DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/17/25 and 11/06/25 was filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Karnik et al (US 2010/0022680 A hereafter Karnik).
Karnik discloses a device and system comprising an inlet microchannel for receiving a first solution and providing a first stream, a second inlet for receiving a second solution and providing a second stream and a third microchannel for receiving the first and second stream and mixing them where the third microchannel has a diameter of about 100 microns [abstract, 0022, 0060, 0070]. The mixer can be a micromixer, such as a chaotic advecation micromixer [0060]. The third channel can also comprise herringbone bas-relief structure [Figures]. The channels have a flow rate of about 1 mL/min, and vary depending on the end use [0087]. The system comprises multiple streams and their flow rate is regulated by the source fluid. Adding the stream flows of at least 2 would result in a flow rate of at least 2.0 mL/min [0089]. The third microchannel has a principal flow direction and one or more surfaces having at least one groove having an orientation forms an angle with principal direction [0067].
Regarding the ratio of the first to second or third streams, it is the position that such limitation do not distinguish over the prior art. These limitations could be achieved through routine experimentation that would have been obvious to those of ordinary skill in the art. The general conditions of streams flowing at a rate of 1.0 mL/minute with multiple streams adding to at least 2.0 mL/min are established by the prior art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233, 235 (CCPA 1955).
With these aspects in mind, it would have been obvious to one of ordinary skill in the art to form a system that produces uniform nanoparticles. It would have been obvious to optimize the disclosures of Karnik to adjust the flow rate in order to achieve optimum particles production. One of ordinary skill in the art would have been motivated to optimize these disclosures to produce uniform and stable microparticles.
Double Patenting
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.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 9,943,846. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a system comprising a first, second and third inlet microchannel, a region adapted for mixing the inlet streams and a first and second pump where the ratio of the flow rate to the second flow rate is 2.0-10.0 and a combined flow rate from at least 2 mL/min. The claims differ in that the 846 claim recites the size of the resulting outlet particles, while the instant claim is silent. However, the scopes overlap by providing a system with the same features and the instant claim does not foreclose those limitations. The claims cannot be allowed together.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 10,843,194. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a system comprising a first, second and third inlet microchannel, a region adapted for mixing the inlet streams and a first and second pump where the ratio of the flow rate to the second flow rate is 2.0-10.0 and a combined flow rate from at least 2 mL/min. The claims differ in that the 846 claim recites the size of the resulting outlet particles, while the instant claim is silent. However, the scopes overlap by providing a system with the same features and the instant claim does not foreclose those limitations. The claims cannot be allowed together.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,648,556. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a system comprising a first, second and third inlet microchannel, a region adapted for mixing the inlet streams and a first and second pump where the ratio of the flow rate to the second flow rate is 2.0-10.0 and a combined flow rate from at least 2 mL/min. The claims differ in that the 846 claim recites the size of the resulting outlet particles, while the instant claim is silent. However, the scopes overlap by providing a system with the same features and the instant claim does not foreclose those limitations. The claims cannot be allowed together.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 12,233,416. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a system comprising a first, second and third inlet microchannel, a region adapted for mixing the inlet streams and a first and second pump where the ratio of the flow rate to the second flow rate is 2.0-10.0 and a combined flow rate from at least 2 mL/min. The claims differ in that the 846 claim recites the size of the resulting outlet particles, while the instant claim is silent. However, the scopes overlap by providing a system with the same features and the instant claim does not foreclose those limitations. The claims cannot be allowed together.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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