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 .
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 “internal structure of the upper housing shell” in claim 1 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant disclosure lacks a written description of “at least one shell stop extending outward from the sidewalls and configured to engage an internal structure of the upper housing shell”. There is no description on how the motor body including the at least one shell stop is interacting with an internal structure of the upper housing shell. It is unclear if the reinforcing ribs in figure 12 are the internal structure.
It is also not clear from disclosure how the reinforcing ribs 144 and connecting wall 146 interacts with the motor body 159.
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.
Claim 20 is 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.
There is no antecedent basis for “the second subassembly”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The preamble of Claim 20 refers to a method of claim 15. However, claim 15 is directed to the drug delivery device. Therefore, the dependency is incorrect and does not further define the preamble claimed subject matter.
For examination purposes, the examiner will interpret this claim be dependent from claim 16.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Besson (US 20220160964 A1).
Regarding claim 13, Besson discloses a drug delivery device (100,300; figs 1-45) comprising:
an upper housing shell 46,320;
a lower housing shell 28,322;
a syringe 16 comprising a barrel 52, a stopper 54, and a needle 56, at least a portion of the syringe positioned within the lower housing shell (figs 2A,22);
a drive assembly 40 comprising a plunger body 80,82,304 configured to move the stopper within the barrel upon actuation of the drive assembly;
a cassette body 26,314 configured to receive the syringe; and
a motor body 42,302 configured to engage the cassette body, wherein the upper housing shell (46,320; figs 20 and 40) comprises:
a pair of spaced apart reinforcing ribs extending along a longitudinal axis of the upper housing shell; and
a connecting wall extending between and connecting the reinforcing ribs.
PNG
media_image1.png
595
576
media_image1.png
Greyscale
Regarding claim 14, Besson discloses the connecting wall extending from a proximal end of the upper housing shell (see figure 40 showing ribs extending from proximal end).
Regarding claim 15, Besson discloses the connecting wall terminates at a location between the proximal end of the upper housing shell and distal ends of the reinforcing ribs (see figure 40 for alternate interpretation).
PNG
media_image2.png
496
812
media_image2.png
Greyscale
Claims 16, 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Besson (US 20220134018 A1).
Regarding claim 16, Besson discloses a method of assembling a drug delivery device, the method comprising:
inserting a syringe 16 into a first subassembly 12, the first subassembly 12 comprising a cassette body 26;
removing a safety pin from a motor body 42 of a second subassembly 14 (fig 14; [0127]); and
bringing the second subassembly 14 into engagement with the first subassembly such that [0127]:
at least one cassette clip 328 of the motor body 42 ([0142-0143], (figs 26, 29-32)) engages at least one opening of the cassette body 314; and
an outer lip of the second subassembly 14,46 engages an inner lip of the first subassembly 12.
PNG
media_image3.png
545
771
media_image3.png
Greyscale
Regarding claim 18, Besson discloses wherein the motor body 302 (figs 27-28) comprises a pair of sidewalls 326 and at least one shell stop at 334,328,332 extending outward from the sidewalls 326, wherein the at least one shell stop 334 is configured to engage an upper housing shell 320 of the second subassembly 14,46 [0142,0148].
Regarding claim 19, Besson discloses wherein the at least one shell stop at 334,328,332 includes a cantilevered end and a radiused edge [0142].
Regarding claim 20, Besson discloses wherein an upper housing shell 320 of the second subassembly 14,46 (figs 26 and 44) comprises:
a pair of spaced-apart reinforcing ribs; and
a connecting wall extending between and connecting the reinforcing ribs.
PNG
media_image4.png
470
769
media_image4.png
Greyscale
Claim Rejections - 35 USC § 103
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 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 17 is rejected under 35 U.S.C. 103 as being unpatentable over Besson (US 20220134018 A1) in view of Appy et al (US 20210196894 A1).
Besson discloses the invention substantially as claimed. However, it fails to disclose applying a label to the first subassembly and the second subassembly.
Appy teaches a drug delivery device where a tamper label 1016 was placed outside the housing 1012 (fig 61) between an end cap 1050 and body 1012. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Besson by applying a label to the first and second subassemblies since it is well known in the art to place a tamper label on a drug delivery device as taught old and well known by Appy for tamper prevention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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.
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.
/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights