DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1-2, 4-6, 10-11, 14-16, 19-20, 22-23, 25-26, 32, 37, 68-69, 71-72 and 75 are pending.
Election/Restrictions
Applicants' election without traverse of Group I, claims 1, 10-11, 14-16, 19-20, 22-23, 25-26, 32, 37, 68-69, 71-72 and 75, in the 2/18/26 reply is acknowledged. Claims 2 and 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 10-11, 14-16, 19-20, 22-23, 25-26, 32, 37, 68-69, 71-72 and 75 are under consideration.
Drawings
Corrected drawings in compliance with 37 CFR 1.121(d) are required because
---The drawings filed 7/6/22 do not comply with 37 C.F.R. 1.84(u)(1), which states that partial views of a drawing which are intended to form one complete view, whether contained on one or several sheets, must be identified by the same number followed by a capital letter. Specifically, “Fig. 2B Continued” should be relabeled as “Fig. 2C”, and Fig. 2C and 2D should be 2D and 2E. Likewise “Fig. 4B Continued”, “Fig. 5B Continued”, “Fig. 6B Continued”, “Fig. 11 Continued”, should be similarly relabeled.
---“Fig. 11 Continued” contains excessive text; specifically, the bottom half of the figure contains 7 full-length sentences titled “Notes”. Per 37 C.F.R 1.84(o), “Legends”, any legend “should contain as few words as possible”. This text should be moved from this figure to the brief description of the figure in the specification.
Once the drawings are changed to meet the separate numbering requirement of 37 C.F.R. 1.84(u)(1), Applicants are required to file an amendment to change the Brief Description of the Drawings and the rest of the specification accordingly. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). Applicants are advised to employ the services of a competent patent draftsperson outside the Office, as the USPTO no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive because it refers generally to any form of treatment of paroxysmal nocturnal hemoglobinuria (PNH), but the claims are limited to a method of treating PNH with pegcetacoplan based on LDH level. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Treatment of Paroxysmal Nocturnal Hemoglobinuria with Pegcetacoplan based on Lactose Dehydrogenase Level”.
---The Brief Description of Figure 1 on page 8, ¶ 32, must be amended to refer to Figures 1A and 1B as set forth above in “Drawings”.
---In the brief description of Fig. 1A (¶ 55), “pegcetacopan” should be “pegcetacoplan”
Appropriate correction is required.
Claim Objections
Claims 1, 10-11, 14-16, 19-20, 22-23, 25-26, 32, 37, 68-69, 71-72 and 75 are objected to because of the following informalities:
In claim 1, the acronym “LDH” should be accompanied by the full terminology the first time it is used in a series of claims; e.g., “lactose dehydrogenase (LDH)”.
In independent claim 68, “PNH” should be accompanied by the full terminology; e.g., “paroxysmal nocturnal hemoglobinuria (PNH)”. Compare with lines 1-2 of claim 1.
In claim 69, line 4, “4 g/d L” should be “4 g/dL”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Claim Interpretation
---With respect to the term “pegcetacoplan”, used in independent claims 1 and 68 and claims depending from these claims, the specification teaches that it “has the structure of the compound of FIG. 1A with n of about 800 to about 1100 and a PEG having an average molecule weight of about 40 kD” (¶ 134); further provides a full chemical name for this structure (¶ 134); and further teaches “APL-2” as an alternate name (¶ 55, 134, 220).
---With respect to the term “about”, the specification defines the term in ¶ 84:
“As used herein, the terms “approximately” or “about” in reference to a number are generally taken to include numbers that fall within a range of 5%, 10%, 15%, or 20% in either direction (greater than or less than) of the number unless otherwise stated or otherwise evident from the context (except where such number would be less than 0% or exceed 100% of a possible value). In some embodiments, the term “about X” includes the number “X” and numbers that fall within a range of 5%, 10%, 15%, or 20% in either direction (greater than or less than) of the number X.”
Claims 16, 19, 37, 68, 69 and 72 each employ the term “about” in conjunction with a numerical value; as such, in each case the definition set forth in the specification applies to the term as used in each claim, and therefore each numerical value encompasses numbers that fall with 20% of the value in either direction.
Claim Rejections - 35 USC § 112(b)
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 16, 19-20, 69 and 71-72 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 pre-AIA the applicant regards as the invention.
In each of claims 16 (two instances), 19 (one instance), 69 (two instances) and 72 (one instance), the phrase “e.g.” (which means “for example”) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Note on Prior Art Rejection(s)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 68-69, 71, 72 and 75 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grossi et al, WO 2018/187813 A1, published 10/11/18 (reference B87 on the 1/27/23 IDS). The earliest date to which the instant application claims priority is 1/7/20.
Independent claim 68 encompasses a method of treating subject suffering from PNH (paroxysmal nocturnal hemoglobinuria) comprising subcutaneously administering to the subject about 1080 mg pegcetacoplan twice weekly or every three days, wherein the treatment increases hemoglobin in the subject to a target hemoglobin level.
The concluding “wherein” clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, in claim 68, the wherein clause simply express the intended result (increase in hemoglobin to a specific level) of a process step positively recited (administering pegcetacoplan). As such, with respect to anticipation by the prior art, claim 68 encompasses a method of treating subject suffering from PNH (paroxysmal nocturnal hemoglobinuria) comprising subcutaneously administering to the subject about 1080 mg pegcetacoplan twice weekly or every three days.
As noted above in the section, “Claim Interpretation”, the term “pegcetacoplan” has the structure shown in Figure 1A, with PEG having an average molecular weight of 40 kD, and the term “about” encompasses a variation of up to 20%, and thus “about 1080 mg” encompasses a range of 869 to 1296 mg.
Grossi teaches “long-acting compstatin analogs” (¶ 3), or “LACA” (¶ 459), for treatment of a complement-mediated disorder (¶ 4) including one that is PNH (¶ 5). Grossi further teaches that LACAs include one with a “molecular weight of about 40 kD and two compstatin analog moieties, referred to herein as LACA-40” (¶ 478). An example is provided in Figure 10(C), which has the same structure as the molecule of Figure 1A of the instant specification. As such, the term “pegcetacoplan” of the instant claims encompasses the LACA-40 taught by Grossi. Grossi further teaches that dosing schedules of the invention include subcutaneous administration that is “twice weekly” subcutaneous administration of a LACA-40 in ranges including several encompassed by “about 1080 mg”, including 1035-1080 mg (¶ 481), and further teaches these dosages for “every third day” administration (¶ 482). As such, the teachings of Grossi anticipate claim 68.
Claims 69, 71 and 72 limit the target hemoglobin level of claim 68, which is a limitation found in the concluding wherein clause. As such, each of these claims is solely directed to a narrowing of the intended result of claim 68. Therefore, the further limitation is interpreted in the same manner as the limitation of parent claim 68. As such, claims 69, 71 and 72 are anticipated by the same teachings of Grossi set forth above for claim 68.
Claim 75 encompasses a method of claim 68 wherein the subject is treated in the absence of a transfusion. The methods of treatment taught by Grossi do not include a step including a transfusion of the subject. As such, the teachings of Grossi that anticipate claim 68 also anticipate claim 75.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 10, 14-16, 19-20, 22-23, 25-26, 32 and 37 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wong et al (2018. Blood. Supplement 1: 2314; 4 pages as printed), and further in view of Grossi et al, WO 2018/187813 A1, published 10/11/18 (reference B87 on the 1/27/23 IDS). The earliest date to which the instant application claims priority is 1/7/20.
