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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 7, 2025 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed February 7, 2025 wherein Claims 21, 26, 41, 44, 45, 49, and 50 are amended, Claims 57 – 65 are newly added, Claims 1 – 20 and 32 – 40 are or were previously cancelled, and Claim 31 is previously withdrawn. Therefore, Claims 21 – 31 and 41 – 65 are currently pending within the Application wherein Claim 31 is withdrawn therefrom.
The Applicant’s amendments to the Drawings dated February 7, 2025 are entered by the Examiner. These amendments overcome each Drawing Objection set forth in the Final Rejection dated October 7, 2024. Therefore, each Drawing Objection set forth in the Final Rejection dated October 7, 2024 is withdrawn.
The Applicant’s amendments to the Specification dated February 7, 2025 are entered by the Examiner. These amendments overcome each Specification Objection set forth in the Final Rejection dated October 7, 2024. Therefore, each Specification Objection set forth in the Final Rejection dated October 7, 2024 is withdrawn.
The Applicant’s amendments to the Claims dated February 7, 2025 overcome each Claim Objection set forth in the Final Rejection dated October 7, 2024. Therefore, each Claim Objection set forth in the Final Rejection dated October 7, 2024 is withdrawn.
The Applicant’s amendments to the Claims dated February 7, 2025 overcome each Claim Rejection under 35 U.S.C. § 112(a) set forth in the Final Rejection dated October 7, 2024. Therefore, each Claim Rejection under 35 U.S.C. § 112(a) set forth in the Final Rejection dated October 7, 2024 is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 14 - 15, filed February 7, 2025 with respect to the rejection(s) of claim(s) 21 under 35 U.S.C 102 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 under 35 U.S.C. 102(a)(1) in view of a new interpretation of Neoh et al. (WO 2017/029361 A1) or, in the alternative, under 35 U.S.C. 103 over Woehr et al. (US 2012/0078200 A1).
Claim Objections
Claim 47 is objected to because of the following informalities:
Claim 47 includes two periods directly after the numbering of the claim. The Examiner suggests removing one of the periods as it is believed to be a typographical error.
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.
Claims 21 – 30 and 41 – 65 are 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 21 recites “A sub-assembly for a needle assembly, said sub-assembly comprising: a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub...” Claim 27 recites “The sub-assembly of claim 21, further comprising a catheter hub and a catheter tube and wherein the needle projects through the catheter tube.”
Dependent Claim 27 causes independent Claim 21 to be indefinite because it is unclear what device Claim 21 is attempting to claim. Is Claim 21 claiming only an intermediate sub-assembly or is the claim reciting how the sub-assembly is created with indifference as to whether the sub-assembly is eventually placed within the catheter hub. Said another way is Claim 21 claiming an intermediate product (the sub-assembly) where the final product (the catheter assembly with the sub-assembly placed within the catheter hub) is explicitly not covered by Claim 21? If this is the case, then dependent Claim 27 creates confusion and indefiniteness because Claim 27 positively recites that the sub-assembly further comprises a catheter hub. If it was intended that Claim 21 only be directed towards the sub-assembly then Claims 27 and its dependent claims would need to be cancelled. The subject matter of Claims 21 and 27 could be written in a subcombination – combination claim format wherein the sub-assembly is the subcombination (Claim 27) and the catheter assembly (Claim 21 & Claim 27) comprising the catheter hub and sub-assembly is the combination.
For the purpose of examination, the Examiner has applied two rejections to Claim 21 and its dependents.
If the Applicant intended to claim both the sub-assembly of Claim 21 inserted within the catheter hub of Claim 27 then the phrase “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” will be treated as a product-by-process limitation wherein the patentability of this subject matter is determined based on the product itself and not the method of production (i.e., the location of the assembly of components). The rejection of the product-by-process interpretation will be made under a 35 U.S.C. 102 rejection in view of Neoh et al. (WO 2017/029361) below.
However, if the Applicant intended to claim only the sub-assembly then Claims 27 and its dependents must be cancelled and the phrase “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” will not be treated as a product-by-process limitation. This interpretation of the claim language is rejected under a 35 U.S.C. 103 rejection in view of Neoh et al. (WO 2017/029361) modified in view of Woehr et al. (US 2012/0078200 A1).
Claims 22 – 30 and 41 – 56 are dependent upon Claim 21 and therefore are rejected under 35 U.S.C. 112(b) for the same rationale.
Claim 57 recites “A sub-assembly for a needle assembly, said sub-assembly comprising: a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub…” Claim 58 recites “The sub-assembly of claim 57, wherein the two proximal ends of the two valve opener arms are spaced from one another by a first distance when outside of the catheter hub and by a second distance when located inside of the catheter hub, and wherein the first distance is greater than the second distance.” Claim 61 recites “The sub-assembly of claim 57, further comprising a catheter hub and a catheter tube and wherein the needle is located inside the catheter tube and the valve opener and the needle guard are located in an interior of the catheter hub.”
