DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The amended drawings were received on 13 November 2025. These drawings are accepted.
Specification
The amendments to the specification were received on 17 October 2025. These amendments are accepted.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 35 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Publication No. 2010/0152655 (“Stamp”)
Regarding Claim 35, Stamp discloses a method of loading a syringe (inter alia 90, 92) into a syringe carrier (100), the syringe having a barrel (not labeled – i.e. the area between 90 and 92), a neck (92) having a smaller diameter than the barrel (see Fig. 9), a needle (not labeled; see Fig. 9) extending from the neck, and a rigid needle shield (17; Par. 76) configured to be removably arranged on the needle, and the syringe carrier comprising an elongate body having a partially cylindrical shape (see Fig. 7 – e.g. windows 103 and gaps 107 create a “partial” cylinder) with an internal diameter substantially corresponding to an outer diameter of the barrel (see Fig. 9), the elongate body comprising a collar (101) at a distal end of the elongate body and a longitudinal slot (i.e. the inner lumen) formed in a portion of the elongate body that is proximal of the collar and extends to a proximal end of the elongate body (see Fig. 8), the proximal end of the elongate body comprising shoulder sections (109) shaped as a portion of a circle arranged in a transverse plane with respect to a longitudinal axis of the syringe carrier (see Fig. 8), the method comprising:
sliding the syringe with the rigid needle shield removably arranged on the needle through the collar (Par. 81, 83, 84) in a proximal direction such that
the proximal end of the elongate body radially deflects when the rigid needle shield abuts the shoulder sections (Par. 81), and then
a portion (108) of the elongate body defining the longitudinal slot flexes radially inward over the barrel of the syringe as the elongate body returns to a non-deflected position as the rigid needle shield passes the shoulder sections (Par. 81), wherein the shoulder sections engage a circumferential gap between a proximal end of the barrel and the rigid needle shield to prevent the syringe from moving axially relative to the syringe carrier while the elongate body is in the non-deflected position (see Fig. 10), and a finger flange of the syringe is spaced distally from the collar of the syringe carrier when the shoulder sections are engaged in the circumferential gap between the barrel and the rigid needle shield (see Fig. 10; Par. 77, 102).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 35 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Publication No. 2010/0152655 (“Stamp”) as applied above, and further in view of U.S. Publication No. 2009/0012471 (“Harrison”)
Regarding Claim 35, should Applicant argue that the phrase “a partially cylindrical shape” in combination with the phrase “a longitudinal slot formed in a portion of the elongate body” requires the carrier to assume a configuration with a break to the cylindrical body extending through an end of the carrier such that the end does not have a circular face the following is presented.
As directed above, Stamp discloses the invention substantially as claimed except that that the longitudinal slot is formed through the side wall of the carrier such that the partially cylindrical shape is not wholly circumferential about the syringe, i.e. the carrier comprises a C-shape. However, Harrison discloses a related carrier (150) which is formed with a longitudinal slot extending through the proximal end wherein the slot creates a C-shaped partially cylindrical carrier (see Fig. 3). Harrison discloses that such a configuration allows the syringe to be side loaded and clipped into the syringe carrier (Par. 26). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the carrier of Stamp to be C-shaped, as disclosed by Harrison, in order to allow for the syringe to be either slid longitudinally through the carrier (as disclosed by Stamp) or side-loaded/clipped through the longitudinal slot (as disclosed by Harrison) depending upon user preference and familiarity with one loading format versus the other wherein either method of loading would have been obvious to employ in such a C-shaped configuration.
Response to Arguments
Applicant's arguments filed 13 November 2025 have been fully considered but they are not fully persuasive.
Applicant’s arguments with respect to the Drawing objections and rejections under 35 USC 112 in association with the Fareita Declaration filed on 17 October 2025 have been found persuasive.
Applicant furnishes no specific arguments with respect to the rejections made under 35 USC 102 or 35 USC 103 with consideration as to the primary reference of “Stamp”. Applicant alleges that the instant claims should be issued “for the same reasons that the claims of the ‘764 patent were issued”. However, this is not a valid or persuasive argument inasmuch as it does not particularly point out any particular or supposed errors in the rejection and further the scope of the issued claims in the ‘764 patent are NOT identical to those in the instant application.
While there may be some correlation between the claimed subject matter in the instant claim and those issued in the ‘764, it is noted that the instant claim diverges in scope from that of the issued patent such that there is no inherent presumption of validity enjoyed by issued claims. Here, the divergence in scope is pursuant to distinctive language used in the claims and in light of the broadest reasonable interpretation in consideration of both the instant specification, but as well as the specification of the issued patent. The distinctive claim language therefore creates a distinct claim which requires separate consideration over the prior art.
While the intent of the amendments was apparently to provoke interference Applicant’s usage of unique language in the instant claims re: “a portion of the elongate body defining the longitudinal slot flexes radially inward over the barrel of the syringe as the elongate body returns to a non-deflected position as the rigid needle shield passes the shoulder sections” versus “a portion of the elongate body defining the longitudinal slot snaps over the barrel of the syringe as the elongate body defining the longitudinal slot snaps over the barrel of the syringe as the elongate body returns to a non-deflected position as the rigid needle shield passes the shoulder sections”, is demonstrative that these are NOT the same claim and suggest that Applicant is pursuing a different scope in the instant claim versus the claims of the issued patent.
