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, 6-8, 10, 12, 14-17, 20, 21, 23, 24, 26, 27 and 30-33 are pending upon entry of amendment filed on 5/13/22.
Claims 1-4 and 30-32 stand withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.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, 20, 21, 23, 24, 26, 27 and 30-33 are under consideration in the instant application.
3. No oath is of record.
4. New title filed on 5/12/26 has been entered.
5. Upon status change of application number 19/048132, the provisional rejection is moot (note section 14 of the office action mailed on 3/11/26). Further in light of the amendment filed on 5/12/26, the double patenting rejection is withdrawn (see section 13 of the office action mailed on 3/11/26).
6. The following rejections remain. Note the claim number is modified to reflect the current status of claims.
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. Claim 6 is 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.
Applicant’s response filed on 5/12/26 has been fully considered but they were not persuasive.
Applicant has asserted that the current amendment obviates the rejection.
Although the amendment obviates the rejections for claims 8 and 14-17, new amendment for claim 6 currently recites droplet sizes of 10um-100um or 25um and 250um remains considered indefinite.
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, 21, 23, 24, 26, 27 and 33 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2018/044948 (IDS reference, of record) in view of U.S. Pat 8,327,844 (of record) for the reasons set forth in the office action mailed on 3/11/26.
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 forth 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.
Applicant’s response filed on 5/12/26 has been fully considered but they were not persuasive.
Applicant has asserted that the currently amended limitations have not been taught by the references and unit dose delivery of 100ul with 10-100um or 25-250um droplet sizes is not suggested. In addition, Applicant has asserted that the teachings of the ‘844 patent focuses on more precise particle size of 10-30um.
Unlike Applicant’s assertion, the use of 100ul is suggested by the unit dose of CD3 antibody in the ‘948 publication ([0132-0133]). Further, the ‘844 patent discloses specific inhalers Turbohaler, Accuhaler or Twisthaler (col. 14-15) delivers 100ul as standard volume, being the unit doses of 0.5mg, 2.5mg or 5.0 mg as taught by the ‘948 publication, the currently amended limitations are envisaged. As such, the combination of the references suggests the currently amended limitations. Further, the 10-30um particle sizes are within the claimed range. Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on the combination of the references.
12. The following new ground of rejection is necessitated by Applicants’ amendment filed on 5/12/26.
13. 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.
14. Claims 6-8, 10, 12, 14, 17, 20, 21, 23, 24, 26, 27 and 33 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 “wherein 10ug-100ug of the anti-CD3 antibody delivered per dose in a volume of 100ul of the formulation and wherein the delivered droplet size is 10um-100ul or 25-250um”. Applicants assert that no new matter is added. The specification supports for wherein 10ug-100ug of the anti-CD3 antibody delivered per dose in a volume of 100ul of the formulation and wherein the delivered droplet size is 10um-100ul or 25-250um ([009-0011]) at most in the presence of excipients of 10-100mM of sodium acetate, 0.01-0.1% of polysorbate, and 50-500mM of sodium chloride. However, the specification does not support for CD3 antibody without reciting excipient combinations as currently amended.
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.
14. 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.
15. Claims 6-8, 10, 12, 14, 17, 20, 21, 23, 24, 26, 27 and 33 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. 11,116,914 (newly cited).
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 ‘914 patent teaches unit dose device for nasal delivery for medicament providing accurate and precise delivery of medicine in the range of 20-500 of particle size in the volume of 100um (Table 13, col. 51-53). The ‘844 patent further teaches that the delivery may be single or multi dose (claims).
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 ‘914 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 for optimal and effective delivery volume.
16. No claims are allowed.
17. 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.
18. 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
June 30, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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