DETAILED ACTION
Notice of Change in Examiner
The present application, previously examined by examiner SHOBHA KANTAMNENI, is currently being examined by ASHLEE WERTZ. The examiner’s contact information can be found below.
Previous Rejections
Applicants' arguments, filed 11/17/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Matter- 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6-18, 21, and 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 6, and 21 introduce new matter as the claims recite the limitation: "that does not have hyperphosphatemia” There is no support in the specification for this limitation. The limitation of the patient not having hyperphosphatemia was not described in the specification as filed, and person skilled in the art would not recognize in the applicant’s disclosure a description of the invention as presently claimed. The specification discloses a method for treatment of hyperphosphatemia in a CKD patient (specification pg. 18, lines 19-30) but does not describe the instantly claimed limitation of administering to “a patient that does not have hyperphosphatemia” and from MPEP 2163.06: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments. Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application.
Claim Rejections - 35 USC § 103 (Maintained)
The following is a quotation of pre-AIA 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 pre-AIA 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, 6-18, 21, and 24-26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chan et al. (US 2009/0186939 A1, PTO-1449) in view of Helenek et al. (US 2007/0161600 A1, PTO-1449), in view of Bortz et al. (US 2006/0134227 A1 – PTO-1449).
Chan teaches a method of treating a human subject, having chronic kidney disease, comprising administering to said subject an effective amount of a ferric organic compound that has a dissolution rate of at least approximately 2 mg/cm4/min, wherein an example of ferric organic compound is ferric citrate. See page 3, paras [0021], [0023]; claims 46-48, 65-68. It is taught that the subject may have any stage of chronic kidney disease e.g. end stage renal disease (ESRD). See paras [0023], [0054], [0059], [0068]; claim 58; Example 4; see para [0175] wherein it is taught that patients with ESRD were administered 2 to 6 g/day of ferric citrate. Chan further teaches that the ferric organic compounds are useful in the treatment of any other disorders responsive to ferric organic compound therapy (see page 4, section [0050]), and it is known that iron supplements are needed to control anemia in chronic kidney disease patients (see page 2, section [0014]). Chan et al. teaches anemia is associated with moderate or chronic renal failure, and occurs prior to the hyperphosphatemia observed with severe renal failure. See page 1, Table. Chan further teaches that ferric iron containing compounds are useful for the treatment of disorders, such as metabolic acidosis, and that the absorbed citrate from ferric citrate is converted to bicarbonate which corrects metabolic acidosis, a condition common in renal failure patients [0015] [0025]. Chan et al. also teaches orally administrable forms include a tablet as claimed in the instant claims. See paras [0052], [0053], page 4; para [0089], tablets and capsules as oral formulations. Chan teaches that the ferric organic compounds therein are more soluble than commercially available ferric organic compounds, smaller amounts of the ferric organic compounds can be used to effectively treat patients suffering from such disorders. See para [0050]. Chan et al. teaches that a daily effective amount of ferric citrate can be 2, 4, 6, or 8 grams, lying within the range as claimed in the instant claims based on the total number of tablets (e.g. 2 tablets correspond to 2 gm). See page 4, section [0053]; see para [0064], page 5, wherein it is taught that 2-20 gm/day of ferric organic compound (ferric citrate, see para [0070]) can be administered and can be formulated as tablet, capsule. Chan et al. also teaches an exemplary dosing regimen wherein capsules are administered 3x a day (see pages 7-9, section [0090]-[0107]). Chan et al. further teaches there are five clinical stages of chronic kidney stage, wherein in the early stages (i.e. stages 1 and 2), dialysis is not required. See para [0056], page 4. Chan teaches that an embodiment of the invention therein is treating a subject or person with early or mid- stage chronic disease with a composition comprising pharmaceutical-grade ferric citrate (see page 4, section [0056]). Thus, the treatment of chronic kidney disease by Chan et al. encompasses non-dialysis chronic kidney disease patients, patients with anemia. It is taught that clinical laboratory assessment includes serum iron, ferritin, transferrin saturation percentage. See page 8, para [0119].
Chan does not explicitly teach oral administration of ferric citrate in the non-dialysis chronic kidney disease patient is used to improve at least one iron storage parameter or increase iron absorption as in instant claims 6-15.
Chan does not explicitly teach oral administration of ferric citrate in the non-dialysis chronic kidney disease patient to treat iron deficiency anemia, or increase/maintain hemoglobin concentration as claimed in the instant claims 21, 24-26 i.e Chan et al. does not provide an example.
Chan does not teach each ferric citrate tablet comprises 1 g of ferric citrate as claimed in the instant claims (claims 16, 17,18), and administration of three tablets per day comprising 1 g of ferric citrate.
