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 .
Status of Claims
Applicant’s reply filed 10/1/25 is acknowledged. Claims 1-28 and 43 are canceled. Claims 29-42 were withdrawn without traverse in the reply filed on 6/10/25. Claims 44-48 are under examination.
Newly submitted claim 49 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The group of invention III (claim 49) does not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, Groups I-III (see Office Action filed 4/10/25) lack the same or corresponding special technical features for the following reasons:
The inventions listed as Group I, Group II and Group III lack unity of invention because even though the inventions of these groups require the technical feature of yield-stress fluid, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Keselowsky et al. (“Keselowsky,” US Pub. No. 2018/0258382). Keselowsky teaches in e.g., [0044], a 3D cell growth medium may be made from materials such that the granular gel material undergoes a temporary phase change due to an applied stress (e.g. a thixotropic or “yield stress” material). Such materials may be solids or in some other phase in which they retain their shape under applied stresses at levels below their yield stress. At applied stresses exceeding the yield stress, these materials may become fluids or in some other more malleable phase in which they may alter their shape. Thus, because the technical feature of the yield-stress fluid is not a special technical feature, the inventions listed as Group I, Group II and Group III lack unity of invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 49 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Reply
Claim Objections
Claim 44 is objected to because of the following informalities: a colon is missing after “comprising” in preamble. Appropriate correction is required.
Drawings
In light of applicant’s arguments, the prior drawing objection is withdrawn.
Claim Rejections - 35 USC § 112
In light of applicant’s claim amendments and arguments, the prior rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Claim Interpretation
The Office asserts that terms and phrases like “for” and “configured” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “for” and “configured” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
Prior Art Rejection
In light of applicant’s claim amendments, the prior art rejection is withdrawn, and a new rejection follows.
Claim Rejections - 35 USC § 102
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.
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.
Claims 44-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carreras et al. (“Carreras,” US Pub. No. 2014/0011033, newly cited).
As to claim 44, Carreras discloses a system for crystallization comprising an apparatus for forming one or more compartments, including: a) a nozzle including an outlet (e.g., figs. 1-3, 5 and 6 disclose pipe, tube, and/or nozzle with outlets) the outlet for introducing one or more volumes; b) a yield-stress fluid (e.g., gelled shell in [0008] et seq.; and/or intermediate phase in [0013] et seq.) in contact with the outlet of the nozzle (figs. 1-3, 5 and 6 disclose fluid(s) in contact with the pipe, tube, and/or nozzle); c) a controller (e.g., [0130] et seq. discloses each feeding means 44, 46, 48 can comprise a pressure generating flow controlling system such as a pressure pot coupled with a flow meter and a flow control system; also [0205] discloses solenoid valves) configured to displace the nozzle and/or the yield-stress fluid relative to each other to introduce one or more volumes into the yield-stress fluid; and d) one or more compartments in the yield-stress fluid containing a crystallized active pharmaceutical ingredient (one or more compartments in the yield-stress fluid in Carreras’ intermediate phase in [0013] et seq.; and/or compartment in the yield-stress fluid in Carreras’ gelled shell made of, e.g., alginate and/or polysaccharides in [0008] et seq.; [0069] et seq. discloses intermediate drop 18 may include one or more edible, cosmetics, or pharmaceutical active ingredients.).
As to claims 45-46, see e.g., [0130] and [0205] disclose a controller capable of selectively perturbing a flow of an input fluid for forming volume(s). See also MPEP 2114.
As to claim 47, see e.g., [0130] et seq. discloses each feeding means 44, 46, 48 each comprise for example a syringe pump, a peristaltic pump or another pressure generating flow controlling system such as a pressure pot coupled with a flow meter and a flow control system.
As to claim 48, under BRI, the vessel can be Carreras’ gelled shell or vessel shown in figs. 1-3, 5 and 6 for containing the capsules.
Response to Arguments
Applicant’s arguments with respect to claims 44-48 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
1/7/2026