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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/09/2026 has been entered.
Status of the Claims
This action is in response to papers filed 02/09/2026 in which claims 2-6 were canceled; claims 11-13 were withdrawn; and claims 1, 7-11 and 13 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 1 and 7-10 are under examination.
Withdrawn Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New Rejections
Necessitate by Applicant’s Claim Amendments
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 and 7-10 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.
Regarding claim 1, the recitation of “the transdermal gel formulation does not comprise a penetration enhancer” renders the claim indefinite because while claim 1 defines ethanol and propylene glycol as co-solvents, said propylene glycol are also known for their function as a penetration enhancer. As evidenced by Wu et al (Int. J. Mol. Sc., 2017, 18 (757): 1-12; cited reference of record), propylene glycol served as a penetration enhancer in brucine gel transdermal delivery. Furthermore, it is noted that paragraph [0007] of the instant specification indicated that the problem is to particularly azone as penetration enhancer, and not the broadly claimed genus of “penetration enhancer.” Thus, it is unclear how claim 1 can exclude the entire genus of penetration enhancers when propylene glycol is required to be present in the claimed gel formulation, and propylene glycol is within the scope of “a penetration enhancer.” Claims 7-10 are also rejected as they depend directly or indirectly from indefinite claim 1.
As a result, claims 1 and 7-10 do not clearly set forth the metes and bounds of patent protection desired.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claim(s) 1 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKenzie et al (US 5,747,021) in view of Chen et al (Fitoterapia, 2013, 86: 193-201), Wu et al (Int. J. Mol. Sc., 2017, 18 (757): 1-12; cited in IDS filed 05/04/2022), and Gupta et al (US 2010/0029765 A1).
Regarding claim 1, McKenzie teaches a gel formulation comprising brucine, a gel matrix material such as carbomer, and a cosolvent such as ethanol, wherein carbomer is present in an amount of 0.25-1.75 % by weight and the ethanol is present in an amount of 10-30% by weight (Abstract; columns 2-6). McKenzie teaches the gel composition is used for treating skin conditions (columns 1-2). McKenzie teaches the gel composition has a viscosity between about 250 cps and 500 cps (column 3, lines 55-59).
While claim 1 recites “a transdermal gel formulation,” said recitation is in the preamble of the claim and thus, is a recitation of intended use and does not add any structure to the claimed gel formulation, as the structures in the body of the gel formulation can stand alone. As discussed above, Mckenzie teaches a gel formulation containing brucine, a gel matrix, and co-solvents such as ethanol, and the gel formulation is applied to the skin. Thus, the brucine gel formulation of Mckenzie would be capable of performing the intended use of “transdermal” as per Wu, brucine gel formulation containing ethanol and a gel matrix is known to be capable of transdermal adminstration (Wu: Abstract; pages 1-8). It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
However, Mckenzie does not teach the amount of brucine and the gel matrix material is sodium polyacrylate or hydroxypropyl methyl cellulose, of claim 1.
Regarding the amount of Brucine of claim 1, Chen teaches a brucine-containing transdermal formulation comprising 5 mg/ml (0.5% by weight percentage) or 10 mg/ml (1% by weight percentage) brucine solution, wherein said weight amount percentage of brucine is effective in possessing analgesic and anti-inflammatory activity (Abstract; pages 194 and 196-201).
It would have been obvious to one of ordinary skill in the art to routinely optimize the weight percentage of brucine in the gel formulation of McKenzie to an amount of 0.5%-1% by weight percentage and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Chen provided the guidance to do so by teaching the effective amount of brucine used in a brucine-containing formulation is 5 mg/ml (0.5% by weight percentage) or 10 mg/ml (1% by weight percentage), as said amount is effective in possessing analgesic and anti-inflammatory activity, which is also the objective of the brucine gel formulation of Mckenzie, to reduce skin inflammation (McKenzie: column 2, lines 5-17). Thus, an ordinary artisan would looked to using 0.5% by weight percentage or % by weight percentage of brucine per guidance from Chen in the formulation of McKenzie so as to provide a brucine gel formulation that provides effective reduction of skin inflammation, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding the gel matrix material of claim 1, Gupta teaches a gel composition in comprising an active ingredient, a gelling agent such as hydroxypropyl methyl cellulose, an antioxidant such as sodium metabisulfite, and a preservative such as benzoic acid or methyl paraben, and water, wherein the gelling agent is present in an amount of about 1% to about 15% by weight of the composition, the antioxidant is present in the composition in an amount of about 0.01% to about 0.3% by weight, and the preservative is present in the composition in an amount about 0.005% to about 2% by weight ([0014]-[0021], [0040]-[0048] and [0054]-[0068]; Examples 1-3; claims 1-19).