Dependent Claims 58 and 61 each cause independent Claim 57 to be indefinite because it is unclear what device Claim 57 is attempting to claim. Is Claim 57 claiming only an intermediate sub-assembly or is the claim reciting how the sub-assembly is created with indifference as to whether the sub-assembly is eventually placed within the catheter hub. Said another way is Claim 57 claiming an intermediate product (the sub-assembly) where the final product (the catheter assembly with the sub-assembly placed within the catheter hub) is explicitly not covered by Claim 57? If this is the case, then dependent claims 58 and 61 each create confusion and indefiniteness. Claim 58 requires the valve actuator to be located within the catheter hub and Claim 61 requires the needle to be located within the catheter tube (only possible if inside the catheter hub according to the specification) and the valve opener and the needle guard being located in the catheter hub. Therefore Claims 58 and 61 each contradict the claim language of independent Claim 57. If it was intended that Claim 57 only be directed towards the sub-assembly then Claims 58, 61, and their dependent claims would need to be cancelled. The subject matter of Claims 58, 61, and their dependents could be written in a subcombination – combination claim format wherein the sub-assembly is the subcombination (Claim 58, 61) and the catheter assembly comprising the catheter hub and sub-assembly is the combination (Claims 61, 58, and 61).
For the purpose of examination, the Examiner has applied two rejections to Claim 57 and its dependents.
If the Applicant intended to claim both the sub-assembly of Claim 57 inserted within the catheter hub of either Claim 58 or 61 then the phrase “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” will be treated as a product-by-process limitation wherein the patentability of this subject matter is determined based on the product itself and not the method of production (i.e., the location of the assembly of components). The rejection of the product-by-process interpretation will be made under a 35 U.S.C. 102 rejection in view of Neoh et al. (WO 2017/029361) below.
However, if the Applicant intended to claim only the sub-assembly then Claims 57 and its dependents must be cancelled and the phrase “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” will not be treated as a product-by-process limitation. This interpretation of the claim language is rejected under a 35 U.S.C. 103 rejection in view of Neoh et al. (WO 2017/029361) modified in view of Woehr et al. (US 2012/0078200 A1).
Claims 58 – 65 are dependent upon Claim 57 and therefore are rejected under 35 U.S.C. 112(b) for the same rationale.
Claim 60 recites “the second bridge.” This claim limitation is unclear because it cannot be determined if “the second bridge” is further limiting “the at least one bridge” or if a separate structure not recited. For the purpose of examination, Claim 60 will be interpreted to recite:
The sub-assembly of claim 57, wherein the at least one bridge is a first bridge, and the at least one bridge further comprising a second bridge connected to the two valve opener arms, and wherein the second bridge comprises a seam or is continuously formed without a seam.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 27 – 28, 41 – 45, 47, 54, 58 and 61 – 64 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 21 recites “A sub-assembly for a needle assembly, said sub-assembly comprising: a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub...” Claim 27 recites “The sub-assembly of claim 21, further comprising a catheter hub and a catheter tube and wherein the needle projects through the catheter tube.”
Claim 27 fails to include all of the limitations of the claim upon which it depends because Claim 21 recites that the needle guard, valve actuator, and needle are assembled to one another outside of a catheter hub while Claim 27 requires that the needle projects through the catheter tube which may only be accomplished through the sub-assembly being located inside the catheter hub (see page 48, lines 17 – 29 of the Specification dated June 3, 2021). Therefore, Claim 27 fails to include all of the limitations of the claim upon which it depends because of the inclusion of the catheter hub.
Claims 28, 41 – 45, 47, and 54 are dependent upon claim 27 and therefore are rejected under 35 U.S.C. 112(d) for the same rationale.
Claim 57 recites “A sub-assembly for a needle assembly, said sub-assembly comprising: a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub…” Claim 58 recites “The sub-assembly of claim 57, wherein the two proximal ends of the two valve opener arms are spaced from one another by a first distance when outside of the catheter hub and by a second distance when located inside of the catheter hub, and wherein the first distance is greater than the second distance.”
Claim 58 fails to include all of the limitations of the claim upon which it depends because Claim 57 recites that the needle guard, valve actuator, and needle are assembled to one another outside of a catheter hub while Claim 58 requires that the valve actuator is located inside the catheter hub. Therefore, Claim 58 fails to include all of the limitations of the claim upon which it depends because of the inclusion of the catheter hub.
