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 regards to the Applicant’s amendment filed 15 December 2025 wherein Claims 27, 28, 47, 58, 61, and 62 are amended, Claims 1 – 20 and 31 – 40 are or previously were cancelled, Claim 66 is newly added. Therefore, Claims 21 – 30 and 41 – 66 are currently pending.
The Applicant’s amendment to the Claims dated 15 December 2025 has overcome each Claim Objection set forth in the Non-Final Rejection dated 13 June 2025 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant's arguments filed 15 December 2025 (hereinafter referred to as the “Remarks”) have been fully considered but they are not persuasive.
Rejection of Claims 21 – 30 and 41 – 65 under 35 U.S.C. § 112(b)
The Applicant’s argument pertaining to the 35 U.S.C. § 112(b) rejection set forth in the Non-Final Rejection is unpersuasive. See pages 9 – 12 of the Remarks. The Applicant alleges that claim 21 recites a sub-assembly that is formed outside of a catheter hub but does not prohibit its placement in a catheter hub after being formed, as required by claim 27. The Examiner finds this argument to be unpersuasive because Claim 21 and Claim 27 recite different scopes that are mutually exclusive.
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, wherein the sub-assembly is located inside the catheter hub, after being assembled outside of the catheter hub, and wherein the catheter hub comprises a catheter tube and wherein the needle projects through the catheter tube.” Claims 21 and 27 are indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Is the invention the sub-assembly assembled outside of the catheter hub (Claim 21) or is the invention the catheter assembly once the sub-assembly has been placed inside the catheter hub (claim 27)? Under the current claim construction, an ordinary artisan would not be able to determine whether the claimed invention is the sub-assembly or the catheter assembly. Therefore, the 35 U.S.C. § 112(b) rejection is maintained.
The Applicant’s analogy to the claimed sub-assembly being analogous to claiming a leg for a chair and then calling out the leg of the chair being part of the chair is also unpersuasive. See page 12 of the Remarks. The same indefiniteness that applies to the current claims would apply to the Applicant’s analogy. If an independent claim recites a leg of a chair specifically separate and unassembled from the remainder of the chair but then a dependent claim recites that the leg of the chair is then assembled with the remainder of the chair, then what is actually being claimed? The leg in a state independent, unassembled from the chair or the leg when assembled with the chair? These scopes and states of assembly are mutually exclusive and cannot coexist.
The Examiner’s argument pertaining to the 35 U.S.C. § 112(b) rejection in view of the indefiniteness of Claims 21 and 27 is repeated and realleged for Claims 57, 58, and 61.
For the aforementioned rationale, the 35 U.S.C. § 112(b) rejection of Claims 21 – 30 and 41 – 65 is maintained.
Rejection of Claims 27, 28, 41 – 45, 47, 54, 61 – 64 under 35 U.S.C. § 112(d)
The Applicant’s argument pertaining to the 35 U.S.C. § 112(d) rejection set forth in the Non-Final Rejection is unpersuasive. See pages 12 – 14 of the Remarks. The Applicant alleges that Claim 27 is not inconsistent with claim 21 and further limits claim 21 by calling out the state of the sub-assembly being inside a catheter hub during a later time sequence. The Examiner respectfully disagrees.
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, wherein the sub-assembly is located inside the catheter hub, after being assembled outside of the catheter hub, and wherein the catheter hub comprises 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 sub-assembly is located inside the catheter hub. When the sub-assembly is located inside the catheter hub, as required by Claim 27, the required limitation of “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub,” as required by Claim 21 is not met. Therefore, Claim 27 fails to include all of the limitations of the claim upon which it depends. The state of the sub-assembly in these claims are mutually exclusive and cannot coexist. The state required for Claim 21 (i.e., the assembling of the sub-assembly outside the catheter hub) cannot exist with the state required for Claim 27 (the sub-assembly being inserted assembled within the catheter hub). Therefore, Claim 27 is rejected for being in improper dependent form for failing to include all the limitations of the claim upon which it depends.
