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 .
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 250-253 and 263-265 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In independent claims 231 and 262, applicant recite that the pharmaceutical composition is in a dosage form for dosing or administration by injection. However, in each of the dependent claims 250-253 and 263-265, applicant recite that the pharmaceutical composition is in a dosage form for I.V. injection or I.V. infusion or that the pharmaceutical composition is in a dosage form for I.V. infusion. It is well known in the art that infusion and injection are different from each other when it comes to medical treatments: see, for example, an internet article found at the website: https://www.ospreypolyclinic.com/blog/infusion-vs-injection-key-differences-and-when-each-is-used (the article states that infusion delivers medication directly into the bloodstream through an I.V. line and is ideal for steady, long-term treatments like chemotherapy whereas injection administers medication into body tissues via a syringe and is suitable for rapid drug delivery such as vaccines). Furthermore, there is no indication in present specification that I.V. infusion represents a preferred embodiment of an injection (on the contrary, in present specification, injection and I.V. injection or infusion seem to represent two alternative embodiments of administration – see [0291], [0421] of US-PGPUB version of present specification). Thus, instant dependent claims 250-253 and 263-265 fail to further limit the subject matter of the independent claims 231 and 262. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Instant 112(d) rejection can be overcome by changing “by injection” in claim 231 (5th line from the bottom) and in claim 262 (3rd line from the bottom) to --- by injection or I.V. infusion ---.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 231, 234-236, 241, 245, 246, 250, 251, 262 and 263 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al (“In Vivo Pharmacokinetics and Pharmacodynamics of APX001 against Candida spp. In a Neutropenic Disseminated Candidiasis Mouse Model”, Antimicrobial Agents and Chemotherapy, vol.62(4), Mar.27, 2018, pg.1-9) in view of EPR (“Breaking old habits: Moving away from commonly used buffers in pharmaceuticals”, European Pharmaceutical Review, an internet article published on July 10, 2012 and obtained at the website: https://www.europeanpharmaceuticalreview.com/article/13699/breaking-old-habits-moving-away-from-commonly-used-buffers-in-pharmaceuticals/ ), University of Oklahoma (“Buffers”, an internet article dated April 7, 2004 and obtained at the website: https://www.ou.edu/research/electron/bmz5364/buffers.html ), DeAngelis (“Phosphate Buffer”, University of Nebraska-Lincoln, an internet article dated January 15, 2007 and obtained at the website: https://www.unl.edu/cahoonlab/phosphate%20buffer.pdf ) and Pikal-Cleland et al (“Protein Denaturation during Freezing and Thawing in Phosphate Buffer Systems: Monomeric and Tetrameric B-Galactosidase” Archives of Biochemistry and Biophysics, vol.384(2), December 15, 2000, pg.398-406) (with (i) “Fosmanogepix”, a product information sheet obtained from the website https://www.medchemexpress.com/fosmanogepix.html , which is cited here merely to support the Examiner’s assertion that APX001 is instant compound of formula (I); and (ii) “E1210”, a product information sheet obtained from the website https://www.medchemexpress.com/e1210.html?utm_source=google&utm_medium=CPC&utm_campaign=US&utm_term=APX001A&utm_content=APX001A&gclid=EAIaIQobChMIwN2b36_d-QIVxMDICh3tEQ0ZEAAYASAAEgJnHvD_BwE , which is cited here merely to support the Examiner’s assertion that APX001A is instant compound of claim 216).