Claim 57 recites “A sub-assembly for a needle assembly, said sub-assembly comprising: a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub…” Claim 61 recites “The sub-assembly of claim 57, further comprising a catheter hub and a catheter tube and wherein the needle is located inside the catheter tube and the valve opener and the needle guard are located in an interior of the catheter hub.”
Claim 61 fails to include all of the limitations of the claim upon which it depends because Claim 57 recites that the needle guard, valve actuator, and needle are assembled to one another outside of a catheter hub while Claim 61 requires that the needle projects through the catheter tube, which may only be accomplished through the sub-assembly being located inside the catheter hub (see page 48, lines 17 – 29 of the Specification dated June 3, 2021), and the valve opener and the needle guard are located in an interior of the catheter hub. Therefore, Claim 61 fails to include all of the limitations of the claim upon which it depends because of the inclusion of the catheter hub.
Claims 62 - 64 are dependent upon claim 61 and therefore are rejected under 35 U.S.C. 112(d) for the same rationale.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 21 – 30 and 41 – 65 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Neoh et al. (US WO 2017/029361 A1; hereinafter referred to as “Neoh”).
Neoh is cited within the IDS dated October 1, 2021.
As set forth above under 35 U.S.C. 112(b) header above, this 35 U.S.C. 102(a)(1) rejection is under the interpretation that the Applicant intended to claim both the sub-assembly of Claim 21 inserted within the catheter hub of Claim 27. Wherein the phrase “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” will be treated as a product-by-process limitation wherein the patentability of this subject matter is determined based on the product itself and not the method of production (i.e., the location of the assembly of components).
With regards to claim 21, Neoh discloses a sub-assembly (132, 134, 108) for a needle assembly (400), said sub-assembly comprising:
a needle guard (132), a valve actuator (134), and a needle (108) assembled to one another outside of a catheter hub (108) (The claimed phrase “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” read in light of Claim 27 is being treated as a product-by-process limitation. As set forth in MPEP 2113, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of the product does not depend on its method of production. If the product in the product-by-process claim is anticipated by a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to Applicant to show a difference. MPEP 2113. Here, the sub-assembly of Claim 21 is anticipated by the sub-assembly taught by Neoh. Although the sub-assembly of Neoh does not explicitly recite the assembly steps of the needle guard, valve actuator, and needle outside of the catheter hub, a person of ordinary skill in the prior art when reviewing the disclosure of Neoh would recognize that the needle guard, valve actuator, and needle could be capable of being assembled outside of the catheter hub. Since this phrase is treated as a product-by-process claim limitation the location of assembly does not matter so long as the product is capable of being performed by the claimed process, which based on the disclosure of Neoh this assembly location is possible.), and wherein:
the valve actuator (134; see Figs. 15A – 16C) comprises an actuator head (436) comprising a body (430) having a through opening (see at 430 in Fig. 15C), two valve opener arms (152) extending proximally of the body (see Fig. 15A and 15C), and at least one bridge (444) connected to the two valve opener arms (see Fig. 15A and 15C), said at least one bridge comprising a distal edge (446a) and a proximal edge (446b) and has a seam (see the bridge 444 in Figs. 16A – 16C where the bridge comprises a seam at 804) or is continuously formed without a seam (see the bridge 444 in Figs. 11 – 12B and 15A – 15C where the bridge is continuous formed without a seam);
the needle guard (132; see Fig. 7) comprises a proximal wall (280) having a perimeter (282) defining a proximal opening (see at 280 in Fig. 11), two arms (288, 290) extending distally of the proximal wall (see Fig. 9 and Fig. 10A), and an elbow (304; see Fig. 11) on each of the two arms with at least one elbow being positioned distally of the distal edge of the valve actuator (see Figs. 13B – 13C); and
the needle (108) is attached to the needle hub (106), the needle comprises a change in profile (144) located proximally of a needle tip (110) (see Fig. 1) and the needle is located at least partially in the needle guard and partially in the valve actuator (see Fig. 10A and page 67, line 21 – page 68, line 2).
With regards to claim 22, Neoh discloses the claimed invention of claim 21, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) the sub-assembly further comprises a guide tab (442; see Figs. 15A – 15C and 16A – 16C) on each of the two valve opener arms (152).
With regards to claim 23, Neoh discloses the claimed invention of claim 21, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the at least one bridge (see the bridge 444 in Figs. 16A – 16C wherein the bridge comprises a seam at 804) comprises the seam and wherein each of the two valve opener arms (152) comprises a proximal end (824; see Figs. 16A – 16B) and wherein the two proximal ends are spaced from one another a first distance in a first position (see page 71, lines 21 – 29 “the actuating elements 152 are flexible and deflectable so that when pushed by a male Luer tip, the actuating elements [[deflect]] or flex. The actuating elements are deflectable by selecting a material that has the requisite resilient properties...the actuating elements 152 can be flexible and deflectable by selecting a material that has the requisite resilient properties and by incorporating one or more weakened sections” wherein during assembly the actuating elements 152 are deflected or flexed when positioning the needle guard 132 within the valve actuator 134. The ability to flex the actuating elements is due to the material of the actuating elements. The first position is when the actuating elements are deflected or flexed before placing the needle guard 132 within the valve actuator) and spaced from one another a second distance in a second position (see Fig. 16A and 16C and the distance between the proximal ends 824 of each valve opener arm 152. The second position is after placement of the needle guard 132 within the actuating elements 152 and the seam returns to its unflexed or non-deflected position as shown in Figs. 16A – 16C), and wherein the first distance and the second distance are unequal (the first distance is unequal to the second distance because while the two proximal ends are flexed or deflected, the first position, the first distance would be a different distance unequal to when the two proximal ends are unflexed or non-deflected, the second position).
With regards to claim 24, Neoh discloses the claimed invention of claim 23, and Neoh further discloses (Figs. 9 – 12B and 16A – 16C) wherein the first distance is greater than the second distance (as the needle guard 132 is positioned within the valve actuator 134 the proximal ends 824 of each valve opener arm 152 would flex or deflect. The flexing or deflection of the proximal end of each valve opener arm would position the proximal end of each valve opener arm to a first distance that is greater than the second distance when the resilient arms return to their normal unbiased position. The second distance of the proximal ends 824 of each valve opener arm 152 is shown in Fig. 16A – 16C).
With regards to claim 23, Neoh discloses the claimed invention of claim 21, and Neoh further discloses (Figs. 9 – 12B and 16A – 16C) wherein the at least one bridge (see the bridge 444 in Figs. 16A – 16C where the bridge comprises a seam at 804) comprises the seam and wherein each of the two valve opener arms (152) comprises a proximal end (824 see Figs. 16A – 16B) and wherein the two proximal ends are spaced from one another a first distance in a first position (see Fig. 16A and 16C and the distance between the proximal ends 824 of each valve opener arm 152. The first position is after placement of the needle guard 132 within the actuating elements 152 and the seam returns to its unflexed or non-deflected position as shown in Figs. 16A – 16C) and spaced from one another a second distance in a second position (see page 71, lines 21 – 29 “the actuating elements 152 are flexible and deflectable so that when pushed by a male Luer tip, the actuating elements [[deflect]] or flex. The actuating elements are deflectable by selecting a material that has the requisite resilient properties...the actuating elements 152 can be flexible and deflectable by selecting a material that has the requisite resilient properties and by incorporating one or more weakened sections” wherein during assembly the actuating elements 152 are deflected or flexed when positioning the needle guard 132 within the valve actuator 134. The ability to flex the actuating elements is due to the material of the actuating elements. The second position is when the actuating elements are deflected or flexed before placing the needle guard 132 within the valve actuator) and wherein the first distance and the second distance are unequal (the first distance is unequal to the second distance because while the two proximal ends are unflexed or non-deflected, the first position, the first distance would be a different distance unequal to when the two proximal ends are flexed or deflected, the second position)
With regards to claim 25, Neoh discloses the claimed invention of claim 23, and Neoh further discloses (Figs. 9 – 12B and 16A – 16C) wherein the first distance is less than the second distance (when the first position is after the placement of the needle guard 132 within the actuating elements 152 as shown in Figs. 16A – 16C and the second position is when the actuating elements are flexed or deflected to position the needle guard between the actuating elements. The first distance, Figs. 16A – 16C, is less than the second distance because the actuating elements are spread further apart in the second position than in the first position in order to insert the needle guard into the valve actuator).
With regards to claim 26, Neoh discloses the claimed invention of claim 21, and Neoh further discloses (Figs. 9 – 12B and 16A– 16C) wherein the at least one bridge is a first bridge (444) (see at the top 850 in Fig. 16B) (see at the top 728 in Fig. 15B), and wherein the at least one bridge further comprises a second bridge (444) (see at the bottom 850 in Fig. 16B) (see at the bottom 728 in Fig. 15b) connected to the two valve opener arms (152) (see Figs. 15A – 16C), wherein the second bridge comprises a seam (see the bridge 444 in Figs. 16A – 16C where the bridge comprises a seam at 804) or is continuously formed without a seam (see the bridge 444 in Figs. 11 – 12B and 15A – 15C where the bridge is continuously formed without a seam).
With regards to claim 27, Neoh discloses the claimed invention of claim 21, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) the sub-assembly further comprising a catheter hub (102) and a catheter tube (104) and wherein the needle (108) projects through the catheter tube (Fig. 9B – 11).
With regards to claim 28, Neoh discloses the claimed invention of claim 27, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) the sub-assembly further comprising a valve (136) located in an interior of the catheter hub along with the valve actuator and the needle guard (see Fig. 9B – 10B which shows the valve 136, valve actuator 134, and needle guard 132 in an interior of the catheter hub 102).
With regards to claim 29, Neoh discloses the claimed invention of claim 21, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the distal edge (446A) is orthogonal to a lengthwise axis of the valve actuator (134) or angled to the lengthwise axis of the valve actuator (see page 31, lines 22 – 28 “an inside edge, each stabilizer segment can also have two side edges, which can be approximately orthogonal to a lengthwise axis of the valve opener”).
With regards to claim 30, Neoh discloses the claimed invention of claim 29, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the distal edge (446a) and the proximal edge (446b) are parallel to one another (see Figs. 15A – 16C) (see page 33, lines 4 – 8, page 40, lines 3 – 9, page 45, lines 28 – 30, and page 78, lines 19 – 25 “the distal edge 446a and the proximal edge 446b of the upper stabilizer 444 are parallel to each other and the distal edge 446a and the proximal edge 446b of the lower stabilizer 444 are parallel to each other”).
With regards to claim 41, Neoh discloses the claimed invention of claim 28, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the valve (136) comprises a plurality of slits defining a plurality of flaps (see page 55, lines 11 – 30 “the valve 136 embodies a valve disc comprising a valve body comprising a valve diameter, a valve thickness measured orthogonal to the valve diameter, and one or more slits defining two or more flaps”).
With regards to claim 42, Neoh discloses the claimed invention of claim 41, and Neoh further discloses (Figs. 9 – 12B, 14A, and 15A – 16C) wherein the valve (136) comprises a distally facing surface (see at 410 in Fig. 14A) and a proximally facing surface (see opposite side of 410 in Fig. 14A), and at least one of a distal flange (see the flange surrounding 410 in Fig. 14A) defining a circular cavity (see at 410 in Fig. 14A) at the distally facing surface and a proximal flange (see at 612 in Fig. 14A) defining a circular cavity (see a the interior of 412 in Fig. 14A) at the proximally facing surface.
With regards to claim 43, Neoh discloses the claimed invention of claim 27, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the catheter hub (102) comprises a pair of spaced apart grooves (130a, 130; shown in Fig. 10A), and wherein the valve actuator (134) is located in the pair of spaced apart grooves (see Figs. 11 and 12B).
With regards to claim 44, Neoh discloses the claimed invention of claim 27, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein an interior cavity (130) of the catheter hub (102) comprises a projection (452; shown in Fig. 10A) and the seam (see the bridge 444 in Figs. 16A – 16C where the bridge comprises a seam at 804) of the at least one bridge (444) is configured to pass through the projection (see Figs. 11 and 12B and the location of the valve actuator 134 in these figures).
With regards to claim 45, Neoh discloses the claimed invention of claim 27, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the at least one bridge further comprises a second bridge (444) (see at the bottom 728 in Fig. 15B)(see at the bottom 850 in Fig. 16B), wherein the second bridge comprises a distal edge (446a) and a proximal edge (446b) (see page 74, lines 17 – 27 “the distal edge 446a, both stabilizers 444, 444 also have a proximal edge 446b”) and wherein the distal edge of the second bridge is orthogonal to lengthwise axis of the valve actuator or angled to the lengthwise axis of the valve actuator (134) (see page 31, lines 22 – 28 “an inside edge, each stabilizer segment can also have two side edges, which can be approximately orthogonal to a lengthwise axis of the valve opener”).
With regards to claim 46, Neoh discloses the claimed invention of claim 21, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the distal edge (446a) and the proximal edge (446b) (see page 74, lines 17 – 27 “the distal edge 446a, both stabilizers 444, 444 also have a proximal edge 446b) of the at least one bridge (444) are parallel to one another (see Figs. 15A – 16C) (see page 33, lines 4 – 8, page 40, lines 3 – 9, page 45, lines 28 – 30, and page 78, lines 19 – 25 “the distal edge 446a and the proximal edge 446b of the upper stabilizer 444 are parallel to each other and the distal edge 446a and the proximal edge 446b of the lower stabilizer 444 are parallel to each other”).
With regards to claim 47, Neoh discloses the claimed invention of claim 45, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the distal edge (446a) and the proximal edge (446b) of the second bridge (444) (see at the bottom 728 in Fig. 15B)(see at the bottom 850 in Fig. 16B) are parallel to one another (see Figs. 15A – 16C) (see page 33, lines 4 – 8, page 40, lines 3 – 9, page 45, lines 28 – 30, and page 78, lines 19 – 25 “the distal edge 446a and the proximal edge 446b of the upper stabilizer 444 are parallel to each other and the distal edge 446a and the proximal edge 446b of the lower stabilizer 444 are parallel to each other”).
With regards to claim 48, Neoh discloses the claimed invention of claim 21, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein an upper surface (see at 444 in Fig. 15C) (see at 456 in Fig. 16C) of the at least one bridge (444) comprises a flat planar surface or a curved surface (see Figs. 15A – 15C which shows the upper surface at 444 in Fig. 15A being a curved surface) (see Figs. 16A – 16C which shows the upper surface at 444 in Fig. 16C being a curved surface).
With regards to claim 49, Neoh discloses the claimed invention of claim 24, and Neoh further discloses (Figs. 9 – 12B and 16A – 16C) wherein the first distance is measured outside of the catheter hub (the claim language of “wherein the first distance is measured outside of the catheter hub” constitutes functional claim language. MPEP 2111.04. The claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Neoh meets the structural limitations of the claim, and is capable of being manipulated such that the first distance is greater than the second distance and the first distance is measured outside of the catheter hub. The at least one bridge 444 comprises a non-continuous ring or a seam. Page 74, line 28 – page 75, line 11 of Neoh. The at least one bridge is also connected to the two valve opener arms. Therefore, the two proximal ends are capable of being spaced from one another such that the first distance is greater than the second distance and the first distance is measured outside of the catheter hub by manipulating and moving the two valve opener arms such that the at least one bridge comprising the non-continuous ring or a seam expand or contract in differing positions. See page 71, lines 21 – 29, page 74, line 28 – 75, line 11 and shown in Figs. 13B – 13C and 16A – 16C of Neoh.).
With regards to claim 50, Neoh discloses the claimed invention of claim 25, and Neoh further discloses (Figs. 9 – 12B and 16A – 16C) wherein the second distance is measured outside of the catheter hub (the claim language of “wherein the second distance is measured outside of the catheter hub” constitutes functional claim language. MPEP 2111.04. The claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Neoh meets the structural limitations of the claim, and is capable of being manipulated such that the first distance is less than the second distance and the second distance is measured outside of the catheter hub. The at least one bridge 444 comprises a non-continuous ring or a seam. Page 74, line 28 – page 75, line 11 of Neoh. The at least one bridge is also connected to the two valve opener arms. Therefore, the two proximal ends are capable of being spaced from one another such that the first distance is less than the second distance and the second distance is measured outside of the catheter hub by manipulating and moving the two valve opener arms such that the at least one bridge comprising the non-continuous ring or a seam expand or contract in differing positions. See page 71, lines 21 – 29, page 74, line 28 – 75, line 11 and shown in Figs. 13B – 13C and 16A – 16C of Neoh.).
With regards to claim 51, Neoh discloses the claimed invention of claim 21, and Neoh further discloses (Figs. 9 – 12B and 16A – 16C) the at least one bridge (444) comprises a first partial bridge (810) having a radial end surface at the seam (see at 810 in Fig. 16A and page 85, lines 1 - 8) and a second partial bridge (812) having a radial end surface at the seam (see at 812 in Fig. 16A and page 85, lines 1 – 8).
With regards to claim 52, Neoh discloses the claimed invention of claim 51, and Neoh further discloses (Figs. 9 – 12B and 16A – 16C) wherein the radial end surface (see at 810 in Fig. 16A) of the first partial bridge (810) and the radial end surface (see at 812 in Fig. 16B) of the second bridge (812) are spaced from one another by a gap (see Figs. 18A – 18C).
With regards to claim 53, Neoh discloses the claimed invention of claim 51, and Neoh further discloses (Figs. 9 – 12B and 16A – 16C) wherein the radial end surface (see at 810 in Fig. 16B) of the first partial bridge (810) and the radial end surface (see at 812 in Fig. 16B) of the second partial bridge (812) contact one another (the claim language of “wherein the radial end surface of the first partial bridge and the radial end surface of the second partial bridge contact one another” constitutes functional claim language. MPEP 2111.04. The claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Neoh meets the structural limitations of the claim, and is capable of being manipulated such that the radial end surface of the first partial bridge and the radial end surface of the second partial bridge contact one another. The at least one bridge 444 comprises a non-continuous ring or a seam. The at least one bridge is also connected to the two valve opener arms. Therefore, the radial end surface of the first partial bridge and the radial end surface of the second bridge are capable contacting one another by manipulating and moving the two valve opener arms such that the at least one bridge comprising the non-continuous ring or a seam expand or contract in differing positions. See Figs. 16A – 16C, page 32, line 28 – 29, page 35, line 25 – page 36, line 3, page 85, lines 1 – 17, and page 88, lines 23 – page 89, line 2).
With regards to claim 54, Neoh discloses the claimed invention of claim 43, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the valve actuator (134) comprises a pair of tabs (442), and wherein each one of the pair of tabs is located in one of the pair of spaced apart grooves (130a, 130; shown in Fig. 10A) (see Figs. 10A – 10B which show the pair of tabs 442 located in one of the pair of spaced apart grooves 130a, 130 because they are located within the groove 130).
With regards to claim 55, Neoh discloses the claimed invention of claim 21, and, Neoh further discloses (Figs. 9 – 12B and 15A – 16C) the at least one bridge (444) comprises only one bridge (see page 73, lines 3 – 11 “In some embodiments, there may be one, three, or a different number of actuating elements or stabilizers 444”).
With regards to claim 56, Neoh discloses the claimed invention of claim 26, and Neoh further discloses (Figs. 9 – 12B and 15A– 16C) wherein each of the first bridge (444) (see at top 850 in Fig. 16b)(see at top 728 in Fig. 15B) and the second bridge (444) (see at bottom 850 in Fig. 16B)(see at the bottom 728 in Fig. 15B) comprises a flat planar outer surface (see at 456 in Fig. 16C) (see at 444 in Fig. 15B)
As set forth above under 35 U.S.C. 112(b) header above, this 35 U.S.C. 102(a)(1) rejection is under the interpretation that the Applicant intended to claim both the sub-assembly of Claim 57 inserted within the catheter hub of Claims 58 or 61. Wherein the phrase “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” will be treated as a product-by-process limitation wherein the patentability of this subject matter is determined based on the product itself and not the method of production (i.e., the location of the assembly of components).
With regards to claim 57, Neoh discloses a sub-assembly (132, 134, 108) for a needle assembly (400), said sub-assembly comprising:
a needle guard (132), a valve actuator (134), and a needle (108) assembled to one another outside of a catheter hub (102) (The claimed phrase “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” read in light of Claims 58 or 61 is being treated as a product-by-process limitation. As set forth in MPEP 2113, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of the product does not depend on its method of production. If the product in the product-by-process claim is anticipated by a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to Applicant to show a difference. MPEP 2113. Here, the sub-assembly of Claim 57 is anticipated by the sub-assembly taught by Neoh. Although the sub-assembly of Neoh does not explicitly recite the step of assembling the needle guard, valve actuator, and needle to one another outside of the catheter hub, a person of ordinary skill in the prior art when reviewing the disclosure of Neoh would recognize that the needle guard, valve actuator, and needle could be capable of being assembled outside of the catheter hub. Since this phrase is treated as a product-by-process claim limitation the location of assembly does not matter so long as the product is capable of being performed in the claimed process which based on the disclosure of Neoh this assembly location is possible.), and wherein:
the valve actuator (134; see Figs. 15A – 16C) comprises an actuator head (436) comprising a body (430) having a through opening (see at 430 in Fig. 15C), two valve opener arms (152) extending proximally of the body (see Fig. 15A and 15C), and at least one bridge (444) connected to the two valve opener arms (see Fig. 15A and 15C), said at least one bridge comprising a distal edge (446a) and a proximal edge (446b) and has a seam (see the bridge 444 in Figs. 16A – 16C where the bridge comprises a seam at 804) or is continuously formed without a seam (see the bridge 444 in Figs. 11 – 12B and 15A – 15C where the bridge is continuous formed without a seam) and each of the two valve opener arms comprising a proximal end to define two proximal ends (824; see Figs. 16A – 16B);
the needle guard (132; see Fig. 7) comprises a proximal wall (280) having a perimeter (282) defining a proximal opening (see at 280 in Fig. 11), two arms (288, 290) extending distally of the proximal wall (see Fig. 9 and Fig. 10A), and an elbow (304; see Fig. 11) on each of the two arms; and
the needle (108) is attached to a needle hub (106), the needle comprising a needle tip (110) at a distal end of a needle shaft (see Fig. 1 at 110); and
the elbow of at least one of the two arms is located distally of the distal edge of the valve actuator (see Figs. 13B – 13C) and the needle is located in the proximal opening of the needle guard and in the through opening of the valve actuator (see Fig. 10A, page 67, line 21 – page 68, line 2 ).
