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 .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 6/8/2026 is acknowledged. Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/8/2026.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “constraint assembly… comprising a second aperture in engagement with a second tubing set in fluid communication with the medicament reservoir” and “a dosing mechanism operatively connected with the medicament reservoir and the first and second tubing sets”, subject matter of claims 2-3, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
Regarding claim 1, “a first aperture in formed” should be corrected to “a first aperture is formed”, all recitations of “the tubing” should be corrected to “the first tubing”, and all recitation of “the aperture” should be corrected to “the first aperture” for claim language consistency and clarity.
Regarding claims 2-4, the claim number should be followed by a comma.
Regarding claim 5, “each insert set” should be corrected to “each insert of the two or more insert sets” for claim language consistency.
Regarding claims 6-7, “wherein the set modular inserts” should be corrected to “wherein the set of modular constraint inserts” for claim language consistency.
Appropriate correction is required.
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 5 and 8 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.
Claim 5 recites the limitation “the set modular insert" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation ”the set modular inserts" in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
The Examiner is unsure if claims 5 and 8 are intended to be dependent on claim 4, which introduces “a set of modular constraint inserts”, or intended to separately introduce a “set modular insert” (claim 5) and “set modular inserts” (claim 8). For clarity and claim language consistency, the Examiner recommends amending the claims to include the same language when referring to the modular inserts.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiejima (US 5925023 A).
Regarding claim 1, Hiejima discloses a constraint assembly for engaging a tubing set for use in medication delivery comprising (abstract & Fig. 6-11): a first portion of an outer housing of a medicament delivery device (closable lid 41 of housing 4, col 5 lines 17-39 & Fig. 6-7);
a second portion of the outer housing, where the first portion and the second portion are configured for connection to each other such that a first aperture in formed in the outer housing (housing main body 42 of housing 4, col 5 lines 6-col line 5 & Fig. 6-7; inserting portion 412 is being interpreted as the first aperture, col 5 lines 17-39 & Fig. 6-9; alternatively, the first aperture may be interpreted as only the left portion of inserting portion 412, in which path 31 is seen positioned in Fig. 9; alternatively, the first aperture may be interpreted as only the left and middle portions of inserting portion 412, in which paths 31 and 32 are seen positioned in Fig. 9); and
a first tubing set in fluid communication with a medicament reservoir, where a portion of the tubing set passes through the aperture (constant flow rate path 31 connected to a medicament reservoir, passes through inserting portion 412, see Col 1 lines 7-20 and Col 5 lines 18-37 & Fig. 6-9), wherein the tubing set is engaged with side walls that define the aperture such that the tubing set is deformed and an interior lumen of the tubing set is constricted to reduce a fluid rate of medicament removed from the medicament reservoir (as seen in Fig. 10(b), path 31 is engaged with side walls, the bottom wall and side wall of housing 42, that define the inserting portion 412 such that path 31 is deformed and an interior lumen of path 31 is constricted to reduce the flow rate, col 5 line 6-col 6 line 42 and Table 1).
Regarding claim 2, Hiejima discloses all the limitations of claim 1. Hiejima further discloses the constraint assembly further comprising a second aperture in engagement with a second tubing set in fluid communication with the medicament reservoir (the right portion of inserting portion 412 is being interpreted as a second aperture, see Fig. 6-9; constant flow rate path 33 is positioned in the second aperture, col 5 lines 17-39 & Fig. 6-9; path 33 connected to the medicament reservoir, col 1 lines 7-20).
Regarding claim 3, Hiejima discloses all the limitations of claim 2. Hiejima further discloses the constraint assembly further comprising a dosing mechanism operatively connected with the medicament reservoir and the first and second tubing sets (“the present invention relates to a multi stage type flow rate switching device suitable for controlling variably a small flow rate by being connected to a ballooned liquid medicine continuous injector (an injector where liquid medicine is filled in a balloon made of an elastic rubber material and liquid medicine is continuously injected over a period of many hours into a human body by utilizing the force produced by contraction of the balloon” col 1 lines 7-16; the reservoir is operatively connected to an injector configured to contract the balloon to deliver fluid to paths 31-33).
Regarding claim 4, Hiejima discloses all the limitations of claim 1. Hiejima further discloses the constraint assembly further comprising a set of modular constraint inserts configured for insertion into the first aperture (plate-like members 7B, 7C, and 7D configured for insertion into inserting portion 412, Col 6 lines 6-36 & Fig. 10).
Regarding claim 5, Hiejima discloses all the limitations of claim 1. Hiejima further discloses the constraint assembly wherein the set modular insert comprises two or more insert sets where each insert set reduces the first aperture opening by a different amount (plate-like members 7B and 7C configured for insertion into inserting portion 412, col 6 lines 6-36 & Fig. 10; members 7B and 7C reduce the first aperture opening by different amounts, col 6 lines 6-36 & Fig. 10).
Regarding claim 6, Hiejima discloses all the limitations of claim 4. Hiejima further discloses the constraint assembly wherein the set modular inserts are removably positioned within the first aperture (col 6 lines 6-36 & Fig. 6-11).
Regarding claim 7, Hiejima discloses all the limitations of claim 4. Hiejima further discloses the constraint assembly wherein the set modular inserts are configured for permanent attachment within the first aperture (plate-like members 7B, 7C, and 7D capable of being permanently attached within the first aperture, Fig. 6-11).
Regarding claim 8, Hiejima discloses all the limitations of claim 1. Hiejima further discloses the constraint assembly wherein the set modular inserts are physically deformed when positioned within the first aperture and engaged with the first tubing set (engaging arms 71 and hooks 711 of plate-like members 7B, 7C, and 7D are bent when positioned within the first aperture and engaged with path 31, col 5 line 40-col 6 line 5 & Fig. 10-11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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, Kevin Sirmons can be reached at (571) 272-4965. 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.
/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights