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 .
Election/Restrictions
Applicant's reply to the Restriction Requirement, dated April 23, 2026, has been received. By way of this reply, Applicant has elected, without traverse, the species of juvenile myasthenia gravis, anti-acetylcholine receptors (AChRs) serum autoantibodies, and MG-ADL score.
Claims 1-21 and 27-28 are pending in the application. Claims 2, 4, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 23, 2026.
Claims 1, 3, 5-18, 20-21, and 27-28 are therefore under examination before the Office.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5-18, 20-21, and 27-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 16, 17, 18, and 19 recite nested numerical ranges, in which narrower ranges fall within broader ranges within the same claim. This creates ambiguity as to the intended scope of the claim, as it is not clear which of these ranges is intended to be the proper limit of the range. MPEP 2173.05(c).
For the purposes of claim construction, the broadest of the recited ranges is interpreted as the intended limit of these claims.
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.
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.
Claims 1, 3, 5-9, 11-13, 15-18, 20-21, and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kehry (US20180016334A1) in view of O'Connell (Front Neurol. 2020 Jul 24:11:743, cited in IDS).
Kehry teaches an anti-FcRn antibody with a light chain variable region labeled SEQ ID NO: 19, which is 100% identical to that of Applicant's SEQ ID NO: 1 and 9, and a heavy chain variable region labeled SEQ ID NO: 24, which is 100% identical to that of Applicant's SEQ ID NO: 2 and 10 (claim 22).
Kehry further teaches that this antibody is useful in treating myasthenia gravis (para. 0140, 0142, and claim 51).
Kehry further teaches dosages of 1-50 mg/kg, intravenous or subcutaneous administration, and multiple week dose regimens (para. 0138), which is pertinent to claims 1, 9, 11-13, and 27-28. Kehry further teaches that the dosage depends on factors including the route of administration, the disease to be treated, and physical characteristics, e.g., age, weight, general health, of the subject, and that the dosage may be adapted by the physician in accordance with conventional factors such as the extent of the disease and different parameters of the subject (para. 0137).
Kehry further teaches that administration of this antibody reduces serum IgG (para. 0122). Kehry further teaches that the serum IgG may be IgG1 (para. 0062), which is pertinent to claim 15.
Kehry further teaches that administration of the above antibody does not decrease serum albumin levels (para. 0118 and 0153), which is pertinent to claim 16.
Kehry further teaches that administration of the above antibody reduces serum autoantibodies (para. 0139), which is pertinent to claim 17.
While Kehry does not explicitly teach that the above antibody reduces serum IgG in the patient by at least 20%, reduces anti-AChR antibodies by at least 25%, changes MG-ADL score, or does not significantly increase levels of total cholesterol, HDL, calculated LDL, and triglycerides, these results appear to be natural properties of performing the claimed method. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d. The instantly claimed active method steps are identical to the method steps taught by Kehry and would therefore elicit identical functional properties whenever performed. In other words, the effects on serum IgG anti-AChR antibodies, MG-ADL score, and cholesterol is a natural result of the prior art. Therefore, the method performed by Kehry inherently anticipates these claims.
However, Kehry does not teach juvenile myasthenia gravis.
O'Connell teaches that treatment for juvenile myasthenia gravis is based upon treatment for adult myasthenia gravis (page 1: "Current practice is taken from treatment guidelines for adult MG...").
O'Connell further teaches that patients with juvenile myasthenia gravis possess autoantibodies for acetylcholine receptors (AChRs) (page 3, right column, second paragraph).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Kehry and O'Connell to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Kehry and O'Connell are concerned with treatments for myasthenia gravis. As Kehry teaches, anti-FcRn antibodies such as those instantly claimed were known to be useful in the treatment of myasthenia gravis. O'Connell teaches that treatment for juvenile myasthenia gravis is based upon treatment for adult myasthenia gravis, and juvenile patients have similar features such as the presence of anti-AChR antibodies. One of ordinary skill in the art could apply the method of Kehry to the patient population of O'Connell by known methods, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kehry and O’Connell as applied to claim 1 above, and further in view of Bishop (US20100209434A1).
