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
This Office Action is in response to the Applicant’s amendment filed 10 October 2025 wherein Claims 8 – 9, 25 – 26, and 28 – 30 are amended, Claims 31 – 38 are newly added, Claims 1 – 7, 10 – 22, 24, and 27 are or previously were cancelled, and Claim 23 is previously withdrawn. Therefore, Claims 8 – 9, 23, 25, 26, and 28 – 38 are currently pending within the Application.
The Applicant’s amendment to the Specification dated 10 October 2025 has been fully considered and is entered. The Applicant’s amendment to the Specification has overcome each Specification Objection set forth in the Non-Final Rejection dated 10 April 2025. Therefore, each Specification Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s replacement figures to the drawings dated 10 October 2025 have been considered and are entered.
The Applicant’s amendment to the Claims dated 10 October 2025 has overcome each Claim Objection set forth in the Non-Final Rejection dated 10 April 2025. Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendment to the Claims dated 10 October 2025 has overcome each Claim Rejection under 35 U.S.C. §§ 112(a) and 112(b) set forth in the Non-Final Rejection dated 10 April 2025. Therefore, each Claim Rejection under 35 U.S.C. §§ 112(a) and 112(b) set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 14 – 19, filed 10 October 2025, with respect to the rejection(s) of claim(s) under 35 U.S.C. §§ 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Salahshoor Kordestani (US 2018/0117253 A1).
Claim Objections
Claims 8 – 9, 32, 33, and 35 are objected to because of the following informalities:
Claims 8 and 9 each recite “The drug delivery system according to claim 25…”. This is the incorrect preamble because Claim 25 recites “A needle guide for guiding…”. Claims 8 and 9 are objected to because they recite the incorrect preamble of Claim 25 which they are dependent upon. The Examiner suggests amending the preamble of Claims 8 and 9 to recite “The needle guide according to claim 25…”
Claim 32 recites “a spherical body slidably disposed in the plurality of slots of the frame lumen, wherein the spherical body comprises a threaded bore; and.” Claim 32 is objected to because it is unclear which frame support the frame lumen is a part of. The Examiner suggests amending this to recite “a spherical body slidably disposed in the plurality of slots of the frame lumen of either frame support, wherein the spherical body comprises a threaded bore; and” to clarify that the spherical body can be disposed in the frame lumen of either frame support.
Claim 33 recites:
The needle guide of claim 25 wherein each of the needle supports comprises a body having a first portion sized to be smaller than the frame lumen and a second portion sized to be larger than the plurality of slots, whereby to allow the needle support to move longitudinally along a slot of the plurality of slots and to pivot relative to a longitudinal axis of the frame support, whereby to adjust the location and orientation of the needle support in the slot of the plurality of slots.
Claim 33 is objected to because it recites “the frame lumen,” “the plurality of slots,” and “the frame support.” It is unclear which frame support, frame lumen, and plurality of slots are being referred to. The Examiner suggests amending this to recite the following to resolve any confusion regarding which frame lumen or frame support is being referred to:
The needle guide of claim 25 wherein each of the needle supports comprises a body having a first portion sized to be smaller than the frame lumen of either frame support and a second portion sized to be larger than the plurality of slots of either frame support, whereby to allow the needle support to move longitudinally along a slot of the plurality of slots and to pivot relative to a longitudinal axis of [[the]] either frame support, whereby to adjust the location and orientation of the needle support in the slot of the plurality of slots.
Claim 35 recites the following:
The needle guide of claim 25 wherein each of the plurality of needle supports is selectively lockable to the frame to prevent longitudinal and pivotal movement of the needle support relative to the frame support.
Claim 35 is objected to because it recites “the frame support.” It is unclear which frame support is being referred to. The Examiner suggests the following amendment to clarify the claim language.
The needle guide of claim 25 wherein each of the plurality of needle supports is selectively lockable to the frame to prevent longitudinal and pivotal movement of the needle support relative to [[the]] either frame support.
Appropriate correction is required.
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.
Claim(s) 26, 28 – 30, and 36 – 38 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. 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.
Claim 26 recites “the plunger comprising a distal end and a proximal end, the proximal end comprising a finger grip, the syringe assist device comprising: a housing comprising a distal end and a proximal end, wherein the distal end of the housing comprises a slot for mounting to the finger grip of the plunger.” This subject matter 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 had possession of the claimed invention.
