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 .
The amendment filed 04/09/2026 has been entered. Claim 6, 12-13, 18, 21-22, 24-26, 28 and 30-59 have been canceled. Claim 1 has been amended. Claims 1-5, 7-11, 14-17, 19-20, 23, 27 and 29 are pending and are under examination.
Claim Rejections Withdrawn
The rejection of claim(s) 1-7, 10-11, 14-17, 19-20, and 29 under 35 U.S.C. 102(a)(1) as being anticipated by Chyung et al. WO 2015/112578 published 7/30/2015 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 1, 23 and 27 under 35 U.S.C. 103 as being unpatentable over Chyung et al. WO 2015/112578 published 7/30/2015 in view of Nixon et al. WO 2014/152232 9-25-2014 cited in IDS is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 1 and 7-9 under 35 U.S.C. 103 as being unpatentable over Chyung et al. WO 2015/112578 published 7/30/2015 in view of Fowler et al. US 10,316,095 6-11-2019, cited in IDS is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 1-7, 10, 11, 20, 23, 27 and 29 under 35 U.S.C. 103 as being unpatentable over ClinicalTrials.gov Identifier: NCT02093923 hereinafter “923”. A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants. 16 Oct 2014. https://clinicaltrials.gov/ct2/show/NCT02093923 [last accessed 10 Sep 2025]. 5 pages. First posted 03-21-2014/last date posted 05-29-2014 cited in IDS in view of Nixon et al. WO 2014/152232 9-25-2014 cited in IDS is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 8 and 9 under 35 U.S.C. 103 as being unpatentable over ClinicalTrials.gov Identifier: NCT02093923 hereinafter “923”. A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants. 16 Oct 2014. https://clinicaltrials.gov/ct2/show/NCT02093923 [last accessed 10 Sep 2025]. 5 pages. First posted 03-21-2014/last date posted 05-29-2014 cited in IDS and Nixon et al. WO 2014/152232 9-25-2014 cited in IDS as applied to claims 1-7, 10, 11, 20, 23, 27 and 29, further in view of Fowler et al U.S. 10,316,095 cited in IDS is withdrawn in view of the amendment to the claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 7, 10-11, 14-17, 19-20, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chyung et al. WO 2015/112578 published 7/30/2015 in view of ClinicalTrials.gov Identifier: NCT02093923 hereinafter “923”. A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants. 16 Oct 2014. https://clinicaltrials.gov/ct2/show/NCT02093923 [last accessed 10 Sep 2025]. 5 pages. First posted 03-21-2014/last date posted 05-29-2014 cited in IDS.
Chyung et al disclose as follows:
1. A method for treating hereditary angioedema (HAE) attack or reducing the rate of HAE attack (see title, abstract), the method comprising:
(1) administering to a subject in need thereof an antibody at multiple doses of about 150 mg in a first treatment period, wherein the antibody DX-2930 which according to the instant specification at. p. 18-19 comprises a heavy chain complementarity determining region (HCDR) | set forth as HYIMM (SEQ ID NO: 5), a HCDR2 set forth as GIYSSGGITVY ADSVKG (SEQ ID NO: 6), a HCDR3 set forth as RRIGVPRRDEFDI (SEQ ID NO: 7) and light chain complementarity determining region (LCDR) | set forth as RASQSISSWLA (SEQ ID NO: 8), a LCDR2 set forth as KASTLES (SEQ ID NO: 9), and a LCDR3 set forth as QQYNTYWT (SEQ ID NO: 10)
-see p. 1 last paragraph, p. 2, p. 3, p. 4 first paragraph, p. 32 disclosing 150 mg dose, p. 33 for multiple doses e.g. daily, every other day etc., at least every two, three, four, five weeks etc., p. 41 paragraph 4 ; and
(ii) further administering the antibody to the subject for a second treatment period after (i)-p. 41 paragraph 4 disclosing a patient may be given multiple doses once every 1-4 weeks, for a suitable period of time, and then followed up with monthly or bi-monthly maintenance treatment, wherein the antibody is administered in multiple doses of about 300 mg every two weeks or every four weeks.