With regards to claim 58, Neoh discloses the claimed invention of claim 57, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the two proximal ends (824; see Figs. 16A – 16B) of the two valve opener arms (152) are spaced from one another by a first distance when outside of the catheter hub (see page 71, lines 21 – 29 “the actuating elements 152 are flexible and deflectable so that when pushed by a male Luer tip, the actuating elements [[deflect]] or flex. The actuating elements are deflectable by selecting a material that has the requisite resilient properties...the actuating elements 152 can be flexible and deflectable by selecting a material that has the requisite resilient properties and by incorporating one or more weakened sections” wherein during assembly the actuating elements 152 are deflected or flexed when positioning the needle guard 132 within the valve actuator 134. The ability to flex the actuating elements is due to the material the actuating elements comprise wherein this flexing of the actuating elements could occur outside of the catheter hub) and by a second distance when located inside of the catheter hub (see Fig. 16A and 16C and the second distance between the proximal ends 824 of each valve opener arm 152 when these arms are unflexed.), and wherein the first distance is greater than the second distance (the claim language of “wherein the first distance is greater than the second distance” constitutes functional claim language. MPEP 2111.04. The claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Neoh meets the structural limitations of the claim, and is capable of being manipulated such that the first distance is greater than the second distance. The at least one bridge 444 comprises a non-continuous ring or a seam. Page 74, line 28 – page 75, line 11 of Neoh. The at least one bridge is also connected to the two valve opener arms. Therefore, the two proximal ends are capable of being spaced from one another such that the first distance is greater than the second distance by manipulating and moving the two valve opener arms such that the at least one bridge comprising the non-continuous ring or a seam expand or contract in differing positions. See page 71, lines 21 – 29, page 74, line 28 – 75, line 11 and shown in Figs. 13B – 13C and 16A – 16C of Neoh.).
With regards to claim 59, Neoh discloses the claimed invention of claim 57, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the at least one bridge (444) comprises the seam (see at 810 in Fig. 16A and page 85, lines 1 - 8) and wherein each of the two valve opener arms (152) comprises part (810, 812) of the at least one bridge (see Fig. 16A and page 85, lines 1 – 8).
With regards to claim 60, Neoh discloses the claimed invention of claim 57, and Neoh further discloses (Figs. 9 – 12B and 15A– 16C) wherein the at least one bridge is a first bridge (444) (see at top 850 in Fig. 16b)(see at top 728 in Fig. 15B), and further comprising a second bridge (444) (see at bottom 850 in Fig. 16B)(see at the bottom 728 in Fig. 15B) connected to the two valve opener arms (152) (see Figs. 15A – 16C), and wherein the second bridge comprises a seam (see the bridge 444 in Figs. 16A – 16C where the bridge comprises a seam at 804) or is continuously formed without a seam (see the bridge 444 in Figs. 11 – 12B and 15A – 15C where the bridge is continuously formed without a seam).
With regards to claim 61, Neoh discloses the claimed invention of claim 57, and Neoh further discloses (Figs. 9 – 12B and 15A– 16C) the sub-assembly further comprises a catheter hub (102) and a catheter tube (104) and wherein the needle (108) is located inside the catheter tube (see Figs. 9B – 11) and the valve opener (134) and the needle guard (132) are located in an interior (130) of the catheter hub (see Fig. 11).
With regards to claim 62, Neoh discloses the claimed invention of claim 61, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) the sub-assembly further comprising a valve (136) located in the interior (130) of the catheter hub (102) along with the valve actuator (134) and the needle guard (132) (see Fig. 11)
With regards to claim 63, Neoh discloses the claimed invention of claim 62 , and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein the valve (136) comprises a plurality of slits defining a plurality of flaps (see page 55, lines 11 – 30 “the valve 136 embodies a valve disc comprising a valve body comprising a valve diameter, a valve thickness measured orthogonal to the valve diameter, and one or more slits defining two or more flaps”).
With regards to claim 64, Neoh discloses the claimed invention of claim 63, and Neoh further discloses (Figs. 9 – 12B, 14A, and 15A – 16C) wherein the valve (136) comprises a distally facing surface (see at 410 in Fig. 14A) and a proximally facing surface (see opposite side of 410 in Fig. 14A), and at least one of a distal flange (see the flange surrounding 410 in Fig. 14A) defining a circular cavity (see at 410 in Fig. 14A) located at the distally facing surface and a proximal flange (see at 612 in Fig. 14A) defining a circular cavity (see a the interior of 412 in Fig. 14A) located at the proximally facing surface.
With regards to claim 65, Neoh discloses the claimed invention of claim 57, and Neoh further discloses (Figs. 9 – 12B, 14A, and 15A – 16C) wherein the needle shaft comprises a crimp (144) located proximally of the needle tip (110) (see page 51, lines 11 – 25 and Fig. 1).
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) 21 – 30 and 41 – 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neoh modified in view of Woehr et al. (US 2012/0078200 A1; hereinafter referred to as “Woehr”).
Neoh is cited within the IDS dated October 1, 2021.
As set forth above under 35 U.S.C. 112(b) header above, this 35 U.S.C. 103 rejection is under the interpretation that the Applicant intended to claim only the sub-assembly of Claim 21. Wherein the phrase “a needle guard, a v