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 .
Claims 5, 7, 9, 11-15, 17, 21, 27, 31, and 33-35 have been cancelled. Claim 36 has been newly added.
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
The rejection of claims 1-3, 6, 8, 10, 18-20, 22-23, 25-26, 28-30, and 32 under 35 U.S.C. 103 as being unpatentable over Bergmann (U.S. Patent Application Publication 2016/0176960) in view of Bergman (WO 2017/182561) is withdrawn in view of the claim amendments to claim 1. The prior art does not speak to preventing relapse of shock or increasing latency between episodes of shock. The “delaying onset of shock” limitation of claim 1 is disregarded as the patient in claim 1 must already be suffering from shock. This art could be reapplied if the claims are amended.
Specification
The disclosure is again objected to because of the following informalities:
Figure 5 contains sequences with no corresponding sequence identifiers. The description of Figure 5 on page 61 of the specification likewise does disclose the corresponding sequence identifiers. The instant application is not in sequence compliance.
Appropriate correction is required. Applicant’s 12/11/2025 response did not address this.
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 recites antibody, antibody fragment” and appears to be missing a conjunction such as “or” with respect to the anti-ADM antibody or anti-ADM antibody fragment Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-4, 6, 8, 10, 16, 18-20, 22-26, 28-30, 32, and 36 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims have been substantively amended and no basis has been pointed to for the changes and none is apparent.
The specification does not define “treating a patient suffering from shock” as being “defined as delaying onset of shock, preventing relapse of shock, or increasing latency between episodes of shock.” As such, claim 1 has no basis. As claim 1 requires that the patient is already suffering from shock, the limitation “delaying onset of shock” is inconsistent and has no basis. As claim 1 requires that the patient is already suffering from shock, the limitation ”preventing relapse of shock” is inconsistent and has no basis. Claim 1 does not require stabilizing, reversing, or curing shock suffered by the patient such that relapse of shock could be prevented. The limitation ”increasing latency between episodes of shock” is inconsistent and has no basis for the same reasons. These limitations particularly have no basis in view of the types of shock recited in dependent claims 2-3. For example, it is unclear how a patient would have a relapse of hypovolemic shock due to trauma or what increasing the latency between episodes of hypovolemic shock due to trauma would mean. It is unlikely that administration of the claimed antibody would prevent or delay a second trauma to the patient that results in hypovolemic shock.
The claims constitute new matter.
Claims 1-4, 6, 8, 10, 16, 18-20, 22-26, 28-30, 32, and 36 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 has been amended to recite a method comprising treating a patient suffering from shock by administering a pharmaceutically effective amount of an anti-adrenomedullin (ADM) antibody or anti-ADM antibody fragment to said patient, wherein treating a patient is defined as delaying onset of shock, preventing relapse of shock, or increasing latency between episodes of shock, and wherein said patient has a level of dipeptidyl peptidase 3 (DPP3) in a sample of bodily fluid below a predetermined threshold and said anti-ADM antibody or anti-ADM fragment binds to the N-terminal part (amino acids 1-21) of ADM: YRQSMNNFQGLRSFGCRFGTO (SEQ ID No. 14), wherein the bodily fluid is selected from the group consisting of whole blood, plasma, and serum.
Delaying onset of shock as recited in claim 1 cannot have occurred as the patient is required to be suffering from shock prior to treatment. This aspect of claim 1 is not enabled.
The specification defines shock at pages 28-31.
Shock is disclosed as being characterized by decreased oxygen delivery and/or increased oxygen consumption or inadequate oxygen utilization leading to cellular and tissue hypoxia. It is a life-threatening condition of circulatory failure and most commonly manifested as hypotension (systolic blood pressure less than 90 mm Hg or MAP less than 65 mmHg). Shock is divided into four main types based on the underlying cause: hypovolemic, cardiogenic, obstructive, and distributive shock.
Hypovolemic shock is disclosed as being characterized by decreased intravascular volume.
Cardiogenic shock (CS) is defined as a state of critical end organ hypoperfusion due to reduced cardiac output.
Obstructive shock is disclosed as being due to a physical obstruction of the great vessels or the heart itself.
Four types of distributive shock are disclosed: neurogenic shock (decreased sympathetic stimulation leading to decreased vasal tone), anaphylactic shock, septic shock and shock due to adrenal crisis.
The claims must be enabled with respect to preventing relapse of shock and increasing latency between episodes of shock for all aspects of shock set forth above. This implies that the shock suffered by the patient prior to therapy must be stabilized, reversed, or cured shock such that relapse of shock could be prevented.