Helenek teaches iron deficiency anemia is associated with chronic kidney disease. See page 1, section [0010]; [0028]. It is taught that subjects with iron deficiency anemia secondary to dialysis or non-dialysis dependent-chronic kidney disease (CKD) will generally have Hgb<12 g/dL; TSAT<25%; and ferritin<300 ng/mL. See para [0049]; Study J, para [0124]. It is taught that the diagnosis of iron deficiency can be based on laboratory tests such as haemoglobin, serum ferritin, transferrin saturation (TIS). See para [0051]. Helenek also teaches it is within the normal skill in the art to adjust the dosage of iron to maintain target levels of hemoglobin (Hb), hematocrit, and laboratory parameters of iron storage to prevent iron deficiency and prevent iron overload (see page 6, section [0058]). It is taught that, for example, where a patient is anemic or iron deficient, intravenous iron can be administered when a patient has a ferritin<800, a TSAT<50, and/or a Hemoglobin<12. See para [0058].
Bortz teaches methods of nutritional or dietary iron supplement compositionsthat include iron to prevent, stabilize, reverse and/or treat disorders related to irondeficiency, such as iron deficiency anemia. See page 1, section [0001]. Bortz teaches the compositions are for administration to humans (see page 2, section [0009]).Bortz also teaches suitable forms of iron include soluble iron salts such as ferriccitrate (see page 2, sections [0020] and [0022]), wherein a preferred dosage form is atablet for oral administration (see page 4, section [0038]). Bortz also teachesnutritional or dietary supplementation helps to regenerate red bloods cells and increasehemoglobin as claimed in instant claims 7 and 9. See page 6, sections [0057]-[0058]. Bortz further teaches a preferred nutritional or dietary supplement composition of the present invention is provided for humans having iron deficiency anemia such as in patients in the pre-dialysis phase of chronic renal failure (chronic kidney disease) and in patients intolerant to intravenous iron. See page 7, section [0067].
It would have been obvious to a person of ordinary skill in the art to administer ferric citrate at a dose of ferric iron ranging from 210 mg-2.520 mg to an end-stage renal disease patient because Chan et al. teaches a method of treating a subject, having end-stage renal disease (ESRD), comprising administering to said subject an effective amount of a ferric citrate; it is taught that patients with ESRD were administered 2 to 6 g/day of ferric citrate.
It would have been obvious to administer the ferric citrate to a patient who does not have hyperphosphatemia, and instead has a different disorder such as metabolic acidosis because Chan teaches that ferric iron containing compounds are useful for the treatment of disorders, such as metabolic acidosis, and that the absorbed citrate from ferric citrate is converted to bicarbonate which corrects metabolic acidosis, a condition common in renal failure patients [0015] [0025].
It would have been obvious to one of ordinary skill in the art at the time of the invention that increasing serum ferritin levels, or increasing transferrrin saturation in the end-stage renal disease human patients would be effected by the treatment of end-stage renal disease patients with oral ferric citrate tablets as taught by Chan et al. because lower serum ferritin levels, and lower transferrrin saturation are known to occur in chronic kidney patients as taught by Helenek et al. In other words, the same patient population end-stage renal disease patients are treated with the same drug (ferric citrate), increase in serum ferritin levels, or increase transferrrin saturation must occur.
It would have been obvious to a person of ordinary skill in the art at the time of invention to administer orally ferric citrate tablets up to 18 tablet dosage forms per day, each tablet comprising 210 mg of ferric iron to an end-stage renal disease patient as in instant claim 2, 3 because 1) Bortz et al. teach ferric citrate tablets can be administrated orally to treat human patients having iron deficiency anemia such as in patients in the pre-dialysis phase of chronic renal failure, 2) Chan et al. teach a method of treating a subject, having ESRD, comprising administering to said subject an effective amount of a ferric organic compound such as ferric citrate; Chen teaches ferric citrate can be administered in tablet form, and Chan et al. teaches that a daily effective amount of ferric citrate can be 2, 4, 6, or 8 grams. Accordingly, it is within the purview of the ordinary artisan to administer the ferric citrate taught by Chan et al. (i.e. 2 g, 4 g) in divided dosages and administer up to 18 tablets so that each tablet contains 210 mg of ferric ion.
Further, the optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art.
It is pointed out that while the prior art references do no teach the claimed increase in serum ferritin levels, and transferrin saturation the combination of references render obvious administration of the same compound ferric citrate in same amounts as in instant claim 1 to the same patient end-stage renal disease (ESRD) human patients, it is expected that in administering the same compound ferric citrate in same amounts to the same patient population (end-stage renal disease patients), said increase in serum ferritin levels, and transferrin saturation concentration as in instant claim 1 would obviously occur when administered for a period of at least 52 weeks.
