DETAILED ACTION
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 . 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.
Election/Restrictions
Applicant’s election of Group I, claims 1-18, in the reply filed on 01/30/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 19 and 28-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/30/2026.
Claim Rejections - 35 USC § 112 –
Indefiniteness and Broad to Narrow Limitations
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.
Claims 1-18 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 applications subject to pre-AIA 35 U.S.C. 112, 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) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation “ultrasound contrast agent”, and the claim also recites “(UCA)” which is the narrower statement of the range/limitation.
In the present instance, claim 18 recites the broad recitation “direct current”, and the claim also recites “(DC)” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The Applicant is encouraged to remove the parenthesis, rather than the abbreviation, from the claims.
Claim Rejections - 35 USC § 103 - Obviousness
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, 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.
Claim(s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al (US 2017/0319718 A1), in view of Shenzhen Meister Biomedical Engineering Co., Ltd. (CN 110433351 A).
Robinson taught a shaking device for forming gas-filled microspheres comprising an identification means capable of identifying, and distinguishing between, a first vial and a second vial, each vial comprising a formulation, and an automated shaking means capable of shaking for only one of at least two different pre-determined periods of time, based on the identification of the vial [0054]. At claim 145, Robinson taught a holder capable of holding a container comprising a UCA lipid formulation [see also ¶s 0048 and 0063-0064]. At ¶s [0232-0233], Robinson taught that the holder is connected to the device.
Further taught was an activation or shaking means, such as an activation or shaking device that was set to shake at one rate (defined in terms of number of shaking motions per minute, for example), or for two or more different pre-determined periods of time [0121-0122]. A means that could be used to change the speed of shaking was taught as a Brushless DC motor [0242].
Robinson did not teach that the motor comprised a transmission.
Shenzhen Meister Biomedical taught an oscillating uniform device comprising an actuator that included a motor, and a toothed belt transmission of tensioning [claim 4].
It would have been prima facie obvious to one of ordinary skill in the art to include a toothed belt transmission within the teachings of Robinson, as taught by Shenzhen Meister Biomedical. The ordinarily skilled artisan would have been motivated to drive the motor, ensuring no slippage (e.g., tensioning), as taught by Shenzhen Meister Biomedical at claim 4.
Robinson, in view of Shenzhen Meister, reads on the instant claims 1-3 and 18.
Claims 4-13 are rendered prima facie obvious because Shenzhen Meister Biomedical taught a toothed belt transmission (134), driving wheels (131, 133), a ring block (16), a bearing (15), the motor (135) and a wheel shaft (132) [see Figures 1-3]. The motivation to combine Shenzhen Meister Biomedical, with Robinson, was previously discussed.
Claims 14-15 are rendered prima facie obvious because Robinson taught an RFID reader [0014].
Claim 16 is rendered prima facie obvious because Robinson taught any suitable detector for reading the indicator (including electromagnetic; e.g., reads on antenna).
Claim 17 is rendered prima facie obvious because Robinson taught shake speeds between 4900 to 5500 rpm [Table 5], or between 4300 to 4800 rpm [Table 6].
The instant claim 17 recites speeds between about 4300 rpm and about 6000 rpm; between about 4300 rpm and about 5000 rpm.
Robinson taught shake speeds between 4900 to 5500 rpm, or between 4300 to 4800 rpm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Nonstatutory Double Patenting
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.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,588,988, in view of Shenzhen Meister Biomedical Engineering Co., Ltd. (CN 110433351 A).
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,097,270, in view of Shenzhen Meister Biomedical Engineering Co., Ltd. (CN 110433351 A).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require the limitation of wherein the shaking means includes a motor arranged to drive movement of the holder via a transmission, wherein at least a portion of the transmission is arranged to prevent slippage during an activation of the UCA formulation, and the said limitation is not required of the issued claims.
Shenzhen Meister Biomedical taught an oscillating uniform device comprising an actuator that included a motor, and a toothed belt transmission of tensioning.
It would have been prima facie obvious to one of ordinary skill in the art to include a toothed belt transmission within the issued claims, as taught by Shenzhen Meister Biomedical. The ordinarily skilled artisan would have been motivated to drive the motor, ensuring no slippage (e.g., tensioning), as taught by Shenzhen Meister Biomedical.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6, 86, 96-97 and 129-132 of copending Application No. 18/893,530, in view of Shenzhen Meister Biomedical Engineering Co., Ltd. (CN 110433351 A).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require the limitation of wherein the shaking means includes a motor arranged to drive movement of the holder via a transmission, wherein at least a portion of the transmission is arranged to prevent slippage during an activation of the UCA formulation, and the said limitation is not required of the copending claims.
Shenzhen Meister Biomedical taught an oscillating uniform device comprising an actuator that included a motor, and toothed belt transmission of tensioning.
It would have been prima facie obvious to one of ordinary skill in the art to include a toothed belt transmission within the copending claims, as taught by Shenzhen Meister Biomedical. The ordinarily skilled artisan would have been motivated to drive the motor, ensuring no slippage (e.g., tensioning), as taught by Shenzhen Meister Biomedical.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
Prosecution Insights