DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-4 and 6-15 are pending upon entry of amendment filed on 4/1/26
3. Applicant’s IDS filed on 4/1/26 has been considered.
4. The following rejections remain.
5. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
6. Claims 1-4 and 6-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Pat. 11,084,884 (of record) in view of Chyung et al (Ann Allergy Asthma Immunology, vol. 113, p. 460-466, 2014, IDS reference, of record) and Frank et al (Pediatrics, vol.138(5):pp 1-11, 2016, of record) for the reason set forth in the office action mailed on 10/3/25.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘884 patent recites method of treating HAE with antibody set forth in SEQ ID NO:1-10. The antibody concentration is 300-400mg at every 2-4 weeks and reducing of dose where the reduction is required upon monitoring.
The claims of the ‘884 differs from the instant claimed invention in that it does not teach the use of pharmaceutical compositions comprising histidine, phosphate, citric acid, NaCl and polysorbate as in claims 11-12 of the instant application and pediatric patient populations and the body weight of less than 35 kg as in claims 3-5 of the instant application, respectively.
Chyung et al teach use of 30mM of phosphate buffer, 19mM of citric acid, 50mM histidine, 90mM of NaCl, 0.01% polysorbate at pH 6 in clinical trials in phase I of HAE in healthy patient for safety (p. 463-464). DX2930 is potently and specifically inhibit plasma kallikrein and available as a validated drug target for HAE. Chyung et al. further teach that there is a need for long term prophylaxis.
Likewise, Frank et al. teach that HAE is a potentially life-threatening inherited disease with onset at childhood. Frank et al. teach that the treatment of the disease at early age is critical and there is need for approved medication for children (p. 1-5).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize teachings of the Chyung and Frank references into the treatment method taught by the ‘884 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the clinically important formulation is already known and there is a need for treatment regimen for children as the treatment is more critical at earlier onset and the disease is being more severe (p. 2).
Applicant’s response filed on 4/1/26 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references does not teach currently amended claims in which recites monitoring swelling in the subject’s arms, legs, lips, eyes tongue and/or throat. Applicant has further asserted that the claims of the ‘884 patent may require reduction of antibody dose and the currently amended claims are limited to pediatric patient. No reduction of dose or low body weight is taught by the ‘884 patent nor combination of the references.
Unlike Applicant’s assertion in that the combination of the cited references does not teach the currently amended limitation, Applicant is reminded that HAE by definition is autosomal self-limited attacks of subcutaneous or submucosal edema affecting face, larynx, gastrointestinal tract, limbs or genitalia (note Chyung reference, p. 460) and monitoring of subject of occurrence of HAE is performed (note p. 461). As such, monitoring swelling achieved after administering and meets the currently amended claims.
Further, as previously discussed, the patient group hereditary angioedema attack (HAE) is pediatric that is less than 18 years of age. Unless specified, the age groups of 1-18 years is expected to encompass “low body weight”. Regardless, Frank et al discloses the average onset of HAE is about 11 year (p.1) and this would encompass less than 35 kg as in claim 4.
As Applicant acknowledges, the claims of the ‘884 patent suggests the reduction of antibody dose. Applicant is reminded that the monitoring the subject may read on assessment of the biomarker level as it gives profiles of patient characteristics. Claims recite administering 300mg every weeks or every four weeks. Further, it is noted reduction of dose or termination of treatment is required upon monitoring the creatine phosphatase level in claims 8-10 of the ‘884 patent.
Applicant has asserted that claims 9-10 of the ‘884 patent recites monitoring creatine phosphokinase and reduction or termination of treatment upon elevation of the level to differentiate the claimed method is distinct from the ‘884 patent.
Applicant is reminded that claim 1 of the ‘884 patent does not require monitoring and the monitoring of the claim 1 of the instant application is readable upon the limitation.
IN addition, the instant claims recite about 300mg for about 2 weeks to reducing to four weeks. However, the ‘884 patent recites 300mg or 400mg for every two weeks in claims 1, 4 or 5 and claim 10 recites reducing of dose till termination that is readable upon reducing. IN light of claims of the ‘884 patent, both methods encompass administering 300mg of the antibody every two weeks and tapering the dose after the first treatment time. Further, Chyung and Frank references cure the deficiency.
