DETAILED ACTION
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 .
Response to Amendment
The rejections of claims 15 and 16 are moot in view of the cancelation of the claims.
The rejection of claims 8-12 and 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of i) the amendment to claims 8-11 and 14 deleting “to be” before “administered”, ii) Applicant’s argument for claim 10 that “a dose which comprise two unit doses of 150 mg” means “a dose” comprises a 300 mg dose obtained from a 150 mg dose administered two times, and iii) the amendment to claims 12 and 14 deleting “e.g.”.
The rejection of claims 1-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for lacking enablement is withdrawn in view of the amendment to independent claim 1 deleting reference to “preventing” Sjögren’s syndrome (SS) and specifying treatment is of SS in a human subject, which would reasonably have been interpreted by the skilled artisan at the time of the invention to mean that the subject has SS, and in view of the cancelation of claims 2-3, the limitations of which have been incorporated into claim 1.
The rejection of claim(s) 1-4, 7, 11 under 35 U.S.C. 102(a)(1) as being anticipated by Dörner et al. (Ann. Rheum. Dis. 2019 May;78(5):641-647, Epub 2019 Mar 2, cited in the IDS filed 7/8/2022) and, separately, of claims 1, 2 and 15 by Doerner et al. (ACR/ARHP Ann. Meeting., Sept, 2016, 124-131, Arthritis Rheumatol. 2016; 68 (suppl 10): Abstr 3033, cited in the IDS filed 1/22/24) are withdrawn in view of the amendment to claim 1 reciting a different route of administration (subcutaneously, s.c.) than the prior art (intravenously, i.v.), and the cancelation of claims 2-3, the limitations of which have been incorporated into claim 1.
The rejection of claim(s) 1 and 2 under 35 U.S.C. 102(a)(1) as being anticipated by ClinicalTrials.gov Database, NCT02962895, ver. 6: 2018-05-30, https://clinicaltrials.gov/study/NCT02962895?cond=sjogren%27s%20syndrome&intr=ianalumab&viewType=Table&rank=3&tab=history&a=6#version-content-panel) is withdrawn in view of the amendment to claim 1 reciting both a route of administration which is s.c. and dosage range, and the cancelation of claims 2-3, the limitations of which have been incorporated into claim 1.
The rejection of claim(s) 1 and 4-12 under 35 U.S.C. 102(a)(1) as being anticipated by US 9,340,620 B2 (‘620) in light of Nair et al. (J. Basic Clin. Pharm. 7(2):27–31, Mar. 2016) and admitted by Applicant in the specification (p. 31, start of second paragraph) is withdrawn in view of Applicant’s argument that disclosure of routes of administration is sufficiently broad in ‘620 so as not to anticipate a subcutaneous route in particular as claimed. However, a new rejection appears below.
The rejection of claim(s) 1 and 11-14 under 35 U.S.C. 103 as being unpatentable over US 9,340,620 B2 (‘620) as applied to claims 1, 11 and 16 above, and further in view of Almagro et al., (Reumatol. Clin. 11(1):41-44, 2015) is withdrawn in favor of the new rejection below. It is noted that Applicant argues (p. 8 of Remarks, last paragraph) that because claim 1 now incorporates the limitations of claims 2 and 3, the rejection is moot. However, the Examiner had incorrectly omitted claims that should have been rejected under 35 USC 103. Because of the new rejection, the argument is moot.
Drawings
The replacement drawings were received on 09/23/2025. These drawings are accepted.
Claim Interpretation
In view of Applicant’s arguments in the middle of p. 6 of the Remarks filed 9/23/2025, concerning claim 10, “a dose which comprise two unit doses of 150 mg” is interpreted to mean in this context that “a dose” comprises 300 mg ianalumab, which is two unit doses of 150 mg ianalumab.
In view of the amendment to independent claim 1 so that it is now drawn to “A method of treating Sjögren’s syndrome in a human subject…”, the claim is being interpreted as meaning the human subject being treated has Sjögren’s syndrome, i.e., the method does not include delaying the onset of or reducing the predisposition toward development of SS in a human who does not have SS.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Because claim 1, upon which claim 8 depends, has been amended to recite administering is subcutaneously, now claim 8, which limits administration to subcutaneous does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 5, 8, 9 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bowman et al. (Arthritis Rheumatol., (October 2019, available online 29 Oct. 2019) Vol. 71, Supp. Supplement 10, pp. 5265-5266, Abstract: L19, cited in the IDS filed 7/8/2022).
Bowman et al. teaches (Methods) treatment of Sjögren’s syndrome (SS) by monthly subcutaneous (s.c.) administration of VAY736 in a dose of 5 mg, 50 mg or 300 mg to human patients. Patients were also given a premedication dose of methylprednisone. VAY736 is also known as ianalumab (Background/Purpose). The 300 mg dose of VAY736 showed significant clinical improvement over placebo (Conclusion and Results).
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.
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 and 4-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 9,340,620 B2 (‘620) in view of Almagro et al., (Reumatol. Clin. 11(1):41-44, 2015) and Morais et al. (Ther. Adv. Musculoskelet. Dis. 7(4):122-151 (Aug. 2015)) and in light of Nair et al. (J. Basic Clin. Pharm. 7(2):27–31, Mar. 2016).
