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
The examiner acknowledges the reply filed on 04/02/2026 in which claims 24, 32, 33, 39, 40, and 43, were amended. Claim 28 has been cancelled. Currently, claims 24-27 and 29-43 are pending for examination in this application.
Response to Arguments
With regards to the modification of the teachings of Stillman, in view of Lerner, applicant’s representative asserts the combination fails to teach the subject matter of “wherein the housing cover assembly consists of two housing covers arranged opposite each other relative to the longitudinal axis” (as incorporated into independent claims 24 and 43). Specifically, applicant’s representative states the combination fails to meets the claim language as the structure taught by Lerner “is not a housing cover assembly configured to hold a syringe in place relative to the housing.” The examiner respectfully disagrees. As noted in the standing rejection, the examiner has not relied upon the prior art to Lerner for teaching a housing cover assembly “configured to hold a syringe in place relative to the housing.” This functionality, as stated in the standing rejection, is clearly taught by the teachings of Stillman. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As such, the examiner finds applicant’s representative’s arguments unpersuasive and the rejection of under Stillman, in view of Lerner, is maintained.
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.
Claim 30 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.
[Claim 30] The claim, which depends directly upon amended independent claim 24, recites the “housing cover assembly is a single integral part.” The examiner is unable to determine the metes and bounds of the claim, since amended independent claim 24 now recites that the “housing cover assembly consists of two housing covers arranged opposite each other relative to the longitudinal axis.” As such, the limitations of claim 24 and claim 30 are contradictory. For purposes of examination, it is interpreted that claim 30 is in error and allows for the housing cover assembly to consist of two separate portions.
Claim Rejections - 35 USC § 112
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 29 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. Claim 29, which depends directly upon amended independent claim 24, recites “wherein the housing cover assembly comprises two separate housing covers.” This is not further limiting of the limitations recited in amended independent claim 24. 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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 24-27, 29-35, and 43, are rejected under 35 U.S.C. 103 as being unpatentable over Stillman (PGPub 2016/0082201), in view of Lerner (PGPub 2014/0039456).
[Claims 24, 29, 30, and 43] Stillman teaches a medicament delivery device (figure 5) comprising:
a housing (figure 5, item 102) extending along a longitudinal axis from a proximal end to a distal end (figure 5), where the housing (figure 5, item 102) comprises a tubular section (figure 5, item 113; paragraph [0017]) with an internal surface facing towards the longitudinal axis and an external surface facing away from the longitudinal axis (figure 5);
an aperture (figure 5, item 120) extending through the tubular section (figure 5, item 113) from the internal surface to the external surface (figure 5; paragraph [0017]);
a syringe carrier (figure 5, items 106/108) axially fixed within the housing (figure 5, item 102);
a syringe (figure 5, item 10) positioned within the syringe carrier (figure 5, items 106/108) and having a shoulder (figure 5, item 20) located at a proximal end of the syringe (figure 5, item 10); and
a housing cover assembly (figure 5, item 104) attached in the aperture (figure 5, item 120) of the housing (figure 5, item 102) (paragraph [0018]), where the housing cover assembly (figure 5, item 104) engages (figure 5, via item 151) the shoulder (figure 5, item 20) to axially fix the syringe (figure 5, item 10) relative to the housing (figure 5, item 102) (paragraph [0033]).
Although disclosing one or more features may be implemented into the device (paragraph [0035]), Stillman does not specifically disclose the housing cover assembly consists of two separate housing covers arranged opposite each other relative to the longitudinal axis.
However, Lerner teaches a medicament delivery device sub-assembly (figure 28, item 100) comprising a housing cover assembly (figure 28, items 112) consisting of two separate housing covers arranged opposite each other relative to a longitudinal axis (figures 29 and 30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Stillman, to have utilized two separate housing covers, as taught by Lerner, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
[Claims 25, 26, and 34] Stillman and Lerner teach the limitations of claim 24, upon which claims 25, 26, and 34, depend. In addition, Stillman discloses the housing cover assembly (figure 5, item 104) comprises a protrusion (figure 5, item 148) extending towards the longitudinal axis (figure 5);
wherein the protrusion (figure 5, item 148) of the housing cover assembly (figure 5, item 104) comprises a surface (figure 5) facing the distal end of the housing (figure 5, item 102), wherein the surface (figure 5) is shaped to fit between a medicament delivery shield and a shoulder of said syringe so as to support said shoulder of said syringe (the examiner notes both the “medicament delivery shield” and the “syringe” are only functionally recited within claims 24/26; as such, the “surface” taught by Stillman is functionally capable of meeting this limitation);
wherein the housing cover assembly (figure 5, item 104) comprises an arm (figure 5, item 140), where the protrusion (figure 5, item 148) of the housing cover assembly (figure 5, item 104) is attached to the arm (figure 5, item 140).
[Claim 27] Stillman and Lerner teach the limitations of claim 24, upon which claim 27 depends. Stillman also teaches a syringe (figure 5, item 10) in the housing (figure 5, item 102), and wherein the syringe (figure 5, item 10) is held relative to the housing (figure 5, item 102) by the housing cover assembly (figure 5, item 104) (paragraph [0033]).
[Claims 31-33] Stillman and Lerner teach the limitations of claim 24, upon which claims 31-33 depend. Stillman further discloses the housing cover assembly (figure 5, item 104) comprises a rigid arm (figure 5, item 148) which extends in a direction parallel (the examiner notes the arm has a thickness with is parallel to the longitudinal axis) to the longitudinal axis (figure 5).
[Claim 35] Stillman and Lerner teach the limitations of claim 24, upon which claim 35 depends. In addition, Stillman discloses the external surface of the tubular section (figure 5, item 113) is configured to be held by a user during use of a medicament delivery device comprising the medicament delivery device sub-assembly (figure 5; the examiner notes the structure is capable of meeting this functional limitation).
Claims 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Stillman (PGPub 2016/0082201), in view of Lerner (PGPub 2014/0039456), in further view of Roervig et al. (PGPub 2015/0174335).
[Claims 36 and 37] Stillman and Lerner teach the limitations of claim 24, upon which claims 36 and 37 depend. Stillman and Lerner do not specifically disclose the housing cover assembly comprises a window.
However, Roervig teaches a medicament delivery device sub-assembly (figure 9) comprising a housing cover assembly (figure 9, item 3a) having a window (figure 9, item 6), wherein a window frame (figure 9, item 11) extends around the window (paragraphs [0081], [0112]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Stillman and Lerner, to have utilized a window in the housing cover assembly, as taught by Roervig, in order to provide increased functionality and versatility, by allowing for an easy means by which a user might visually inspect the contents of the syringe within the housing (Roervig; paragraph [0081]).
Allowable Subject Matter
Claims 38-42 are 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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, 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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/JASON E FLICK/Primary Examiner, Art Unit 3783 06/05/2026
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