As such, consideration must be made to possible differences in scope to ALL claim limitations. Examiner makes no statement or avowal as to whether Stamp would or would not be readable on the claims of the ‘764 patent and analysis in the instant rejection is made ONLY with respect to the instantly elected claim which is unique from those issued in the ‘764 patent. Specifically, the instant Claim 35 (in contrast to the issued Claim 24 of the ‘764 patent) recites, inter alai:
“then (ii) a portion of the elongate body defining the longitudinal slot flexes radially inward over the barrel of the syringe as the elongate body returns to a non-deflected position as the rigid needle shield passes the shoulder sections…”
in contrast to:
“ii) a portion of the elongate body defining the longitudinal slot snaps over the barrel of the syringe as the elongate body returns to a non-deflected position as the rigid needle shield passes the shoulder sections…”
Here the phrase “snaps” in the ‘764 patent indicates a “snap-fit” arrangement which necessitates an internal resiliency as to the body portion which allows the body portion to be elastically flexed/deformed, but suddenly return to its original shape under a restorative elastic force once the source of flexing/deformation is removed. This is more specific than the instant claim language of “flexes radially inward” which COULD cover a snap-fit arrangement, but could also cover non-resilient flexing.
Given that the language of pending Claim 35 conspicuously deviates from issued Claim 25 of the ‘764 patent the claim presents unique and distinct issues that diverge from the issues of Claims 11-34 and 36 which more particularly correspond to the language of the issued claims of the ‘764 patent. Consideration must therefore be made independently from the consideration afforded in the ‘764 patent.
The instant Restriction Requirement is based on the claims AS PRESENTED in the instant Application and given the deviation of scope of the claims (see above and see also Claim 11 which includes distinctive language, re: ““the longitudinal slot is adapted to flex radially inward over the barrel of the syringe when the syringe is axially inserted through the collar and the portion of the elongate body defining the longitudinal slot” which is not only distinctive from the language of the elected Claim 35, but also distinctive from any of the issued claims of the ’764 patent), Examiner submits that current Examination cannot be beholden to any restriction requirements made or not made during the prosecution of the ‘764 patent.
Restriction here is appropriate inasmuch as separating the independent and distinct inventions streamlines prosecution and simplifies the number of issues to be considered during prosecution. Specifically, the claims which diverge in scope (e.g. 11 and 35) from those issued in the ‘764 patent must be separately considered over the prior art and cannot be presumed to be valid because they do not substantially correspond to the claims in an issued patent. Furthermore, for the reasons cited in the original requirement the method of using a syringe carrier (Clm. 35) is independent and distinct from the claimed syringe carrier (e.g. Clm. 11), per se, because the two claims positively require a different combination of hardware (e.g. Clm. 11 does not require the syringe) and different weight should be given to functional limitations directed toward how a syringe carrier, per se, could be used (particularly when not paired with a syringe) and how a method of using a syringe carrier with a particular syringe via necessary and specific method steps.
As such, the instant requirement is maintained.
With respect to the rejection of Claim 35 over Stamp, alone or in view of Harrison, is maintained with additional clarification provided below concerning the broadest reasonable interpretation. Here, particularly inasmuch as Applicant asserts that the scope of the limitations (at least those which are identical to those in the issued ‘764 patent) are intended to provoke an interference the broadest reasonable interpretation must be made not only in consideration of the instant specification, but also the scope of the ’764 specification (which presents multiple disclosed embodiments, see at least Fig. 4 and 32 which both have been printed on the covered sheet of the issued patent, but consider also ALL species Fig. 1-48 as they may or may not apply to the instant claim language).
For example, the phrase “partially cylindrical shape” should be understood as including not only the ‘C’-shaped profile of the instantly disclosed invention (see Fig. 2 of the instant application), but ANY profile which is constructed as an incomplete cylinder (see e.g. Fig. 4 of the issued ‘764 patent which also appears on the cover sheet of the issued patent being demonstrative that the claims of the issued patent were understood to be inclusive of such a configuration). Given such an interpretation, consideration of the invention of Stamp to be “partially cylindrical” would certainly be reasonable since it presents as an incomplete cylinder with various cut-outs (see e.g. windows 103 or slots 107) which interrupt the completeness of the cylinder in a manner similar to at least the embodiment of Fig. 4 of the issued ‘764 patent. It is further noted that the phrase “partially cylindrical” never appears in the instant patent application.
Likewise, phrases such as “a longitudinal slot formed in a portion of the elongate body that is proximal, of the collar and extends to a proximal end of the elongate body” would be understood to be similarly broad so as to encompass the profile of the inner lumen of the invention of Stamp inclusive to the slots (107) which permit flexing of the elongate body to accommodate a received syringe.
Additionally the phrase “extends to a proximal end of the elongate body”, must be understood to encompass a more general region of the body (re: proximal end) versus a narrower proximal terminal end. Specifically, looking at Par. 8 of the instant specification, Applicant recites, "said syringe having a proximal end comprising a neck..." As understood the "neck" of the syringe is not at the proximal-most end, but rather in a region which seats somewhat back from the proximal-most terminus under BRI. Likewise the "proximal end" (Par. 32) used to describe the autoinjector device, in general, points to a region set back a distance from the proximal-most face. As such, the breadth of “proximal end” in the instant specification is certainly broader than a proximal terminus. Likewise, consideration of the phrase in light of the issued ‘764 patent demonstrates the breadth of the phrasing. For example, the shoulder (1.4 – see Fig. 32 of the ‘764 patent) is claimed (and disclosed) as being part of the “distal [proximal] end”, but is set back a distance from the proximal terminus. This is clear that the “proximal end” (or “distal end” given the reference frame used in ‘764), as understood by the broadest reasonable interpretation of the instant claims, is a general region which extends some indeterminate distance back from the terminus and is therefore permissive to the location of the slots (107) and shoulder (109) of Stamp which extend in a region forward of the longitudinal midline of the carrier.
Furthermore, consideration has been made as to modifications of Stamp in view of Harrison which have not been specific addressed or rebutted by Applicant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783
01/02/2026