Claim 1 encompasses a method of treating a subject suffering from paroxysmal nocturnal hemoglobinuria (PNH) comprising subcutaneously administering to the subject pegcetacoplan, wherein the frequency of dosage is contingent on the subject’s LDH level. If the LDH level is greater than twice the upper limit of normal (>2 x ULN), pegcetacoplan is administered in a 1080 mg dose every three days. Thus, claim 1 in the alternative encompasses the following embodiment: a method of treating a subject suffering from PNH and having an LDH level of greater than >2 x ULN comprising subcutaneously administering pegcetacoplan in a 1080 mg dose every three days.
As set forth above in the section, “Claim Interpretation”, the instant specification teaches that pegcetacoplan is also known as APL-2.
Wong teaches:
“PNH is characterized by a degree of bone marrow failure and hemolysis resulting in debilitating hemolytic anemia and an increased risk of thrombosis. Uncontrolled complement activation leads to intravascular hemolysis mediated by the membrane attack complex and extravascular hemolysis mediated by accumulation of C3 fragments, such as C3b, at the cell surface” (pages 1-2).
Wong further teaches “APL-2, a cyclic peptide inhibitor of C3”, which “acts to prevent intravascular and extravascular hemolysis” (page 2), and is another name for pegcetacoplan (see above). Wong further teaches treatment of “patients with PNH” with APL-2 by “daily subcutaneous injection (SC)” (“Aims”; page 2). Wong further teaches that the treated patients had “LDH levels >2 times upper limit of normal (x ULN)” (“Methods”; page 2). Wong further teaches that a cohort of patients was administered 270 mg/d of APL-2. Wong reports that “systemic inhibition of C3 with APL-2, controls both intravascular and extravascular hemolysis in patients with PNH as shown by significant reductions in LDH, total bilirubin and ARC” (page 3).
While Wong teaches patients with LDH levels that are greater than twice the upper limit of normal, and teaches treatment of such patients with APL-2 (pegcetacoplan), the teachings of Wong are limited to daily administration of APL-2 in a dose of 270 mg per day, and do not include that such treatment is administered in a 1080 mg dose every three days as required by claim 1.
Grossi teaches “long-acting compstatin analogs” (¶ 3), or “LACA” (¶ 459), for treatment of a complement-mediated disorder (¶ 4) including one that is PNH (¶ 5). Grossi further teaches that “[c]ompstatin is a cyclic peptide that binds to C3 and inhibits complement activation” (¶ 75). Grossi further teaches that LACAs include one with a “molecular weight of about 40 kD and two compstatin analog moieties, referred to herein as LACA-40” (¶ 478). An example is provided in Figure 10(C), which has the same structure as the molecule of Figure 1A of the instant specification. Grossi further teaches that “LACA-40 is a potent and selective inhibitor of complement C3” (¶ 640). Grossi further teaches that “in clinical trials in subjects with PNH, subcutaneous administration of 180 mg or more per day of LACA-40 resulted in relevant changes in blood biomarkers (e.g., as described in Examples 21 and 22)” (¶ 478). Grossi further teaches that:
“In some aspects, the present disclosure provides the insight, based at least in part on data acquired in these clinical trials and pharmacokinetic modeling, that a LACA comprising a PEG having a molecular weight of about 40 kD and two compstatin analog moieties has a suitable profile for administration according to dosing regimens in which doses are administered subcutaneously no more often than once every two days, e.g., every other day, three times a week (sometimes referred to as "thrice weekly"), every third day, twice a week (sometimes referred to as "twice weekly"), every fourth day, every fifth day, every sixth day, or once a week (sometimes referred to as "once weekly" or "weekly"). In some aspects, such dosing regimens may provide increased convenience for patients as compared, e.g., to regimens in which a LACA is administered daily. In some aspects, such dosing regimens may provide a similar or greater average (mean) plasma concentration of LACA-40 at steady state as does daily subcutaneous (SC) administration at a lower dose (e.g., between 180 mg and 270 mg daily) and /or a similar or greater minimum (trough) plasma concentration of LACA-40 at steady state as does daily SC administration at a lower dose (e.g., between 180 mg and 270 mg daily), yet avoid excessive fluctuations in plasma concentration that may potentially result in a peak (maximum) plasma concentration that might be undesirably high and/or a trough (minimum) plasma concentration that might be undesirably low and might have an adverse impact on efficacy. Without wishing to be bound by any theory, this may in part be a consequence of LACA-40 having a relatively slow rate of absorption into the vascular compartment following subcutaneous administration” (¶ 478).