It would have been obvious to one of ordinary skill in the art at the time of theinvention that at least one iron storage parameter i.e. increasing hemoglobin concentration in non-dialysis chronic kidney disease human patients as taught by Bortz et al. would be affected by the treatment of non-dialysis chronic kidney disease patients having anemia with oral ferric citrate as taught by Chan et al. One of ordinary skill in the art would have had a reasonable expectation of success that the improving of at least one iron storage parameter i.e. increasing hemoglobin concentration in non-dialysis chronic kidney disease human patients as taught by Bortz et al. would be effected by the treatment of non-dialysis chronic kidney disease patients having anemia with oral ferric citrate as taught by Chan et al. because the same patient population (non-dialysis chronic kidney disease patients with iron-deficiency anemia) is treated with the same drug (ferric citrate), so the improving of at least one iron storage parameter (i.e. increasing hemoglobin concentration) in non-dialysis chronic kidney disease human patients must occur.
In regards to claims 8 and 10-15, while the prior art references do not teachthe claimed iron storage parameters (i.e. decreasing in iron-binding capacity, increasing the transferrin saturation, increasing the serum iron levels, increasing the liver iron levels, increasing the spleen iron levels, or increasing the serum ferritin levels), it is expected that in administering the same composition ferric citrate tablet to the same patient population (non-dialysis chronic kidney disease patients with iron deficiency anemia) said improvement in iron storage parameter must obviously occur. Further, it is known from Helenek et al. that modifying the dosage to adjust iron storage parameters to prevent iron deficiency and to prevent iron overload is within the purview of the ordinary artisan.
In regards to claims 17 and 18, while the prior art references do not teach tablets containing 1 g of ferric citrate, it is deemed to be within the purview of the ordinary artisan to administer the ferric citrate taught by Chan et al. (i.e. 2 g) in divided dosages so that each tablet contains 1 g of ferric citrate.
Chan does not explicitly teach oral administration of ferric citrate in the non-dialysis chronic kidney disease patient to treat iron deficiency anemia, or provide hemoglobin concentration/level as claimed in the instant claims 21, 24-26 i.e Chan et al. does not provide an example.
It would have been obvious to one of ordinary skill in the art at the time of the invention that anemia, iron deficiency anemia, increasing/provide hemoglobin concentration/level in non-dialysis chronic kidney disease human patients as taught by Bortz et al. would be effected by the treatment of non-dialysis chronic kidney disease patients having anemia with oral ferric citrate tablets as taught by Chan et al. because iron deficiency and iron deficiency anemia are known to occur in non-dialysis chronic kidney patients as taught by Helenek et al. In other words, the same patient population (non-dialysis chronic kidney disease patients with iron deficiency anemia) is treated with the same drug (ferric citrate), so treatment of the anemia, iron deficiency anemia, and increasing and/or maintaining hemoglobin must occur.
Further, it would have been obvious to a person of ordinary skill in the art to adjust the dosage of ferric citrate to provide hemoglobin levels as in instant claims 25, 26 in the non-dialysis chronic kidney disease patient because Helenek et al. also teach it is within the normal skill in the art to adjust the dosage of iron to maintain target levels of hemoglobin (Hb), hematocrit, and laboratory parameters of iron storage to prevent iron deficiency and prevent iron overload (see page 6, section [0058]).
Further, the optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art.
Thus, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time it was made.
Response to Arguments
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive
Applicant argues that the cited references, individually or in combination fail to disclose that the treated patient does not have hyperphosphatemia.
The Examiner disagrees. Chan teaches that ferric iron containing compounds are useful for the treatment of disorders, such as metabolic acidosis, and that the absorbed citrate from ferric citrate is converted to bicarbonate which corrects metabolic acidosis, a condition common in renal failure patients [0015] [0025]. Therefore, Chan does not require that the patient has hyperphosphatemia and teaches that the ferric citrate is administered to patients with renal failure who have other conditions, such as metabolic acidosis.
Applicant argues that the deficiencies of Chan cannot be cured by Helenek nor Bortz.
The Examiner disagrees. Chan is not deficient except where Helenek teaches lower serum ferritin levels, and lower transferrrin saturation are known to occur in chronic kidney patients and it is within the normal skill in the art to adjust the dosage of iron to maintain target levels of hemoglobin (Hb), hematocrit, and laboratory parameters of iron storage to prevent iron deficiency and prevent iron overload and Bortz teaches nutritional or dietary supplementation helps to regenerate red bloods cells and increase hemoglobin and ferric citrate tablets can be administrated orally to treat human patients having iron deficiency anemia such as in patients in the pre-dialysis phase of chronic renal failure.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1) Claims 6-18, 21, 24, 25-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7, 9, 13, 18, 24-25, 27, 29-31, 34, 39, 50, and 53-55 of copending Application No. 18/517,274 (reference application), in view of Chan et al. (US 2009/0186939 A1, PTO-1449), Helenek et al. (US 2007/0161600 A1 – PTO-1449), and Bortz et al. (US 2006/0134227 A1 – PTO-1449). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a method of treating iron deficiency in a non-dialysis chronic kidney disease patient, comprising orally administering ferric citrate to the non-dialysis chronic kidney disease patient. Claims of ‘274 of drawn to a method of treating iron deficiency anemia in a subject in need thereof comprising administering to the subject an effective amount of ferric citrate, wherein the subject is < about 18 years of age, and wherein the subject has chronic kidney disease; claims of ‘274 are also drawn to pharmaceutical composition in the form of tablets comprising ferric citrate.
