Prosecution Insights
Last updated: April 19, 2026
Application No. 17/916,576

REACTION DEVICE, MICROSPHERE PREPARATION DEVICE AND EXTRACTION METHOD AND LIPOSOME DRUG LOADING METHOD

Final Rejection §102§112
Filed
Oct 02, 2022
Examiner
CLEVELAND, TIMOTHY C
Art Unit
1774
Tech Center
1700 — Chemical & Materials Engineering
Assignee
BIODOSAGE TECH CO., LTD.
OA Round
2 (Final)
60%
Grant Probability
Moderate
3-4
OA Rounds
3y 0m
To Grant
77%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allow Rate
544 granted / 907 resolved
-5.0% vs TC avg
Strong +17% interview lift
Without
With
+17.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
47 currently pending
Career history
954
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
41.5%
+1.5% vs TC avg
§102
21.1%
-18.9% vs TC avg
§112
30.2%
-9.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 907 resolved cases

Office Action

§102 §112
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 . Response to Amendment The objections to the drawings and rejection under §112(b) have been withdrawn in light of the amendment filed 3 September 2025 and the prior art rejection has been slightly modified to account for the additional limitations. A new rejection under §112(b) has been entered to account for a newly entered limitation. Claim Rejections - 35 USC § 112 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 1-7 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. In regard to claim 1, it is noted that the limitation of “a parametric gradient” is recited in line 11 and again in line 12. The Examiner is unable to determine if the limitations refer to the same or to different gradients. Claim Rejections - 35 USC § 102 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guan et al. (CN 102211008; hereinafter “Guan”; with reliance upon English-language machine translation). In regard to claims 1 and 4, Guan discloses a reaction device, comprising: a reactor body (T-type tube 6) capable of enclosing a first liquid (not explicitly recited by the apparatus claim), having a first end (the left side in Figure 1) and a second end (the right side in Figure 2); a first injection port (the connection to the pump 5) is provided at a location in a longitudinally (i.e. along the length) intermediate position between a first end and second end of the reactor body, the first injection port being positioned such that fluid introduced therethrough does not enter at either end of the reactor body but rather into an intermediate potion of the reactor body (see Figure 1), and a discharge port (the connection leading to observation cell 7) is provided at the second end of the reactor body; and a supply device (injection pump 5), communicated with the first injection port, capable of injecting a continuous phase (not explicitly recited by the apparatus claim). See Figure 1 and [0012]. It is noted that the apparatus claims recite the contents of the apparatus during an intended operation of the apparatus. The Courts have held that “[e]xpressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim.” Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” See In re Young, 75 F.2d *>996<, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Therefore, the limitations do not further limit the patentability of the apparatus claims. Furthermore, the cited prior art teaches all of the positively recited structure of the claimed apparatus and the limitations of “to create or maintain a parametric gradient within the reactor body, to create or maintain a parametric gradient extending along the length of the reactor body” do not further limit the structure of the apparatus claims and merely amount to a statement of intended use, manner of operation or function of the apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). In regard to claims 2-3, Guan discloses a second injection port (the connection leading from the stop clamp 4) in the first end (left side of tube 6 as depicted in figure 1). It is noted that the claims recite the orientation of the reactor body during an intended use of the apparatus which does not further limit the patentability of the apparatus claims. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). In regard to claim 5, Guan discloses wherein the reactor body (tube 6) comprises a first accommodating portion (left side of the tube 6 as depicted in Figure 1) and a second accommodating portion (right side of the tube 6 as depicted in Figure 1); a first joint (the connection point to the flow path 61)) connecting the first accommodating portion and the second accommodating portion, one end of the first accommodating portion away from the first joint is the first end, and the first injection port is disposed in or on the first connection joint; a second joint (connection to the conduit leading to observation cell 7) communicates with the second accommodating portion to form the second end and the discharge port is provided on the second joint. See Figure 1. In regard to claim 6, the cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). The Courts have held that if the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967); and In re Otto, 136 USPQ 458, 459 (CCPA 1963). The Courts have held that it is well settled that the recitation of a new intended use, for an old product, does not make a claim to that old product patentable. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (see MPEP § 2114). Therefore, the limitation of claim 6 does not further limit the patentability of the recited apparatus. In regard to claim 7, Guan discloses a third injection port (the connection leading from the stop clamp 4) positioned at the first end of the reactor body which would be capable of receiving embryonic microspheres (not explicitly recited) from a material injection mechanism (such as from tank 3 but the material injection mechanism has not been positively recited by the instant claim), and a collector (flat 8 for collecting material; [0017]) which is communicated with the second end of the reactor body to be capable of collecting microspheres. It is noted that the contents of the apparatus during an intended use thereof (i.e. the embryonic microspheres) do not further limit the patentability of the recited apparatus. Response to Arguments Applicant's arguments filed 3 September 2025 have been fully considered but they are not persuasive. Applicant argues that the prior art reference of Guan does not disclose an intermediate portion of a reactor body as claimed but rather discloses “simply a mixing junction.” Applicant further states that that Guan “provides no TSM for this limitation.” The Examiner respectfully disagrees. The claims merely require “a first injection port […] into an intermediate portion of the reactor body” and the structure of the connection to pump 5 in the tube 6 meets the limitation as the connection occurs intermediate of the two ends of the tube 6. It is not clear how “a mixing junction” is distinct from the claimed invention as Applicant has provided no rationale to explain the difference from the amended limitation and the disclosure of Guan. Further, in regard to the statement that Guan “provides no TSM for this limitation,” the Examiner notes that Guan has been cited under §102 for anticipating the claim. Therefore, the TSM test is not needed as it is only used in making rejections under §103 for obviousness. Applicant argues that Guan does not disclose the function of the continuous phase flows within the reactor body to create or maintain a parametric gradient extending along the length of the reactor body. The Examiner has fully considered the argument but has not found it to be persuasive. The limitation does not further limit the patentability of the apparatus claim as it merely regards the contents of the apparatus during an intended use of the apparatus. Guan discloses all the positively recited structure of the claimed apparatus. The Courts have held that “[e]xpressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim.” Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969). Furthermore, “[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims.” See In re Young, 75 F.2d *>996<, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). 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 TIMOTHY C CLEVELAND whose telephone number is (571)270-5041. The examiner can normally be reached M-F 9:00-5:30. 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, Claire Wang can be reached at (571) 270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TIMOTHY C CLEVELAND/Primary Examiner, Art Unit 1774
Read full office action

Prosecution Timeline

Oct 02, 2022
Application Filed
Oct 02, 2022
Response after Non-Final Action
Jun 02, 2025
Non-Final Rejection — §102, §112
Sep 03, 2025
Response Filed
Sep 16, 2025
Final Rejection — §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
60%
Grant Probability
77%
With Interview (+17.0%)
3y 0m
Median Time to Grant
Moderate
PTA Risk
Based on 907 resolved cases by this examiner. Grant probability derived from career allow rate.

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