Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/29/26 has been entered.
Claim Status
Claims 4, 9-11, 15-42 are cancelled.
Claims 1-3, 5-8, 12-14 and 43-49 are pending.
Withdrawn rejections
Applicant's amendments and arguments filed 1/29/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1-3, 5-8, 12-14 and 43-49 were rejected under 35 U.S.C. 103(a) as being unpatentable over Cancer Network (Consider High Dose Melphalan as Standard Conditioning for Multiple Myeloma February 2000;volume 9(2): 3 pages; IDS filed 8/30/22) and Thompson et al. (WO2004024126) and Ma et al. (International Journal of Pharmaceutics 1999;189:227-234; IDS filed 8/30/22) and ALKERAN® (Prescribing Information 2002 11 pages; IDS filed 8/30/22) and Loftsson et al. (Expert Opinion Drug Delivery 2005;2(2):335-351). This rejection is withdrawn in favor of the rejection to follow.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-3, 5-8, 12-14 and 43-49 remain rejected under 35 U.S.C. 103(a) as being unpatentable over Cancer Network (Consider High Dose Melphalan as Standard Conditioning for Multiple Myeloma February 2000;volume 9(2): 3 pages; IDS filed 8/30/22) and Thompson et al. (WO2004024126) and Ma et al. (International Journal of Pharmaceutics 1999;189:227-234; IDS filed 8/30/22) and ALKERAN® (Prescribing Information 2002 11 pages; IDS filed 8/30/22) and Stella et al. (Toxicologic Pathology, 36:30-42, 2008) and Strickley, RG (Pharmaceutical Research, Vol. 21, No. 2, February 2004; 201-230).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Applicant claims for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical oncology research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from oncology medicine, oncology drug formulation and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
With regard to instant claims 1-3, the Cancer Network teaches a conditioning regimen in patients diagnosed with the neoplastic disorder multiple myeloma (myeloma is synonymous with multiple myeloma), where 140 mg/m2 or 200 mg/m2 of melphalan (Alkeran) is administered (page 1, paragraphs 1 and 2). The patient is therefore a subject suffering from a neoplastic disorder. Cancer Network teaches that high dose melphalan alone should be the standard conditioning regiment for autologous transplantation in patients with newly diagnosed multiple myeloma (page 3, first paragraph) and higher doses are feasible (last paragraph page 3).
With regard to instant claims 1-3, 8 and 45-49, ALKERAN® teaches that ALKERON® for Injection a freeze-dried powder of melphalan hydrochloride in one vial and sterile diluent in another vial (Page 2, lines 29-33) and is indicated for the palliative treatment of patients with multiple Myeloma (page 4, lines 94-96), hence a neoplastic disorder. It is supplied as a single use vial with 50 mg melphalan hydrochloride in one vial and the other diluent vial is substantially free of alcohol (only 0.52 mL in 10 mL water for injection) (page 2, lines 29-33). ALKERAN® teaches that a pediatric patient survived a 254-mg/m2 overdose, thus teaching the treatment of pediatric patients (page 9, line 230-231). ALKERAN® teaches that the melphalan powder must be reconstituted to make a 5 mg/mL solution which is then diluted in 0.9% sodium chloride, which is a saline solution, to a concentration of not greater than 0.45 mg/mL which is administered by injection over 15-60 minutes into the patient, thus reading on systemic limb perfusion, and provides palliative treatment of multiple myeloma (pages 9, line 253-page 10, line 260 Preparation for Administration/Stability). ALKERAN® also teaches to keep the time between reconstitution/dilution and administration to a minimum and not to refrigerate (page 10, lines 263-269).
