DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 30 January 2026. The Examiner acknowledges the amendments to claims 1 and 9-11. Claims 1-20 are pending.
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 .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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) 11-17 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mijers (US-20160129181-A1, previously presented).
Regarding claim 11, Mijers teaches
A flow restriction device, comprising:
a flow insert comprising a fluid passage extending therethrough, the fluid passage comprising a first segment formed by an outer surface of the flow insert, and a second segment formed by an inner surface of the flow insert [support structure 45 (Mijers Figs. 3-6); a support structure 45 separately molded and installed in the cavity 28 to be held between upper and lower cavity walls on peripheral crenellated flanges 43 which abut the upper cavity wall and lower cavity wall while providing for the passage of fluid between crenellations (Mijers ¶0049); see also Annotated Fig. 1 below];
a resilient valve comprising a first end engaged against the outer surface of the flow insert, the first end having an inner portion aligned with the second segment of the fluid passage, and an outer portion aligned with the first segment of the fluid passage [elastomeric diaphragm 24 (Mijers Figs. 2, 4-6); see also Annotated Fig. 1], and an aperture that extends through the resilient valve, from the first end to a second end of the resilient valve [at least one passage of passages 38 (Mijers Figs. 2, 4-6)];
wherein the inner portion of the resilient valve is flexible, relative to the flow insert [a flexible valve element, such as an elastomeric diaphragm 24, for example, fabricated of injection molded silicone rubber or the like (Mijers ¶0046)] such that in a first configuration of the resilient valve, the inner portion is spaced apart from the flow insert by a first distance to permit a fluid to move from the first segment to the second segment of the fluid passage [see Mijers Fig. 6, wherein as depicted, the identified inner portion of the elastomeric diaphragm 24 (resilient valve) is spaced apart from the identified first segment], and in a second orientation of the resilient valve, the inner portion is spaced apart from the flow insert by a second distance to resist movement of the fluid from the first segment to the second segment of the fluid passage [see Mijers Fig. 4, wherein as depicted, the identified inner portion of the elastomeric diaphragm 24 (resilient valve) is spaced apart from the identified first segment by a second distance (of zero), such that no flow path from the first segment and the segment is defined].
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Annotated Fig. 1. The Examiner has annotated Fig. 6 of Mijers to identify the portions of support structure 45 [flow insert] considered to read on the claimed first segment [depicted as being formed by an outer surface of support structure 45 and defining a portion of a fluid passage of the support structure based on the fluid path of Fig. 6] and second segment [depicted as being formed by an inner surface of the support structure 45 and defining a portion of the fluid passage of the support structure based on the fluid path of Fig. 6] of the flow insert, as well as the portions of elastomeric diaphragm 24 [resilient valve] considered to read on the claimed first end and second end of the diaphragm 24. The Examiner notes that as depicted in Mijers Fig. 6, the identified first end of the diaphragm 24 [depicted as facing the lower end 12] defines a portion engaged against the outer surface of the support structure 45 to define an outer portion aligned with the first segment of the fluid passage [see Mijers Fig. 4, which is considered to depict the identified outer portion engaged against the outer surface of the support structure 45], wherein a portion of the first end of diaphragm 24 defining a center of the first end [the Examiner notes that as depicted in at least Mijers Fig. 2, the diaphragm 24 is circular, such that the portion of diaphragm 24 identified as the outer portion is considered to encircle an inner portion, based on the broadest reasonable interpretation of “inner” referring to “being near a center especially of influence” (https://www.merriam-webster.com/dictionary/inner)] is considered to be axially aligned with the second segment along an axis 30 of the device of Mijers.
Regarding claim 12, Mijers teaches
The flow restriction device of Claim 11, wherein the second segment of the fluid passage defines an axis therethrough, and the first segment of the fluid passage extends around the axis [wherein as depicted in Mijers Fig. 4, the identified first segment of the support structure 45 extends around axis 30].
Regarding claim 13, Mijers teaches
The flow restriction device of Claim 11, wherein the first segment of the fluid passage extends radially outward in a spiral direction away from the second segment of the fluid passage [see Annotated Fig. 2 below].