Chyung et al disclose “in some embodiments, the second dosage is higher than the first dosage”. See p. 2 2nd to last paragraph.
Chyung et al disclose “In some embodiments, the therapeutically or prophylactically effective amount of an antibody described herein (e.g., DX-2930) is 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 110 mg, 120 mg, 130 mg, 140 mg, 150 mg, 160 mg, 170 mg, 180 mg, 190 mg, 200 mg, 210 mg, 220 mg, 230 mg, 240 mg, 250 mg, 260 mg, 270 mg, 280 mg, 290 mg, 300 mg, 310 mg, 320 mg, 330 mg, 340 mg, 350 mg, 360 mg, 370 mg, 380 mg, 390 mg, or 400 mg”. See p. 32 last bridging paragraph to page 33 first paragraph.
Thus, Chyung et al disclose administering multiple doses of 150 mg in the first treatment period and multiple doses of 300 mg for the second treatment period (Chyung et al disclose “in some embodiments, the second dosage is higher than the first dosage).
Chyung et al disclose the subject is a human patient who had experienced at least two HAE attacks per year prior to the first treatment period- Chyung et al disclose a person with untreated HAE suffers from attacks every 1 or 2 weeks. See p. 36 paragraph 4. Thus, the human patient has necessarily has at least two HAE attacks per year prior to the first treatment period.
2. The method of claim 1, wherein the instant specification at p. 18-19 discloses that antibody DX-2930 comprises a heavy chain variable domain set forth as
EVQLLESGGGLV QPGGSLRLSCAASGFTFSH YIMMW VRQAPGKGLEWVSGIYSSGGITV YADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCAYRRIGVPRRDEFDIWGQGTM VTVSS (SEQ ID NO: 3) and a light chain variable domain set forth as
DIQMTQSPSTLSAS VGDRVTITCRASQSISS WLAW YQQKPGKAPKLLIYKASTLESGVPS RFSGSGSGTEFTLTISSLQPDDFATY YCQQYNTY WTFGQGTKVEIK (SEQ ID NO: 4). See p. 20 disclosing the DX-2930 antibody.
Also see p. 44-45 of Chyung et al disclosing the antibody sequences set forth above.
3. The method of claim 1, wherein the antibody is a full length antibody or an antigen-binding fragment thereof. See page 16-20.
4. The method of claim 3, wherein the antibody is an IgG molecule. See p. 6 for the term antibody and p. 16-20.
5. The method of claim 4, wherein the antibody is an IgG1 molecule. See p. 8 3rd paragraph and p. 16-20.
7. The method of claim 1, wherein the antibody is formulated in a pharmaceutical composition comprising a pharmaceutically acceptable carrier. See p. 29 under pharmaceutical compositions.
10. The method of claim 1, wherein the antibody is administered subcutaneously. See p. 30 3rd paragraph.
11. The method of claim 1, wherein the subject is a human patient having, suspected of having, or at risk for HAE, optionally, wherein the subject has HAE type I or type II. See page 2.
14. The method of claim 1, wherein the subject is a human patient who has received one or more prior HAE treatments prior to the first treatment period. See p. 43 disclosing administering other HAE treatments with the antibody sequentially in any order. See p. 43 paragraph 4.
15. The method of claim 14, wherein the prior HAE treatment comprises an Cl- inhibitor, a plasma kallikrein inhibitor, a bradykinin receptor antagonist, or a combination thereof. See p. 43 paragraph 3-4.
16. The method of claim 15, wherein the prior HAE treatment comprises an Cl- INH, ecallantide or a combination thereof. See p. 43 paragraph 3-4.
17. The method of claim 1, wherein the method comprises a tapering period for the one or more prior HAE treatments – see p. 43 paragraph 4 and 5 disclosing the antibody is used to reduce the dosage of the other HAE therapy e.g. at least 10, 20, 30, or 50% lower than would be used.