Chan et al. (US 2009/0186939 A1, PTO-1449), Helenek et al. (US 2007/0161600 A1 – PTO-1449), and Bortz et al. (US 2006/0134227 A1 – PTO-1449) are applied as discussed above in the 35 U.S.C. 103(a).
It would have been obvious to a person of ordinary skill in the to administer orally ferric citrate in a tablet dosage form to a non-dialysis chronic kidney disease patient to treat iron deficiency or anemia because ‘274 teaches to a method of treating iron deficiency anemia in a subject in need thereof comprising administering to the subject an effective amount of ferric citrate, wherein the subject is < about 18 years of age, and wherein the subject has chronic kidney disease; and ‘274 also teaches a pharmaceutical composition in the form of tablets comprising ferric citrate.
It would have been obvious to one of ordinary skill in the art to administer to a patient that does not have hyperphosphatemia because Chan teaches that ferric iron containing compounds are useful for the treatment of disorders, such as metabolic acidosis, and that the absorbed citrate from ferric citrate is converted to bicarbonate which corrects metabolic acidosis, a condition common in renal failure patients [0015] [0025].
It would have been obvious to one of ordinary skill in the art at the time of theinvention that at least one iron storage parameter i.e. increasing hemoglobin concentration in non-dialysis chronic kidney disease human patients as taught by Bortz et al. would be affected by the treatment of non-dialysis chronic kidney disease patients having anemia with oral ferric citrate as taught by ‘274. One of ordinary skill in the art would have had a reasonable expectation of success that the improving of at least one iron storage parameter i.e. increasing hemoglobin concentration in non-dialysis chronic kidney disease human patients as taught by Bortz et al. would be effected by the treatment of non-dialysis chronic kidney disease patients having anemia with oral ferric citrate as taught by ‘274 because the same patient population (non-dialysis chronic kidney disease patients with iron-deficiency anemia and without hyperphosphatemia) is treated with the same drug (ferric citrate), so the improving of at least one iron storage parameter (i.e. increasing hemoglobin concentration) in non-dialysis chronic kidney disease human patients must occur.
In regards to claims 8 and 10-15, while the prior art references do not teachthe claimed iron storage parameters (i.e. decreasing in iron-binding capacity, increasing the transferrin saturation, increasing the serum iron levels, increasing the liver iron levels, increasing the spleen iron levels, or increasing the serum ferritin levels), it is expected that in administering the same composition (ferric citrate tablet) to the same patient population (non-dialysis chronic kidney disease patients with iron deficiency anemia), said improvement in iron storage parameter must obviously occur. Further, it is known from Helenek et al. that modifying the dosage to adjust iron storage parameters to prevent iron deficiency and to prevent iron overload is within the purview of the ordinary artisan.
In regards to claims 17, 18, while the prior art references do not teach tablets containing 1 g of ferric citrate, it is deemed to be within the purview of the ordinary artisan to administer the ferric citrate taught by ‘274 in divided dosages so that each tablet contains 1 g of ferric citrate.
It would have been obvious to a person of ordinary skill in the art to adjust the dosage of ferric citrate to provide hemoglobin levels as in instant claims 25, 26 in the non-dialysis chronic kidney disease patient because Helenek et al. also teach it is within the normal skill in the art to adjust the dosage of iron to maintain target levels of hemoglobin (Hb), hematocrit, and laboratory parameters of iron storage to prevent iron deficiency and prevent iron overload (see page 6, section [0058]).
Further, the optimization of result effect parameters e.g., dosage range, dosing regimens, dosing duration is obvious as being within the skill of the artisan, involving merely routine skill in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Double Patenting Arguments
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive.
Applicant argues that the reference claims do not provide the claim limitation where the human patient does not have hyperphosphatemia, which is required by the instant claims.
The Examiner disagrees because it would have been obvious to one of ordinary skill in the art to administer to a patient that does not have hyperphosphatemia because Chan teaches that ferric iron containing compounds are useful for the treatment of disorders, such as metabolic acidosis, and that the absorbed citrate from ferric citrate is converted to bicarbonate which corrects metabolic acidosis, a condition common in renal failure patients [0015] [0025].
Conclusion
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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