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Annotated Fig. 2. The Examiner has annotated Fig. 3 of Mijers to indicate how the first segment of the fluid passage [valve seat 46] is considered extend radially outward in a spiral direction [see arrow indicating radial spiral direction, wherein the Examiner notes that “spiral” does not limit any particular structure and merely limits the radial direction] from the second segment of the fluid passage [see also perspective of Mijers Figs. 4-5 and Annotated Fig. 1, which are considered to depict the first segment of the fluid passage extending radially outward].
Regarding claim 14, Mijers teaches
The flow restriction device of Claim 11, wherein the first segment of the fluid passage is formed by a channel that extends into the outer surface of the flow insert [see channel defined between raised valve seats 44 and 46 as depicted in Mijers Fig. 3].
Regarding claim 15, Mijers teaches
The flow restriction device of Claim 14, wherein the outer surface of the flow insert extends along a plane that is transverse relative to an axis through the second segment of the fluid passage [wherein as depicted in Mijers Fig. 4, the outer surface of the support structure 45 extends along a plane transverse to axis 30].
Regarding claim 16, Mijers teaches
The flow restriction device of Claim 11, wherein the flow insert comprises a groove that extends into the outer surface of the flow insert, between the first and second segments of the fluid passage [see groove defined between raised valve seats 44 and 46 as depicted in Mijers Fig. 3].
Regarding claim 17, Mijers teaches
The flow restriction device of Claim 11, wherein the first end of the resilient valve forms a convex surface along the inner portion, and the second end of the resilient valve forms a concave surface along the inner portion [wherein as depicted in Mijers Fig. 6 and Annotated Fig. 1, the first end of diaphragm 24 forms a convex surface along the inner portion and the second end forms a concave surface along the inner portion].
Regarding claim 19, Mijers teaches
The flow restriction device of Claim 11, wherein the aperture of the resilient valve is aligned with the first segment of the fluid passage [wherein the at least one passage of passages 38 are considered to define a fluid pathway along the identified first segment of Annotated Fig. 1, such that the aperture is considered to be aligned with the first segment].
Regarding claim 20, Mijers teaches
The flow restriction device of Claim 11, wherein the resilient valve comprises an alignment ridge that extends from the first end in a direction away from the second end [outer peripheral region 32 (Mijers Figs. 2, 4-5); see Annotated Fig. 5].
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mijers (US-20160129181-A1, previously presented) in view of Brignola (US-4244378-A, previously presented).
Regarding claim 1, Mijers teaches
A flow restriction device, comprising:
a proximal housing portion comprising a first end portion forming a proximal port, a second end portion, and a passage extending through the first and second end portions [upper end 16 of bidirectional valve 10 (Mijers Figs. 4-6); An upper end 16 of the bidirectional valve 10 may provide for a needle-free luer connector 18 such as a female luer lock or luer slip connector that may receive a corresponding connector 20 of a syringe 22, for example, for flushing, sampling or aspiration. Alternatively, the upper end 16 may receive a corresponding connector of an IV bag, infusion pump, or the like (not shown) (Mijers ¶0044); see also Annotated Fig. 3];
a distal housing portion comprising a first end portion, a second end portion forming a distal port, and a passage extending through the first and second end portions [lower end 12 of bidirectional valve 10 (Mijers Figs. 4-6); The lower end 12 of the bidirectional valve 10 may provide for a standard needle-free tubing connector 17, as known in the art, providing, for example, a tube of the flexible catheter 14 with a frustoconical outer surface receiving the IV line and expanding it into a barbed collar around the tube (Mijers ¶0043); see also Annotated Fig. 3];
a flow insert positioned in a cavity formed between the proximal housing and the distal housing, the flow insert comprising a fluid passage extending therethrough, the fluid passage comprising a first segment formed by an outer surface of the flow insert, and a second segment formed by an inner surface of the flow insert [support structure 45 (Mijers Figs. 3-6); a support structure 45 separately molded and installed in the cavity 28 to be held between upper and lower cavity walls on peripheral crenellated flanges 43 which abut the upper cavity wall and lower cavity wall while providing for the passage of fluid between crenellations (Mijers ¶0049); see also Annotated Fig. 1];
