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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-17 in the reply filed on 25 March 2026 is acknowledged. Claims 18-20 is/are withdrawn as being directed toward a non-elected invention.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 5-8 and 16-17 are not found to be supported by the disclosure of the claimed parent application 17/123,968 and provisional application 62/949,984 and are therefore not entitled to the claimed priority date. These claims are afforded only the actual filing date of 11 September 2023. It is noted that the publication of 17/123,968 as U.S. Publication No. 2021/0187198 antedates the actual filing date for these claims by more than one year (24 June 2021 being the publication date of the ‘198 pre-grant publication).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-4 and 9-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-23 of U.S. Patent No. 11,752,269. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 1, the reference patent claims (see Clm. 1) each and every limitation of the instant claim 1 such that the issued claim anticipates the instant claim.
Regarding Claim 2, this claim is anticipated by the text of Clm. 1 of the issued reference patent.
Regarding Claim 3, this claim is anticipated by Clm. 2 of the issued reference patent.
Regarding Claim 4, this claim is anticipated by Clm. 3 of the issued reference patent.
Regarding Claim 9, this claim is anticipated by Clm. 6 of the issued reference patent.
Regarding Claim 10, this claim is anticipated by Clm. 7 of the issued reference patent.
Regarding Claim 11, this claim is anticipated by Clm. 1 of the issued reference patent.
Regarding Claim 12, this claim is anticipated by Clm. 8 of the issued reference patent.
Regarding Claim 13, this claim is anticipated by Clm. 13 of the issued reference patent.
Regarding Claim 14, this claim is anticipated by Clm. 11 of the issued reference patent.
Regarding Claim 15, this claim is anticipated by Clm. 12 of the issued reference patent.
Regarding Claims 6-8 and 16-17, these claims are not found to be anticipated by the claims of the issued reference patent and are likewise not found to be supported by the disclosure of the issued reference patent. As such, the prior filing constitutes prior art for these claims as detailed in the prior art rejections below.
Claim Rejections - 35 USC § 103
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(s) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0187198 (“Salari”) as applied above (see the Double Patenting Rejection), in further view of EP 0198708 (“Fumino”).
Regarding Claim 5-6, as discussed above, Salari discloses the invention substantially as claimed except that the trigger further comprises an “internal lever” when paired with a “trigger lever” of Claim 5. Salari does disclose an “internal lever” (25) biased toward a trigger element (26) by a return spring (27) disposed within the housing, but this trigger element (26) is a push-button and NOT the claimed “trigger lever”. However, Fumino discloses a related medicament delivery system (Fig. 1) which, in some embodiments, includes a telescoping push-button (5, 81 – Fig. 6) to trigger actuation. As an alternative to this telescoping push-button Fumino discloses that various alternative user actuatable triggering mechanism can be including various actuatable, pivoting trigger levers (86 – Fig. 7; 96 – Fig. 11) as alternatives to a telescoping push-button. It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the telescoping push-button of the invention of Salari with a pivoting, external lever trigger, as disclosed by Fumino, as a product of obvious design choice pursuant to the substitution of known equivalents to obtain a predictable and expected outcome, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Examiner notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Various minor changes in shape and arrangement of a pivoting/camming lever used to trigger the internal actuator lever of Salari, in view of Fumino are therefore obviated pursuant to obvious and expected modifications by the ordinary artisan in order to adapt a lever trigger into the system of Salari, whereby changes in shape and location are understood to be obvious design considerations by the ordinary artisan, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding Claim 7, Salari discloses, as modified in view of Fumino, provides for an internal extension means (see e.g. camming surface 96a - Fumino) connected to the trigger lever about the trigger lever pivot point (97 -Fumino), the internal extension is configured to counteract said return spring (52 – Fumino) when said trigger lever is engaged.
Regarding Claim 8, Salari discloses the return spring is a clip spring (27) biased against the internal lever of the trigger.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0187198 (“Salari”) as applied above (see the Double Patenting Rejection), in further view of WO 01/52920 (“Patel”).