‘620 teaches in claim 1 a method of treating an autoimmune disease by administering the subject an antibody that binds BAFF-R, which may have the heavy and light chain CDR sequences set forth in claim 1. The antibody is MOR6654, with version MOR6654B produced in an afucosylated form (col. 51, lines 4-6). Claim 2 specifies the autoimmune disease to be treated is selected from rheumatoid arthritis, systemic lupus erythematosus, Sjogren's Syndrome, multiple sclerosis and pemphigus vulgaris. Claim 3 designates the subject being treated as “human”. The antibody is in a dosage within the range of 1-10 mg/kg, including 1, 3 or 5 mg/kg, with treatment every 1, 2, 3 or 4 weeks or monthly (col. 36, lines 27-32). “Dosage regimens are adjusted to provide the optimum desired response (e.g., a therapeutic response).” (col. 36, lines 5-6) Administration may be intravenous or subcutaneous injection (col. 35, lines 44-46). The antibody may be in combination with an immunosuppressive agent such as a corticosteroid (col. 39, line 55, through col. 40, line 4).
Almagro et al. teaches (p. 42, col. 1, toward end of first paragraph) treatment of a symptom of Sjögren’s syndrome (SS), myelitis transverse, with 50 mg/day oral prednisone. The treatment in combination with azathioprine resulted in progressive increase in visual acuity, sphincter control, muscle balance and the ability to walk without support.
Morias et al. teach that BAFF receptor (BAFFR) binds both membrane-bound (mb) and soluble BAFF (Fig. 1). Three BAFF inhibitors have been used therapeutically (Fig. 1 legend): Belimumab is an anti-BAFF antibody that binds only soluble BAFF. Tabalumab is a monoclonal antibody that binds soluble and mbBAFF. Blisibimod is a fusion protein comprising four BAFF-binding domains fused to an immunoglobulin Fc fragment. A BAFF transgenic mouse develops systemic lupus erythematosus (SLE)/ Sjögren’s syndrome (SS) like syndrome, and SLE-prone mice generally have increased BAFF serum levels, while blockade of BAFF reduces disease symptoms (p. 123, col. 2, fourth paragraph). Many clinical trials for treatment of an autoimmune disease with a BAFF inhibitor are discussed, some of which administer the therapeutic intravenously and other subcutaneously (see Tables 1-4, and, e.g., p. 142, col. 1, first full paragraph). For example, patients with SLE were treated with a 120 mg unit dose every 2 weeks of tabalumab. Biological activity was observed and was consistent with inhibition of the BAFF pathway (p. 139, col. 2, first paragraph). Blisibimod administered subcutaneously to SLE patients showed biological activity at a dose of 200 mg/wk (paragraph bridging pp. 139-140). “Mice transgenic for BAFF develop clinical features resembling SS…” (p. 143, col. 1, second paragraph) Clinical trials showed 63% of patients with primary SS treated with belimumab reached the primary endpoint (p. 143, col. 2 first paragraph). The discussion of SS ends with (p. 143, col. 2, second paragraph), “Although these studies involved a relatively few patients, given the importance of B-cell abnormalities seen in pSS, BAFF blockade seems to be a promising therapy, justifying the realization of RCTs of belimumab and other anti-BAFF drugs in patients with pSS.”
Nair et al. teach the average weight of a human is 60 kg (Table 1). Therefore, a 1 mg/kg dose is about 60mg, a 3 mg/kg dose is 180 mg and a 5 mg/kg is 300 mg antibody.
It would have been obvious to the artisan of ordinary skill before the effective filing date of the instant application to have treated SS with an antibody that blocked the BAFF/BAFFR signaling pathway as suggested by Morais et al., including with ianalumab as taught by ‘620. It would have been obvious wherein the antibody was administered i.v. or s.c. as suggested by ‘620 and because Morais showed that anti-BAFF antibodies had been administered by both routes and shown efficacy. It would have been obvious wherein the dose administered was between about 50 and 300 mg, more particularly about 150 to 300 mg as taught by ‘620 (about 3 mg/kg and 5 mg/kg) in light of Nair et al. and recognizing that there is some weight variation between humans. It would have been obvious wherein the administration was monthly or twice monthly or every two weeks as suggested by ‘620 to obtain the most beneficial dose. As ‘620 says (col. 36, lines 5-6), “Dosage regimens are adjusted to provide the optimum desired response (e.g., a therapeutic response).” It further would have been obvious wherein the SS subject treated with MOR6654B was also treated with a corticosteroid, including wherein the corticosteroid was prednisone administered in a dose of about 50 mg orally because this dose of prednisone was shown to effectively help treat symptoms of SS as taught by Almagro et al.
Prior Art
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure.
US 10,556,009 B2 teaches formulations for subcutaneous administration of antibody belimumab (an anti-BLys antibody) in a concentration of 200 mg/ml (col. 22, lines 23-31). It is taught as useful for treatment of autoimmune diseases, including SS (col. 13, lines 2-10). It is stated that compared to intravenous administration (col. 1, lines 23-32), “Alternative administration pathways are subcutaneous or intramuscular injection, which offer potential advantages in terms of patient compliance and ease of administration.” BLys is also known as BAFF (see Morais et al., supra, p. 122, col. 2, last paragraph). US 10,556,009 is cumulative with Morais et al. above for teaching belimumab and support for its subcutaneous administration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Kaufman, whose telephone number is (571) 272-0873. Examiner Kaufman can generally be reached Monday through Friday 7am-3:30pm, Eastern Time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached at (571) 272-0857.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
Official papers filed by fax should be directed to (571) 273-8300. NOTE: If applicant does submit a paper by fax, the original signed copy should be retained by the applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
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 .
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Claire Kaufman
/Claire Kaufman/
Primary Examiner, Art Unit 1674
November 19, 2025