a resilient valve positioned between the outer surface of the flow insert and the distal housing, the resilient valve comprising a first end having an inner portion and an outer portion, the inner portion aligned with the second segment of the fluid passage of the flow insert, and the outer portion aligned with the first segment of the fluid passage of the flow insert [elastomeric diaphragm 24 (Mijers Figs. 2, 4-6); see also Annotated Fig. 1], and the resilient valve forming portion of a fluid flow path between the distal housing portion and the proximal housing portion [see apertures 38 of elastomeric diaphragm 24 and fluid flow path of Mijers Fig. 6];
wherein the inner portion of the resilient valve is flexible, relative to the proximal housing [a flexible valve element, such as an elastomeric diaphragm 24, for example, fabricated of injection molded silicone rubber or the like (Mijers ¶0046)], such that in a first position of the resilient valve, the inner portion is spaced apart from the flow insert by a first distance to permit a fluid to move from the first segment to the second segment of the fluid passage [see Mijers Fig. 6, wherein as depicted, the identified inner portion of the elastomeric diaphragm 24 (resilient valve) is spaced apart from the identified first segment], and in a second position, the inner portion is spaced apart from the flow insert by a second distance to resist movement of the fluid from the first segment to the second segment of the fluid passage [see Mijers Fig. 4, wherein as depicted, the identified inner portion of the elastomeric diaphragm 24 (resilient valve) is spaced apart from the identified first segment by a second distance (of zero), such that no flow path from the first segment and the segment is defined].
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Annotated Fig. 3. The Examiner has annotated Fig. 4 of Mijers to indicate the respective first end portions and second end portions of each of the proximal housing portion and the distal housing portion; wherein the Examiner notes that based on the annotation, the first end portion and second end portion of the proximal housing portion are considered to define a passage extending therethrough [lower channel 50], and the first end portion and second end portion of the distal housing portion are considered to define a passage extending therethrough [upper channel 48].
However, Mijers fails to explicitly disclose wherein the proximal housing portion is an individual proximal housing and wherein the distal housing portion is an individual housing.
Brignola discloses a flow restriction device comprising separate proximal housing and distal housing structures defining a cavity therebetween [the assembly is generally designated by the numeral 22 and comprises a housing or casing 24 having a valve chamber 26 therein and a disc-like valve element 28 actuatable between a closed position (FIG. 4) blocking flow between the inlet side and the outlet side and an open, depressed position (FIG. 5) permitting flow from the inlet to the outlet side around the valve element 28. In the present instance the housing or casing 24 is a two-piece assembly comprising inner and outer sections 24a and 24b which may be assembled together in the manner shown by a press fit (Brignola Col 4:48-58, Fig. 4)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Mijers to employ wherein the proximal housing portion is an individual proximal housing and wherein the distal housing portion is an individual housing, as this modification would amount to merely making a structure separable [In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (MPEP § 2144.04(V)(C))].
Regarding claim 2, Mijers in view of Brignola teaches
The flow restriction device of Claim 1, wherein the second segment of the fluid passage defines an axis therethrough, and the first segment of the fluid passage extends around the axis [wherein as depicted in Mijers Fig. 4, the identified first segment of the support structure 45 extends around axis 30].
Regarding claim 3, Mijers in view of Brignola teaches
The flow restriction device of Claim 1, wherein the first segment of the fluid passage extends radially outward in a spiral direction away from the second segment of the fluid passage [see Annotated Fig. 2].
Regarding claim 4, Mijers in view of Brignola teaches
The flow restriction device of Claim 1, wherein the first segment of the fluid passage is formed by a channel that extends into the outer surface of the flow insert [see channel defined between raised valve seats 44 and 46 as depicted in Mijers Fig. 3].
Regarding claim 5, Mijers in view of Brignola teaches
The flow restriction device of Claim 4, wherein the outer surface of the flow insert extends along a plane that is transverse relative to an axis through the second segment of the fluid passage [wherein as depicted in Mijers Fig. 4, the outer surface of the support structure 45 extends along a plane transverse to axis 30].