The Applicant’s analogy to the claimed sub-assembly being analogous to claiming a leg for a chair and then calling out the leg of the chair being part of the chair is also unpersuasive. See page 13 of the Remarks. The independent claim of a leg separate from the remaining components of a chair cannot then be further limited by reciting that the leg is assembled with the chair. These claims recite mutually exclusive limitations. How could the leg be both separate from the remaining components of the chair and assembled with the remaining components of the chair? The independent claim reciting that the leg is separate from the remaining components of the chair directly contradicts the dependent claim reciting that the leg is assembled with the other remaining components of the chair.
The Examiner’s argument pertaining to the 35 U.S.C. § 112(d) rejection in view of the improper dependency of Claim 27 is repeated and realleged for Claims 58 and 61.
For the aforementioned rationale, the 35 U.S.C. § 112(d) rejection of Claims 27 – 28, 41 – 45, 47, 54, 58, and 61 – 64 is maintained.
Rejection of Claims 21 – 30 and 41 – 65 as anticipated under 35 U.S.C. § 102(a)(1) in view of Neoh et al. (WO 2017/029361 A1).
The Applicant’s argument that the Office’s “product-by-process” construction of Claim 21 is improper is unpersuasive. See page 14 of the Remarks.
Claim 21 recites “said sub-assembly comprising: a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub.” This claim limitation is attempting to claim the product of a sub-assembly via the process in which it is assembled rather than the product structure itself. "[E]ven 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 a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); MPEP 2113(I).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding "interbonded by interfusion" to limit structure of the claimed composite and noting that terms such as "welded," "intermixed," "ground in place," "press fitted," and "etched" are capable of construction as structural limitations). See also In re Nordt Dev. Co., 881 F.3d 1371,1375-76, 125 USPQ2d 1817, 1820 (Fed. Cir. 2018)(holding "the specification demonstrates that ‘injected molded’ connotes an integral structure," and discussing several cases since Garnero that held "limitations to convey structure even when they also describe a process of manufacture"); MPEP 2113(I).
The structure implied by the process step of “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” would not be expected to impart distinctive structural characteristics to the final product. The process step provides no structure that would be imparted but rather only limits the location of assembly.
The Applicant’s argument that the Office did not once consider the specification in reaching its “product-by-process” limitation is also unpersuasive. See pages 14 – 15 of the Remarks. The Applicant’s Specification, including the Specification passages recited by the Applicant within pages 10 – 12 of the Remarks, lacks any disclosure, teaching, or suggestion that this process step conveys any structure that imparts a distinctive structural characteristic to the final product.
The Applicant’s argument that the Office failed to cite a single functional language in Claim 21 that would cause the “product-by-process” construction is also unpersuasive. See page 15 of the Remarks. The Office specifically identified the product-by-process limitation to be the claim language of “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” a plurality of times within the Non-Final Rejection. See pages 5, 10, and 11 of the Non-Final Rejection.
In view of the foregoing reasons, the Office maintains that the limitation “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” is a product-by-process limitation.
The Applicant’s further arguments that Neoh fails to disclose the claimed sub-assembly in the configuration recited outside or prior to installing into a catheter hub is unpersuasive. See pages 16 and 17 of the Remarks. Based on the aforementioned reasons, the limitation “ a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” 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. Therefore, the Applicant’s arguments that Neoh does not anticipate the claimed sub-assembly of Claim 21 is unpersuasive.
Regarding Claim 57, the Office refers the Applicant to the 35 U.S.C. § 102 rebuttal argument for Claim 21 above. The same arguments for Claim 21 are reiterated and repeated for Claim 57. The claim language of “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” of Claim 57 is treated as a product-by-process limitation which Neoh anticipates similar to the previous rebuttal argument pertaining to Claim 21.