Grossi further provides the parameters for such “every third day” dosing schedules, including that such may be given at “any of the doses described above” (¶ 482), which includes preceding paragraph ¶ 481, which includes dosages of 1080 mg.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of treating a subject suffering from PNH and having an LDH level of > 2 x ULN comprising subcutaneously administering APL-2 (pegcetacoplan) at 270 mg daily as taught by Wong, and to modify said method to subcutaneously administer the APL-2 (pegcetacoplan) at 1080 mg every three days as taught by Grossi for cyclic peptide inhibitors of C3 for treatment of PNH. The person of ordinary skill in the art would have been motivated to make such a change in order to employ the advantages taught by Grossi for less frequent administration, including providing increased convenience to patients as compared to daily administration. The person of ordinary skill in the art would have had a reasonable expectation of success because Wong and Grossi both teach treatment of PNH with cyclic peptide inhibitors of C3, and making such a modification merely requires adjusting the dosage to a higher concentration with longer intervals between doses. Furthermore, per MPEP 2144.05, "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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)". This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claim 10 encompasses a method of claim 1, wherein the subject is initially administered pegcetacoplan in a 1080 mg dose twice weekly, and if during treatment, the subject’s LDH level is assessed to be greater than twice the upper limit of normal, the subject subsequently is administered pegcetacoplan in a 1080 mg dose every three days (which would include three days of administration in the first week). As the method of the parent claim 1 only results in twice weekly administration of pegcetacoplan if the subject’s LDH level was less than or equal to twice the upper limit of normal (≤ 2 x ULN), this means that claim 10 is limited to the alternative embodiment of parent claim 1 directed to treatment of a subject suffering from PNH and having an LDH level of ≤ 2 x ULN. Furthermore, claim 10 then requires that such a treated patient is further assessed for LDH, found to have a LDH level that is > 2 x ULH, and switched to pegcetacoplan at 1080 mg every three days. The teachings of Wong are limited to treatment of subjects having greater than > 2 x ULH, but Grossi also teaches treatment of patients with 1.5 x ULH with a cyclic peptide inhibitor of C3 and continued monitoring said patients LDH levels (¶ 601). Grossi further teaches twice weekly administration at 1080 mg as one of the alternate dosage options for treatment (¶ 481). It would have further been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of treatment of PNH with APL-2 obvious over the teachings of Wong in view of Grossi and to modify it to treat a subject having an LDH level of 1.5 x ULN as taught by Grossi with any of the dosages taught by Grossi (including twice weekly) and to further monitor LDH as taught by Grossi and to further adjust the dosage to a more frequent administration is the LDH level rises to > 2 x ULH as taught by Wong. Such monitoring and modification of dosages is obvious in view of MPEP 2144.05, "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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)".
Claim 14 encompasses a method of claim 1 wherein pegcetacoplan is self-administered using a pump. Grossi further teaches that the methods of the invention including subcutaneous administration of a LACA via “a pump”, which “may be any device that moves fluids by mechanical action as opposed to a conventional manually actuated syringe characterized in that the individual administering the medication (e.g., a health care provider or a subject who self-administers the medication) must directly depress a plunger into a barrel containing medication in order to effect the injection”. As such, the teachings of Grossi further include self-administration of the LACA. As such, it would have further been obvious to include such an embodiment when practicing the method obvious over Wong in view of Grossi.