Regarding Claim 16, Salari discloses the invention substantially as claimed except that the system further comprises a “prefilled syringe adapter” to permit aseptic transfer between a prefilled syringe into the fluid injection system. Salari does suggest a “vial adapter” (Par. 70) comprising a needle-free syringe connector end opposite a via connector end with a straw extending therethrough in order to assist a user in filling the syringe, but does not suggest that this “vial adapter” should be paired with a “pre-filled syringe”. However, Patel discloses a related fluid injection system (Fig. 2) wherein a needleless injector (12) can be provided with a pre-filled syringe adapter (70) for interfacing with a prefilled syringe (72), the adapter comprising a needle-free syringe connector end (82) opposite a prefilled syringe connector end (88) and a straw (96) extending therethrough, wherein the adapter is configured for sealing connection between a needle free syringe (24) and a prefilled syringe (72) to permit aseptic transfer of a fluid (28) from the prefilled syringe into the needle-free syringe (Fig. 3). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the invention of Salari with a prefilled syringe adapter, as disclosed by Patel, in order to allow for the system to be filled by prefilled syringe to allow for needle-less transfer of a medicament to a patient in a predictable and expected fashion to treat patients who are afraid of needles.
Regarding Claim 17, Salari, as modified in view of Patel, discloses the prefilled syringe adapter prefilled syringe connector end comprises a luer lock connector configured to engage with a luer lock prefilled syringe (see Fig. 15, 16). as an alternative to the illustrated luer slip arrangement (see Fig. 2, 3) both configurations being obvious variants of one another, either of which the ordinary artisan would have considered obvious for providing adapters to permit the device of Salari to be filled by various pre-filled syringe arrangements known to be encountered in the art.
Claim(s) 1-4 and 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 205322929 (“Xin”) in further view of U.S. Patent No. 4,874,367 (“Edwards”).
Regarding Claim 1, Xin discloses a fluid injection system (Fig. 1), comprising:
a housing (1) comprising an inner surface (6) and an outer surface (5) which extend from a proximal trigger end (3) to a distal dispensing end (2) along an injection axis (17);
a housing top retainer (see generally 18 – note specifically the cross-hatching which demonstrates that 18 is the transverse surface of a larger component which extends distally past the spring 11) at said trigger end, the retainer comprising a lower stop socket (see i.e. the distal right end – Fig. 2 – which forms a socket interface for receiving the corresponding geometry of the housing) and an upper pop-in socket (see i.e. the upper left end – Fig. 2 – which comprises a male feature which engages into a corresponding female feature);
A syringe adapter (4) connected to the dispensing end of the housing and configured to retain a needle-free syringe such that a plunger of the needle-free syringe is movable within the housing along the injection axis (Par. 34);
A piston (8) retained within the housing by the syringe adapter (note the diameter of 4 in association with the diameter of the radial shelf of the piston circa the head 7) and movable along the injection axis between a loaded position (Fig. 2) near the trigger end and an unloaded position (not shown; i.e. when spring 15 is uncompressed) near the dispensing end, the piston comprising a piston head (7) near the dispensing end and a trigger catch (10, 20) near the trigger end of the housing, the piston head being movably positioned to bias the plunger of the needle-free syringe along the injection axis (Par. 34);
A compression spring (15) associated with the piston, the piston and compression spring sized relative to the housing such that the compression spring is compressible along the injection axis within the housing (see Fig. 2); and
A trigger (16, 13) mounted within the housing near the trigger end and movable between a non-actuated position (Fig. 2) and an actuated position (not shown, i.e. when the trigger is depressed so as to disconnected 12, 19 from 10, 20) by depression of a user trigger means (16) positioned at said trigger end of the housing, the trigger comprising a trigger latch (12 – see particularly at 19) configured to engage the trigger catch when the trigger is in the non-actuated position (see Fig. 2) and the piston is in the loaded position and to release the trigger catch when the trigger is in the actuated position (Par. 34).
