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. The Art Unit and the examiner of your application in the PTO has changed. To acid in correlating any papers for this application, all further correspondence regarding this application should be directed to Yunsoo Kim, Art Unit 1641, Technology Center 1600.
3. Claims 1-4, 6-8, 10, 12, 14-17 and 20-32 are pending upon entry of amendment filed on 2/13/26.
Applicant’s election of group II, claims 6-8, 10, 12, 14-17 and 20-29 without traverse in the reply filed on 2/13/26 has been acknowledged.
Accordingly, claims 1-4 and 30-32 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 6-8, 10, 12, 14-17 and 20-29 are under consideration in the instant application.
The claims under consideration comprise one independent claim and the claimed invention is a unit dose device for intranasal administration of foralumab comprising 0.25mg/ml or 0.5mg/ml of antibody, about 10-100mM of sodium acetate trihydrate, about 0.01-1% polysorbate and about 50-500mM sodium chloride.
4. Applicant’s IDS filed on 12/15/23, 4/25/24, 10/3/24, 2/24/25 and 2/19/26 have been acknowledged.
5. No oath is of record.
6. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
7. 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.
8. Claims 8 and 14-17 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claims recite the narrow recitation the temperature between 2-8oC for at least 3 months, and the claims also recite at least 6 months, 12 months, 2 years, 3 years or 5 years which is the broader statement of the range/limitation. Further, relative standard deviation (RSD) of no greater than 10% with no greater than 3% in claim 8 and remaining potency of anti-CD3 antibody within 10% and within 35% are recited in claim 17.
9. 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 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.
10 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 of this title, 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.
11. Claims 6-8, 10, 12, 14, 17, 20-29 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2018/044948 (IDS reference) in view of U.S. Pat 8,327,844..
The ‘948 publication teaches a unit dose formulation of 0.1-10mg of anti-CD3 antibody, 25mM of sodium acetate trihydrate, 125mM of NaCl and 0.02% of polysorbate ([0012]) readable upon a formulation recited by the instant application. The specific unit dose of 0.5mg, 2.5mg or 5.0 mg ([133]). The ‘948 publication teaches that the formulation may have pH of 5-6 [0073].
Given that the sodium acetate trihydrate has 136.08 g/mole, 25mM is equivalent of 3.4mg/ml, NaCl having 58.44 g/mole, the claimed 7.31mg/ml is equivalent of 125mM, 0.02% polysorbate is equivalent of 0.2mg/ml and claims 28-29 are included in this rejection (note [137]).
Further, the claimed CDRs of the heavy and light chains set froth in SEQ ID NO:1-7 and heavy and light chain variable sequences set forth in SEQ ID NO:8-9 are taught by [0061-0063] of the ‘948 publication. Note the foralumab recited in claim 27 of the instant application has the claimed SEQ ID NO:1-9 and included in this rejection.
In addition, the ‘948 publication teaches the formulation maintains stability at 4oC for at least 3 months and has less than 1% and claims 14-16 are included. The ‘948 publication teaches the nasal administration of CD3 antibody formulation in a suitable container ([127]) especially for aerosol ([140]).
The disclosure of the ‘948 publication differs from the instant claimed invention in that it does not teach the use of unit dose device and specific characters of the device as in claims 6, 10-12 and 20-24 or the instant application.
The ‘844 patent teaches unit dose device for nasal delivery for medicament providing accurate and precise delivery of medicine in the range of 20-30um of particle size (col. 3-4, pictures). The ‘844 patent further teaches that the delivery may be single or multi dose (col. 5-8).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the nasal delivery device taught by the ‘844 patent to the anti-CD3 antibody formulation taught by the ‘948 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of nasal device provides convenient, precise delivery of medicament for single or repeated administration to the target site.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. 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.
13. Claims 6-8, 10, 12, 14, 17, 20-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Pat. 10,688,186 in view of U.S. Pat. 8,327,844.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘186 patent recites a pharmaceutical composition comprising anti-CD3 antibody at 0.1-10mg in the presence of 25mM sodium acetate trihydrate, 125mM NaCl and 0.02% polysorbate 80.
The claims of the ‘186 patent different from the claimed invention in that it does not teach the unit dose device as in claim 6 of the instant application.
The ‘844 patent teaches unit dose device for nasal delivery for medicament providing accurate and precise delivery of medicine in the range of 20-30um of particle size (col. 3-4, pictures). The ‘844 patent further teaches that the delivery may be single or multi dose (col. 5-8).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the nasal delivery device taught by the ‘844 patent to the anti-CD3 antibody formulation taught by the ‘186 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of nasal device provides convenient, precise delivery of medicament for single or repeated administration to the target site.
14. Claims 6-8, 10, 12, 14, 17, 20-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Application No. 19/048132.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘132 application recites a pharmaceutical composition comprising anti-CD3 antibody at 0.1-10mg in the presence of 25mM sodium acetate trihydrate, 125mM NaCl and 0.02% polysorbate 80.
The claims of the ‘132 application different from the claimed invention in that it does not teach the unit dose device as in claim 6 of the instant application.
The ‘844 patent teaches unit dose device for nasal delivery for medicament providing accurate and precise delivery of medicine in the range of 20-30um of particle size (col. 3-4, pictures). The ‘844 patent further teaches that the delivery may be single or multi dose (col. 5-8).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the nasal delivery device taught by the ‘844 patent to the anti-CD3 antibody formulation taught by the ‘132 application.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of nasal device provides convenient, precise delivery of medicament for single or repeated administration to the target site.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
15. No claims are allowed.
16. 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 Mon-Fri 8:30-5.
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, Misook Yu can be reached at 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
March 5, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641