It would have been obvious to one of ordinary skill in the art to incorporate or substitute hydroxypropyl methyl cellulose as the gelling agent (in place of carbomer) in the gel formulation of McKenzie, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Gupta indicated that carbomers are sensitive to electrolytes and thus cause a serious reduction in viscosity of the polymer and compromises their application characteristics on the skin and thus, a hydroxy cellulose such as hydroxypropyl methylcellulose can be used in place of carbomer as the gelling agent, as hydroxy celluloses dissolves readily in water to give clear, smooth, viscous solutions that are non-toxic (Gupta: [0010]-[0014] and [0019]). Thus, an ordinary artisan seeking to provide a more stable gel formulation would have looked to modifying the gel formulation of McKenzie and use hydroxypropyl methyl cellulose in place of carbomer as the gelling agent, and produce Applicant’s claimed invention with reasonable expectation of success.
It would also have been obvious to one of ordinary skill in the art routinely optimize the weight percentage of hydroxypropyl methyl cellulose as the gelling agent in the gel formulation of McKenzie to 0.5%-3% by weight, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do because as discussed above, Gupta provided the guidance to do so by teaching that the weight percentage of gelling agent such as hydroxypropyl methyl cellulose used in a gel composition can be optimize from an amount of about 1% to about 15% by weight of the composition, which is a weight percentage parameter that not only overlaps the parameter of the claimed invention, but also overlaps the parameter of gelling agent used in McKenzie. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of gel matrix material in a gel formulation would have been obvious before the effective filing date of applicant's invention. “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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
Regarding claim 7, McKenzie teaches the gel contains sodium hydroxide (column 3, lines 5-10).
Regarding claims 8-9, as discussed above, Gupta teaches a gel composition in comprising an active ingredient, a gelling agent such as hydroxypropyl methyl cellulose, an antioxidant such as sodium metabisulfite, and a preservative such as benzoic acid or methyl paraben, and water, wherein the antioxidant is present in the gel composition in an amount of about 0.01% to about 0.3% by weight and the preservative is present in the gel composition in an amount about 0.005% to about 2% by weight ([0014]-[0021], [0040]-[0048] and [0054]-[0068]; Examples 1-3; claims 1-19).
It would also have been obvious to one of ordinary skill in the art to include antioxidant such as sodium metabisulfite, and a preservative such as benzoic acid or methyl paraben, in the gel composition of McKenzie, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Gupta provided the guidance to do so by teaching include an antioxidant to a gel formulation to retard oxidation and deterioration of the active ingredient, as well as, include a preservative such as benzoic acid or methyl paraben, as like the antioxidant, preservatives are common pharmaceutically acceptable excipients in gel formulations (Gupta: [0041]-[0044] and [0059]-[0062]). Thus, an ordinary artisan seeking to retard oxidation and deterioration of the active ingredient, as well as, to inhibit microbial growth in a gel formulation would have looked to including include antioxidant such as sodium metabisulfite, and a preservative such as benzoic acid or methyl paraben, in the gel composition of McKenzie, and produce Applicant’s claimed invention with reasonable expectation of success.
It would also have been obvious to one of ordinary skill in the art to optimize the amounts of antioxidant such as sodium metabisulfite, and preservative such as benzoic acid or methyl paraben, to amounts as claimed, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Gupta teaches a gel formulation can contain about 0.01% to about 0.3% by weight of antioxidant and about 0.005% to about 2% by weight of preservative, which overlaps the claimed ranges for antioxidant and bacteriostatic agent of claims 8 and 9. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of antioxidant and preservative in a gel formulation would have been obvious before the effective filing date of applicant's invention. “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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKenzie et al (US 5,747,021) in view of Chen et al (Fitoterapia, 2013, 86: 193-201), Wu et al (Int. J. Mol. Sc., 2017, 18 (757): 1-12; cited in IDS filed 05/04/2022), and Gupta et al (US 2010/0029765 A1), as applied to claim 1 above, and further in view of Kandavilli et al (US 2019/0224181 A1).
The gel formulation of claim 1 is discussed above, said discussion being incorporated herein in its entirety.
However, McKenzie, Chen, Wu, and Gupta do not teach the amount of water of claim 10.
Regarding claim 10, Kandavilli teaches a gel composition comprising an active agent, a gelling agent such as carbomer or hydroxypropyl methyl cellulose, an antioxidant such as vitamin C, and a preservative such as sodium benzoate, benzyl alcohol or methyl paraben, a solvent such as ethanol, and water, wherein the content of water in the gel composition can be from about 50% by weight to about 90% by weight ([0027]-[0053], [0073]-[0074], [0078]-[0079], [0092], and [0097]-[0102]).