Regarding claims 1, 5-8, 13-14 and 43-49, Ma et al. teach injectable melphalan formulations utilizing SBE7-β-CD, which the Examiner interprets to be a species of instant Formulas I and II as shown below:
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with a degree of substitution of 4-8, to improve the current melphalan hydrochloride injectable formulation of ALKERAN® where a major concern with ALKERAN® is the co-solvents (alcohols as taught by Ma et al. Page 228, left column and ALKERAN® above) that cause significant cell disruption (page 228, right column Biocompatibility issues) and chemical stability (Abstract). Ma et al. teach that when cyclodextrins were used as diluents, the use of organic solvents can be eliminated and the shelf life greatly enhanced (Abstract). Ma et al. teach that “(SBE)7m-b-CD (Captisol™), may be suitable for parenteral use due to their low systemic toxicity. Both (SBE)7m-b-CD and HP-b-CD are excellent solubilizers and stabilizers for melphalan based on our previous studies” (page 228, right column). Ma et al. teach lyophilized solid powder (Page 229 2.5 (SBE)7m-b-CD used as the freeze-drying excipient in a melphalan formulation).
Further regarding claims 1, 7, 43-45, Ma et al. teach compositions comprising 10 mL aqueous 0.1 M (SBE)7m- β-CD, which is about 0.125 M, plus 50 mg melphalan, which is between 25-125 mg melphalan, and comprising 100 mL aqueous 0.1 M (SBE)7m- β-CD plus 0.5 g melphalan. (p. 228, col. 1; p. 229, Sec. 2.3 and 2.5) Ma et al. teach the molecular weight of the (SBE)7m- β-CD is 2248.64. Therefore, 1 L of 0.1 M (SBE)7m- β-CD would have 224.864 g of (SBE)7m- β-CD. 100 mL would use 22.4864 g and 10 mL would use 2.24864 g. When compared to 0.5 g and 50 mg respectively this is a ratio of about 45 to 1, (SBE)7m- β-CD to melphalan, which is sufficiently close to 50:1 or about 54:1 such that the same properties are expected. See MPEP 2144.05(I): “Similarly, a prima facie case of obviousness exists where 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 the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).”
With regard to instant claim 1, Ma et al. teaches diluting the compositions in aqueous 0.9% NaCl for injection (page 229, right column).
Regarding claim 1, Ma et al. teach a shelf life of the composition reconstituted with SBE of 17.4 hours (T-90%) ostensibly at room temperature (Table 1, page 230; Figure 1), thus taking 17.4 hours to reach 90% and appears to degrade by 4% or less at 25 C within 10 hours of dilution or less than 2% at about 25 C within 5 hours, especially when the cyclodextrin is the same as claimed and it is the same active agent. Ma et al. report stable lyophilized powder formulations of melphalan/(SBE)7m-β-CD (page 233, lower right column) and stable over a period of 1 year (page 234, lower left column) and no precipitation of reconstituted Alkeron upon refrigeration (page 232, 3.1 right column). Ma et al. teach on page 233, left column:
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With regard to claims 1, 5-7 and 43-44, Thompson et al. guide the artisan to Captisol cyclodextrin where n = 6.0-7.1, (Page 4, 3rd paragraph through page 5) as shown below:
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Thompson et al. also studied SBE having about 6.5-7.5 degrees of substitution (Page 18, 2nd paragraph; page 19, 1st paragraph). Thompson et al. teach complexes of SBe7-β-CD in a weight ratio of derivatized cyclodextrin to active agent in excess of 100 or 1000 or even more (Page 35 1st through 3rd paragraphs) and where the drug can be melphalan (Page 55, 2nd paragraph). Thompson et al. teach: “Thus, the CD will generally be, but need not be, present in excess of the active agent. The amount of excess will be determined by the intrinsic solubility of the agent, the expected dose of the agent, and the binding constant for inclusion complexation between the specific drug (agent) and the specific CD derivative used.” (Page 35, 3rd paragraph).
Regarding claim 1, Stella et al. teach: “A number of workers have attempted to identify, prepare, and evaluate various CD derivatives with superior inclusion complexation and maximal in vivo safety for various biomedical uses. A systematic study led to SBE-β-CD (Captisol), a polyanionic variably substituted sulfobutyl ether of β-CD, as a non-nephrotoxic derivative and HP-β-CD, a modified CD developed by Janssen. SBE-β-CD and HP-β-CD have undergone extensive safety studies and are currently used in six products approved by the Food and Drug Administration (four for Captisol and two for HP-β-CD). They are also in use in numerous clinical and preclinical studies.” (Abstract and page 31, left column last paragraph).
Regarding claims 1 and 5-7, Strickley is a review of commercially available oral and injectable solubilizing excipients including sulfobutylether-β-cyclodextrin (Abstract; Page 209, Table II “Captisol®”) where the sulfobutylether-β-cyclodextrin, has average degree of substitution: 6.5 and a MW = 2163 from Captisol (Table III, page 212). Strickley report that: “The newest cyclodextrin to be commonly used is sulfobutylether-β-cyclodextrin (Captisol, www.cydexinc.com, Overland Park, KS, USA, Table III). Captisol is very safe, chemically stable, water-soluble, and is an excellent solubilizing drug delivery technology for molecules in which it forms an inclusion complex.” (Page 224, left column 2nd paragraph).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Cancer Network is that Cancer Network do not expressly teach diluting 25-125 mg of lyophilized melphalan HCl powder and the cyclodextrin derivative in saline where the melphalan in the dilute pharmaceutical composition degrades by 2% or less at about 25°C within 0.5 hours after the diluting or by 4% or less at 25° C within 10 hours after the diluting as instantly claimed in a ratio of at least 50:1 cyclodextrin to melphalan, or 50:1 to about 100:1 about 54:1, and injecting that diluted composition into the patient to provide palliative treatment of multiple myeloma. This deficiency in Cancer Network is cured by the teachings of ALKERAN®, Thompson et al., Ma et al., Stella et al. and Strickley.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to perform the method of Cancer Network by diluting 25-125 mg of melphalan HCl and the cyclodextrin derivative where the melphalan in the dilute pharmaceutical composition degrades by 2% or less at about 25°C within 0.5 hours after the diluting or by 4% or less at 25° C within 10 hours after the diluting as instantly claimed in a ratio of at least 50:1 cyclodextrin to melphalan, or 50:1 to about 100:1 about 54:1, and injecting into a patient to provide palliative treatment of multiple myeloma, as suggested by ALKERAN®, Ma et al., Thompson et al., Stella et al. and Strickley, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because Cancer Network teaches using ALKERAN® in the method but Ma et al. have shown that ALKERAN® has serious problems and to overcome those problems Ma et al. have developed and injectable melphalan formulations utilizing SBE7-β-CD from Captisol to improve the current melphalan injectable formulation of ALKERAN®. Ma et al., Thompson et al., Stella et al. and Strickley all direct the artisan to Captisol. Strickley points to the ease of access of the SBE6.5-β-CD MW = 2163 from Captisol that is “an excellent solubilizing drug delivery technology” and Stella et al. also teach the desirable properties of Captisol, such as FDA approval, for the cyclodextrin as further motivation to select that product. Thus, the ordinary artisan would find it desirable to switch from ALKERAN® to the improved injectable composition of Ma et al. using (SBE)7m-β-CD (Captisol™), which is also known in the art as, Captisol SBE6.5-β-CD MW = 2163 for the cyclodextrin as suggested by Strickley and inject it into a patient with a reasonable expectation of success. Consequently, the ordinary artisan would employ the improved melphalan Captisol SBE7-β-CD composition of Ma et al. at a pH of 6 by diluting a composition with 25-125 mg of melphalan and a Captisol cyclodextrin derivative taught by Ma et al., Thompson et al. and Stella et al., and intravenously injecting the diluted pharmaceutical composition into the subject in need thereof for systemic palliative treatment of multiply myeloma as suggested by ALKERAN®. Regarding the weight ratio of at least 50:1 limitation, the Examiner has shown above that Ma et al. teach a weight ratio of about 45:1. And the Examiner has shown through the teachings of Thompson et al. to employ derivatized cyclodextrins such as SBE7-β-CD with the active agent melphalan where the weight ratio or molar ratio of the derivatized cyclodextrin to active agent can exceed 100 or more, hence 100:1. That reasonably provides a weight ratio range of 45:1 to greater than 100:1, which encompasses the claimed ranges of at least 50:1, 50:1 to 100:1 or about 54:1. See MPEP 2144.05(I): “A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case.” It