Additionally, the Chyung reference teaches pharmacokinetics indicate long-term ½ life or long-lasting kallikrein activities was retained for 28 days (p. 464-465). As such, the DX-2930 was available in serum for 28 days and in light of teaching of reduction of dose in the ‘884 patent, the idea of tapering off (e.g. in second treatment as currently amended) is suggested in combination of the references.
Under KSR, the rationale to support a conclusion that the claims would have been obvious to try combination of biweekly and monthly administrations in course of regiment to reducing the dose when biweekly administration or monthly administration is equally effective as in claim 1. Further, Fig 2 discloses multiple doses till 168th day readable upon 4-8 months. The deficiency in formulation or including pediatric patients is cured by the secondary references and the rejection is maintained.
Further in light of the discussion above in section 5 of this office action, the monitoring step whether a blood test is required or not, the currently amended claims do not exclude CPK level analysis, the statements in the declaration are not commensurate with the scope of the claimed invention. Thus, the rejection is maintained.
7. Claims 1-4 and 6-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Pat. 11,286,307 in view of Frank et al (Pediatrics, vol.138(5):pp 1-11, 2016) for the reasons set forth in the office action mailed on 10/3/25.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘307 patent recites method of treating HAE with antibody set forth in SEQ ID NO:1-10. The antibody concentration is 300-400mg at every 2-4 weeks and reducing of dose where the reduction is required upon monitoring. The ‘307 patent recites excipient concentrations required by the instant claims.
The claims of the ‘307 differs from the instant claimed invention pediatric patient populations and the body weight of less than 35 kg as in claims 3-5 of the instant application.
Frank et al. teach that HAE is a potentially life-threatening inherited disease with onset at childhood. Frank et al. teach that the treatment of the disease at early age is critical and there is need for approved medication for children (p. 1-5).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize teachings of the Frank reference into the treatment method taught by the ‘307 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because there is a need for treatment regimen for children as the treatment is more critical at earlier onset and the disease is being more severe (p. 2).
Applicant’s response filed on 4/1/26 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references does not teach currently amended claims in which recites monitoring swelling in the subject’s arms, legs, lips, eyes tongue and/or throat. Applicant has further asserted that the claims of the ‘307 patent fail to teach currently amended claimed method of second treatment. The skilled person would have no motivation to modify the administration method of the ‘307 patent or the currently amended limitations of “low body weight”.
Unlike Applicant’s assertion in that the combination of the references does not teach the currently amended limitation, Applicant is reminded that HAE by definition is skin swelling, severe abdominal pain and upper airway swelling (note Frank reference, abstract) and monitoring of subject of occurrence of HAE is performed (note p. 2). As such, monitoring swelling achieved after administering and meets the currently amended claims.
As previously discussed, the claims of the ‘307 patent recites multiple doses of 300mg biweekly in claims 1-2 for 26weeks of longer (claim 17) reads on 6 months (e.g. long term) and tapering of the dose for one or more treatments for 2-4 weeks (claims 13-15). Therefore, the claims of the ‘307 patent construed as multiple dosages of 300mg biweekly administrations for 6 months and additional tapering periods for monthly administrations of 300mg (claims 13-16) readable upon claim 1 of the instant application with DX2930. Further in light of the discussion above in section 6 of the office action, the combination of the references remains obvious.
Note claims 17-18 of the ‘307 patent recites “first HAE treatment” which constitutes 26 week treatment and the tapering off (e.g. reduction) follows after the first treatment reads on the claimed second treatment meeting the limitations of the currently amended claims. The multiple administrations of 300mg biweekly for 4-9 months and reducing of administration of 300mg every four weeks as required by the claims of the instant application that reads on long term treatments. The rejection is maintained.
8. The following new ground of rejection is necessitated by Applicants’ amendment filed on 4/1/26.
9. 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.
10. Claims 1-4 and 6-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
The specification or the original claims as filed does not provide a written description the phrases “subject reported monitoring of swelling in the subject’s arms, legs, lips, eyes, tongue and/or throat”. Applicants assert that no new matter has been added. However, the specification or the original claims does not support for such limitations.
The currently amended range is not supported by the original claims or instant specification.
The instant claims now recite a limitation which was not clearly disclosed in the specification as filed, and now changes the scope of instant disclosure as filed.
Such limitations recited in the present claims, which did not appear in the specification as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C.112.
11. No claims are allowable.
12. 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached on Mon-Fri 8:30-5. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
June 2, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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