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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/26/25 has been entered.
Claims 1, 6, 17 and 19 have been amended. Claims 12-13, 18, 21-22, 24-26, 28 and 30-59 have been cancelled. Claims 1-11, 14-17, 19-20, 23, 27 and 29 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement filed 11/26/25 has been considered and an initialed copy is enclosed.
Allowable Subject Matter
The indicated allowability of claims 23 and 27 is withdrawn in view of the new rejections set forth below.
Claim Rejections Withdrawn
The rejection of claim 6, 17, 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment to the claims.
The rejection of claim 6 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 1-7, 10-11, 14-17, 19-20, and 29 under 35 U.S.C. 35 U.S.C. 102(a)(2) as being anticipated by Chyung et al. WO 2015/112578 published 7/30/2015 and filed 1/21/15 is withdrawn in view of Applicants statement that Application No. 17/672,748 and WO 2015/112578 were, not later than the effective filing date of the claimed invention in Application No. 17/672,748, owned by Dyax Corporation.
The rejection of claim(s) 1-11, 14-17, 19-20, and 29 under 35 U.S.C. 102(a)(2) as being anticipated by Chyung et al. WO 2016/1690926 with priority to 62/140,289 (‘289) filed 3/30/15 is withdrawn in view of Applicants statement that Application No. 17/672,748 and WO 2016/1690926 were, not later than the effective filing date of the claimed invention in Application No. 17/672,748, owned by Dyax Corporation.
The rejection of claims 1-3, 7-11, 20 and 29 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 13 of copending Application No. 17/792,299 (‘299) is withdrawn in view of the amendment to the claims to recite that the human patient is 12 years or older.
Claim Rejections Maintained
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-7, 10-11, 14-17, 19-20, and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chyung et al. WO 2015/112578 published 7/30/2015.
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 at a same or lower dose;
wherein 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.
6. The method of claim 1, wherein the antibody is administered in multiple doses of about 300 mg every two weeks or every four weeks.
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.
Response to Applicant’s Argument
Applicant states in the reply that it appears that the rejection under 35 USC 102(a)(1) was included in error since no basis is provided for it in the Office Action.
Applicant’s argument is not found persuasive. The claims were rejected under both 35 USC 102(a)(1) and 35 USC 102(a)(2). The Office action provided the basis for the rejection for both 35 USC 102(a)(1) and 35 USC 102(a)(2) by citing the appropriate paragraphs that formed the basis for the rejection. See page 4 of the Office Action quoting both paragraph (a)(1) and (a)(2) of 35 USC 102.
Applicants reply has overcome the rejection under 35 USC 102(a)(2) but has not overcome the rejection under 35 USC 102(a)(1). Chyung et al. WO 2015/112578 was published 7/30/2015 which is before the effective filing date of the claimed invention.
Claim Rejections Based on Amendment
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
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 as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention 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.
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 in view of Nixon et al. WO 2014/152232 9-25-2014 cited in IDS.
Chyung et al 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.
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 Chyung et al 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.
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 in view of Fowler et al. US 10,316,095 6-11-2019, cited in IDS..
Chyung 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)
It would have been prima facie obvious to one having ordinary skill in the art as of the effective filing to formulate the DX2930 antibody with buffers comprising phosphate, citrate and histidine, sodium chloride and polysorbate 80, 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 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).
Claim(s) 1-7, 10, 11, 20, 23, 27 and 29 is/are rejected 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.
“923 disclose as follows:
1, 3: 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 at least 18 years of age in need thereof an DX-2930 antibody twice, two weeks apart 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); and
(ii) further administering the antibody to the subject for a second treatment period after the first dose i.e. the DX-2930 is administered twice, two weeks apart.
wherein the subject is a human patient who had experienced ≥2 HAE attacks per year prior to the first treatment period. See under inclusion criteria.
2. 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). The instant specification discloses that DX-2930 is a full length antibody.
4-5. The instant specification and “923 discloses that DX-2930 is an IgG1 molecule.
7. The DX-2930 antibody necessarily formulated as a pharmaceutical composition and would necessarily comprise a pharmaceutically acceptable carrier.
10. “923 disclose the antibody is administered subcutaneously. See brief summary under study description.
11. The “923 disclose 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 under inclusion criteria
20. The “923 disclose the subject is a human patient who is free of prior HAE treatment. See exclusion criteria.
29. The “923 disclose the human patient free of long term prophylaxis for HAE. See exclusion criteria.
The ‘923 claims does not disclose the DX-2930 antibody is administered at multiple doses of about 150 mg in a first treatment period.
Nixon et al teaches the DX2930 anti-PKal antibody which is disclosed as being used for treating HAE. See p. 1 under summary of the invention, p. 5, p. 16-17 and p. 27 line 3.
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 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 1, administering to the subject in need thereof the DX2930 antibody at multiple doses of about 150 mg in a first treatment period and further administering the antibody to the subject for a second treatment period 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.
Regarding claim 6, administering to the subject in the second treatment period the DX2930 antibody in multiple doses of about 300 mg every two weeks or every four 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.
Regarding claim 23, the first treatment period being 26 weeks or longer and/or the second treatment period being 26 weeks or longer, 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 in view of the teachings of Nixon et al.
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, 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 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, 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 as a result of routine optimization based on the general conditions disclosed by 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 that affect dosage regimens are well known to those of ordinary skill in the art and can be addressed with no more than routine experimentation.
Claim(s) 8 and 9 is/are rejected 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.
The combination of 923 and Nixon is set forth above but does not disclose the pharmaceutical composition comprises sodium phosphate, citric acid, histidine, sodium chloride and polysorbate 60.
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.
It would have been prima facie obvious to one having ordinary skill in the art at as of the effective filing date of the instant invention to formulate the DX2930 antibody with buffers comprising phosphate, citrate, histidine, sodium chloride and polysorbate 80, thus resulting in the instant invention with a reasonable expectation of success. This is because Nixon et al teach that the pharmaceutical composition can be formulated as conventional in the art and Fowler et al teach conventional buffers, excipients and surfactants to add to such antibody formulations. As to 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).
Status of Claims
Claims 1-11, 14-17, 19-20, 23, 27 and 29 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645