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
The amendment filed on 10/29/2025 has been entered. Claims 1-8, 10, and 22-26 are pending in the application. Claims 9 and 11-21 are cancelled. Claim 26 is new. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 4/29/2025.
Claim Objections
Claims 3 and 24-26 are objected to because of the following informalities:
-Claim 3, line 2: please correct “and” to “or”
-Claim 24, line 1: please correct “the recess” to “the first recess”
-Claim 24, line 2: please correct “the recess” to “the second recess”
-Claim 25, line 18: please correct “the other periphery” to “the outer periphery”
-Claim 26, line 4: please correct “projector” to “protector”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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.
Claim 4 recites the structure “the locking structure” in line 1. Since claim 25, from which claim 4 depends, has been amended to change “a locking structure” to “a first locking structure” and “a second locking structure”, it is unclear whether “the locking structure” in claim 4 should be interpreted as “the first locking structure”, “the second locking structure”, “one of the first locking structure or the second locking structure”, “at least one of the first locking structure or the second locking structure”, or “the first locking structure and the second locking structure”. For examination purposes, the Examiner interprets “the locking structure” in claim 4 as “the first locking structure and the second locking structure”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, 22, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Sasso (US 2002/0111581 A1) in view of Wu et al. (US 2012/0041253 A1). Note: the rejection of claim 25 is written before the rejections of claims 1-8, 10, 22-24, and 26 since claims 1-8, 10, 22-24, and 26 depend from claim 25.
Regarding claim 25, Sasso discloses an assembly (see Figs. 1-4) to deliver a fluid into an anatomic space of a patient (see par. [0030]), the assembly comprising:
a needle (needle 22) to penetrate into the anatomic space and connected to a needle tubing (flexible tubing 58) along a first longitudinal axis (longitudinal axis of flexible tubing 58, see Fig. 1) (see Figs. 1-4, par. [0020]-[0021] and [0030]);
a needle protector (hub 26 and wings 28 and 30) having a body (body of hub 26 and wings 28 and 30) having a second longitudinal axis (longitudinal axis of wings 28 and 30) perpendicular to the first longitudinal axis (longitudinal axis of flexible tubing 58) (see Figs. 1-4), the needle protector (hub 26 and wings 28 and 30) having a first extension (wing 28) and a second extension (wing 30) hinged to the body (body of hub 26 and wings 28 and 30) and movable between a closed, compact position (see Figs. 2-4) and an expanded, open position (see Figs. 1-2, par. [0023]-[0027]), each of the first extension (wing 28) and the second extension (wing 30) having an outer periphery (outer edge of wings 28 and 30) at least partially surrounding an interior surface (inner surface of wings 28 and 30) (see Figs. 1-4), the first extension (wing 28) also having a first locking structure (posts 44/46/48) to mate with a second locking structure (apertures 50/52/54) of the second extension (wing 30) and lock the first extension (wing 28) and the second extension (wing 30) together in the closed, compact position (see Figs. 1-4, par. [0029]); and
a first recess (slot 34) disposed in the first extension (wing 28) and a second recess (slot 40) disposed in the second extension (wing 30) to guide and maintain the needle protector (hub 26 and wings 28 and 30) in a substantially 90 degree orientation relative to the first longitudinal axis (longitudinal axis of flexible tubing 58) prior to insertion into the anatomic space (see Figs. 1-4, par. [0025]-[0029], note: "prior to insertion into the anatomic space" is a functional limitation and the wings 28 and 30 are capable of being opened and closed prior to insertion into the anatomic space since posts 44/46/48 are releasable from apertures 50/52/54 and the living hinges of wings 28 and 30 allow the wings 28 and 30 to readily flex open and closed), the first recess (slot 34) having a first opening (opening of slot 34 closest to flexible tubing 58, see Fig. 1) at an end opposite the first longitudinal axis (longitudinal axis of flexible tubing 58) (see Fig. 1) and the second recess (slot 40) having a second opening (opening of slot 40 closest to flexible tubing 58, see Fig. 1) at an end opposite the first longitudinal axis (longitudinal axis of flexible tubing 58) (see Fig. 1).
However, Sasso fails to expressly state the first opening of the first recess extends through the outer periphery of the first extension along the second longitudinal axis, and the second opening of the second recess extends through the outer periphery of the second extension along the second longitudinal axis.
Wu teaches an assembly (see Figs. 1-4) comprising a first recess (groove 211) disposed in a first extension (wing 21) and having a first opening (opening of recess 211 closest to needle body 12, see Fig. 1) at an end opposite the first longitudinal axis (longitudinal axis of needle body 12) that extends through the outer periphery (peripheral edge of wing 21) of the first extension (wing 21) along the second longitudinal axis (longitudinal axis of wings 21 and 22) (see Figs. 1-4, par. [0026]), and a second recess (groove 221) disposed in the second extension (wing 22) and having a second opening (opening of recess 221 closest to needle body 12, see Fig. 1) at an end opposite the first longitudinal axis (longitudinal axis of needle body 12) that extends through the outer periphery (peripheral edge of wing 22) of the second extension (wing 22) along the second longitudinal axis (longitudinal axis of wings 21 and 22) (see Figs. 1-4, par. [0026]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the first and second recesses of Sasso such that the first and second openings extend through the outer periphery of the first and second extensions, respectively, along the second longitudinal axis, as taught by Wu, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (ССРА 1966). In the instant case, the assembly of Sasso would not operate differently with the claimed shape since the modification would simply adjust the first and second recesses of Sasso, which are already present, to extend to the outer periphery of the first and second extensions.
Regarding claim 1, modified Sasso teaches the assembly of claim 25 substantially as claimed. Sasso further teaches wherein the first extension (wing 28) and the second extension (wing 30) are movable between the closed, compact position (see Figs. 2-4) and the expanded, open position (see Figs. 1-2) without any significant biasing force tending to force the first extension (wing 28) and the second extension (wing 30) into either of the closed, compact position (see Figs. 2-4) or the expanded, open position (see Figs. 1-2) (see par. [0025]-[0029], since posts 44/46/48 are releasable from apertures 50/52/54 and the living hinges of wings 28 and 30 allow the wings 28 and 30 to readily flex open and closed, there is no significant biasing force forcing the wings into the closed or open positions).
Regarding claim 2, modified Sasso teaches the assembly of claim 1 substantially as claimed. Sasso further teaches wherein the interior surface of the first extension (wing 28) comprises a first guide (projecting wall 38) and the interior surface of the second extension (wing 30) comprises a second guide (recess 42), wherein the first (projecting wall 38) and second guide (recess 42) prevent misalignment during movement of the first extension (wing 28) and the second extension (wing 30) to the closed, compact position (see Figs. 1-4, par. [0028]-[0029]).
Regarding claim 3, modified Sasso teaches the assembly of claim 2 substantially as claimed. Sasso further teaches wherein the first guide (projecting wall 38) comprises a first guiding mechanism (projecting wall 38 is a guiding mechanism in that it guides alignment of the wings 28/30) and the second guide (recess 42) comprises a second guiding mechanism (recess 42 is a guiding mechanism in that it guides alignment of the wings 28/30), wherein one of the first guiding mechanism (projecting wall 38 is a guiding mechanism in that it guides alignment of the wings 28/30) and the second guiding mechanism (recess 42 is a guiding mechanism in that it guides alignment of the wings 28/30) comprises a curved protrusion (projecting wall 38 is a protrusion which has curved surfaces and the peripheral walls of recess 42 are protrusions which have curved surfaces) (see Figs. 1-4, par. [0028]-[0029]).
Regarding claim 4, modified Sasso teaches the assembly of claim 25 substantially as claimed. Sasso further teaches wherein the first locking structure (posts 44/46/48) and the second locking structure (apertures 50/52/54) are configured to provide sensory feedback to a user to indicate the first extension (wing 28) and the second extension (wing 30) are in the closed, compact position (see Figs. 1-4, par. [0029], see 112b rejection/interpretation of claim 4 above).
Regarding claim 5, modified Sasso teaches the assembly of claim 25 substantially as claimed. Sasso further teaches wherein the body (body of hub 26 and wings 28 and 30) comprises a hub (hub 26) and the first extension (wing 28) comprises a first wing (wing 28) extending from the hub (hub 26) and the second extension (wing 30) comprises a second wing (wing 30) extending from the hub (hub 26) (see Figs. 1-4), with the first locking structure (posts 44/46/48) comprises a projection (posts 44/46/48 are projections) and the second locking structure (apertures 50/52/54) comprises a recess (apertures 50/52/54 are recesses) to receive the projection (posts 44/46/48 are projections) (see Figs. 1-4, par. [0029]).
Regarding claim 22, modified Sasso teaches the assembly of claim 25 substantially as claimed. Sasso further teaches wherein the body (hub 26 and wings 28 and 30) is in the closed, compact position (see Figs. 2-4) but not a locked position prior to the insertion (see Figs. 2-4, par. [0029], posts 44/46/48 are releasably connectable to apertures 50/52/54 such that wings 28 and 30 are not completely locked to each other while closed).
Regarding claim 24, modified Sasso teaches the assembly of claim 25 substantially as claimed. Sasso further teaches wherein the recess (slot 34) disposed in the first extension (wing 28) is a mirror image of the recess (slot 40) disposed in the second extension (see Figs. 1-4, par. [0028]-[0029]).
Regarding claim 26, modified Sasso teaches the assembly of claim 25 substantially as claimed. Modified Sasso further teaches wherein the first recess (Sasso, slot 34) has a third opening (Sasso, opening of slot 34 furthest from flexible tubing 58, see Fig. 1) near the first longitudinal axis (Sasso, longitudinal axis of flexible tubing 58) at an end opposite the first opening (Sasso, opening of slot 34 closest to flexible tubing 58, see Fig. 1) and the second recess (Sasso, slot 40) has a fourth opening (Sasso, opening of slot 40 furthest from flexible tubing 58, see Fig. 1) near the first longitudinal axis (Sasso, longitudinal axis of flexible tubing 58) at an end opposite the second opening (Sasso, opening of slot 40 closest to flexible tubing 58, see Fig. 1), and wherein the needle (Sasso, needle 22) extends through the first and second openings (Sasso, openings of slots 38 and 40 closest to flexible tubing 58, see Fig. 1, see previous modifications in rejection of claim 25 above) when the needle protector (Sasso, hub 26 and wings 28 and 30) is moved to the closed, compact position (see Sasso Figs. 2-4, Sasso par. [0028]-[0029], see previous modifications in rejection of claim 25 above, see Wu Figs. 3-4).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Sasso (US 2002/0111581 A1) in view of Wu et al. (US 2012/0041253 A1), as applied to claim 5 above, further in view of Rogers et al. (US 2019/0030293 A1).
Regarding claim 6, modified Sasso teaches the assembly of claim 5 substantially as claimed. However, modified Sasso fails to state wherein at least one of the first extension or the second extension comprises: a raised surface including a plurality of substantially smooth, spaced projections to increase a surface area of the interior surface(s) of the at least one of the first extension or the second extension and create a diffuse patient contact surface for contacting the patient without causing substantial pain or irritation.
Rogers teaches an assembly (see Figs. 17A-B) to deliver a fluid into an anatomic space of a patient (see par. [0039]) wherein at least one of the first extension or the second extension (wings 312) comprises: a raised surface (ridges, gripping members, see par. [0068]) including a plurality of substantially smooth, spaced projections (ridges, gripping members, see par. [0068]) to increase a surface area of the interior surface(s) (bottom surface of wings 312) of the at least one of the first extension or the second extension (wings 312) and create a diffuse patient contact surface for contacting the patient without causing substantial pain or irritation (see par. [0068]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sasso to include wherein at least one of the first or the second extension comprises: a raised surface including a plurality of substantially smooth, spaced projections to increase a surface area of the interior surface(s) of the at least one of the first extension or the second extension and create a diffuse patient contact surface for contacting the patient without causing substantial pain or irritation, as taught by Rogers, in order to assist with gripping during venipuncture and with adhering the extensions to the patient's skin (see Rogers par. [0068]).
Regarding claim 7, modified Sasso teaches the assembly of claim 6 substantially as claimed. Sasso further teaches hinges connecting the first wing (wing 28) and the second wing (wing 30) to the hub (hub 26) (see Figs. 1-4, par. [0027]), the hinges being in a neutral and substantially un-compressed state when the first wing (wing 28) and the second wing (wing 30) are in the expanded, open position (see Figs. 1-2) and the hinges are disposed no more than 10 degrees from horizontal when the first wing (wing 28) and the second wing (wing 30) are in the expanded, open position (see Figs. 1-2, par. [0027] and [0029], wings 28 and 30 are fully flat in the open position such that the hinges of wings 28 and 30 are 0 degrees from horizontal in the open position).
Regarding claim 8, modified Sasso teaches the assembly of claim 7 substantially as claimed. Sasso further teaches wherein each of the hinges is less thick than a remainder of the first wing (wing 28) and the second wing (wing 30) (see Fig. 2, par. [0027]), and that less force is required to lock the first wing (wing 28) and the second wing (wing 30) in the closed, compact position (see par. [0027] and [0029]) than to unlock the first wing (wing 28) and the second wing (wing 30) (see Fig. 2, par. [0027] and [0029]; since posts 44/46/48 and apertures 50/52/54 engage to lock the wings 28 and 30, it would require more force to disengage/unlock the posts 44/46/48 than to lock them).
However, modified Sasso fails to explicitly state wherein each of the hinges is less than about 0.3 mm thick and about three or less pounds of force is required to lock the first wing and the second wing in the closed, compact position and about six or more pounds of force is required to unlock the first wing and the second wing.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sasso to include that each of the hinges is less than about 0.3 mm thick since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device". Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the assembly of modified Sasso would not operate differently with the claimed thickness and since the hinges are shown to have a thickness, the assembly would function appropriately having the claimed thickness. Further, it appears that Applicant places no criticality on the range claimed (see Specification par. [00061]).
Modified Sasso teaches that the amount of force required to open and close the first wing (Sasso wing 28) and the second wing (Sasso wing 30) needs to be optimized to allow the first wing (Sasso wing 28) and the second wing (Sasso wing 30) to lock to protect the needle (Sasso needle 22) and unlock for use (see Sasso Figs. 1-4, par. [0027] and [0029]; since posts 44/46/48 and apertures 50/52/54 engage to lock the wings 28/30, it would require more force to disengage/unlock the posts 44/46/48 than to lock them). Thus, the amount of force required to open and close the first wing and the second wing is a result effective variable in that changing the amount of force required to open and close the first wing and the second wing affects the ability of the assembly to lock and unlock. Further, it appears that a person of ordinary skill in the art would have had a reasonable expectation of success in modifying the assembly of modified Sasso to open and close with forces within the claimed ranges, as it involves only adjusting components already present. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sasso by adjusting the locking structures such that about three or less pounds of force is required to lock the first wing and the second wing in the closed, compact position and about six or more pounds of force is required to unlock the first wing and the second wing as a matter of routine optimization since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (ССРА 1955). Further, Applicant appears to place no criticality on the values claimed, stating merely that the respective forces have values “such as” those within the claimed ranges (see Specification par. [000162]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sasso (US 2002/0111581 A1) in view of Wu et al. (US 2012/0041253 A1), as applied to claim 25 above, further in view of McCullough et al. (US 2020/0197628 A1).
Regarding claim 10, modified Sasso teaches the assembly of claim 25 substantially as claimed. However, modified Sasso fails to state a ball-and-pivot mechanism to receive a portion of the needle and allow rotation by the needle to reduce forces transmitted to the needle during use of the assembly.
McCullough teaches an assembly (see Figs. 3A and 4, par. [0048]) to deliver a fluid into an anatomic space of a patient (see par. [0031]) comprising a ball-and-pivot mechanism (ball valve, par. [0048]) to receive a portion of the needle (needle 40) and allow rotation by the needle (needle 40) to reduce forces transmitted to the needle (needle 40) during use of the assembly (see par. [0048]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sasso to include a ball-and-pivot mechanism to receive a portion of the needle and allow rotation by the needle to reduce forces transmitted to the needle during use of the assembly, as taught by McCullough, in order to allow the needle to communicate with a fluid source and manipulate the needle to be inserted into the patient through different configurations of drug delivery devices (see McCullough par. [0044] and [0048]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Sasso (US 2002/0111581 A1) in view of Wu et al. (US 2012/0041253 A1), as applied to claim 22 above, further in view of Baid (US 2012/0232500 A1).
Regarding claim 23, modified Sasso teaches the assembly of claim 22 substantially as claimed. However, modified Sasso fails to state a rubber band holding the body in the closed, compact position but not the locked position prior to the insertion.
Baid teaches an assembly (see Figs. 1-2) to deliver fluid into an anatomic space of a patient, comprising a rubber band (tension element 52, see par. [0032]) holding the body (needle guard 26) in the closed, compact position but not the locked position prior to the insertion (see Figs. 1-2, par. [0031]-[0032]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly of modified Sasso to include a rubber band holding the body in the closed, compact position but not the locked position prior to the insertion, as taught by Baid, in order to enclose the first and second extensions and add to the protecting effect of the assembly (see Baid par. [0016] and [0032]).
Response to Arguments
Applicant's arguments filed 10/29/2025 have been fully considered but they are not persuasive.
Applicant argues that Wu fails to teach the amended limitations of “the first recess having a first opening at an end opposite the first longitudinal axis that extends through the outer periphery of the first extension along the second longitudinal axis and the second recess having a second opening at an end opposite the first longitudinal axis that extends through the outer periphery of the second extension along the second longitudinal axis”. The Examiner respectfully disagrees. The limitations “at an end opposite the first longitudinal axis” as recited in the claim may be more broadly interpreted by the Examiner than what the Applicant appears to intend. The Examiner interprets “an end opposite the first longitudinal axis” as an end which is spaced apart/away from the first longitudinal axis, or in other words is not located directly on the first longitudinal axis. It is also noted that “an end” is not limited to “an end of the first recess” or “an end of the second recess”, respectively. “An end” as recited in the claim could be interpreted as an end of some other structure of the assembly which is spaced apart/away from the first longitudinal axis. As shown in Wu, the ends of grooves 211 and 221 which are located closest to the needle body 12 as shown in Fig. 1 have openings extending through the outer periphery of wings 21 and 22 and the positions of these openings are spaced apart/away from the longitudinal axis of needle body 12 such that they read on the aforementioned limitations as currently recited in the claim. Although Wu’s grooves 211 and 221 each have other ends (i.e. the ends of grooves 211 and 221 located furthest from the needle body 12 as shown in Fig. 1) which do not appear to extend through the outer periphery of the wings, the language in the claim does not require these ends to correspond to the ends opposite the first longitudinal axis. Therefore, the Examiner maintains their position that Wu teaches the aforementioned limitations as currently recited.
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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783