It would have been obvious to one of ordinary skill in the art to routinely optimize the amount of water in the gel composition of McKenzie to an amount of 68% to 80% by weight, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Kandavilli teaches that the amount of water in a gel formulation can be optimize in the amount from 50% by weight to about 90% by weight, which is a range that overlaps the claimed range of 68% to 80% by weight. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of the amount of water in a gel formulation would have been obvious before the effective filing date of applicant's invention. “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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 02/09/2026 have been fully considered but they are not persuasive.
Below is the Examiner’s response to Applicant’s arguments as they pertain to the pending 103 rejections.
Applicant argues that the claimed invention is nonobvious over the prior art in view of the amendments to claim 1. Applicant alleges that “the prior art provides no teaching or suggestion regarding the strychnine transdermal gel formulation and its composition, nor does it teach or suggest that by using a specific solubilizer, it is possible to achieve unexpected technical effects without containing a transdermal enhancer.” (Remarks, bottom of page 7 to page 8 and page 10).
In response, the Examiner disagrees. First, it is noted that claim 1 is not drawn to a “strychnine” transdermal gel formulation but rather a “brucine” transdermal gel formulation. Thus, Applicant’s argument directed to strychnine transdermal gel formulation is not pertinent to cited prior art or the claimed invention. As discussed above in the pending 103 rejection, claim 1 remains obvious over the combined teachings of McKenzie, Chen, Wu, and Gupta, as McKenzie teaches the use of the same co-solvent such as ethanol as the claimed invention in a brucine gel formulation. See 103 rejection pages 5-8 of this office action. Thus, Applicant’s technical effects are not unexpected.
Applicant argues “the amended claim 1 also limits the co-solvent as ethanol and propylene glycol. As can be seen from Test Example 2 in the specification, compared with the prior art, the use of a cosolvent selected from ethanol and propylene glycol brings unexpected technical effects: the brucine gel formulation of the present invention has better pharmacokinetic characteristics and transdermal effect.” (Remarks, page 8, 2nd paragraph).
In response, the Examiner disagrees. First, it is noted that claim 1 is not limited to only the combination of ethanol and propylene glycol as the co-solvent, but rather claim 1 recites a Markush group in which the co-solvent is selected from ethanol, propylene glycol, or a combination thereof. Claim 1 is not limited to specifically a combination of ethanol and propylene glycol as the co-solvent.
Second, as discussed above, the brucine gel formulation of McKenzie contains ethanol and thus, reads on the claimed “the co-solvent is selected from the group consisting of ethanol, propylene glycol, or a combination thereof.” Furthermore, the use of solvent such as ethanol to improve pharmacokinetic characteristics and transdermal effects of brucine is well established in the prior art per Chen (Abstract; pages 194 and 196-201). Thus, Applicant’s alleged technical effects of better pharmacokinetic characteristics and transdermal effect are not unexpected, but rather expected by the teachings from Chen.
Applicant argues that “if the technical problem or purpose addressed by the prior art is significantly different from that of the present invention, then the prior art cannot constitute a reasonable expectation of success for subsequently solving the problem of the present invention, and the "general problem" referred to by the examiner is insufficient to provide effective teaching and inspiration to those skilled in the art for solving the problem of the present invention.” (Remarks, page 8, last paragraph).
In response, the Examiner disagrees. As discussed above, the brucine gel formulation of McKenzie contains ethanol and thus, reads on the claimed “the co-solvent is selected from the group consisting of ethanol, propylene glycol, or a combination thereof.” Furthermore, the use of solvent such as ethanol to improve pharmacokinetic characteristics and transdermal effects of brucine is well established in the prior art per Chen (Abstract; pages 194 and 196-201). Thus, Applicant’s alleged technical effects of better pharmacokinetic characteristics and transdermal effect are not unexpected, but rather expected by the teachings from Chen. Thus, the combined teachings of the cited prior arts in the pending 103 rejection are indeed proper to render obvious Applicant’s claimed invention.
