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 1-30 are pending upon entry of amendment filed on 12/4/25 and are presently being examined.
3. Applicant’s submission of IDS filed on 12/4/25 has been considered.
4. The following rejections remain.
5. 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.
6. Claims 1-30 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 “feeding an aqueous first liquid into an apparatus at a first flow rate…controlling the residence time of the droplets in the second liquid…forming particles” as in claim 1 and “wherein the ratio of the first flow rate to the second flow rate is about 1:100” and in claim 3 of the instant application. Applicants assert that the currently added limitation is found from the specification in [212], [289], [442], [272], [004], [203] of the instant application. The specification supports particle diameter of 1-100um at most. However, the specification does not support for entire method of feeding separate liquids with different flow rate in producing particles with controlling residence time of the liquids.
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.
Applicant’s response filed on 12/4/25 have been fully considered but they are not persuasive.
Applicant has asserted that the support was found from the exemplary support in p. 6 of the response.
However, although the support is present for specific conditions such as paragraph [0442] where the solution was pumped at a rate of “approximately 0.03mL/min with ethyl acetate”, no support is present for general “first flow rate”. Applicant is advised to recite the first flow rate of 0.03ml/min with appropriate organic solvent.
Further, the location of forming particles is “during residence in the individual channel”. Appropriate correction is required. The rejection is maintained.
7. 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.
8. Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/759,592.
Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOPEMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application(s).” id. Notably absent from the legislative history, in the courts view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” id. at 1361. From there, the court “concludes that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” id. at 1362. Accordingly, the court decided that the §121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id. We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 17/759,592 case as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
The claims of 17/759,592 are drawn to a method of forming particles comprising providing a first liquid, including an aqueous liquid, comprising a therapeutic biologic, including an antibody, and a solvent, contacting the first liquid with a second liquid, thereby forming liquid droplets comprising the therapeutic biologic, contacting the liquid droplets with a third liquid, thereby allowing the liquid droplets to dry, and removing the first, second and third liquids, thereby forming particles comprising the therapeutic biologic, wherein the particles comprise less than about 10% internal void spaces, a circularity of from about 0.8 to about 1.0 after removal of the liquids. The first liquid may comprise a carbohydrate, a salt, a protein stabilizer, an amino acid, a surfactant, an antioxidant, or a sugar amongst others, or a combination thereof.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
Given that the double patenting rejection is not the only remaining issue, the rejection is maintained.
9. Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, 11, 22, 26, 28, 29, 38-45, 48, 49, 52-56 and 142 of copending Application No. 17/916,618.
Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOPEMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application(s).” id. Notably absent from the legislative history, in the courts view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” id. at 1361. From there, the court “concludes that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” id. at 1362. Accordingly, the court decided that the §121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id. We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 17/916,618 case as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
The claims of 17/916,618 are drawn to a method of forming particles comprising providing an aqueous first liquid comprising a therapeutic biologic, including an antibody, contacting the first liquid with an organic second liquid, thereby forming liquid droplets comprising the therapeutic biologic, dehydrating the aqueous liquid droplets in the mixture, removing the first and second liquids, thereby forming particles comprising the therapeutic biologic, wherein the particles comprise less than about 10% internal void spaces, a circularity of from about 0.8 to about 1.0 after removal of the liquids.
The first liquid may comprise saline, lactated Ringer’s solution, a buffer, dextrose or combination thereof, or may further comprise a carbohydrate, a salt, a chelator, mineral, polymer protein stabilizer, emulsifier, antiseptic, amino acid, antioxidant, protein, preservative surfactant or a biologic or chemical excipient, or a combination thereof.
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
Given that the double patenting rejection is not the only remaining issue, the rejection is maintained.
10. Claims1, 2, 5-7, 9-12 and 14-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10, 15, 17, 19, 36, 44, 49, 55- 58, 71, 72, 76, 78, 80 and 81 of copending Application No. 18/565,193.
The claims of 18/565,193 are drawn to a method for screening formulations comprising particles for stability of a protein in the particles, wherein the particles comprise a therapeutic biologic protein at greater than about 60% protein by weight, have less than about 5% aggregation of the protein and have less than about 10% internal void volume. The said method includes a step of selecting a formulation based on the stability of the protein disposed in the particles. The claims of 18/565,193 also recite a method by which a mixture of particles is prepared. At one step in the method the particles are suspended in a composition comprising a sugar, an antioxidant, and/or a surfactant. The first aqueous liquid and organic liquid is removed by lyophilization or vacuum desiccation (i.e., no residual moisture).
As Applicant has requested that this double patenting rejection be held in abeyance until patentable subject matter has been identified in the instant application, the double patenting rejection is maintained.
Given that the double patenting rejection is not the only remaining issue, the rejection is maintained.
11. No claim is allowed.
12. THIS ACTION IS MADE FINAL. 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 Mon-Fri 8:30-5.
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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
January 21, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641