(It is to be noted that the internet article by the University of Oklahoma is dated April 7, 2004, as shown below:
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Zhao teaches (see the 2nd paragraph under “DISCUSSION” on pg.5) that APX001 (which is instant compound of formula (I), as evidenced by “Fosmanogepix”, a product information sheet obtained from the website https://www.medchemexpress.com/fosmanogepix.html) is a first-in-class, intravenous and oral broad-spectrum antifungal agent in clinical development for the treatment of invasive fungal infections. Zhao teaches (see the 3rd paragraph under “MATERIALS AND MEHODS” on pg.7 and the paragraph under “Pharmacokinetics” on pg.8) a single oral dose (0.2 ml/dose) of APX001 at dose levels of 4, 16, 64 and 256 mg/kg of body weight, which is administered to female ICR/Swiss mice weighing 23-27 g. This gives the dose amount of APX001 (for the mice) which ranges from 0.092 mg to 6.912 mg of APX001 (i.e., 4 mg x 23/1000 to 256 mg x 27/1000). Since the dose is given in 0.2 ml aqueous solution (see the last two lines in the 1st paragraph under “MATERIALS AND METHODS” on pg.7) containing NaOH (a pH adjuster) and glucose (an excipient), this gives APX001 concentration range of 0.46 mg/ml – 34.56 mg/ml (i.e., 0.092 mg/0.2 ml to 6.912 mg/0.2 ml). Such concentration range overlaps with instant concentration range of 10-50 mg/ml of claims 231 and 262 for the compound of Formula (I), as well as with instant concentration ranges of claims 234, 245, 251 and 263, thus rendering instant ranges prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Alternatively, under the guideline (i.e., 0.46 mg/ml-34.56 mg/ml as discussed above) given by Zhao, instant rages of claims 231, 262, 234, 245, 251 and 263 (for the concentration of instant compound of Formula (I) for injection) as well as instant concentration (290 mg/ml) of claims 236 and 246 would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to instant pH range of 7.5-8.5, since Zhao teaches that its APX001 formulation was prepared in NaOH (same pH adjuster used by applicant – see [0022] of present specification), it is the Examiner’s position that the pH of Zhao’s formulation would fall within or at least overlap with instant pH range of 7.5-8.5 (of claims 231 and 262), thus either teaching or rendering instant ranges prima facie obvious. In re Wertheim, supra. Also, since Zhao uses the same pH adjuster used by applicant, the pH of Zhao’s formulation would either teach instant pH value 8.0 of claim 241 or at least would be very close to 8.0, thus rendering instant pH value of 8.0 prima facie obvious. Where the claimed ranges and prior art do not overlap but are close enough that one skilled in the art would have expected them to have the same properties, a prima facie case of obviousness would also exist which may also be overcome by a showing of unexpected results, In re Titanium Metals Corporation of America v. Banner, 227 USPQ 773 (Fed. Cir. 1985).
With respect to instant phosphate buffer, Zhao does not teach the use of it. As already stated above, Zhao teaches that APX001 (instant compound of formula (I)) is a first-in-class, antifungal agent that can be used intravenously for the treatment of invasive fungal infections. Phosphate buffer is the most commonly used buffer in parenteral formulations and has many advantages, as evidenced by (i) the internet article by EPR (“Breaking old habits: . . .”), (ii) the internet article by the University of Oklahoma (“Buffers”) and (iii) the internet article by DeAngelis (“phosphate buffer”): (i) EPR states (see the first paragraph on pg.2/13) that pharmaceutical formulators generally prefer precedented excipients because of their well-established safety profile as well as the risks and costs associated with approving a new excipient. In its Table 1, EPR lists frequency of buffers used in parenteral products. The most common buffers found in parenteral formulations have been phosphate buffers (30.6% frequency as calculated by the Examiner), citrate buffers (21.9% frequency) and acetate buffers (19.7% frequency). EPR furthermore states (see under “Citric acid” on pg.3/13 and 4/13) even though citric acid is one of the most commonly used buffers, citrate buffered solutions induce more pain upon subcutaneous injections than phosphate buffers; (ii) The internet article by the University of Oklahoma teaches that phosphate buffers are most physiological of common buffers, non-toxic to cells and shows little pH changes with temperature and stable for several weeks at 4oC; (iii) The internet article by DeAngelis teaches (see the 1st paragraph) that phosphate buffers have a very high buffering capacity and are highly soluble in water. Furthermore, Pikal-Cleland teaches (see abstract) that during freezing in sodium phosphate buffer, a significant pH decrease from 7.0 to as low as 3.8 occurs whereas the pH during freezing in potassium phosphate buffer only increases by at most 0.3 pH units. Based on what is already known in the art about phosphate buffers in general (as discussed above), and also based on Pikal-Cleland’s teaching that potassium phosphate buffer maintains a constant pH even during freezing, it would have been obvious to one skilled in the art to use a potassium phosphate buffer in Zhao’s parenteral formulation of APX001 with a reasonable expectation of achieving many advantages including stability, high buffering capacity, high solubility in water and a minimal pH change even when frozen.
With respect to instant limitation as to the potassium phosphate buffer comprising monobasic potassium phosphate and dibasic potassium phosphate, the internet article by DeAngelis teaches that the most commonly used phosphate buffers are Gomori buffers which consist of a mixture of monobasic dihydrogen phosphate (KH2PO4) and dibasic monohydrogen phosphate (K2HPO4). It would have been obvious to one skilled in the art to use the mixture of KH2PO4 (instant monobasic potassium phosphate of claim 238) and K2HPO4 (instant dibasic potassium phosphate of claim 239) as the potassium phosphate buffer in Zhao’s parenteral formulation of APX001 with a reasonable expectation of achieving stability, high buffering capacity, high solubility in water and a minimal pH change even when frozen.