Regarding claim 6, Mijers in view of Brignola teaches
The flow restriction device of Claim 1, wherein the flow insert comprises a groove that extends into the outer surface of the flow insert, between the first and second segments of the fluid passage [see groove defined between raised valve seats 44 and 46 as depicted in Mijers Fig. 3].
Regarding claim 7, Mijers in view of Brignola teaches
The flow restriction device of Claim 1, wherein the first end of the resilient valve forms a convex surface along the inner portion, and a second end of the resilient valve forms a concave surface along the inner portion [wherein as depicted in Mijers Fig. 6 and Annotated Fig. 1, the first end of diaphragm 24 forms a convex surface along the inner portion and the second end forms a concave surface along the inner portion].
Subject Matter Not Taught By Prior Art
Claim(s) 8-10 and 18 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record of regarding the subject matter of claims 8-10 and 18 is Mijers (US-20160129181-A1, previously presented) as applied above.
However, the Examiner notes that Mijers fails to explicitly disclose, teach, or suggest the subject matter regarding the aperture as positioned through the outer portion [see claims 8-9 and 18], as the particular interpretation of Mijers as applied in the § 102 and § 103 rejections above identifies the portion of the elastomeric diaphragm 24 of Mijers where an aperture of apertures 38 is positioned as being the inner portion. Furthermore, Mijers fails to explicitly disclose, teach, or suggest the subject matter regarding an alignment ridge that extends from the first end in a direction toward the flow insert [see claim 10], as the particular interpretation of Mijers as applied in the § 102 and § 103 rejections above identifies the mounting rim 40 as the alignment ridge [in at least claim 20], which is depicted as extending from the first end in a direction away from the second end [Mijers Figs. 4-6]. Due to the particular functionality and structure of Mijers, it would not have been obvious to one of ordinary skill in the art to have modified Mijers to employ the limitations identified as not being taught by Mijers without the benefit of hindsight.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 6, filed 30 January 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections for reference character(s) not mentioned in the description have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6, with respect to the previously presented claim objections have been fully considered and are persuasive. The objection to claim 11 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 6, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejection of claim 10 under § 112(b) has been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 7-11, with respect to the previously applied rejections of claim 11 and those dependent therefrom under § 102 and claim 1 and those dependent therefrom under § 103 have been fully considered but they are not persuasive.
Regarding claims 11 and 1, the Applicant asserts that Mijers fails to disclose or teach each and every feature of claims 11 and 1, particularly with respect to at least the features in which the “inner portion of the resilient valve is flexible, relative to the flow insert such that in a first orientation of the resilient valve, the inner portion is spaced apart from the flow insert by a first distance to permit a fluid to move from the first segment to the second segment of the fluid passage, and in a second orientation of the resilient valve, the inner portion is spaced apart from the flow insert by a second distance to resist movement of the fluid from the first segment to the second segment of the fluid passage”. However, the Examiner disagrees that Mijers fails to disclose or teach each and every feature of claim 11 and 1, as the Examiner presents a new interpretation of Mijers [see Annotated Fig. 1 above], wherein elements of Mijers are considered to read on the argued limitation in which the inner portion of the resilient valve is flexible, relative to the flow insert such that in a first orientation of the resilient valve, the inner portion is spaced apart from the flow insert by a first distance to permit a fluid to move from the first segment to the second segment of the fluid passage [see Mijers Fig. 6, wherein as depicted, the identified inner portion of the elastomeric diaphragm 24 (resilient valve) is spaced apart from the identified first segment], and in a second orientation of the resilient valve, the inner portion is spaced apart from the flow insert by a second distance to resist movement of the fluid from the first segment to the second segment of the fluid passage [see Mijers Fig. 4, wherein as depicted, the identified inner portion of the elastomeric diaphragm 24 (resilient valve) is spaced apart from the identified first segment by a second distance (of zero), such that no flow path from the first segment and the segment is defined].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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