As each of the Applicant’s arguments regarding Claims 21 – 30 and 41 – 65 are found to be unpersuasive, the Office maintains the 35 U.S.C. § 102 rejection of Claims 21 – 30 and 41 – 65 as being anticipated under Neoh.
Rejection of Claims 21 – 30 and 41 – 65 under 35 U.S.C. § 103 as obvious over Neoh in view of Woehr (US 2012/0078200)
If it is determined that the process step of “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” does impart distinctive structural characteristics to the final product, then the Examiner had also provided a 35 U.S.C. § 103 rejection of Claims 21 – 30 and 41 – 65 as obvious over Neoh in view of Woehr. The Examiner maintains the 35 U.S.C. § 103 rejection and finds the Applicant’s arguments pertaining to the 35 U.S.C. § 103 Rejection to be unpersuasive.
In response to Applicant’s argument, see page 19 of the Remarks, that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Although Neoh does not use the term “sub-assembly” within its disclosure. Neoh discloses each of the claimed components comprising the sub-assembly within its disclosure. For example, Neoh discloses a needle guard 132, a valve actuator 134, and a needle 108. See page 51 of Neoh. Neoh further discloses that the needle guard 132 and valve actuator can be assembled outside of a catheter hub 102 based on what is shown in Figures 13B – 13C. Neoh is only silent with regards to assembling the needle with the needle guard and valve actuator outside of the catheter hub.
Nonetheless Woehr teaches assembling the needle guard 120 over the needle 16 prior to sliding the needle guard and needle into the catheter hub 26. See [0098] and [0099] of Woehr. When read together, a person having ordinary skill in the art would recognize that the needle guard, a valve actuator, and the needle could be assembled to one another outside of a catheter hub. This conclusion of obvious took into account only knowledge which was known within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from the Applicant’s disclosure because the knowledge was gleaned from the disclosure, teachings, and suggestions of Neoh and Woehr. Therefore, the Applicant’s hindsight reasoning argument is unpersuasive.
Furthermore, the Office Action also does not violate 35 U.S.C. § 132 for failing to provide a sufficient Office Action that informs the Applicant why the claims are rejected. See page 20 – 21 of the Remarks. Figures 13A – 13C of Woehr disclose the needle guard 132 and valve actuator 134 being assembled to one another outside of a catheter hub 102. The Applicant alleges that Figures 13A – 13C can only be read as depicting an alternative valve opener without its surrounding for clarity. See page 20 of the Remarks. However, nowhere in Neoh is this supported within the disclosure. Rather, this is the Applicant’s opinion about what is shown in these figures.
Page 78, line 26 – page 79, line 26 of Woehr recites that these figures show a perspective view of a valve actuator 134 embodiment. This embodiment is separate and distinct from the actuator 134 shown in Figures 1 – 4 and 10A - 12B. Figures 13A – 13B teaches the needle guard 132 and actuator 134 being assembled outside of the catheter hub 102 because these figures do not include the catheter hub 102 within them. Therefore, the Office Action is fully compliant with 35 U.S.C. § 132 because the Office Action includes the stated the reasons for the rejection together with such information as may be useful in judging of the propriety of continuing the prosecution of the application.
Regarding Claim 57, the Office refers the Applicant to the 35 U.S.C. § 103 rebuttal argument for Claim 21 above. The same arguments for Claim 21 are repeated and reiterated for Claim 57.
As each of the Applicant’s arguments regarding Claims 21 – 30 and 41 – 65 are found to be unpersuasive, the Office maintains the 35 U.S.C. § 103 rejection of Claims 21 – 30 and 41 – 65 as being obvious under Neoh in view of Woehr.
New Claim 66
Regarding Claim 66, the Examiner refers the Applicant to the 35 U.S.C. § 102 rejection of Claims 21 and 57 rebuttal argument above and the 35 U.S.C. § 103 rejection of Claims 21 and 57 rebuttal argument above. Claim 66 is rejected for the same rationale as provided above regarding Claims 21 and 57.
