], [0030]-[0032]). Wang ’485 discloses for TBN for treatment or prevention of neurological or cardiovascular diseases, inflammatory disorders, or cancers(See [0024]-[0025],[0039]).
Regarding tablet formulation of TBN and inactive ingredients recited in instant claims 4-8, Wang ’485 teaches TBN may be mixed with pharmaceutical carriers/excipients into a tablet, wherein the excipients comprise lactose, sucrose, mannitol, sorbitol; cellulose derivative (e.g. methyl cellulose, etc.) and polyvinylpyrrolidone (PVP),etc.(See [0062]). It’s noted mannitol is instant elected filler species and lactose, sucrose, sorbitol also read on the filler of instant claim 6; methyl cellulose and polyvinylpyrrolidone (PVP) read on the binder of instant claim 6.
Wang’ 485 collectively teaches tablet composition comprising a therapeutically effective amount of TBN, or a pharmaceutically acceptable salt thereof, and pharmaceutically acceptable excipient/ carrier for treating neurological or cardiovascular diseases.
Wang ’485 is silent about enteric tablet comprising a tablet core and enteric coating and other inactive ingredients in the tablet.
Regarding the tablet limitation of claims 1 and 2, Gao teaches a microporous osmotic pump controlled-release tablet of ligustrazine phosphate( tetramethylpyrazine phosphate (TMPP), wherein the tablet comprise a tablet core and a coating (See abstract; Examples 1-6; claims 1-6; Description translated by Google, [0020]-[0027]). Gao teaches tablet embodiments(See Examples 1-6; claims 1-6), wherein
1) the tablet core comprises active ingredient(TMPP), alkalizing agent (sodium bicarbonate), and/or a binder(e.g. polyvinyl pyrrolidone, etc.), and/or a filler(mannitol, lactose, sucrose, etc.), and/or a lubricant(magnesium stearate, etc.);
2) the coating comprises cellulose, plasticizer (e.g. polyethylene glycol, PEG-400), etc.;
3) coating weight accounts for 2-5% of the tablet core weight (which read on new claims 11-12).
Regarding the alkalizing agent recited in instant claim 4 and ratio to active ingredients of new claims 16, 18 and 19, Gao teaches embodiments of tablet core comprising sodium bicarbonate (30mg or 40 mg ) wherein sodium bicarbonate adjust the solubility of active ingredients and control its dissolution rate (See Example 2 and 6, claim 6, [0027] of translated Description ). The ratio of active ingredient TMPP (75mg) to sodium carbonate (30mg) in Example 6 is calculated to be 100: 40 (which is close to the ratio recited in new claims 16, 18 and 19).
Regarding the enteric layer of instant claim 5, Gao teaches coating material comprising various amount of cellulose acetate (See Example 2, claim 6, [0027] of translated Description ).
Regarding the inactive ingredients of instant claims 6 and ratio to active ingredients recited in new claims 17-20 , Gao teaches multiple embodiments of tablet core, e.g. core (350 mg ) comprising active ingredients (ligustrazine phosphate TMPP)(75mg), sodium bicarbonate (30 or 40 mg), PVP (30mg), mannitol (30 mg) , magnesium stearate (1.8 mg) (See Example 2, 3, 6, Description machine translated by Google [0089]-0096],etc. ), wherein weight ratio of
active ingredients to alkalizing agent (sodium bicarbonate) is 100: 40 or 2.5:1 (=75 mg/ 30 mg)
active ingredients to binder(PVP) is 100: 40 or 2.5:1 (=75 mg/ 30 mg);
active ingredients to filler (mannitol) is 100: 40 or 2.5:1 (=75 mg/ 30 mg);
active ingredients to lubricant (magnesium stearate) is about 100: 2.4 (=75 mg/1.8 mg);
Regarding further limitation of enteric layer of instant claim 5 and 8, Gao teaches embodiments of enteric layer comprising coating material (e.g. cellulose acetate) and plasticizer (e.g. polyethylene glycol, PEG-400)(See Example 1).
Gao teaches preparation of tablet wherein tablet core materials (active ingredients, alkalizing agent, binder and/or filler, and/or lubricant, etc.) are sieved, mixed, granulated and pressed into tablets, coating the tablet core with coating materials at 40-50 C (See claim 7-10).
Gao teaches release-control tablet is capable of controlling the release for 12 hours through optimized selection of penetration-promoting agent, porogen, a plasticizer and film thickness, etc. thereby providing beneficial (e.g. prolonged drug action, reduced frequency of drug delivery, etc. ) and providing experience and technology for formulation development of similar drugs(See abstract).
Gao is silent about isolation layer comprising a coating and anti-sticking agent between tablet core and enteric layer of claim 3 and 8.
Oliveira Varum teaches delayed release formulation comprising a drug core, a delayed release coating, and an isolation layer between the drug core and the delayed release coating, wherein isolation layer prevents erosion at the edges of the tablets prior to coating and accelerates initial drug release in the intestine of a subject (See abstract, [0025]-[0027], [0029], claims 1-14, 23, 47, 53). Oliveira Varum explicitly teaches isolation layer improves the stability of the formulations during storage by preventing deceleration of initial release over time(See [0030]). Oliveira Varum teaches embodiment of isolation layer for accelerating drug release at the small intestine at pH 5.5 to 7.2 (See [0049], [0072]) and HPMC isolation layer improves the stability of the tablet during storage ( See [0266]). Oliveira Varum teaches preparation process of enteric tablet embodiments comprising drug core, isolation layer and enteric layer (both inner and outer layer), which comprise a variety of inactive ingredients, e.g. filler, binder, disintegrant, lubricant, anti-sticking agent, coating materials, etc. that read on instantly claimed filler, binder, disintegrant, lubricant, anti-sticking agent, coating materials, etc. (See Examples 1-3).
Regarding coating material of instant claim 5 , Oliveira Varum and its incorporated reference teach enteric polymer coating materials e.g. cellulose acetate phthalate; cellulose acetate trimellitate; hydroxypropyl methylcellulose phthalate; hydroxypropyl methylcellulose acetate succinate; polyvinyl acetate phthalate; poly(methacrylic acid, methyl methacrylate) 1:1; poly(methacrylic acid, ethyl acrylate) 1: 1; and compatible mixtures thereof (See [0019], Examples ).
Regarding inactive ingredients of instant claims 6 and 8, Oliveira Varum teaches variety of filler, binder, disintegrant, lubricant, anti-sticking agent, etc. at various amount(See [0127]). For example, Oliveira Varum teaches tablet core embodiment comprising 76.9 wt% 5ASA(400mg; drug) ,14.7wt% lactose (filler); 1.7 wt % PVP (binder); 3.5 wt % sodium starch glycolate (disintegrant); and 2 wt% talc (anti-sticking agent) and 1.2 wt% magnesium stearate (lubricants) (See Examples 1-3, [0200]-[0205]).
Regarding instant claims 8, Oliveira Varum teaches variety of plasticizers (e.g. triethyl citrate TEC and polyethylene glycol PEG 6000 ), anti-tack agents ( e g. glyceryl monostearate or GMS), surfactants (e.g. polysorbate 80) and coating material in the isolation layer (e.g. HMPC) in various amounts up to 30 wt % of the final composition of the outer coating preparation(See Examples 1-3, [0191])(which also read on claims 13-15). Oliveira Varum teaches isolation layer embodiments comprising Opadry (See Example 3, [0191])(which read on instant claimed moisture barrier).
As elaborated, Oliveira Varum collectively teaches enteric tablet comprising drug core, isolation layer and enteric layer, comprising a variety of inactive ingredients that read on instantly claimed filler, binder, disintegrant, lubricant, anti-sticking agent, coating materials, etc..
Gao and Oliveria Varum are silent about the opaquer of enteric layer. However, an ordinary skilled in the art would have known that opaquer/opacifiers can protect light-sensitive drug from light and increase the stability of light-sensitive drug. A skilled artisan would know to add opacifiers to the enteric layer as needed for the stability of light-sensitive drug.
Zhong teaches preparation of controlled release tablet comprising a drug core, a controlled release coating, and an isolation layer, which comprise variety of pharmaceutical excipients that read on instantly claimed filler, binder, disintegrant, lubricant, anti-sticking agent, coating materials, etc. (See abstract, claims 1-55). Zhong teaches titanium dioxide ( 2g, 20 to 60%) is used as a white pigment in the coating layer (See [0111] [0248] of Description translated by Google). For example, Zhong teaches embodiment comprising ingredients for 1000 tablets (See [02148]): 30g polyvinyl acetate , 45g mannitol granules(anti-sticking/anti-caking agent), 1.8g triacetin (plasticizer), 2g titanium dioxide (opaquer) (which are close to the ratio of opaquer recited in claims 8, 17 and 21). Zhong also teaches isolation layer comprising hydroxypropyl methylcellulose, hydroxypropyl cellulose and benefit of isolation layer, such as avoid hydrolysis of water-sensitive drugs during the coating process, reduce the porosity, and ensure the continuity of the coating film, improve the brittleness of the core material to avoid breakage during the coating process, etc.(See [0149] of Description translated by Google).
A person of ordinary skilled in the art would have known TBN taught by Wang’ 485 is a derivative of tetramethylpyrazine (TMP), which is the active ingredient of TMPP tablet taught by Gao. When faced with technical problem of how to improve property of TBN tablet (e.g. stability, bioavailability, etc.), a skilled artisan would be motivated to explore TBN formulation based on the controlled release TMPP tablet comprising a core and overcoat taught by Gao. Oliveira Varum and Zhong explicitly teach benefit of isolation layer (accelerates initial drug release, improves the stability of the formulations, etc.). It would be obvious and logical for a skilled artisan to explore Wang’ 485 TBN tablet based on Gao’s teachings, together with further optimization based on Oliveira Varum and Zhong teachings of isolation layer and general knowledge of nitrone compounds and enteric pharmaceutical composition. 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 normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to further optimize combination of inactive ingredients and ratio thereof for desired degradation/release and stability profile.
The combined teachings of prior art, together with optimization based on general knowledge of nitrone compound would provide a novel TBN pharmaceutical composition (e.g. enteric tablet) with desired degradation/release and stability profile. One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the teachings of prior art, together with further optimization based on general knowledge of nitrone compounds and enteric pharmaceutical composition. 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LIYUAN MOU/ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
Prosecution Insights