19. The method of claim 1, wherein the one or more prior HAE treatments terminate either before the first dose of the antibody – p. 43 paragraph 4 discloses that the time between administration of the one agent and another agent can be minutes, hours, days or weeks.
20. The method of claim 1, wherein the subject is a human patient who is free of prior HAE treatment i.e. no HAE symptoms at the time of the treatment. See p. 39 paragraph 3.
29. Chyung et al disclose the human patient free of an HAE treatment involving an angiotensin- converting enzyme (ACE) inhibitor, an estrogen-containing medication, or an androgen during the second treatment period. Chyung et al discloses administering maintenance dose of the same antibody during the second treatment period. See p. 41 paragraph 4.
Chyung et al discloses the subject is a human patient and does not make mention of children younger than 12 years of age as the human patient. To better address the age limitation of “12 years or older” who had experienced at least two HAE attacks per year prior to the first treatment period, “923 (Clinical Trial NCT02093923) is cited below.
“923 (Clinical Trial NCT02093923) disclose a method of treating HAE attack or reducing the rate of HAE attack comprising administering DX-2930 antibody to a human patient population of at least 18 years of age who has had 2 or more HAE attacks per year prior to first treatment with said antibody. See under participation criteria and the experimental drug being DX-2930 antibody. See Study plan section.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have practiced the method of Chyung et al in a human patient population of at least 18 years of age who has had 2 or more HAE attacks per year prior to the first treatment with said antibody, thus resulting in the instant invention with a reasonable expectation of success. The teaching, suggestion and motivation to do so is that Chyung et al practices the method of treating HAE attack or reducing the rate of HAE attack in human patients in need thereof and “923 (Clinical Trial NCT02093923) disclose a human patients in need thereof wherein the human patients at least 18 years of age who has had 2 or more HAE attacks per year prior to first treatment with said antibody. “923 (Clinical Trial NCT02093923) shows that the DX-2930 antibody can be administered to human patients at least 18 years of age who has had 2 or more HAE attacks per year prior to first treatment with said antibody. The study plan of “923 (Clinical Trial NCT02093923) disclose the primary purpose of administering the antibody to said patient population is for treatment.
Response to Applicant’s Argument
Applicants disagree with the fact that Chyung anticipates claim 1 because it discloses that a person with untreated HAE suffers from attacks every 1 or 2 weeks, pointing to paragraph 4 of page 36 and thus the human patient necessarily has at least two
HAE attacks per year prior to the first treatment period.
Applicant disagrees with this argument and states that the text that the Examiner is referring to states: "On average, untreated individuals have an attack every 1 to 2 weeks, and most episodes last for about 3 to 4 days. The frequency and duration of attacks vary greatly among people with hereditary angioedema, even among people in the same family."
Applicants argue that the Examiner appears to have ignored the fact that having an HAE attack every 1 to 2 weeks is only an average for untreated patients. This means that there will be patients whose HAE attack frequency will be longer than 2 weeks, and those patients will not anticipate the method of claim 1.
Applicants argument have been carefully considered but is not found persuasive.
Claim 1 recites “wherein the subject is a human patient who is 12 years or older who had experience at least two HAE attacks per year prior to the first treatment period”. If an untreated individual is having an attack every 1 to 2 weeks even as an average for untreated patients, it follows that on average said human patient necessarily has at least two HAE attacks per year. Furthermore, the combination of Chyung et al and “923 (Clinical Trial NCT02093923) disclose human patients at least 18 years of age who has had 2 or more HAE attacks per year prior to first treatment with said antibody.
Applicants argue that claim 1 has been amended to recite (ii) further administering the antibody to the subject for a second treatment period after (i) wherein in the second treatment period the antibody is administered in multiple doses of about 300 mg every two weeks or every four weeks.