Xin discloses the invention substantially as claimed except that the housing top retainer specifically includes a “venting slot”. However, Edwards discloses a related fluid injection device (Fig. 1) which likewise includes a housing (12) and a housing top retainer (14) which includes a button (72) disposed through a transverse face thereof. Edwards discloses the housing top retainer to also include a “vent” (73) which “allows air to pass through the back wall 15 as the gun is cocked and/or fired” (Detailed Description, Par. 12). It would have been obvious for a person having ordinary skill in the art at the time the invention was made to configure the device of Xin to comprise a vent within the housing top retainer, as disclosed by Edwards, in order to allow for the venting of air from the housing top retainer incident to operation of the triggering mechanism as the piston is either cocked or released to improve operation of the device. Examiner submits that the precise location of the vent is an obvious design choice depending on user preference/ergonomics and the described utility to vent toward air between the retainer interior to the exterior, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Regarding Claim 2, Xin, as modified, discloses the invention substantially as claimed except for explicitly disclosing that “the housing, syringe adapter, and needle-free syringe are configured such that a sound created within the housing is directed toward the trigger end, away from a subject being injected, and out the venting slot”. However, Examiner notes that the construction of the Xin injection device is substantially similar to that described in the instant specification, the two inventions having substantially identical constructions save for the specific inclusion of a venting slot. Examiner further notes modification to the invention of Xin, in view of Edwards, to include a specific and particular venting slot in the trigger end of the housing, with the venting slot, as shown in Edwards, being clearly and unambiguous directed to provide direction of air (and therefore sound) toward the trigger end and away from a subject being injected (i.e. where the direction toward the subject being injected is toward the injection end of the device). As such, there is a reasonable conclusion that the device of modified Xin, when particularly provided with a venting slot of the type and general location described by Edwards, would, arrive upon the claimed invention in terms of satisfying the instant functional language pertaining to sound redirection through the venting slot.
Regarding Claim 3, Xin, as modified above, discloses the trigger catch comprises an annular engagement surface (see i.e. the annular shoulder at 10) extending radially outward from the injection axis and facing towards the dispensing end of the housing; and
The trigger latch comprises an engagement surface (see at 19) extending inwardly towards the injection axis and facing towards the trigger end of the housing (see Fig. 2), and which engages the annular engagement surface of the trigger catch when the trigger is in the non-actuated position and clears the trigger catch when the trigger is in the actuated position (Par. 34).
Regarding Claim 4, Xin discloses the trigger catch further comprises an annular beveled surface (see i.e. the face opposite 10) which faces away from the injection axis towards the trigger end of the housing (see Fig. 2); and
The trigger latch further comprises a beveled surface which faces towards the injection axis and towards the dispensing end of the housing (see i.e. the surface of 12 opposite 19).
Regarding Claim 9, Xin discloses wherein the safety cap is pivotally mounted to the external actuation surface of the housing top retainer (see Fig. 2 – see Par. 43).
Regarding Claim 10, Xin discloses the interior surface of the housing comprises a portion extending towards the injection axis and which blocks the compression spring from contacting the trigger (see Fig. 2 – see i.e. the transverse wall in apposition with the proximal end of the spring to thereby separate it from the trigger mechanism).
Regarding Claim 11, Xin discloses the syringe adapter comprising a rounded outer surface that extends away from the injection axis beyond the outer surface of the housing (See Fig. 2),
Regarding Claims 12 and 13, Xin, as modified, discloses the invention substantially as claimed except for explicitly reciting that the syringe adapter is “removable” and the housing is configured to removably accept alternatively configured syringe adaptors. However, Examiner notes that the figures of Xin appear to illustrate threads between the adapter and distal end of the housing (see Fig. 2) thereby suggesting to the ordinary artisan that the adapter and housing may be disassembled from one another. It would have been obvious for a person having ordinary skill in the art at the time the invention was made to make the adapter of Xin to be removable from the housing via the threads, since it has been held that constructing the components of a device to be separable from one another requires only routine and customary skill in the art, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). Such a construction would allow the device to be user serviceable allowing for the replacement of damaged components – the concept of replaceable parts being a hallmark of industrial innovation.
Regarding Claim 14, Xin, as modified, discloses the invention substantially as claimed except the syringe adapter is irremovably affixed to the dispensing end of the housing. However, it has been held that constructing in an integral fashion a device which was previously constructed of separable components requires only routine and customary skill in the art, see In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965), e.g. by using adhesive between the threads, in order to prevent tampering or accidental disassembly of the device. Examiner submits that the instant specification makes no particular claims as to any benefits of removable versus irremovable configurations and recalls them in a conclusory fashion that presents them as merely alternatives to one another (Par. 13) – as such, in association with prior jurisprudence, see In re Larson, 340 F.2d 965, 144 USPQ 347 (CCPA 1965) and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), constructing the adapter to be either removable or irremovable from the housing is found to be a mere obvious design choice conferring only the expected results of creating a configuration wherein the adapter can be easily removed by a user to allow for replacement/servicing of the device or irremovable to prevent tampering of the device.