is then merely routine optimization by increasing the ratio of the cyclodextrin derivative to melphalan ratio to achieve the functional limitation of where the melphalan in the dilute pharmaceutical composition degrades by 2% or less at about 25°C within 0.5 hours after the diluting or by 4% or less at 25° C within 10 hours after the diluting with a reasonable expectation of success. Especially when Applicant also employs Captisol with an average MW of 2163 g/mol (Specification [0058-0059]; Examples 1-4, 8 and 10-13). Consequently, it appears the claimed functional parameters naturally flow from employing Captisol. Furthermore, pharmaceutical dose has been recognized as a result-effective parameter susceptible to routine optimization. See, e.g., Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed. Cir. 1989) (drug dosage limitations resulted from routine experimentation). From MPEP 2144/05 (II) (A): “[W]here 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 also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). With any evidence of a criticality, adjusting the weight ratio is merely mechanical improvement, which expresses no patentable quality as there must be ingenuity over and above mechanical skill. Thus, the ordinary artisan would have a reasonable expectation of success because it is merely increasing the amount of cyclodextrin derivative in solution as suggested by Thompson et al. and arrive at the instantly claimed limitation where it is well-known in the art that increasing the amount of cyclodextrin concurrently increases the stability as taught by Ma et al. Especially when Thompson et al. teach and suggest weight ratios of cyclodextrin:active agent melphalan of 100 or more. Accordingly, the ordinary artisan would have a reasonable expectation of success in so doing.
2. The difference between the instant application and Cancer Network is that Cancer Network do not expressly teach storing the composition for about 0.5-12 hours prior to administering; the functional degradations properties or the Cmax or AUC that is at least 20% greater than an equivalent dose that lacks cyclodextrin derivative or bioavailability that is greater than an equivalent dose that lacks cyclodextrin derivative as instantly claimed. This deficiency in Cancer Network is cured by the teachings of Ma et al., Thompson et al., Stella et al. and Strickley.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to perform the method of Cancer Network with the melphalan cyclodextrin derivative Captisol of Ma et al., Thompson et al., Stella et al. and Strickley where the composition is stored for about 0.5-12 hours prior to administering; the functional degradations properties or the Cmax or AUC that is at least 20% greater than an equivalent dose that lacks cyclodextrin derivative or bioavailability that is greater than an equivalent dose that lacks cyclodextrin derivative as instantly claimed, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because these functional properties are implicit in the melphalan SBE7-β-CD composition of Ma et al., Thompson et al., Stella et al. and Strickley where the sulfobutyether-β-cyclodextrin with a MW of 2163 and average degree of substitution of 6.5 is from Captisol. Applicant employs the same Captisol (See the specification [0058-0059]; Examples 1-4, 8 and 10-13). Therefore, administration of the Captisol composition suggested by Ma et al., Thompson et al., Stella et al. and Strickley, naturally has a Cmax and/or AUC that is at least 20% greater than an equivalent dose that lacks cyclodextrin derivative or bioavailability that is greater than an equivalent dose that lacks cyclodextrin derivative in the absence of evidence to the contrary. “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” Regarding the limitation of storing the composition for about 0.5-12 hours prior to administering, it is the Examiner’s position that this is at the discretion of the ordinary medical artisan would have exercised sound medical judgment, policies, and practices as to when to store the composition until it is needed within medical guidelines and good practice, which would ostensibly be shortly after reconstitution such as within 30 minutes or several hours with a reasonable expectation of success.
