DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 31 October 2025 has been entered.
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) 27-29 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by U.S. Patent No. 3,076,455 (“McConnaughey”).
Regarding Claim 27, McConnaughey discloses a syringe holder system (e.g. Fig. 1), comprising:
a syringe holder (10) comprising—
a proximal end portion (circa 16) having a proximal support collar (16);
a distal end portion (circa 18) having a distal support collar (18); and
a holder wall (14) extending between the proximal and distal end portions (see Fig. 1), the holder wall having a slot extending distally from the proximal end portion such that the syringe holder has a c-shaped cross- sectional shape at the proximal end (see Fig. 1),
wherein the syringe holder is configured to receive a rigid needle shield of a syringe through the distal end portion, and wherein, when the syringe advances proximally through the syringe holder, the rigid needle shield moves along the proximal support collar, causing the c-shaped proximal support collar to flex radially outward to allow the rigid needle shield to extend beyond the proximal end portion (see Col. 3, Ln. 60-71).
Specifically, Examiner notes the functional nature of this limitation and notes that neither the syringe nor rigid needle shield are specifically required by the instant claim. Here the phrase “configured” to receive is held to be met by the design considerations of McConnaughey which create a device which is suited for use in the claimed manner when paired with a suitably sized and dimensioned syringe, wherein the holder of McConnaughey is not limited to ONLY the syringe (20) specifically illustrated, but may be used with a variety of different syringes having differing diameters and exterior profiles. Particularly, McConnaughey describes that the holder material has an inherent “resiliency” with walls which are “springy” to permit lateral deflection “without difficulty or damage”. This is held to constitute the structural limitations required by the “configured” to language of the claims.
Here, the design of McConnaughey, if provided with a syringe and needle shield wherein the needle shield (not positively required by the claims) is only minimally larger than the inner diameter at the proximal collar (16) and provided with a tapered shape such that the proximal end passes through the center of the collar (16) unencumbered and the increasing diameter of the shield serves as a ramp/inclined plane, will certainly be configured to receive a rigid needle shield of a syringe (the suitably dimensioned, but unrequired syringe) through the distal end portion, and wherein, when the syringe advances proximally through the syringe holder, the rigid needle shield moves along the proximal support collar, causing the c-shaped proximal support collar to flex radially outward to allow the rigid needle shield to extend beyond the proximal end portion.
Regarding Claim 28, McConnaughey discloses the distal support collar comprises protrusions (18) extending radially outward from the holder wall and configured to support a flange of the syringe (Fig. 1).
Regarding Claim 29, McConnaughey discloses a construction which, when paired with a suitably dimensions syringe and shield combination, is configured such that when a distal end of the rigid needle shield is moved proximal to the proximal support collar, the proximal support collar is configured to flex back radially inward behind the rigid needle shield (see Col. 3, Ln. 60-71).
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.
Claim 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 3,076,455 (“McConnaughey”) as applied above, and further in view of U.S. Patent No. 5,137,516 (“Rand”).
Regarding Claim 30, McConnaughey discloses the invention substantially as claimed except that that the system comprises an “autoinjector housing configured to receive the syringe holder”. Examiner notes that the phrase “autoinjector housing” is exceedingly broad as claimed, particularly inasmuch as the claim does not set forth a function of the “housing” or how, precisely, it is “configured to receive the syringe holder”. Examiner submits that under the broadest reasonable interpretation of such a non-descript claim limitation that the “autoinjector housing” could reference a simple case/packaging which holds an autoinjector/syringe. For example, Rand describes a syringe may be provided as part of a kit (1) comprising a housing (2) for an auto-injector (10). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of McConnaughey with a housing configured to receive the syringe holder (along with any other necessary additional components and accessories), as disclosed by Rand, in order to provide a convenient kit to assist a user in storing their injection device and injectables for use as needed.
Claim(s) 27-30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2007/083115 (“Stamp”) in view of U.S. Publication No. 2009/0012471 (“Harrison”).
Regarding Claim 27, Stamp discloses a syringe holder system (100), comprising:
a syringe holder (100) comprising—
a proximal end portion (104 to 110) having a proximal support collar (109);
a distal end portion having a distal support collar (10); and
a holder wall (102) extending between the proximal and distal end portions;
wherein the syringe holder is configured to receive a rigid needle shield (17) of a syringe through the distal end portion, and wherein, when the syringe advances proximally through the syringe holder, the rigid needle shield moves along the proximal support collar, causing the proximal support collar to flex radially outward to allow the rigid needle shield to extend beyond the proximal end portion (see Pg. 13 and 14).
Stamp discloses the invention substantially as claimed except that that the holder wall has a slot extending distally from the proximal end portion such that the syringe holder has a c-shaped cross-sectional shape at the proximal end. Rather, Stamp illustrates the holder to be wholly circumferential. However, Harrison discloses a related syringe holder (150) which comprises a slot extending distally from the proximal end portion such that the syringe holder has a c-shaped cross-sectional shape at the proximal end in order to allow the syringe and shield to be inserted laterally (Par. 14, 26). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the holder of the invention of Stamp to comprise a slot defining a C-shaped profile, as disclosed by Harrison, in order to allow the syringe to be inserted either axially (as described by Stamp) or laterally (as described by Harrison) depending on user preference.
