DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). No new matter should be entered.
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 subject matter (see below) 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.
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(s) 11-40 is/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 and/or under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
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 and their exists evidence that the fail(s) to correspond in scope with that which the inventor or a joint inventor, or for pre-AIA applications the applicant regards as the invention and therefore renders the interpreted subject matter of the claims unclear as the instant specification does not clearly support the verbiage of these claims, particularly in consideration of the broadest reasonable interpretation in light of the patent specification from which these claims were substantially copied (see U.S. Patent No. 11,400,221).
Regarding Claim(s) 11, 26, 28, and 29, Applicant recites “first and second radial protrusions” particularly reciting that these “protrusion” “extend radially outward from the collar”. However, this limitation creates confusion inasmuch as such “protrusions” are not identified in the specification such that there presents confusion as to what particular structure these “protrusions” must have and what it means, in the context of the disclosed invention, for such a “protrusion” to “extend radially outward from the collar”. A “distal supporting collar” is identified in the text of the specification as element (49 – see Fig. 1). This “distal supporting collar” is described as performing the function of “being arranged around the outer periphery of said syringe holder wall to support said syringe by the radially extending flange” (Par. 8). However, this collar does not appear to include any structure which could conceivably be considered to comprise a “first and second radial protrusion” which extend “radially outward from the collar”, especially ones formed as “elongate ribs” which extend parallel to one another. The only “radially” extending “protrusion” appears to be the contiguous rim of the collar itself (as opposed to two discrete “ribs”) and does not appear to be “elongate” in any common parlance of the phrase.
It is therefore unclear to what disclosed structure Applicant references. Examiner notes that the figures illustrate a number of different projections including, for example, “guiding means” (41), “snap-fitting fastening means 43” - as well as various unlabeled radially projecting elements (e.g. the sides of slot 48). However, none of these projections appear to be particularly associated with the identified distal “collar” as identified in the specification. As therefore it is unclear if the error of the offending claims lies in inconsistent interpretation of the “collar” (in a manner contrasting with its use in the specification) or an inconsistent interpretation of radially extending protrusions forming ribs (language not found in the specification).
The dependent claims provide no additional clarity and in fact introduce more uncertainty. For example - Claims 12, 14, 30, require the “ribs” to extend “in a plane perpendicular to a longitudinal axis of syringe carrier”, but no such “plane” is identified in the specification. Claim(s) 13, 14, 31 require the ribs to “extend parallel to a longitudinal axis”, but this phrasing is not used in the specification. Claim(s) 15, 31, 32 require the “ribs” of “each” the protrusions to additional elongate ribs suggesting that each “protrusion” comprises a total of two discrete ribs somehow constructing a singular “protrusion”. Claim(s) 16 require the protrusions to be spaced apart to define a “recessed region therebetween” – language that is not present in the specification and language having a broadest reasonable interpretation that does not appear to be consistent with the disclosed invention.
Regarding Claims 18 and 34, Applicant recites the limitation “the proximal surface… of the elongate body abuts the rigid needle shield”. However, this limitation renders the claim indefinite inasmuch as it uses the positive limitation “abuts” to describe an interaction between the elongate body and a component which appears to only have been previously functionally required (see Clm. 11 – re: “to allow a syringe” with the preamble setting forth that the claimed invention is directed toward the “syringe carrier”, per se).
Regarding Claims 21, Applicant recites “the rigid needle shield has an outer diameter substantially equal to an outer diameter of then barrel of the syringe”. However, this limitation requires a comparison to be made between the claimed “carrier” and a component (re: the syringe) which is only functionally recited such that determination as to infringement of the claimed invention cannot possibly be made until a specific syringe is selected to be paired with the claimed “carrier” to provide such a comparison whereby the exact same carrier could simultaneously infringe or not infringe (without any modification) depending upon what syringe the user intends to pair with the carrier.
Regarding Claims 24 and 39, Applicant recites “an aperture opposite the slot” – however so such “aperture” is identified in the specification. In fact, the side “opposite” the slot (48) is never illustrated so it is unclear to what “aperture” applicant could possibly reference unless the phrase “opposite the slot” is being used very loosely (Examiner notes that this phrase is likewise never used in the specification).
Regarding Claims 24 and 39, Applicant recites “a first projection that extends along an edge of the slot and a second projection that extends along an edge of the aperture”. However, such “projections” are never identified in the specification and therefore it becomes unclear if these are the same or different “projections” from those recited in the parent claim as well as what it means to “extend along an edge of the slot” and more particularly what it means to “extend along an edge of the aperture” whereby no aperture can be identified in the specification.
Regarding Claims 25 and 35, Applicant recites “a circumferential region of the syringe carrier between the first and second radial protrusions is free of radial protrusion”. However, this phrasing never appears in the specification and presents substantial confusion over that structure is being identified.
