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 .
Response to Amendment
This office action is responsive to the amendments filed on February 10, 2026 and December 30, 2026. As directed by the amendment: claims 1, 9, and 14 have been amended and claims 16-20 have been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to claims 1, 9, and 14 have been considered but are moot because the arguments do not apply to the current grounds of rejection as necessitated by applicant’s amendments.
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 1-13 and 16-20 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.
Regarding claim 1, the claim is drawn towards a device having a medicine cartridge with a passage having a cross-sectional shape and a plunger actuator having a cross-sectional shape. The claim further recites that the respective shapes are configured to permit delivery when the shape of the plunger actuator is uniquely keyed to be compatible with the medicine cartridge passage shape. Due to the presence of the term “when”, it is unclear if the claims are requiring the respective shapes to be uniquely keyed. For examination purposes, the cross-sectional shape of the plunger actuator is uniquely keyed to be compatible with an engage the medicine cartridge passage cross-sectional shape.
Regarding claims 1 and 9, the claim recites that the syringe body passage is uniquely keyed to the compatible with a unique medicine cartridge passage cross-sectional shape. It is unclear if this cross-sectional shape is the same cross-sectional shape recited earlier in the claim or a different cross-sectional shape. For examination purposes, the uniquely keyed medicine cartridge passage cross-sectional shape is considered the same as the previously recited medicine cartridge passage cross-sectional shape.
Claims 2-8, 10-13, and 16-20 are also rejected by virtue of being dependent on claims 1 or 9.
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.
Claim(s) 1-3, 7, 8, 16, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davies (GB 2216801).
Regarding claim 1, Davies discloses a secure device for delivering a medication, the device comprising:
a cartridge nest (cylindrical body 1 in fig. 1);
a medicine cartridge adapted to be laterally removable from selectively received within the cartridge nest (cartridge 3 in fig. 3; pg. 8 discloses the cartridge being removable, it is understood the cartridge would be removable laterally from the opening 2), wherein the medicine cartridge includes a passage defined therethrough (slot 21 in fig. 3 extends partially through stopper 17 which is part of the cartridge), the medicine cartridge passage having a cross-sectional shape (shape of slot 21 in fig. 3); and
a plunger actuator (plunger 4 in fig. 1) having a shaft with a cross-sectional shape (head 22 in fig. 1);
wherein the cross-sectional shape of the plunger actuator shaft and the cross-sectional shape of the medicine cartridge passage are configured to permit the delivery of the medication when the cross-sectional shape of the plunger actuator shaft is uniquely keyed to be compatible with and engage a unique medicine cartridge passage cross-sectional shape (pg. 6, 2nd paragraph discloses that the width/length of head 22 is such that it can be inserted in slot 21, so as to be uniquely keyed).
Regarding claim 2, Davies discloses the cross-sectional shape of the plunger actuator shaft and the cross-sectional shape of the medicine cartridge passage are adapted for allowing the plunger actuator shaft to pass through the medicine cartridge passage (pg. 6, 2nd paragraph).
Regarding claim 3, Davies discloses the cross-sectional shape of the plunger actuator shaft defines a first uniquely-keyed pattern (height/width of head 22 in fig. 1); the cross-sectional shape of the medicine cartridge passage defines a second uniquely- keyed pattern (height/width of slot 21 in fig. 3); and the first pattern matches the second pattern (fig. 1 and 3; pg. 6, 2nd paragraph).
Regarding claim 7, Davies discloses a plunger seal located in an interior of the medicine cartridge (stopper 17 in fig. 3).
Regarding claim 8, Davies discloses the plunger actuator shaft is adapted for passing through the medicine cartridge passage and pushing the plunger seal within the medicine cartridge (pg. 6, 2nd paragraph).
Regarding claim 16, Davies discloses the cross-sectional shape of the medicine cartridge passage matches the cross-sectional shape of the plunger actuator shaft (fig. 2 and 4).
Regarding claim 17, Davies discloses the cartridge nest further comprises at least one tab configured to removably attach the cartridge nest to a syringe body (external threaded projection 8 in fig. 1).
Claim(s) 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tang (US 20040236283).
Regarding claim 14, Tang discloses a secure device for delivering a medication, the device comprising:
a syringe body (positioning plates 7 in fig. 1) including a passage defined therethrough (fig. 1), the syringe body passage having a cross-sectional shape with a first uniquely-keyed X-shaped pattern (fig. 10);
a cartridge nest (barrel 6 in fig. 1);
a plunger actuator (plunger 5 in fig. 8) having a shaft (shaft formed by body pieces 53 in fig. 8) with a cross-sectional shape with a second uniquely-keyed X-shaped pattern (fig. 8 shows a splined cross-sectional shape which forms an X-shape);
wherein the first pattern and the second pattern are uniquely keyed to be compatible with a unique medicine cartridge to permit the delivery of the medication therefrom (the patterns are capable of being uniquely keyed to a compatible medicine cartridge since the cartridge is only functional).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies, as applied to claim 1 above, and further in view of Baker (US 20210060257).
Regarding claim 19, Davies discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the cross-sectional shape of the medicine cartridge passage and the cross-sectional shape of the plunger actuator shaft each include an X- shape.
Baker is directed towards a similar device (fig. 2 and 3) comprising a medicine cartridge passage having an X-shaped cross-sectional shape (X-shaped cross-section of disc member 124 in fig. 3) and a plunger actuator shaft having a X-shaped cross-sectional shape (X-shaped cross-sectional shape of end of plunger 114 in fig. 2).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the cross-sectional shapes of the medicine cartridge passage and the plunger actuator shaft to be X-shaped, as taught by Baker, since Baker teaches this is a suitable way to non-rotationally connect the plunger and the stopper (paragraph 38) and since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Allowable Subject Matter
Claims 4-6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 9-13, 18, and 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 4 and 9, as best understood by the examiner due to the 112(b) issues above, the closest prior art is Davies which further discloses a syringe body including a passage defined therethrough (sleeve 5 in fig. 1), the syringe body passage having a cross-sectional shape (fig. 1). While Davies discloses that the plunger actuator (plunger 4 in fig. 1) has a cross-sectional shape which matches the cross-sectional shape of the syringe body passage (fig. 1), this cross-sectional shape is not uniquely keyed to be compatible with the medicine cartridge. The cross-sectional shape of the plunger actuator shaft which is uniquely keyed to the medicine cartridge (shape of head 22) comprises a different cross-sectional shape of the remainder of the plunger actuator (plunger 4 in fig. 1).
Regarding claim 15, the closest prior art is Tang which does not teach or disclose medicine cartridge adapted to be received within a cartridge nest, wherein the medicine cartridge includes a passage defined therethrough, the medicine cartridge passage having a cross- sectional shape with a third uniquely-keyed pattern; wherein the first pattern matches both the second pattern and the third pattern in order for the plunger actuator to be compatible for use with both the syringe body and the medicine cartridge and deliver the medication therefrom.
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 COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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