Applicants argue that Chyung et al does not anticipate claim 1, clause (ii), because it discloses 0.1 to 3 mg/kg, which may be administered once every 1-4 weeks e.g. biweekly or month, for a suitable period of time, then followed up with monthly or bi-monthly maintenance treatment at same or lower dose and Chyung et al therefore only discloses administering an antibody in a second treatment period at the same or lower dose than the first treatment period.
Applicants argument has been carefully considered but is not found persuasive because the combination of Chyung et al and “923 (Clinical Trial NCT02093923) discloses the second dose can be higher than the first dose.
See Chyung et al disclosing “in some embodiments, the second dosage is higher than the first dosage”. See p. 2 2nd to last paragraph.
See Chyung et al disclosing “In some embodiments, the therapeutically or prophylactically effective amount of an antibody described herein (e.g., DX-2930) is 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 90 mg, 100 mg, 110 mg, 120 mg, 130 mg, 140 mg, 150 mg, 160 mg, 170 mg, 180 mg, 190 mg, 200 mg, 210 mg, 220 mg, 230 mg, 240 mg, 250 mg, 260 mg, 270 mg, 280 mg, 290 mg, 300 mg, 310 mg, 320 mg, 330 mg, 340 mg, 350 mg, 360 mg, 370 mg, 380 mg, 390 mg, or 400 mg”. See p. 32 last bridging paragraph to page 33 first paragraph.
See Chyung et al also disclosing in some embodiments, the antibody (e.g. DX-2930) is administered as a multiple doses such as once every 1-4 weeks e.g. biweekly or by monthly (e.g. every 28 days) administration.
Thus, the combination of Chyung et al and “923 (Clinical Trial NCT02093923) disclose administering multiple doses of 150 mg in the first treatment period and multiple doses of 300 mg for the second treatment period every two weeks (biweekly) or four weeks (28 days).
Claim(s) 1, 23 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chyung et al. WO 2015/112578 published 7/30/2015 and ClinicalTrials.gov Identifier: NCT02093923 hereinafter “923”. A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants. 16 Oct 2014. https://clinicaltrials.gov/ct2/show/NCT02093923 [last accessed 10 Sep 2025]. 5 pages. First posted 03-21-2014/last date posted 05-29-2014 cited in IDS as applied to claims 1-5, 7, 10-11, 14-17, 19-20, and 29 above further in view of Nixon et al. WO 2014/152232 9-25-2014 cited in IDS.
The combination of Chyung et al and “923 (Clinical Trial NCT02093923) is set forth above, but does not disclose the first treatment period is 26 weeks or longer and/or the second treatment period is 26 weeks or longer; and the second treatment period comprises one or more doses of the antibody at about 300mg, optionally wherein the second treatment period comprises multiple doses of the antibody at about 300 mg every two weeks.
Nixon et al disclose effective amounts of the antibody required to confer therapeutic effect on the subject, either alone or in combination with one or more other active agents. Nixon et al disclose effective amounts vary, as recognized by those skilled in the art, depending on the particular condition being treated, the severity of the condition, the individual patient parameters including age, physical condition, size, gender and weight, the duration of the treatment, the nature of concurrent therapy (if any), the specific route of administration and like factors within the knowledge and expertise of the health practitioner. Nixon et al disclose these factors are well known to those of ordinary skill in the art and can be addressed with no more than routine experimentation.
Nixon et al disclose for administration of the antibody herein, an initial candidate dosage can be about 2 mg/kg and a typical daily dosage might range from about any of 0.1 g/kg to 3 g/kg to 30 g/kg to 300 g/kg to 0 3 mg/kg, to 30 mg/kg to 100 mg/kg or more, depending on the factors mentioned above.
Nixon et al for repeated administrations over several days or longer, depending on the condition, the treatment is sustained until a desired suppression of symptoms occurs or until sufficient therapeutic levels are achieved to alleviate a disease or disorder associated with PKal, or a symptom thereof.
Nixon et al disclose an exemplary dosing regimen comprises administering an initial dose of about 2 mg/kg, followed by a weekly maintenance dose of about 1 mg/kg of the antibody, or followed by a maintenance dose of about 1 mg/kg every other week.
Nixon et al disclose other dosage regimens may be useful, depending on the pattern of pharmacokinetic decay that the practitioner wishes to achieve and for example, dosing from one-four times a week is contemplated.
Nixon et al disclose in some embodiments, dosing ranging from about 3 g/mg to about 2 mg/kg (such as about 3 μg/mg, about 10 μg/mg, about 30 μg/mg, about 100 μg/mg, about 300 μg/mg, about 1 mg/kg, and about 2 mg/kg) may be used.
Nixon et al disclose dosing frequency is once every week, every 2 weeks, every 4 weeks, every 5 weeks, every 6 weeks, every 7 weeks, every 8 weeks, every 9 weeks, or every 10 weeks; or once every month, every 2 months, or every 3 months, or longer and the progress of this therapy is easily monitored by conventional techniques and assays.
Nixon et al disclose for an adult patient of normal weight, doses ranging from about 0.3 to 5.00 mg/kg may be administered. Nixon et al disclose the particular dosage regimen, i.e., dose, timing and repetition, will depend on the particular individual and that individual's medical history, as well as the properties of the individual agents (such as the half-life of the agent, and other considerations well known in the art).
Nixon et al disclose the appropriate dosage of an anti-PKal antibody (DX2930) will depend on the specific antibody (or compositions thereof) employed, the type and severity of the disease/disorder, whether the antibody is administered for preventive or therapeutic purposes, previous therapy, the patient's clinical history and response to the antagonist, and the discretion of the attending physician. Nixon et al disclose typically the clinician will administer an anti-PKal antibody, until a dosage is reached that achieves the desired result.
See Nixon et al p.28-30.
Regarding claim 23, the first treatment period being 26 weeks or longer and/or the second treatment period being 26 weeks or longer, would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention in view of the teachings of Nixon et al. Nixon et al disclose the particular dosage regimen, i.e., dose, timing and repetition, will depend on the particular individual and that individual's medical history. Nixon et al disclose effective amounts vary, as recognized by those skilled in the art, depending on the particular condition being treated, the severity of the condition, the individual patient parameters including age, physical condition, size, gender and weight, the duration of the treatment, the nature of concurrent therapy (if any), the specific route of administration and like factors within the knowledge and expertise of the health practitioner. Nixon et al disclose these factors are well known to those of ordinary skill in the art and can be addressed with no more than routine experimentation. For these reasons, it would not have been inventive for the first treatment period being 26 weeks or longer and/or the second treatment period being 26 weeks or longer.
Thus, the combination of Chyung et al and “923 (Clinical Trial NCT02093923) and Nixon et al renders claim 23 prima facie obvious.
Regarding claim 27, the second treatment period comprising one or more doses of the antibody at about 300mg, optionally wherein the second treatment period comprises multiple doses of the antibody at about 300 mg every two weeks, would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention in view of the teachings of Nixon et al.
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); 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."). MPEP 2144.05.
Nixon et al disclose various effective concentrations of the antibody required to confer therapeutic effect on the subject and frequency of dosing, maintenance doses and that effective amounts vary, as recognized by those skilled in the art, depending on the particular condition being treated, the severity of the condition, the individual patient parameters including age, physical condition, size, gender and weight, the duration of the treatment, the nature of concurrent therapy (if any), the specific route of administration and like factors within the knowledge and expertise of the health practitioner. Nixon et al disclose these factors are well known to those of ordinary skill in the art and can be addressed with no more than routine experimentation.
Thus, one of ordinary skill in the art as of the effective filing date of the instant invention would have arrived at the claimed invention of claim 27 as a result of routine optimization based on the general conditions disclosed by the combination of Chyung et al and “923 (Clinical Trial NCT02093923) and Nixon et al and there would have been a reasonable expectation of success especially in view of the fact that Nixon et al disclose that the knowledge and expertise of the health practitioner and factors within the knowledge and expertise of the health practitioner are well known to those of ordinary skill in the art and can be addressed with no more than routine experimentation. For these reasons, it would not have been inventive for the second treatment period 26 weeks or longer to have treated with one or more doses of the antibody at about 300mg, optionally wherein the second treatment period comprises multiple doses of the antibody at about 300 mg every two weeks.