The teachings of Kehry and O'Connell have been discussed supra. Kehry also teaches that the antibody may be administered as a pharmaceutical composition, comprising the antibody in a therapeutically effective dose amount and one or more pharmaceutically acceptable carriers or excipients (para. 0047-0048). However, Kehry and O'Connell do not teach the claimed pharmaceutical composition.
Bishop teaches the use of common excipients and/or additives such as buffering agents, saccharides, salts and surfactants for use in an antibody formulation. These agents include phosphate, trehalose, polysorbate 80, and sodium chloride (para. 0079-0080). Bishop also teaches concentrations of buffering agents of about 25 millimolar (para. 0087), concentrations of trehalose of 1-40% (para. 0101), and concentrations of polysorbate 80 of about 0.001% to about least about 0.1% (para. 0109).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Kehry, O'Connell, and Bishop to arrive at the claimed invention. As stated above, methods of treating juvenile myasthenia gravis with anti-FcRn antibodies was known in the art, according to the teachings of Kehry and O'Connell. Antibody formulations and suitable parameters for such were taught by Bishop. It would have been obvious to a person of ordinary skill in the art at the time the invention was made to select the recited carriers, excipients, and stabilizers of Bishop and adjust their concentrations as needed to produce a stable pharmaceutical formulation for the anti-FcRn antibody of Kehry. One of ordinary skill in the art at the time the invention was made would have been motivated to do so, in view of the art-recognized need to optimize formulations of therapeutic antibodies, and have a reasonable expectation of success, based on the knowledge and skill in the art and in view of the routine nature of the experimentation involved.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kehry and O’Connell as applied to claim 1 above, and further in view of Brock (WO2020079086A1).
The teachings of Kehry and O'Connell have been discussed supra. However, Kehry and O'Connell do not teach the claimed infusion times.
Brock teaches that anti-FcRn antibodies are useful in treatment of myasthenia gravis (page 3, lines 22-24).
Brock further teaches that this antibody is administered by subcutaneous infusion over 30 minutes (page 47, lines 35-37).
Brock also teaches that this treatment may reduce IgG serum levels and/or anti-AChR antibody serum levels by 50% compared to baseline (page 38, lines 13-15), and improves MG-ADL score (Figure 3).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Kehry, O'Connell, and Brock to arrive at the claimed invention. Kehry and Brock are both concerned with the use of anti-FcRn antibodies for myasthenia gravis, with Kehry specifying the claimed antibody. Brock teaches that said antibody may be infused over 30 minutes, which is within the claimed ranges. One of ordinary skill in the art could apply the infusion of Brock to the method of Kerry and O'Connell by known methods, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5-18, 20-21, and 27-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the listed U.S. patents and patent publications in view of Kehry, O’Connell, Bishop, and Brock:
Conflicting patents/ Conflicting
Patent applications Claims
10,676,526 1-2, 10
11,732,047 1-5, 20, 22
12,528,867 1
17/260,318 1-7, 12-18, 23
17/519,811 1-2, 4-6, 10-11, 13-16, 19, 21-23
17/597,928 88, 93, 98, 100, 102-103, 105-107
18/351,827 1-2
By means of example, the '526 patent claims an antibody with identical sequences to those of the instant claims (claims 1-2).
However, the '526 patent does not claim a method of treating pediatric myasthenia gravis.
Kehry teaches an anti-FcRn antibody with a light chain variable region labeled SEQ ID NO: 19, which is 100% identical to that of Applicant's SEQ ID NO: 1 and 9, and a heavy chain variable region labeled SEQ ID NO: 24, which is 100% identical to that of Applicant's SEQ ID NO: 2 and 10 (claim 22).