3. The difference between the instant application and Cancer Network is that Cancer Network do not expressly teach all the neoplastic disorders of claim 2. However, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to perform the method of Cancer Network with the melphalan Captisol cyclodextrin derivative of Ma et al., Thompson et al., Stella et al. and Strickley on patients with any of the neoplastic disorders of claim 2, as suggested by ALKERAN® and Ma et al. and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because ALERAN® teaches that melphalan is an alkylating agent that is active against human neoplastic diseases (Page 1, lines 16-18) and Ma et al. teach that melphalan is an anti-neoplastic agent (Abstract). It is then merely judicious selection of known neoplastic disorders by the ordinary oncologist in this art to treat with the melphalan formulation of Ma et al., Thompson et al., Stella et al. and Strickley with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined 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 at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed on 1/29/26 have been carefully considered but are not persuasive.
On pages 6-7 of remarks, Applicant summarizes the rejection.
On page 7 of remarks, Applicant asserts: “Applicant disagrees and traverses for the reasons of record including at least the reasons that Thompson is only related to oral compositions and the Loftsson teaches away from the Examiner's proposed modification.” However, Thompson is not relied upon for oral compositions and Loftsson is no longer applied.
On page 7 of remarks, Applicant argues: “there is no reasonable expectation of success that the presently claimed formulations, when used in the presently claimed method, would be suitable to treat a neoplastic disorder as claimed. However, none of the references provide any bioavailability data associated with administration of cyclodextrin/melphalan complexes. For that reason alone, there can be no reasonable expectation cyclodextrin/melphalan compositions-let alone cyclodextrin/melphalan compositions could provide melphalan in amounts efficacious to treat a neoplastic disorder as claimed.” Respectfully, the Examiner does not agree because melphalan is known as an antineoplastic compound effective in treatment of various cancers (Ma et al. (Page 227, right column), thus providing some degree of predictability. Applicant is reminded that the expectation of success need only be reasonable and not guaranteed. See MPEP 2143.02(II): Obviousness does not require absolute predictability, however, at least some degree of predictability is required.
On page 7 of remarks, Applicant states: “the enhancement in Cmax and AUC for the SBE6.5-β-CD containing melphalan formulation in human patients is wholly unexpected." However, the data in [0215] is not a comparison with the closest prior art and the control is a cyclodextrin free melphalan composition. The burden of showing unexpected results rests on the person who asserts them by establishing that the difference between the claimed invention and the closest prior art was an unexpected difference. See In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972).
On pages 7-8, Applicant argues the claimed stabilities and degradation and asserts that “the systems studied in Example 11, the 75 mM SBE6.5-β-CD formulation had a time for 10% loss of 11 hours (nearly double what Ma purportedly shows)… this composition, despite having a lower weight ratio of cyclodextrin than the weight ratio of Ma's 100 mM (SBE)7m-β-CD (32.4<45), had more than double the stability.” Applicant cited [0157] and the Pipkin Declaration. In [0157]: “Pharmaceutical compositions containing a cydodextrin derivative (SBE6.5-β-CD, CAPTISOL®, avg" M.\V.=2163 g/mol)…”. The Examiner has carefully considered this argument and it is not persuasive for the following reasons. Independent claim 1 is not limited to any particular degree of substitution or cyclodextrin derivative, dependent claim 8 provides a degree of substitution range of 4-8 and claim 7 introduces the sulfobutylether (SBE) substituent. Applicant’s finding is limited to the cyclodextrin formulation employed. Unexpected results must be "commensurate in scope with the degree of protection sought by the claimed subject matter." In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005). Applicant’s have not shown that their results would be achieved with other cyclodextrin derivatives, let alone other SBE-β-CDs, within the scope of the claim. See MPEP 716.02(d)(II): To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). There is no evidence in this record of other cyclodextrin derivatives that achieve the same result. The evidence shown by Applicant does not provide a reasonable basis for concluding that the untested embodiments encompassed by the claims would behave in the same manner as the tested embodiment. Therefore, Applicant’s findings are not commensurate in scope with the claimed subject matter. Respectfully, Applicant’s arguments are not persuasive at this time.
Conclusion
No claims are allowed.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613