Thus, the combination of Chyung et al and “923 (Clinical Trial NCT02093923) and Nixon et al renders claim 27 prima facie obvious.
Response to Applicants’ Argument
Applicants argue that the deficiencies of Chyung not disclosing or suggesting that the subject is a human patient who is 12 years or older who had experienced at least two HAE attacks per year prior to the first treatment period is reiterated and Nixon does not remedy the deficiencies of Chyung because it does not disclose or suggest that the subject is a human patient who is 12 years or older who had experienced at least two HAE attacks per year prior to the first treatment period.
Applicants argument has been carefully considered but is not found persuasive. This is because as set forth above the combination of Chyung et al and “923 (Clinical Trial NCT02093923) and Nixon et al discloses or suggests a human patient who is 18 and who had experienced at least two HAE attacks per year prior to the first treatment period as explained above.
Claim(s) 1 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chyung et al. WO 2015/112578 published 7/30/2015 and ClinicalTrials.gov Identifier: NCT02093923 hereinafter “923”. A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants. 16 Oct 2014. https://clinicaltrials.gov/ct2/show/NCT02093923 [last accessed 10 Sep 2025]. 5 pages. First posted 03-21-2014/last date posted 05-29-2014 cited in IDS as applied to claims 1-5, 7, 10-11, 14-17, 19-20, and 29 above, further
in view of Fowler et al. US 10,316,095 6-11-2019, cited in IDS.
The combination of Chyung et al and “923 (NCT02093923) is set forth above but does not disclose the pharmaceutical composition comprising the antibody comprises sodium phosphate, citric acid, histidine, sodium chloride and polysorbate 80.
Fowler et al teach conventional formulations of a human antibody comprising at least one buffer selected from histidine about 10 mM to about 50 mM, citrate, phosphate, additional excipient that can be sodium chloride and further includes at least on surfactant where the surfactant tis polysorbate 80 (see claims 1, 9, 10, 12, 13 and 14) and disclosure of Sodium phosphate Dibasic Anhydrous, Sigma, C/N 59763 or equivalent and Sodium phosphate Monobasic Monohydrate, Sigma, C/N 59638 or equivalent in column 94 lines 3-6.
It would have been prima facie obvious to one having ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of the combination of Chyung et al and “923 (NCT02093923) by formulating the DX2930 antibody with buffers comprising sodium phosphate, citrate and histidine, sodium chloride and polysorbate 80 as taught by Fowler et al, thus resulting in the instant invention with a reasonable expectation of success. This is because Chyung et al teach that the pharmaceutical composition can be formulated with conventional excipients and Fowler et al teach conventional buffers, excipients and surfactants to add to such antibody formulations. As to concentrations of sodium phosphate, citrate and histidine, sodium chloride and polysorbate 80 in claim 9, "where 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).
Response to Applicants’ Argument
Applicants argue that the deficiencies of Chyung not disclosing or suggesting that the subject is a human patient who is 12 years or older who had experienced at least two HAE attacks per year prior to the first treatment period is reiterated and Nixon does not remedy the deficiencies of Chyung because it does not disclose or suggest that the subject is a human patient who is 12 years or older who had experienced at least two HAE attacks per year prior to the first treatment period.
Applicants argument has been carefully considered but is not found persuasive. This is because as set forth above the combination of Chyung et al and “923 (NCT02093923) and Fowler et al discloses or suggests a human patient who is 12 years or older who had experienced at least two HAE attacks per year prior to the first treatment period as explained above.
Status of Claims
Claims 1-5, 7-11, 14-17, 19-20, 23, 27 and 29 are rejected.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
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