Regarding Claim 15, Xin discloses the compression spring is retained around the piston by the piston head (see i.e. the radially enlarged shoulder of the piston head upon which the distal end of the compression spring abuts).
Claim(s) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 205322929 (“Xin”) in further view of U.S. Patent No. 4,874,367 (“Edwards”) as applied above, and further in view of EP 0198708 (“Fumino”).
Regarding Claims 5-6, as discussed above, Xin discloses the invention substantially as claimed except that the trigger further comprises an “internal lever” when paired with a “trigger lever” of Claim 5. Xin does disclose an “internal lever” (12) biased toward a trigger element (16) by a return spring (11) disposed within the housing, but this trigger element is a push-button and NOT the claimed “trigger lever”. However, Fumino discloses a related medicament delivery system (Fig. 1) which, in some embodiments, includes a telescoping push-button (5, 81 – Fig. 6) to trigger actuation. As an alternative to this telescoping push-button Fumino discloses that various alternative user actuatable triggering mechanism can be including various actuatable, pivoting trigger levers (86 – Fig. 7; 96 – Fig. 11) as alternatives to a telescoping push-button. It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the telescoping push-button of the invention of Xin with a pivoting, external lever trigger, as disclosed by Fumino, as a product of obvious design choice pursuant to the substitution of known equivalents to obtain a predictable and expected outcome, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Examiner notes that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Various minor changes in shape and arrangement of a pivoting/camming lever used to trigger the internal actuator lever of Xin, in view of Fumino are therefore obviated pursuant to obvious and expected modifications by the ordinary artisan in order to adapt a lever trigger into the system of Xin, whereby changes in shape and location are understood to be obvious design considerations by the ordinary artisan, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding Claim 7, Xin discloses, as modified in view of Fumino, provides for an internal extension means (see e.g. camming surface 96a - Fumino) connected to the trigger lever about the trigger lever pivot point (97 -Fumino), the internal extension is configured to counteract said return spring (52 – Fumino) when said trigger lever is engaged.
Regarding Claim 8, Xin discloses the return spring is a clip spring (11) biased against the internal lever of the trigger.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 205322929 (“Xin”) in further view of U.S. Patent No. 4,874,367 (“Edwards”) as applied above, and in further view of WO 01/52920 (“Patel”).
Regarding Claim 16, Xin discloses the invention substantially as claimed except that the system further comprises a “prefilled syringe adapter” to permit aseptic transfer between a prefilled syringe into the fluid injection system. However, Patel discloses a related fluid injection system (Fig. 2) wherein a needleless injector (12) can be provided with a pre-filled syringe adapter (70) for interfacing with a prefilled syringe (72), the adapter comprising a needle-free syringe connector end (82) opposite a prefilled syringe connector end (88) and a straw (96) extending therethrough, wherein the adapter is configured for sealing connection between a needle free syringe (24) and a prefilled syringe (72) to permit aseptic transfer of a fluid (28) from the prefilled syringe into the needle-free syringe (Fig. 3). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the invention of Xin with a prefilled syringe adapter, as disclosed by Patel, in order to allow for the system to be filled by prefilled syringe to allow for needle-less transfer of a medicament to a patient in a predictable and expected fashion to treat patients who are afraid of needles.
Regarding Claim 17, Xin, as modified in view of Patel, discloses the prefilled syringe adapter prefilled syringe connector end comprises a luer lock connector configured to engage with a luer lock prefilled syringe (see Fig. 15, 16). as an alternative to the illustrated luer slip arrangement (see Fig. 2, 3) both configurations being obvious variants of one another, either of which the ordinary artisan would have considered obvious for providing adapters to permit the device of Xin to be filled by various pre-filled syringe arrangements known to be encountered in the art.
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 05/19/2026
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