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 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, wherein the sub-assembly is located inside the catheter hub, after being assembled outside of the catheter hub, and wherein the catheter hub comprises 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 is located inside the 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 A1) 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 A1) 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 the sub-assembly is outside of the catheter hub and by a second distance when the sub-assembly is located inside of the catheter hub, after being assembled outside of the catheter hub, and wherein the first distance is greater than the second distance.” Claim 61 recites “The sub-assembly of claim 57, wherein the needle is located inside a catheter tube and the valve opener and the needle guard are located in an interior of the catheter hub, after being assembled outside 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 A1) 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 A1) 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 “wherein the at least one bridge is a first bridge, and further comprising a second bridge.” It is unclear what is further comprising “a second bridge.” Does the “at least one bridge” further comprise the second bridge or is the second bridge not one of the at least one bridge?
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, wherein the sub-assembly is located inside the catheter hub, after being assembled outside of the catheter hub, and wherein the catheter hub comprises 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 sub-assembly is located inside the catheter hub. When the sub-assembly is located inside the catheter hub, as required by Claim 27, the required limitation of “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub,” as required by Claim 21 is not met. Therefore, Claim 27 fails to include all of the limitations of the claim upon which it depends.
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 the sub-assembly is outside of the catheter hub and by a second distance when the sub-assembly is located inside of the catheter hub, after being assembled outside 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 sub-assembly is located inside the catheter hub. When the sub-assembly is located inside the catheter hub, as required by Claim 58, the required limitation of “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub,” as required by Claim 57 is not met. Therefore, Claim 58 fails to include all of the limitations of the claim upon which it depends.
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, wherein the needle is located inside a catheter tube and the valve opener and the needle guard are located in an interior of the catheter hub, after being assembled outside 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 the sub-assembly is located inside the catheter hub When the sub-assembly is located inside the catheter hub, as required by Claim 61, the required limitation of “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub,” as required by Claim 57 is not met.. 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 – 66 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Neoh et al. (WO 2017/029361 A1; hereinafter referred to as “Neoh”).
Neoh is cited within the IDS dated October 1, 2021.
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 (102) (The claimed phrase “a needle guard, a valve actuator, and a needle assembled to one another outside of a catheter hub” 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) wherein the sub-assembly is located inside the catheter hub (102), after being assembled outside of the catheter hub (see the rejection of Claim 1 above wherein the assembly process step is being treated as a product-by-process limitation), and wherein the catheter hub comprises 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) wherein a valve (136) is 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)
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” 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 the sub-assembly is 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 the sub-assembly is 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.), after being assembled outside of the catheter hub, and wherein the first distance is greater than the second distance (this claim language 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 two proximal ends of the two valve opener arms are spaced from one another by a first distance when the sub-assembly is outside of the catheter hub and by a second distance when the sub-assembly is located inside of the catheter hub, after being assembled outside of the catheter hub, and wherein 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) wherein the needle (108) is located inside a 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, after being assembled outside of the catheter hub (see Fig. 11) (see the rejection of Claim 1 above wherein the assembly step is being treated as a product-by-process limitation).
With regards to claim 62, Neoh discloses the claimed invention of claim 61, and Neoh further discloses (Figs. 9 – 12B and 15A – 16C) wherein a valve (136) is 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).
With regards to claim 66, 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” 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 Figures 15A – 15C) comprises an actuator head (436) comprising a body (430) having a through opening (see at 430 in Figure 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 Figures 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 continuously 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 a needle hub (106), the needle comprises a shaft (see at 108 in Fig. 1) with a change in profile (144) located proximally of a needle tip (110) (see Fig. 1) at a distal end (see Fig. 1) of the shaft and the needle is located in the proximal opening of the needle guard and partially in the valve actuator (see Fig. 10A and page 67, line 21 – page 68, line 2).
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 – 66 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”).
Woehr is cited in the Notice of References Cited form dated 13 June 2025.
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) and a valve actuator (134), assembled to one another outside of a catheter hub (102) (see Figs. 13B – 13C), 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 continuously 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).
However Neoh is silent with regards to a needle guard, a valve actuator, and a needle being assembled to one another outside of a catheter hub.
Nonetheless Woehr, which is within the analogous art of intravenous catheters (see abstract and title), teaches assembling the needle guard (120) over the needle (16) prior to forming a change in profile (138) along the needle shaft (see [0098] “sliding the needle guard 120 over the sharpened tip 18 of the needle 16 before the crimp 138 is formed in the needle 16”and [0099] “Next, the needle 16, having the needle guard 120 thereon, is slid into the catheter hub 26 such that the sharpened tip 18 of the needle 16 enters the catheter 24.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle of the sub-assembly of Neoh in view of a teaching of Woehr such that the needle guard, the valve actuator, and the needle being assembled to one another outside of a catheter hub. Here Neoh already teaches the needle guard and valve actuator assembled to one another prior to insertion in the catheter hub. Woehr teaches assembling the needle guard to the needle prior to inserting the needle within the catheter hub. Combining these two references teachings together teaches the needle guard, the valve actuator, and the needle being assembled to one another outside of the catheter hub. One of ordinary skill in the art would have been motivated to make this modification because Woehr teaches this assembly step as a method for assembling the needle and needle guard in order to automatically prevent accidental or inadvertent contact with the needle tip after use (see [0010] of Woehr).
The sub-assembly of Neoh modified in view of a teaching of Woehr will hereinafter be referred to as the sub-assembly of Neoh and Woehr.
With regards to claim 22, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 21, and Neoh further teaches the sub-assembly further comprising 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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 21, and Neoh further teaches 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 the actuating elements comprise. 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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 23, and Neoh further teaches (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. Wherein 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. 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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 21, and Neoh further teaches (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 the actuating elements comprise. 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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 23, and Neoh further teaches (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 as the flexed or deflected position would create a first distance that is less than the second distance).
With regards to claim 26, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 21, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 21, and Neoh further teaches (Figs. 9 – 12B and 15A – 16C) wherein the sub-assembly is located inside the catheter hub (102), after being assembled outside of the catheter hub (see the rejection of Claim 1 above where the assembly step is taught to occur outside the catheter hub prior to placement of the sub-assembly inside the catheter hub) and wherein the catheter hub comprises a catheter tube (104) and wherein the needle (108) projects through the catheter tube (Fig. 9B – 11).
With regards to claim 28, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 27, and Neoh further teaches (Figs. 9 – 12B and 15A – 16C) wherein a valve (136) is 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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 21, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 29, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 28, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 41, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 27, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 27, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 27, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 21, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 45, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 21, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 24, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 25, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr discloses the claimed invention of claim 21, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches 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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 51, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 43, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 21, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 26, and Neoh further teaches (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)
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) and a valve actuator (134), assembled to one another outside of a catheter hub (102) (see Figs. 13B – 13C), 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 ).
However Neoh is silent with regards to a needle guard, a valve actuator, and a needle being assembled to one another outside of a catheter hub.
Nonetheless Woehr, which is within the analogous art of intravenous catheters (see abstract and title), teaches assembling the needle guard (120) over the needle (16) prior to forming a change in profile (138) along the needle shaft (see [0098] “sliding the needle guard 120 over the sharpened tip 18 of the needle 16 before the crimp 138 is formed in the needle 16”and [0099] “Next, the needle 16, having the needle guard 120 thereon, is slid into the catheter hub 26 such that the sharpened tip 18 of the needle 16 enters the catheter 24.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle of the sub-assembly of Neoh in view of a teaching of Woehr such that the needle guard, the valve actuator, and the needle being assembled to one another outside of a catheter hub. Here Neoh already teaches the needle guard and valve actuator assembled to one another prior to insertion in the catheter hub. Woehr teaches assembling the needle guard to the needle prior to inserting the needle within the catheter hub. Combining these two references teachings together teaches the needle guard, the valve actuator, and the needle being assembled to one another outside of the catheter hub. One of ordinary skill in the art would have been motivated to make this modification because Woehr teaches this assembly step as a method for assembling the needle and needle guard in order to automatically prevent accidental or inadvertent contact with the needle tip after use (see [0010] of Woehr).