Thus, Zhao in view of EPR, University of Oklahoma, DeAngelis and Pikal-Cleland renders obvious instant claims 231, 234, 236, 241, 245, 246, 250, 251, 262 and 263 (since Zhao in view of the other cited prior arts teaches every components of instant claim 231 and also teaches the use of potassium phosphate (instant phosphate buffer of claim 232), it is the Examiner’s position that the APX001 parenteral formulation as taught by Zhao in view of the other cited prior arts would naturally be stable for a period of up to 12 months at a temperature of -20oC as recited in claim 231).
With respect to instant claim 235, Zhao teaches that its APX001 is the prodrug of APX001A (which is instant compound of claim 235, as evidenced by “E1210”, a product information sheet obtained from the website https://www.medchemexpress.com/e1210.html?utm_source=google&utm_medium=CPC&utm_campaign=US&utm_term=APX001A&utm_content=APX001A&gclid=EAIaIQobChMIwN2b36_d-QIVxMDICh3tEQ0ZEAAYASAAEgJnHvD_BwE ), which means that the APX001A is obtained only after the APX001 (prodrug) is administered and metabolized into APX001A (an active drug). Thus, the initial dosage of APX001 before it is administered would be free of APX001A. Thus, Zhao in view of EPR, University of Oklahoma, DeAngelis and Pikal-Cleland renders obvious instant claim 235.
Claims 237 and 242-244 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al (“In Vivo Pharmacokinetics and Pharmacodynamics of APX001 against Candida spp. In a Neutropenic Disseminated Candidiasis Mouse Model”, Antimicrobial Agents and Chemotherapy, vol.62(4), Mar.27, 2018, pg.1-9) in view of EPR (“Breaking old habits: Moving away from commonly used buffers in pharmaceuticals”, European Pharmaceutical Review, an internet article published on July 10, 2012 and obtained at the website: https://www.europeanpharmaceuticalreview.com/article/13699/breaking-old-habits-moving-away-from-commonly-used-buffers-in-pharmaceuticals/ ), University of Oklahoma (“Buffers”, an internet article dated April 7, 2004 and obtained at the website: https://www.ou.edu/research/electron/bmz5364/buffers.html ), DeAngelis (“Phosphate Buffer”, University of Nebraska-Lincoln, an internet article dated January 15, 2007 and obtained at the website: https://www.unl.edu/cahoonlab/phosphate%20buffer.pdf ) and Pikal-Cleland et al (“Protein Denaturation during Freezing and Thawing in Phosphate Buffer Systems: Monomeric and Tetrameric B-Galactosidase” Archives of Biochemistry and Biophysics, vol.384(2), December 15, 2000, pg.398-406) as applied to claim 231 above, and further in view of Matsukura (US 2009/0233883 A1).
With respect to instant claims 237 and 242-244, Zhao does not give the dosage amount of APX001 for humans. Matsukura teaches (claim 20) instant compound of Formula (I). Matsukura teaches ([0014]-[0015]) that its inventive compound (such as the one shown in its claim 20) is used as an antifungal agent that has excellent antifungal action, excellent solubility in water and stability in an aqueous solution. In [0102], Matsukura teaches that the dose for the compound varies depending on the patient’s disease, symptom severity, age and sex, drug susceptibility or the like. Matsukura then teaches that dosage amount for oral preparation is preferably ranges from 10 to 2000 mg/adult/day. Under such guidelines, instant range of 10-1,000 mg of claim 237, instant ranges of claim 242 (50-600 mg) and claim 243 (250-450 mg), as well as instant 350 mg of claim 244 (for the amount of instant compound of Formula (1) for injection) would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra.
Thus, Zhao in view of EPR, University of Oklahoma, DeAngelis and Pikal-Cleland et al, and further in view of Matsukura renders obvious instant claims 237 and 242-244.