Example 4 concerns sepsis mortality in a mouse model. Peritonitis was surgically induced in five rats followed by administration of the NT-M anti-ADM antibody resulted in a 70% survival rate after four days. A second experiment administered NT-M FAB2. The four day survival rate was 75%. The example does not test DPP3 levels in the rats. This animal model is not an art accepted model for all types of shock encompassed by the claims. It does not reflect the claimed method. In addition, there is no disclosure or evidence of record that administration of the antibody prevented relapse of shock or increased latency between episodes of shock in any rat.
Example 8 concerns NT-ADM antibodies in patients with septic shock and elevated adrenomedullin levels. Patients with septic shock and bio-ADM concentration > 70 ng/ml were treated with a single IV infusion with placebo, adrecizumab at 2 ng/kg or adrecizumab at 4 ng/kg. Lower short term mortality was observed in patients treated with adrecizumab as compared to placebo. Figure 8 (all levels of DPP3) shows improved survival at two weeks as compared to placebo. Figure 9 (DPP3 level < 50 ng/ml) shows further improved survival at two weeks as compared to placebo. Figure 10 (DPP3 level > 50 ng/ml) shows no improved survival at two weeks as compared to placebo. Table 7 shows hazard risks for 14-day mortality with different pre-dose DPP3 levels. See also Example 9 and Figures 11a-b which evaluated the response in patients with different adrenomedullin levels and DPP3 levels of less than or equal 70. See also pages 61-62 of the specification.
This example does not demonstrate or speak to administration of the antibody preventing relapse of shock or increasing latency between episodes of shock. The results of this example cannot be extrapolated to all types of shock encompassed by the claims. At least for example, results for sepsis cannot be extrapolated or predict results for anaphylactic shock. Note that only instant claim 10 requires that the subject being treated has a particular level of adrenomedullin (>40 pg/ml) and this amount is lower than that in the example. Note that only instant claim 4 requires that the subject being treated has a particular level of DPP3, a predetermined threshold of 120 ng/ml. This threshold is substantially higher than that in the example. Again, Figure 10 shows DPP3 levels > 50 ng/ml showed no improvement at two weeks compared to placebo.
The examples and prior art of record do not demonstrate the therapeutic effects required by claim 1 for any type of shock encompassed by the claims, particularly in subjects with various DPP3 levels.
The only therapeutic result shown in the specification is improved survival from septic shock as compared to controls. This is not a limitation of the claims. Therapeutic effects such as increased oxygen delivery, reversing tissue hypoxia, increased intravascular volume, improved cardiac output, removing physical obstruction of great vessels, increasing sympathetic stimulation leading to increased vasal tone, reversing anaphylactic shock, and/or reversing adrenal crisis have not been shown (and are also not limitations of the claims). The results from the septic shock examples cannot be extrapolated to predict therapeutic effects in other types of shock. Septic shock models are not art accepted models for the various types of shock encompassed by the claims. At least for example, hypovolemic shock due to hemorrhage caused by trauma (i.e. traumatic amputation of a limb) is mechanistically distinct from septic shock due to infection.
None of the examples demonstrates preventing relapse of shock and/or increasing latency between episodes of shock for all aspects of shock set forth above. Delaying onset of shock as recited in claim 1 cannot have occurred as the patient is required to be suffering from shock prior to treatment.
Note that none of the examples concerns patients as recited in claim 3 that have suffered all of the various diseases recited therein.
The claims are not enabled.
Applicant’s arguments are not persuasive and do not address the current limitations of the claims with respect to the therapeutic effect required. In contrast to applicant’s arguments, the claims have no limitations to vasodilation, vasoconstriction, vascular permeability, impaired microcirculation, or activation of neurohumoral and inflammatory mediators. Applicant’s arguments with respect to EP 355084 and WO 2004/091658 will not be addressed as these documents are not of record.
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 1-4, 6, 8, 10, 16, 18-20, 22-26, 28-30, 32, and 36 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.
Claim 1 is confusing. The claim requires that the patient is already suffering from shock. As such, the limitation “delaying onset of shock” is inconsistent and confusing. As claim 1 requires that the patient is already suffering from shock, the limitation ”preventing relapse of shock” is inconsistent and confusing. Claim 1 does not require stabilizing, reversing, or curing shock suffered by the patient such that relapse of shock could be prevented. The limitation ”increasing latency between episodes of shock” is inconsistent and confusing for the same reasons. These limitations are particularly confusing in the context of the types of shock recited in dependent claims 2-3. For example, it is unclear how a patient would have a relapse of hypovolemic shock due to trauma or what increasing the latency between episodes of hypovolemic shock due to trauma would mean. It is unlikely that administration of the claimed antibody would prevent or delay a second trauma to the patient that results in hypovolemic shock. The metes and bounds of the claims cannot be determined.
Claim 3 is confusing in reciting “hemorrhagic disease including gastrointestinal bleed…” The recitation of “including” does not make clear what the metes and bounds of hemorrhagic disease are.
Claim 18 is confusing in reciting “blood” where claim 1 is more specific in reciting “whole blood.” It appears that claim 18 is broader than claim 1 and improperly dependent.
Claim 19 lacks antecedent basis for “ADM-Gly.” The first amino acid in SEQ ID NO: 14 is Tyr (Y). It is unclear what was intended. It is noted that the specification at page 24, lines 21-22, defines ADM-NH2 as meaning SEQ ID NO: 20. The first amino acid of SEQ ID NO: 20 is Tyr (Y). Applicant’s response did not address this.
Claim 24 is confusing as the CDRs within SEQ ID NOS: 32 and 33 that provide the antigen binding recited in claim 1 are not required to be retained in view of the “sequence that is > 95% identical” limitations. This claim does not appear to be properly dependent. Applicant’s response did not address this.
Claim 26 contains the trademark/trade name “Biacore 2000.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular piece of equipment marketed by Cytiva and, accordingly, the identification/description is indefinite. Applicant’s response did not address this.
Claim 30 is confusing in reciting that the pharmaceutical formulation being administered to the subject in in a freeze-dried state. This does not appear to be an art accepted method of administration. Applicant’s response did not address this.
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.
Claims 1-3, 6, 8, 10, 16, 18, 20, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 7, 16-19, 26-28, and 33 of copending Application No. 17/802,799 (2/19/2026 claim set; inventor Bergmann; applicant 4TEEN4 Pharmaceuticals). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of co-pending claim 1 determines the levels of DPP3 in a sample from a shock patient and treats with an anti-ADM antibody or anti-ADM antibody fragment wherein the antibody binds to the N-terminal part (amino acid 1-21) of ADM (SEQ ID NO: 14) if the level of DPP3 is below a predetermined threshold. SEQ ID NO: 14 in the co-pending and instant claims is the same sequence.
Co-pending claims 3-4 disclose the limitations of instant claims 2-3, respectively. Co-pending claim 5 discloses the limitations of instant claim 10. Co-pending claim 19 indicates that the sample can be blood, plasma, or serum as in instant claims 1, 6 and 18. Co-pending claim 7 discloses the limitations of instant claim 8. Co-pending claims 16-18 disclose the limitations of instant claims 10 and 16. Co-pending claim 25 discloses the limitations of instant claim 20. SEQ ID NO: 24 in the co-pending and instant claims is the same sequence. Co-pending claims 26-28 disclose the antibody sequence limitations of instant claims 22-24. The sequence identifiers in the co-pending and instant claims reflect the same sequences.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The patent term filing date of 17/802,799 is 2/26/2021. This is prior to the instant application’s patent term filing date of 3/1/2021.
Applicant has acknowledged this rejection.
Claims 1, 19, 25-26, 28-30, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 7, 16-19, 26-28, and 33 of copending Application No. 17/802,799 (2/19/2026 claim set; inventor Bergmann; applicant 4TEEN4 Pharmaceuticals) in view of Bergmann (U.S. Patent Application Publication 2016/0176960).
The co-pending claims with respect to instant claim 1 are set forth as above.
Bergmann discloses administering anti-ADM antibodies to treat shock and septic shock patients. Pharmaceutical formulations with pharmaceutically acceptable excipients, in solution, as ready-to-use solutions, and freeze-dried are disclosed. Intra-muscular, intra-vascular, infusion, and systemic administration is disclosed. (See instant claims 29-30 and 32.) See at least paragraphs [0093-0096 and 0220] and claims, particularly claims 12, 14-15, 19-25, and 27. Various antibody formats such as IgG are disclosed. See at least paragraph [0154]. An IgG1 would have been an obvious and well known IgG form. See instant claim 28. Antibodies that bind to amino acids 1-10 of ADM are disclosed. See instant claim 25. See at least paragraphs [0015 and 0178], Figure 2, and SEQ ID NO: 27. SEQ ID NO: 27 corresponds to SEQ ID NO: 26 in instant claim 25. Antibodies that bind to the first amino acid “Y” of AMD (SEQ ID NO: 21 corresponding to instant SEQ ID NO: 20) are disclosed. See instant claim 19. See at least paragraph [0179]. Anti-ADM antibodies with affinities tested by means of label-free surface plasmon resonance using a Biacore 2000 system are disclosed. Antibodies with affinity constants of less than 10-7 M are disclosed. See instant claim 26. See at least paragraphs [0469-0470]. SEQ ID NOS: 1-14 in Bergmann correspond to SEQ ID NOS: 1-3, the sequence RVS, and SEQ ID NOS: 5-13, respectively, of the instant claims.