Regarding Claim 28, Stamp illustrates that the distal collar can be provided without a protruding rim (see Fig. 9) or with a protruding rim (see Fig. 21), where Harrison illustrates that when a syringe holder is provided with a protruding rim in a split carrier the distal supporting collar will comprise protrusions extending radially outward from the holder wall (see Fig. 3). 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 have protrusions at the distal collar, as illustrated in association with Harrison, since Stamp and Harrison both illustrate that a protruding collar is a valid design construction for such a holder. In the instant case neither Stamp nor Harrison expressly discuss using the protrusions to “support” a flange of the syringe, however, Examiner notes that the syringe is not positively required.
Regarding Claim 29, Stamp discloses when a distal end of the rigid needle shield is moved proximal to the proximal support collar, the proximal support collar is configured to flex back radially inward behind the rigid needle shield (Pg. 13 and 14).
Regarding Claim 30, Stamp discloses an autoinjector housing configured to receive the syringe holder (see Fig. 4).
Response to Arguments
Applicant argument (Pg. 6-7) regarding Harrison have been found persuasive. Specifically, in the instant case the disclosure of Harrison has not specifically and particularly established that the proximal c-shaped collar is necessarily “flexible”. Particularly sufficiently flexible so as to permit a rigid needle shield having a diameter larger than the diameter of the collar to be moved along the holder and through the collar so as to “flex radially outward to allow the rigid needle shield to extend beyond the proximal end portion”.
Applicant's arguments filed with respect to McConnaughey and Stamp in view of Harrison have been fully considered but they are not persuasive.
Applicant argues (Pg. 8) “Thus, McConnaughey’s holder provides for lateral insertion of a syringe”. However, this is not persuasive. The instant claim is directed toward the syringe holder, per se, and does not positively require the “a syringe” or “a rigid needle shield” which are only functionally recited in association with the claim. The limitations directed toward this syringe are very limited and do not specify any particular or specific structural qualities about the syringe other than it must be sized and shaped such that its rigid needle shield must be able to be received “through the distal end portion” and when advanced proximally along then proximal support collar the diameter of the syringe is within the range that causes the c-shaped proximal support collar to flex radially outward to allow the rigid needle shield to extend beyond the proximal end portion.
However, as noted above, it is well-understood that syringes (and their caps/rigid needle shields) may assume a wide variety of shapes and sizes dependent upon intended application (e.g. volume of injectate), desired ergonomics, and mere design preference. Here the functional language must be understood as merely intending to bound the diameter of the syringe holder distal and proximal ends such that they, in association with the inherent flexibility of the syringe holder, are of a suitable size to permit passage of A syringe and shield combination through the diameter of the distal collar AND nominally flex at the proximal end to permit receipt of the rigid needle shield therethrough as the syringe is passed proximally through the holder and collars, where such “A” syringe may comprise any of the multitude of designs known to the prior art, but also conventional variations to those designs.
Here the syringe holder of McConnaughey is formed in a manner such that the walls “must be springy enough to permit the cartridge to be pressed laterally into the holder without difficulty or damage to the cartridge…” As such, it is understood that proximal c-shaped collar of the holder of McConnaughey is configured to flex radially outward in the event that a suitably diameter syringe is passed therethrough, whereby there is no difference in the ability of the syringe collar to flex from lateral insertion versus longitudinal insertion. McConnaughey also illustrates the distal end of the syringe (see at 12) to be larger than the diameter of the proximal c-shaped collar (16) such that ANY article having a sufficient diameter to provide receipt through the proximal collar (16) can certainly be passed through the distal collar, as required by the claim. As such, the holder of McConnaughey is clearly configured such that when paired with a syringe having a necked down portion smaller than the outer diameter of the syringe and nominally larger than the diameter of the proximal collar and having a rigid needle shield likewise only nominally larger than the diameter of the proximal collar will perform in the claimed functional manner.
Here, the “purposeful design” of the claimed invention is understood to be qualified by the “springy” nature of the holder of McConnaughey which is purposefully designed specifically and intentionally to permit resilient bending of the proximal c-shaped collar when a suitably diameter object is passed therethrough as well as consideration that the distal collar of the holder has been designed such that it is larger in diameter than the proximal collar. This is in contrast with Harrison which does not appear concerned with the inherent resilient flexibility of the holder nor consideration of receipt of the syringe barrel through the open end of the distal collar. As such, it is clear that McConnaughey is configured in a manner not explicitly contemplated by Harrison, but which relevant to the broad functional language recited in the instant claims.
Applicant’s arguments with respect to Stamp, as modified by Harrison, do not actually address the fact that the Stamp reference is the primary reference and clearly pertains to longitudinal insertion of the syringe through the syringe holder when paired with radial flexing of the proximal supporting collar to permit passage of the rigid needle shield therethough. Applicant’s remarks and arguments do not address the modifications of Stamp to obviate a C-shaped proximal end configuration, in view of Harrison, to permit a user to insert a syringe through the holder in EITHER a longitudinal or lateral manner. As such, Applicant’s remarks/arguments are incomplete and cannot be found persuasive.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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).
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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
02/09/2026