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 .
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 6-8 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.
Regarding claim 6, there is insufficient antecedent basis for the limitation of “the support element” which is recited in claim 4.
Claim Rejections - 35 USC § 102
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) 1-9, 17-19, and 21 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US Pre-Grant Publication 2022/0387706 to De Donatis et al. (Donatis hereinafter).
Regarding claim 1, Donatis teaches a device (1) for subcutaneous delivery of a medicament, comprising: a dispensing module (2) comprising a base wall (6) having a substantially flat outer surface configured to be applied to skin of a patient (either indirectly per paragraph 106 or directly by application of adhesive tape around the other surface of the outer wall); an elongated seat (10) arranged inside the dispensing module and extending along a longitudinal direction, the elongated seat comprising at least one rest portion (3a); a cartridge (11) arranged in the elongated seat and comprising a container holding the medicament; an elongated opening (between rest portions 3a) formed on the base wall at the elongated seat and configured to allow an insertion of the cartridge into the elongated seat through the elongated opening along an insertion direction (i.e. vertical in Fig. 1) that is orthogonal to the outer surface of the base wall; and retaining members (36, 37) configured to interact with the cartridge along a retaining direction and to lock the cartridge inside the elongated seat in a predetermined position (as shown in Fig. 2b), the retaining direction being parallel to or coincident with the longitudinal direction; wherein: the device has an initial configuration (as illustrated in Fig. 2a) in which the retaining members do not act on the cartridge along the retaining direction and the cartridge rests on the at least one rest portion and is movable in the elongated seat along the longitudinal direction; and the device has a final configuration (Fig. 2b) in which the retaining members interact with the cartridge along the retaining direction and lock the cartridge in the predetermined position.
Regarding claim 2, Donatis teaches that the cartridge does not contact or rest on the rest portion (3a).
Regarding claim 3, Donatis teaches that the retaining members comprise: a support element (36, left end in Fig. 2b) arranged at a first end portion of the elongated seat; and a pushing element (20) that, when the device is in the initial configuration, is arranged at a second end portion of the elongated seat, the pushing element being movable towards the support element to transition the device from the initial configuration to the final configuration.
Regarding claim 4, Donatis teaches that the container comprises an end portion (11a) proximate to the support element; and the support element comprises an abutment surface (36a) that, when the device is in the initial configuration, is in a position distal from the end portion and that, when the device is in the final configuration, is in abutment against the end portion.
Regarding claim 5, Donatis teaches that the cartridge comprises a plunger (15) sealingly arranged inside the container; and the pushing element comprises a piston (20)configured to exert a thrust on the plunger, wherein the thrust of the piston on the plunger is configured to causes a displacement of the cartridge towards the support element (paragraph 114) before the device reaches the final configuration, and wherein the thrust of the piston on the plunger is configured to cause a sliding of the plunger inside the container and an outflow of the medicament from the container through a piercing needle (7) after the device reaches the final configuration (paragraph 127).
Regarding claim 6, as best understood by the examiner, Donatis teaches a rest element (underneath the container 11 at the left end of 3a, as shown in Fig. 2a) configured to support the end portion of the container.
Regarding claim 7, Donatis teaches that the container comprises a main portion and a neck having a reduced section (see e.g. Fig. 2a), the neck being interposed between the main portion and the end portion, wherein, when the device is in the initial configuration, the neck rests on the rest element and the main portion rests at least indirectly on the at least one rest portion.
Regarding claim 8, Donatis teaches that the neck does not directly rest on the rest element in the final configuration (Fig. 2b), having moved to the left.
Regarding claim 9, Donatis teaches an upper shell (paragraph 107) which acts to close the elongated opening.
Regarding claim 17, Donatis teaches that the retaining members comprise: a support element (36, left end in Fig. 2b) arranged at a first end portion of the elongated seat; and a pushing element (20) that, when the device is in the initial configuration, is arranged at a second end portion of the elongated seat, the pushing element being movable towards the support element to transition the device from the initial configuration to the final configuration.
Regarding claim 18, Donatis teaches that the container comprises an end portion (11a) proximate to the support element; and the support element comprises an abutment surface (36a) that, when the device is in the initial configuration, is in a position distal from the end portion and that, when the device is in the final configuration, is in abutment against the end portion.
Regarding claim 19, Donatis teaches that the cartridge comprises a plunger (15) sealingly arranged inside the container; and the pushing element comprises a piston (20)configured to exert a thrust on the plunger, wherein the thrust of the piston on the plunger is configured to causes a displacement of the cartridge towards the support element (paragraph 114) before the device reaches the final configuration, and wherein the thrust of the piston on the plunger is configured to cause a sliding of the plunger inside the container and an outflow of the medicament from the container through a piercing needle (7) after the device reaches the final configuration (paragraph 127).
Regarding claim 21, Donatis teaches that the elongated opening is configured to allow insertion of the cartridge from an exterior of the device through the opening (which spans between the walls 3a) along the insertion direction. The examiner notes that the claim is silent to any other possible housing members, and as such, does not disclaim any housing member which may need to be removed to provide the claimed access.
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.
Claim(s) 10, 12-16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donatis in view of US Pre-Grant Publication 2011/0166512 to Both et al. (Both).
Regarding claim 10, Donatis teaches the limitations of claim 9 as discussed above, but does not teach a transparent closing door. Both teaches another delivery device generally, and particularly teaches an inspection window (30) for inspecting the contents of the cartridge (32) of the device. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a transparent inspection window as taught by Both to the door of Donatis in order to allow for visual inspection of the fluid being delivered. Alternatively, Donatis is silent to the attachment method of the closing door. Both teaches the use of welding in the delivery device (e.g. paragraph 54) for forming permanent connections. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use welding as taught by Both to form a permanent connection with the closing door of Donatis.
Regarding claims 12 and 20, Donatis is silent regarding ribs on the closing door. Both teaches ribs on the housing (see on 116 in Fig. 5) which correspond to and complement the shape of the elements in the interior. Those of ordinary skill in the art will appreciate that such ribs provide added structural strength. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide ribs as taught by Both to the closing door of Donatis in order to provide added strength.
Regarding claim 13, as illustrated in Fig. 5, Both teaches that the ribs are spaced from, i.e. do not contact, the interior elements. Those of skill will appreciate that this spacing prevents damage to and interference with the interior elements.
Regarding claim 14, Both teaches a plurality of such ribs, which all mutually reinforce each other. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide such a plurality to increase the added strength. Thus provided, any one of the plurality would constitute a perimeter rib and the rest would constitute reinforcing ribs.
Regarding claims 15 and 16, Donatis teaches that the dispensing module comprises an interface wall (sidewall above reference sign 5 in Fig. 2a) arranged on a side to the base wall opposite the cartridge. As discussed above, Both teaches that the dispensing module comprises an inspection window (30); and the cartridge is at least partially vertically interposed between the inspection window and the closing door of the elongated opening.
Response to Arguments
Applicant's arguments filed 24 June 2026 have been fully considered but they are not persuasive.
Applicant argues that the portions of Donatis mapped against the elongated opening are not on an outer surface. The examiner notes that there is no inside of the housing versus outside of the housing in the claim. In other words, there is no requirement that the outer surface face away from pump structure or the like. The bare configuration of a surface for application to skin does not convey any particular structure, since the upper surface of Donatis may be applied to skin by the use of adhesive tape holding it in that position, or indirectly in a manner more analogous to applicant’s. Accordingly, the examiner does not agree that the claim as drafted patentably distinguishes over Donatis. The examiner is open to standard interview practice and would be favorably disposed to grant such an interview before applicant’s further response.
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 14 September 2026
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