Claim 15 encompasses a method of claim 1 that is limited by a further wherein clause indicating administration of pegcetacoplan results in an increase in the hemoglobin level of the subject to a target level. This wherein clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, in claim 15, the wherein clause simply express the intended result (increase in hemoglobin to a specific level) of a process step positively recited (administering pegcetacoplan). As such, claim 15 is obvious over the teachings of Wong in view of Grossi for the same reasons as set forth above for parent claim 1. It is noted that while the intended result recited in the wherein clause of claim 15 does not distinguish the claimed method from the prior art, Wong does further teach that the treatment will result in an increase the treated subject’s target hemoglobin; see “Results”, page 3.
Claims 16, 19-20 and 22 each further limit the target hemoglobin level of the wherein clause of claim 15. As such, each of these claims is solely directed to a narrowing of the intended result of claim 15. Therefore, the further limitation is interpreted in the same manner as the limitation of parent claim 15. Thus, claims 16, 19-20 and 22 are also obvious over the teachings of Wong in view of Grossi for the same reasons as set forth above for parent claims 1 and 15.
Claim 23 encompasses a method of claim 1 that is limited by a further wherein clause indicating administration of pegcetacoplan results in a reduction of transfusions to a target number. This wherein clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04 as quoted above for claim 15. Specifically, in claim 23, the wherein clause simply express the intended result (reduction in the number of transfusions) of a process step positively recited (administering pegcetacoplan). As such, claim 23 is obvious over the teachings of Wong in view of Grossi for the same reasons as set forth above for parent claim 1. It is noted that while the intended result recited in the wherein clause of claim 23 does not distinguish the claimed method from the prior art, Wong does further teach that the treatment will result in a decrease in transfusion, with many patients requiring no transfusion during treatment; see “Results”, page 3.
Claims 25 and 26 each further limit the target number of transfusions of parent claim 23. As such, each of these claims is solely directed to a narrowing of the intended result of claim 23. Therefore, the further limitation is interpreted in the same manner as the limitation of parent claim 23. Thus, claims 25 and 26 are also obvious over the teachings of Wong in view of Grossi for the same reasons as set forth above for parent claims 1 and 23.
Claim 32 encompasses a method of claim 1 that is limited by a further wherein clause indicating administration of pegcetacoplan results in a reduction of reticulocytes to a target level. This wherein clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04 as quoted above for claim 15. Specifically, in claim 23, the wherein clause simply express the intended result (reduction in the number of reticulocytes) of a process step positively recited (administering pegcetacoplan). As such, claim 32 is obvious over the teachings of Wong in view of Grossi for the same reasons as set forth above for parent claim 1. It is noted that while the intended result recited in the wherein clause of claim 15 does not distinguish the claimed method from the prior art, Wong does further teach that the treatment will result in a decrease to the subject’s absolute reticulocyte count, or ARC; see “Results”, pages 3-4.
Claim 37 further limits the target number of reticulocytes of parent claim 32. As such, this claim is solely directed to a narrowing of the intended result of claim 32. Therefore, the further limitation is interpreted in the same manner as the limitation of parent claim 32. Thus, claim 32 is also obvious over the teachings of Wong in view of Grossi for the same reasons as set forth above for parent claims 1 and 32.
Notes on Patentability
---Dependent claim 11 encompasses a method of claim 1 wherein if the subject is administered pegcetacoplan in a 1080 mg dose every three days after exhibiting an LDH level greater than twice the upper limit of normal, the method further comprises having the subject’s LDH level assessed twice weekly for at least two weeks. No prior art was identified teaching or suggesting assessing LDH levels twice weekly when treating PNH with pegcetacoplan or another drug. Brodsky et al (2009. Blood. 113(26): 6522-6527) describes treatment of PNH with a different drug, eculizumab, and teaches monitoring of LDH levels “weekly for the first 4 weeks and then monthly thereafter” (page 6525). Wong et al (2019; cited above), while teaching daily administration of APL-2, only measures LDH levels once per week (page 3).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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