Kehry further teaches that this antibody is useful in treating myasthenia gravis (para. 0140, 0142, and claim 51).
Kehry further teaches dosages of 1-50 mg/kg, intravenous or subcutaneous administration, and multiple week dose regimens (para. 0138), which is pertinent to claims 1, 9, 11-13, and 27-28. Kehry further teaches that the dosage depends on factors including the route of administration, the disease to be treated, and physical characteristics, e.g., age, weight, general health, of the subject, and that the dosage may be adapted by the physician in accordance with conventional factors such as the extent of the disease and different parameters of the subject (para. 0137).
Kehry further teaches that administration of this antibody reduces serum IgG (para. 0122). Kehry further teaches that the serum IgG may be IgG1 (para. 0062), which is pertinent to claim 15.
Kehry further teaches that administration of the above antibody does not decrease serum albumin levels (para. 0118 and 0153), which is pertinent to claim 16.
Kehry further teaches that administration of the above antibody reduces serum autoantibodies (para. 0139), which is pertinent to claim 17.
While Kehry does not explicitly teach that the above antibody reduces serum IgG in the patient by at least 20%, reduces anti-AChR antibodies by at least 25%, changes MG-ADL score, or does not significantly increase levels of total cholesterol, HDL, calculated LDL, and triglycerides, these results appear to be natural properties of performing the claimed method. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d. The instantly claimed active method steps are identical to the method steps taught by Kehry and would therefore elicit identical functional properties whenever performed. In other words, the effects on serum IgG anti-AChR antibodies, MG-ADL score, and cholesterol is a natural result of the prior art. Therefore, the method performed by Kehry inherently anticipates these claims.
O'Connell teaches that treatment for juvenile myasthenia gravis is based upon treatment for adult myasthenia gravis (page 1: "Current practice is taken from treatment guidelines for adult MG...").
O'Connell further teaches that patients with juvenile myasthenia gravis possess autoantibodies for acetylcholine receptors (AChRs) (page 3, right column, second paragraph).
Bishop teaches the use of common excipients and/or additives such as buffering agents, saccharides, salts and surfactants for use in an antibody formulation. These agents include phosphate, trehalose, polysorbate 80, and sodium chloride (para. 0079-0080). Bishop also teaches concentrations of buffering agents of about 25 millimolar (para. 0087), concentrations of trehalose of 1-40% (para. 0101), and concentrations of polysorbate 80 of about 0.001% to about least about 0.1% (para. 0109).
Brock teaches that anti-FcRn antibodies are useful in treatment of myasthenia gravis (page 3, lines 22-24).
Brock further teaches that this antibody is administered by subcutaneous infusion over 30 minutes (page 47, lines 35-37).
Brock also teaches that this treatment may reduce IgG serum levels and/or anti-AChR antibody serum levels by 50% compared to baseline (page 38, lines 13-15), and improves MG-ADL score (Figure 3).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the '526 patent with teachings of Kehry, O'Connell, Bishop, and Brock to arrive at the claimed invention. The instantly claimed anti-FcRn antibody is also claimed by the '526 patent. As Kehry teaches, this antibody was known to be useful in the treatment of myasthenia gravis. O'Connell teaches that treatment for juvenile myasthenia gravis is based upon treatment for adult myasthenia gravis, and juvenile patients have similar features such as the presence of anti-AChR antibodies. One of ordinary skill in the art could apply the antibody claimed by the '526 patent to the method of Kehry and the patient population of O'Connell by known methods, with each component of the combination performing its known, usual function, and the combination would yield nothing more than predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Williams (WO2020023310A1) teaches that the anti-FcRn antibody M281 is useful in treating autoimmune diseases (page 1, lines 12-14). Williams further teaches that the disease may be neonatal myasthenia gravis (page 13, line 23).
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER JOHANSEN/Examiner, Art Unit 1644
Prosecution Insights