Claims 247 and 248 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al (“In Vivo Pharmacokinetics and Pharmacodynamics of APX001 against Candida spp. In a Neutropenic Disseminated Candidiasis Mouse Model”, Antimicrobial Agents and Chemotherapy, vol.62(4), Mar.27, 2018, pg.1-9) in view of EPR (“Breaking old habits: Moving away from commonly used buffers in pharmaceuticals”, European Pharmaceutical Review, an internet article published on July 10, 2012 and obtained at the website: https://www.europeanpharmaceuticalreview.com/article/13699/breaking-old-habits-moving-away-from-commonly-used-buffers-in-pharmaceuticals/ ), University of Oklahoma (“Buffers”, an internet article dated April 7, 2004 and obtained at the website: https://www.ou.edu/research/electron/bmz5364/buffers.html ), DeAngelis (“Phosphate Buffer”, University of Nebraska-Lincoln, an internet article dated January 15, 2007 and obtained at the website: https://www.unl.edu/cahoonlab/phosphate%20buffer.pdf ) and Pikal-Cleland et al (“Protein Denaturation during Freezing and Thawing in Phosphate Buffer Systems: Monomeric and Tetrameric B-Galactosidase” Archives of Biochemistry and Biophysics, vol.384(2), December 15, 2000, pg.398-406) as applied to claim 231 above, and further in view of Mahler et al (US 2004/0170632 A1).
With respect to instant claims 247 and 248, as already discussed above, Zhao teaches that its APX001 formulation was prepare in NaOH which means that the pH of Zhao’s formulation would be 7.5-8.5 (since applicant uses the same pH adjuster). Furthermore, as evidenced by Mahler (see [0014]), a phosphate buffer (such as potassium phosphate) is known to be used in a concentration that ranges anywhere from 2mM to 100 mM in a liquid pharmaceutical formulation. Based on the guideline given by Mahler, instant range (20-50 mM) of claim 247 or instant value of 20 mM of claim 248 for the concentration of the phosphate buffer would have been obvious to one skilled in the art before the effective filing date of the claimed invention since discovering the optimum or workable range for the phosphate buffer concentration that would successively maintain the pH of Zhao’s liquid formulation (in the range of about 7.5-8.5) would involve only routine skill in the art. Thus, Zhao in view of EPR, University of Oklahoma, DeAngelis and Pikal-Cleland et al, and further in view of Mahler renders obvious instant claims 247 and 248.
Claims 252, 253, 264 and 265 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al (“In Vivo Pharmacokinetics and Pharmacodynamics of APX001 against Candida spp. In a Neutropenic Disseminated Candidiasis Mouse Model”, Antimicrobial Agents and Chemotherapy, vol.62(4), Mar.27, 2018, pg.1-9) in view of EPR (“Breaking old habits: Moving away from commonly used buffers in pharmaceuticals”, European Pharmaceutical Review, an internet article published on July 10, 2012 and obtained at the website: https://www.europeanpharmaceuticalreview.com/article/13699/breaking-old-habits-moving-away-from-commonly-used-buffers-in-pharmaceuticals/ ), University of Oklahoma (“Buffers”, an internet article dated April 7, 2004 and obtained at the website: https://www.ou.edu/research/electron/bmz5364/buffers.html ), DeAngelis (“Phosphate Buffer”, University of Nebraska-Lincoln, an internet article dated January 15, 2007 and obtained at the website: https://www.unl.edu/cahoonlab/phosphate%20buffer.pdf ) and Pikal-Cleland et al (“Protein Denaturation during Freezing and Thawing in Phosphate Buffer Systems: Monomeric and Tetrameric B-Galactosidase” Archives of Biochemistry and Biophysics, vol.384(2), December 15, 2000, pg.398-406) as applied to claim 231 (or claim 262) above, and further in view of Matsukura (US 2009/0233883 A1) and Mahler et al (US 2004/0170632 A1).