Regarding Claim 40, Applicant recites “the elongate rib of each of the first and second radial protrusions extends radially beyond a finger flange of the syringe”. Firstly, the instant claim requires a positive comparison between the carrier and a component (RE: the syringe) which is only functionally recited such that infringement cannot be determined until such time as the claimed carrier is specifically paired with an unrequired “syringe” for comparison. Furthermore, the specification fails to clearly disclose protrusions which “extends radially beyond a finger flange” such that it is not clear what it means to “extend radially beyond” the finger flange of the syringe.
Examiner submits that within the context of the instant specification the recited claims are unintelligible such that it is impossible for significant consideration of the instant claims over the prior art to be performed. The closest analogous prior art has been cited, but it is unclear if such art can or cannot be applied over the instant claims because Examiner has been provided with absolutely no clear standard by which the prior art can be applied over the broadest reasonable interpretation of the claims. It appears that Applicant may be attempting to use specific claim language found with respect to the claims of a patent family issued to Sanofi-Aventis Deutschland (see e.g. 11,400,221) and while these inventions, as disclosed, are very similar (in some embodiments) there does not appear to be significant consideration as to whether or not the instant application discloses an invention which actually supports the language of the instant claims.
For example, the issued claims of 11,400,221 recites language (see e.g. Clm. 1) which is significantly similar to that used in the instant application. However, this claim language directed toward “a first radial protrusion” and “a second radial protrusion” which “extends radially outward from said collar” as to comprise “ribs” is used in reference to the structure shown in Fig. 29-33 – e.g. 1.60 and 1.62 (see Col. 9) which are different in structure than the singularly contiguous rim of the collar (49) illustrated in Applicant’s invention. As such, the instant claims are alternatively rejected under 35 USC 112(a) inasmuch as they appear to attempt to claim a physical structure which is distinctive from that disclosed in the instant specification and which has not been demonstrated to have been in Applicant’s possession at the time of filing (i.e. Applicant’s invention appears to lack first and second ribs as understood in light of the broadest reasonable interpretation from the disclosure of the patent from which the instant claims were substantially copied). Examiner is unable to define any structure in the originally disclosed invention which would reasonably be considered to apprise the claimed “first and second radial protrusions extend radially outward from the collar, and each of the first and second radial protrusions comprises elongate ribs that extend parallel to one another” (among other limitations). The disclosed collar portion (49) comprises only a singular, unitary and contiguous projecting rim” which would not be reasonably considered to comprise discrete “first and second radial protrusions” formed, particularly, as “elongate ribs” as claimed.
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 –
Claim(s) 11-40 is/are rejected under pre-AIA 35 U.S.C. 102(b) and/or pre-AIA 35 U.S.C. 102(e) as being clearly anticipated by U.S. Patent No. 11,400,221 (“Houmand”).
Regarding Claim(s) 11-40, the instant claims are substantially copied from those issued in the Houmand patent save for the distal/proximal convention. However, Examiner submits that such a difference is not a distinction and refers to the same, equivalent ends as those claimed (and disclosed) in the Hourmand reference, where the reversal of the convention (proximal/distal) is merely a linguistic choice by the authors of the instant specification and the authors of Hourmand depending on whether they considered “proximal” and “distal” to be based on whether the hand performing the injection is considered the frame of reference OR the tissue area receiving the injection is considered the frame of reference. Examiner notes that the Hourmand has an earlier priority date (08 December 2011) and is presumed to provide proper written description support for the claimed subject matter. The instantly claimed subject matter as recited by Applicant, as noted above, does not appear to be “invented” by Applicant until the time of filing of the instant claim amendments 01 August 2023 whereby the disclosure of the Houmand reference substantially antedates the instant application (first published as a PGPUB on 24 February 2022 with the allowed claims first published in their current form on 22 June 2022 as part of the file wrapper for 17/453,257 which was publicly accessible on Public Pair and therefore publicly accessible using ONLY publicly available information – i.e. the application serial number).
Response to Arguments
Applicant’s remarks have been reviewed and carefully considered. In the instant case it does not appear as though Applicant has presented any arguments and appears to be in agreement with respect to the Non-Prior Art issues raised in the Non-Final Office Action and has provided no response with respect to the Prior Art rejections made in view of Hourmand. However, to the extent that the original intent of Applicant’s filing included substantially copied versions of the claims issued in Hourmand it is presumed that Applicant would acquiesce to Examiner’s findings that the claims of the instant patent are clearly taught by, at least, the issued claims of the Hourmand patent. As such, the original ground(s) of rejection are hereby maintained and made final.
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 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).
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, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
09/10/2025