Applicant argues “the viscosity of the topical aqueous composition of Gupta is less than about 20,000 cps in the presence of hydrophilic cellulose derivative and Gupta indicates that carbomers may cause a serious reduction in viscosity (claim 1, [0010]). This theoretical upper limit is significantly higher than the maximum viscosity of 500 cps of the topical composition of McKenzie (column 4, line 34). Therefore, replacing the carbomer in the topical composition of McKenzie with hydroxypropyl methyl cellulose as taught by Gupta would likely result in a gel viscosity far exceeding the desired range of 250-500 cps of the topic composition of McKenzie. This replacement creates a clear obstacle to optimizing the topical composition of McKenzie based on the teachings of Gupta. Both McKenzie and Gupta place emphasis on viscosity: McKenzie maintains a viscosity of 250-500 cps using carbomer, and Gupta maintains viscosity below 20,000 cps using hydroxypropyl methyl cellulose. This indicates that viscosity is important for the realization of their technical scheme. This means that they are all concerned about whether the formulation can be better applied to the skin.” Applicant goes on to argue that “[i]n contrast, the present application is directed to achieving transdermal delivery without the use of penetration enhancers, which represents a fundamentally different objective. Notably, the present invention does not require a specific viscosity range for its technical effect. This divergence in technical motivation further underscores that one of ordinary skill in the art would not have a reasonable expectation of success in substituting the hydroxypropyl methyl cellulose from Gupta for the carbomer in the topical composition of McKenzie to arrive at the invention as claimed in currently amended claim 1 of the present application.” (Remarks, page 9).
In response, the Examiner disagrees. . As discussed in the 103 rejection, McKenzie and Gupta are both drawn to formulating gel formulations. The claimed invention does not require any viscosity property for gel. Thus, the objective of the claimed invention is a gel formulation of an active ingredient (brucine), which is no different from the objectives of McKenzie and Gupta in providing gel formulations of an active ingredient. Given that Applicant had focused on viscosity effect of the gel (which is not pertinent to the claimed gel formulation as discussed supra), Applicant is noted that Gupta teaches the viscosity of the gel composition is between about 100 and about 15,000 cP (Gupta: [0068]), which is a range that encompassed or include the viscosity of between 250 to about 500 cps that is disclosed in McKenzie. Thus, the combination of McKenzie and Gupta and the obviousness analysis in the pending 103 rejection with respect to incorporating or substituting hydroxypropyl methylcellulose as the gelling agent (in place of carbomer), is indeed proper to render obvious Applicant’s claimed invention.
Applicant argues “both weight percentage (W/W) and weight/volume ratio (W/V) are commonly used methods of expressing content or concentration in the art. Those skilled in the art know that they are not the same; weight/volume ratio (W/V) is more commonly used in liquid formulations, expressing mass (weight) per unit volume; weight percentage expresses the percentage of a component's weight relative to the total weight of the composition (formulation). For formulations containing aqueous solutions, the content expressed by w/v is clearly different from weight percentage. As we pointed out previously, the lowest concentration of strychnine disclosed in Wu is 0.058 mg/L, and its concentrations used in gel formulations are 0.5 mg/ml for the low-dose group and 2 mg/ml for the high-dose group. In the cytotoxicity test described in Wu, the highest dose of strychnine was 0.46 mg/L and the lowest dose was 0.058 mg/L, which is approximately 0.058 x10-4 - 0.46 x10-4% w/w by weight. Clearly, this range is about 10 times lower than the strychnine content in present claim 1, i.e., an order of magnitude lower. Furthermore, even considering the high concentration of strychnine in the gel formulation described in Wu as 2 mg/ml, this dose, calculated as a weight percentage, is 0.2% w/w, still far below the lower limit of 0.5% w/w for strychnine in present claim 1.” (Remarks, page 9, last paragraph to page 10).
In response, the Examiner disagrees. Wu was not used in the pending 103 rejection for teaching the weight percentage of brucine. Rather, Chen was used for the claimed weight percentage for brucine. As discussed in the pending 103 rejection, Chen teaches a brucine-containing transdermal formulation comprising 5 mg/ml (0.5% by weight percentage) or 10 mg/ml (1% by weight percentage) brucine solution, wherein said weight amount percentage of brucine is effective in possessing analgesic and anti-inflammatory activity (Chen: Abstract; pages 194 and 196-201). 5 mg/ml (0.5% by weight percentage) or 10 mg/ml (1% by weight percentage) as taught in Chen is indeed a weight percentage because 0.5% means there is 0.5 grams of solute in 100 milliliters of solution, which translates to 5 mg/ml.
Thus, as discussed above in the pending 103 rejection, Chen provided the guidance for the effective amount of brucine used in a brucine-containing formulation to be 5 mg/ml (0.5% by weight percentage) or 10 mg/ml (1% by weight percentage), as said amount is effective in possessing analgesic and anti-inflammatory activity, which is also the objective of the brucine gel formulation of McKenzie, to reduce skin inflammation (McKenzie: column 2, lines 5-17). As such, the weight percentage of 0.5%-1% as claimed is well-established in the prior art as known effective amounts used for brucine formulations, especially for analgesic and anti-inflammatory activity.
As a result, for at least the reasons discussed above, claims 1 and 7-10 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the pending 103 rejections as set forth in this office action.
Conclusion
No claim is allowed.
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/DOAN T PHAN/Primary Examiner, Art Unit 1613