As already explained in Paragraph 5 above, Zhao renders obvious instant pH range (7.5-8.5) and instant concentration range (10-30 mg/mL) for the compound of Formula (I) as claimed in claims 252 and 264 as well as instant pH (8.0) and instant concentration (20 mg/mL) for the compound of Formula (I) as claimed in claims 253 and 265. With respect to instant range (250-450 mg) of claims 252 and 264 for the amount of instant compound of Formula (I), Matsukura teaches (claim 20) instant compound of Formula (I) and teaches ([0014]-[0015]) that its inventive compound (such as the one shown in its claim 20) is used as an antifungal agent that has excellent antifungal action, excellent solubility in water and stability in an aqueous solution. In [0102], Matsukura teaches that the dose for the compound varies depending on the patient’s disease, symptom severity, age and sex, drug susceptibility or the like. Matsukura then teaches that dosage amount for oral preparation is preferably ranges from 10 to 2000 mg/adult/day. Under such guidelines, instant range of 250-450 mg of claims 252 and 264 as well as instant 350 mg of claims 253 and 265 (for the amount of instant compound of Formula (1) for injection) would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra. With respect to instant range 20-50 mM for the phosphate buffer concentration as claimed in claims 252 and 265 and instant 20 mM for the phosphate buffer concentration as claimed in claims 253 and 265, as already discussed above, Zhao teaches that its APX001 formulation was prepared in NaOH which means that the pH of Zhao’s formulation would be about 7.5-8.5 (since applicant uses the same pH adjuster). Furthermore, as evidenced by Mahler (see [0014]), a phosphate buffer is known to be used in a concentration that ranges anywhere from 2mM to 100 mM in a liquid pharmaceutical formulation. Based on the guideline given by Mahler, instant range (20-50 mM) of claims 252 and 264 or instant value of 20 mM of claims 253 and 265 for the concentration of the phosphate buffer would have been obvious to one skilled in the art before the effective filing date of the claimed invention since discovering the optimum or workable range for the phosphate buffer concentration that would successively maintain the pH of Zhao’s liquid formulation (in the range of about 7.5-8.5) would involve only routine skill in the art. Thus, Zhao in view of EPR, University of Oklahoma, DeAngelis and Pikal-Cleland, and further in view of Matsukura and Mahler renders obvious instant claims 252, 253, 264 and 265.
Response to Arguments
The Examiner believes that applicant’s argument (presented on pg.13 of REMARKS) with respect to instant 112(d) rejection is already answered in Paragraph 4 above.
With respect to instant 103 rejections, referring to the Examiner’s statement which is from the last Office Action and shown below:
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, applicant argue that the Examiner’s such statement is problematic because it incorporates hindsight of present invention. That is, applicant argue that prior to applicant’s invention, it was not know that a pH range of 7.5-8.5 was critical for solubility and stability of the compound of formula (I). Applicant argue that Zhao does not consider a buffer to be necessary and that the reference is silent regarding pH. Applicant argue that the prior art does not teach one skilled in the art that there would be a difference between use of no buffer, use of sodium phosphate or use of potassium phosphate, or any other buffer and argue that only when it is known that the pH range is critical it becomes apparent that the choice of buffer is also critical. The Examiner disagrees. First of all, Zhao’s studies mainly focused on demonstrating in vivo efficacy of APX001 against various bacteria, not so much on the long term storage stability of the solution containing APX001. However, for long term storage of Zhao’s solution containing APX001, one would surely include a pH buffer in the solution because it is already well known in the art that parenteral formulations usually comprise a buffer in order to maintain pH and provides solubility and stability (see for example, US 2010/0292291 A1 ([0016]) and US 2018/0015123 A1 ([0092])). Since Zhao teaches that APX001 can be used intravenously, and since the other cited references show that phosphate buffer is the most commonly used buffer in parenteral formulations and has many advantages (e.g., The internet article by the University of Oklahoma teaching that phosphate buffers are most physiological of common buffers, non-toxic to cells and shows little pH changes with temperature and stable for several weeks at 4oC; The internet article by DeAngelis teaching that phosphate buffers have a very high buffering capacity and are highly soluble in water; and Pikal-Cleland teaching that potassium phosphate buffer maintains a constant pH even during freezing), one skilled in the art would have been sufficiently motivated to use a potassium phosphate buffer in Zhao’s parenteral formulation of APX001 in order to achieve many advantages including long term storage stability, high buffering capacity, high solubility in water and a minimal pH change even when frozen. Thus, the Examiner disagrees with applicant’s argument of hindsight. Furthermore, as to applicant’s argument that prior to applicant’s invention, it was not known that a pH range of 7.5-8.5 was critical for solubility and stability of the compound of formula (I), Matsukura (one of the references cited above) already teaches that APX001 is more soluble at pH above 7 (see Table 2 in [0390]).
For the reasons stated above, instant 103 rejections still stand.
It is to be noted that if applicant change “a potassium phosphate buffer” in both of independent claims 231 and 262 to --- 20 mM - 50 mM potassium phosphate buffer ---, instant 103 rejections over Zhao in view of EPR, University of Oklahoma, DeAngelis and Pikal-Cleland would be overcome. Applicant also need to make necessary changes in dependent claims (including deleting claim 247).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
January 9, 2026