Figure 21A of the drawings and page 15 of the specification of the current application discloses that the finger grips of the syringe 20 are placed in slots 189 at the base of the syringe assist device. This contradicts the current claim language of claim 26 which recites that the finger grip of the plunger is placed in the slot. The disclosure of the current application does not support that the plunger may comprise a finger grip or that the housing comprises a slot for mounting the finger grip of the plunger. Therefore, Claim 26 fails to comply with the written description requirement.
Claims 28 – 30 and 36 – 38 are dependent upon Claim 26. Therefore, Claims 28 – 30 and 36 - 38 are rejected under 35 U.S.C. § 112(a) for the same rationale.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 26, 28 – 30, and 36 – 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salahshoor Kordestani (US 2018/0117253 A1 hereinafter referred to as “Salahshoor”).
With regards to claim 26, Salahshoor discloses (Figs. 2A – 2C) a syringe assist device (101) (see [0023]) for use with a syringe (218) (see [0024]) containing a drug (see [0027] “a vial section 219 that may hold the liquid medication”) which is to be delivered into a patient’s spine (see [0021] “patient’s body”), wherein the syringe comprises (a) a syringe body (219) having a cavity (see at 219 in Fig. 2B) containing the drug and an output port (see near 219 in Fig. 2B and [0027]), and (b) a plunger (220) (see [0027]) movably disposed in the cavity for driving the drug out of the output port, the plunger comprising a distal end (see the end opposite 223 in Fig. 2B) and a proximal end (223) (see [0027]), the proximal end comprising a finger grip (see at 223 in Fig. 2B), the syringe assist device comprising:
a housing (201) comprising a distal end (see at 202 in Fig. 2B) and a proximal end (see the end opposite 202 in Fig. 2B), wherein the distal end of the housing comprises a slot (see at 202 in Fig. 2B) for mounting to the finger grip of the plunger (see [0024] “Main body 201 may further include a threaded portion 202 at a distal end of main body 201 that may function as a coupling means for coupling main body 201 with medication cartridge assembly 218.” and [0027]);
a driver (103) (see [0023]) for engaging the plunger and moving the plunger so as to drive the drug contained in the cavity out of the output port (see [0027]); and
a power unit (107 or 207) for moving the driver (see [0025] - [0028]).
With regards to claim 28, Salahshoor discloses the claimed invention of claim 26, and Salahshoor further discloses (Figs. 2A – 2C) wherein the power unit (207) comprises a spring (see [0025] “spring 207”).
With regards to claim 29, Salahshoor discloses the claimed invention of claim 28, and Salahshoor further discloses (Figs. 2A – 2C) wherein the syringe assist device further comprises a member (211, 217) for releasably holding the spring (207) in an energized condition (see [0025]).
With regards to claim 30, Salahshoor discloses the claimed invention of claim 26, and Salahshoor further discloses (Figs. 2A – 2C) wherein the power unit (107) comprises an electrical motor (see [0028] “Linear actuating mechanism 107 may be a mechanism that transforms a rotary motion of an electric motor to a linear motion of engagement member 108”).
With regards to claim 36, Salahshoor discloses the claimed invention of claim 29, and Salahshoor further discloses (Figs. 2A – 2C) wherein the driver (103) (see [0023]) comprises a plurality of teeth (204) (see [0025]), and further wherein the member (211, 217) is configured to be received in at least one of the plurality of teeth (see Fig. 2C and [0025]).
With regards to claim 37, Salahshoor discloses the claimed invention of claim 29, and Salahshoor further discloses (Figs. 2A – 2C) wherein the member (211, 217) comprises a spring arm (217) (see [0025] – [0026]).
With regards to claim 38, Salahshoor discloses the claimed invention of claim 26, and Salahshoor further discloses (Figs. 2A – 2C) wherein the syringe assist device comprises a safety lock (211, 217) (see [0025] – [0026]) preventing longitudinal movement of the driver (103) (see [0023]).