It would have been obvious to administer the anti-ADM antibody of the co-pending claims and of Bergmann to treat shock as the co-pending method determines that this treatment is required based on the DPP3 levels. Bergmann discloses methods of administration and formulations for anti-ADM antibodies as recited in the instant claims.
This is a provisional nonstatutory double patenting rejection. The patent term filing date of 17/802,799 is 2/26/2021. This is prior to the instant application’s patent term filing date of 3/1/2021.
Applicant has acknowledged this rejection.
Claims 1-4, 6, 10, 18-19, 22-26, 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 17/802,817 (8/7/2025 claim set; inventor Bergmann; applicant Adrenomed AG).
Although the claims at issue are not identical, they are not patentably distinct from each other. Co-pending claim 1 is directed to a method of treatment for shock by administering an anti-ADM antibody that binds to the N-terminal part (aa 1-21) of ADM (SEQ ID NO: 4). Co-pending SEQ ID NO: 4 corresponds to instant SEQ ID NO: 14. Dependent claim 12 requires that a sample of bodily fluid from the patent exhibits a level of DPP3 < 50 ng/ml, wherein the bodily fluid is selected from the group consisting of whole blood, plasma, or serum. Claims 9-10 recite treating shock due to hypovolemia, cardiogenic shock, obstructive shock, distributive shock, and septic shock. See instant claims 2-3. Claim 11 discloses the limitations of instant claim 10. (Bio-ADM in the co-pending claims is the same as ADM-NH2 in the instant claims.) Co-pending claims 14-15 disclose the limitations of instant claim 26. Co-pending claim 16 discloses the limitations of instant claim 28. Co-pending claims 18 discloses the limitations of instant claim 19. Co-pending claims 22-24 disclose the limitations of instant claims 22-24. SEQ ID NOS: 5-8, the sequence RVS, and SEQ ID NOS: 10-17, and SEQ ID NOS: 22-23 in the co-pending claims correspond to SEQ ID NOS: 1-3, the sequence RVS, SEQ ID NOS: 5-13, and SEQ ID NOS: 32-33, respectively, of the instant claims. Co-pending claim 25 discloses the limitations of instant claim 25.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The patent term filing date of 17/802,817 is 3/1/2021. This is the same as the instant application’s patent term filing date of 3/1/2021.
Contrary to applicant’s arguments, no terminal disclaimer has been filed with respect to this application.
Claims 1-4, 6, 8, 10, 18-20, 22-26, 28-30, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-11, 14, 18-25, and 27-28 of copending Application No. 19/099,348 (3/25/2025 claim set; inventor Bergmann; applicant Adrenomed AG).
Although the claims at issue are not identical, they are not patentably distinct from each other. Co-pending claim 1 is directed to a method of treating shock by administering an anti-ADM antibody to patient with a DPP3 level below a threshold of less than or equal to 40 ng/ml. Co-pending claim 4 discloses a threshold of less than or equal to 30 ng/ml. See instant claims 1 and 4. Co-pending claims 2-3 disclose the limitations of instant claims 2-3. Co-pending claims 9-10 disclose the limitations of instant claims 8 and 10. Co-pending claim 11 discloses the limitations of instant claim 10. Co-pending claim 14 discloses the limitation of instant claims 6 and 18. Co-pending claims 18 discloses the limitations of instant claim 19. Co-pending claims 19-20 disclose the limitations of instant claim 20. Co-ending claims 21-23 disclose the sequences of instant claims 22-24. Co-pending claims 24-25 disclose the limitations of instant claims 25-26, respectively. Co-pending claim 27 discloses the limitations of claim instant claim 28. Co-pending claim 28 discloses the limitations of instant claims 29-30 and 32.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The patent term filing date of 19/099,348 is 7/31/2023. This is after the instant application’s patent term filing date of 3/1/2021.
Contrary to applicant’s arguments, no terminal disclaimer has been filed with respect to this application.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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