The sub-assembly of Neoh modified in view of a teaching of Woehr will hereinafter be referred to as the sub-assembly of Neoh and Woehr.
With regards to claim 58, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 57, and Neoh further teaches (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 the sub-assembly is 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 the sub-assembly is 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.), after being assembled outside of the catheter hub, and wherein the first distance is greater than the second distance (this claim language 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 two proximal ends of the two valve opener arms are spaced from one another by a first distance when the sub-assembly is outside of the catheter hub and by a second distance when the sub-assembly is located inside of the catheter hub, after being assembled outside of the catheter hub, and wherein 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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 57, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 57, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 57, and Neoh further teaches (Figs. 9 – 12B and 15A– 16C) wherein the needle (108) is located inside a 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, after being assembled outside of the catheter hub (see Fig. 11) (see the rejection of Claim 1 above where the assembly step is taught to occur outside the catheter hub).
With regards to claim 62, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 61, and Neoh further teaches (Figs. 9 – 12B and 15A – 16C) wherein a valve (136) is 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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 62 , and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 63, and Neoh further teaches (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, the sub-assembly of Neoh and Woehr teaches the claimed invention of claim 57, and Neoh further teaches (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).
With regards to claim 66, Neoh discloses a sub-assembly (132, 134, 108) for a needle assembly (400), said sub-assembly comprising:
a needle guard (132) and a valve actuator (134) assembled to one another outside of a catheter hub (102) (see Figures 13B – 13C), and wherein:
the valve actuator (134; see Figures 15A – 15C) comprises an actuator head (436) comprising a body (430) having a through opening (see at 430 in Figure 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 Figures 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 continuously 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 a needle hub (106), the needle comprises a shaft (see at 108 in Fig. 1) with a change in profile (144) located proximally of a needle tip (110) (see Fig. 1) at a distal end (see Fig. 1) of the shaft and the needle is located in the proximal opening of the needle guard and partially in the valve actuator (see Fig. 10A and page 67, line 21 – page 68, line 2).
However Neoh is silent with regards to a needle guard, a valve actuator, and a needle being assembled to one another outside of a catheter hub.
Nonetheless Woehr, which is within the analogous art of intravenous catheters (see abstract and title), teaches assembling the needle guard (120) over the needle (16) prior to forming a change in profile (138) along the needle shaft (see [0098] “sliding the needle guard 120 over the sharpened tip 18 of the needle 16 before the crimp 138 is formed in the needle 16”and [0099] “Next, the needle 16, having the needle guard 120 thereon, is slid into the catheter hub 26 such that the sharpened tip 18 of the needle 16 enters the catheter 24.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the needle of the sub-assembly of Neoh in view of a teaching of Woehr such that the needle guard, the valve actuator, and the needle being assembled to one another outside of a catheter hub. Here Neoh already teaches the needle guard and valve actuator assembled to one another prior to insertion in the catheter hub. Woehr teaches assembling the needle guard to the needle prior to inserting the needle within the catheter hub. Combining these two references teachings together teaches the needle guard, the valve actuator, and the needle being assembled to one another outside of the catheter hub. One of ordinary skill in the art would have been motivated to make this modification because Woehr teaches this assembly step as a method for assembling the needle and needle guard in order to automatically prevent accidental or inadvertent contact with the needle tip after use (see [0010] of Woehr).
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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
09/24/2026