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) 8, 9, 25, and 31 – 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 11,724,033 (hereinafter referred to as ’033 Patent). The ’033 Patent is cited in the Notice of References Cited form dated 10 April 2025. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
With regards to claim 25, Claims 1 or 10 of ’033 Patent recites a needle guide for guiding and holding a plurality of needles during insertion into a patient’s body (see Col. 10, lines 25 – 26 and Col. 11, lines 51 – 52), the needle guide comprising:
a frame comprising two frame supports and at least one arm adjustably connecting the two frame supports, wherein each of the frame supports comprises a frame lumen and a plurality of slots communicating with the frame lumen (see Col. 10, lines 35 – 39 and Col. 11, lines 61 - 65); and
a plurality of needle supports movably disposed in the plurality of slots, wherein the plurality of needle supports are longitudinally and rotationally movable within the plurality of slots, and further wherein each of the needle supports comprises a lumen for receiving a needle (see Col. 10, lines 40 – 44 and Col. 11, line 66 – Col. 12, line 3).
With regards to claim 8, Claims 1 or 10 of ’033 Patent recites the claimed invention of Claim 25, and Claims 2 or 11 of the ’033 Patent further recites wherein the frame supports are formed out of a radiolucent material, and further wherein the radiopaque markers are disposed on the frame supports (see Col. 11, lines 6 – 10 and Col. 12, lines 32 - 35).
With regards to claim 9, Claims 1 or 10 of ’033 Patent recites the claimed invention of Claim 25, and Claims 3 or 12 of the ’033 Patent further recites wherein the plurality of needle supports are formed out of a radiolucent material, and further wherein radiopaque markers are disposed on the plurality of needle supports (see Col. 11, lines 11 – 14 and Col. 12, lines 36 – 39).
With regards to claim 31, Claims 1 and 10 of ’033 Patent recites the claimed invention of Claim 25, and Claims 1 and 10 ’033 Patent further recites wherein the at least one arm comprises a telescoping arm (see Col. 10, lines 35 – 36 and Col. 11, lines 61 – 62).
With regards to claim 32, Claim 1 of ’033 Patent recites the claimed invention of Claim 25, and Claim 1 of the ’033 Patent further recites wherein each of the needle supports comprises:
a spherical body slidably disposed in the plurality of slots of the frame lumen, wherein the spherical body comprises a threaded bore; and
a body having a threaded projection sized to be threadingly received in the threaded bore of the spherical body;
such that (i) the body can be spaced from either frame support, whereby to allow each needle support to move longitudinally within the frame lumen of either frame support and to pivot relative to a longitudinal axis of either frame support; and (ii) the body can be brought into engagement with either frame support, whereby to lock each needle support against longitudinal movement and to prevent pivotal movement of each needle support (see Col. 10, line 51 – Col. 11, line 5).
With regards to claim 33, Claim 10 of ’033 Patent recites the claimed invention of Claim 25, and Claim 10 of the ’033 Patent further recites wherein each of the needle supports comprises a body having a first portion sized to be smaller than the frame lumen and a second portion sized to be larger than the plurality of slots, whereby to allow the needle support to move longitudinally along a slot of the plurality of slots and to pivot relative to a longitudinal axis of the frame support, whereby to adjust the location and orientation of the needle support in the slot of the plurality of slots (see Col. 12, lines 10 – 31).
With regards to claim 34, Claim 10 of ’033 Patent recites the claimed invention of Claim 25, and Claim 10 of the ’033 Patent further recites wherein each of the needle supports comprises:
a tubular body slidably disposed in the frame lumen of either frame support, wherein the tubular body comprises a pair of diametrically-opposed openings; and
a tapered member having a first portion smaller than the pair of diametrically-opposed openings and a second portion larger than the pair of diametrically-opposed openings;
such that (i) the first portion of the tapered member can be disposed in the pair of diametrically-opposed openings, whereby to allow the tubular body to move longitudinally within the frame lumen of either frame support and to rotate relative to a longitudinal axis of either frame support; and (ii) the second portion of the tapered member can be disposed in the pair of diametrically-opposed openings, whereby to lock the tubular body against longitudinal movement and to prevent rotational movement of the tubular body (see Col. 12, lines 10 – 31).
With regards to claim 35, Claims 10 and 11 of ’033 Patent recites the claimed invention of Claim 25, and Claims 10 and 11 of the ’033 Patent further recites wherein each of the plurality of needle supports is selectively lockable to the frame to prevent longitudinal and pivotal movement of the needle support relative to the frame support (see Col. 11, lines 1 – 5 and Col. 12, lines 26 – 31).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 12/23/2025